DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to because:
Reference characters “6”, “7”, “8”, and “9” are not found in the specification (Figs 3B-1 and 3B-2).
Figs 5, 6, 8A-8B, 12A-12D, 13A-13D, 14A-14D, 15A-15D, 16A-16D, 17A-17D, 18A-18D, and 19A-19D lack clear, distinct, sufficient dark lines that are adequate for reproduction. It is noted that photographs are ordinarily not permitted unless it is the only practicable medium for illustrating the claimed invention. See 37 CFR 1.84(b) and (l) for more details.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The use of all of the names of the drugs in parentheses (paragraph 0063), “Sensirion” (paragraph 00103), “Bluetooth” (paragraphs 00114 and 00170), “Milliplex” (paragraphs 00195 and 00204), “Millipore” (paragraphs 00195 and 00204), which are trade names or marks used in commerce, have been noted in this application. Each term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (paragraph 00181). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Claims 21, 30, 31, 35-38, and 40 are objected to because of the following informalities:
The phrase “A droplet device” should be changed to –A droplet delivery device—for consistency with the rest of the claims (Claim 21, Line 1).
The phrase “claim 29” should have a comma afterward for consistency (Claim 30, Line 1).
The phrase “claim 29” should have a comma afterward for consistency (Claim 31, Line 1).
The numbering of Claim 35 should be corrected by adding a period after “35” to correct the typographical error (Claim 35, Line 1).
The phrase “the reservoir” should be changed to –the fluid reservoir—for consistency (Claim 35, Line 1).
The phrase “the reservoir” should be changed to –the fluid reservoir—for consistency (Claim 36, Line 1).
The phrase “the reservoir” should be changed to –the fluid reservoir—for consistency (Claim 37, Line 1).
The phrase “claim 29” should have a comma afterward for consistency (Claim 40, Line 1).
Claims 35 and 38 are objected for being dependent on canceled Claim 1. For examination purposes, Claims 35 and 38 will be interpreted as being dependent on Claim 21.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21, 27, 28, 34, 38, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Germinario et al. (US 2017/0319796 A1).
Regarding Claim 21, Germinario discloses a droplet device (apparatus of Figs 2A-2D) for treating pulmonary conditions (delivering precise and repeatable dosages to a subject for pulmonary use, Abstract) comprising: a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); an aperture plate (108, Fig 2A) in fluid communication with the fluid reservoir (108 communicating with 110, Fig 2A); and a piezoelectric actuator (106, Fig 2A) directly or indirectly coupled to the aperture plate (106 coupled to 108, Fig 2A), wherein the piezoelectric actuator indirectly oscillates the aperture plate to produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (will energize the piezoelectric actuator 106 to vibrate the aperture plate 108 to cause an ejected stream of droplets to be ejected through the aperture plate 108 in a predefined direction, paragraph 0097; the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100).
Regarding Claim 27, Germinario discloses a housing (116, Fig 2A) within which the aperture plate and actuator are configured in an in-line arrangement along the airflow path through the housing (108 and 106 are along the housing 116 and are in an in-line arrangement with the airflow path through housing, Figs 1A and 2A).
Regarding Claim 28, Germinario discloses a mouthpiece at an airflow exit of the housing (154, Fig 2C; mouthpiece closest to user’s mouth, Fig 1A).
Regarding Claim 34, Germinario discloses the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a). It is noted that Applicant has not specified the particular direction of the droplets when ejected into the airflow.
Regarding Claim 38, Germinario discloses the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015).
Regarding Claim 39, Germinario discloses the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Germinario et al. (US 2017/0319796 A1) alone.
Regarding Claim 35, Germinario discloses the claimed invention of Claim 21. The current embodiment of Germinario fails to disclose the reservoir comprises an internal flexible membrane separating a first background pressure fluid volume from a second drug volume.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, Germinario discloses the claimed invention of Claim 28. The current embodiment of Germinario fails to disclose the reservoir comprises an internal flexible membrane separating a first background pressure fluid volume from a second drug volume.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Claims 22-24, 29-31, 37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Germinario et al. (US 2017/0319796 A1) in view of Surber (US 2015/0196543 A1).
Regarding Claim 22, Germinario discloses the claimed invention of Claim 21. Germinario also discloses the droplet delivery devices of the disclosure may be used to treat various diseases, disorders and conditions by delivering therapeutic agents to the pulmonary system of a subject (paragraph 0071). Germinario fails to disclose the fluid reservoir includes a fluid including a cancer therapeutic.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer. There is nothing structurally in Germinario that would prevent the utilization of the cancer therapeutics.
