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 .
Claim Status
Claims 1-4, 6-8, 11, 13-15, 22 and 24-26 are pending.
Claims 1, 4 and 6-7 are currently amended.
Claims 5, 9-10, 12, 16-21 and 23 have been canceled.
Claims 24-26 have been added.
Claims 1-4, 6-8, 11, 13-15, 22 and 24-26 are currently under consideration.
Claims 1-4, 6-8, 11, 13-15, 22 and 24-26 are rejected.
Acknowledgement of Receipt
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/11/2025 has been entered.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 09/08/2025 and 12/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, these IDSs have been considered by the Examiner.
Withdrawn Objections and/or Rejections
In light of the new amendments and/or upon further consideration, the rejection of claims 4 and 22 under 35 U.S.C. § 112(b) as being indefinite is withdrawn.
Claim Objections
Claim 13 is objected to because of the following informalities: the preposition “from” appears to be in duplicate in line 2 of claim 13. Appropriate correction is required.
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 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 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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.
Applicant Claims
The instant claims are directed to a skin care composition comprising: a) 0.0001-10% sucrose ester (sucrose laurate, sucrose dilaurate); b) 0.01-1% hydrophobically modified aqueous rheology modifier, not a polyacrylamide-based thickener; c) 0.005-5% non-ionic stearic acid derivative emulsifier; d) 0.1-10%, 3-7%, and 5% hexyldecanol; e) vitamin B3, undecylenoyl phenylalanine, vitamin E, palmitoylated dipeptides, palmitoylated pentapeptides, vitamin A; f) 70-99%, 80-95% aqueous carrier; and is in the form of an oil-in-water emulsion; is a cream, lotion, serum, or essence; wherein the sucrose ester comprises sucrose laurate and sucrose dilaurate; and the weight ratio of the sucrose laurate to the sucrose dilaurate is from about 3:1 to about 3:2. The skin care composition exhibits and Instability Index value less than about 2%, 20%, 5%.
The non-ionic, stearic acid derivative emulsifier is steareth-2 steareth-21, PEG-100 stearate, or glycereth-25 pyrrolidonecarboxylic acid isostearate; wherein the hydrophobically modified aqueous rheology modifier is chosen from acrylates/C10-30 alkyl acrylate cross-polymer, acrylates vinyl isodeconate crosspolymers, polyacrylate crosspolymer-6, or sodium polyacryloyldimethyl taurate; free of polyether-modified silicone emulsifiers.
An additional ingredient is vitamins, minerals, peptides, sugar amines, sunscreen, oil control agents; flavonoid compounds, anti-oxidants, preservatives, protease, tyrosinase inhibitors; anti-inflammatory, moisturizing, exfoliating, skin lightening agents; lubricants, anti-acne actives, chelating agents, anti-wrinkle, anti-atrophy actives; phytosterols, N-acyl amino acid compounds, antimicrobials, and antifungals, conditioning agents, emulsifiers, or rheology modifiers; wherein an emulsifier is PEG-100 stearate, Steareth-2, steareth-21, or glycereth-25 pyrrolidonecarboxylic acid isostearate.
A method of cosmetically treating skin, comprising: i. identifying a target portion of skin where treatment is desired; and ii. applying the skin care composition to the target portion of skin.
Claims 1-4, 7-8, 11, 13-15 and 24-26 are rejected under 35 U.S.C. § 103 as being unpatentable over Gujraty et al. (US 20170367957 A1, pub. 12/28/2017) in view of Pham (WO 2013/049599 A2, pub. 04/03/2013) evidenced by Lubrizol (Lubrizol/Personal-Care/Documents/ Technical-Papers-and-Posters/MakeItSimple_Poster_DEC2012.pdf) herein referenced Gujraty, Pham, and Lubrizol.
Gujraty discloses a cosmetic composition suitable for topical application comprising: about 1% to about 30% glycerin; about 0.05% to about 3% of a lipid bilayer structurant with a glyceryl headgroup selected from glyceryl esters and glyceryl ethers; about 0.01% to about 10% of a penetration enhancer selected from N-undecylenoy1-L-phenylalanine, 2-hexyldecanol, octyl salicylate, isopropyl lauroyl sarcosinate, oleic acid, isostearic acid, linoleic acid, linolenic acid, and combinations thereof; and about 1% to about 10% niacinamide (Vitamin B3) as a skin care active ([0007], [0024], [0039], claim 1). Gujraty’s general descriptions of the chassis used in the permeation experiments include oil-in-water (O/W) emulsions and water gels ([0083], Table 4).
Gujraty teaches that the cosmetic composition may comprise from about 1% to about 95% by weight of one or more oils ([0053]). Gujraty teaches that the cosmetic composition may comprise from about 1% to about 95% by weight of water ([0053]). The composition may comprise, particularly when the cosmetic composition is in the form of an emulsion, from about 0.05% to about 20% emulsifier ([0062]). Gujraty teaches that suitable emulsifiers in the composition include the following classes of ethers and esters: ethers of C12-30 fatty alcohols comprising and of sucrose or of glucose, esters of sucrose and of C12-30 fatty acids ([0063]). To reiterate, isostearic acid (i.e., stearic derivative) is taught as an emulsifier and penetration enhancer ([0033], [0039], claim 1).
