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 .
Response to Arguments
This Office Action is in response to the amendment filed on September 10, 2026. As directed by the amendment, Claims 2, 3, 7-12, and 16-21 have been amended. Claim 6 has been canceled. Claims 2-5 and 7-21 are pending in the instant application.
Regarding the Office Action mailed June 10, 2026:
All objections to the drawings have been fully resolved and are withdrawn.
All objections to the specification have been fully resolved and are withdrawn.
All objections to the claims have been fully resolved and are withdrawn.
All rejections under 35 USC 112(a) and 35 USC 112(d) have been fully resolved and are withdrawn.
All rejections under 35 USC 112(b) have not been fully resolved and are maintained.
All rejections under Double Patenting have not been fully resolved and are maintained.
Applicant’s arguments regarding the 35 USC 112(b) rejections have been fully considered but they are not persuasive.
Applicant argues that Claims 2 and 10 now explicitly discuss the inhalation opening being aligned with a longitudinal axis of the housing and the linear internal airflow pathway extending along that longitudinal axis (Remarks: Page 7).
Examiner respectfully disagrees with this argument. Though the claims explicitly discuss this, Applicant has not resolved the 35 USC 112(b) rejections regarding the “internal components” involved in Claims 2 and 10. Even though Applicant’s intentions are to claim that the internal components are arranged in-line so that the housing extends linearly, Applicant has not specifically identified what these internal components are and thus it is indefinite on what sort of internal components are involved that must be arranged in-line. Since the device would have various internal components involved, it is recommended that Applicant specifically claim the exact internal components that must be arranged in-line.
Applicant’s arguments regarding the 35 USC 103 rejections have been considered but are moot because the new ground of rejection does not rely on any reference and/or interpretation applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant has amended Claim 2 to further limit the structural orientation of components in the device. See 35 USC 103 rejections below for more details.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-5 and 7-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 states “the internal components” (Line 3). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say any components within the device are arranged in-line. However, since this is the first time this is mentioned, it is unclear what it is referring back to. Additionally, the internal components are never identified. Therefore, the identity of the term cannot be determined. For examination purposes, the claim limitation will be interpreted as any components within the device are arranged in-line. Similar rejections are applied to Claim 10 (Line 3).
Claims 3-5, 7-9, and 11-21 are rejected for being dependent on rejected Claims 2 and 10.
Claim Rejections - 35 USC § 103
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 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 2-5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fink et al. (US 2018/0021530 A1) in view of Takei et al. (US 2010/0282254 A1) and Edwards et al. (US 2013/0327327 A1).
Regarding Claim 2, Fink discloses a droplet delivery device (100, Figs 1A, 1B, and 2; aerosolization device, Abstract) comprising: a housing (108, Figs 1B and 2) defining a linear internal airflow pathway (102, Fig 1B) within the housing that terminates at a first end (end of 108 closest to 110, Fig 1B) at an inhalation opening (110, Fig 1B; conduit 102 may include a mouthpiece end 110 through which a user may inhale to produce an inspiratory flow to deliver aerosolized medicament to the user's respiratory system, paragraph 0035), wherein the internal components of the droplet delivery device are arranged in-line so that the housing extends linearly between the inhalation opening at the first end and a second opposite end (end of 108 closest to 138, Fig 1B) of the droplet delivery device (various internal components including 112, 124, 114, and 106 are arranged in-line so that 108 extends linearly between end of 108 closest to 110 and end of 108 closest to 138, Fig 1B), and wherein the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2); an ejector mechanism (112, Fig 1B) having a transducer configured to vibrate and coupled directly or indirectly to an aperture plate (vibratable mesh may be domed shaped and be vibrated by an annular piezoelectric element, vibratable mesh will be vibrated at a frequency, paragraph 0024; mesh are known to have a plurality of openings), wherein the aperture plate includes an exit side face that is non- parallel to a direction of airflow through the airflow pathway (112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B); and a fluid reservoir (114, Fig 1B) in fluid communication with the aperture plate (liquid medicament can be dispensed onto the vibratable mesh 112, either directly from a vial of liquid medicament or indirectly by being funneled onto the vibratable mesh 112 by tapered walls of a fluid receiving chamber 114, paragraph 0035). Fink also discloses liquid medicament may be provided to an aerosolization device in a metered dose (paragraph 0020).