Regarding Claim 23, Germinario-Surber combination teaches the cancer therapeutic comprises a chemotherapeutic agent (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, Germinario-Surber combination teaches the cancer therapeutic includes a chemotherapeutic agent selected from the group consisting of paclitaxel, doxorubicin, gemcitabine, cisplatin, carboplatin, and combinations thereof (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, Germinario discloses the claimed invention of Claim 28. Germinario also discloses the droplet delivery devices of the disclosure may be used to treat various diseases, disorders and conditions by delivering therapeutic agents to the pulmonary system of a subject (paragraph 0071). Germinario fails to disclose the fluid reservoir includes a fluid including a cancer therapeutic.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer. There is nothing structurally in Germinario that would prevent the utilization of the cancer therapeutics.
Regarding Claim 30, Germinario-Surber combination teaches the cancer therapeutic comprises a chemotherapeutic agent (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, Germinario-Surber combination teaches the cancer therapeutic includes a chemotherapeutic agent selected from the group consisting of paclitaxel, doxorubicin, gemcitabine, cisplatin, carboplatin, and combinations thereof (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, Germinario-Surber combination teaches the claimed invention of Claim 29. The current Germinario-Surber combination fails to teach the reservoir comprises an internal flexible membrane separating a first background pressure fluid volume from a second drug volume.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, Germinario-Surber combination teaches the mouthpiece is removably coupled with the device (Germinario: aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108).
Claims 25, 26, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Germinario et al. (US 2017/0319796 A1) and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1).
Regarding Claim 25, Germinario-Surber combination teaches the claimed invention of Claim 22. Germinario-Surber combination fails to teach the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors, and combinations thereof.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, Germinario-Surber combination teaches the claimed invention of Claim 22. Germinario-Surber combination fails to teach the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab, Nivolumab, Atezolizumab, Avelumab, Durvalumab, and Ipilimumab, and combinations thereof.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, Germinario-Surber combination teaches the claimed invention of Claim 29. Germinario-Surber combination fails to teach the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors, and combinations thereof.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, Germinario-Surber combination teaches the claimed invention of Claim 29. Germinario-Surber combination fails to teach the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab, Nivolumab, Atezolizumab, Avelumab, Durvalumab, and Ipilimumab, and combinations thereof.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, and 13 of U.S. Patent No. 9956360 B2, hereafter ‘360, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘360 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘360-Germinario combination teaches all of the claimed invention (‘360: Claim 1).
Regarding Claim 28, ‘360-Germinario combination teaches all of the claimed invention (‘360: Claim 1).
Regarding Claim 34, ‘360-Germinario combination teaches all of the claimed invention (‘360: Claim 2).
Regarding Claim 35, the current ‘360-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current ‘360-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘360-Germinario combination teaches all of the claimed invention (‘360: Claim 10).
Regarding Claim 39, ‘360-Germinario combination teaches all of the claimed invention (‘360: Claim 13).
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13 of U.S. Patent No. 9956360 B2, hereafter ‘360, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘360-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘360-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘360-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘360-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘360-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘360-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘360-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘360-Germinario-Surber combination teaches all of the claimed invention (‘360: Claim 13).
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9956360 B2, hereafter ‘360, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘360-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘360-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘360-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘360-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 10, 17, 19 of U.S. Patent No. 10449314 B2, hereafter ‘314, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘314 discloses most of the claimed invention (Claim 1, Claim 16) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘314-Germinario combination teaches all of the claimed invention (‘314: Claim 1, Claim 16).
Regarding Claim 28, ‘314-Germinario combination teaches all of the claimed invention (‘314: Claim 1, Claim 16).
Regarding Claim 34, ‘314-Germinario combination teaches all of the claimed invention (‘314: Claim 10).
Regarding Claim 35, the current ‘314-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current ‘314-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘314-Germinario combination teaches all of the claimed invention (‘314: Claim 6, Claim 17).
Regarding Claim 39, ‘314-Germinario combination teaches all of the claimed invention (‘314: Claim 9, Claim 19).
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 16, and 19 of U.S. Patent No. 10449314 B2, hereafter ‘314, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘314-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘314-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘314-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘314-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘314-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘314-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘314-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘314-Germinario-Surber combination teaches all of the claimed invention (‘314: Claim 9, Claim 19).
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of U.S. Patent No. 10449314 B2, hereafter ‘314, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘314-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘314-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘314-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘314-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 12 of U.S. Patent No. 10525220 B2, hereafter ‘220, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘220 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘220-Germinario combination teaches all of the claimed invention (‘220: Claim 1).