Gujraty teaches that the lipid bilayer structurant has a has a carbon chain length of C14 or more and may include batyl alcohol (i.e., fatty alcohol) ([0051], claim 3, 6). Gujraty discloses that examples of aqueous or water structuring agents to increase viscosity, thicken, solidify, or provide solid or crystalline structure to the cosmetic composition, include polymeric agents, natural or synthetic gums, polysaccharides ([0066]). The cosmetic composition may comprise from about 0.0001 % to about 25% by weight of the cosmetic composition, of one or more structuring agents ([0066]). While polyacrylamide polymers may be a suitable aqueous phase thickening agent, it is not required ([0067]).
Pham is provided to teach sucrose laurate/dilaurate.
Pham discloses an invention that relates to a personal care composition comprising an oil-in-water emulsifier system comprising at least one sucrose fatty acid ester and at least one nonionic surfactant, said system being substantially free of silicone emulsifiers (pg. 2, lines 5-7; claim 1, 11). Pham teaches that personal care composition refers to compositions for topical application to the skin or hair to include lotions and face creams (pg. 3, lines 1-8). Pham discloses an oil-in-water emulsifier system comprising at least one sucrose fatty acid ester and at least one non-ionic surfactant (claim 1). The sucrose fatty acid ester is preferably selected from the group consisting of sucrose dilaurate, sucrose distearate, sucrose hexaerucate; sucrose hexaoleate/hexapalmitate/hexastearate, sucrose hexapalmitate, sucrose laurate (pg. 5, lines 7-11; claim 2).
In one embodiment, the vitamin B3 compound is niacinamide and the composition may comprise from about 0.001% to about 20% by weight of the composition, of a vitamin B3 compound (pg. 6, lines 10-12, claim 6). Pham provides example formulations (I.-IX.) in which a sucrose ester is present (0.5% to 2.0%) in an oil-in-water emulsion (pg. 14). Glycerin is mixed with xanthan (rheology modifier) at 1.60% for each of the examples provided (pg. 14).
Regarding sucrose laurate/dilaurate of instant claim 1 and the ratios of instant claim 4, the term "emulsifier system" of Pham refers to the combination of both the sucrose fatty acid ester and nonionic surfactant (pg. 5, lines 22-30). Pham discloses that said sucrose fatty acid ester is sucrose stearate and said nonionic surfactant is methyl glucose sesquisterate and are comprised at a ratio ranging from about 1:3 to about 3:1 (claims 4-5) to read on the ratio limitation. While Pham does not explicitly teach that the sucrose laurate and sucrose dilaurate are in this ratio, one of ordinary skill in the art would be directed to substitute the sucrose stearate with sucrose laurate and substitute the methyl glucose sesquisterate with sucrose dilaurate for the following reasons.
Pham discloses that the hydrophile-lipophile balance (HLB) value for the emulsifier system is 1.5 to 13.0 (pg. 5, line 31). Pham teaches that HLB values for commonly-used surfactants are readily available in the literature and are well known in the art (pg. 6, lines 5-7). One of ordinary skill in the art would discern the HLB value for sucrose stearate as being considerably higher than that of methyl glucose sesquisterate. As such, one skilled in the art would consider the sucrose laurate since it is known to have one of the highest HLB values. Similarly sucrose dilaurate would be considered as a suitable ingredient of lower HLB value. It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to substitute one known sugar-derived emulsifier with a sucrose laurate, and to substitute a known nonionic emulsifier with a sucrose dilaurate for a similar purpose of creating an emulsion system where one component has a considerably higher HLB value than the other to improve stability. Simple substitution of one nonionic emulsifier/surfactant for another is within the purview of the skilled artisan and would yield predictable results.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to utilize the sucrose laurate and sucrose dilaurate taught by Pham in the emulsifier system of the cosmetic composition taught by Gujraty with expected results. One would be motivated to do so with a reasonable expectation of success because Pham teaches and suggests that the ratio minimizes the “soapy” film without having to employ traditionally used silicone, or specifically dimethicone (Pham pg. 5, 12) which would contribute to the art, absent a clear showing of evidence to the contrary. Further, an artisan would understand Pham’s teaching of nonionic surfactant to indicate a sugar derived emulsifier that overlaps with the claimed sucrose dilaurate.
As mentioned above, both references disclose niacinamide (Vitamin B3). Gujraty advantageously discovers that the ingredients collectively known as penetration enhancers, e.g., undecylenoyl-L-phenylalanine, hexyldecanol (e.g. 2-hexyl 1-decanol), and isostearic acid can enable glycerin to synergistically enhance the penetration of niacinamide into and through the stratum corneum ([0033]); specifically with glycerin, penetration enhancer, and a lipid-bilayer structurant with a glyceryl head ([0048]).
