DETAILED ACTION
This office action is responsive to the amendment filed 10/24/2025. As directed, claims 1-31, 33-35, 47, and 51 have been canceled, claim 32 has been amended, and no claims have been added. Thus claims 32, 36-46, and 48-50 are currently pending.
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 .
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(s) 32, 36-39, 41-44, 46, and 48-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alelov (2012/0048266) in view of Johnson et al. (2015/0351456).
Regarding claim 32, Alelov discloses a first chamber (114), a second chamber (116), and an outlet (128), the first chamber (114) includes a first aperture (gas exit openings where gas exits the chamber) and containing a first inert liquid including water ([0021] lines 1-10 discloses a transport agent or coloring and [0020] lines 1-5 disclose a humidifier which includes water) and having a heat source (118) ([0021] lines 10-15 disclose a heating source) adapted to thermally vaporize a quantity of the first liquid to form a relatively warm first vapor ([0021] lines 1-16) and the second chamber (116) includes a second aperture (gas exit openings where gas exits the chamber) and containing an active molecule or medicament ([0021] lines 1-10, [0022] lines 1-10) forming the cold second vapor ([0022] lines 1-10), the second chamber provided with an atomizer (120) for delivery of the second vapor ([0022] lines 15-20 discloses an atomizer) adapted to atomize a quantity of a second liquid without heating of the second liquid to form a mist of a relatively cold second vapor ([0022] lines 1-20 disclose the generator could be a vibration generator or atomizer thus not using heat), wherein the warm and cold vapors mix at the outlet ([0020] last 10 lines disclose vapors are mixed to flow through outlet 128), the pulmonary delivery device further comprises a main body portion (main body) and a filter chamber (i.e. distal hollow interior of housing 12 i.e. downstream of chamber 114 and upstream of outlet 128 as filter/mixing chamber) provided at the distal end of the main body (112) and having an outlet (adjacent inner end of outlet 128) spaced apart from the heat source (as shown the heat source is embedded or within chamber 118 and thus spaced apart from the distal interior) and configured to receive and mix the first and second vapors released from the first and second apertures of the first and second chambers to form a mixture of the first and second vapors in a hollow space of the filter/mixing chamber in the vicinity of the outlet ([0020] last 10 lines disclose vapors that exit the chambers are mixed to flow to outlet 128) in which a user can inhale a mixture of the first and second vapors ([0020] last 10 lines).
Alelov discloses first and second atomizers which can be a thermal or non-thermal atomizer (0021] lines 1-20, [0022] lines 1-20) and releasing the contents of the cartridges individually ([0021] last 15 lines, [0022] last 15 lines) but does not specifically disclose that the
second chamber has an outlet aperture and is different than the first chamber having an outlet aperture in that it is has a non-thermal atomizer. However, Johnson discloses (see figs. 5A, 6, 6A) a second chamber (62,74) having an outlet (outlet of cartridge, see flow arrow C) different from the first (66, 72) with an outlet (out; see flow arrows A) in that the second chamber (i.e. 74) does not include the heater (63, 72’) ([0041] last 6 lines, [0044] lines 1-10, [0049] lines 1-15. As shown, flow A from the 1st cartridge, can extend around the 2nd cartridge at flow arrow B and mix with the flow C from the 2nd cartridge at the outlet 38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the chambers of Alelov to be of different vaporizing methods with outlet apertures as taught by Johnson to provide the advantage of enhanced dose variability and flow control.
Regarding claim 36, Alelov discloses a heater ([0021] lines 1-10) and further comprises a circuit (200) configured to apply a time-dependent heating profile ([0037] lines 1-10) by temporally controlling an electric current in the heater ([0037] lines 1-10) in response to a measured temperature thereof ([0029] lines 1-5, [0043] lines 1-15) but does not specifically disclose the specific type of heat source. However, Johnson discloses a resistive heating wire [0051] last 10 lines). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heater of Alelov to include a resistance heater as taught by Johnson to provide enhanced cost efficiency and effectiveness.
Regarding claim 37, the modified Alelov discloses infrared emitters ([0006] lines 1-4 of Johnson).
Regarding claim 38, Alelov discloses the second liquid is vaporized by atomizing to form the mist of the second vapor ([0022] lines 1-10 discloses an atomizer).
Regarding claim 39, Alelov discloses an ultrasonic vibrator ([0022] lines 1-10).
Regarding claims 41 and 42, the modified Alelov discloses (see figs. 5-6 of Johnson) the first chamber has a vaporizer comprising a reservoir (67) comprising a vial for retaining, in use, a quantity of the respective liquid and a conveyor (65) comprises a wick adapted to convey, in use, the liquid from the reservoir to the heat source ([0044] lines 1-10 of Johnson) and a resistive heating wire or coil is wrapped around the wick to vaporize the liquid (as shown, the heater is around the wick 65).
