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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/2026 has been entered.
Response to Amendments
This present office action is in responsive to the Arguments/Remarks filed on 06/09/2026. As directed, claims 1, 10, and 19 have been amended and claim 20 has been added. Thus, claims 1-20 are presently pending in this application.
Applicant has amended claim 1, and 10 to address minor informalities. Thus, previously held claim objections have been hereby withdrawn.
Applicant has canceled the limitation, “wherein the aperture plate is spaced apart from the reservoir and receives the low surface tension composition by capillary flow”. Thus, previously held drawing objection and claim rejection under 35 U.S.C. § 112(a) have been hereby withdrawn.
Response to Arguments
Applicant’s arguments, see section under "Claim Rejections under 35 U.S.C. §102(a)(1)", filed 066, with respect to the rejections of claims 1, 8-10, and 19 have been fully considered and are not persuasive.
Applicant argues that the prior art, Germinario (US 20170319796 A1), does not disclose each element of amended claim 1 which now includes, the housing is “in-line and handleless” and “wherein the electronic actuator, aperture plate, and housing are oriented in a generally in-line or parallel configuration.”
Examiner respectfully disagree with Applicant’s argument. Applicant emphasize that the housing is handleless without a separate handle which is supported by the drawings of the instant application, but the description of the instant application does not specifically disclose that the device having without a separate handle as the device is described as the device is arranged that it is forming a small, hand-held device / a handheld unit (¶0061, 0064).
In regards to the parallel configuration, said components are arranged/ oriented in a generally parallel configuration in approximately to a z-axis. Examiner notes that the reference axis/point does not limit the orientation of these components with respect to any particular external coordinate system. The longitudinal or center axes of the housing, the actuator, and the aperture plate may be defined and compared relative to one another, and the components may reasonably be considered arranged in a parallel configuration based on their relative alignment.
For these reasons, the prior arts of record are maintained and the rejections under 35 U.S.C. §102 are modified as necessitated by the amendments as discussed below.
Applicant’s arguments, see sections under "Claim Rejections under 35 U.S.C. §103" in PG 8-10, filed 12/09/2025, with respect to the rejections of claims 2-19 have been fully considered and are not persuasive. Applicant argues that that each reference fails to teach or suggest of the limitation of claim 1.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Therefore, the rejections under 35 U.S.C. §103 are modified as necessitated by the amendments as discussed below.
Claim Objections
Claim 1-20 are objected to because of the following informalities:
Claim 1 recites, “wherein the electronic actuator, aperture plate, and housing are” in ln 11-12 which Examiner suggest amending to read --wherein the electronic actuator, the aperture plate, and the housing are--
Claims 2-20 are objected by virtue of dependency to claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the amended claim recites, “an inline and handleless housing”.
While it has been established that negative limitations are not themselves indefinite or improper, issues under 112(a) arise when negative limitations recited in the claims are not supported in the specification, particularly when the originally filed disclosure is silent with respect to the claimed negative limitations (see MPEP 2173.05(i)). In other words, silence as to negative limitations recited in the claims is not sufficient to support the inventor’s possession of the claimed invention at the time of filing.
Claims 2-20 are rejected by dependency to claim 1.
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 1-20 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 1 recites, “an inline and handleless housing” which renders claim indefinite. A handle is generally understood to be a structure configured to be grasped by a user’s hand to hold or manipulate a device. However, the claim does not set forth the structural characteristics that distinguish a “handle” from other portions of the housing that may likewise be grasped by a user during normal operation. It is unclear where the boundary between a “handleless” housing and a housing which is held by a hand lies. Looking at another consideration, since virtually any handheld device housing may be grasped by a user, the metes and bounds of the claim cannot be reasonably determined.
Claims 2-20 are rejected by dependency to claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8-10 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Germinario et al. (US 20170319796 A1).
