CTNF 18/721,076 CTNF 101773 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 1-15 are pending. Priority This application is filed 06/17/2024 and claims the benefit of domestic priority as below: PNG media_image1.png 153 910 media_image1.png Greyscale Information Disclosure Statements Three IDS(s) received on 6/17/2024, 10/21/2025, and 5/19/2026 have been considered unless marked with a strikethrough. 07-30-03-h AIA Claim Interpretation Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard consistent with the specification (See MPEP 2111). The phrase “comprising” is interpreted as including additional ingredients, phases, additives, emulsifiers, preservatives, fragrances, or other cosmetic components. The terms “water”, “oil”, and “fatty acid” are interpreted according to their ordinary cosmetic formulation meaning/ingredients. In particular, “fatty acid” is interpreted to encompass free fatty acids as well as fatty acid chains, moieties, or residues present in or associated with oil or lipophilic components, unless the specification clearly limits the term to free fatty acid only. The phrase “hydrophobicized by the fatty acid” is interpreted to include hydrophobic association, complexation, or interaction between the cationic polymer and fatty acid having at least 4 carbon atoms (fatty acid section in page 21 of the specification) containing lipophilic components, and may also imply that this limitation is met when both components are present. The terms “aqueous phase”, and “fatty phase” are interpreted to mean a water containing phase and an oil/lipophilic phase, respectively. These terms do not require complete physical separation or isolation of the phases. The phrase “keratin substance such as skin” refers to the substrate to which the cosmetic composition is applied, including skin, and the phrase “drying the composition to form a cosmetic film” is interpreted as meaning that, after the cosmetic composition is applied to the skin, volatile components such as water are removed by drying, leaving a cosmetic residue or film on the skin. It does not require formation of separately peeled or freestanding film. Claim Rejections - 35 USC § 112(b), second paragraph 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 2-5, 8-11, and 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The phrase “hydrophobicized by the fatty acid” in claim 2 is a relative term which renders the claim indefinite. The phrase “hydrophobicized by the fatty acid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree of hydrophobicization, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular, claim 2 does not identify what structural , chemical or functional relationship must exist between the cationic polymer and fatty acid having at least 4 carbon atoms (fatty acid section in page 21 of the specification) for the polymer to be considered “hydrophobicized by” the fatty acid. For example, it is unclear whether the fatty acid must be chemically bonded to the cationic polymer, physically associated with the cationic polymer, ionically associated with the cationic polymer, or merely present in the same composition. As stated in the claim interpretation section, the Examiner is taking the position that if a fatty acid having at least 4 carbon atoms is present with the cationic polymer, then this limitation is deemed met. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation cyclopolymers of dialkyldiallylammonium, (co)polyamines and cationic (co)polyaminoacids, and the claim also recites (co)polydiallyldialkyl ammonium chloride, (co)polylysines and chitosans, and collagen and cationic cellulose polymers which is the narrower statement of the range/limitation; claim 4 recites the broad recitation a keratin substance, and the claim also recites skin which is the narrower statement of the range/limitation; claim 5 recites the broad recitation the amount of the (a-1) cationic polymer(s) in the composition is from 0.01% to 15% by weight, and the claim also recites preferably from 0.05% to 10% by weight, and more preferably from 0.1% to 5% by weight which is the narrower statement of the range/limitation; claim 8 recites the broad recitation the (b-1) oil is selected from plant oils, synthetic ester oils, and mixtures thereof, and the claim also recites preferably from plant oils which is the narrower statement of the range/limitation; claim 9 recites the broad recitation the amount of the (b-1) oil(s) in the composition is from 1% to 50% by weight, and the claim also recites preferably from 10% to 45% by weight, and more preferably from 20% to 40% by weight which is the narrower statement of the range/limitation; claim 10 recites the broad recitation the (b-2) fatty acid is selected from C 4 -C 22 , and the claim also recites preferably C 6 -C 20 , more preferably C 8 -C 18 which