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 Amendment
Applicant’s amendment to claims 25, 35-36, and 40, cancellation of claims 31 and 33-34, amendment to the drawings, amendment to the specification, and accompanying remarks filed 09/17/2025 (“Amendment”) have been entered. Accordingly, the objections to the drawings, specification, and claims, the claim rejections under 35 USC 112, and the claim rejections under 35 USC 103 based on Hazani are withdrawn. However, the claim rejections under 35 USC 103 based on Shahaf and other references are maintained (the Amendment incorporated the subject matter of claim 34 into claim 25, and thus the previous rejection applied to claim 34 is now applied to claim 25). Additionally, a new rejection of claim 36 under 35 USC 112 is necessitated by the amendment. Claims 25-30, 32, 35-41 remain pending and are examined herein.
Response to Arguments
Applicant's arguments regarding (1) the rejection of claim 34/amended claim 25 under 35 USC 103 (Amendment p. 9-13) and (2) the rejections of the other dependent claims under 35 USC 103 (Amendment p. 14-15) have been fully considered but they are not persuasive.
Regarding (1), Applicant specifically argues that Rubin’s negative pressure threshold valve only pertains to inhalation and therefore the combination of Shahaf and Rubin does not read on the stop valve of amended claim 25 (Amendment p. 9-12). The Examiner respectfully disagrees because the argument essentially attacks Rubin individually, but one of ordinary skill in the art would combine the references in a functional manner. 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). Rubin’s negative pressure threshold valve indeed pertains to inhalation as alleged by Applicant, but the inhalation must still exceed a pressure threshold (Rubin at [0060]). One of ordinary skill in the art would recognize that the negative pressure threshold valve ensures gas is delivered with sufficient pressure, regardless of whether such gas relates to nebulization or inhalation. It would be obvious to place such a valve between Shahaf’s air chamber 2 and nozzle in order to better control the gas flow therebetween, particularly because Shahaf already discloses a regulator for controlling gas pressure (Shahaf at [0805]).
Further regarding (1), Applicant specifically argues that the combination would not avoid sputtering and other issues avoided by the present invention, and thus the combination would not read on amended claim 25 and lacks motivation to combine (Amendment p. 12-13). However, the Examiner respectfully disagrees because the argument is directed to unclaimed features. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim merely requires the stop valve to close/open below/above the reference minimum pressure, which is met by the combination. Motivation to combine the references exists as set forth in the rejections below, and the argument does not specifically attack the cited motivation beyond asserting that Shahaf and Rubin are “fundamentally different” (Amendment p. 13), which the Examiner respectfully disagrees with.
Regarding (2), the Examiner respectfully disagrees and submits that the dependent claims are not allowable because amended claim 25 is not allowable.
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.
Claim 36 is 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 36 as amended recites “a pressure regulator located between said second tank arranged to contain said cold liquid atomizer”, which appears to be a typo of “a pressure regulator located between said second tank and said cold liquid atomizer” in view of original claim 20, the specification at p. 25, and Figs. 4-5 showing pressure regulator 10 between second tank 4 and assembly E (which contains cold liquid atomizer 2). Claim 36 is interpreted as such for purposes of this office action.
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 25-26, 29, 36-37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf (US 2018/0344951 A1) in view of Rubin (US 2013/0327323 A1).
Regarding claim 25, Shahaf discloses a device for aerosolized delivery of a substance to a natural orifice of the body (Title). To activate the device, a user inhales on a mouthpiece 5 which releases compressed gas from an air chamber 2 (“a second tank”) to pass through a substance capsule 21 and a nozzle (“a cold liquid atomizer” and “an assembly”) ([0379, 0393-0394] and Fig. 3, reproduced below). The device includes a mechanism for releasing the gas (“a trigger”) which is not shown in Fig. 3 [0393]. The air chamber 2 includes a piston 8 (“a pump”) which retracts to pull air in, then extends to compress the gas [0393]. A liquid in the substance capsule 21 is held in a holding chamber 2200 (“a first tank”) to be contacted by the compressed gas ([0473, 0488-0490, 0566] and Figs. 7A-C). The mouthpiece is not “in fluid communication with an outlet of said atomizer”, because the gas is delivered via nosepiece 6 [0393]. However, Shahaf broadly discloses that the device can deliver the substance to body orifices including the mouth [0325].
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 device to deliver the compressed gas and substance via the mouthpiece 5, in order to deliver the substance to the mouth as taught by Shahaf.
