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
This office action is in response to the amendment filed 7/29/2026. As directed by the amendment, claims 82, 90, 92-95 and 99 have been amended. Claims 81-100 are pending in the instant application.
Applicant has amended the title to be more descriptive and corrected a minor informality in the specification; the objections to the specification are withdrawn.
Applicant has amended claim 95 such that claimed subject matter is now shown in the drawings; the objection to the drawings is withdrawn.
Applicant has amended the claims to address some of the minor informalities therein; any claim objection not maintained below has been withdrawn.
Applicant has amended the claims to provide antecedent basis and clarity; the rejections under 35 USC 112(b)/second paragraph are withdrawn.
Response to Arguments
Applicant's arguments filed 7/29/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Regarding claim 81, Applicant argues on page 9 of Remarks that “Inagaki teaches the opposite of the claimed configuration and closes the reservoir when negative pressure is detected.”
The Examiner disagrees with Applicant’s mischaracterization of Inagaki. Inagaki does not close the reservoir when negative pressure is detected; Inagaki opens the reservoir when negative pressure is detected. Indeed, if Inagaki closed the reservoir when negative pressure/inhalation is detected as incorrectly asserted by Applicant, the device of Inagaki would not function to produce and deliver aerosol during inhalation as explicitly described by Inagaki, see e.g. the relevant sections of Inagaki cited below. Inagaki teaches a common inhalation detection sensor/valve arrangement that functions by detecting the negative pressure/pressure drop/increased flow induced by inhalation through the device and opens the reservoir/valve(s) to allow aerosol to be delivered during inhalation, and closes the reservoir when the inhalation/negative pressure/pressure drop/flow stops in order to conserve medicament by not delivering it when inhalation is not occurring, see Inagaki Fig. 2 and the following relevant descriptions: by the controller 12a operating…solenoid valve 8a to open the first passage 6…the aerosol 11 can be supplied to the user, para [0062]; controller 12a is configured to, when the aerosol supply device becomes no longer used…operate the solenoid valve 8a to thereby close the first passage, para [0096]; controller 12a is configured to, in response to a signal transmitted from the detector (negative pressure sensor 16) and associated with the start of suction…control the volatilization preventing part (solenoid valve 8a) to deactivate a function of the volatilization preventing part (solenoid valve 8a) that prevents volatilization of the liquid 10 [i.e. open the valve]. By [opening the valve] in response to a signal associated with the start of suction of the aerosol 11 as described above, the aerosol supply device 21 can be used smoothly, paras [0104-105]; see also paras [0070-75] and [0107] regarding the all the valves being breath-directed, electronically driven valves. Therefore, contrary to Applicant’s assertion, Inagaki anticipates the claimed invention as maintained in the art rejections below.
Applicant further argues on page 9 of Remarks that “the skilled person, starting from Inagaki, would be led away from the present invention…Inagaki also provides no teaching, hint or suggestion of the advantages this modification would provide which permits release of the product when a pressure drop o[r] increased flow is detected.”
The Examiner disagrees. As discussed above and in the rejections maintained below, Inagaki teaches a breath detection sensor/valve arrangement that functions by detecting the negative pressure/pressure drop/increased flow induced by inhalation through the device and opens associated valves to allow product/aerosol to be produced and delivered (only) during inhalation/while the valves are open as claimed. This anticipates/leads an artisan directly to the invention of claim 81, and it provides the well-known advantages of breath-controlled aerosol delivery, including those discussed by Inagaki paras [0007-10], [0079], [0095-107].
Applicant does not argue any of the dependent claims separately from the independent claim 81; therefore, the rejections of the dependent claims are maintained/updated below as required by the amendments thereto.
Claim Objections
Claims 92-94 and 98 are objected to because of the following informalities:
Claims 92, 93 and 98 should have a comma after the preambles thereof, i.e. they should read “claim X,”, in keeping with the remainder of the claims
Claim 93, line 9 should read “wherein, in the first position,”
Claim 94, line 10 should read “in the second position,”
Claim 94, line 12 should read “in the second position,”
Appropriate correction is required.
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.
Claim(s) 81, 82, 86, 87, 89 and 100 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inagaki et al. (WO 2020/209111; hereinafter “Inagaki,” wherein the PGPub of the WIPO document, US 2022/0022546 A1, will be referenced in the rejection below as a translation of the WIPO document).
Regarding claim 81, Inagaki discloses an inhaler (aerosol supply device 1) (Figs. 1-2 and 5-6) comprising:
an electronic air pressure or flow rate sensor (negative pressure sensor 16) configured to detect a pressure drop or flow rate due to inhalation by a user (paras [0101-107]);
a reservoir (cartridge 4) configured to contain a product for inhalation by the user (paras [0047-55]);
a valve (solenoid valve 8a) movable between a first configuration configured to prevent release of the product from the reservoir and a second configuration configured to release a dose of the product from the reservoir in response to the detection of the pressure drop or increased flow rate by the electronic sensor (paras [0059-62] and [0090-96]);
an outlet (second passage 7, port 3a and/or the aperture within valve 8b/28b) for delivering the dose of the product from the reservoir to the user (Fig. 2); and
a second valve member (valve 8b or 28b), the second valve member configured to selectively obscure the outlet (Fig. 2 or 6; paras [0063-74]).