is the narrower statement of the range/limitation; claim 11 recites the broad recitation the amount of the (b-2) fatty acid(s) in the composition is from 0.01% to 15% by weight, and the claim also recites preferably from 0.05% to 10% by weight, and more preferably from 0.1% to 5% by weight which is the narrower statement of the range/limitation; claim 14 recites the broad recitation a keratin substance, and the claim also recites skin which is the narrower statement of the range/limitation; and claim 15 recites the broad recitation the amount of the (b-1) oil in the composition to be 1% by weight, and the claim also recites preferably 10% by weight, and more preferably 20% by weight which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The phrase “in order to increase the amount of the oil” in claim 15 is a relative term which renders the claim indefinite. The phrase “in order to increase the amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular, it does not identify a baseline composition relative to which the amount of the oil is increased. For example, it is unclear whether the comparison is made against an otherwise identical composition lacking the fatty acid, against a composition having a low amount of fatty acid, or against another reference composition. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Notwithstanding the indefiniteness issues identified under 35 USC 112. This rejection is made in the alternative based on the above claim interpretation. 07-15-aia AIA Claim(s) 1-3, 5, 8, 10, and 12-13 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by the commercial product, “Chitocare Face Cream” from chito care beauty (Personal Care Product Council., https://incidecoder.com/products/chito-care-beauty-chitocare-face-cream, updated 11/05/2020, hereinafter “INCI”). The reference is from “INCI” that is a list of the standardized and internationally accepted names used in the declaration of ingredients on cosmetic and personal care products. It is published by the Personal Care Product Council . With respect to claims 1, claim recites that a composition, comprising:(a-1) at least one cationic polymer; (a-2) at least one monovalent non-polymeric acid or a salt thereof; (a-3) water; (b-1) at least one oil; and (b-2) at least one fatty acid. INCI discloses a single cosmetic product, “Chitocare Face Cream”, comprising chitosan, lactic acid, water, glycine soja (soybean) oil, cocos nucifera (coconut) oil, and macadamia ternifolia seed oil (ingredients overview). Chitosan corresponds to the (a-1) cationic polymer; lactic acid corresponds to the (a-2) monovalent non-polymeric acid; water corresponds to the (a-3) water; and glycine soja (soybean) oil, cocos nucifera (coconut) oil, and macadamia ternifolia seed oil correspond to the (b-1) oil. The disclosed plant oils necessarily contain fatty acid chains, fatty acid moieties or fatty acid residues, including saturated and/or unsaturated fatty acid chains. INCI states that “Glycine Soja (Soybean) Oil contains 48-59% barrier-repairing linoleic acid, 17-30% nourishing oleic acid and also some (4.5-11%) potentially anti-inflammatory linolenic acid” (glycine soja (soybean) oil section). Oleic acid is an 18-carbon, monounsaturated omega-9 fatty acid. Accordingly, under the broadest reasonable interpretation (BRI) of “fatty acid”, INCI expressly and inherently discloses the (b-2) fatty acid limitation. Therefore, INCI discloses each limitation of claim 1. With respect to claims 2, claim recites that the (a-1) cationic polymer is hydrophobized by the (b-2) fatty acid. INCI teaches a single cosmetic composition comprising chitosan together with plant oils, including soybean oil, coconut oil, and macadamia seed oil (ingredients overview). Chitosan corresponds to the cationic polymer. The disclosed plant oils necessarily contain fatty acid species, as discussed above. Under the claim interpretation, “hydrophobized by the fatty acid” encompasses an associative interaction between the cationic polymer and fatty acid containing components within the same composition, including physical, ionic, or other non-covalent association. INCI discloses chitosan in the same cream composition s fatty acid containing plant oils. Because the same composition contains chitosan and fatty acid containing oil components, the hydrophobized state of the cationic polymer is an inherent property of the disclosed formulation. (see MPEP 2112) Accordingly, INCI discloses, expressly or inherently, the limitation of claim2 under the BRI of the claim language. With respect to claims 3, claim recites that the composition wherein the (a-1) cationic polymer is selected from the group consisting of cyclopolymers of alkyldiallylamine and cyclopolymers of dialkyldiallylammonium such as (co)polydiallyldialkyl ammonium chloride, (co)polyamines such