Shahaf also discloses that a typical nebulizer may include a regulator to control the gas pressure to improve repeatability of the nebulizer [0805]. Shahaf also discloses a valve restraining the substance and gas, which may be mechanical or a frangible seal ([0321, 0465] and Figs. 6-7). However, Shahaf fails to explicitly disclose “a stop valve located upstream from said cold liquid atomizer, said stop valve comprising a second inlet and a second outlet, the second inlet being connected by a first fluid connection to an outlet of said second tank, and the second outlet being connected by a second fluid connection to a first inlet of said cold liquid atomizer, said stop valve being configured to be and remain closed as long as a pressure of said pressurised gas at said second inlet is less than a reference minimum pressure and being configured to open when and as long as said pressure of said pressurised gas at said second inlet is greater than or equal to the reference minimum pressure”.
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Rubin is directed to a nebulizer having different negative pressure threshold settings (Title). A user must exert increased inhalation effort in order to actuate the negative pressure threshold valve [0012] (which reads on the claimed stop valve configuration). Rubin explains that increased thresholds can be desirable in certain circumstances, such as for patient lung exercise [0008].
One of ordinary skill in the art would recognize that the negative pressure threshold valve is also useful to ensure delivered gas has a threshold pressure, particularly in view of Shahaf’s disclosure of a regulator to control the gas pressure for repeatability. 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 Shahaf’s device to include the valve of Rubin between the air chamber 2 and nozzle, to ensure that air with sufficient pressure is controllably delivered as taught by Shahaf and Rubin.
Regarding claim 26, the inlet of the holding chamber 2200 receives the compressed gas from the air chamber 2, as set forth above (which reads on “wherein an inlet of said first tank is in fluid communication with said second tank”) [0473, 0488-0490].
Regarding claim 29, the piston 8 includes a lever 4 and handle 3 which are pulled apart by a user to retract the piston 8, and pushed to extend the piston 8 (“a manual pump”) [0393].
Regarding claim 36, Shahaf discloses that a typical nebulizer may include a regulator to control the gas pressure to improve repeatability of the nebulizer [0805] (“a pressure regulator located between said second tank arranged to contain a pressurised gas and said cold liquid atomizer”).
One of ordinary skill in the art would recognize that a regulator could be positioned between the air chamber 2 and nozzle to control the pressure of delivered air. 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 device to include a regulator between the air chamber 2 and substance capsule 21 to improve repeatability of the device as taught by Shahaf.
Regarding claim 37, Shahaf does not teach or suggest a battery for the device (“wherein the device is free of a battery”).
Regarding claim 39, Shahaf discloses a method of using the device to cause compressed gas to exit the air chamber 2, pass through the substance capsule 21, and exit via the nosepiece 6 [0392-0393] (which reads on “A method of using a device for inhaling a substance according to claim 25, the method comprising atomizing at least one substance to be inhaled”).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf (US 2018/0344951 A1) in view of Rubin (US 2013/0327323 A1) as applied to claim 26 above, further in view of Maier (US 2021/0162148 A1).
Shahaf discloses the device according to claim 25 as set forth above. However, the nozzle (the claimed “cold liquid atomizer”) is not disclosed as having multiple inlets or as being within the holding chamber 2200 (the claimed “first tank”), so Shahaf fails to explicitly disclose “wherein a first inlet of said cold liquid atomizer is in fluid communication with said second tank, and wherein a second inlet of said cold liquid atomizer is in fluid communication with said first tank” as in claim 27 and “wherein said cold liquid atomizer is located at least partially in said first tank” as in claim 28.
Maier is directed to an airway inhalant nebulizer cartridge (Title) and discloses that Venturi nozzles are well known devices useful in un-heated nebulizers using pressurized air [0008]. Maier discloses a nebulizer with a Venturi nozzle 43 that directs and accelerates a stream of air across a fluid opening 40 to draw up and aerosolize the material [0029-30] (which reads on “wherein a first inlet of said cold liquid atomizer is in fluid communication with said second tank, and wherein a second inlet of said cold liquid atomizer is in fluid communication with said first tank” per claim 27 and “wherein said cold liquid atomizer is located at least partially in said first tank” per claim 28).
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 nozzle of Shahaf to be a Venturi nozzle directing the pressurized air across an opening of the holding chamber 2200, with motivation being to accelerate the air and thus improve aerosolization as taught by Maier.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Shahaf (US 2018/0344951 A1) in view of Rubin (US 2013/0327323 A1) as applied to claim 29 above, further in view of Jung (US 2016/0341186 A1).
Shahaf discloses the piston 8 which is manipulated by a user to load pressurized air into chamber 2, as set forth above [0393]. However, Shahaf fails to disclose “a two-way pump” as in claim 30.