Regarding claim 1, Germinario et al. discloses, an electronically actuated droplet delivery device (200, Fig 3A) for delivering a low surface tension composition (¶0083, The ejected stream of droplets includes, without limitation, solutions, suspensions or emulsions which have viscosities in a range capable of droplet formation using the ejector mechanism”) as an ejected stream of droplets to a pulmonary system of a subject (abstract, “the droplet delivery device is then actuated to generate a stream of droplets having an average ejected droplet diameter within the respirable size range, e.g, less than about 5 μm, so as to target the pulmonary system of the user”), the device comprising:
an in-line and handleless housing (116, Fig 3A; ¶0110, “The housing 116 may be handheld”; Examiner notes that the housing of 3A can be used to hold the device without a separate handle) with an airflow pathway and an airflow exit (see annotation below, Fig 3A; ¶0021, “…when a subject applies an inspiratory breath to an airflow exit side of the housing”);
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a reservoir (110, Fig 3; ¶0110, “surface tension plate 114 (FIG. 3C), reservoir 110, which may optionally be coupled to the ejector mechanism 104 to form a combination reservoir/ejector mechanism module”; see the combination reservoir/ejector mechanism module 400 of Figs 4A-4B) including the low surface tension composition (¶0083-0085,0093, implies that the drug/liquid/prescription/OTC are disposed within the reservoir for usage...) disposed within or in fluid communication with the housing (¶0083, “the droplet delivery device generally includes a housing and a reservoir disposed in or in fluid communication with the housing, an ejector mechanism in fluid communication with the reservoir”);
an electronically actuated ejector mechanism (400, Fig 4A-4B; ¶0110-0113, “…coupled to the ejector mechanism 104 to form a combination reservoir/ejector mechanism module…that the fluid within the reservoir is in constant contact with the fluid contact surface of the aperture plate”) in fluid communication with the reservoir and configured to generate the ejected stream of droplets (¶0110, “to cause an ejected stream of droplets to be ejected”); and
the ejector mechanism including an electronic actuator (106, Figs. 4A-4B) and an aperture plate (108, Figs. 4A-4B), the aperture plate having a plurality of openings, and the electronic actuator operable to oscillate the aperture plate at a frequency to thereby generate the ejected stream of droplets (¶0011, “the aperture plate having a plurality of openings formed through its thickness and the piezoelectric actuator operable to oscillate the aperture plate at a frequency to thereby generate an ejected stream of droplet”),
wherein the electronic actuator, the aperture plate and the housing are oriented in a generally in-line or parallel configuration so as to form a hand-held device (104, 108, 116 are arranged in a generally in-line configuration as shown in Fig 3A),
wherein the ejector mechanism is configured to generate the ejected stream of droplets wherein at least about 50% of the droplets have an average ejected droplet diameter of less than about 6 microns, such that at least about 50% of a mass of the ejected stream of droplets is delivered in a respirable range to the pulmonary system of the subject during use (¶0013,0021, “the ejector mechanism configured to generate the ejected stream of droplets wherein at least about 70% of the droplets have an average ejected droplet diameter of less than about 5 microns, such that at least about 70% of the mass of the ejected stream of droplets is delivered in a respirable range to the pulmonary system of the subject during use”).
Regarding claim 8, Germinario et al. discloses the device of claim 1 as discussed above.
Germinario et al. discloses, wherein the aperture plate is composed of a material selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (¶0015, “aperture plate of the droplet delivery device comprises a domed shape. In other aspects, the aperture plate is composed of a material selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE)”;¶0134).
Regarding claim 9, Germinario et al. discloses the device of claim 1 as discussed above.
Germinario et al. discloses, wherein one or more of the plurality of openings have different cross-sectional shapes or diameters to thereby provide ejected droplets having different average ejected droplet diameters (¶0015, “one or more of the plurality of openings of the aperture plate have different cross-sectional shapes or diameters to thereby provide ejected droplets having different average ejected droplet diameters”).
Regarding claim 10, Germinario et al. discloses, a method for delivering a low surface tension composition (¶0083, The ejected stream of droplets includes, without limitation, solutions, suspensions or emulsions which have viscosities in a range capable of droplet formation using the ejector mechanism”) as an ejected stream of droplets in a respirable range to the pulmonary system of a subject (abstract), the method comprising:
(a) generating the ejected stream of droplets from the low surface tension composition via a an electronically actuated droplet delivery device of claim 1 (see claim 1 rejection above), wherein at least about 50% of the ejected stream of droplets have the average ejected droplet diameter of less than about 6 µm (¶0013,0021); and
(b) delivering the ejected stream of droplets to the pulmonary system of the subject such that at least about 50% of the mass of the ejected stream of droplets is delivered in the respirable range to the pulmonary system of a subject during use (¶0013,0021).