Regarding Claim 28, ‘220-Germinario combination teaches all of the claimed invention (‘220: Claim 1).
Regarding Claim 34, the current ‘220-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘220-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '220-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘220-Germinario combination teaches all of the claimed invention (‘220: Claim 8).
Regarding Claim 39, ‘220-Germinario combination teaches all of the claimed invention (‘220: Claim 12).
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12 of U.S. Patent No. 10525220 B2, hereafter ‘220, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘220-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘220-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘220-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘220-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘220-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘220-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘220-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘220-Germinario-Surber combination teaches all of the claimed invention (‘220: Claim 12).
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10525220 B2, hereafter ‘220, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘220-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘220-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘220-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘220-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 12, 16 of U.S. Patent No. 10898666 B2, hereafter ‘666, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘666 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘666-Germinario combination teaches all of the claimed invention (‘666: Claim 1).
Regarding Claim 28, ‘666-Germinario combination teaches all of the claimed invention (‘666: Claim 1).
Regarding Claim 34, ‘666-Germinario combination teaches all of the claimed invention (‘666: Claim 6).
Regarding Claim 35, the current ‘666-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '666-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘666-Germinario combination teaches all of the claimed invention (‘666: Claim 12).
Regarding Claim 39, ‘666-Germinario combination teaches all of the claimed invention (‘666: Claim 16).
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16 of U.S. Patent No. 10898666 B2, hereafter ‘666, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘666-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘666-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘666-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘666-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘666-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘666-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘666-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘666-Germinario-Surber combination teaches all of the claimed invention (‘666: Claim 16).
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10898666 B2, hereafter ‘666, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘666-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘666-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘666-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘666-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 of U.S. Patent No. 11285283 B2, hereafter ‘283, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘283 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘283-Germinario combination teaches all of the claimed invention (‘283: Claim 1).
Regarding Claim 28, ‘283-Germinario combination teaches all of the claimed invention (‘283: Claim 1).
Regarding Claim 34, ‘283-Germinario combination teaches all of the claimed invention (‘283: Claim 2).
Regarding Claim 35, the current ‘283-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '283-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, the current ‘283-Germinario combination fails to teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, the current ‘283-Germinario combination fails to teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11285283 B2, hereafter ‘283, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘283-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘283-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘283-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘283-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘283-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘283-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘283-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, the current ‘283-Germinario combination fails to teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11285283 B2, hereafter ‘283, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘283-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘283-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘283-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘283-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 15, 17, 18, 20 of U.S. Patent No. 9962507 B2, hereafter ‘507, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘507 discloses most of the claimed invention (Claim 1, Claim 17) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘507-Germinario combination teaches all of the claimed invention (‘507: Claim 1).
Regarding Claim 28, ‘507-Germinario combination teaches all of the claimed invention (‘507: Claim 1).
Regarding Claim 34, ‘507-Germinario combination teaches all of the claimed invention (‘507: Claim 10, Claim 15).
Regarding Claim 35, the current ‘507-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '507-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘507-Germinario combination teaches all of the claimed invention (‘507: Claim 6, Claim 18).
Regarding Claim 39, ‘507-Germinario combination teaches all of the claimed invention (‘507: Claim 9, Claim 20).
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9, 17, 20 of U.S. Patent No. 9962507 B2, hereafter ‘507, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘507-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘507-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘507-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘507-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘507-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘507-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘507-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘507-Germinario-Surber combination teaches all of the claimed invention (‘507: Claim 9, Claim 20).
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9962507 B2, hereafter ‘507, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘507-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘507-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘507-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘507-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12569627 B2, hereafter ‘627, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘627 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘627-Germinario combination teaches all of the claimed invention (‘627: Claim 1).
Regarding Claim 28, ‘627-Germinario combination teaches all of the claimed invention (‘627: Claim 1).
Regarding Claim 34, the current ‘627-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘627-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '627-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘627-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘627-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12569627 B2, hereafter ‘627, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘627-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘627-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘627-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘627-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘627-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘627-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘627-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘627-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12569627 B2, hereafter ‘627, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘627-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘627-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘627-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘627-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12521498 B2, hereafter ‘498, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘498 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘498-Germinario combination teaches all of the claimed invention (‘498: Claim 1).
Regarding Claim 28, ‘498-Germinario combination teaches all of the claimed invention (‘498: Claim 1).
Regarding Claim 34, the current ‘498-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘498-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '498-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘498-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘498-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12521498 B2, hereafter ‘498, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘498-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘498-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘498-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘498-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘498-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘498-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘498-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘498-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12521498 B2, hereafter ‘498, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘498-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘498-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘498-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘498-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26 of U.S. Patent No. 12564690 B2, hereafter ‘690. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘690 discloses all of the claimed invention (Claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26).
