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 Preliminary Amendment
This Office Action is in response to the preliminary amendment filed on 03/10/2025. Claims 1, 12, 18, and 30 are as currently amended. Claims 5, 16-17, 19-29, and 34 are canceled. Claims 2-4, 6-11, 13-15, 31-33, and 35-36 are as previously presented. As such, claims 1-4, 6-15, 18, 30-33, and 35-36 are pending in the instant application.
Claim Objections
Claims 9-11, 32, and 36 are objected to because of the following informalities:
Claim 9, lines 2-3: “API in which at least 30%, of the emitted dose has aerodynamic diameters” should read “including the API in which at least 30% of the emitted dose has aerodynamic diameters” for clarity.
Claim 10, line 1: “the aerosol dose” should read “an aerosol dose” for clarity and to establish antecedent basis.
Claim 11, line 1: “the emitted dose” should read “an emitted aerosol dose” for clarity and to establish antecedent basis.
Claim 32, line 1: “the SMI” should read “an SMI” for clarity and to establish antecedent basis.
Claim 36: “wherein the nebulizer is selected from a jet nebulizer, an ultrasonic nebulizer, a mesh nebulizer” should read “wherein the nebulizer is one of a jet nebulizer, an ultrasonic nebulizer, or a mesh nebulizer” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 6-7, 9, 11-12, 18, and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by White (US 9016274 B1).
Regarding claim 1, White discloses an inhaler (device 10 for vaporizing and delivering an agent in the form of an aerosol, see col. 6, lines 25-27 and lines 29-30; Fig. 1) for delivering an API in aerosol form (col. 6, lines 1-6), the inhaler comprising:
(a) a container (85; Fig. 12) that includes an API and one or more pharmaceutically acceptable carriers in a liquid formulation (col. 14, lines 63-66, where the aerosol agent and the aerosol forming agent are in a solution, see col. 11, lines 36-38 and lines 62-63);
(b) a nozzle, valve, or outlet in communication with the container (end of aerosol delivery tube 82 closest to substrate 85, see Fig. 12) to deliver an aerosol obtained from the liquid formulation (col. 15, lines 5-9);
(c) an insert (filter portion 88; Fig. 12) located downstream of the nozzle, valve or outlet (see Fig. 12).
Regarding claim 3, White discloses the invention as set forth in claim 1, wherein the insert includes a centrally located orifice (filter portion 88 has central longitudinally extending hole 86, see Fig. 12).
Regarding claim 4, White discloses the invention as set forth in claim 1, wherein the insert provides obstructions along from about 10% to about 90% of a total cross-sectional area along an airpath downstream of the nozzle, valve, or outlet (see Annotated Fig. 12 below, where filter portion 88 is about 2.8 cm and airpath is about 3.5 cm, hence the filter portion 88 provides obstruction along about 80% of the total cross-sectional area along the airpath).
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Annotated Fig. 12
Regarding claim 6, White discloses the invention as set forth in claim 1, wherein the container includes API is in an aqueous solution (aerosol forming agent can be a liquid, see col. 11, lines 55-63; aerosol agent and aerosol forming agent are in a liquid solution, see col. 11, lines 36-38 and lines 62-63, see col. 10, lines 33-36).
Regarding claim 7, White discloses the invention as set forth in claim 6, wherein the aqueous solution includes an alcohol (col. 11, lines 62-64).
Regarding claim 9, White discloses the invention as set forth in claim 1, wherein the inhaler (device 10) emits an aerosol dose including the API in which at least 30%, of the emitted dose has aerodynamic diameters between 0.5 - 3.5 micrometers (aerosol particle size of about 0.2-3.0 micron, see col. 6, lines 4-6, where “micron” is commonly known as a shortened and informal name a micrometer).
Regarding claim 11, White discloses the invention as set forth in claim 1, wherein at least 40% the emitted dose is contained in droplets with aerodynamic sizes less than about 4 microns (aerosol particle size of about 0.2-3.0 micron, see col. 6, lines 4-6).