as (co)polylysines and chitosans, cationic (co)polyaminoacids such as collagen, cationic cellulose polymers, and salts thereof. INCI teaches chitosan as an ingredient (ingredients overview), and it is one of the cationic polymers specifically encompassed by claim 3. With respect to claims 5, claim recites that the composition according to any one of wherein the (a-2) monovalent non-polymeric acid is a monovalent non-polymeric organic acid, preferably a monovalent carboxylic acid, and more preferably lactic acid. INCI teaches lactic acid and sodium lactate as an ingredient (ingredients overview), and lactic acid is specifically encompassed by claim 5. Lactic acid is a monovalent non-polymeric organic carboxylic acid, and sodium lactate is a salt of lactic acid. With respect to claims 8, claim recites that the composition according to any one of wherein the (b-1) oil is selected from plant oils, synthetic ester oils, and mixtures thereof, and preferably from plant oils. INCI teaches glycine soja (soybean) oil, cocos nucifera (coconut) oil, and macadamia ternifolia seed oil. Each of these ingredients is a plant oil. Accordingly, INCI discloses that plant oil limitation recited in claim 8. With respect to claims 10, claim recites that the composition according to any one of wherein the (b-2) fatty acid is selected from C 4 -C 22 , preferably C 6 -C 20 , more preferably C 8 -C 18 saturated and unsaturated, linear or branched fatty acids. INCI teaches that a composition comprising plant oils, including soybean oil, coconut oil, and macadamia seed oil. These plant oils necessarily contain fatty acid chains, fatty acid moieties or fatty acid residues. Such fatty acid species include saturate and unsaturated fatty acid chains falling within the C4-C22 genus recited in claim 10. For example, the glycine soja (soybean) oil contains C18 unsaturated fatty acid chains, including linoleic acid, oleic acid, and linolenic acid residues (glycine soja (soybean) oil section).Therefore, under the BRI of “fatty acid”, the C4-C22 fatty acid limitation is inherently disclosed by the fatty acid chains, moieties, or residues necessarily present in the disclosed plant oils. Under MPEP 2112, extrinsic evidence may be used to show that a characteristic nor expressly disclosed in the primary reference is inherent, provided that the evidence establishes that the missing matter is necessarily present in the disclosed product. Therefore, the C4-C22 fatty acid limitation is inherently met by the fatty acid species necessarily present in the disclosed plant oils. With respect to claims 12, claim recites that the composition comprises an (a) aqueous phase comprising the (a-1) cationic polymer, the (a-2) monovalent non-polymeric acid or a salt thereof, and the (a-3) water. INCI teaches a cream composition comprising aqua, lactic acid, sodium lactate, and chitosan. Aqua is water, lactic acid and sodium lactate are a monovalent non-polymeric acid and salt, respectively, and chitosan is the cationic polymer. Because the prior art product is a water containing cream composition comprising water together with lactic acid, sodium lactate, and chitosan, and because lactic acid and sodium lactate are water soluble or water compatible components and chitosan is water dispersible or acid solubilized in the presence of lactic acid, the disclosed product necessarily includes an aqueous phase comprising water, lactic acid, and/or lactate, and chitosan. (see MPEP 2112) Accordingly, the composition of the prior art product inherently discloses the aqueous phase limitation of claim 12. With respect to claims 13, claim recites that the composition the composition wherein the composition comprises (b) fatty phases comprising the (b-1) oil, and the (b- 2) fatty acid. INCI teaches that the composition comprising plant oils, including glycine soja oil, cocos nucifera oil, and macadamia ternifolia seed oil. These ingredients correspond to the claimed oil. The disclosed plant oils necessarily contain fatty acid chains, fatty acid moieties or fatty acid residues. Because these oil components are lipophilic components of the cream, the disclosed product necessarily comprises a fatty phase containing plant oils and fatty acid containing components. (see MPEP 2112) Accordingly, the prior art product discloses the oil containing formulation and inherently discloses the fatty phase comprising oil and fatty acid containing components . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. Notwithstanding the indefiniteness and written description issues identified under 35 USC 112. This rejection is made in the alternative based on the above claim interpretation. Moreover, the 103 rejection is made in the alternative to the 102 rejection and addresses any limitation not found to be expressly or inherently disclosed by INCI. 07-21-aia AIA Claim (s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over the commercial product, “Chitocare Face Cream” from chito care beauty (Personal Care Product Council., https://incidecoder.com/products/chito-care-beauty-chitocare-face-cream, updated 11/05/2020, hereinafter “INCI”), in view of Shipovskaya et al. (RU 2667130 C1, pub’d 07/18/2017), and in further view of Meier-Zimmerer et al. (WO 2006/040091 A2, pub’d 02/10/2022, hereinafter "Meier") . With respect to independent claim 1 , the claim recites that a composition, comprising:(a-1) at least one cationic polymer; (a-2) at least one monovalent non-polymeric acid or a salt thereof; (a-3) water; (b-1) at least one oil; and (b-2) at least one fatty acid. The teachings of INCI are disclosed above and at least those teachings are incorporated by reference herein. INCI fails to teach separately list free fatty acid as an INCI ingredient. However, INCI discloses glycine soja (soybean) oil. As discussed above in USC 35 102, soybean oil establishes that soybean oil contains fatty acid components, including linoleic acid, oleic acid, and linolenic acid (glycine soja (soybean) oil section). These fatty acid components correspond to the fatty acid of feature (b-2), at least under the BRI of the claim language. Moreover, Shipovskaya teaches that a related chitosan containing cosmetic skin care hydrogel comprising low molecular weight chitosan corresponding to feature (a-1), lactic acid corresponding to feature (a-2), and water corresponding to feature (a-3) (claim 1). Shipovskaya further teaches that chitosan in an amount of 2.7-7.0 wt%, lactic acid 2.0-2.2 wt%, water as the remainder, and optional aminocaproic acid in an amount of 0.9 - 1.1 wt.% (claim 1-2). Aminocaproic acid is a C6 amino carboxylic acid, as classified as an omega-amino fatty acid, used in a related chitosan/lactic acid/water skincare formulation taught by Shipovskaya. The fatty acid limitation is primarily taught by the fatty acid containing plant oils disclosed in INCI, including soybean oil containing linoleic acid, oleic acid, and linolenic acid components. Shipovskaya further identifies the cosmetic advantage of the composition as providing an increase in skin moisture, wrinkle reduction, and lifting effect (abstract). Shipovskaya may guide one of ordinary skill in the art toward lower amounts of oils, fats, waxes, and various biologically active additives in prior cosmetic compositions (2 nd and 4 th paragraph on page 7 of the specification). The specification further identifies, as a disadvantage of a prior mask composition, that the presence of excessive amount of oils and biologically active components, together with an aqueous acetic acid solution, may cause allergic reaction (2 nd and 4 th paragraph on page 7 of the specification). However, this guidance toward lower amounts is made in the specific context of Shipovskaya’s aqueous chitosan hydrogel formulation and its lifting application. Shipovskaya is not relied upon as the primary reference for the oil containing cream or emulsion structure. Instead, Shipovskaya is relied upon for its teaching of chitosan/lactic acid/water amounts and related skincare benefits. Shipovskaya does not define what constitutes a “large” or “excessive” amount of oil, and its disclosure should not be read as a general prohibition against the use of oils in all skincare formulations, particularly where INCI already discloses plant oils in a cosmetic cream and Meier addresses chitosan containing oil/lipid emulsion systems. Accordingly, Shipovskaya does not teach away from the claimed composition. (See MPEP 2145) The combination of teachings fails to teach the stability or compatibility considerations associated with a chitosan containing oil or lipid emulsion system. Meier teaches chitosan containing cosmetic formulations and recognizes that chitosan containing nano-, micro-, or macroemulsions can suffer from instability, turbidity, phase separation, and water deposits due to interactions between chitosan, emulsifiers, and emulsified oils or lipids (3 rd paragraph on page 5, and 11 th paragraph on page 13 of Meier’s specification). Therefore, Meier supplies a formulation rationale for modifying a chitosan, oil, water cosmetic cream to improve compatibility and stability of the oil containing emulsion system. It would have been obvious to a PHOSITA at the time of the invention to combine the INCI composition using the chitosan/lactic acid/water amounts taught by Shipovskaya, and the chitosan emulsion stability teaching of Meier. The motivation would have been to obtain the predictable advantages expressly taught by Shipovskaya and Meier, improved skin moisture, wrinkle reduction, lifting effect, and improved stability/appearance of a chitosan contain oil in water cosmetic emulsion. The combination