Jung is directed to a hydraulic double-acting hand pump (Title) and is therefore reasonably pertinent to the problem solved in the instant application (e.g., assisting the user in manually pumping to a sufficient pressure). The pump has high and low pressure sides with pistons 200 [0033]. When one piston 200 moves downward and pushes fluid out of the pump, the other piston moves upward and simultaneously sucks fluid into the pump [0060, 0064] (which reads on “a two-way pump” per claim 30). The pump includes a handle 300 which a user presses to move the pistons 200 downward [0073]. When a relief valve 107 is opened, pressure on the handle decreases, which assists the user in pumping the handle 300 [0073].
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 device and piston 8 of Shafah to include the hydraulic double-acting hand pump of Jung, with motivation being to assist the user in manually filling the air chamber 2.
Claims 32 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf (US 2018/0344951 A1) in view of Rubin (US 2013/0327323 A1) as applied to claim 29 above, further in view of Buchberger (GB 2529201 A).
Shahaf discloses the piston 8 which is manipulated by a user to load pressurized air into chamber 2, as set forth above [0393]. However, Shahaf fails to disclose “a device arranged to transform mechanical energy into electrical energy” as in claim 32 and “a device arranged to transform mechanical energy provided by a user into electrical energy to activate the pump when the pump is a manual pump” as in claim 40.
Buchberger is directed to an aerosol delivery device (Title). The device may include, in lieu of a battery, a mechanical power source such as a spring or dynamo (“a device” as recited in claims 32 and 40; see Applicant’s specification at p. 9 l. 25 listing a dynamo as an example of the device for transforming mechanical to electrical energy) [0021].
One of ordinary skill in the art would recognize that the dynamo of Buchberger could similarly be applied to the device of Shahaf. See MPEP 2143(I)(C); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). Shahaf’s device with piston 8 is a base device which is comparable to the aerosol delivery device of Buchberger. The aerosol delivery device of Buchberger has been improved by the dynamo which allows for a mechanical power source rather than a battery. One of ordinary skill in the art could similarly and predictably incorporate the dynamo into Shahaf’s device and piston 8. 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 device of Shahaf to include the dynamo of Buchberger, because this is a use of a known technique to improve a similar device in the same way, which is within the purview of the skilled artisan.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Shahaf (US 2018/0344951 A1) in view of Rubin (US 2013/0327323 A1) as applied to claim 25 above, further in view of Dexue (CN 108295345 A).
Shahaf discloses the device according to claim 25, the valve, and the regulator as set forth above ([0321, 0465, 0805] and Figs. 6-7). However, Shahaf fails to explicitly disclose “a safety valve comprising an inlet fluidically connected to the second tank arranged to contain a pressurised gas, and an outlet in fluid communication with an outer surrounding environment, said safety valve being configured to be and remain closed as long as an inlet pressure at the inlet of the safety valve is less than a predetermined safety pressure and being configured to open when and as long as said inlet pressure at the inlet of the safety valve is greater than the predetermined safety pressure.”
Dexue is directed to a medical nebulizer which uses high pressure gas and crushing to finely atomize particles [0005-7]. Dexue discloses an air pressure safety valve 10 within the atomization chamber 2, which automatically releases excessive pressure to ensure user safety (which reads on the claimed safety valve configuration) ([0030] and Fig. 1).
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 device of Shahaf to include the air pressure safety valve 10 downstream of the air chamber 2, in order to automatically release excessive pressure to ensure user safety as taught by Dexue.
Claims 38 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf (US 2018/0344951 A1) in view of Rubin (US 2013/0327323 A1) as applied to claim 25 above, further in view of Hearn (US 2011/0315152 A1).
Shahaf discloses the device of claim 25 including the pressurized air chamber 2 as set forth above. However, Shahaf fails to explicitly disclose “a station for filling said second tank with gas” per claim 38 and “a station for filling said second tank with air and/or recharging the device for inhaling a substance with electrical energy” per claim 41.
Hearn discloses a system comprising a simulated cigarette device and a refill device (“a station”) containing a compressed, vaporisable liquid propellant and nicotine [0018, 53]. The refill device allows the cigarette device 1 to use a small reservoir 7 in order to achieve a consistent discharge flow rate [0008-12, 0020-23].
One of ordinary skill in the art would recognize that the refill device would similarly be useful to achieve a consistent discharge flow rate in the air chamber 2 of Shahaf, which delivers its predetermined volume of pressurized air to the substance capsule 21 as set forth above. 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 device of Shahaf so that the air chamber 2 can be refilled by the refill device of Hearn containing compressed air, with motivation being to achieve a consistent discharge flow rate as taught by Hearn.
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 MICHAEL PATRICK MULLEN whose telephone number is (571)272-2373. The examiner can normally be reached M-F 10-7 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H. Wilson can be reached on (571) 270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL PATRICK MULLEN/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747