Regarding claim 12, White discloses the invention as set forth in claim 1, wherein the API is nicotine (aerosol agent may be nicotine, see col. 11, lines 47-50) or a salt thereof.
Regarding claim 18, White discloses a method for performing Nicotine Replacement Therapy (NRT) on a subject to reduce or prevent consumption of cigarettes and other forms of tobacco (col. 1, lines 6-11; col. 2, lines 63-67) comprising administering to the subject an inhaler (device 10 for vaporizing and delivering an agent in the form of an aerosol, see col. 6, lines 25-27 and lines 29-30; Fig. 1) comprising:
(a) a container (85; Fig. 12) that includes nicotine (aerosol agent may be nicotine, see col. 11, lines 47-50) or salt thereof and one or more pharmaceutically acceptable carriers in a liquid formulation (col. 14, lines 63-66, where the aerosol agent and the aerosol forming agent are in a solution, see col. 11, lines 36-38 and lines 62-63);
(b) a nozzle, valve, or outlet in communication with the container (end of aerosol delivery tube 82 closest to substrate 85, see Fig. 12) to deliver an aerosol from the liquid formulation (col. 15, lines 5-9);
(c) an insert (filter portion 88; Fig. 12) located downstream of the nozzle, valve or outlet in a mouthpiece of the inhaler (see Fig. 12).
Regarding claim 30, White discloses an inhaler (device 10 for vaporizing and delivering an agent in the form of an aerosol, see col. 6, lines 25-27 and lines 29-30; Fig. 1) comprising:
(a) a container (85; Fig. 12) that includes nicotine (aerosol agent may be nicotine, see col. 11, lines 47-50) or a salt thereof and one or more pharmaceutically acceptable carriers in a liquid formulation (col. 14, lines 63-66, where the aerosol agent and the aerosol forming agent are in a solution, see col. 11, lines 36-38 and lines 62-63);
(b) a nozzle, valve, or outlet in communication with the container (end of aerosol delivery tube 82 closest to substrate 85, see Fig. 12) to deliver an aerosol from the liquid formulation suitable for pulmonary administration to a human (col. 15, lines 5-18, where aerosol is breathed in using inhaler device 10, hence the aerosol is suitable for and delivered to the user by pulmonary administration); and
(c) a mouthpiece sized for administration to a mouth of the human (end of aerosol delivery tube 82 at filter portion 88, see Fig. 12).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over White (US 9016274 B1) in view of Abiko et al. (US 4846168 A; hereinafter “Abiko”).
Regarding claim 2, White discloses the invention as set forth in claim 1, but fails to explicitly disclose wherein the insert is located from about 1 to about 10 mm downstream from the nozzle, valve, or outlet.
However, Abiko teaches an analogous inhaler (Fig. 8) with a porous plate (12; Fig. 8) located about 1.5 cm to 3.5 cm downstream from a bent section (1b; Figs. 8-9) formed in a hollow barrel section (1a; Figs. 8-9) of the inhaler (col. 6, lines 59-64).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify White such that the filter portion (88) is located about 1.5 cm to 3.5 cm downstream from the end of the aerosol delivery tube (82) closest to the substrate (85), as taught by Abiko (Figs. 8-9; col. 6, lines 59-64) to increase the inhaling efficiency of the aerosol (Abiko col. 6, lines 65-68). Additionally, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to further modify the distance from the filter portion to the end of the aerosol delivery tube closest to the substrate in the White device because Applicant has not disclosed that providing the insert about 1 mm to 10 mm downstream from the nozzle, valve, or outlet provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant’s specification discloses “the insert is located from about 1 to about 10 mm downstream from the location where the aerosol is generated” (see [0017] of US PGPub 2025/0128002 A1). One of ordinary skill in the art, furthermore, would have expected the filter portion (88) of White, as modified by Abiko above, and Applicant’s insert, to perform equally well because both mechanisms perform the same function of providing obstructions along a portion of an airpath downstream of where an aerosol is generated and/or released to be delivered to a user, such that the passage of larger particulate matter is prevented. Therefore, it would have been prima facie obvious to further modify White to obtain the invention as specified in claim 2 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired distance between the filter portion (88) and the end of the aerosol delivery tube (82) closest to the substrate (85), and thus fails to patentably distinguish over the prior art of White, as modified by Abiko.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over White (US 9016274 B1) in view of Gonda (US 20140261474 A1).