Regarding claim 43 and 44, the modified Alelov discloses (see figs. 5-6 of Johnson) the second chamber has a vaporizer comprising a reservoir (67) comprising a pressured vessel containing a liquid and propellant (PEG) for retaining, in use, a quantity of the respective liquid and a conveyor (65) comprises a valve (63) , in use, the liquid from the reservoir to a heater [0044] lines 1-10 of Johnson).
Regarding claim 46, the modified Alelov discloses (see figs. 5-6 of Johnson) the first and second chambers comprise a pressure vessel (cartridge) , each chamber having a release valve (63) and containing the first or second liquid respectively and a propellant (PEG) , the first chamber being adapted to deliver the vaporized first liquid released via the release valve (63)to a heat source ([0044] lines 1-5 of Johnson).
Regarding claim 48, Alelov discloses a controller (224) adapted to the relative amounts of the first and second vapors in the mixture([0028[ lines 1-8, [0037] lines 1-5).
Regarding claim 49, Alelov discloses a push button (471) and the modified Alelov discloses heaters on during inhalation ([0032] lines 15-25 of Johnson).
Regarding claim 50, Alelov discloses the first chamber (114) containing a first liquid comprises an inert liquid including water ([0021] lines 1-10 discloses a transport agent or coloring and [0020] lines 1-5 disclose a humidifier which includes water) and having a heat source (118) ([0021] lines 10-15 disclose a heating source) adapted to thermally vaporize a quantity of the first liquid to form a relatively warm wet first vapor ([0021] lines 1-16) and the second chamber (116) containing an active molecule or medicament ([0021] lines 1-10, [0022] lines 1-10) forming the cold second vapor ([0022] lines 1-10), the second chamber provided with an atomizer (120) for delivery of the second vapor ([0022] lines 15-20 discloses an atomizer) adapted to atomize a quantity of a second liquid without heating of the second liquid to form a mist of a relatively cold non-thermally degraded second vapor ([0022] lines 1-20 disclose the generator could be a vibration generator or atomizer thus not using heat). The modified Alelov discloses mixtures of mixture of water and glycol and a propellant and liquid nicotine ([0035] lines 1-10 of Johnson).
Claim 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alelov.
Regarding claim 40, Alelov substantially teaches the claimed invention except for particles produced in the mist of the second vapor have an average diameter of less than 5 micrometers. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mist of Alelov to include particles within the claimed range as such is well known in the art, well within an artisan’s skill, and would provide the advantage of enhanced particle size delivery. In addition, it has been held that where the general conditions of a claim are known, it is not inventive to determine optimum or workable range by routine experimentation.
Claim 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alelov in view Johnson, as applied to claim 43 above, and further in view of Hon (2012/0273589).
Regarding claim 45, Alelov substantially teaches the claimed invention except for the second chamber comprises a spring-loaded syringe-driver comprising a syringe cylinder containing a quantity of the liquid, a spring-biased piston adapted to force the liquid out of the cylinder via an outlet aperture and a flow control valve for selectively opening and closing the outlet aperture. However, Hon teaches a spring-loaded syringe-driver (111) comprising a syringe cylinder containing a quantity of the liquid ([0032] lines 1-20), a spring-biased piston (5050) adapted to force the liquid out of the cylinder via an outlet aperture (405) and a flow control valve (112) for selectively opening and closing the outlet aperture. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuator of Alelov to include a syringe pump as taught by Hon to provide enhanced cost efficiency and delivery.
Response to Arguments
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive.
Applicant argues on page 7 2nd paragraphs through last paragraphs that that vapors flow through and around the cartridge and thus warm and cold vapors mix before the outlet. Examiner respectfully disagrees as the distal hollow interior of the housing as mixing/filter chamber mixes the gases that exit the cartridges in the outlet 28. It is further noted that even if some portion of the vapors are pre-mixed before reaching the outlet, the vapors continue to mix at, through, and in the vicinity of the outlet since the vapors are fluid. Therefore, Alelov teaches this limitation as claimed.
Applicant argues on page 8 4th paragraphs through page 9 2nd paragraph that warm vapors of the modified Alelov would mix with the cold vapors such that the cold vapors are not mixed in the vicinity of the outlet and further argues that the references do not disclose heat degradation. Examiner respectfully disagrees and notes that the limitation of preventing heat degradation is not found in the language of claim 32. Alelov discloses in [0022] lines 1-20 the generator could be a vibration generator or atomizer thus not using heat and discloses a second liquid containing an active molecule or drug ([0022] lines 1- 10). Johnson discloses (see figs. 5A, 6, 6A) a second chamber (62,74) having an outlet (outlet of cartridge, see flow arrow C) different from the first (66, 72) with an outlet (out; see flow arrows A) in that the second chamber (i.e. 74) does not include the heater (63, 72’) ({0041] last 6 lines, [0044] lines 1-10, [0049] lines 1-15). As shown, flow A from the 1st cartridge, can extend around the 2nd cartridge at flow arrow B and mix with the flow C from the 2nd cartridge at the outlet 38. Thus the combination of Alelov and Johnson teach this limitation as claimed.
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 LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/Primary Examiner, Art Unit 3785