Fink fails to explicitly disclose a removable fluid reservoir in fluid communication with the aperture plate, wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Takei, of the same field of endeavor, teaches a drug ejecting apparatus (Abstract) including a removable fluid reservoir (2, Figs 3-6) in fluid communication with the ejector mechanism (drug tank 2 is pushed into the ejection head unit 1, the hollow needle 38 breaks through the fixed rubber stopper 36, and the ejection head unit 1 and drug tank 2 are communicated, paragraph 0070; ejection head unit 1 and drug tank 2 will be exchanged when amount of a drug in the drug tank 2 becomes less than amount of the drug to be doped in one-time inhalation, paragraph 0063) to allow for exchanging of drug tank once it’s been used up (paragraph 0063).
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 or fluid receiving chamber to be removable, as taught by Takei, to allow for exchanging of the drug tank once it’s been used up (Takei: paragraph 0063). Fink does discuss the use of a vial of liquid medicament to add the medicament into the chamber or mesh. Takei further teaches having a removable chamber in which the liquid medicament can be more easily replaced or exchanged when the chamber is empty. This allows the device to be reused and allows for interchangeability among different types of medicament or different doses of medicament.
Fink-Takei combination teaches the use of a “end of dose” indicator to indicate that substantially all of the dose of medicament has been delivered, and the user may take several inhalations or a single inhalation depending on volume of liquid drug (Fink: paragraph 0042). Fink-Takei combination also teaches it is determined whether the liquid measure obtained by subtracting the full dosage, used for the past, from the first medical fluid amount is larger than maximum ejection amount in the following ejection (Takei: paragraph 0086) and ejection head unit 1 and drug tank 2 will be exchanged when amount of a drug in the drug tank 2 becomes less than amount of the drug to be doped in one-time inhalation (Takei: paragraph 0063). Takei-Fink combination implies that there could be at least one dose contained in the reservoir or drug tank.
Fink-Takei combination fails to teach wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge amount for disposable cartridges.
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 size of the removable reservoir to hold ten doses or less, as taught by Edwards, since this is a known cartridge amount for disposable cartridges. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs.
Regarding Claim 3, Fink-Takei-Edwards combination teaches the removable fluid reservoir has a maximum capacity of one dose of the fluid convertible to droplets by the ejector mechanism (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claim 4, Fink-Takei-Edwards combination teaches the fluid reservoir is disposable (Takei: ejection head unit 1 and drug tank 2 will be exchanged when amount of a drug in the drug tank 2 becomes less than amount of the drug to be doped in one-time inhalation, paragraph 0063; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the drug tank whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 5, Fink-Takei-Edwards combination teaches the fluid reservoir is disposable (Takei: ejection head unit 1 and drug tank 2 will be exchanged when amount of a drug in the drug tank 2 becomes less than amount of the drug to be doped in one-time inhalation, paragraph 0063; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the drug tank whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 7, Fink-Takei-Edwards combination teaches the exit side face of the aperture plate is perpendicular to the direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
Regarding Claim 8, Fink-Takei-Edwards combination teaches the exit side face of the aperture plate is perpendicular to the direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
Regarding Claim 9, Fink-Takei-Edwards combination teaches the exit side face of the aperture plate is perpendicular to the direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
Claims 10-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fink et al. (US 2018/0021530 A1) in view of Collins et al. (US 2004/0256487 A1) and Edwards et al. (US 2013/0327327 A1).
Regarding Claim 10, Fink discloses a droplet delivery device (100, Figs 1A, 1B, and 2; aerosolization device, Abstract) comprising: a housing (108, Figs 1B and 2) defining a linear internal airflow pathway (102, Fig 1B) within the housing that terminates at a first end (end of 108 closest to 110, Fig 1B) at an inhalation opening (110, Fig 1B; conduit 102 may include a mouthpiece end 110 through which a user may inhale to produce an inspiratory flow to deliver aerosolized medicament to the user's respiratory system, paragraph 0035), wherein the internal components of the droplet delivery device are arranged in-line so that the housing extends linearly between the inhalation opening at the first end and a second opposite end (end of 108 closest to 138, Fig 1B) of the droplet delivery device (various internal components including 112, 124, 114, and 106 are arranged in-line so that 108 extends linearly between end of 108 closest to 110 and end of 108 closest to 138, Fig 1B), and wherein the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2); an ejector mechanism (112, Fig 1B) having a transducer configured to vibrate and coupled directly or indirectly to an aperture plate (vibratable mesh may be domed shaped and be vibrated by an annular piezoelectric element, vibratable mesh will be vibrated at a frequency, paragraph 0024; mesh are known to have a plurality of openings); and a fluid reservoir (114, Fig 1B) in fluid communication with the aperture plate (liquid medicament can be dispensed onto the vibratable mesh 112, either directly from a vial of liquid medicament or indirectly by being funneled onto the vibratable mesh 112 by tapered walls of a fluid receiving chamber 114, paragraph 0035). Fink also discloses liquid medicament may be provided to an aerosolization device in a metered dose (paragraph 0020).
