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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/18/26 has been entered.
Claims 46-65, 72, 73, 76-78, 80 and 81 are pending. Claims 46-62 and 65 have been withdrawn. Claims 63 and 76 have been amended. Claims 63, 64, 72, 73, 76-78, 80 and 81 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 6/18/26, 7/1/26, and 8/6/26. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 63, 64, 72 and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2016/0374912) in view of Trumbore et al. (US 2017/0087178) and Gross (US 2009/0117061).
Lu et al. teach a topically applicable chemical peel composition and method of use having from about 5% to about 25%, by weight, of alpha hydroxy acid (e.g. abstract and paragraph 0001) for the treatment of photodamaged skin, hyperpigmentation, and acne vulgaris (e.g. paragraph 0003, and Claim 18). Lu et al. teach that the alpha hydroxy acids include lactic acid, mandelic acid, and pyruvic acid (e.g. paragraph 0019; Claim 7). Lu et al. teach that the solvent includes ethanol (e.g. 0030 and 0031; Claim 2). It would have been obvious to one of ordinary skill in the art at the time of filing to select the combination of lactic acid, mandelic acid, and pyruvic acid as the alpha hydroxy acids in the composition of Lu et al. Lu et al. teach the inclusion of alpha hydroxy acids and mixtures thereof, and it would have been obvious to have selected any of the recited acids, including lactic acid, mandelic acid, and pyruvic acid as claimed. “When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007).
While Lu et al. teach about 5% to about 25%, by weight, of alpha hydroxy acids, they do not teach individual concentrations for lactic, pyruvic, and mandelic acids. This is made up for by the teachings of Trumbore et al. In addition, Lu et al. teach that the composition may further include additional agent and antioxidants (e.g. paragraph 0034), but do not teach the inclusion of Silybum marianum extract present in an amount of from about 0.01 wt.% to about 2 wt.%. This is made up for by the teachings of Gross.
Trumbore et al. teach formulations that, once applied to the skin, increase dermal GAG concentrations comprising a first formulation, which is a peel (e.g. paragraphs 0026-0028; Examples). Trumbore et al. teach that the peel comprises 1-4 wt% lactic acid and 1-4 wt% mandelic acid (e.g. paragraphs 01160120). Trumbore et al. also teach the inclusion of pyruvic acid, but do not disclose a concentration (e.g. paragraph 0068).
Gross teaches skin care products containing two or more enhancers which increase the beneficial effects of skin care ingredients in the products resulting in enhanced skin care properties (e.g. paragraph 0002). Gross teaches at least one skin care ingredient includes silymarin (i.e. Silybum marianum extract), which both increases collagen levels and reduces skin inflammation (e.g. Claim 1; paragraphs 0007, Examples). Gross exemplify silymarin at 0.1 wt%, 0.02 wt%, which are within the claimed range, and more generally from 0-5 wt% (e.g. paragraphs 0059, 0060, 0067, 0068).
Regarding Claims 63, 72 and 81, it would have been obvious to one of ordinary skill in the art at the time of filing to look to the teachings of Trumbore et al. for selection of appropriate lactic and mandelic acid concentrations for use in the peels of Lu et al. One of ordinary skill in the art would have predicted success as they are both drawn to skin peel composition, and one would have been motivated to seek further guidance on appropriate individual concentrations, as Lu et al. are silent. Lu et al. teach about 5% to about 25%, by weight of total alpha hydroxy acids, and Trumbore et al. teach that the peel comprises 1-4 wt% lactic acid and 1-4 wt% mandelic acid (e.g. paragraphs 01160120). After including pyruvic acid, this results in an amount of greater than 0 to 17 wt% pyruvic acid. These values and resulting ratios are within or overlap the claimed values. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I). It further would have been obvious to have included 0.1 wt% or 0.02wt% of silymarin, as suggested by Gross. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions are useful as topical skin compositions, and one of ordinary skill would have been motivated in order to provide the benefits of collagen production and reduced skin inflammation, as taught by Gross. “When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976).