Regarding claim 8, White discloses the invention as set forth in claim 7, but fails to explicitly disclose wherein the alcohol is ethanol.
However, Gonda teaches an analogous inhaler for inhaling a smoke-free form of nicotine ([0001]), where the liquid formulation to be aerosolized and supplied to the patient includes alcohol, specifically ethanol ([0073]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the alcohol aerosol forming agent taught by White, to be ethanol, as taught by Gonda, to reduce the particle size of the aerosol being generated (Gonda [0073], lines 13-19), thus improving the abortion of the aerosol agent.
Claims 10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over White (US 9016274 B1) in view of Wensley et al. (US 20140190496 A1; hereinafter “Wensley”).
Regarding claim 10, White discloses the invention as set forth in claim 1, but fails to explicitly disclose wherein the aerosol dose is emitted at inspiratory flow rates between 5 - 140 L/min.
However, Wensley teaches an analogous aerosol generating device to deliver nicotine, or another pharmaceutically active agent, to a user in an aerosol dose (Abstract; [0008]; [0014]; [0019]), where the aerosol dose is emitted at a flow rate from about 20 LPM to about 80 LPM ([0019], lines 12-16), which falls within an flow rate range of 5 LPM to 140 LPM.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify White to emit the aerosol dose at a flow rate of 20 LPM to about 80 LPM, as taught by Wensley, such that the aerosol is provided to the user at a flow rate safe for the user’s lungs and to successfully deliver the aerosol to a deep lung of the user (Wensley [0019], lines 12-15), improving absorption of the aerosol.
Regarding claim 13, White discloses the invention as set forth in claim 12, but fails to explicitly disclose wherein the API is in the form of a nicotine salt.
However, Wensley teaches an analogous aerosol generating device to deliver nicotine, or another pharmaceutically active agent, to a user in an aerosol dose (Abstract; [0008]; [0014]; [0019]), where the aerosol agent is nicotine ([0138], lines 1-3) and can be in the form of a nicotine salt by adding a buffer of citric acid ([0139]) to create nicotine citrate salt.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the aerosol agent (i.e. nicotine) with a citric acid buffer, as taught by Wensley, such that the aerosol agent (i.e. nicotine) is in the form of nicotine citrate salt to adjust the pH of the aerosol agent to match previous stimulus characteristics of smoking, and thus improving the success of NRT during the initial transition off of combustible tobacco (Wensley last sentence of [0333]).
Regarding claim 14, White as modified teaches the invention as set forth in claim 13, wherein the nicotine salt is a citrate salt or a sulphate salt (addition of citric acid to nicotine creates nicotine citrate salt, see claim 13 above; Wensley [0138], lines 1-3 and [0139]).
Regarding claim 15, White discloses the invention as set forth in claim 12, but fails to explicitly disclose wherein from about 0.01 mg to about 1 mg of nicotine (free base basis) is delivered per actuation.
However, Wensley teaches an analogous aerosol generating device to deliver nicotine, or another pharmaceutically active agent, to a user in an aerosol dose (Abstract; [0008]; [0014]; [0019]), where 25 µg to 200 µg of freebase nicotine is delivered per each dose ([0122], lines 1-3), where the device of Wensley delivers one dose at a time to the user (second sentence of [0095]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the aerosol dose, as taught by White, is 25 µg to 200 µg of freebase nicotine (Examiner’s Note: this is equal to 0.02 mg to 0.2 mg of freebase nicotine), as taught by Wensley, to reduce back of the throat impaction and upper airway deposition of the dose (Wensley [0095], lines 3-8), thereby increasing the amount of the dose being received by the deep lungs of the user, and improving absorption of the dose by the user’s deep lungs.
