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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to National Stage App. No. PCT/US2020/063889 filed December 9, 2020 and to U.S. Provisional App. No. 62/945,748 filed December 9, 2019.
Status of Claims
This Office Action is responsive to the amendment filed on August 7, 2025. Claims 1-20 are presently pending in this application, claims 18-20 being withdrawn from consideration.
Election/Restrictions
Restriction to one of the following inventions was previously required under 35 U.S.C. 121:
I. Claims 1-17, drawn to an inhaler, classified in A61M15/0035.
II. Claim 18, drawn to a drug formulation, classified in A61K9/0075.
III. Claim 19, drawn to a method of manufacture, classified in A61K9/14.
IV. Claim 20, drawn to an inhaler for a dry powder medicament, classified in A61M2202/064.
Applicant’s election without traverse of Group I, claims 1-17 in the reply filed on August 7, 2025 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first air inlet hole and the second air inlet hole each have a constant transverse cross-section along a predetermined length of the air inlet hole” of claims 3 and 17. must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3 and 17, and claims 4-9 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites “wherein the first air inlet hole and the second air inlet hole each have a constant transverse cross-section along a predetermined length of the air inlet hole.”, ln 1-3. Applicant’s specification describes the first air inlet hole and the second air inlet hole as distinct elements (See Instant Spec. para. 0014, 0051) and describes the air inlet hole separately (¶ 0011). Applicant’s specification fails to describe the air inlet hole comprising the first air inlet hole and the second air inlet hole along its length. Therefore, claim 3 contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention.
Claim 17 is rejected using similar rational.
Claim 3, and claims 4-9 by dependency, are 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 3 recites “wherein the first air inlet hole and the second air inlet hole each have a constant transverse cross-section along a predetermined length of the air inlet hole.”, ln 1-3 it is unclear whether the air inlet hole, first air inlet hole, and second air inlet hole are each separate elements; the air inlet hole is the first air inlet hole and the second air inlet hole; or the air inlet hole is an element that comprises the first air inlet hole and the second air inlet hole. Applicant’s specification describes the first air inlet hole and the second air inlet hole as distinct elements (See Instant Spec. para. 0014, 0051) and describes the air inlet hole separately (¶ 0011). Applicant’s specification fails to provide description on the air inlet hole comprising the first air inlet hole and the second air inlet hole along its length.
Claim 17 is rejected using similar rational.
Therefore, Examiner is not making a judgment on the subject matter of claims 3 and 17 because the Examiner is unable to provide cogent and reasonable interpretation for claim 3 and 17 that would resolve the issues listed above and not require a rejection under 35 U.S.C 112(a).
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) 1-2, 10, 11, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zierenberg (U.S. Pub. No. 2006/0251586).
Regarding Claim 1, Zierenberg discloses a suction operated inhaler device, comprising a bottom inhaler body (1; Fig. 1) having an air inlet hole (13; Fig. 1), the bottom inhaler body further defining a recess (A, Fig. A annotated below) configured to hold therein a capsule (6; Fig. 1) containing a substance to be inhaled (¶¶ 0030-0035, 0040) and a top mouthpiece (12; Fig. 1) communicating with the recess (Fig. 1; ¶¶ 0032-0033), the top mouthpiece having a bottom flange (B, Fig. A annotated below) and being rotatably coupled to the bottom inhaler body (¶ 0033) to provide, as the top mouthpiece is manually rotated by an inhaler device user (¶ 0033; Examiner notes: Zierenberg discloses top mouthpiece can be flipped open or shut), at least two operating conditions including an open condition in which the recess for the capsule can be accessed to engage therein a new capsule or to withdraw therefrom a used capsule (¶ 0033; Examiner notes: Zierenberg discloses top mouthpiece can be flipped open or shut), and a closed use condition in which the inhaler device mouthpiece can be operated (¶ 0033; Examiner notes: Zierenberg discloses top mouthpiece can be flipped open or shut), the inhaler device further comprising at least one perforating needle (7; Fig. 1) associated with the inhaler body and adapted to perforate the capsule to allow a contents of the capsule to enter the capsule recess (¶ 0033), thereby allowing an inhaling suction generated air flow passing through a first air inlet hole (hole created by perforating needle) to mix with the contents of the capsule for inhaling the contents in the recess through the mouthpiece (¶ 0033), wherein the first air inlet hole has a width no greater than 1.17 mm (¶¶ 0033-0038) for the purpose of adjusting the sizes of the air inelt hole, first air inlet hole and the second air inlet hole such that the flow resistance is set to the target value. (0023-0029, 0034) [Examiner notes: For the purpose of this Office Action the air inlet hole, first air inlet hole, and second air inlet hole have bene interpreted as each being separate elements and Zierenberg discloses at least three inlets (13; Fig. 1; ¶¶ 0033-0038); See above: 35 USC § 112].
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Figure A, Adapted from Figure 1 of Zierenberg.
Regarding Claim 2, Zierenberg discloses the inhaler device wherein the device comprises a second air inlet hole (13; Fig. 1; ¶¶ 0033-0034) configured to cooperate with the first air inlet hole to allow air into the capsule recess to mix with the contents of the capsule for inhaling the contents in the recess through the mouthpiece, wherein the second air inlet hole has a width no greater than 1.17 mm (¶¶ 0033-0038).
Regarding Claim 10, Zierenberg discloses the inhaler device wherein the first air inlet hole has an outwardly facing radius of about 1.60 mm (¶¶ 0033-0038).