Regarding Claim 64, as evidenced by the instant Specification Examples, amounts as low as 0.2-0.1% lactic acid and pyruvic acid inhibit the growth of harmful bacteria. As Lu et al. teach 5% to about 25% by weight of alpha hydroxy acid, then the limitation “effective amount” has been reached.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2016/0374912), Trumbore et al. (US 2017/0087178) and Gross (US 2009/0117061) as applied to claims 63, 64, 72 and 81 above, and further in view of Epstein et al. (US 6,017,548).
Regarding Claims 63, 64, 72 and 81, the teachings of Lu et al., Trumbore et al. and Gross are described supra. Lu et al. teach the inclusion of pyruvic acid, but do not teach the salt sodium pyruvate. This is made up for by the teachings of Epstein et al.
Epstein et al. teach compositions for treating skin comprising an acid material (e.g. abstract). Epstein et al. teach that the acidic component is preferably an alpha-hydroxy acid including lactic acid, mandelic acid, and pyruvic acid and mixtures thereof (e.g. column 2, lines 29-50; Claim 10). Epstein et al. teach that the presence of the acidic component aids in the ability to deliver humectant (e.g., glycerin) to the stratum corneum in amounts beyond that predictable from simple consideration of humectant concentration (e.g. column 2, line 65-column 3, line 2). Epstein further teach that cations such as Na enhance the ability of the emulsions of this invention to transport moisturizers across the skin membrane (i.e. sodium pyruvate) (e.g. column 5, lines 6-11).
Regarding Claims 73, it would have been obvious to one of ordinary skill in the art at the time of filing to include the alpha-hydroxy acid sodium pyruvate of Epstein et al. in the composition of Lu and Trumbore. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Lu, Trumbore, and Epstein et al. all teach a mixture of alpha-hydroxy acids for application for skin. One of ordinary skill in the art would have been motivated to include the sodium pyruvic of Epstein et al. in order to enhance the delivery. In addition, as both Lu et al. and Epstein teach topical skin compositions it would have been obvious to combine the compositions. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Claims 76-78 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2016/0374912), Trumbore et al. (US 2017/0087178) and Gross (US 2009/0117061) as applied to claims 63, 64, 72 and 81, and further in view of Dreher (US 2014/0315995).
Regarding Claims 63, 64, 72 and 81, the teachings of Lu et al., Trumbore et al. and Gross are described supra. Lu et al. teach that the composition may further include antioxidants (e.g. paragraph 0034). They do not teach the inclusion of one or more agents selected from the group consisting of 4-butyl resorcinol, hexylresorcinol, and dimethylmethoxy chromanol. This is made up for by the teachings Dreher.
Dreher teaches a non-irritating, stable topical compositions including at least Vitamin C, Vitamin E and a polyphenol antioxidant, which may be in the form of a skin care product or exfoliant (e.g. abstract, paragraph 0155). Dreher teaches the composition may comprise 0.01-15 wt% of 4-butyl resorcinol, 0.01-15 wt% hexylresorcinol, milk thistle (i.e. Silybum marianum extract), and 0.01-1 wt% dimethylmethoxy chromanol (e.g. paragraphs 0022, 0023, 0025, 0085, 0086, 0202, 0203). Dreher teaches that the compositions provide improved and/or superior antioxidant activity that are suitable for topical application and/or administration (e.g. paragraph 0007).
Regarding Claims 76-78 and 80, it would have been obvious to one of ordinary skill in the art at the time of filing to include the antioxidants and skin agents of Dreher in the composition of Lu et al., Trumbore et al. and Gross. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as all of Lu, Trumbore, Gross and Dreher teach compositions for skin, which may include antioxidants. One of ordinary skill in the art would have been motivated to include the agents of Dreher in order to enhance the skin through inclusion of the additional antioxidants and skin agents, which is suggested by Lu et al. “When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976).
Response to Arguments
Applicant’s arguments with respect to claim(s) 63, 64, 72, 73, 76-78, 80 and 81 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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