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 . 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.
Election/Restrictions
Applicant’s election without traverse of SEQ ID 3 in the reply filed on 11 May, 2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Applicants elected SEQ ID 3. A search was conducted for this invention, and it was determined to be both novel and unobvious over the prior art (although non-prior art rejections apply). The closest prior art found was Alsina-Fernandez et al (WO 2019125938, cited by applicants). Example 11 gives a sequence that is very similar to those of applicants, Y-Aib-QGTFTSDYSI-αMeL-LDKK(same modification)AQ-Aib-AFIEYLLEGGPSSGAPPPS (p22, 2nd paragraph). However, motivation to make the changes to this sequence to arrive at applicant’s invention is tenuous. For example, with the the P38Ac3c mutation, it is known that Ac3c has similar properties to Pro in the context of helices (Alias et al, Org. Biomol. Chem. (2010) 8 p788-792, abstract), but that is rather tenuous motivation for making the claimed modification. Similarly, with the F6αMePhe modification, a similar substitution is known in Glp-1 chemistry (Ding et al, Amino Acids (2020) 52 p1207-1226, p1212, 2nd column, 3d paragraph), and can improve BBB penetration in a different context (p1214, 2nd column, 2nd paragraph), but it is not clear that this gives a motivation to modify that specific Phe residue, except as an improper obvious to try. Thus, the claimed subject matter is novel and unobvious over the prior art. Following the same rationale, SEQ IDs 1 and 2 are rejoined and also found novel and unobvious over the prior art.
Claims Status
Claims 26-34 are pending.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 26-34 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 26-34 of copending Application No. 19/649,504 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Examiner’s Note
A scope of enablement rejection was considered for claims 30, 32, and 34, over type I diabetes, but a search has shown that GLP-1 analogs have been used for those patients (Resnick et al, Front. Endocrinol. (2025) 1520313, title).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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