Regarding Claim 11, Zierenberg discloses the inhaler device wherein the capsule recess has an outer wall (C, Fig. A annotated above) with a constant diameter (at C Fig. A annotated above), the outer wall being continuous with no air pockets therein (Fig. 1).
Regarding Claim 15, Zierenberg discloses the inhaler device wherein the device has an airflow resistance of about 0.128 cmH2O0.5/LPM, which is equivalent to a flow rate of about 50 LPM at 4 kPa (¶¶ 0023-0029).
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.
Claim(s) 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zierenberg.
Regarding Claim 12, Zierenberg discloses the inhaler device of claim 11 wherein the diameter of the capsule recess accepts the capsule, shown above.
Zierenberg does not explicitly discloses the inhaler device wherein the diameter of the capsule recess is about 19.00 mm.
There is no evidence of record that establishes that changing the diameter of the capsule recess (at C Fig. A annotated above) would result in a difference in function of the Zierenberg device. Further, a person having ordinary skill in the art, being faced with modifying the diameter of the capsule recess of Zierenberg, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter. Lastly, applicant has not disclosed that the claimed dimension solves any stated problem (¶¶ 0011, 0054), and therefore there appears to be no criticality placed on the dimension as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of the capsule recess of Zierenberg to be about 19.00 mm as an obvious matter of design choice within the skill of the art.
Regarding Claim 13, Zierenberg discloses the inhaler device of claim 1 wherein the mouthpiece has an inside diameter (D, Fig. A annotated above).
Zierenberg does not explicitly discloses the inhaler device wherein the mouthpiece has an inside diameter of about 11.00 mm.
There is no evidence of record that establishes that changing the inner diameter of the mouth piece (D, Fig. A annotated above) would result in a difference in function of the Zierenberg device. Further, a person having ordinary skill in the art, being faced with modifying the inner diameter of the mouth piece of Zierenberg, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter. Lastly, applicant has not disclosed that the claimed dimension solves any stated problem (¶¶ 0011, 0056), and therefore there appears to be no criticality placed on the dimension as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner diameter of the mouth piece of Zierenberg to be about 11.00 mm as an obvious matter of design choice within the skill of the art.
Regarding Claim 14, Zierenberg discloses the inhaler device of claim 1 wherein the inhaler device has an internal bypass gap (E, Fig. A annotate above; ¶ 0034) located between the bottom flange of the top mouthpiece and the bottom inhaler body (¶ 0034).
Zierenberg does not explicitly discloses the inhaler device wherein the internal bypass gap being no greater than about 0.1 mm.
There is no evidence of record that establishes that forming the gap between the bottom flange of the top mouthpiece and the bottom inhaler body would result in a difference in function of the Zierenberg device. Further, a person having ordinary skill in the art, being faced with modifying the gap between the bottom flange of the top mouthpiece and the bottom inhaler body of Zierenberg, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed dimension. Lastly, applicant has not disclosed that the claimed dimension solves any stated problem (¶¶ 0011, 0057), and therefore there appears to be no criticality placed on the dimension as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the gap between the bottom flange of the top mouthpiece and the bottom inhaler body of Zierenberg to be about 0.1 mm as an obvious matter of design choice within the skill of the art.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannon (WO 2018/195086 A1) in view of Zierenberg.
Regarding Claim 16, Hannon discloses a dry powder inhaler device (¶¶ 0010, 0068, 0083; Fig. 7, 9) comprising: a housing body (312, 428) having a cylindrically shaped recess (328, 430; Fig. 7-9) therein, the recess having a longitudinal axis (at A, Fig. B annotated below), a height (A, Fig. B annotated below) along the longitudinal axis that is larger than a diameter (B, Fig. B annotated below) of a capsule (314, 434) containing a substance to be inhaled (¶¶ 0068, 0083), and a diameter (C, Fig. B annotated below) transverse to the longitudinal axis that is larger than a length (D, Fig. B annotated below) of the capsule, thereby allowing the capsule room to spin within the recess generally about a transverse axis of the capsule and generally about the longitudinal axis of the recess (¶¶ 0064, 0068, 0090); a pair of air inlets (310; Fig. 7) each fluidically connecting the recess to an aperture (E, Fig. B, Annotated below) on an exterior surface (at E, Fig. B, Annotated below) of the housing body, each inlet having a surface (F, Fig. B annotated below) that is aligned with a tangent to an outer surface (G, Fig. B annotated below) of the recess (Fig. 7), each inlet having a height no greater than the height of the recess and a width no greater than 1.17 mm (¶ 0062); and an outlet body (302, 402; Fig. 7, 9) coupled to the housing body and having a channel (308, 408; Fig. 7, 9) fluidically connecting the recess to an opening (328; Fig. 7) configured to allow a user to draw air through the opening, thereby allowing an airstream to be drawn through the air inlets, into the housing body recess where it causes the capsule to spin and eject its contents into the airstream (¶¶ 0060, 0062-0065, 0068-0070, 0090), and through the outlet body channel and opening to deliver the substance into the user's lungs (¶¶ 0062-0065, 0068-0070, 0090; Fig. 7).
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Figure B, Adapted from Figure 7 of Hannon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Citterio (U.S. Pub. No. 2003/0000523) discloses an inhaler device comprising at least one perforating needle (Fig. 1; ¶¶ 0023, 0024).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785