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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 9, 2026 has been entered.
The Applicants Amendment to the Claims filed on May 26, 2026 is entered.
The Applicants Amendment to the Specification filed on May 26, 2026 is entered.
Claims 1-6, 12, and 17-20 are canceled.
Claims 7-11, and 13-16 are pending and under examination.
Priority
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. Please note that no English language translation is of record for the foreign priority document of FRANCE 2011742 and therefore the effective filing date is presently the filing date of PCT/EP2021/081723 filed on 11/15/2021.
Response to Amendment
All objections and rejections made in a previous office action and not repeated in this office action are withdrawn in view of the Applicants’ Amendment to the Claims entered with the submission filed on June 9, 2026.
Nucleotide and/or Amino Acid Sequence Disclosures – maintained-in-part
Please note that the following deficiencies were noted in the previous office action but were not addressed. A complete response to this office action requires an appropriate corrections to such deficiencies.
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 claim 11.
Claim Rejections - 35 USC § 103 – new ground necessitated by amendment
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 7-11, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shiratsuchi et al (US 20190111103 A1 published 04/18/2019), in view of Mitts et al (WO 01/91700 A2, published 12/06/2001; IDS ref), in view of 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 claim 7, Shiratsuchi et al teaches the peptide VPGA for enhancing proliferation of fibroblast cells and compositions for enhancing elastin production in fibroblast skin cells. See Abstract; reference claim 1-8; para 0017; entire document). For example, the Abstract recites:
A peptide or a salt thereof having an amino acid sequence represented by (a) or (b) shown below having a promotive effect on a proliferation of fibroblast cells, a composition for enhancing proliferation of fibroblast cells containing one or more of them, a composition for enhancing elastin production in fibroblast cells containing one or more peptides or salts thereof having an amino acid sequence represented by (a), (b) or (c) shown below and a composition for enhancing elastin production in chondrocytes containing one or more peptides or salts thereof having an amino acid sequence represented by (c) shown below. (a) Val-Pro-Gly-Gly (b) Val-Pro-Gly-Ala (c) Val-Pro.
Regarding claim 8, Shiratsuchi et al teaches the peptide VPGA is useful for a therapeutic or pharmaceutical composition in a physiologically acceptable medium. (See para 0053). Shiratsuchi et al suggest such peptide may be useful for maintenance of elasticity in skin for use as an anti-aging composition (para 006, 0007, 0029, 0065).
However, Shiratsuchi et al does not explicitly disclose a cosmetic or topical cream composition and do not disclose palmitoyl as the amino-terminus of the peptide (X of Formula 1).
Regarding claims 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 claim 8, 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 claim 10, 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 claim 13, 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 7. (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 claim 7, Sandberg et al teach cosmetic compositions for treatment of the skin comprising a therapeutic tetrapeptide: X-AVPG-Z (reference SEQ ID NO: 16, Table 1) which is a tetrapeptide 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 claim 8, 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 claim 10, 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 claim 16, 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(i.e., amino-terminus of the peptide).
Regarding currently amended claim 7, 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 Shiratsuchi et al and Mitts et al because all references are in the same field of using peptides in therapeutic compositions for enhancing elasticity of 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 claim 11, 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”. Shiratsuchi et al suggest such VPGA peptide may be useful for maintenance of elasticity in skin for use as an anti-aging composition including preventing or reducing wrinkles (para 006, 0007, 0029, 0065).
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 rendered obvious over the combination of Shiratsuchi et al, in view of Mitts et al, Sandberg, Park et al, and Marini 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 06/09/2026 have been fully considered as they may relate to this new grounds of rejection but are unpersuasive. The applicants argue that claims are amended to an independent claim 7 reciting the tetrapeptide Pal-VPGA-OH (SEQ ID NO:15) and that therefore are not rendered obvious over Mitts or Sandberg in view of Park, Marini, and Denommee. However, this argument is not persuasive for reasons provided in the body of the rejection above. Specifically, the new grounds of rejection adds the reference of Shiratsuchi et al (US 20190111103 A1 published 04/18/2019). Shiratsuchi et al teaches the peptide VPGA for enhancing proliferation of fibroblast skin cells and compositions for enhancing elastin production in fibroblast skin cells. See Abstract; reference claim 1-8; entire document).
Conclusion
No claim is allowed.
Related prior art which may be applied in a future office action if appropriate:
Sandberg et al WO 99/45941 A1 (published 09/16/1999; IDS ref). Sandberg discloses cosmetic/therapeutic compositions comprising tetrapeptides for enhancing skin elasticity.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
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