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 .
Status of the Application
The amendment and election of 21 July 2026 are entered.
Claims 2-8 and 15 have been canceled. Claims 1, 9-14, and 16-19 are pending. Claims 16, 18, and 19 are withdrawn without traverse. Claims 1, 9-14, and 17 are being examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 9-14, and 17) and the species of Z1=SEQ ID NO: 306, Z2=SEQ ID NO: 320, and Z3=SEQ ID NO: 307 in the reply filed on 21 July 2026 is acknowledged.
Claims 16, 18, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 21 July 2026.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 12 is objected to because of the following informalities: SEQ ID NOs: 634-637, 640, and 643 are repeated within the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 12 is 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 1 recites a polypeptide Z1-Z2-Z3, where Z1 is Y-Aib-EGTFTSDYSI-Aib-LEKQAQ-Aib-AFVEWLIK, Z2 is GGPSSG, and Z3 is ASLRHYYNWLTRQRY. Claim 12 further claims species of peptides, including SEQ ID NOs: 328-631, 634-640, and 643. The dependent claim is indefinite because at least a portion of the claimed sequences do not read upon the Z1-Z2-Z-3 framework as set forth above, for instance see SEQ ID NO: 328. See also at least SEQ ID NO: 634-640 and 643.
The language of claim 12 is such that the frequent listing of species followed by a species such as “and SEQ ID NO:635, respectively (Y-Aib-E-G-T-F-T-S-D-Y-S-I-Aib-E-K-Q-A-Q-Aib-A-F-V-Q-W-L-I-K(1,3)-G-G-P-E-S-G-A-S-L-R-H-Y-Y-N-W-L-T-R-Q-R-Y-NH2.CD18DA-E-E-E-E-E-eLys(1,2))” makes it such that it is not clear whether the Markush group ends at this given the “respectively” or if the entire claim is one long list of Markush species. See lines 13-15, 31-33, 37-42, 46-48, 56-60, 63-64, 66-68, 70-71, 75-77, 79-80, and 83-85.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As noted above, claim 1 recites a polypeptide Z1-Z2-Z3, where Z1 is Y-Aib-EGTFTSDYSI-Aib-LEKQAQ-Aib-AFVEWLIK, Z2 is GGPSSG, and Z3 is ASLRHYYNWLTRQRY. Claim 12 recites many species, and not every peptide reads upon the framework established by claim 1, for instance SEQ ID NO: 328 and 329, and SEQ ID NOs: 634-640 and 643. Accordingly, the claims do not limit the base claim. Claim 17 while it recites species reading upon claim 1 is of improper dependent form since it depends from claim 12, which fails to limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1, 9-11, 13, and 14 are allowed.
The following is an examiner’s statement of reasons for allowance:
The prior art fails to recognize a GLP1/GIP/NPY2 triple agonist of formula Z1-Z2-Z3 as claimed, since the Z1 formula Y-Aib-EGTFTSDYSI-Aib-LEKQAQ-Aib-AFVEWLIK and the Z3 formula ASLRHYYNWLTRQRY are not disclosed in the prior art. Milliken et al. (J. Med. Chem. 64:1127-1138) discuss dual GLP-1/NPY2 agonists of varying formulas using exendin-4 derivatives combined with a PYY fragment, but none of these constructs match or reasonably lead to the Z1 or Z3 elements as claimed. Nothing from Milliken or other prior art suggests using only residues 22-36 of PYY, alteration of residue 28 to Tyr, insertion of a Trp between residues 29 and 30, and deletion of residue 31 to reach a ASLRHYYNWLTRQRY sequence instead of the wild-type ASLRHYLNLVTRQRY. Similarly, there is no rationale to alter the exendin-4 to the claimed Y-Aib-EGTFTSDYSI-Aib-LEKQAQ-Aib-AFVEWLIK sequence. While the GGPSSG sequence is present in the wild-type exendin-4, there is no particular rationale to alter the exendin-4 to match Z1, choose to leave only the GGPSSG sequence as a linking region, and combine with the claimed Z3 sequence. Z3/SEQ ID NO: 307 is found in WO 2016/198682 A1, but only in the context of a larger peptide and not containing Z1 or Z2 (see e.g. Compounds 42 and 48 for instance). No suggestion or rationale is found in ‘682 to isolate only the portion of SEQ ID NO: 307 as instantly claimed and utilize it in a fusion with SEQ ID NO: 306 and 320.
No other art discloses or suggests Z1-Z2-Z3 in an arrangement of SEQ ID NOs: 306-320-307 as claimed. The claimed polypeptide is therefore novel and unobvious.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached Mon-Thurs 7-5.
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, Melissa Fisher can be reached at (571) 270-7430. 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.
/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