Regarding Claim 27, ‘690 discloses all of the claimed invention (Claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26).
Regarding Claim 28, ‘690 discloses all of the claimed invention (Claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26).
Regarding Claim 39, ‘690 discloses all of the claimed invention (Claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26).
Claims 34, 35, 36, 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26 of U.S. Patent No. 12564690 B2, hereafter ‘690, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 34, the current ‘690-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘690-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '690-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘690-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Claims 22-24, 29-31, 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26 of U.S. Patent No. 12564690 B2, hereafter ‘690, as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘690 does not disclose the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘690-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘690-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘690 does not disclose the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘690-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘690-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 40, ‘690-Surber combination teaches all of the claimed invention (‘690: Claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26).
Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7, 12-14, 16, 18, 19, 21, 25, and 26 of U.S. Patent No. 12564690 B2, hereafter ‘690, and Surber (US 2015/0196543 A1) as applied to Claim 29, and in further view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 37, ‘690-Surber combination fails to teach all of the claimed invention.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12564690 B2, hereafter ‘690, and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘690-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘690-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘690-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘690-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 19 of U.S. Patent No. 12491324 B2, hereafter ‘324, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘324 discloses most of the claimed invention (Claim 1, Claim 19) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘324-Germinario combination teaches all of the claimed invention (‘324: Claim 1, Claim 19).
Regarding Claim 28, ‘324-Germinario combination teaches all of the claimed invention (‘324: Claim 1, Claim 19).
Regarding Claim 34, ‘324-Germinario combination teaches all of the claimed invention (‘324: Claim 3, Claim 4).
Regarding Claim 35, the current ‘324-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '324-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘324-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘324-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 19 of U.S. Patent No. 12491324 B2, hereafter ‘324, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘324-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘324-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘324-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘324-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘324-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘324-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘324-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘324-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 19 of U.S. Patent No. No. 12491324 B2, hereafter ‘324, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘324-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘324-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘324-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘324-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 of U.S. Patent No. 11285274 B2, hereafter ‘274, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘274 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘274-Germinario combination teaches all of the claimed invention (‘274: Claim 1).
Regarding Claim 28, ‘274-Germinario combination teaches all of the claimed invention (‘274: Claim 1).
Regarding Claim 34, ‘274-Germinario combination teaches all of the claimed invention (‘274: Claim 6).
Regarding Claim 35, the current ‘274-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '274-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘274-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘274-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11285274 B2, hereafter ‘274, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘274-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘274-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘274-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘274-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘274-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘274-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘274-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘274-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11285274 B2, hereafter ‘274, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘274-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘274-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘274-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘274-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, and 10 of U.S. Patent No. 11285284 B2, hereafter ‘284, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘284 discloses most of the claimed invention (Claims 1, 9, 10) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘284-Germinario combination teaches all of the claimed invention (‘284: Claims 1, 9, 10).
Regarding Claim 28, ‘284-Germinario combination teaches all of the claimed invention (‘284: Claims 1, 9, 10).
Regarding Claim 34, ‘284-Germinario combination teaches all of the claimed invention (‘284: Claim 6).
Regarding Claim 35, the current ‘284-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '284-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘284-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘284-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10 of U.S. Patent No. 11285284 B2, hereafter ‘284, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘284-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘284-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘284-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘284-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘284-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘284-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘284-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘284-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10 of U.S. Patent No. 11285284 B2, hereafter ‘284, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘284-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘284-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘284-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘284-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 of U.S. Patent No. 11285285 B2, hereafter ‘285, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘285 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘285-Germinario combination teaches all of the claimed invention (‘285: Claim 1).
Regarding Claim 28, ‘285-Germinario combination teaches all of the claimed invention (‘285: Claim 1).
Regarding Claim 34, ‘285-Germinario combination teaches all of the claimed invention (‘285: Claim 5).
Regarding Claim 35, the current ‘285-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '285-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘285-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘285-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11285285 B2, hereafter ‘285, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘285-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘285-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘285-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘285-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘285-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘285-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘285-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘285-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11285285 B2, hereafter ‘285, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘285-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘285-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘285-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘285-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10, 14, 23, 25 of U.S. Patent No. 11738158 B2, hereafter ‘158, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘158 discloses most of the claimed invention (Claims 1, 14) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘158-Germinario combination teaches all of the claimed invention (‘158: Claims 1, 14).
Regarding Claim 28, ‘158-Germinario combination teaches all of the claimed invention (‘158: Claims 1, 14).