would have yielded predictable results because all teachings concern chitosan contain cosmetic skin care formulations, and the modification merely uses known cosmetic formulation variable for their known purposes. The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. Examples of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Applying KSR example rationale (A)/(B) in the independent claim 1 , it would have been prima facie obvious to combine the known chitosan/lactic acid/water/oil cosmetic composition of the product of INCI with the working chitosan/lactic acid/water/fatty acid amounts and skin care advantages taught by Shipovskaya and the chitosan emulsion stability teachings of Meier. It represents the predictable use of known elements according to their established functions, yielding predictable results. (see MPEP 2141) With respect to claims 3, 5, and 8 , the claims recite that the list of the composition for the (a-1) cationic polymer, the (a-2) monovalent non-polymeric acid, and the (b-1) oil. As discussed above in 35 USC 102, INCI teaches chitosan, which correspond to the claimed (co)polylysines and chitosans serving as the (a-1) cationic polymer; lactic acid, which correspond to the claimed a monovalent non-polymeric organic acid serving as the (a-2) monovalent non-polymeric acid; and glycine soja (soybean) oil, cocos nucifera (coconut) oil, and macadamia ternifolia seed oil which correspond to the claimed plant oils serving as the (b-1) oil. This limitation is therefore taught by INCI alone, and the additional references are relied upon for the limitations discussed below. With respect to claims 4, and 6 , the claims recite that the amount of the (a-1) cationic polymer(s) in the composition is from 0.01% to 15% by weight, preferably from 0.05% to 10% by weight, and more preferably from 0.1% to 5% by weight, and the amount of the (a-2) monovalent non-polymeric acid or a salt thereof in the composition is from 0.01% to 20% by weight, preferably from 0.05% to 15% by weight, and more preferably from 0.1% to 10% by weight, relative to the total weight of the composition. Shipovskaya teaches a chitosan containing cosmetic skin care hydrogel comprising low molecular weight chitosan 2.7-7.0 wt%, and lactic acid 2.0-2.2 wt% (claim 1). These amounts fall within or overlap the claimed range for the cationic polymer and the monovalent non polymer acid recited in claims 4, and 6. Accordingly, Shipovskaya’s disclosed ranges overlap the claimed ranges for the amount of the (a-1) cationic polymer and the amount of the (a-2) monovalent non-polymeric acid or salt thereof, and the overlapping ranges support a prima facie case of obviousness. (see MPEP 2144.05) With respect to claim 7 , the claim recites that the composition according to any one of wherein the amount of the (a-3) water in the composition is from 40% to 90% by weight, preferably from 45% to 85% by weight, and more preferably from 50% to 80% by weight, relative to the total weight of the composition. Shipovskaya teaches a chitosan 2.7-7.0 wt%, lactic acid 2.0-2.2 wt%, glycolic acid 0.2 - 0.5 wt% and water as the remainder (claim 1). Shipovskaya further teaches the hydrogel may additionally contain high molecular weight chitosan in an amount of 3.9 - 4.9 wt% and /or aminocaproic acid in an amount of 0.9 - 1.1 wt% (claim 2). When Shipovskaya’s optional high molecular weight chitosan and aminocaproic acid are included, the total amount of non-water components is approximately 9.7-15.7 wt%, and the calculated water amount is approximately 84.3-90.3 wt%. This range substantially overlaps the claimed water range of 40% to 90% by weight, and at least the portion from 84.3-90.0 wt% falls within the claimed range. (see MPEP 2144.05) With respect to claim 9 , the claim recites that the composition according to wherein the amount of the (b-1) oil(s) in the composition is from 1% to 50% by weight, preferably from 10% to 45% by weight, and more preferably from 20% to 40% by weight, relative to the total weight of the composition. The combination of teachings fails to teach the recited the amount of the (b-1) oil(s) in the composition is from 1% to 50% by weight, preferably from 10% to 45% by weight, and more preferably from 20% to 40% by weight, relative to the total weight of the composition. However, INCI teaches the composition comprising cocos nucifera (coconut) oil, macadamia ternifolia seed oil (ingredients overview). In addition, Meier teaches the general chitosan/water/oil cosmetic emulsion system, and identifies stability issue that arise form interactions among chitosan, emulsifiers, and emulsified oils or lipids (3 rd paragraph on page 5, and 11 th paragraph on page 13 of Meier’s specification). Thus, the precise amount of oil or lipophilic components is a result effective variable because it affect