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 .
The Applicants’ Amendment to the Claims filed on February 18, 2026 is entered.
Claims 2-6 and 12 are canceled.
Claims 17-20 are new.
Claims 1, 7-11, and 13-20 are pending and under examination.
This US18/035860 filed on 05/08/2023 which is a 371 of PCT/EP2021/081723 filed on 11/15/2021 claims foreign priority benefit of FRANCE 2011742 filed on 11/17/2020. The Filing Receipt filed on 09/07/2023 is most recent.
Response to Amendment
All objections and rejections made in the previous office action and not repeated in this office action are withdrawn in view of the Applicants’ Amendment to the Claims filed on 02/18/2026.
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). See specification, page 4, para 7; page 13, lines 5, 12, 13 & 24; page 15, Table 2. Also, see present claims 11 and 19.
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.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 is presently amended and now recites in lines 10-12: …wherein: (Xaa)n is AV, n=2 and m=0, or (Xaa)n is V and n=1, and (Xaa)m is A and m=1. There is now a discrepancy regarding the term in line 11: (Xaa)n is AV, n=2 because the term “n” is already defined as AV.
Further, it appears that these parameters are redundant because the tetrapeptide is already limited to any one of the SEQ ID NOs 7 and 13 to 15. For improved clarity, claim 1 should be amended to clarify that the tetrapeptide of Formula 1 requires any one of the SEQ ID NOs 7 and 13 to 15 and that the parenthesis surrounding the SEQ ID NOs 7 and 13 to 15 is not intended to mean that the amino acid sequences of SEQ ID NOs 7 and 13 to 15 are merely exemplary. Appropriate correction is required.
Claims 10 and 18 are objected to because of the following informalities: For improved clarity, claims 10 and 18 should be amended to “selected from the group consisting of”.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Currently amended claims 1, 7-11, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mitts et al (WO 01/91700 A2, published 12/06/2001; IDS ref), or Sandberg et al (US2005/054578, published 03/10/2005; IDS ref), in view of Park et al (EP2623097A1, published 08/07/2013; IDS ref) and Marini (WO 2009/148551A1, published 12/10/2009; IDS ref), in view of Denommee et al (US 2007/237735; of record). This is new grounds necessitated by amendment.
Regarding claims 1 and 7-8, Mitts et al teach a tetrapeptide of Formula 1 wherein Z is OH. Mitts et al teach the peptide AVPG (instant SEQ ID 14; Mitts ref SEQ NO:16), and the use in a cosmetic composition, containing a compound for the improvement of the skin, such as a retinoid compound. (See Table 1, page 12 for Ref SEQ ID NO:16; ref claims 15-22) Regarding claim 7, Mitts et al teaches the instant tetrapeptide: X-AVPG-Z which is instant SEQ ID NO: 14. (See page 12, ref SEQ 16). Regarding claims 8 and 17, Mitts et al discloses a cosmetic composition comprising at least one tetrapeptide of the peptide AVPG (instant SEQ ID NO: 14; ref SEQ ID NO:16) and a physiologically acceptable medium. (See page 4; page 37, para 2; ref claims 15-22). Mitts et al disclose the peptide in Table 1 and explicitly state in page 11, (para 1) that the list of peptides sequences” in combination with other skin enhancing agents exhibit desirable characteristics”.
Regarding claim 9, Mitts et al discloses the composition according claim 8, wherein the amount of at least one tetrapeptide is between 10-7% and 20% relative to the total weight of the composition. (See page 4, para 2).
Regarding claims 10 and 18, Mitts et al discloses the composition according claim 8, comprising at least one additional active ingredient selected from vitamin B3, niacinamide, tocopherol, retinoid compounds, hexamidine, a-lipoic acid, resveratrol, DHEA, hyaluronic acid and one or more cosmetic peptides. (See page 37, para 2; ref claims 16-19).
Regarding claims 13 and 20, Mitts et al discloses a non-therapeutic cosmetic method of improving general condition of the skin and/or its appendages and treating imperfections of the skin and/or its appendages, the method comprising contacting/applying to the skin and/or its appendages with at least one tetrapeptide according to claim 1. (See page 4).
Regarding claim 14, Mitts et al discloses that the contacting is topical . (See page 4, para 3).
Regarding claim 15, Mitts et al discloses that the method is for anti-aging. (See page 7, para 3).