Regarding Claim 34, ‘158-Germinario combination teaches all of the claimed invention (‘158: Claims 1, 14).
Regarding Claim 35, the current ‘158-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '158-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘158-Germinario combination teaches all of the claimed invention (‘158: Claims 8, 23).
Regarding Claim 39, ‘158-Germinario combination teaches all of the claimed invention (‘158: Claims 10, 25).
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 14, 25 of U.S. Patent No. 11738158 B2, hereafter ‘158, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘158-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘158-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘158-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘158-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘158-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘158-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘158-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘158-Germinario-Surber combination teaches all of the claimed invention (‘158: Claims 10, 25).
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 14, 25 of U.S. Patent No. 11738158 B2, hereafter ‘158, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘158-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘158-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘158-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘158-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 12, 14 of U.S. Patent No. 11771852 B2, hereafter ‘852, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘852 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘852-Germinario combination teaches all of the claimed invention (‘852: Claim 1).
Regarding Claim 28, ‘852-Germinario combination teaches all of the claimed invention (‘852: Claim 1).
Regarding Claim 34, ‘852-Germinario combination teaches all of the claimed invention (‘852: Claim 2).
Regarding Claim 35, the current ‘852-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '852-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘852-Germinario combination teaches all of the claimed invention (‘852: Claim 12).
Regarding Claim 39, ‘852-Germinario combination teaches all of the claimed invention (‘852: Claim 14).
Claims 22-24, 29-31, 37, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12 of U.S. Patent No. 11771852 B2, hereafter ‘852, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘852-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘852-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘852-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘852-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘852-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘852-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘852-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘852-Germinario-Surber combination teaches all of the claimed invention (‘852: Claim 14).
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11771852 B2, hereafter ‘852, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘852-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘852-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘852-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘852-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 12642920 B2, hereafter ‘920. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 21, ‘920 discloses all of the claimed invention (Claim 14).
Regarding Claim 27, ‘920 discloses all of the claimed invention (Claim 14).
Regarding Claim 28, ‘920 discloses all of the claimed invention (Claim 14).
Regarding Claim 34, ‘920 discloses all of the claimed invention (Claims 15, 16).
Regarding Claim 39, ‘920 discloses all of the claimed invention (Claim 17).
Claims 35, 36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12642920 B2, hereafter ‘920, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 35, ‘920 does not disclose all of the claimed invention of Claim 35.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, ‘920 does not disclose all of the claimed invention of Claim 36.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘920 does not disclose all of the claimed invention of Claim 38.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Claims 22-24, 29-31, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 17 of U.S. Patent No. 12642920 B2, hereafter ‘920, in view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 22, ‘920 does not disclose the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘920-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘920-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘920 does not disclose the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘920-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘920-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, ‘920-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘920-Surber combination teaches all of the claimed invention (‘920: Claim 17).
Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 17 of U.S. Patent No. 12642920 B2, hereafter ‘920, and Surber (US 2015/0196543 A1) as applied to Claim 29, and in further view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 37, ‘920-Surber combination fails to teach all of the claimed invention.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Claims 25, 26, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12642920 B2, hereafter ‘920, and Surber (US 2015/0196543 A1) as applied to Claims 22 and 29, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 25, ‘920-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘920-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘920-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘920-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8 of copending Application No. 19/052203 (reference application), hereafter ‘203, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘203 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘203-Germinario combination teaches all of the claimed invention (‘203: Claim 1).
Regarding Claim 28, ‘203-Germinario combination teaches all of the claimed invention (‘203: Claim 1).
Regarding Claim 34, the current ‘203-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘203-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '203-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘203-Germinario combination teaches all of the claimed invention (‘203: Claims 5-8).
Regarding Claim 39, ‘203-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052203 (reference application), hereafter ‘203, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘203-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘203-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘203-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘203-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘203-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘203-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘203-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘203-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052203 (reference application), hereafter ‘203, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘203-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘203-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘203-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘203-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6-10, 30 of copending Application No. 19/052182 (reference application), hereafter ‘182, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘182 discloses most of the claimed invention (Claims 1, 30) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘182-Germinario combination teaches all of the claimed invention (‘182: Claim 1).
Regarding Claim 28, ‘182-Germinario combination teaches all of the claimed invention (‘182: Claim 1).
Regarding Claim 34, the current ‘182-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘182-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '182-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘182-Germinario combination teaches all of the claimed invention (‘182: Claims 6-10).
Regarding Claim 39, ‘182-Germinario combination teaches all of the claimed invention (‘182: Claims 3, 4).
