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 .
Status of Claims
Claims 1, 3-4, 6-7, and 12-13 are currently amended. Claims 2 and 5 are original. Claims 8-11 and 14-17 are previously presented. Claims 1-17 are pending and under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202211547056.XA, filed on 12/05/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Rejections Withdrawn
All 35 USC § 112(b) rejections imposed in the previous office action are withdrawn due to applicant’s amendments of claims 6, 7, and 13.
All 35 USC § 102 rejections imposed in the previous office action are withdrawn due to applicant’s amendments of incorporating the key elements of the previously presented claims 4 and 6 into the independent claim 1.
All 35 USC § 103 rejections imposed in the previous office action are withdrawn due to applicants’ amendment of incorporating the key elements of the previously presented claims 4 and 6 into the independent claim 1, in addition to their arguments. Applicant’s arguments, see pages 5, 13-14, was filed on 02/18/2026. Applicant argued that their specification data (table 18 and Figure 1) showed that their inventive formulations comprising an absorption enhancer increased the bioavailability of inhaled Semaglutide compared to its subcutaneous injections (which typically has a higher bioavailability than inhaled formulations) ––which is unexpected over the prior art based on information and data in the specification as filed. None of the recited prior art in the previous office action obviate the enhanced bioavailability of Semaglutide using this method of formulation, which renders the currently amended independent claim 1 non-obvious, and thus, its subsequent dependent claims are also non-obvious. The closest prior art to such invention is Moeller et al. (US20200164042A1). However, the embodiments of Moeller et al. do not contain the absorption enhancers of currently amended claim 1. Consequently, the 35 USC § 103 rejections of claims 1-17 have been withdrawn.
New rejections: As required by applicant’s amendments to claim 1
Claim Rejections - 35 USC § 112 (b)
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.
Claims 5, 7, and 13 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 5 recites that the composition of claim 1 “further comprises a pharmaceutically acceptable bacteriostatic agent of phenol or benzyl alcohol”, yet these elements are already presented in independent claim 1 as a Markush group. Therefore, it is unclear whether this statement is further limiting the bacteriostatic agents already stated in claim 1, or it is adding an additional bacteriostatic agent with additional amounts. Therefore, this claim is rendered indefinite.
Claim 7 recites that claim 1 “further comprises 0.01% to 0.15% of an absorption enhancer of polysorbate 80, by weight to volume”. Yet, this element of polysorbate 80 as an absorption enhancer is already presented in independent claim 1 within a Markush group. Therefore, it is unclear whether this statement is further limiting the absorption enhancer already stated in claim 1, or it is adding an additional absorption enhancer with additional amounts. Therefore, this claim is rendered indefinite.
Claim 13 recites that claim 1 “further comprises 0.01% to 10% of an absorption enhancer… selected from the group consisting of polysorbate 80, sodium octanoate, sucrose laurate and a combination thereof”. The above elements are already presented in independent claim 1, with the same absorption enhancers already stated in a Markush group. Therefore, it is unclear whether this statement is further limiting the absorption enhancer already stated in claim 1, or it is adding an additional absorption enhancer with additional amounts. Therefore, this claim is rendered indefinite.
Response to Arguments
Applicant’s arguments with respect to claims 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claims 1-4, 6, 8-12, and 14-17 are allowable as the rejections over these claims are withdrawn as stated above.
Examiner Notes
The affidavit filed on 02/18/2026, which contains appendix A-C, is not being considered by the examiner. This is because the declaration failed to include an acknowledgment by the declarant that willful false statements and the like are punishable by fine or imprisonment, or both (18 U.S.C. § 1001) and may jeopardize the validity of the application or any patent issuing thereon (see MPEP 716 regarding affidavits and declarations).
Examiner attempted to contact the authorized patent attorneys and agents of the applicant on 5/28/2026 and 5/29/2026 to notify them of the issues with the affidavits and the 35 USC § 112s. The agent of the applicant requested that the examiner submits a final rejection citing such issues if they would like the declaration to be of the record.
Conclusions
Claims 1-4, 6, 8-12, and 14-17 are allowable. Claims 5, 7, and 13 are not found allowable.
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 ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 9:00AM - 5:00 PM.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
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