DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Response to Election/Restriction filed on 9/11/2025 is acknowledged.
3. Claim filed on 9/19/2025 is acknowledged.
4. Claims 1-30, 32-46 and 49-71 have been cancelled.
5. Claims 31, 47 and 48 are pending in this application.
6. Claims 31, 47 and 48 are under examination.
Elections/Restrictions
7. Applicant’s election of compound 3BP-4785 with the structure
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as species of compound comprising a cyclic peptide of formula (I) in the reply filed on 9/11/205 is acknowledged. 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)). The requirement is made FINAL in this office action.
The instant claims 31, 47 and 48 are drawn to a compound comprising a cyclic peptide of formula (I):
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, and an N-terminal modification group A attached to Xaa1. A search was conducted on the elected species; and this appears to be free of prior art. A search was extended to the genus in claim 31; and this too appears to be free of prior art. Claims 31, 47 and 48 are examined on the merits in this office action.
Please note: An interview has been held with Applicant’s representative, Michael G. Raucci, on 10/7/2025 to discuss amendments to put this application in condition for allowance (see PTO-413 mailed on 10/9/2025). However, the Examiner is informed that Applicant would like to receive an office action. Therefore, a non-final office action is issued hereby.
Sequence Non-Compliance
8. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. All sequences disclosed in the application must comply with the requirements of 37 C.F.R. 1.821-1.825, not only those recited in the claims.
In the instant case, claim 47 and instant specification disclose various peptides including various cyclic peptides throughout the specification. However, these peptides are not in the sequence listing filed on 1/7/2022.
All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database.
Objections
9. The specification is objected to for the following minor informality: The instant specification discloses various peptides including various cyclic peptides throughout the specification. However, these peptides are not in the sequence listing filed on 1/7/2022; and they are missing the sequence identifier. Applicant is required to amend the specification to comply with 37 CFR 1.821(c) and 1.821(d).
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 (see MPEP § 608.01).
10. Claim 31 is objected to for the following minor informality: Applicant is suggested to amend claim 31 as "A compound comprising a cyclic peptide of formula (I)
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(I)
and an N-terminal modification group A attached to Xaa1,
wherein:
the peptide sequence is drawn from left to right in N to C-terminal direction,
Xaa1 is an amino acid of formula (II)
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(II),
wherein:
R1a is –NH-,
R1b is H,
n = 0,
the N-terminal modification group A is covalently attached to the nitrogen atom of R1a,
the carbonyl group of Xaa1 is covalently attached to the nitrogen atom of Xaa2,
and the sulfur atom of Xaa1 is covalently attached as thioether to Yc;
Xaa2 is an amino acid of formula (IV)
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(IV),
wherein:
p = 1;
Xaa3 is an amino acid of formula (V)
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(V),
wherein:
X3 is CH2,
p = 1, and
R3a is H;
Xaa4 is an amino acid of formula (VI)
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(VI),
wherein:
R4a is OH,
q = 1, wherein one hydrogen of the CH2-group is substituted by methyl,
R4b is H;
Xaa5 is an amino acid of formula (VII)
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(VII),
wherein:
R5 is OH, and
r = 2;
Xaa6 is an amino acid of formula (VIIIa)
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(VIIIa),
wherein:
s is 0,
R6a and R6b are H, and
R6c is absent;
Xaa7 is an amino acid of formula (IX),
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(IX),
wherein:
R7a is –CO-, wherein an amino acid is attached to Xaa7, and wherein the amino acid is Asp, and
t is 1;
Yc is a structure of formula (X)
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(X),
wherein Yc links the S atom of Xaa1 and the S atom of Xaa7 via two thioether linkages to form a cyclic structure of formula (XXI)
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(XXI),
wherein:
the substitution pattern of the aromatic group in formula (X) is meta,
n, t, A, R1b, R7a, Xaa2, Xaa3, Xaa4, Xaa5 and Xaa6 are defined as above,
Y1 is C-H,
Y2 is C-Rc1, and
Rc1 is H;
wherein the N-terminal modification group A is Nle,
and wherein the amino acid Nle is covalently attached to a linker consisting of 1,13-diamino-4,7,10-trioxatridecan-succinamic acid (Ttds) and PPAc, wherein Ttda is covalently linked to the amino acid Nle, and the PPAc is covalently linked to a chelator Z”.
11. Claim 47 is objected to for the following minor informality: The compound recited in instant claim 47 is not disclosed in the sequence listing filed on 1/7/2022; and it is missing the sequence identifier. Applicant is required to amend instant claim 47 to comply with 37 CFR 1.821(c) and 1.821(d).
Furthermore, the quality of the image of the compound recited in instant claim 47 is extremely poor. Applicant is required to amend claim 47 to recite a clear image of the compound.
In addition, claim 47 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.
12. Claim 48 is objected to for the following minor informality: Applicant is suggested to amend claim 48 as “The compound of claim 31, wherein the compound further comprises a diagnostically active nuclide or a therapeutically active nuclide”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
13. 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.
14. Claims 31 and 48 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 pre-AIA the applicant regards as the invention.
15. Claim 31 recites the limitation “…Xaa7 is a residue of an amino thiol…”. With regards to the recited “a residue of an amino thiol”, the instant specification fails to define it. Therefore, it is unclear what is encompassed with the recited “Xaa7 is a residue of an amino thiol”. Thus, the metes and bounds of instant claim 31 is vague and indefinite. Because claim 48 depends from indefinite claim 31, and it does not clarify the point of confusion, it must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Examiner’s Notes
16. The compound comprising a cyclic peptide of formula (I):
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, and an N-terminal modification group A attached to Xaa1 recited in instant claims 31, 47 and 48 is free of prior art. The closest prior art is Yang et al (WO 2019/083990 A2, filed with IDS). Yang et al, throughout the patent, teach imaging and radiotherapeutics agents targeting
fibroblast-activation protein-α (FAP-α), for example, Abstract. However, there is no teaching, motivation, or other type of suggestion to modify the imaging and radiotherapeutics agents in Yang et al and arrive at the compound recited in instant claims 31, 47 and 48. Therefore, the compound recited in instant claims 31, 47 and 48 is both novel and unobvious over the prior arts of record. And the claimed compound is markedly different from what exist in nature.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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