Regarding claim 19, Germinario et al. discloses the device of claim 1 as discussed above.
Germinario et al. discloses, wherein the low surface tension composition is delivered to a subject to treat or ameliorate a disease, condition or disorder (¶0071-0073) selected from the group consisting of asthma, COPD epilepsy, seizure disorders, pain, chronic pain, neuropathic pain, headache, migraine, arthritis, multiple sclerosis, anorexia, nausea, vomiting, anorexia, loss of appetite, anxiety, or insomnia (¶0072-0073, “for the treatment or prevention of pulmonary diseases or disorders such as asthma, chronic obstructive pulmonary diseases (COPD) cystic fibrosis (CF)… diabetes mellitus, rheumatoid arthritis, plaque psoriasis, Crohn's disease, hormone replacement, neutropenia, nausea, influenza”).
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 2-4, 6, 11-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Germinario et al. as applied to claims 1 and 10 above, and further in view of Bayat et al. (US Pub 2021/0219605).
Regarding claim 2, Germinario et al. discloses the device of claim 1 as discussed above.
While Germinario et al. discloses that it may be desirable to provide the coatings or surface modification to the aperture plates (chemical or structural) in order to enhance microfluidic properties, render surfaces either hydrophilic or hydrophobic or render surfaces antimicrobial (¶0135), Germinario et al. is silent on the aperture plate is coated with a hydrophobic polymer.
However, Bayat et al. which is analogous art to the claim invention given the ejector mechanism including the electronic actuator (56, Fig 6) and the aperture plate (a mesh element 10, Fig 6; 10 with a first layer 12 and second layer 14, Fig 2-3) for generating of an aerosol exhibiting a small droplet size, teaches that the aperture plate (10, Fig 2-4) is coated with a hydrophobic polymer (¶0049 - The hydrophobic coating may be provided on the entire outer surface of the mesh element…may comprise at least one of polyurethane (PU), a fluorocarbon (PFC), polytetrafluoroethylene (PTFE)) in order to increase or maximized contact angle for improving the release of liquid droplet from outer surface while reducing or minimizing the size of the liquid droplets (¶0047).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of the Germinario et al. to include wherein the aperture plate of the droplet delivery device is coated with a hydrophobic polymer as taught by Bayat et al. in order to increase or maximized contact angle for improving the release of liquid droplet from outer surface while reducing or minimizing the size of the liquid droplets (¶0047).
Regarding claim 3, Germinario et al. in view of Bayat et al. discloses the device of claim 2 as discussed above.
Modified Germinario et al. further discloses, wherein the hydrophobic polymer is selected from the group consisting of polytetrafluoroethylene, a siloxane, paraffin, and polyisobutylene (Bayat et al.: ¶0049 as discussed above).
Regarding claim 4, Germinario et al. in view of Bayat et al. discloses the device of claim 2 as discussed above.
Modified Germinario et al. further discloses, wherein the hydrophobic polymer is coated on at least a portion of droplet exit side surface of the aperture plate. (Bayat et al.: Figs 2-4; ¶0049 as discussed above).
Regarding claim 6, Germinario et al. in view of Bayat et al. discloses the device of claim 2 as discussed above.
Modified Germinario et al. further discloses, wherein the hydrophobic polymer coating is chemically or structurally modified or treated (Germinario et al.: ¶0135).
Regarding claim 11, Germinario et al. discloses the method of claim 10 as discussed above.
While Germinario et al. discloses that it may be desirable to provide the coatings or surface modification to the aperture plates (chemical or structural) in order to enhance microfluidic properties, render surfaces either hydrophilic or hydrophobic or render surfaces antimicrobial (¶0135), Germinario et al. is silent on the aperture plate is coated with a hydrophobic polymer.
