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 .
Applicant’s response filed on 1/20/2026 is acknowledged and fully considered.
Status of Application, Amendments, And/Or Claims
The amendments of claims 1 and 3, and the addition of claim 4 have been made of record.
Claims 1-4 are pending and under consideration.
Response to Arguments
Claim Rejections - 35 USC § 102-withdrawn
The rejection of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Coskun et al. (IDS, Mol. Metab. (2018), 18: 3-14) is withdrawn in view of applicant’s amendments to the claim to delete the amino acid “Aib” as Xaa1.
Claim Rejections - 35 USC § 103-maintained
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.
Claim(s) 1-3 remain rejected under 35 U.S.C. 103 as being unpatentable over Coskun et al. (IDS, Mol. Metab. (2018), 18: 3-14) in view of Rao et al.(Bull. Chem. Soc. Jpn., 70:293-299 (1997)) as evidenced by Bielicki et al.(US Appl.No.20140287994) for the reasons of record at pg. 4-6 of the office action of 10/22/2025 and as discussed below.
Coskun et al. teach a GLP-1 and GIP dual agonist amino acid sequence (see Figure A.) having 100% sequence identity with the instantly claimed SEQ ID NO:2, however, they teach that the compound has X is Aib and fatty di-acid is C20 carbon (Palmitoyl). The prior art teaches that fatty diacid having carbon C14, C16, C18 or C20 are functionally equivalent (see claim 1 suggest that the length of (CH2) can be 5-25). Coskun et al do not teach replace Xaa, from Aib to 1-aminocyclobutane-1-carboxylic acid or with 1-aminocyclopentane-1-carboxylic acid.
Rao et al. teach performed conformation studies using molecular mechanics on model peptides with 1-aminocycloalkane-1carboxylic acid residues (see the title). They determined angle and average bond length using crystallography and suggest that the number of (CH2) can be 1, 2 or 3 while maintaining the structure. Therefore, one ordinary skill in the art would be able to swap 1-aminocylobutane-1 carboxylic acid with 1-aminocyclopropane-1-carboxylic acid or even Aib for each other. Further, Bielicki et al. teach that 1-aminocyclopropane-1-carboxylic acid, 1-aminocyclobutane-1-carboxylic acid (ABC), 1-aminocyclopentane-1-carboxylic acid (cycloleucine) and Aib are hydrophobic analogs of leucine, valine, isoleucine, glycine, alanine and methionine (see paragraph [0143). Therefore, substituting Xaa at positions 2 or 13 of Coskun et al with 1-aminocyclobutane-1-carboxylic acid for Aib would have been obvious to one ordinary skill in the art.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to substitute 1-aminocyclobutane-1-carboxylic acid for Aib as taught by Rao et al and as evidence by Bielicki et al. in the dual agonist of GLP-1 and GIP as taught by Coskun et al. Additionally, one would have been motivated to do so because Rao et al teach that the number of (CH2) in the ring can be 1, 2 or 3 and Bielicki et al. teach that Aib and 1-aminocyclobutane-1-carboxylic acid are glycine, valine, leucine and isoleucine homologs [0143]. Further, one would have a reasonable expectation of success in replacing non-natural amino acids 1-aminocyclobutane-1-carboxylic acid or 1-aminocyclopropane-1-carboxylic acid for Aib in the GlP/GLP-1 dual agonist compound taught by Coskun et al because these non-natural amino acids are glycine, methionine, valine or leucine analogs and provide stability and functions as hydrophobic analog in the peptide.
Applicants argue that Coskun recites a dual GIP and GLP-1 agonist, LY3298176, which has Aib at position 2 and 13 but not
PNG
media_image1.png
123
326
media_image1.png
Greyscale
as recited in the claim. They argue that Rao recites that peptides with conformationally restricted 1-aminocyclopropane-1- carboxylic acid (Acc) moiety exhibit preference for Y-turn structure in solution phase and solid phase but Rao does not teach that 1-aminopropane-1-carboxylic acid is interchangeable with 1-aminobutane-1-carboxylic acid. They argue that Bielicki does list various non-natural amino acids, including Aib, 1-aminocyclobutane-1-cabroxylic acid and 1-aminocyclopopane-1-carboxylic acid as hydrophobic analogs but they Bielicki does not teach to replace Aib within a dual GIP and GLP-1 receptor agonist. They argue that the instantly claimed peptide shows reduced GI side effects than Coskun’s dual agonist.
Applicants’ arguments have been fully considered but they are not found persuasive because Coskun teaches a GIP and GLP-1 dual agonist having Aib at position 2 and 13 and Bielicki teaches that Aib is similar in function as 1-aminocyclobutane-1-cabroxylic acid and 1-aminocyclopopane-1-carboxylic acid and therefore, one ordinary skill would be able to substitute one for other. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., reduced side effects) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Claims 1-3 are rejected.
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
THIS ACTION IS MADE FINAL. 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 GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GYAN CHANDRA/Primary Examiner, Art Unit 1674