Fink fails to explicitly disclose a removable fluid reservoir in fluid communication with the aperture plate, wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Collins, of the same field of endeavor, teaches a fluid atomizer (Abstract) including a removable fluid reservoir (126, Fig 3; 120 is preferably a removable and replaceable cartridge 126, paragraph 0077) in fluid communication with the aperture plate (proximal end 142 is immersed in the fluid 122 in the reservoir 120, standing waves are formed which draw the fluid 122 into the proximal end 142 of the prime mover 140 and along the lumen 1410, as the prime mover 140 vibrates at ultrasonic frequencies, the prime mover 140 transfers a portion of its vibrational power to a mesh plate 156 in the nozzle assembly 150, fluid 122 that has been propelled along the lumen 1410 contacts the mesh plate 156, paragraph 0107; 126 communicates with 156 via 140), wherein the fluid reservoir externally couples and decouples to an external surface of the housing (126 is shown to connect to the external surface of body 130, Fig 3; replaceable cartridge 126 that is securably connectable to the body 130, paragraph 0077) to allow easy replacement when reservoir is empty or when reservoirs of different types of liquids are desired to be connected (paragraph 0077).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a removable reservoir that is attachable to the external surface of the housing, as taught by Collins, to allow easy replacement when reservoir is empty or when reservoirs of different types of liquids are desired to be connected (Collins: paragraph 0077). Fink does discuss the use of a vial of liquid medicament to add the medicament into the chamber or mesh. This improvement would allow for easy removal, replacement, and attachment of the reservoir from the outside of the housing.
Fink-Collins combination fails to teach the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge amount for disposable cartridges.
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 size of the removable reservoir to hold ten doses or less, as taught by Edwards, since this is a known cartridge amount for disposable cartridges. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs.
Regarding Claim 11, Fink-Collins-Edwards combination teaches the removable fluid reservoir has a maximum capacity of five doses or less of the fluid convertible to droplets by the ejector mechanism (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172).
Regarding Claim 12, Fink-Collins-Edwards combination teaches the removable fluid reservoir has a maximum capacity of one dose of the fluid convertible to droplets by the ejector mechanism (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claim 13, Fink-Collins-Edwards combination teaches the fluid reservoir is disposable (Collins: 120 is preferably a removable and replaceable cartridge 126, paragraph 0077; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the cartridge whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 14, Fink-Collins-Edwards combination teaches the fluid reservoir is disposable (Collins: 120 is preferably a removable and replaceable cartridge 126, paragraph 0077; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the cartridge whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 15, Fink-Collins-Edwards combination teaches the fluid reservoir is disposable (Collins: 120 is preferably a removable and replaceable cartridge 126, paragraph 0077; Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; a user could choose to dispose of the cartridge whenever they want to). It is noted that Applicant has not further elaborated on the details regarding the reservoir’s disposability.
Regarding Claim 16, Fink-Collins-Edwards combination teaches an exit face of the aperture plate is non-parallel to a direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
Regarding Claim 17, Fink-Collins-Edwards combination teaches an exit face of the aperture plate is non-parallel to a direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
Regarding Claim 18, Fink-Collins-Edwards combination teaches an exit face of the aperture plate is non-parallel to a direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
Regarding Claim 19, Fink-Collins-Edwards combination teaches an exit face of the aperture plate is non-parallel to a direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
Regarding Claim 20, Fink-Collins-Edwards combination teaches an exit face of the aperture plate is non-parallel to a direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
Regarding Claim 21, Fink-Collins-Edwards combination teaches an exit face of the aperture plate is non-parallel to a direction of airflow through the airflow pathway (Fink: the exit side face of 112 shown to be non-parallel or perpendicular to the direction of airflow through 102, Fig 1B).
