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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 20, 2023, November 29, 2024, January 9, 2025, May 8, 2025, May 15, 2025, July 17, 2025, and September 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner, except for the following references.
Non-patent literature documents 26, 27, and 28 from IDS dated September 20, 2023 are not in English, and accordingly have not been considered by the Examiner (MPEP 609.04(a)).
Claim Status
Claims 1 – 13 are examined here-in.
Claim Objections
Claim 12 is objected to because of the following informalities:
The last line of claim 12 recites “wherein the composition does not a cationic surfactant”, which appears to be missing a linking verb “have” or “include” or “comprise” to read “wherein the composition does not comprise a cationic surfactant”.
Appropriate correction is required.
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, 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 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 non-obviousness.
Claims 1 – 3 and 5 – 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (US 2021/0212908 A1) in view of Larm (US 2006/0057168 A1).
Hernandez teaches compositions for application to the skin, methods for their formulation, and methods for their use (abstract).
Hernandez teaches compositions for topical formulations should include a solvent system that enable transdermal delivery of active agents (paragraphs 0002 – 0003). Hernandez teaches that dermatological formulations often use either a) strong solvents that cause disruption to the skin barrier, requiring other treatments, or b) mild solvents which are ineffective in delivery of active agents (paragraph 0003). Hernandez teaches a solvent system which maintains product stability for active agents and antioxidants, while also promoting efficiency and delivery of the active agents (paragraphs 0012, 0037, 0067).
Hernandez a solvent system that includes a non-ionic surfactant in an amount ranging from 1 to 40% by weight (paragraphs 0012, 0062). Hernandez teaches polyglyceryl esters as non-ionic surfactants (paragraphs 0014, 0061).
Hernandez teaches the solvent system includes a polyol, such as dipropylene glycol in the amount of 10 to 90% by weight (paragraphs 0054 - 0055). Hernandez teaches that polyols also have the benefit of holding water in the skin and creating a smooth film over the skin surfaces (paragraph 0054).
Hernandez teaches ferulic acid, ascorbic acid, and tocopherol are antioxidants that may be included in the composition (paragraphs 0079, 0126, 0127, claim 8). Hernandez teaches that antioxidants are anti-inflammatory and provide skin soothing, protection, anti-irritant, and repair activity (paragraph 0038).
Hernandez teaches that ethoxylated fatty alcohols are suitable emulsifiers for inclusion in the composition (paragraph 0118).
Hernandez teaches that the formulation may form an anhydrous micro-emulsion (paragraph 0053).
Hernandez does not teach an HLB value greater than 13 for the polyglyceryl fatty acid ester non-ionic surfactant.
Larm teaches a missing element of Hernandez.
Larm teaches a microemulsion composition for dermal delivery of an active ingredient (abstract).
Larm teaches that consideration of the HLB value of a surfactant helps determine an appropriate non-ionic surfactant for the desired microemulsion system (paragraphs 0010 – 0011). Larm teaches the HLB number for the surfactants included in the composition should be between 8 and 15 (paragraphs 0039, 0064).
Larm teaches polyglyceryl esters are suitable coupling agents for inclusion in the composition that help to improve the miscibility of oils and promote clarity of the composition (paragraphs 0085, 0124).
Larm teaches that ethoxylated fatty alcohols are a popular non-ionic emulsifier (paragraph 0127). Larm teaches that the degree of ethoxylation has a greater impact than chain length in the assembly of a microemulsion (paragraph 0127). Larm teaches ceteareth-12, -20, -30, oleyth-10, laureth-4, -23, and steareth-4 as examples of alkoxylated alcohols that act as non-ionic surfactants (paragraph 0129). Larm teaches surfactants should be included in an amount of at least 1.8% w/w (paragraph 0130)
Larm teaches polyols are a solvent for poorly soluble active ingredients (paragraph 0076). Larm teaches propylene glycol is commonly used because it acts as a penetration enhancer (paragraph 0077). Larm teaches that propylene glycol can be included in up to 50% w/w (paragraph 0078).
Claims 1 – 3 and 5 – 12 are rendered prima facie obvious over the combination of Hernandez and Larm because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., active agents, non-ionic surfactants, dipropylene glycol) were known in the prior art (e.g., cosmetic compositions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a cosmetic composition comprising an active agent, non-ionic surfactant, and dipropylene glycol) to one of ordinary skill in the art (MPEP 2143(i)(a)). A person of ordinary skill in the art would have been motivated to include Larm’s teachings for an appropriate HLB value with Hernandez’s composition because Larm teaches that the HLB value of a surfactant is an important consideration for formulating a microemulsion system (paragraph 0010).