Regarding claim 16, Mitts et al discloses that the method is for one or more of:
treating wrinkles and fine lines;
improving firmness, tone, elasticity, and/or flexibility of the skin;
increasing the density and volume of the skin;
treating stretch marks;
treating skin sagging; and
improving the uniformity and radiance of the skin complexion. (See page 7, para 3).
In addition, regarding claims 1 and 7, Sandberg et al teach cosmetic compositions for treatment of the skin comprising the tetrapeptide: X-AVPG-Z (reference SEQ ID NO: 16, Table 1) which is the tetrapeptides of instant SEQ ID NO 14. (See ref claims 16-24, 27, 28.) Sandberg et al discloses the tetrapeptide wherein Z is OH. (See para 0063; ref claims 16-24, 27, 28.) Regarding claims 8 and 17, Sandberg et al discloses a cosmetic composition comprising the peptide AVPG and the use of such in cosmetic compositions for the improvement of the skin and a physiologically acceptable medium. (See ref claims 16-24, 27, 28.) Regarding claim 9, Sandberg et al discloses the composition according claim 8, wherein the amount of at least one tetrapeptide is between 10-7% and 20% relative to the total weight of the composition. (See para 0051; ref claims 16-24, 27, 28.)
Regarding claims 10 and 18, Sandberg et al discloses the composition according claim 8, comprising at least one additional active ingredient selected from vitamin B3, niacinamide, tocopherol, retinoid compounds, hexamidine, a-lipoic acid, resveratrol, DHEA, hyaluronic acid and one or more cosmetic peptides. (See para 0069-0070.) Regarding claim 13, Sandberg et al discloses a method of improving general condition of skin and/or its appendages, the method comprising applying at least one tetrapeptide according to claim 1 to the skin and/or appendages. (See para 0115.) Regarding claim 14, Sandberg et al discloses that the contacting is applied topically. (See para 0113.) Regarding claim 15, Sandberg et al discloses that the method is for anti-aging treatment. (See para 0058.)
Regarding claims 16 and 20, Sandberg et al discloses that the method is for one or more of: treating wrinkles and fine lines; improving firmness, tone, elasticity, and/or flexibility of the skin; increasing the density and volume of the skin; treating stretch marks; treating skin sagging; and/or improving the uniformity and radiance of the skin complexion. (See para 0058.)
However, Mitts et al do not disclose palmitoyl as the X of Formula 1.
Regarding currently amended claim 1, Sandberg et al disclose that peptides of the invention may include derivatives in which R1 is an organic acid with enhanced liposolubility. Examples include wherein R1 is a palmitate and may be 3Beta-palmitoyl-DHEA. (See para 0059 and 0066). Also, Park et al disclose use of elastin-like polypeptides and disclose acylated compounds including palmitoyl (C16). (See Park et al paragraph 0032; ref claims 1, 2, 8, 9, 12; paragraph 0035). Park et al discloses that the acyl group CO-R1 is selected from an octanoyl (C8), decanoyl (C10), lauroyl (C12), myristoyl (C14), palmitoyl (C16), stearoyl (C18), biotinoyl, elaidoyl, oleoyl and lipoyl. (See Park et al para 0032). Park et al disclose “wherein the group comprises 3 to 24 carbon atoms” (See Park et al para 0032). Park et al discloses wherein X is an acyl group -CO-R1 and at the C terminal end Z is a group selected from OH. (See Park et al para 0031-0032). In addition, Marini disclose use of elastin-like polypeptides or topical skin cosmetics (see Abstract, page 1-2) and disclose that acylated compounds including palmitoyl (C16). (See page 2, para 9 “Acylated Peptides”, ref claims 1-6).
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to use palmitoyl groups at the N-terminal of the therapeutic tetrapeptide compositions in cosmetic compositions for applying to the skin for the rational of increasing moisture in the compositions and thus to the skin as suggested by Sandberg et al.
It would have been obvious to combine the suggestion of a palmitoyl group on the tetrapeptides of Sandberg, Park et al and Marini et al with the tetrapeptide composition of Mitts et al because all references are in the same field of using peptides in cosmetic compositions for applying to the skin.
In view of the high skill level in the art it is considered that one of ordinary skill in the art would have had a reasonable expectation of success combining the elements of the cited references to arrive at the presently claimed invention.
