DETAILED ACTION
Examiner acknowledges receipt of the reply filed 11/13/2025, in response to the restriction requirement mailed 09/16/2025.
Claims 1-14 are pending. Claims 5, 13, and 14 are withdrawn from further consideration for the reasons set forth below.
Claims 1-4 and 6-12 are being examined on the merits in this office 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 .
Priority
The filing receipt dated 02/24/2023 provides the following:
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Election/Restrictions
Examiner notes conflicting statements by Applicant.
Applicant states in the reply filed 11/13/2025 at p. 5, 1st para [reads on electing Group 2 without traverse]:
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However, Applicant then states at the end of para. 3: “Without demur or prejudice, Applicants conditionally elect Group 1, with traverse” [electing Group 1].
Examiner believes that the election of Group 1 was the intended group election because Applicant provides arguments for traverse.
Applicant's election with traverse of Group 1 in the reply filed on 11/13/2025 is acknowledged. The traversal is on the ground(s) that Group 2 is drawn to a method of treating a metabolic disease comprising the polypeptide derivative of Group 1 (reply at p. 5., para 3). Applicant asserts that Groups 1 and 2 can be considered to be directed to a product and a therapeutic use. Id. This is not found persuasive because the technical feature of a polypeptide of formula I is not a special technical feature as it does not make a contribution over the prior art in view of Peterson et al. (U.S. 2013/157953- previously cited). Please refer to pp. 6-8 of the restriction requirement for specific details. Applicant did not address the cited reference does used to split unity in the reply filed 11/13/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/13/2025.
Applicant elected the following species in the reply filed 11/13/2025- see p. 5:
polypeptide of formula I- compound dgc005, SEQ ID NO:8,
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linker- absent [this is inaccurate as the elected linker is γGlu-γGlu-]
side chain moiety- not applicable [this is inaccurate as the elected moiety with linker is
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]
disease - diabetes
Claims 1-3 and 6-12 read on the elected species.
Applicant states that the species election is made with traverse (reply at p. 5). However, applicant did not provide any arguments for traversal. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/2025.
Upon searching the elected species, an additional species was found e.g., SEQ ID NOs:16-21. Accordingly, for purposes of compact prosecution, the election of species is modified only to the extent of examining this additional species. Otherwise the election of species requirement is still retained. Claim 4 reads on SEQ ID NOs:16-21 (although claim 4 recites -NH2 at C terminus).
In reply to this office action, status identifiers of withdrawn claims should be revised to reflect withdrawn claim status.
Information Disclosure Statement
NPL1 of the IDS filed 4/24/2025 has been struck-through. The reference is not in English and has not been considered. The NPL also appears to have been submitted twice. See file wrapper.
Applicant should file an English translation and/or a statement of relevance for the reference in order for the reference to be considered.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claim Objections
Claims 1-4 and 6-12 are objected to because of the following informalities:
Claim 1 should be amended to remove recitation of the term “or” twice in the preamble: “A polypeptide derivative, [[or]] a modified derivative, or a salt thereof,”.
Claims 2-4 and 6-11 should be amended to recite “The polypeptide derivative, [[or]] the modified derivative, or the salt thereof according to”.
Claim 2 further should be amended to recite “claim 1, wherein”.
Claim 3 further should be amended to recite “claim 1, wherein X2 is Aib”.
Claim 4 further should be amended to recite “claim 1, wherein X17 …”.
Claim 6 should further be amended to recite “wherein :[[.]] 4 to SEQ ID NO:[[.]] 27”.
Claim 7 should further be amended to recite “wherein at X20
Claim 10 should be split into two separate claims:
10. The polypeptide derivative, [[or]] the modified derivative, or the salt thereof according to claim 7, wherein 14-20 fatty acyl group
New claim 15. The polypeptide derivative, the modified derivative, or the salt thereof according to claim 10, wherein the fatty acyl group is a C14-20 monofatty acyl group or a C14-20 fatty diacid monoacyl group.
Claim 11 should be amended to recite “wherein 16-18 fatty acyl group”.
Claim 12 should be amended to recite “A pharmaceutical composition, comprising the polypeptide derivative, [[or]] the modified derivative, or the salt thereof according to claim 1, and optionally…”.
Appropriate correction is required.
Sequence Compliance- Specification
This application is objected to because the peptide sequences at least at pages 8, last 3 lines are not associated with a sequence identifier (a SEQ ID NO). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. See MPEP § 2421-2422. Applicant must amend the specification in response to this office action and must confirm that all peptide sequences of the specification are included in the sequence listing.
Examiner requests that the Applicants review the specification to confirm that all of the peptides, as required, comply with MPEP § 2421-2422.
Sequence Interpretation/Claim Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising an amino acid sequence of SEQ ID NO: 1” requires only a dipeptide or more within SEQ ID NO: 1, “comprising the amino acid sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with or without additional amino acids at any N-/C-terminal ends or additional nucleotides at 5' /3' ends, “consisting of an amino acid sequence of SEQ ID NO: 1” would encompass any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, and “consisting of the amino acid sequence of SEQ ID NO: 1” would be limited to the sequence of the amino acids as specified by SEQ ID NO: 1, and nothing more or less; "an amino acid selected from the group consisting of SEQ ID NOs: 1, 2 and 3” is any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, 2 or 3; and “the amino acid selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
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 10 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.