The combination of Hernandez’s teaching for an anhydrous formulation that includes an antioxidant, a non-ionic surfactant, an ethoxylated fatty alcohol, and dipropylene glycol (paragraphs 0012, 0053, 0054, 0062, 0079, 0118, 0126, 0127, claim 8) with Larm’s teachings that the surfactant should have an HLB value between 8 and 15 (paragraphs 0039, 0064) reads on instant claim 1. Larm’s teaching for an HLB value between 8 and 15 (paragraphs 0039, 0064) overlaps on the instantly claimed HLB value of “no less than 13” recited in claim 1. Claimed ranges that overlap with teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Hernandez’s teaching the antioxidant is ferulic acid, ascorbic acid, or tocopherol (paragraphs 0079, 0126, 0127, claim 8) reads on instant claim 2.
Hernandez teaches polyglyceryl fatty acid esters are fatty acid esters of polyglycerin with n ethoxy groups, teaching 2 and 4 as examples for n and caprate and isostearate as examples of fatty acids (paragraph 0113). Caprate has 10 carbons and isostearate has 18 carbons. Therefore, Hernandez’s teaching for 2 to 4 ethoxy groups and 10 or 18 carbon atoms overlaps on the instantly claimed ranges of mono-, di-, or tri-esters and 8 to 12 carbon atoms recited in claim 3. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Hernandez’s teaching for ethoxylated fatty alcohols such as ceteareth-n (paragraph 0118) reads on instant claim 5. Ceteareth refers to a C16-18 carbon chain, which overlaps on the instantly claimed C14 – C22 recited in claim 5.
Larm’s teaching for an ethoxylated fatty alcohol such as ceteareth-12, -20, -30, oleyth-10, laureth-4, -23, and steareth-4 (paragraph 0129) reads on instant claim 6. Ceteareth-12, -20, -30, oleyth-10, laureth-4, -23, and steareth-4 each have between 1 and 40 ethylene oxide units, falling within the claimed range recited in claim 6. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Hernandez’s teaching for a non-ionic surfactant, which may be a polyglyceryl ester, in an amount ranging from 1 to 40% by weight (paragraphs 0012, 0014, 0061, 0062) overlaps on the instantly claimed range of 0.5 to 10 wt. % recited in claim 7.
Larm’s teaching that ethoxylated fatty alcohols are a popular non-ionic surfactant and that surfactants should be included in an amount of at least 1.8% w/w (paragraphs 0127, 0130) overlaps on the instantly claimed range of 1 to 10 wt. % recited in claim 8.
Hernandez’s teaching for dipropylene glycol in the amount of 10 to 90% by weight (paragraphs 0054 - 0055) overlaps on the instantly claimed range of 5 to 30 wt. % recited in claim 9.
Larm’s teaching to include propylene glycol to help solubilize poorly soluble ingredients and to act as a penetration enhancer in an amount of up to 50% w/w (paragraphs 0076 – 0078) reads on instant claims 10 and 11. Propylene glycol in an amount of up to 50% w/w (paragraph 0078) overlaps on the instantly claimed range of 1 to 50 wt. % recited in claim 11. A person of ordinary skill in the art would be motivated to include propylene glycol as taught by Larm because Larm teaches that propylene glycol is an effective penetration enhancer (paragraph 0077). Therefore, a person of ordinary skill in the art would expect the combination of Hernandez and Larm to yield a microemulsion suitable for application to the skin that has favorable delivery of active ingredients to the skin.
Hernandez’s teaching for an anhydrous formulation that includes an antioxidant which may be ferulic acid, ascorbic acid, or tocopherol, a non-ionic surfactant in the amount of 1 to 40% by weight, and dipropylene glycol in the amount of 10 to 90% by weight (paragraphs 0012, 0014, 0053 – 0055, 0061, 0062, 0079, 0118, 0126, 0127, claim 8) reads on instant claim 12. Non-ionic surfactant in the amount of 1 to 40% by weight and dipropylene glycol in the amount of 10 to 90% by weight overlaps on the instantly claimed amounts of 1 to 4 wt. % and 5 to 20 wt. %, respectively. Claimed ranges that overlap with teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (as cited above) and Larm (as cited above) and further in view of Matsuzawa (US 2014/0227217 A1).
Hernandez and Larm’s teachings are discussed above.
