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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 12/31/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 1-10 and 16-20 are pending, claims 1-10 and 20 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/31/2025 is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
Claims 1-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US20230210835) in view of Edgar (US20200206487).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Davis teaches A composition for topical dermatological delivery of a medicinal or cosmeceutical or cosmetic active including a functional co-enhancer delivery system comprises a primary active agent in combination with an ancillary user adherence-improving skin barrier restoring system comprising nicotinamide and polyhydroxy acid. The composition generally comprises a water-miscible solvent and C12 or C14 fatty acids or C14 alcohol in combination with a hydrocarbyl methyl siloxane, other volatile silicones and a blend of silicone elastomers (abstract). Davis teaches dispersing the glycol
co-enhancer system within a silicone elastomer-silicone fluid-silicone emollient continuous phase to form a cream. On application to the skin of glycol-co-enhancer silicone dispersions, the consumer experiences the soft and silky skin feel of the mixed silicone elastomer-silicone emollient fluid continuous phase (page 3, [0024]). A composition for topical application comprising: a primary active agent for topical treatment of the skin, and a user adherence-improving skin barrier restoring combination of: 1.0 to 5% w/w of nicotinamide, 1.0 to 5% w/w of polyhydroxy acid, 10 to 60% w/w of a partition coefficient enhancer (PC enhancer), having a structure of the general formula: CnH2n+202 where n represents an integer from 3 to 5 inclusive, a diffusion coefficient enhancer (DC enhancer) selected from the group consisting of a C12 to C14 straight chain fatty acid and a C14 straight chain primary alcohol, a first dimethicone macromer mixture including a dimethicone macromer and a hydrocarbyl methyl siloxane emollient selected from the group consisting of an alkyl methyl siloxane, an aryl methyl siloxane and an alkyl aryl methyl siloxane, and a second dimethicone macromer mixture including a methyl siloxane compound and a cross-linked dimethicone macromer; wherein the composition comprises less than 15% water by weight, and this is polyol-silicone dispersion (page 6, [0067-0077). Generally, the composition comprises a solution, suspension or dispersion of the active agent in the carrier. Preferably, the active is in solution (page 6, [0079]). Generally, the partition coefficient enhancer is propylene glycol (page 9, [0135]). The composition comprises 5 to 45% w/w first dimethicone macromer mixture, and 5 to 45% w/w second dimethicone macromer mixture (claims 1 and 3). The composition comprising less than 0.05% w/w water or substantially no water; the polyhydroxy acid is selected from lactobionic acid, gluconolactone or galactose and any mixture of these; 0.5-2% by weight of diffusion coefficient enhancer; the product pH is in the range 4.4-6.00 (claims 1, 9, 11, 13 and 15). In one embodiment, the active agent is nicotinamide at 5-10% by weight (claims 1, 18 and 25). Tranexamic acid or Vitamin D is only recited as alternative and not required (claims 1, 17 and 26). Davis further teaches nicotinamide (NAM) be added to sunscreens and after-sun lotions to improve protection from immunosuppression and skin cancers (page 15, [0225]); Due to the chemopreventive activity of NAM against keratinocyte cancers, its DNA repair enhancing effects in melanocytes and now its potential enhancement of tumour-infiltrating lymphocytes, clinical trials on use of nicotinamide for melanoma chemoprevention are indicated. It can be concluded from these studies that nicotinamide has the potential to help prevent AK, BCC, SCC and melanoma, particularly when used with broad spectrum sunscreens (page 15, [0228]). The composition may comprise more than one primary active agent ranges from about 0.001% to about 10% by weight of the composition (page 18, [0270]). In one embodiment, suitable UV blocking agents such as nano and micro particles of titanium, zinc or silicone or other inorganic oxides are included (page 20, [0301]; claims 1, 20 and 22). In another embodiment, the active agent is active agent for treating acne such as salicylic acid ([page 19, [0294]; page 21, [0329]).