emollience, viscosity, spread-ability, skin feel, phase stability, compatibility, between the aqueous chitosan phase and the oil phase and film behavior. Because INCI already discloses multiple plant oils in a cosmetic cream and Meier teaches that oil/lipid components affect the stability and appearance of chitosan containing emulsions, a person of ordinary skill in the art would have had reason to adjust the oil amount to obtain a workable cosmetic cream having acceptable stability, appearance, and skin feel. Accordingly, under MPEP 2144.05 and absent a showing of criticality or unexpected results for the specifically claimed the precise amounts of oils, selecting a plants oil type or cosmetic emulsion system based on these result effective variables would have involved no more than routine experimentation. With respect to claims 10, 12, and 13 , the claims recite that the (b-2) fatty acid is selected from C 4 -C 22 , preferably C 6 -C 20 , more preferably C 8 -C 18 saturated and unsaturated, linear or branched fatty acids, and the composition comprises an (a) aqueous phase comprising the (a-1) cationic polymer, the (a-2) monovalent non-polymeric acid or a salt thereof, and the (a-3) water and (b) fatty phases comprising the (b-1) oil, and the (b-2) fatty acid. INCI teaches that the single cosmetic product, Chitocare Face Cream, comprising aqua, glycine soja (soybean) oil, sodium lactate, cocos nucifera (coconut) oil, macadamia ternifolia seed oil, lactic acid, and chitosan (ingredients overview). INCI further teaches a glycine soja (soybean) oil that contains 48-59% barrier-repairing linoleic acid, 17-30% nourishing oleic acid and also some (4.5-11%) potentially anti-inflammatory linolenic acid (glycine soja (soybean) oil section). Oleic acid is C18 monounsaturated omega-9 fatty acid. Moreover, Shipovskaya teaches a related chitosan containing cosmetic skin care hydrogel comprising low molecular weight chitosan/lactic acid/aminocaproic acid /water, and further evidences the suitability of carboxylic acid containing additives in chitosan/lactic acid/water skincare compositions (claims 1-2). Meier teaches chitosan containing oil/lipid emulsion systems and identifies issue caused by interactions among chitosan, emulsifiers, and emulsified oils or lipids (page 12, (3 rd paragraph on page 5, and 11 th paragraph on page 13 of Meier’s specification). It would have been obvious to provide the plant oils and fatty acid containing lipophilic materials in a fatty phase in combination with an aqueous phase with chitosan/lactic acid/water. Such an arrangement is consistent with ordinary cosmetic emulsion formulation practice and is further supported by Meier’s teaching. The same rationale discussed with respect to independent claim 1 applies to claims 10, 12, and 13. With respect to claim 11 , the claim recites the amount of the (b-2) fatty acid(s) in the composition is from 0.01% to 15% by weight, preferably from 0.05% to 10% by weight, and more preferably from 0.1% to 5% by weight, relative to the total weight of the composition. The combinations of teachings fail to teach the recited the total weight of the (b-2) fatty acid (s) in the composition. However, the fatty acid limitation is primarily taught by the fatty acid containing plant oils disclosed in INCI, as discussed above. The amount of fatty acid containing components would have been a results effective variable in view if INCI and Meier because such components affect oil loading, emulsion stability, compatibility between the aqueous chitosan phase and the oil phase, viscosity, skin feel, spread-ability, and film behavior (3 rd paragraph on page 5, and 11 th paragraph on page 13 of Meier’s specification). MPEP 2144.05 states that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges by routine experimentation is ordinarily obvious, particularly where the variable is recognized as result effective. Accordingly, INCI discloses the use of plant oils containing fatty acid components in a chitosan containing cosmetic cream, and Meier identifies oil/lipid emulsion stability as a relevant formulation issue in chitosan containing systems. Thus, selecting a fatty acid containing component amount within the claimed range would have been a routine optimization of a results effective formulation variable, absent a showing of criticality or unexpected results. With respect to claim 14 , the claim recites that a cosmetic process for a keratin substance such as skin, comprising: applying to the keratin substance the composition according to Claims 1 and drying the composition to form a cosmetic film on the keratin substance. INCI teaches the prior art product is a face cream for moisturizer and is therefore intended for application to facial skin. Moreover, Shipovskaya teaches cosmetic skin care using a chitosan containing hydrogel