Regarding claim 10, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
To overcome this rejection the last clause of claim 10 should be recited in a new dependent claim.
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.
Claim(s) 1, 3, 4, and 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. (U.S. 2013/157953- previously cited).
Peterson et al. teach glucagon-GLP-1 dual agonist polypeptides having a structure of R1—X—Z1—Z2—R2 wherein: R1 is hydrogen; X has the Formula I:X1-X2-X3-GTFTSD-X10-S-X12-YL-X15-X16-X17-X18-A-X20-X21-F-X23-X24-WL-X27-X28-X29 (SEQ ID NO:105) wherein R2 is hydrogen; X1 is His; X2 is Ser, Aib or D-Ser; X3 is Gln; X10 is Tyr; X12 is Lys; X15 is Asp or Glu; X16 is Glu; X17 is Arg, Lys, or Gln; X18 is Ala; X20 is Lys; X21 is Asp or Glu; X23 is Val or Ile; X24 is Ala;X27 is Glu; X28 is Ser or Ala; X29 is Glu or Gly; X30 is absent; R2 is NH2 or OH; and Z1 is absent (e.g., paras. [0023]-[0030], [0211]-[0236], claims 6, 123, 134-135). Peterson et al. teach that the polypeptide is modified with a lipophilic substituent (fatty acyl group) through a spacer (hydrophilic linker fragment) (e.g., paras [0211]-[0236]). The lipophilic substituent is preferably conjugated to lysine, e.g., X20 (e.g., paras. [0221]-[0232]). The lysine side chain can be modified with a lipophilic moiety, e.g., hexadecanoyl-gamma-Glu (e.g., paras. [0228]).
Although Peterson et al. disclose glucagon-GLP-1 dual agonist polypeptides of formula I, the reference did not reduce to practice a polypeptide of Formula I.
It would have been obvious to the one of ordinary skill the art to have prepared a polypeptide derivative of general formula I. The skilled artisan would have recognized that Peterson et al taught glucagon-GLP-1 dual agonist polypeptides comprising the claimed amino acids and positional arrangement. The rationale to support a conclusion that a polypeptide of Formula I would have been obvious is that all the claimed elements were taught by Peterson et al and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969). It is apparent that a preponderance of evidence dictates that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made as evidenced by the teachings of Peterson et al.
Accordingly, a polypeptide of formula I is deemed to be rendered obvious in view of the prior art.
Regarding claim 3, Peterson et al teach that X2 can be Aib (e.g., para [0024], claim 6).
Regarding claims 4 and 6, it would been obvious to one of ordinary skill in the art to have prepared a polypeptide of one of instant SEQ ID NOs:16-21 which contained 29 amino acids, wherein X30 is absent. The polypeptides of SEQ ID NOs:16-21 further require X17 is Arg or Lys; X28 is Gly; X29 is Gly; X30 is absent; and the C-terminal carboxyl group is amidated. Peterson et al teach that the C-terminus (R2) can be either -NH2 or -OH (e.g., paras. [0023]-[0027], claim 6). The rationale to support a conclusion that a polypeptide of Formula I would have been obvious is that all the claimed elements were taught by Peterson et al and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969). It is apparent that a preponderance of evidence dictates that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made as evidenced by the teachings of Peterson et al.
Regarding claims 7-9, Peterson teach that X20 can be modified at the side chain ε-amino group with a fatty acyl group (lipophilic substituent) through a hydrophilic linker fragment (spacer) (e.g., paras [0211]-[0236]). Hydrophilic linker fragments include one or more of the repeat units of the spacer Glu, γ-Glu, Gly, and 8-amino-3,6-dioxaoctanoyl (Ado) (e.g., paras. [0221-[0225]).
Regarding claims 10-11, the lipophilic substituent include a hydrocarbon chain having 10 to 24 C atoms. The hydrocarbon chain is substituted with acyl, and accordingly the hydrocarbon chain may be part of an alkanoyl group, for example a dodecanoyl, 2-butyloctanoyl, tetradecanoyl (C14), hexadecanoyl (C16), heptadecanoyl (C17), octadecanoyl (C18), or eicosanoyl group (C20) ( paras. [0215]-[0228]-[0236]).
Regarding claim 12, Peterson et al teach a pharmaceutical composition, comprising the polypeptide and one or more pharmaceutically acceptable adjuvants (e.g., paras. [0279]-[0286]).
Accordingly, claims 1, 3, 4, and 6-12 are rendered obvious in view the teachings of Peterson et al.
Relevant Art Not Relied Upon
Instant SEQ ID NO:8 has 92.3% identity with amino acids 1-30 of SEQ ID NO:5 of Han et al (U.S. 2024/0252592).
Conclusion
No claims are allowed.
Claims 1-14 are pending. Claims 5, 13, and 14 are withdrawn.
Claims 1, 3, 4, and 6-12 are rejected. Claim 2 is objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654