Regarding claim 82, Inagaki discloses the inhaler according to claim 81, wherein the second valve member is configured to open in response to sensing of the pressure drop or flow rate by the electronic sensor (paras [0074] and [0107]).
Regarding claim 86, Inagaki discloses the inhaler according to claim 81, wherein the second valve member seals against or abuts the outlet (Fig. 2 or 6, where the valve 8b seals against/abuts the sides of passage 7, port 3a and/or seals the valve opening).
Regarding claim 87, Inagaki discloses the inhaler according to claim 81, wherein the second valve member is configured to abut against the outlet during exhalation by the user (Fig. 2 or 6 and paras [0063-79], where the valve 8b seals against/abuts the sides of passage 7 or port 3a whenever inhalation is not occurring, e.g. during exhalation).
Regarding claim 89, Inagaki discloses the inhaler according to claim 81, including a compartment (passage 7 and/or port 3a, when the outlet is considered the valve aperture) configured to receive at least a portion of the second valve member (Fig. 2 or 6).
Regarding claim 100, Inagaki discloses the inhaler according to claim 81, including a controller (controller 12a) configured to:
vary the dose of the product released from the reservoir in dependence upon the sensed pressure drop or flow rate (paras [0062], [0090-96]), [0104-107], [0110]); and/or
sense the sensed pressure drop or flow rate (paras [0103-104]).
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.
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.
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) 83, 90, 91 and 95-97 are rejected under 35 U.S.C. 103 as being unpatentable over Inagaki in view of Drachmann et al. (US 2003/0098023 A1; hereinafter “Drachmann”).
Regarding claim 83, Inagaki discloses the inhaler according to claim 81, wherein Inagaki further discloses/teaches wherein the outlet includes a nozzle (discharge port 3a) and wherein the second valve member is configured to selectively obscure the nozzle (Fig. 6; paras [0115-116]), but Inagaki is silent regarding a fluid pathway operatively connected to a mouthpiece; and wherein the nozzle extends into the fluid pathway. However, Drachmann teaches that it was known in the inhaler art before the effective filing date of the claimed invention for a double-valved inhaler arrangement such as that of Inagaki to include a fluid pathway (within outer wall 38) (Fig. 1) operatively connected to a mouthpiece (mouthpiece 22 and/or spacer 28); and
wherein the outlet (chamber 14) includes a nozzle (comprising outlet 18) which extends into the fluid pathway (Fig. 1), wherein the second valve member (valve 24) is configured to selectively obscure the nozzle (Fig. 1; para [0135]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Inagaki to include a fluid pathway operatively connected to a mouthpiece; and wherein the nozzle which extends into the fluid pathway as taught by Drachmann, in order to provide a known means (concentric pathway with exterior vents that leads to a mouthpiece) around the outlet port 3a/passage 7 of Inagaki (with a single valve for closing the port 3a to predictably reduce costs by reducing the number of valves and/or to prevent debris from entering into passage 7 at all as taught by Inagaki Fig. 6 OR Drachmann Fig. 1), to provide the predictable result of allowing for exhalation through the device (Drachmann para [0135]) for convenience and/or, if not including an exhalation valve component/functionality as taught by Drachmann, to also provide the predictable result of a bypass flow path for increasing the amount of flow through the inhaler and/or to prevent aerosolized product from contacting mouthpiece walls by providing a sheath gas.
Regarding claim 90, Inagaki in view of Drachmann teaches the inhaler according to claim 83, wherein Drachmann further educates Inagaki to include wherein the second valve member includes first and second portions (when including an exhalation valve component as discussed above regarding claim 83, the first portion would be the central inhale valve portion over the nozzle and the second portion would be the concentrically outward valve portion providing the exhale valve functionality, see Inagaki Fig. 6 modified below), wherein the second portion is configured to obscure the nozzle (Inagaki Fig. 6 modified below; Inagaki paras [0063-74]; Drachmann Fig. 1 and para [0135]).
Regarding claim 91, Inagaki in view of Drachmann teaches the inhaler according to claim 90, wherein Inagaki further teaches wherein the first and second portions extend towards each other and define an apex (where the sides of the duckbill valve meet at the top, see Inagaki Fig. 2/6), wherein a pivot is provided adjacent said apex (the sides of the duckbill valve both pivot at the bases thereof, which are adjacent the apex, see Inagaki Fig. 2/6).
Regarding claim 95, Inagaki in view of Drachmann teaches the inhaler according to claim 83, wherein modified Inagaki further teaches wherein the second valve member does not completely obstruct airflow through the fluid pathway when not including an exhalation valve component as discussed above regarding claim 83, e.g. modified Inagaki would look like modified Fig. 6 below, optionally including the valve outside the port 3a as discussed above regarding claim 83.