The combination of Hernandez and Larm does not teach the polyglyceryl fatty acid ester is a polyglyceryl caprylate with a polyglyceryl moiety derived from 2 to 10 glyceryl units.
Matsuzawa teaches a missing element of the combination of Hernandez and Larm.
Matsuzawa teaches a cosmetic composition which includes a polyglyceryl fatty acid ester (abstract).
Matsuzawa teaches that the carbon chain on polyglycerol fatty acid esters impacts characteristics (paragraphs 0037 – 0039). Specifically, Matsuzawa teaches that a carbon chain of 5 or fewer carbon atoms tends to cause skin irritancy and that a carbon chain with 31 or more carbon atoms has low water solubility (paragraphs 0037 – 0038). Matsuzawa teaches that caprylic acid is a suitable fatty acid for esterification with a polyglycerol (paragraph 0038).
Matsuzawa teaches that the degree of polymerization for polyglycerols should be between 3 and 50 (paragraph 0042). Matsuzawa teaches polyglyceryl caprylate with a degree of polymerization between 3 and 10 is a preferred polyglycerol fatty acid ester (paragraph 0055).
The combination of Hernandez, Larm, and Matsuzawa’s teachings renders claim 4 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to modify the composition of Hernandez and Larm with Matsuzawa’s teachings to include polyglyceryl caprylate specifically because Matsuzawa teaches polyglyceryl caprylate has a suitable carbon chain length and degree of polymerization to optimize compound properties (paragraphs 0037 – 0039, 0042, 0055). Therefore, a person of ordinary skill in the art would expect the combination of Hernandez, Larm, and Matsuzawa to yield a cosmetic microemulsion suitable for application to the skin.
The combination of Hernandez’s teaching for an anhydrous formulation that includes an antioxidant, a polyglyceryl fatty acid ester non-ionic surfactant, and dipropylene glycol (paragraphs 0012, 0053, 0054, 0062, 0079, 0118, 0126, 0127, claim 8) with Larm’s teachings that the surfactant should have an HLB value between 8 and 15 (paragraphs 0039, 0064), and further combined with Matsuzawa’s teaching for polyglyceryl caprylate with a degree of polymerization between 2 and 10 as polyglyceryl fatty acid ester (paragraph 0055) reads on instant claim 4. Matsuzawa’s teaching for a dree of polymerization between 2 and 10 overlaps on the instantly claimed 2 to 10 glycerol units recited in claim 4. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (as cited above) and Larm (as cited above) and further in view of Speaker (WO 2020/065541 A1).
Hernandez and Larm’s teachings are discussed above.
The combination of Hernandez and Larm does not teach a process for caring for keratin materials by i) mixing an anhydrous composition and water or a hydrous system to form a microemulsion, and ii) applying the microemulsion to the keratin materials.
Speaker teaches a missing element of the combination of Hernandez and Larm.
Speaker teaches a composition which comprises an oil and a surfactant, that may also be mixed with an aqueous phase to make a microemulsion (abstract, claims 92, 93, 179 – 181). Speaker teaches the oil and surfactant are mixed with the aqueous phase to form a microemulsion (claims 92, 93, 179 – 181).
Speaker teaches the microemulsion composition is for application to the skin, and that the microemulsion composition provides excellent skin feel and lubricity (paragraph 0202). Speaker teaches that the sub-micron dimensions of oil droplets in microemulsions enables the composition to penetrate pores or follicles more efficiently than larger droplets (paragraph 0211).
The combination of Hernandez, Larm, and Speaker’s teachings renders claim 13 prima facie obvious as according to MPEP 2143(i)(g). A person of ordinary skill in the art would be motivated to apply Speaker’s teachings to combine an oil, surfactant, and an aqueous phase to form a microemulsion to Hernandez and Larm’s teachings for a microemulsion composition because the formulations components overlap, and Speaker teaches the sub-micron dimensions of microemulsions enables better penetration of the composition to the skin (paragraph 0211).
The combination of Hernandez’s teaching for an anhydrous formulation that includes an antioxidant, a non-ionic surfactant, and dipropylene glycol (paragraphs 0012, 0053, 0054, 0062, 0079, 0118, 0126, 0127, claim 8) with Larm’s teachings that the surfactant should have an HLB value between 8 and 15 (paragraphs 0039, 0064) and further combined with Speaker’s teaching to mix oil, surfactant, and an aqueous phase to form a microemulsion (claims 92, 93, 179 – 181) reads on claim 13. Furthermore, Speaker teaches the microemulsion composition is then applied to the skin (paragraphs 0202, 0211), reading on instant claim 13.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612