Edgar teaches A device and a method are for application of a composition to a treatment surface (e.g., skin) (abstract). The composition to be applied to the skin may comprise, for example, any suitable cosmetic ingredients for modifying an appearance of the skin, such as, for example, an opaque substance, a tinted cosmetic, or any other suitable compositions for enhancing the appearance of skin. The composition may also comprise ingredients such as a moisturizer for hydration, a carrier, or a benefit agent (e.g., a beneficial compound/composition/extract or an active ingredient) for treating and/or ameliorating a skin condition, e.g., acne, hyperpigmentation, eczema, hives, vitiligo, psoriasis, rosacea, warts, shingles, cold sore, pigmentation and tone, redness/oxidative skin stress, wrinkles, brightening, sagging/elasticity, etc. Exemplary embodiments of benefit agents that may be incorporated into the composition are further described below ([0044]). A non-limiting list of useful benefit agents for acne includes benzoyl peroxide, retinoids including retinol, retinal, retinoic acid, retinyl acetate, and retinyl palmitate, hydroxy acids include, but are not limited, to glycolic acid, lactic acid, malic acid, salicylic acid, citric acid, and tartaric acid, sulfur, Zinc PCA (Zinc Pyrrolidone carboxylic acid), Allantoin (5-ureidohydantoin), Rosemary, 4-hexylresorcinol, N-acetyl glucosamine, gluconolactone, niacinamide, azelaic acid, and resveratrol ([0046]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Davis is that Davis does not teaches N-acetyl glucosamine. The deficiency of Davis is cured by teaching of Edgar.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
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 invention of Davis, as suggested by Edgar, to produce the instant invention.
One of ordinary skill in the art would have been motivated to include N-acetyl glucosamine as active agent in the topical composition because -acetyl glucosamine is a suitable and known skin active. MPEP 2144.07. Under guidance from Davis teaching about 0.001% to about 10% of active agent for treating acne, Edgar teaching N-acetyl glucosamine as benefit agent for treating acne, it is obvious for one of ordinary skill in the art to include N-acetyl glucosamine as active agent at about 0.001% to about 10% in the topical composition and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-4, 7, 10 and 20, prior art teaches a topical composition comprising a primary active agent N-acetyl glucosamine about 0.001%-about 10%, 1.0 to 5% w/w of nicotinamide; 1.0 to 5% w/w of polyhydroxy acid; 10 to 60% w/w of a partition coefficient enhancer (PC enhancer) propylene glycol; a diffusion coefficient enhancer (DC enhancer) selected from the group consisting of a C12 to C14 straight chain fatty acid and a C14 straight chain primary alcohol; 5 to 45% w/w of a first dimethicone macromer mixture including a dimethicone macromer and a hydrocarbyl methyl siloxane emollient selected from the group consisting of an alkyl methyl siloxane, an aryl methyl siloxane and an alkyl aryl methyl siloxane, and 5 to 45% w/w of a second dimethicone macromer mixture including a methyl siloxane compound and a cross-linked dimethicone macromer; wherein the composition comprises less than 0.05% water by weight; pH 4.4 to 6. Davis further teaches first and second dimethicone macromers as continuous phase, and (propylene) glycol is dispersed phase, and nicotinamide is expected to be in glycol phase because prior art teaches the same or substantially same composition, the same or substantially same composition is expected to have the same property so that nicotinamide is in glycol phase.
Regarding the limitation of N-acetyl glucosamine skin integrity enhancer, which is interpreted as “N-acetyl glucosamine as skin integrity enhancer”. Since prior art teaches N-acetyl glucosamine, the same N-acetyl glucosamine must have the same skin integrity enhancer property, and the limitation is met.
Regarding claim 5, Davis teaches polyhydroxy acid is selected from lactobionic acid, gluconolactone or galactose.
Regarding claim 6, Davis teaches diffusion coefficient enhancer (DC enhancer) selected from the group consisting of a C12 to C14 straight chain fatty acid and a C14 straight chain primary alcohol at 0.5-2% by weight.
Regarding claim 8, tranexamic acid, zinc, or Vitamin D is recited as alternative to nicotinamide as active agent, not required.
Regarding claim 9, Davis teaches UV-block such as titanium oxide, which is sun-blocking agent.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that there is no teaching of N-acetyl glucosamine as well as its advantage. All related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. The modified 103 rejection has already addressed the limitation of N-acetyl glucosamine and the amount in the topical composition. Since applicants failed to provide any evidence to show advantage of N-acetyl glucosamine, and failed to compare with closest prior art teaching, no unexpected results has been established, and the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
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 JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613