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 30 of copending Application No. 19/052182 (reference application), hereafter ‘182, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘182-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘182-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘182-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘182-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘182-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘182-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘182-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘182-Germinario-Surber combination teaches all of the claimed invention (‘182: Claims 3, 4).
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 30 of copending Application No. 19/052182 (reference application), hereafter ‘182, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘182-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘182-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘182-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘182-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052634 (reference application), hereafter ‘634, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘634 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘634-Germinario combination teaches all of the claimed invention (‘634: Claim 1).
Regarding Claim 28, ‘634-Germinario combination teaches all of the claimed invention (‘634: Claim 1).
Regarding Claim 34, the current ‘634-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘634-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '634-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, the current ‘634-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘634-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052634 (reference application), hereafter ‘634, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘634-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘634-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘634-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘634-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘634-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘634-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘634-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘634-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052634 (reference application), hereafter ‘634, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘634-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘634-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘634-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘634-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052911 (reference application), hereafter ‘911, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘911 discloses most of the claimed invention (Claim 1) except for: produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce droplets of less than 6 microns, as taught by Germinario, since these are known droplet respirable dimensions to target the pulmonary system of the user. This would be particularly useful for drugs treating respiratory illnesses.
Regarding Claim 27, ‘911-Germinario combination teaches all of the claimed invention (‘911: Claim 1).
Regarding Claim 28, ‘911-Germinario combination teaches all of the claimed invention (‘911: Claim 1).
Regarding Claim 34, the current ‘911-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘911-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '911-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, the current ‘911-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘911-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052911 (reference application), hereafter ‘911, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘911-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘911-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘911-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘911-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘911-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘911-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘911-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘911-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052911 (reference application), hereafter ‘911, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘911-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘911-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘911-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘911-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 25 of copending Application No. 19/052152 (reference application), hereafter ‘152, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘152 discloses most of the claimed invention (Claim 1, 25) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘152-Germinario combination teaches all of the claimed invention (‘152: Claims 1, 25).
Regarding Claim 28, ‘152-Germinario combination teaches all of the claimed invention (‘152: Claims 1, 25).
Regarding Claim 34, the current ‘152-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘152-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '152-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘152-Germinario combination teaches all of the claimed invention (‘152: Claim 6).
Regarding Claim 39, ‘152-Germinario combination teaches all of the claimed invention (‘152: Claim 5).
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 25 of copending Application No. 19/052152 (reference application), hereafter ‘152, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘152-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘152-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘152-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘152-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘152-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘152-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘152-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘152-Germinario-Surber combination teaches all of the claimed invention (‘152: Claim 5).
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 25 of copending Application No. 19/052152 (reference application), hereafter ‘152, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘152-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘152-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘152-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘152-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052199 (reference application), hereafter ‘199, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘199 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘199-Germinario combination teaches all of the claimed invention (‘199: Claim 1).
Regarding Claim 28, ‘199-Germinario combination teaches all of the claimed invention (‘199: Claim 1).
Regarding Claim 34, the current ‘199-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘199-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '199-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, the current ‘199-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘199-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052199 (reference application), hereafter ‘199, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘199-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘199-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘199-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘199-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘199-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘199-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘199-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘199-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052199 (reference application), hereafter ‘199, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘199-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘199-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘199-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘199-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052173 (reference application), hereafter ‘173, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘173 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘173-Germinario combination teaches all of the claimed invention (‘173: Claim 1).
Regarding Claim 28, ‘173-Germinario combination teaches all of the claimed invention (‘173: Claim 1).
Regarding Claim 34, the current ‘173-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, ‘173-Germinario combination teaches all of the claimed invention (‘173: Claim 1).
Regarding Claim 36, ‘173-Germinario combination teaches all of the claimed invention (‘173: Claim 1).
Regarding Claim 38, the current ‘173-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘173-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052173 (reference application), hereafter ‘173, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘173-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘173-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘173-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘173-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘173-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘173-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, ‘173-Germinario-Surber combination teaches all of the claimed invention (‘173: Claim 1).
Regarding Claim 40, ‘173-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/052173 (reference application), hereafter ‘173, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘173-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘173-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘173-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘173-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 12, 14 of copending Application No. 18/219329 (reference application), hereafter ‘329, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘329 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘329-Germinario combination teaches all of the claimed invention (‘329: Claim 1).
Regarding Claim 28, ‘329-Germinario combination teaches all of the claimed invention (‘329: Claim 1).
Regarding Claim 34, ‘329-Germinario combination teaches all of the claimed invention (‘329: Claim 2, 3).
