DETAILED ACTION
Examiner acknowledges receipt of the replies filed 02/04/2026 and 03/04/2026, in response to the final office action mailed 12/10/2025.
Claims 83, 84, 86, 87, 91-95, 97-105 are pending. Claims 77 and 78 have been cancelled.
Claims 100 and 105 are withdrawn from further consideration are withdrawn from further consideration for the reasons set forth herein, and previously made of record.
Claims 83, 84, 86, 87, 91-95, 97-99, and 101-104 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/04/2026 has been entered.
Denial of Priority- maintained
The earliest filing date for the instant application is deemed to be the filing date of PCT/US2020/048523, filed 8/20/2020- for the reasons previously made of record.
Specification- withdrawn
The objection to the specification is withdrawn in view of the amendment filed 3/04/2026.
Drawings-withdrawn
The objection to the drawings is withdrawn in view of the amendment filed 3/04/2026.
Claim Objections- withdrawn
The objection of claim 94 is withdrawn in view the amendment filed 03/04/2026.
The objection of claim 97 is withdrawn in view of the amendment filed 3/04/2026.
Claim Rejections - 35 USC § 112- withdrawn
The rejection of claims 77, 78, 83, 84, 86, 87, 91-95, 97-99, and 101-104 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the amendment filed 3/04/2026 which canceled independent claim 77.
The rejection of claims 77, 78, 83, 84, 86, 87, 91-95, 97-99, and 101-104 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 3/04/2026.
Response to Arguments
Applicant's arguments and amendment filed 3/04/2026 with respect to the above objections and rejections have been fully considered and are persuasive. The objections and rejections have been withdrawn.
Upon further consideration, a new grounds of objection and rejections are made in view of the claims filed 3/04/2026.
An action on the merits is set forth herein.
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.
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- New
Claim 97 is objected to because of the following informalities:
Claim 97 should be amended to recite “SEQ ID NOs: 7-119”.
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.
Claims 83, 84, 86, 87, 91-95, 97-99, and 101-104 are 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. This rejection is necessitated by the amendment filed 3/4/2026.
The metes and bounds of claim 83 are deemed to be indefinite. Claim 83 recites GGYPEDILDKHLQRVIL (SEQ ID NO:121) which is 17 amino acids in length. This is inconsistent with the Sequence Listing filed 2/28/2022 which relates to a defined peptide that is 25 amino acids in length, longer than the recited peptide.
In contrast, the Sequence listing provides SEQ ID NO:125 which provides the recited peptide sequence of GGYPEDILDKHLQRVIL.
Because claims 84, 86, 87, 91-95, 97-99, and 101-104 depend from indefinite claim 83 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Regarding claim 84, the metes and bounds of the claim are deemed to be indefinite. Independent claim 83 is limited to a Markush grouping of peptides, and does NOT encompass a conjugate, fusion protein, etc. Claim 84 recites a peptide further comprising a cyclic cell penetrating peptide (cCPP) conjugated to a linker. This is inconsistent and incompatible with independent claim 83 which is limited to a peptide of SEQ ID NO:120, 121, 129, or 131-133. Claim 83 does not allow for conjugates, fusion proteins, polypeptides, etc.
Additionally, claim 84 recites a linker. The linker comprises at least one amino acid, alkylene, alkenylene, alkynylene, aryl, cycloalkyl, cycloalkenyl, cycloalkynyl, heterocyclyl, heteroaryl, ether, or a combination thereof, each of which are optionally substituted. Peptides are limited to contiguous amino acids and do not comprise alkylene, alkenylene, alkynylene, aryl, cycloalkyl, cycloalkenyl, cycloalkynyl, heterocyclyl, heteroaryl, ether, or a combination thereof.
Because claims 86 and 87 depend from indefinite claim 84 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Of note- claim 86 recites “the cCPP comprises 6 to 10 amino acids and is from the cyclization of terminal amino acids”. Thus, the claimed cCPP would be unable to form a contiguous amino acid sequence as required by the peptide recited in claim 83, e.g., a peptide comprising SEQ ID NO:120, 121, 129, or 131-133.
Claim 91 depends from claim 83. The metes and bounds of the claim are deemed to be indefinite. Claim 91 recites a peptide of claim 83, further comprising a cCPP and a stapled peptide of formula IA, IB, or IC. As noted above, independent claim 83 is limited to a peptide, and does NOT encompass a conjugate, polypeptide, fusion protein, etc. The cCPP and stapled peptide of claim 91 are inconsistent and incompatible with the claim scope of independent claim 83, drawn to a peptide of SEQ ID NO:120, 121, 129, or 131-133.