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 2-5 and 7-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. US 11738158 B2, hereafter ‘158, in view of Edwards et al. (US 2013/0327327 A1) and Fink et al. (US 2018/0021530 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘158 discloses most of the claimed invention (Claims 1 and 14) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘158-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claim 3, ‘158-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘158-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 7-9, ‘158-Edwards-Fink combination teaches all of the claimed invention (‘158: Claims 1 and 14).
Regarding Claim 10, ‘158 discloses most of the claimed invention (Claims 1 and 14) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘158-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claims 11-12, ‘158-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘158-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘158-Edwards-Fink combination teaches all of the claimed invention (‘158: Claims 1 and 14).
Claims 2-5 and 7-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. US 11458267 B2, hereafter ‘267, in view of Edwards et al. (US 2013/0327327 A1) and Fink et al. (US 2018/0021530 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘267 discloses most of the claimed invention (Claim 2) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘267-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claim 3, ‘267-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘267-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 7-9, ‘267-Edwards-Fink combination teaches all of the claimed invention (‘267: Claim 2).
Regarding Claim 10, ‘267 discloses most of the claimed invention (Claim 2) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘267-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claims 11-12, ‘267-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘267-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘267-Edwards-Fink combination teaches all of the claimed invention (‘267: Claim 2).
Claims 2-5 and 7-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. US 12285559 B2, hereafter ‘559, in view of Edwards et al. (US 2013/0327327 A1) and Fink et al. (US 2018/0021530 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘559 discloses most of the claimed invention (Claim 2) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘559-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claim 3, ‘559-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘559-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 7-9, ‘559-Edwards-Fink combination teaches all of the claimed invention (‘559: Claim 2).
Regarding Claim 10, ‘559 discloses most of the claimed invention (Claim 2) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘559-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claims 11-12, ‘559-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘559-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘559-Edwards-Fink combination teaches all of the claimed invention (‘559: Claim 2).
Claims 2-5 and 7-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. US 11771852 B2, hereafter ‘852, in view of Edwards et al. (US 2013/0327327 A1) and Fink et al. (US 2018/0021530 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘852 discloses most of the claimed invention (Claim 2) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘852-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claim 3, ‘852-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘852-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 7-9, ‘852-Edwards-Fink combination teaches all of the claimed invention (‘852: Claim 2).
Regarding Claim 10, ‘852 discloses most of the claimed invention (Claim 2) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘852-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claims 11-12, ‘852-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘852-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘852-Edwards-Fink combination teaches all of the claimed invention (‘852: Claim 2).
Claims 2-5 and 7-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. US 12642920 B2, hereafter ‘920, in view of Edwards et al. (US 2013/0327327 A1) and Fink et al. (US 2018/0021530 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 2, ‘920 discloses most of the claimed invention (Claim 15) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘920-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claim 3, ‘920-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘920-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 7-9, ‘920-Edwards-Fink combination teaches all of the claimed invention (‘920: Claim 15).
Regarding Claim 10, ‘920 discloses most of the claimed invention (Claim 15) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘920-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claims 11-12, ‘920-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘920-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘920-Edwards-Fink combination teaches all of the claimed invention (‘920: Claim 15).
Claims 2-5 and 7-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/219,329, hereafter ‘329, in view of Edwards et al. (US 2013/0327327 A1) and Fink et al. (US 2018/0021530 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection.
Regarding Claim 2, ‘329 discloses most of the claimed invention (Claim 2) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘329-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claim 3, ‘329-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘329-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 7-9, ‘329-Edwards-Fink combination teaches all of the claimed invention (‘329: Claim 2).
Regarding Claim 10, ‘329 discloses most of the claimed invention (Claim 2) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘329-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claims 11-12, ‘329-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘329-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘329-Edwards-Fink combination teaches all of the claimed invention (‘329: Claim 2).
Claims 2-5 and 7-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 19/191,443, hereafter ‘443, in view of Edwards et al. (US 2013/0327327 A1) and Fink et al. (US 2018/0021530 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection.
Regarding Claim 2, ‘443 discloses most of the claimed invention (Claim 5) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘443-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claim 3, ‘443-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘443-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 7-9, ‘443-Edwards-Fink combination teaches all of the claimed invention (‘443: Claim 5).