However, Bayat et al. which is analogous art to the claim invention given the ejector mechanism including the electronic actuator (56, Fig 6) and the aperture plate (a mesh element 10, Fig 6; 10 with a first layer 12 and second layer 14, Fig 2-3) for generating of an aerosol exhibiting a small droplet size, teaches that the aperture plate (10, Fig 2-4) is coated with a hydrophobic polymer (¶0049 - The hydrophobic coating may be provided on the entire outer surface of the mesh element…may comprise at least one of polyurethane (PU), a fluorocarbon (PFC), polytetrafluoroethylene (PTFE)) in order to increase or maximized contact angle for improving the release of liquid droplet from outer surface while reducing or minimizing the size of the liquid droplets (¶0047).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of the Germinario et al. to include wherein the aperture plate of the droplet delivery device is coated with a hydrophobic polymer as taught by Bayat et al. in order to increase or maximized contact angle for improving the release of liquid droplet from outer surface while reducing or minimizing the size of the liquid droplets (¶0047).
Regarding claim 12, Germinario et al. in view of Bayat et al. discloses the device of claim 11 as discussed above.
Modified Germinario et al. further discloses, wherein the hydrophobic polymer is selected from the group consisting of polytetrafluoroethylene, a siloxane, paraffin, and polyisobutylene (Bayat et al.: ¶0049 as discussed above).
Regarding claim 13, Germinario et al. in view of Bayat et al. discloses the method of claim 11 as discussed above.
Modified Germinario et al. further discloses, wherein the hydrophobic polymer is coated on at least a portion of droplet exit side surface of the aperture plate. (Bayat et al.: Figs 2-4; ¶0049 as discussed above).
Regarding claim 15, Germinario et al. in view of Bayat et al. discloses the method of claim 11 as discussed above.
Modified Germinario et al. further discloses, wherein the hydrophobic polymer coating is chemically or structurally modified or treated (Germinario et al.: ¶0135).
Claims 5, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Germinario et al. in view of Bayat et al. as applied to claims 2 and 11 above, and further in view of Wilkerson et al. (US Pub 2013/0299607).
Regarding claim 5, Germinario et al. in view of Bayat et al. discloses the device of claim 2.
While modified Germinario et al. discloses that the hydrophobic surfaces increase or maximized contact angle for improving the release of liquid droplet from outer surface while reducing or minimizing the size of the liquid droplets (Bayat et al. ¶0047), modified Germinario et al. does not specifically discloses, wherein the hydrophobic polymer is coated within at least a portion of the interior of at least one of the openings.
However, Wilkerson et al. which is analogous art to the claimed invention given the electric actuator (5504, Fig 55A) and the aperture plate (5502, 5532, Fig 55A) for user of delivering safe, suitable and repeatable dose of fluids to a subject for ophthalmic, topical, oral, nasal, or pulmonary use (¶0010) teaches wherein the hydrophobic polymer is coated within at least a portion of the interior of at least one of the openings (Fig 55A; ¶0232 – one or both of the surface 5522 of ejector plate 5502 and the wetted surface of generator plate 5532 that faces the reservoir 5520 may be coated with a hydrophilic or hydrophobic coating) in purpose of providing protecting and/or prevention of interaction with the fluid (¶0226).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of the modified Germinario et al. to include wherein the hydrophobic polymer is coated within at least a portion of the interior of at least one of the openings as taught by Wilkerson et al. in purpose of providing protecting and/or prevention of interaction with the fluid (¶0226). Further, applicant places no criticality on the hydrophobic polymer is coated within at least a portion of the interior of the at least one of the openings as claimed, indicating simply different arrangement of the coating as described in ¶0113 of the instant application by making various slight alterations in design from different embodiments. The differently disclosed embodiments thus suggest applicant considered the different designs to be merely design choice alternatives.
Regarding claim 14, Germinario et al. in view of Bayat et al. discloses the method of claim 11.
While modified Germinario et al. discloses that the hydrophobic surfaces increase or maximized contact angle for improving the release of liquid droplet from outer surface while reducing or minimizing the size of the liquid droplets (Bayat et al. ¶0047), modified Germinario et al. does not specifically discloses, wherein the hydrophobic polymer is coated within at least a portion of the interior of at least one of the openings.
