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 the Claims
Claims 1, 2, 204-222 are pending.
Claims 1, 2, 204-206, 207-211, 217-220, and 222 are withdrawn.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/CN2021/076260, filed 02/09/2021; and further claims priority to FOR Application numbers PCT/CN2020/075105 and PCT/CN2020/075103 filed on 2/13/2020. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
All references from IDS(s) received 08/12/2022, 5/22/2023, and 8/15/2025 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I without traverse in the reply filed on 8/15/2025 is acknowledged.
Claims 217-220 and 222 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
Applicant’s election of species of the Compound 101 elected in the reply without traverse filed on 8/15/2025 is acknowledged.
Claims 2, 205, 207-209, and 211 are withdrawn for not reading on the elected species.
Claims 1, 204, 206, and 210 are also withdrawn as not reading on the elected species because of the wherein clause at the end of claim 1.
Applicant filed a supplemental amendment (11/07/2025) which included the elected species in claim 214, but no other amendments were made. Therefore, the above withdrawal still applies. Claims were also filed 11/07/2025 but not seen in the file wrapper by the Examiner who had posted the non-final before the new claims were present, as noted in the interview summary. The amended/new claims do not change the rejections and they have been added accordingly. This is the reason for the second non-final.
Claims 212-216 and 221 will be examined on their merits.
No anticipatory art was found of the elected species, so the Examiner expanded the species pursuant to MPEP 803.02. See 102 rejection below.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 214 and 221 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhong, W. et al. (WO2020207474A1; which claims priority to PCT/CN2019/082381, filed Apr. 12, 2019; cited in the IDS filed 8/12/2022; “Zhong”).
This rejection applies to the expanded specie, compound 120w.
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539
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Zhong teaches a structural example of compound 120w of claims 214 (Page 65, Compound 94), see below.
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141
649
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Therefore, the genus structure taught by Zhong anticipates the expanded specie and instant claim 214.
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.
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.
Claims 212-216 and 221 are rejected under 35 U.S.C. 103 as being unpatentable over Aspnes, G. et al. (US20180170908A1; cited in the IDS filed 5/22/2023; “Aspnes”) in view of Zhong, W. et al. (WO2020207474A1; which claims priority to PCT/CN2019/082381, filed Apr. 12, 2019; cited in the IDS filed 8/12/2022; “Zhong”).
This rejection applies to the elected specie.
Aspnes teaches an overlapping genus structure with the elected specie as a GLP-1 agonist.
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412
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Aspnes fails to teach an embodiment where instant Ring A can be partially saturated.
Zhong teaches an overlapping genus structure with instant Formula I as a GLP-1 agonist.
Zhong fails to explicitly teach a structural example of the elected specie, however, Zhong does teach different examples of the embodiments of the elected specie. For example, compound 320 teaches all the embodiments of the elected specie except the partially unsaturated instant Ring A, however, compounds 319 and 329 show examples where instant Ring A can be unsaturated or partially unsaturated.
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319
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(Zhong, Compound 320)
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301
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(Zhong, Compound 319)
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287
808
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(Zhong, Compound 329)
Therefore, it would be obvious to a person skilled in the art at the time to extract the structure taught by Aspnes and substitute the ring where instant Ring A is placed with any level of saturated ring.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the structure of the GLP-1 agonist taught by Aspnes and substitute the ring where instant Ring A is placed with any level of saturated ring, as taught and motivated by the teachings of GLP-1 agonists by Zhong. Therefore, claims 212-216 and 221 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 212-216 and 221 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621