and identifies skin care benefits including skin moisture increase, wrinkle reduction, and lifting effect (abstract). In view of the chitosan containing skincare compositions of INCI and Shipovskaya, and the ordinary drying of water containing topical compositions after application to skin, it would have been obvious that applying the composition to skin and allowing water or other volatile components to evaporate would leave a residue or film comprising chitosan and nonvolatile components on the skin. It would have been obvious to apply the product of INCI to skin and allow it to remain or dry to form a cosmetic film, and the same rationale discussed with respect to independent claim 1 applies to claim 14. With respect to claims 2 and 15 , the claims recite that the cationic polymer is hydrophobicized by the fatty acid, and a use of (b-2) at least one fatty acid in a composition, comprising: (a-1) at least one cationic polymer; (a-2) at least one monovalent non-polymeric acid or a salt thereof; (a-3) water; and (b-1) at least one oil, in order to increase the amount of the (b-1) oil in the composition to be 1% by weight or more, preferably 10% by weight or more, and more preferably 20% by weight or more, relative to the total weight of the composition. INCI teaches a cosmetic composition containing chitosan, lactic acid/lactate, water, and plant oils that containing fatty acids (ingredients overview). Shipovskaya teaches that a related chitosan containing cosmetic skin care hydrogel comprising low molecular weight chitosan/lactic acid/aminocaproic acid (i.e., omega-amino fatty acid)/water (claims 1-2, and abstract). Meier teaches that chitosan containing emulsions can suffer from instability, turbidity, phase separation, and water deposits due to interactions between chitosan, emulsifiers, and emulsified oils or lipids (3 rd paragraph on page 5, and 11 th paragraph on page 13 of Meier’s specification). It would have been obvious to adjust fatty acid containing lipophilic components and their interaction with the chitosan containing aqueous phase to improve compatibility between the aqueous phase and oil phase and to support higher oil loading while maintaining emulsion stability. The motivation would have been to reduce phase separation, turbidity and water separation, improve cosmetic appearance, and maintain acceptable skin feel and film behavior. In this context, hydrophobic association between the chitosan containing phase and fatty/oil phase components would have been a predictable formulation strategy. (see MPEP 2143) In addition, the amount of the (b-1) oil in the composition is result effective variables routinely adjusted to balance solubility, emulsion stability, and emulsification performance. Selecting specific component and values within disclosed workable ranges to produce a stable formulation would have constituted routine optimization. (see MPEP 2144.05) Accordingly, optimization of result effective variable, such as component elements, and concentration, thorough routine experimentation does not confer patentability. Furthermore, where the claimed elements and concentration ranges represent selection from known prior art components used for their known purposes, the claimed subject matter is obvious when the combination yields predictable results. Conclusion Claims 1-15 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SEONG JONG KIM/ Examiner, Art Unit 1621 /CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621 Application/Control Number: 18/721,076 Page 2 Art Unit: 1621 Application/Control Number: 18/721,076 Page 3 Art Unit: 1621 Application/Control Number: 18/721,076 Page 4 Art Unit: 1621 Application/Control Number: 18/721,076 Page 5 Art Unit: 1621 Application/Control Number: 18/721,076 Page 6 Art Unit: 1621 Application/Control Number: 18/721,076 Page 7 Art Unit: 1621 Application/Control Number: 18/721,076 Page 8 Art Unit: 1621 Application/Control Number: 18/721,076 Page 9 Art Unit: 1621 Application/Control Number: 18/721,076 Page 10 Art Unit: 1621 Application/Control Number: 18/721,076 Page 11 Art Unit: 1621 Application/Control Number: 18/721,076 Page 12 Art Unit: 1621 Application/Control Number: 18/721,076 Page 13 Art Unit: 1621 Application/Control Number: 18/721,076 Page 14 Art Unit: 1621 Application/Control Number: 18/721,076 Page 15 Art Unit: 1621 Application/Control Number: 18/721,076 Page 16 Art Unit: 1621 Application/Control Number: 18/721,076 Page 17 Art Unit: 1621 Application/Control Number: 18/721,076 Page 18 Art Unit: 1621 Application/Control Number: 18/721,076 Page 19 Art Unit: 1621 Application/Control Number: 18/721,076 Page 20 Art Unit: 1621 Application/Control Number: 18/721,076 Page 21 Art Unit: 1621 Application/Control Number: 18/721,076 Page 22 Art Unit: 1621
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