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Claims 1, 2, 204-206, 207-211, 217-220, and 222 are withdrawn.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.
Response to Arguments
Applicant’s arguments filed 6/29/2026, with respect to the rejections of claims 212-216 and 221 under 35 U.S.C. 102 and 103 have been fully considered and are found not persuasive.
With respect to the 102 rejection, the Applicant argues that Zhong fails to teach the imidazopyridine moiety of the instant compound 120w. The Applicant points out that Zhong teaches a benzimidazole moiety. Upon the applicant pointing it out, the Examiner agrees that Zhong does not teach an anticipatory compound of the instant claims. Zhong, however, does teach an example of an imidazopyridine (Compound 102). Therefore, it would be obvious to a person skilled in the art to substitute the benzimidazole for an imidazopyridine. However, this is not anticipatory and therefore, with regards to the 102 rejection, it is moot and withdrawn. However, a 103 rejection is made in light of this and therefore this is considered a SECOND NON-FINAL.
With respect to the 103 rejection, the Applicant first argues that the PCT cited by the Examiner does not disclose compounds 319, 320, and 329. The Examiner argues that the art cited by the Examiner is application WO2020207474A1, which claims priority to the PCT application. The ‘474 publication does teach the compounds. Although the PCT application may not explicitly teach the compounds, it does provide the antecedent basis for the compounds in the ‘474 application that is claiming priority. Second, the Applicant argues that the primary reference cited by the Examiner (“Apnes”) does not teach instant Ring A can be a partially saturated or unsaturated ring and that the secondary reference (“Zhong”) is too broad to motivate a person to substitute one for the other and arrive at the instant invention. The Examiner argues that it would be obvious to a person skilled in the art motivated by the structures being almost identical otherwise and having the same use as GLP-1 agonists. The burden is shifted to the Applicant to show that this substitution would lead to unexpected results. Therefore, the Examiner does not find this argument persuasive and the 103 rejection is maintained. See below.
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 214-216 and 221 are rejected under 35 U.S.C. 103 as being unpatentable over 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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Zhong teaches a structural example similar to compound 120w of claims 214 (Page 65, Compound 94), see below.
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649
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Zhong also teaches a structural example containing an imidazopyridine (Compound 102).
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601
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Therefore, it would be obvious to a person skilled in the art to substitute the benzimidazole of compound 94 for an imidazopyridine, as taught in compound 102.
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 Zhong and substitute the benzimadzole ring with a imidazopyridine ring. A person skilled in the art would have been motivated to do so because Zhong teaches both as structural examples as GLP-1 agonists. 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 214-216 and 221 would be obvious to a person skilled in the art at the time.
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. Apnes also fails to teach an imidazopyridine in place of the benzimidazole.
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. First, Zhong teaches a structural example containing an imidazopyridine (Compound 102).
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Therefore, it would be obvious to a person skilled in the art to substitute the benzimidazole taught by Aspnes for an imidazopyridine, as taught by Zhong.
Further, Zhong 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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789
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(Zhong, Compound 320)
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301
807
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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