Examiner expressly notes that claim 91 recites:
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These structures are inconsistent with a peptide, e.g., contiguous amino acids. Claim 91 attempts to redefine the peptides of claim 83, which recites SEQ ID NOs:120, 121, 129, and 131-133. Claim 91 further recites:
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Claim 83 recites peptide sequences in which each amino acid is fully defined. In contrast, claim 91 recites completely different definitions and amino acids that may or may not be present, e.g., variables U, J, and Z’ “when present” are not required.
Additionally, claim 84 recites a linker. The linker comprises at least one amino acid, alkylene, alkenylene, alkynylene, aryl, cycloalkyl, cycloalkenyl, cycloalkynyl, heterocyclyl, heteroaryl, ether, or a combination thereof, each of which are optionally substituted. Peptides are limited to contiguous amino acids and do not comprise alkylene, alkenylene, alkynylene, aryl, cycloalkyl, cycloalkenyl, cycloalkynyl, heterocyclyl, heteroaryl, ether, or a combination thereof.
Because claims 92-95, 97-99, and 101-104 depend from indefinite claim 91 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Of note- claims 93 and 94 recite “the cCPP comprises 6 to 10 amino acids and is from the cyclization of terminal amino acids”. Thus, the claimed cCPP would be unable to form a contiguous amino acid sequence as required by the peptide recited in claim 83, e.g., a peptide comprising SEQ ID NO:120, 121, 129, or 131-133.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diderich et al (ACS Chemical Biology 11:1422-1427 (2016)- cited in IDS filed 12/20/2023). This is a new rejection necessitated by the amendment filed 3/04/2026.
Diderich et al teach α-helical peptides. The peptides included two cysteine residues in positions i and i + 4 and to connect them with thiol-reactive, helix-stabilizing linkers (p. 1422, abstract). Diderich et al taught the peptide GGYPECILDCHLQRVIL, which has 100% identity with instant SEQ ID NO:120 (Table 1).
Accordingly, the limitations of claim 83 are satisfied.
Examiner cautions applicant from amending the claims in a manner which would introduce new matter, or change claim scope to be different than the as-filed, elected claims.
Relevant Art Not Relied Upon
SEQ ID NOs:121, 129, and 131-133 appear to be free of the prior art. The closest prior to the sequences is the following.
Instant SEQ ID NO:121 has 59% identity with SEQ ID NO:9 of Li et al (U.S. 2017/0152286- previously cited). See SCORE
Instant SEQ ID NO:129 has 63.4% identity with SEQ ID NO:52 of Verdine et al (U.S. 2014/0005118). See SCORE
Instant SEQ ID NO:131 has 68.3% identity with SEQ ID NO:9 of Li et al (U.S. 2017/0152286- previously cited). See SCORE
Instant SEQ ID NO:132 has 68.3% identity with SEQ ID NO:9 of Li et al (U.S. 2017/0152286- previously cited). See SCORE
Instant SEQ ID NO:133 has 57.7% identity with SEQ ID NO:9 of Li et al (U.S. 2017/0152286- previously cited). See SCORE
Instant SEQ ID NO:1 has 68.9% identity with SEQ ID NO:9 of Li et al (U.S. 2017/0152286- previously cited). See SCORE.
Instant SEQ ID NO:1 has 57.8% identity with SEQ ID NO: 755029 of Mintz et al (U.S. 2007/0083334). See SCORE.
Pei et al (WO2019/084528 102(a)(2) date10/27/2017- by inventor and applicant- previously cited) taught polypeptide conjugate comprising a) a stapled peptide comprising a peptide and at least one staple which holds the peptide in an a-helical confirmation; and b) at least one cyclic cell-penetrating peptide (cCPP) conjugated to the stapled peptide (claim 1). The reference taught polypeptide conjugate has a structure according to Formula IA, IB, or IC (claim 12). The cyclic CPP can have a sequence of Formula II, or Formulas IIIA-D (claims 13 and14).
Pei et al do not teach or suggest a peptide that binds β-catenin, much less a peptide having at least 75% identity with SEQ ID NO:1.
Conclusion
No claims are allowed.
Claims 83, 84, 86, 87, 91-95, and 97-105 are pending. Claims 100 and 105 are withdrawn.
Claims 83, 84, 86, 87, 91-95, 97-99, and 101-104 are rejected.
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