However, especially regarding claims 11 and 19, the combination of references do not suggest a mixture of Pal-GHK and Pal-GQPR and/or the peptide Ac-YR-hexadecyl ester.
Denommee teaches anti-aging composition comprising at least one biomimetic oligopeptide including: Pal-GHK, Pal-GQPR, Pal-KTTKS, a mixture of Pal-GHK and Pal- GQPR or Pal-VGVAPG that act as messengers of a fake aggression on skin cells, thereby triggering activation of a mechanism similar to wound healing or matrix renewal. They generally exercise feedback control on the process of connective tissue renewal and cell proliferation, for example by stimulating neo-synthesis of collagen |, Ill, IV, fibronectin, laminin-5 and/or glycosaminoglucans by fibroblasts (abstract; paragraphs 0013, 0028, 0029; claim 4).
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to combine the elements of the cited references for the rationale to treat skin wrinkling and sagging using topical composition comprising the tetrapeptides rendered obvious over Mitts et, Park et al, and Marini and further add peptide selected from Pal-GHK, Pal-GQPR, Pal-KTTKS, a mixture of Pal-GHK and Pal-GQPR or Pal-VGVAPG as taught by Denommee.
It would have been obvious to one of ordinary skill in the art to do so because Denommee teaches that such peptides act as messengers of a fake aggression on skin cells, thereby triggering activation of a mechanism similar to wound healing or matrix renewal and exercise feedback control on the process of connective tissue renewal and cell proliferation by stimulating neo-synthesis of collagen, fibronectin, laminin-5 and/or glycosaminoglucans by fibroblasts. Also, Mitts et al disclose the peptide in Table 1 and explicitly state in page 11, (para 1) that the list of peptides sequences” in combination with other skin enhancing agents exhibit desirable characteristics”.
Thus, it is considered that there would be a reasonable expectation of success treating skin wrinkling and sagging using topical composition comprising the tetrapeptide compositions of Mitts et al combined with acetyl- tyrosine-arginine-o-hexadecyl, and peptide selected from Pal-GHK, Pal-GQPR, Pal- KTTKS, a mixture of Pal-GHK and Pal-GQPR or Pal-VGVAPG of Denommee wherein the composition effectively combat aging and stimulates cell proliferation and fibroblast to synthesis collagen and other elements of the matrix useful in skin renewal.
Response to Arguments
The Applicants’ arguments filed on February 18, 2026 have been fully considered but are unpersuasive. The applicants argue that claim 1 as amended, and all claims dependent thereon, are not rendered obvious by the combination of Mitts, Park and Marini. Further, the applicants argue that “Denommee appears to be cited by the Examiner for its teaching of a biomimetic oligopeptide including Pal- GHK, Pal-GQPR, Pal-KTTKS, a mixture of Pal-GHK and Pal- GQPR or Pal-VGVAPG (page 15 of the Office Action)”. Further, the applicants argue that “In contrast, amended claim 1 recites X-AVPG-OH and X-VPGA-OH”. The applicants conclude that “[a]s a result, Demommee does not remedy the previously noted deficiencies present in Mitts, Park and Marini”.
However, this argument is unpersuasive for reasons provided in the body of the rejection and specifically because regarding the argument that the amended claim 1 recites X-AVPG-OH and X-VPGA-OH, these are listed in the alternative. Mitts et al teach the peptide AVPG (instant SEQ ID 14). Further, it is noted that X is amended in claim 1 to recite X is palmitoyl (C16). However, as noted in the body of the rejection, Park et al disclose use of elastin-like polypeptides and disclose acylated compounds including palmitoyl (C16). (See Park et al paragraph 0032; ref claims 1, 2, 8, 9, 12; paragraph 0035). In addition, Marini disclose use of elastin-like polypeptides or topical skin cosmetics (see Abstract, page 1-2) and disclose that acylated compounds include palmitoyl (C16). (See page 2, para 9 “Acylated Peptides”, ref claims 1-6). Further, Mitts et al teach the peptide AVPG and the use in a cosmetic composition, containing a compound for the improvement of the skin, such as a retinoid compound. Mitts et al disclose the peptide in Table 1 and explicitly state in page 11, (para 1) that the list of peptides sequences” in combination with other skin enhancing agents exhibit desirable characteristics”.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658