Regarding claim 96, Inagaki in view of Drachmann teaches the inhaler according to claim 83, wherein modified Inagaki further teaches wherein the second valve member only extends a portion of a height of the fluid pathway when not including an exhalation valve component as discussed above regarding claim 83, e.g. modified Inagaki would look like modified Fig. 6 below, optionally including the valve outside the port 3a as discussed above regarding claim 83.
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Regarding claim 97, Inagaki in view of Drachmann teaches the inhaler according to claim 83, wherein modified Inagaki further teaches wherein the second valve member extends a full height of the fluid pathway when including an exhalation valve component as discussed above regarding claim 83, e.g. modified Inagaki would look like modified Fig. 6 below.
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Claim(s) 84 and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Inagaki in view of Drachmann as applied to claim 83 above, and further in view of Bruna et al. (US 5,447,151; hereinafter “Bruna”).
Regarding claims 84 and 85, Inagaki in view of Drachmann teaches the inhaler according to claim 83, wherein modified Inagaki further teaches wherein the second valve member is moveable to a first position where a portion of the second valve member obscures the nozzle, and wherein the second valve member is movable to a second position where the second valve member is displaced from the nozzle (Inagaki Fig. 6, paras [0063-74] OR Drachmann Fig. 1, para [0135]), but modified Inagaki is silent regarding wherein the valve is specifically rotatable. However, where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another," the claim is unpatentable under 35 U.S.C. 103(a), see MPEP 2143.I.B, and Bruna teaches that it was known in the inhaler art before the effective filing date of the claimed invention to utilize a rotatable valve (non-return valve 85) (Fig. 2) for blocking exhalation and/or debris access into an inhaler (col. 14, lines 15-29). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Inagaki to include wherein the second valve member is a rotatable valve, e.g. a flap valve, as taught by Bruna, because this is a combination that only unites old elements (inhaler outlet and a known valve) with no change in the respective functions of those old elements (valved outlet), and the combination of those elements yields predictable results, such that the claim is obvious because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another.
Claim(s) 88 is rejected under 35 U.S.C. 103 as being unpatentable over Inagaki in view in view of Bruna.
Regarding claim 88, Inagaki discloses the inhaler according to claim 81, wherein the second valve member is operatively connected to a motor to effect movement of the second valve member (paras [0074] and [0107]), but Inagaki is silent regarding wherein movement of the valve is specifically rotation. However, where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another," the claim is unpatentable under 35 U.S.C. 103(a), see MPEP 2143.I.B, and Bruna teaches that it was known in the inhaler art before the effective filing date of the claimed invention to utilize a rotatable valve (non-return valve 85) (Fig. 2) for blocking exhalation and/or debris access into an inhaler (col. 14, lines 15-29). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Inagaki to include wherein the second valve member is a rotatable valve, e.g. a flap valve, as taught by Bruna, because this is a combination that only unites old elements (inhaler outlet and a known valve) with no change in the respective functions of those old elements (valved outlet), and the combination of those elements yields predictable results, such that the claim is obvious because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another.
Claim(s) 98 and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Inagaki
Regarding claim 98, Inagaki discloses the inhaler according to claim 81 wherein Inagaki further discloses including a controller (controller 12a) arranged to trigger selective movement of the valve to the second configuration when inhalation is detected by the negative pressure sensor (paras [0062] and [0090-96]), but Inagaki does not explicitly recite wherein the trigger occurs only if the pressure drop or flow rate meets a predetermined criterion. However, Inagaki does teach monitoring the pressure for comparison to a threshold (para [0095]), and it would have been obvious to an artisan before the effective filing date of the claimed invention for the controller of Inagaki to be configured to only trigger to the movement to open the valve/start aerosolization if the pressure drop or flow rate meets a predetermined criterion, in order to predictably ensure before triggering that an inhalation is of a sufficient degree to ensure that the aerosolized material will reach the lungs and/or that the pressure/flow change is an intentional inhalation and not a random spike from e.g. mishandling.
Regarding claim 99, Inagaki discloses the inhaler according to claim 81, wherein the inhaler includes a dosing chamber (comprising the chamber within cartridge 4) (Fig. 2), the dosing chamber being filled with a predetermined amount (liquid 10) to prime the inhaler prior to sensing the pressure drop or flow rate and/or prior to movement of the valve to the second configuration (Fig. 2; paras [0024], [0045-55], [0062], [0087]), but Inagaki does not explicitly state that the cartridge is a single-use and/or single dose cartridge such that the amount therein is a dose. However, it would have been obvious to an artisan before the effective filing date of the claimed invention for the cartridge of Inagaki to be a single-use and/or single dose cartridge such that the amount therein is a dose, in order to provide the predictable result of a single use inhaler and/or cartridge for convenience and/or sanitary purposes.
Allowable Subject Matter
Claims 92-94 would be allowable if rewritten to overcome the objections and the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, Tu-Th 8a-2p, F 7:30-11:30a 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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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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