Regarding Claim 35, the current ‘329-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '329-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘329-Germinario combination teaches all of the claimed invention (‘329: Claim 12).
Regarding Claim 39, ‘329-Germinario combination teaches all of the claimed invention (‘329: Claim 14).
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14 of copending Application No. 18/219329 (reference application), hereafter ‘329, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘329-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘329-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘329-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘329-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘329-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘329-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘329-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘329-Germinario combination teaches all of the claimed invention (‘329: Claim 14).
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/219329 (reference application), hereafter ‘329, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘329-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘329-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘329-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘329-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 of copending Application No. 19/185906 (reference application), hereafter ‘906, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘906 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113) to allow for easy disposal and replacement.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable, as taught by Germinario, to allow for easy disposal and replacement.
Regarding Claim 27, ‘906-Germinario combination teaches all of the claimed invention (‘906: Claim 1).
Regarding Claim 28, ‘906-Germinario combination teaches all of the claimed invention (‘906: Claim 1).
Regarding Claim 34, the current ‘906-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the aperture plate includes an exit side (side of 108 facing towards the airflow path and cavity of 116, Fig 2A) positioned across the airflow path in a non-parallel direction to direction of airflow through the housing (side of 108 is facing downward which is ejecting droplets perpendicular to the direction of airflow, Figs 1A and 2a) since this is a known ejection configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture plate to be positioned non-parallel, as taught by Germinario, since this is a known ejection configuration.
Regarding Claim 35, the current ‘906-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '906-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘906-Germinario combination teaches all of the claimed invention (‘906: Claim 8).
However, Germinario further teaches the aperture plate includes one or more of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), nickel, nickel-cobalt, nickel-palladium, palladium, platinum, and metal alloys thereof (listed materials, paragraph 0015) since these are known materials used for aperture plates.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these materials, as taught by Germinario, since these are known materials used for aperture plates.
Regarding Claim 39, ‘906-Germinario combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/185906 (reference application), hereafter ‘906, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘906-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘906-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘906-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘906-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘906-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘906-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘906-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘906-Germinario-Surber combination does not teach all of the claimed invention.
However, Germinario further teaches the mouthpiece is removably coupled with the device (aerosol delivery mouthpiece tube may be removable, replaceable and sterilizable, paragraph 0108) to allow for replacement and sterilization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the mouthpiece removeable, as taught by Germinario, to allow for replacement and sterilization.
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/185906 (reference application), hereafter ‘906, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘906-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘906-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘906-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘906-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Claims 21, 27, 28, 34, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-13, 15 of copending Application No. 17/609610 (reference application), hereafter ‘610, in view of Germinario et al. (US 2017/0319796 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 21, ‘610 discloses most of the claimed invention (Claim 1) except for: a removable fluid reservoir; produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns.
However, Germinario, of the same field of endeavor, teaches a droplet delivery device (Abstract) including a removable fluid reservoir (110, Fig 2A; the reservoir of the droplet delivery device is removably coupled with the housing, paragraph 0018; the reservoir and ejector mechanism may be integrated together into a combination reservoir/ejector mechanism module that may be removable and/or disposable, paragraph 0113); produce droplets from fluid received from the fluid reservoir having a mass mean aerodynamic diameter of less than 6 microns (the ejector mechanism is configured to eject a stream of droplets having an average ejected droplet diameter of less than 5 microns, paragraph 0067; openings 108 a and ejector mechanism 104 may be configured to generate an ejected stream of droplets having a MMAD of 5 μm or less, paragraph 0100) to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be removable and to produce droplets of less than 6 microns, as taught by Germinario, to allow for easy disposal and replacement and since these are known droplet respirable dimensions to target the pulmonary system of the user.
Regarding Claim 27, ‘610-Germinario combination teaches all of the claimed invention (‘610: Claim 1).
Regarding Claim 28, ‘610-Germinario combination teaches all of the claimed invention (‘610: Claim 1).
Regarding Claim 34, ‘610-Germinario combination teaches all of the claimed invention (‘610: Claims 9, 10).
Regarding Claim 35, the current ‘610-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 36, the current '610-Germinario combination does not teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 38, ‘610-Germinario combination teaches all of the claimed invention (‘610: Claim 15).
Regarding Claim 39, ‘610-Germinario combination teaches all of the claimed invention (‘610: Claims 11-13).
Claims 22-24, 29-31, 37, 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-13 of copending Application No. 17/609610 (reference application), hereafter ‘610, and Germinario et al. (US 2017/0319796 A1) as applied to Claims 21 and 28, and in further view of Surber (US 2015/0196543 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 22, ‘610-Germinario combination does not teach the claimed invention of Claim 22.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 23, ‘610-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 24, ‘610-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 29, ‘610-Germinario combination does not teach the claimed invention of Claim 29.
