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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 19-25, in the reply filed on 4/28/2026 is acknowledged.
Claims 26-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/28/2026.
In response to the species election, applicant elected the peptide sequence of SEQ ID NO: 6 (FCLGPCPYIWSLDTVLSL).
Claim Status
Claims 19-37 are pending.
Claims 1-18 are cancelled.
Claims 26-37 are withdrawn as being directed to a non-elected invention, the election having been made on 4/28/2026.
Claims 19-25 have been examined.
Priority
This application is a 371 of PCT/KR2021/019667 filed on 12/22/2021 claiming foreign priority of KOREA, REPUBLIC OF 10-2020-0182441 filed on 12/23/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/22/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 19-20 and 22-24 are rejected under 35 U.S.C. 101 because the claims encompass a natural protein of transforming growth factor-β (TGF-β). The eligibility of patent subject of 101 analysis is further analyzed as follows.
Step 1. The claim is directed to a polypeptide product comprising the peptide formula I sequence of F[C/S]LGP[C/S]PYIW[C/S]LDT.
Step 2A-Prone 1 (judicial exception). No, the claim does not cite judicial exceptions
Step 2A-Prone 2 (whether the claim as whole integrates the recited judicial exception into a practical application of the exception). No, there is nothing in the claim to integrate the judicial exception (JE) into any particular practical application. The amounts in the claims are the amounts in which the peptides naturally occurring.
Step 2B: No, there is nothing in the claim that causes it to amount to significantly more than the JE. The high level of generality for a protein comprising the peptide formula sequence encompasses a natural protein of human transforming growth factor-β (TGF-β) as evidenced by Uniport human transforming growth factor beta-1 proprotein shown as follows (https://www. uniprot.org/uniprotkb/P01137/entry#sequences). Thus, the claim 19 as a whole with a combination of all elements amounts to significantly no more than the JEs.
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With respect to claim 20, human transforming growth factor-β comprises A319 at the N-terminus of the underlined peptide motif of FCLGPCPYIWSLDT and S337 at the C-terminus of the underlined peptide motif.
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With respect to claims 22-24, a side-by-side comparison of the naturally occurring human transforming growth factor beta-1 proprotein to the instant SEQ ID NO: 1 shows 95.7% homology above.
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.
Claims 19, 22-23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ezquerro Saenz et al. (US 7,057,013 B1, cited in IDS).
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Claim 19 is drawn to a peptide comprising at least 80% homology to the peptide formula 1 of F[C/S]LGP[C/S]PYIW[C/S]LDT.
Ezquerro Saenz et al. teach TGF-β1 inhibitor peptide (Title). A side-by-side comparison Ezquerro Saenz’s SEQ ID NO: 2 (col 16, Table 3) with the peptide formula 1 and instant SEQ ID NO: 5 is shown above, reading on claims 19 and 22-23 and 25. A single amino acid mismatch out of a peptide with 14 amino acid in length is 92.8% homology.
Claims 19-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ezquerro et al. (Cytokine 22 (2003) 12–20, cited in IDS).
Claim 19 is drawn to a peptide comprising 80% homology to the peptide formula 1 of F[C/S]LGP[C/S]PYIW[C/S]LDT.
Ezquerro et al. show inhibition of human TGF-b1 by synthetic peptides comprising the peptide P12 derived from human TGF-β1. A side-by-side comparison Ezquerro’s peptide P12 (p13, Table 1) with the peptide formula 1 and the instant SEQ ID NO: 1 is shown as follows,
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reading on the instant claims 19-25. Ezquerro’s P12 peptide has 100% homology to the instant SEQ ID NO: 1.
Examiner’s Note:
The closest prior art reference, Ezquerro et al. (Cytokine 22 (2003) 12–20, cited in IDS), does not teach or suggest a peptide of formula 1 immediately linked to a tetrapeptide VLSL or VLSF at the C-terminus.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
15-May-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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