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. 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 for the cited rejections 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.
3. Response to Election/Restriction filed on 6/29/2026 is acknowledged.
4. Claim filed on 6/29/2026 is acknowledged.
5. Claim 12 has been cancelled.
6. Claims 1-11 and 13-20 are pending in this application.
7. Claims 1, 3, 11, 13, 14, 19 and 20 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/29/2026. Claims 4-10 and 17 are withdrawn from consideration as being drawn to non-elected species.
Please note: During the search for the elected species, prior art was found for the non-elected species of composition recited in instant claim 16. Therefore, for the purpose of compact prosecution, claim 16 is examined in the current office action.
8. Claims 2, 15, 16 and 18 are under examination.
Elections/Restrictions
9. Applicant’s election with traverse of Group 2 (claims 2, 4-10 and 15-18) and election of peptide 11 as species of peptide; and a composition comprising peptide 11 and micronized tissue as species of composition in the reply filed on 6/29/2026 is acknowledged. The traverse is on the ground(s) that SEQ ID NO: 9 shares common core sequence with SEQ ID NO: 10 or 11 recited in instant claim 2, and it is distinct from the peptide of Group 1. Therefore, SEQ ID NO: 9 should be in Group 2. This is found persuasive. Therefore, SEQ ID NO: 9 recited in the amended claim 2 will be searched and examined in the current office action. Other than this, the requirement is still deemed proper and is made Final in this office action.
Please note: Peptide 11 in the elected species is interpretated as the peptide of instant SEQ ID NO: 11.
Group 2 is drawn to a peptide comprising a sequence selected from: GPQGPPG SIGPQ (SEQ ID NO: 9), GPPGSPGPA (SEQ ID NO: 10) or PGTSGPPGLAGPPGSPG PQ (SEQ ID NO:11); and wherein the peptide does not include hydroxyproline, or a pharmaceutically acceptable salt thereof; and a composition comprising one or more of such peptides. A search was conducted on the elected species; and these appear to be free of prior art. A search was extended to the genus in claims 1 and 15; and prior art was found. Claims 4-10 and 17 are withdrawn from consideration as being drawn to non-elected species. Claims 2, 15, 16 and 18 are examined on the merits in this office action.
Sequence Non-Compliance
10. 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, instant specification discloses various peptides on pages 5-6, paragraphs [0031]-[0034] of instant specification. However, these peptides are not disclosed in the filed sequence listing.
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.
Claim Interpretations
11. With regards to the term “peptide” recited in instant claims, the instant specification discloses that “As used herein, "peptides" are short chains of two or more amino acids linked by peptide bonds and have a molar mass of 12,000 Da or lower” (see page 12, paragraph [0076] of instant specification). Therefore, in the instant case, the Examiner is interpreting the peptide recited in instant claims has a molar mass of 12,000 Da or lower. Such interpretations apply to all rejections set forth below.
Objections
12. The specification is objected to for the following minor informality: The instant specification discloses various peptides on pages 5-6, paragraphs [0031]-[0034] of instant specification. However, these peptides are not disclosed in the filed sequence listing; and they are missing the respective sequence identifier. Applicant is required to amend the specification to comply with 37 CFR 1.821(c) and 1.821(d).
13. The specification is objected to for the following minor informality: The specification recites “peptide 4 (GPIGPVGAR-NH2) (SEQ ID NO: 4)” on page 31, paragraph [0177] of instant specification. However, peptide of SEQ ID NO: 4 in the rest of the specification and in the filed sequence listing is one consisting of the amino acid sequence GPIGPVGAR. Applicant is required to correct this error.
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).
14. Claim 2 is objected to for the following minor informality: Applicant is suggested to amend claim 2 as "A peptide comprising a sequence selected from: GPQGPPGSIG PQ (SEQ ID NO: 9), GPPGSPGPA (SEQ ID NO: 10) or PGTSGPPGLAGPPGSPGPQ (SEQ ID NO:11), or a pharmaceutically acceptable salt thereof; wherein the peptide does not include hydroxyproline".
Rejections
Claim Rejections - 35 U.S.C. § 102(a)(1)
15. 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.
16. Claims 2, 15, 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Calenoff et al (US 2002/0193295 A1), and as evidenced by Finnegan et al (ADVANCES IN WOUND CARE, 2015, 4, pages 415-421).
The instant claims 2, 15, 16 and 18 are drawn to a peptide comprising a sequence selected from: GPQGPPGSIGPQ (SEQ ID NO: 9), GPPGSPGPA (SEQ ID NO: 10) or PGTSGPPGLAGPPGSPGPQ (SEQ ID NO:11); and wherein the peptide does not include hydroxyproline, or a pharmaceutically acceptable salt thereof; and a composition comprising one or more of such peptides.
Calenoff et al teach peptide of SEQ ID NO: 30 consisting of the amino acid sequence AVGAPGAPGPPGSPGPAGPTGKQGD (comprising the amino acid sequence of instant SEQ ID NO: 10, underlined), wherein the peptide does not include hydroxyproline; and a composition comprising such peptide dissolved in 20 mM Tris chloride, pH 7.4, containing 600 mM sodium chloride, 30 mg/mL polyethylene glycol 4000, 1 mm ethylenediaminetetraacetic acid, 1 mM ethylene glycol-bis(§-aminoethyl ether)N,N,N',N'-tetraacetic acid, 0.5 mg/mL triton x-405 and 0.2 mg/mL thimerosal, for example, Figure 8, SEQ ID NO: 30; and page 6, Example 2, in particular, paragraphs [0080] and [0093]. And as evidenced by Finnegan et al, ethylenediaminetetraacetic acid (EDTA) is an antimicrobial agent recited in instant claim 18 (see for example, Title). Therefore, the peptide of SEQ ID NO: 30 and the composition comprising such peptide in Calenoff et al meet the limitations of instant claims 2, 15, 16 and 18.
Since the reference teaches all the limitations of instant claims 2, 15, 16 and 18; the reference anticipates instant claims 2, 15, 16 and 18.
Examiner’s Notes
17. The peptide and the composition comprising such peptide recited in instant claims 2, 15, 16 and 18 appear to be fragment of collagen and composition comprising such fragment of collagen. However, naturally occurring collagen comprises hydroxyproline. Therefore, it is the Examiner’s position that the instant claimed peptide and the composition comprising such peptide are 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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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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