However, Surber, of the same field of endeavor, teaches formulations for aerosolization for treatment of diseases associated with the lung, heart, kidney, liver, eye and central nervous system (Abstract) including the fluid reservoir includes a fluid including a cancer therapeutic (the lung disease is lung cancer and the treatment comprises inhibiting, reducing or slowing the growth of lung tumor stroma, paragraph 0012; listed drugs to treat non-small cell lung cancer, paragraph 0309; the nebulizer used in any of the methods described herein is a liquid nebulizer, in some embodiments, the nebulizer used in any of the methods described herein is a jet nebulizer, an ultrasonic nebulizer, a pulsating membrane nebulizer, a nebulizer comprising a vibrating mesh or plate with multiple apertures, or a nebulizer comprising a vibration generator and an aqueous chamber, provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer, paragraph 0024) since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize cancer therapeutics within the device, as taught by Surber, since it is known to use cancer therapeutics in nebulizers for the treatment of lung cancer and since it is known for cancer therapeutics to be delivered via droplets with a diameter of 5 microns or less. Considering that Surber teaches that nebulizers can be used to deliver cancer therapeutics, it would be obvious for one of ordinary skill in the art to add these types of therapeutics into the device for the purpose of treating lung cancer.
Regarding Claim 30, ‘610-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; the listed drugs are chemotherapeutic agents).
Regarding Claim 31, ‘610-Germinario-Surber combination teaches all of the claimed invention (Surber: listed drugs to treat non-small cell lung cancer, paragraph 0309; doxorubicin treats tumors, paragraph 0207; the listed drugs are chemotherapeutic agents).
Regarding Claim 37, the current ‘610-Germinario-Surber combination fails to teach all of the claimed invention.
However, an alternate embodiment of Germinario teaches the reservoir comprises an internal flexible membrane (1302, Fig 13; 1302 packaged within 1304 and 1306, paragraph 0152) separating a first background pressure fluid volume (airtight drug container, paragraph 0152; background pressure fluid volume is the volume of ambient air pressure surrounding the container) from a second drug volume (drug inside of 1302, Fig 13) to provide an airtight drug container (paragraph 0152).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be a flexible drug ampoule, as taught by Germinario, to provide an airtight drug container (Germinario: paragraph 0152). This would be particularly useful to ensure drugs are not contaminated or exposed to the ambient air or surrounding environment.
Regarding Claim 40, ‘610-Germinario-Surber combination teaches all of the claimed invention (‘610: Claims 11-13).
Claims 25, 26, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/609610 (reference application), hereafter ‘610, Germinario et al. (US 2017/0319796 A1), and Surber (US 2015/0196543 A1) as applied to Claims 21 and 28, and in further view of Feltquate et al. (US 2017/0158776 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, ‘610-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 26, ‘610-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 32, ‘610-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group consisting of CTLA-4 inhibitors (discussion regarding anti-CTLA-4 Antibodies, paragraphs 0078 and 0079; ipilimumab, paragraphs 0079 and 0080), PD-1 inhibitors, PD-L1 inhibitors (discussion regarding anti-PD-1 and anti-PD-L1 Antibodies, paragraph 0067; nivolumab, paragraph 0068; pembrolizumab, paragraph 0069; avelumab, paragraph 0077; durvalumab, paragraph 0077), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Regarding Claim 33, ‘610-Germinario-Surber combination fails to teach all of the claimed invention.
However, Feltquate, reasonably pertinent to the problem of cancer therapy, teaches a method for treating a subject afflicted with lung cancer (Abstract) including the cancer therapeutic includes an immune checkpoint inhibitor selected from the group Pembrolizumab (pembrolizumab, paragraph 0069), Nivolumab (nivolumab, paragraph 0068), Avelumab (avelumab, paragraph 0077), Durvalumab (durvalumab, paragraph 0077), and Ipilimumab (ipilimumab, paragraphs 0079 and 0080), and combinations thereof since these are known cancer therapeutics for treating lung cancer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these forms of cancer therapeutics, as taught by Feltquate, since these are known cancer therapeutics for treating lung cancer. These forms of cancer therapeutics are known in the art to treat lung cancer. It would be obvious for one of ordinary skill in the art to utilize these cancer therapeutics as part of the various ways to treat cancer patients and provide the desired treatment for each individual patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including:
US 20180021530 A1 discusses an aerosolization device with similar component layout.
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/BRIAN T KHONG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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