However, Wilkerson et al. which is analogous art to the claimed invention given the electric actuator (5504, Fig 55A) and the aperture plate (5502, 5532, Fig 55A) for user of delivering safe, suitable and repeatable dose of fluids to a subject for ophthalmic, topical, oral, nasal, or pulmonary use (¶0010) teaches wherein the hydrophobic polymer is coated within at least a portion of the interior of at least one of the openings (Fig 55A; ¶0232 – one or both of the surface 5522 of ejector plate 5502 and the wetted surface of generator plate 5532 that faces the reservoir 5520 may be coated with a hydrophilic or hydrophobic coating) in purpose of providing protecting and/or prevention of interaction with the fluid (¶0226).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Germinario et al. to include wherein the hydrophobic polymer is coated within at least a portion of the interior of at least one of the openings as taught by Wilkerson et al. in purpose of providing protecting and/or prevention of interaction with the fluid (¶0226). Further, applicant places no criticality on the hydrophobic polymer is coated within at least a portion of the interior of the at least one of the openings as claimed, indicating simply different arrangement of the coating as described in ¶0113 of the instant application by making various slight alterations in design from different embodiments. The differently disclosed embodiments thus suggest applicant considered the different designs to be merely design choice alternatives.
Claims 7, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Germinario et al. as applied to claims 1 and 10 above, and further in view of Surber et al. (US Pub 2010/0037890).
Regarding claim 7, Germinario et al. discloses the device of claim 1 as discussed above.
While Germinario et al. discloses, the ejected stream of droplets includes, without limitation, solutions, suspensions or emulsions which have viscosities in a range capable of droplet formation (¶0083) and various therapeutic agents for treating/preventing pulmonary diseases/disorders or inducing symptoms (¶0072-0074), Germinario et al. is silent on wherein the low surface tension composition comprises an alcohol as a solvent.
However, Surber et al. which is analogous art to the claimed invention for aerosol administration of fluoroquinolone antimicrobials for the treatment of pulmonary bacterial infections (abstract) teaches, the liquid pharmaceutically administrable compositions in a carrier such as water, saline, aqueous dextrose, glycerol, glycols, ethanol or the like to form a solution or suspension which can be aerosolized in conventional forms (¶0149; ¶0180, “liquid components other than water which may be useful include propylene glycol, glycerol, and polyethylene glycol”; ¶0223, “in which the drug substance is essentially insoluble…suitable non-aqueous media include ethanol, trichloromonofluormethane, and dichlorotetrafluoroethane”) in order to provide various composition intended for therapeutic administration with different clinical and pharmacological requirement (¶0007-0009).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Germinario et al. to include an alcohol as a solvent for the low surface tension composition as taught by Surber et al. in order to provide various composition intended for therapeutic administration with different clinical and pharmacological requirement (¶0007-0009).
Regarding claim 16, Germinario et al. discloses the method of claim 10 as discussed above.
While Germinario et al. discloses, the ejected stream of droplets includes, without limitation, solutions, suspensions or emulsions which have viscosities in a range capable of droplet formation (¶0083) and various therapeutic agents for treating/preventing pulmonary diseases/disorders or inducing symptoms (¶0072-0074), Germinario et al. is silent on wherein the low surface tension composition comprises an alcohol as a solvent.
However, Surber et al. which is analogous art to the claimed invention for aerosol administration of fluoroquinolone antimicrobials for the treatment of pulmonary bacterial infections (abstract) teaches, the liquid pharmaceutically administrable compositions in a carrier such as water, saline, aqueous dextrose, glycerol, glycols, ethanol or the like to form a solution or suspension which can be aerosolized in conventional forms (¶0149; ¶0180, “liquid components other than water which may be useful include propylene glycol, glycerol, and polyethylene glycol”; ¶0223, “in which the drug substance is essentially insoluble…suitable non-aqueous media include ethanol, trichloromonofluormethane, and dichlorotetrafluoroethane”) in order to provide various composition intended for therapeutic administration with different clinical and pharmacological requirement (¶0007-0009).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Germinario et al. to include an alcohol as a solvent for the low surface tension composition as taught by Surber et al. in order to provide various composition intended for therapeutic administration with different clinical and pharmacological requirement (¶0007-0009).
Regarding claim 17, Germinario et al. discloses the method of claim 10 as discussed above.
