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 with traverse of Group I, claims 1-13, in the reply filed on 1/22/2026 is acknowledged. The traversal is on the ground(s) that it would not present an undue burden on the Examiner to search multiple species of active ingredients while searching the specific elected tetrapeptide. This is not found persuasive. As stated in the prior Restriction Requirement and reiterated here, the technical feature (tetrapeptide) of the claims is not a special technical feature as it does not make a contribution over the prior art in view of Willert (WO2020/154475 A1, published 7/30/2020), which teaches the species KLEL (instant SEQ ID NO: 27). Therefore, the requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of the species SEQ ID NO: 38 in addition to Pal-GHK + Pal-GQPR as additional active ingredients in the reply filed on 1/22/2026 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)).
Claim Status
Claims 1-17 are pending and currently amended. Claims 2, 3, and 14-17 are hereby withdrawn as non-elected inventions (claims 14-17) and species (claims 2 and 3).
Priority
The instant application is the 371 national stage entry of PCT/EP2021/081930, filed 12/14/2023, which claims priority to FR2011743, filed 11/17/2020. Applicant has claimed the effective filing date of 11/17/2020 based on FR2011743 but no translation has been made of record.
Information Disclosure Statement
The IDS submitted on 5/8/2023 is under consideration.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
See Abstract; Pg 5, first line; Pg 7, 4th paragraph, last line; Pg 11, Kollaren™ sentence; Pg 13, under “A – Example…”, bottom of this paragraph, and second to last paragraph; Pg 14 “B – Example…”; Tables 1 and 2.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See Pg 7, second paragraph). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www, or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 12 is objected to because of the following informalities: The claim lists an amino acid sequence with 4 or more specifically defined and enumerated residues and therefore requires a SEQ ID NO. However, no SEQ ID NO is listed in the claim. See MPEP 2422 and 37 C.F.R. 1.821. Appropriate correction is required.
Claim Interpretation
The claims are drawn to a tetrapeptide of Formula 1, wherein the N- and C-termini are modified/represented by X and Z, respectively; X and Z are being interpreted as terminal modifications where no additional amino acids can be added to either terminus.
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 1 and 4-13 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.
Claim 1 recites the limitation "the group" in line 12. There is insufficient antecedent basis for this limitation in the claim as there are two prior recitations of a “group,” one in line 7 (“biotinoyol group”) and one in line 10 (“aryloxy group”), and it is unclear which of these two options “the group” refers to.
By virtue of their dependency on claim 1, claims 4-13 are also hereby rejected for this same reasoning.
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 1, 7, and 9-10 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception.
The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)):
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)?
2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception?
Applying the three-part test to the instant claims:
Regarding 1), the claims are drawn to peptides, which are compositions of matter.
Regarding 2a), the peptides claimed read on products of nature. SEQ ID NO: 6-39, as recited in claim 1, wherein X is H and Z is OH, reads on natural products. For example, regarding SEQ ID NO: 38 wherein X is H and Z is OH reads on:
FKBP prolyl isomerase family member 1C (UniProt ID A0ABD2F8D3_DAUMA)
Mitochondrial translational initiation factor 2 (UniProt ID A0A1D5RMP2_HUMAN)
Signal recognition particle 54 kDa subunit (UniProt ID T1YX19_9CNID)
Others not listed here
While some of these proteins may be longer than the limit imposed by the claims, in Ass’n for Molecular Pathology v Myriad Genetics, the Supreme Court stated that fragments of a biopolymer still trigger this statute. Thus, the fact that these sequences are longer than those claimed does not make the rejection invalid, unless the fragment is significantly different from the full-length polypeptide.
Regarding 2b), none of the claims above integrate the tetrapeptides into a practical application, wherein they are significantly different from the natural products. Thus, the claims are drawn to patent ineligible subject matter and are rejected here.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) for the rejection 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 4-13 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Peschard et al. (US20180000717A1, published 1/4/2018).
Peschard teaches peptides comprising at least one amino acid selected from lysine, ornithine, diaminopropionic acid or diaminobutyric acid or a derivative thereof for use in topical cosmetic treatments (Abstract).
Peschard teaches that said peptides have the general formula I: X-(AA)n-(AA)*-(AA)m-Z, wherein AA* can be lysine, n and m can be 0-4, AA can be selected from lysine, aspartic acid, glutamic acid, and leucine among others, selected independently from each other when n+m>1; X is selected from H, -COR1, and SO2R1; and Z is selected from OH, OR1, NH2, NHR1, NR1R2; and R1 and R2 are, independently, alkyl, aryl, aralkyl, alkylaryl, alkoxy and aryloxy radical, that can be linear, branched, cyclic, polycyclic, unsaturated, hydroxylated, carbonylated, phosphorylated and/or sulphated, which said radical can comprise in its skeleton a heteroatom, in particular O, S and/or N ([0031-0038]). Additionally, R1 and/or R2 is an alkyl chain comprising 1 to 24 carbon atoms, preferably a lipophilic alkyl chain comprising 3 to 24 carbon atoms ([0065]).
Where X and Z are any of the defined above; (Xaa)* is Lys; (Xaa)n is Leu, Glu, or Asp and n is 1 and (Xaa)m is Leu or Glu and m is 2; or (AA)n is n=0 and (AA)m is Leu, Lys, Glu or Asp and m is 3 reads on the instant Formula 1. Thus, claim 1 is anticipated.
Peschard teaches R1 and/or R2 is an alkyl chain comprising 1 to 24 carbon atoms, preferably a lipophilic alkyl chain comprising 3 to 24 carbon atoms ([0065]). Thus, claim 4 is anticipated.
Peschard teaches X can be an acyl group COR1 and Z can be selected from OH, OMe, OEt, and NH2 ([0065]). Thus, claim 5 is anticipated.
Peschard teaches the acyl group COR1 can be selected from an octanoyl (C8), decanoyl (C10), lauroyl (C12), myristoyl (C14), palmitoyl (C16), stearoyl (C18), biotinoyl, elaidoyl, oleoyl and lipoyl ([0065]). Thus, claim 6 is anticipated.
Peschard teaches Z can be OH ([0065]). Thus, claim 7 is anticipated.
Based on the general Formula 1 of Peschard, when X is palmitoyl (C16), Z is OH, (AA)* is Lys, (AA)n is Leu and n is 1, (AA)m is Leu and then Glu and m is 2 reads on the elected SEQ ID NO: 38. Thus, claim 8 is anticipated.
Peschard teaches cosmetics comprising as an active ingredient at least one peptide and a physiologically acceptable medium ([0093]). Thus, claim 9 is anticipated.
Peschard teaches the concentration of the additional peptide, in the composition, ranges from 1×10−7% and 20% ([0119]). Thus, claim 10 is anticipated.
Peschard teaches adding additional active ingredients to said composition such as the mixture of Pal-GKH and Pal-GQPR ([0121]); said compositions are designed for cosmetic purposes and, therefore, intended for a consumer. Thus, claims 11-13 are anticipated.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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