Regarding Claim 10, ‘443 discloses most of the claimed invention (Claim 5) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘443-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claims 11-12, ‘443-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘443-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘443-Edwards-Fink combination teaches all of the claimed invention (‘443: Claim 5).
Claims 2-5 and 7-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 17/609,610, hereafter ‘610, in view of Edwards et al. (US 2013/0327327 A1) and Fink et al. (US 2018/0021530 A1). Although the claims are not identical, the instant claims are anticipated and/or made obvious by the cited application and prior art.
This is a provisional nonstatutory double patenting rejection.
Regarding Claim 2, ‘610 discloses most of the claimed invention (Claim 9) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) since this is a known cartridge dosage amount for disposable cartridges in medical applications.
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 removeable and to hold ten doses or less, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘610-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claim 3, ‘610-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 4-5, ‘610-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 7-9, ‘610-Edwards-Fink combination teaches all of the claimed invention (‘610: Claim 9).
Regarding Claim 10, ‘610 discloses most of the claimed invention (Claim 9) except for: the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis; a removable fluid reservoir; wherein the fluid reservoir has a maximum capacity of ten doses or less of fluid convertible to droplets by the ejector mechanism and externally couples and decouples to an external surface of the housing.
However, Edwards, of the same field of endeavor, teaches an aerosol delivery apparatus (Abstract) with aerosol produced via an ultrasound source (paragraph 0190) and aerosol that can be medicine or drugs (paragraphs 0096, 0097, and 0208) including a removable fluid reservoir (cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171); the fluid reservoir has a maximum capacity of ten doses of fluid convertible to droplets by the ejector mechanism (cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171; multiple doses of a consumable product are contained within a single physical device, device element or cartridge, and dosing is regulated by the user or by some other means, as needed, paragraph 0172) and externally couples and decouples to an external surface of the housing (712 shown to couple and decouple to the external surface of 700, Figs 1A-1B) since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing.
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 removeable, to attach to the housing externally, and to hold ten doses, as taught by Edwards, since this is a known cartridge dosage amount for disposable cartridges in medical applications and since this is a known way to attach a cartridge to the housing. Sizing the reservoir to these amounts of doses would reduce the waste of medicament involved as well as provide better control over how many doses are provided to the user depending on the medicament involved. Additionally, one of ordinary skill in the art would be capable of modifying the size of the reservoir according to a desired amount of medicament delivered to a user based on routine experimentation and optimization and based on their individual treatment needs. Having the reservoir be removeable and disposable allows for easier interchanging of medicament, reusability, and ensuring the medicament is not contaminated after a prolonged period of time.
‘610-Edwards combination fails to teach the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis of the housing and the linear internal airflow pathway extends along the longitudinal axis.
However, Fink, of the same field of endeavor, teaches an aerosolization device (Abstract) including the inhalation opening at the first end and the second opposite end are linearly aligned along a longitudinal axis (longitudinal, horizontal axis going through 108, Fig 1B) of the housing (end of 108 closest to 110 and end of 108 closest to 138 are linearly aligned along that longitudinal, horizontal axis of 108 since 108 is longer in length horizontally, Figs 1B and 2) and the linear internal airflow pathway extends along the longitudinal axis (102 extends along the longitudinal axis of 108 since 102 is extending in parallel to the horizontal length of 108, Figs 1B and 2) since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
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 housing to have an airflow pathway be extending along a longitudinal axis of the housing, as taught by Fink, since this is a known positioning and arrangement of the housing in relation to an airflow conduit.
Regarding Claims 11-12, ‘610-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridge or cartridge elements contain a single dose, cartridge or cartridge elements contain more than one dose, cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 13-15, ‘610-Edwards-Fink combination teaches all of the claimed invention (Edwards: cartridges may be disposable and designed to deliver a consumable product dosage 1, 2, 5, 10, 15, 30, or more times, before being discarded, paragraph 0171).
Regarding Claims 16-21, ‘610-Edwards-Fink combination teaches all of the claimed invention (‘610: Claim 9).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN THAI-BINH KHONG whose telephone number is (571)272-1857. The examiner can normally be reached Monday to Thursday 9:00 am-6:00 pm.
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/BRIAN T KHONG/ Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/ Primary Examiner, Art Unit 3785
