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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/16/2026 (“Amendment”), which includes amendments to claims 25 and 36, addition of new claims 42-43, and accompanying remarks, has been entered. Accordingly, the rejection of claim 36 under 35 USC 112 is withdrawn. The claim rejections under 35 USC 103 are maintained (albeit modified in view of the amended claim language). Claims 25-30, 32, and 35-43 are pending and examined herein.
Response to Arguments
Applicant's arguments regarding the rejections under 35 USC 103 (Amendment p. 5-10) have been fully considered but they are not persuasive.
Applicant argues that combining Shahaf and Rubin would result in a device that would not be closed as long as the pressure in the air chamber 2 is less than a minimum pressure between 0.1 and 1 bar, which does not read on claim 25 (Amendment p. 6-7). The Examiner respectfully disagrees because, as set forth in the rejection below, Rubin’s valve may be configured to open at a pressure above 100 cmH20 and below a pressure achievable by human lungs, which reads on the claimed pressure range.
Applicant further argues that the device would remain closed due to Rubin’s compressed gas inlet 111 exceeding the inhalation pressure and preventing the circular disc 133 from opening the valve, and thus the combination fails to attain a working device as claimed (Amendment p. 7). The Examiner respectfully disagrees because in the combination set forth below, the circular disc 133 would be arranged such that is opened by Shahaf’s compressed gas (i.e., Shahaf’s compressed gas in chamber 2 would be configured to active the valve similar to the inhalation, rather than keeping it shut via the inlet 111). It would be obvious to one of ordinary skill in the art to combine Shahaf and Rubin in a manner that utilizes Rubin’s negative pressure threshold valve rather than in a manner that keeps it closed.
Applicant further argues that Rubin’s valve is not actuated if an input pressure is higher than a certain value (Amendment p. 7-8), but the Examiner respectfully disagrees because Rubin’s valve in fact opens when the inhalation pressure (which in combination is the pressurized gas from Shahaf’s air chamber 2) is higher than a certain value (Rubin [0059]).
Applicant’s arguments regarding using Rubin’s baffles 119 to control particle size (Amendment p. 8) are moot because such baffles 119 are not discussed in the rejection below. Rather, particle size is controlled via delivery pressure as taught by both Shahaf and Rubin.
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, 39, and 42-43 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 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). Shahaf further discloses that the aerosol droplet size depends on delivery pressure [0385] and that the droplet size can be optimized [0641] (notably, Applicant’s specification at p. 19 l. 20-p. 20 l. 3 similarly explains that a sufficiently high pressure ensures a sufficiently small particle size). Shahaf further discloses experimental values with median particle sizes well below 100 µm ([0746-0761], Figs. 53-66, Table 13), for instance 40-45 and 50-65 µm ([0746-47], Figs. 53-54). 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, said minimum pressure comprising 0.1 to 1 bar to configure said device to form an aerosol having particles with a diameter less than 100 µm” as claimed.
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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]. Rubin discloses that the negative pressure threshold can be varied with a dialable valve, and thresholds may be above 1 centimeter of water, preferably above 3 cmH20, or above 10, 20, 50, or even above 100 cmH20, so long as it is well under a negative pressure threshold that is humanly impossible to reach [0060]. It is a well-known pressure-unit relationship that 1 bar = 1019.716 cmH20, and thus Rubin’s disclosure of > 100 cmH20 is equivalent to approximately > 0.1 bar, which overlaps the claimed range of 0.1-1 bar. Rubin teaches that many of the particles produced are above 15 µm in size [0057], which overlaps the claimed range. Rubin also teaches that a diameter of under 5 µm is desirable, or preferably under 2 µm [0057]. 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.
Applicant’s specification at p. 19 l. 17-p. 20 l. 3 explains that the stop valve with reference minimum pressure of 0.1-1 bar ensures sufficient pressure at the inlet of the cold liquid atomizer to form an aerosol having particles of sufficiently reduced size, for example, particles having a diameter less than 100 µm. Thus, modified Shahaf having the negative pressure threshold valve of Rubin with a negative pressure threshold of > 100 cmH20 would inherently produce particles “with a diameter less than 100 µm” as claimed.
Therefore, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify Shahaf’s device to include the negative pressure threshold valve of Rubin between Shahaf’s air chamber 2 and nozzle, because Shahaf and Rubin are both directed to nebulization devices which is the same field of endeavor as the claimed invention, Shahaf teaches controlling delivery pressure and teaches optimizing droplet size via the pressure, which one of ordinary skill in the art would recognize as being advantageously achieved by Rubin’s valve, and this would involve combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
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”).
Regarding claims 42-43, Rubin teaches the negative pressure threshold which is > ~0.1 bar and less than a humanly impossible upper limit, as set forth above in the discussion of claim 25, which overlaps the claimed ranges of 0.2-0.7 bar and 0.3-0.4 bar in claims 42 and 43, respectively, and therefore renders them obvious. See MPEP 2144.05(I); see also In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Further, Rubin teaches that a smaller particle size is desirable for inhalation [0057], and Shahaf teaches that particle size can be optimized by pressure [0641], and thus the claimed ranges are further obvious via routine optimization. See MPEP 2144.05(II); see also In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify the nozzle of Shahaf to be a Venturi nozzle directing the pressurized air across an opening of the holding chamber 2200, because Shahaf and Maier are both directed to nebulization devices, Maier teaches accelerating the air and thus improving aerosolization, and this would involve combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
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, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify the device and piston 8 of Shahaf to include the hydraulic double-acting hand pump of Jung, because Shahaf is in the same field of endeavor as the claimed invention and Jung is reasonably pertinent thereto, Jung teaches assisting the user in manually filling the air chamber 2, and this would involve combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
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, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify the device of Shahaf to include the dynamo of Buchberger, because both Shahaf and Buchberger are directed to aerosolization devices, and this would involve the use of a known technique to improve a similar device in the same way, which is within the purview of the skilled artisan. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
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, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify the device of Shahaf to include Dexue’s air pressure safety valve 10 downstream of the air chamber 2, because Shahaf and Dexue are both directed to nebulization devices, Dexue teaches automatically releasing excessive pressure to ensure user safety, and this would involve combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
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, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify the device of Shahaf so that the air chamber 2 can be refilled by the refill device of Hearn containing compressed air, because Shahaf and Hearn are both within the same field of endeavor as the claimed invention, Hearn teaches achieving a consistent discharge flow rate, and this would involve combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Conclusion
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/MICHAEL PATRICK MULLEN/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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