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
Applicants elected compound 58 to induce weight loss (interpreted as treating obesity) without traverse in the reply filed on 9 Dec, 2025.
Claims Status
Claims 1-4, 6-8, 10-15 are pending.
Claims 1, 6, and 8 have been amended.
Claims 14 and 15 are new.
Claims 3, 11, 12, 14, and 15 have been withdrawn due to an election/restriction requirement.
Withdrawn Objections
The objection to the disclosure due to the lack of a sequence listing is hereby withdrawn due to amendment.
The objection to the disclosure due to the lack of SEQ ID numbers is hereby withdrawn due to amendment.
Maintained/Modified Objections
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The current title merely states that the subject matter of the application comprises a pharmaceutical polypeptide; this provides little information for someone searching for their claimed subject matter.
response to applicant’s arguments
Applicants argue that they have changed the title to one that is more descriptive.
Applicant's arguments filed 20 May, 2026 have been fully considered but they are not persuasive.
Applicants have changed the title of the specification, not the invention. To do that, they need to file a new or amended application data sheet (37 CFR 1.72).
Claim Objections
Claim 6 is objected to because of the following informalities: this claim gives sequences with at least 4 identifiable amino acids, but have no SEQ ID numbers. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03). Appropriate correction is required.
response to applicant’s arguments
Applicants state that they have amended this claim to overcome the objection.
Applicant's arguments filed 20 May, 2026 have been fully considered but they are not persuasive.
Applicants have deleted the names of the compounds, but not the compounds themselves from the claim. It is suspected that they intended to delete the compounds, but the latest claim set maintains the structures in this claim.
New Objections
Claim Objections
Claim 1 is objected to because of the following informalities: the claim refers to formula (IV) without defining it. While it is defined in the specification (p3 as filed), the claim would be clearer if the definition is in the claim.
Appropriate correction is required.
Withdrawn Rejections
The rejection of claims 8 and 9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of enablement is hereby withdrawn due to amendment.
The rejection of claim 9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to the disorders treated is hereby withdrawn due to amendment.
The rejection of claim(s) 1, 7-10, and 13 under 35 U.S.C. 102(a)(1) as being anticipated by Kadereit et al (US 20150166627) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 2, 4, 6-8, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kadereit et al (US 20150166627) in view of Kolterman (US 20060069029) and Just et al (US 20160257729).
Kadereit et al discuss dual GLP-1/GIP agonists (title). Among the sequences described by the reference is SEQ ID 10, Y-Aib-EGTFTSDL SIQLEKEAVR LFIEWLKAGG PSSGAPPPS-NH2 (table 8, p14). Note that this reads on the sequences of claim 1, with X1=L, X11=I, X2=Q, X12=L, X3=K, X4=E, X5=V, X6=R, X13=L, X7=I, X8=E, X9=K, X14=A, and X10=GPSSGAPPPS. This sequence is explicitly claimed by the inventors (claim 13), making it clear that the inventors were interested in this sequence, and making it a reasonable sequence as a starting point for further modification. Formulations of these sequences with a carrier are contemplated (paragraph 118). They can be used to reduce the body weight of a patient (paragraph 47). The sequence was made by chemical synthesis (paragraph 291).
The difference between this reference and the claims, and applicant’s elected species, is that this reference has a few mutations compared to the elected species, and lacks a fatty acid based plasma lifetime extension moiety.
Kolterman et al discuss exendin analogs (title), which is also a GLP-1 agonist (paragraph 9). By alanine mutation studies, it was determined that the Glu residue at position 24 (corresponding to position 24 of applicant’s elected species) can be mutated to a Lys residue to provide a location to attach a PEG or equivalent (paragraph 213). This reference suggests amending position E24 of Kadereit et al to Lys to provide an attachment point for a plasma lifetime extending moiety.
Just et al also discusses GLP-1/GIP agonists (title). Position 13 can be Ala (paragraph 11), and numerous examples have Ala in that position (paragraphs 19-26). A lipophilic group can be attached to a Lys residue to increase binding to albumin, shielding the compound from enzymatic degradation and renal clearance, enhancing the plasma lifetime of the material (paragraphs 67 and 68). Among the linker/fatty acid moieties expressly discusses is [19-carboxy-nonadecanoyl]-isoGlu-Peg3-Peg3, with the structure
PNG
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312
514
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Greyscale
(paragraph 118, p14). Note that this is identical to the moiety that applicants have attached to position 24 of their elected species. This reference discusses attachment of a fatty acid-amino acid-PEG group to a lysine to increase plasma lifetime, and mutating position 13 to Ala.
Therefore, it would be obvious to mutate position 24 of Kadereit et al to Lys, to provide an attachment point for a plasma lifetime extension moiety, as discussed by Kolterman et al. As these peptides are for the same purpose (GLP-1 agonism), an artisan in this field would attempt this modification with a reasonable expectation of success.
Furthermore, it would be obvious to use the plasma lifetime extension moiety of Just et al instead of the PEG of Kolterman et al, as a simple substitution of one known element (the PEG of Kolterman et al) for another (the fatty acid-AA-PEG of Just et al) yielding expected results (plasma lifetime extension). As plasma extension moieties similar to Just et al are common in the art, an artisan in this field would attempt this modification with a reasonable expectation of success.
Finally, it would be obvious to make a Q13A mutation in the sequence of Kadereit et al as a substitution of one known element (the Gln of Kadereit et al) for another (the Ala of Just et al) yielding expected results (GLP-1 binding). As both references discuss GLP-1 and GIP binding, an artisan in this field would attempt this substitution with a reasonable expectation of success.
The combination of references renders obvious applicant’s elected species, compound 58, rendering obvious claims 1, 2, 4, and 6.
Kadereit et al discusses pharmaceutical compositions, rendering obvious claim 7.
Kadereit et al discusses using the peptides for weight loss, rendering obvious claims 8 and 10.
Kadereit et al discusses chemical synthesis, rendering obvious claim 13.
response to applicant’s arguments
Applicants argue that the references disclosing the modifications to the sequence of Kadereit et al are of different peptides, so would not be expected to be effective in the sequence of Kadereit et al.
Applicant's arguments filed 20 May, 2026 have been fully considered but they are not persuasive.
Applicant’s argument is that the sequences of Kolterman et al and Just et al are different than those of Kadereit et al, so the mutations they discuss would not be expected to be effective when used in the sequences of that reference. This assumes that they are binding to different receptors in different ways. However, all these references discuss various GLP-1 analogs, some with capability of binding to other receptors. The portions that are mutated have almost identical local identity to those of Kadereit et al, which means that they are binding to the same receptor at that location.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of copending Application No. 17/421,297 (US 20220127323).
Competing claim 1 describes a genus of sequences comprising a genus of sequences, while claim 6 describes a Markush group of peptides, including compound 30, which is almost identical to compound 15 of the examined claims, save for a slightly longer fatty acid, which is not a patentable distinction (MPEP 2144.09(II)), anticipating examined claims 1, 2, 4, and 5, and rendering obvious examined claim 6.
response to applicant’s arguments
Applicants state that they have amended the claims to no longer read on compound 15.
Applicant's arguments filed 20 May, 2026 have been fully considered but they are not persuasive.
Examined claim 6 still reads on compound 15.
New Rejections
Claim Rejections - 35 USC § 112(d)
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.
Claim 6 is 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. Claim 6 has a number of sequences that do not meet the limitations of claim 1, from which it depends. For example, compound 15 requires an Aib residue at position X2, which is not allowed by 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone 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.
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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