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over White (US 9016274 B1) in view of Karle et al. (US 9084660 B2; hereinafter “Karle”), as supported by Anderson (Anderson P. (2006). Use of Respimat Soft Mist inhaler in COPD patients. International journal of chronic obstructive pulmonary disease, 1(3), 251–259. https://doi.org/10.2147/copd.2006.1.3.251).
Regarding claim 31, White discloses the invention as set forth in claim 30, but fails to explicitly disclose wherein the inhaler is a soft mist inhaler (SMI).
However, Karle teaches an analogous inhaler that nebulizes a medicament preparation to generate an aerosol to be delivered to a user (col. 1, lines 6-10), where the inhaler is a soft mist inhaler (col. 1, lines 13-15; col. 2, lines 36-38).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhaler taught by White to be a soft mist inhaler, as taught by Karle, as the slowed delivery speed of the aerosol by the soft mist inhaler (Karle col. 1, lines 13-15; Karle col. 7, lines 42-46) improves lung drug deposition (see Abstract of Anderson, pg. 1).
Regarding claim 32, White discloses the invention as set forth in claim 30, but fails to explicitly disclose wherein the SMI forms intersecting jets to form aerosol droplets.
However, Karle teaches an analogous inhaler that nebulizes a medicament preparation to generate an aerosol to be delivered to a user (col. 1, lines 6-10), where the inhaler is a soft mist inhaler (col. 1, lines 13-15; col. 2, lines 36-38) formed by intercepting jets to form aerosol droplets (col. 7, lines 42-50).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhaler taught by White to be a soft mist inhaler with intercepting jets to aerosol droplets, as taught by Karle, as the slowed delivery speed of the aerosol by the soft mist inhaler (Karle col. 1, lines 13-15; Karle col. 7, lines 42-46) improves lung drug deposition (see Abstract of Anderson, pg. 1).
Claims 33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over White (US 9016274 B1) in view of Denyer et al. (US 9302060 B2; hereinafter “Denyer”).
Regarding claim 33, White discloses the invention as set forth in claim 30, but fails to disclose wherein the inhaler is a propellant-driven inhaler.
However, Denyer teaches an analogous aerosol drug delivery device for generating and delivering an inhaled pharmaceutical aerosol to a patient (see Abstract), where the inhaled pharmaceutical aerosol delivery device is a metered dose inhaler that is driven by a propellant (col. 12, lines 21-39).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhaler taught by White to be propellant-driven, as taught by Denyer, such that the aerosol is rapidly generated independent of the user’s breathing strength (Denyer col. 12, lines 30-39) to improve the accuracy and consistency of the aerosol dose delivered to the patient.
Regarding claim 35, White discloses the invention as set forth in claim 30, but fails to disclose wherein the inhaler includes a nebulizer.
However, Denyer teaches an analogous aerosol drug delivery device for generating and delivering an inhaled pharmaceutical aerosol to a patient (see Abstract), where the aerosol drug delivery device is a nebulizer, such as an ultrasonic nebulizer or a mesh nebulizer (col. 4, lines 39-50).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inhaler taught by White to include a nebulizer, such as an ultrasonic nebulizer or a mesh nebulizer, as taught by Denyer above, to facilitate the inhalation and delivery of the aerosol dose to the user without the need of special breathing coordination that a conventional inhaler requires.
Regarding claim 36, White as modified teaches the invention as set forth in claim 35, wherein the nebulizer is selected from a jet nebulizer, an ultrasonic nebulizer, a mesh nebulizer (Denyer col. 4, lines 49-50).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Atterbury et al. (WO 2004078244 A1): Regarding an inhaler that generates an aerosol for pulmonary administration to a user, and therapeutic agents that are dissolved in ethanol.
Campitelli & Mohseni (US 20220379053 A1): Regarding an inhaler with a filter element downstream of a capsule cavity, where the filter element has a length of about 10 mm to about 30 mm.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 9:00 AM to 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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