While Instability Index values (instant claims 2-3 and 15) are not provided per se, Gujraty and Pham teach emulsifier systems. The prior art teaches a composition and process for forming said composition described by Applicants. Having an instability index value of a specific value does not give patentable weight. Just as the mere addition of a characterization to a prior art patented invention is not patentable, the measurement of a previously unmentioned parameter that is found in a known composition, is also not patentable.
Regarding claim 7, Gujraty teaches Pemulen (Table 6). As evidenced by Lubrizol, Pemulen is referred to as acrylate/C10-30 alkyl acrylate cross polymers (Lubrizol, pg. 1, para. 1).
Regarding claim 8, while Gujraty mentions linear or branched type silicone emulsifiers may also be used and identifies polyether modified silicones in paragraph ([0064]), they are not required. In light of Pham’s teachings of the ratio of sucrose ester to nonionic surfactant mitigates the need to use traditionally used silicones (in order to minimize the soapy film). Pham discloses a cosmetic composition comprising an emulsifier system premix, said premix consisting of a sucrose fatty acid ester and a nonionic surfactant; wherein said composition is substantially free of silicone emulsifiers (claim 11).
Regarding claim 11, both Gujraty and Pham teach vitamins, specifically niacinamide, i.e., Vitamin B3 compound (Gujraty, claims 1, 12-13; Pham, claim 6).
Regarding claim 14, Gujraty (claims 12-13) and Pham (pg. 12, see “applied to user’s forearm”) both disclose applying the composition to an identified targeted skin portion.
Regarding claims 24-25, Gujraty teaches that 2-hexyldecanol is present from about 0.01% to about 10% (claim 1).
Regarding claim 26, as mentioned above, Gujraty discloses that water may be present from 1% to about 95% ([0053]) and provides examples where water is at QS (quantum satis) (see Table 5).
Claims 6 and 22 are rejected under 35 U.S.C. § 103 as being unpatentable over Gujraty and Pham evidenced by Lubrizol as applied to claims 1-4, 7-8, 11, 13-15 and 24-26 above, and further in view of Ikeda et al. (US 11,260,000 B2, filed 06/10/2015) herein referenced Ikeda.
The teachings of Gujraty and Pham as evidenced by Lubrizol above are incorporated herein.
Gujraty and Pham do not explicitly teach the species of claim 6 and serum/essence.
Ikeda discloses a composition, preferably a cosmetic composition, comprising: (a) at least one oil; (b) at least one polyglyceryl fatty acid ester, preferably with a polyglyceryl moiety derived from 2 to 6 glycerins; (c) at least one compound selected from the group consisting of resorcinol and resorcinol derivatives; and (d) water (abstract, claim 1). The composition according to the present invention can be in the form of a nano- or micro-emulsion, or can have a lamellar structure or a lamellar phase, with better transparency and stability (col. 41, see Examples). Ikeda discloses that (b) at least first polyglyceryl fatty acid ester and second polyglyceryl fatty acid ester comprises a combination of two polyglyceryl fatty acid esters in which the HLB value of the first polyglyceryl fatty acid ester is greater than 10, and the HLB value of the second polyglyceryl fatty acid ester is less than 10 (claims 1-2, 7).
Regarding claim 6, Gujraty discloses stearic derived fatty acids (claim 5) that share primary functions as the species recited of instant claim 6.
Ikeda discloses Steareth-2 (col. 29, line 58) to read on the limitation and also teaches polyglyceryl monooleate (col. 2, line 44) to overlap with Gujraty (claim 5). It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to substitute one known glycerol and isostearic based emollient with the specific Steareth-2 taught by Ikeda for a similar purpose of providing a similar fatty acid tail for emolliency. Simple substitution of one glycerol and isostearic based ester for another is within the purview of the skilled artisan and would yield predictable results.
Regarding claim 22, Gujraty describes a composition as a water gel (Table 4). Pham lotions and face creams (pg. 3, lines 6-7). Ikeda teaches that oil-in-water (O/W) or water-in-oil (W/O) emulsions are well known in the field of cosmetics and dermatology, in particular for the preparation of cosmetic products, such as milks, creams, tonics, serums or toilet waters (col. 1, line 26) to read on the claim. Further, Ikeda discloses a composition according to the present invention can have better transparency, the composition can be preferably used for cosmetics such as a lotion and a serum (col. 6, line 19).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply the Steareth-2 and serum taught by Ikeda in the compositions of Gujraty and Pham evidenced by Lubrizol with expected results. One would be motivated to do so with a reasonable expectation of success because Ikeda echoes the teachings of Gujraty with respect to the range of ratios of ingredients in emulsifier systems. Ikeda teaches systems that enable stability of the emulsion (bridging col. 1-2; col. 40, line 26) and thereby contributes to the art, absent a clear showing of evidence to the contrary.
For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Response to Arguments
Applicants’ arguments are based on newly amended limitations which have been addressed by the new grounds of rejection above.
Conclusion
Claims 1-4, 6-8, 11, 13-15, 22 and 24-26 are rejected; no claims are currently allowable.
The Examiner asks Applicant to provide support for the amendments in the application disclosure by referencing page numbers, paragraphs, figures, etc. for the sake of compact prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614