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 .
This application is the national stage entry of PCT/FR2022/052285, filed 08 Dec 2022; and claims benefit of foreign priority document FRANCE 2113302, filed 10 Dec 2021. This foreign priority document is not in English.
Claims 1-13 and 15-21 are pending in the current application and are examined on the merits herein.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-13 and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mallard (WO 2018/122344 A1, published 05 July 2018, provided by Applicant in IDS filed 07 June 2024).
Mallard teaches composition comprising, in a physiologically acceptable medium, a crosslinked hyaluronic acid (HA), having a degree of modification less than 1.9 mole%; a HA with a molecular weight of about 50 kDa or less; and/or an agent stimulating endogenous HA synthesis. The invention also relates to a cosmetic use of such composition in skin care and/or anti-ageing treatment (abstract). Generally, the term "hyaluronic acid" can also encompass all variants and combinations of variants of hyaluronic acid, hyaluronate or hyaluronan. That is, the term also encompasses the various hyaluronate salts of hyaluronic acid with various counter ions, such as sodium hyaluronate (page 8, lines 25-30). The invention compulsory comprises a crosslinked HA, wherein the degree of modification of said crosslinked HA is less than 1.9 mole% (page 9, line 30). Preferably, the degree of modification of hyaluronic acid according to the invention is in the range between 0.1 and 1.9 mole %, preferably about 1.0 mole % (page 10, line 20), addressing limitations of claim 6 and 15. The chemical crosslinking agent may for example be selected from the group consisting of divinyl sulfone, multiepoxides and diepoxides (page 11, lines 5-10). Preferably, the composition as disclosed herein comprises from 0.1% to 10% by weight, for example from 0.5 to 5% by weight, and for example 1% by weight, of the crosslinked HA relative to the total weight of the composition (page 18, line 5), addressing limitations of claims 7 and 16-17. The non-crosslinked HA with a low molecular weight preferably has a molecular weight between 20 and 50 kDa (page 18, line 15), addressing limitations of claims 1 and 3. Preferably, the composition as disclosed herein comprises from 0.01% to 5% by weight, for example from 0.1% to 1% by weight, of the HA with a molecular weight of about 50 kDa or less, relative to the total weight of the composition (page 19, line 20), addressing limitations of claim 7 and 16-17. The physiologically acceptable medium may include optional excipients necessary to achieve desirable fragrance presentation, and optional ingredients to be used together with the claimed invention such as an antioxidant agent, emollient, or moisturizing agent (page 7, line 30 to page 8, line 15), addressing limitations of claim 8. In another embodiment the composition comprises an agent stimulating endogenous HA synthesis, such as retinoids which are often used as anti-ageing ingredients in skin care products (page 20, lines 10-15). In another embodiment the composition further comprises an anti-ageing active ingredient (page 22, lines 5-30), addressing limitations of claim 8. The compositions may be in any of the galenical forms normally employed for topical administration. Exemplary topical preparations include a lotion, gel, emulsions of the milk type, O/W or W/O emulsions, or emulsions of the cream, gel, or ointment type (page 24, line 30 to page 25, line 5), addressing limitations of claim 10 and 19. Another object of the invention is the cosmetic use of the composition in skin care and/or anti-ageing treatment, notably for decreasing and/or preventing the characteristics of wrinkles, smoothing the skin, maintaining and /or restoring skin elasticity. The composition targets visible signs of skin ageing with complementary biological activities (page 25, lines 15-30), addressing limitations of claims 11-13 and 20-21.
Mallard does not specifically disclose the crosslinked HA having a molecular weight greater than or equal to 2000 kDa (claim 1). Mallard does not specifically disclose the embodiment wherein the crosslinked HA has the INCI name: sodium hyaluronate crosspolymer (claim 4).
Mallard further teaches the residence time of HA in tissues is only slightly dependent on molecular weight, i.e. exogenous HA of 100,000 Da has a half-life time of 10h; exogenous HA of 6,000,000 Da has a half-life time of 13h. Endogenous and exogenous hyaluronic acid generally has a molecular weight ranging from 1 to 10 million Da. Then, the most common way of prolonging the residence time of HA in tissue is by crosslinking (page 4, line 30 to page 5, line 5). Mallard further teaches the improved stabilized crosslinked HA confers an optimized long-term effect of HA (page 10, lines 20-25)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Mallard in order to select the molecular weight of the crosslinked HA to be, for example, 6000 kDa, and to select the chemical crosslinking agent divinyl sulfone. One of ordinary skill in the art would have been motivated to modify the teachings of Mallard with a reasonable expectation of success because Mallard suggests it is desired to increase the residence time of HA in tissues to provide the optimized long-term effect of HA, such as by crosslinking the HA, and teaches the residence time of the HA is greater for high molecular weight HA, such as exogenous HA of 6000 kDa, providing motivation to select the HA of the crosslinked HA to have a molecular weight such as 6000 kDa. Regarding claim 4 reciting the structure defined by the crosslinked HA having the INCI name sodium hyaluronate crosspolymer, this name defines a structure crosslinked with 1,1’-sulfonylbis(ethene), also known as divinyl sulfone, and Mallard teaches chemical crosslinking agent may be selected to be divinyl sulfone, suggesting it would have been obvious to select the structure defined by the crosslinked HA having the INCI name. Regarding claim 5 reciting the structure defined by the low molecular weight non-crosslinked HA having the INCI name sodium hyaluronate or hyaluronic acid, Mallard teaches the non-crosslinked HA with a molecular weight of about 50 kDa or less, which has the same structure defined by the INCI name. See also MPEP 2131 providing “The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).” In this case Mallard teaches the structural elements arranged as required by the claim, and the identity of terminology in terms of the INCI name is not required.
Regarding claims 9 and 18, Mallard does not teach the presence of a filler in the composition. The examined application at paragraphs 94-96 as published define the meaning of the filler as claimed and defines the meaning of “less than 5%” or “less than 2%” to encompass 0% or the composition devoid of filler. In this case, Mallard suggests a composition that has 0% filler or is devoid of filler addressing the limitations of claims 9 and 18.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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