While Germinario et al. discloses, the ejected stream of droplets includes, without limitation, solutions, suspensions or emulsions which have viscosities in a range capable of droplet formation (¶0083) and various therapeutic agents for treating/preventing pulmonary diseases/disorders or inducing symptoms (¶0072-0074), Germinario et al. is silent on wherein the low surface tension composition comprises an agent that is insoluble in water.
However, Surber et al. which is analogous art to the claimed invention for aerosol administration of fluoroquinolone antimicrobials for the treatment of pulmonary bacterial infections (abstract) teaches, the low surface tension composition (¶0009) comprises an agent that is insoluble in water (¶0180, “liquid components other than water which may be useful include propylene glycol, glycerol, and polyethylene glycol”; ¶0223, “in which the drug substance is essentially insoluble…suitable non-aqueous media include ethanol, trichloromonofluormethane, and dichlorotetrafluoroethane”) in order to provide various composition intended for therapeutic administration with different clinical and pharmacological requirement (¶0007-0009).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Germinario et al. to include the low surface tension composition comprises an agent that is insoluble as taught by Surber et al. in order to provide various composition intended for therapeutic administration with different clinical and pharmacological requirement (¶0007-0009).
Regarding claim 20, Germinario et al. discloses the device of claim 1 as discussed above.
While Germinario et al. discloses, the ejected stream of droplets includes, without limitation, solutions, suspensions or emulsions which have viscosities in a range capable of droplet formation (¶0083) and various therapeutic agents for treating/preventing pulmonary diseases/disorders or inducing symptoms (¶0072-0074), Germinario et al. is silent on wherein the low surface tension composition comprises an alcohol as a solvent.
However, Surber et al. which is analogous art to the claimed invention for aerosol administration of fluoroquinolone antimicrobials for the treatment of pulmonary bacterial infections (abstract) teaches, an agent having a solubility in water of less than 500 mg/L at 25 °C (¶0149; ¶0180, “liquid components other than water which may be useful include propylene glycol, glycerol, and polyethylene glycol”; ¶0223, “in which the drug substance is essentially insoluble…suitable non-aqueous media include ethanol, trichloromonofluormethane, and dichlorotetrafluoroethane”; Examiner interprets “a solubility in water of less than 500 mg/L at 25 °C” as to --an agent that is in soluble or sparingly soluble in water-- as described in ¶0036-0038 such as alcohol solution ) in order to provide various composition intended for therapeutic administration with different clinical and pharmacological requirement (¶0007-0009).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Germinario et al. to include an alcohol as a solvent for the low surface tension composition as taught by Surber et al. in order to provide various composition intended for therapeutic administration with different clinical and pharmacological requirement (¶0007-0009).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Germinario et al. in view of and Surber et al. as applied to claim 17 above, and further in view of Rubin (US Pub 2019/0321570).
Regarding claim 18, Germinario et al. in view of Surber et al. discloses the method of claim 17.
Modified Germinario et al. does not specifically discloses, wherein the agent that is insoluble or sparingly soluble in water is selected from the group consisting of cannabinoids and derivatives thereof, fluticasone furoate, and fluticasone propionate.
However, Rubin which is analogous art to the claimed invention, teaches delivering aerosols of various substances including water insoluble substance (¶0293) wherein the agent that is insoluble or sparingly soluble in water is selected from the group consisting of cannabinoids and derivatives thereof, fluticasone furoate, and fluticasone propionate (¶0216, flavored nicotine solutions and cannabis oils, etc.; ¶0292-296 – pharmaceutical aerosols that can be delivered that include, but are not limited to: fluticasone propionate, sumatriptan, tetrahydrocannabinol) in purpose of enhancing the deliverability of drug candidate and more pharmaceutical are being made available for inhalation. (¶0292)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Germinario et al. to include wherein the agent that is insoluble or sparingly soluble in water is selected from the group consisting of cannabinoids and derivatives thereof, fluticasone furoate, and fluticasone propionate as taught by Rubin for the purpose of enhancing the deliverability of drug candidate and more pharmaceutical are being made available for inhalation (¶0292).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
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/J.J./Examiner, Art Unit 3785 /JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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