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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/29/2026 has been entered.
Withdrawn Rejections:
Applicant's amendments and arguments filed on 04/29/2026 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.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 1-3, 5-10 and 16-20 are pending, claims 1-3, 5-10 and 20 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/29/2026 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 1-3, 5-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US20230210835) in view of Morariu (US20070065396).
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]). The DC enhancer is about 0.5-2% of the composition (page 9, [0129]). 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, 25 and 29) for the treatment of skin condition such as acne. 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 antiacne for treating acne such as retinoid (page 18, [0271]; page 19, [0294]; page 21, [0329]).
Morariu teaches Anti-acne agents may also be combined with the formulation of the present invention. Since both free radicals and inflammation are cofactors in acne, especially in adult skin, a combination with one or more anti-acne ingredient may be used in the topical formulation of the present invention. A non-limiting list of useful anit-acne agents includes (−)-epigallocatechin, (−)-epigallocatechin-gallate, α-pinene, α-terpineol, anacardic-acid, azelaic-acid, baicalein, berberastine, berberine, β-carotene, camphor, caryophyllene, cryptotanshinone, δ-cadinene, γ-linolenic-acid, indole, linoleic acid, nerolidol, pufa, pufas, pyridoxine, resorcinol, selenium, sulfur, terpinen-4-ol; thymol, tin, and zinc ([0136]).
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 linoleic acid. The deficiency of Davis is cured by teaching of Morariu.
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 Morariu, to produce the instant invention.
One of ordinary skill in the art would have been motivated to include linoleic acid together with nicotinamide in the topical composition because both linoleic acid and nicotinamide are recognized as anti-acne agent. MPEP 2144.06, "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). Under guidance from Davis teaching nicotinamide as anti-acne agent and more than one active agent in the composition; Morariu. teaching linoleic acid as anti-acne agent in topical composition, it is obvious for one of ordinary skill in the art to include linoleic acid together with nicotinamide in the topical composition and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-3, 5-7, 10 and 20, prior art teaches a topical composition comprising mixture of linoleic acid and nicotinamide as active agent at about 0.001%-about 10%, and each of linoleic acid and nicotinamide is 0.001% to about10% as long as the total amount is no more than 10%; 1.0 to 5% w/w of nicotinamide; 1.0 to 5% w/w of polyhydroxy acid (mixture of lactobionic acid and gluconolactone, each of them is 1-5% as long the total amount is no more than 5%); 10 to 60% w/w of a partition coefficient enhancer (PC enhancer) propylene glycol; a diffusion coefficient enhancer (co-enhancer in applicant’s claim 6) 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%; 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 amount of nicotinamide, Davis teaches 0.001% to about 10% nicotinamide as active agent and additional 1.0 to 5% w/w of nicotinamide in the carrier system, the total amount of nicotinamide is about 1% to 15% by weight.
Regarding the limitation of linoleic acid skin integrity enhancer, which is interpreted as “linoleic acid as skin integrity enhancer”. Since prior art teaches linoleic acid, the same linoleic acid must have the same skin integrity enhancer property, and the limitation is met.
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 amended claim 1. All related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. The modified 103 rejection has already addressed each claimed limitation and applicant’s arguments are moot. Thus, 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.
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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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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