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 .
DETAILED ACTION
Status of the Claims
Claims 1-4, 6, 8, 11, 13-15, 22 and 24-28 are pending. Claims 5, 7, 9-10, 12, 16-21 and 23 have been canceled. Claims 1, 6, and 13 have been amended. Claims included in the prosecution are claims 1-4, 6, 8, 11, 13-15, 22 and 24-28.
Information Disclosure Statement
The Information Disclosure Statement submitted 07/19/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this IDS has been considered by the Examiner.
Withdrawn Objections/Rejections
The objection to claim 13 is withdrawn.
In light of the new amendments and/or upon further consideration, the rejection of claims under 35 U.S.C. § as being are withdrawn.
New Rejections
Applicants’ amendments have necessitated the following grounds of rejection:
Claim Objections
Claim 27 is objected to because of the following informalities: the phrase “comprising chosen” in the first line of element c) appears to need rewording. 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 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.
Claims 1-4, 8, 11, 14, 15, and 24-26 are rejected under 35 U.S.C. § 103 as being unpatentable over Gujraty et al. (US 20170367957 A1) in view of Pham (WO 2013049599 A2) evidenced by Lubrizol (Lubrizol/Personal-Care/Documents/ Technical-Papers-and-Posters/MakeItSimple_Poster_DEC2012.pdf).
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). The teaching of niacinamide reads on element e) of claim 1. The requirement of element d) of claim 1 is met with Gujarty’s teaching 2-hexyldecanol (at 0.01-10% as mentioned above) to read on the recited “from about 0.1% to about 10% of a fatty alcohol comprising hexyldecanol.”
As Gujraty teaches Pemulen at 0.2 (%) in cosmetic compositions set forth in Table 6 that were prepared in the same manner as Example 2 (see paragraph [0095] and [0092]). With evidence from Lubrizol, Pemulen is acrylate/C10-30 alkyl acrylate cross polymers (Lubrizol, page 1, para. 1). Here the prior art reads on element b) of claim 1 which requires about 0.01% to 1% by weight rheological component chosen from the same acrylate/C10-30 alkyl acrylate species.
With respect to the emulsion aspect recited in element f) of claim 1, Gujraty’s general descriptions of the chassis (i.e., base formulation or carrier system) used in the permeation experiments include oil-in-water (O/W) emulsions and water gels ([0083], Table 4). Gujraty’s composition has about 1% to about 95% by weight of one or more oils and from about 1% to about 95% by weight of water ([0053]). Particularly as emulsion the composition has from about 0.05% to about 20% emulsifier ([0062]). Emulsifiers suited for the composition include ethers of C12-30 fatty alcohols comprising and of sucrose or of glucose, esters of sucrose and of C12-30 fatty acids ([0063]). With respect to the stearic acid (emulsifier) of the claims, to reiterate, Gujraty teaches isostearic acid (i.e., stearic derivative) as an emulsifier and penetration enhancer ([0033], [0039], claim 1) and therefore reads on element c) of claim 1.
Gujraty focuses on improved emulsion stability of cosmetic compositions and the teachings therein are directed to achieving such compositions. Gujraty teaches lipid bilayer structurant between about 0.05% and 3% (paragraph [0051]), having a carbon chain length of C14 or more (claim 3), includes fatty alcohol (e.g., batyl alcohol, see claim 5 and 6). Gujraty provides 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; and may comprise from about 0.0001 % to about 25% by weight of the cosmetic composition, of one or more structuring agents ([0066]).
Gujraty discloses laurates, hexyl laurate and isohexyl laurate as esters with hydrocarbyl chains derived from fatty acids or alcohols to serve as a suitable oil ([0059], [0053] see from about 0.1% to about 90%).
Gujraty differs from the claimed invention insofar as not clearly teaching element a) of claim 1.
However, 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 (page 2, lines 5-7; claim 1, 11). Pham teaches personal care composition for topical application to the skin or hair to include lotions and face creams (page 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 that includes sucrose dilaurate and sucrose laurate (page 5, lines 7-11; claim 2).
Pham teaches vitamin B3 niacinamide from about 0.001% to about 20% by weight of the composition (page 6, lines 10-12; claim 6). Formulations (I.-IX.) show a sucrose ester present (0.5% to 2.0%) in an oil-in-water emulsion (page 14). Glycerin is mixed with xanthan (rheology modifier) at 1.60% for each of the examples provided (page 14).
Regarding claim 4 (3:1 – 3:2) and sucrose laurate/dilaurate of the claims, the term "emulsifier system" of Pham refers to the combination of both the sucrose fatty acid ester and nonionic surfactant (page 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. Pham does not explicitly teach sucrose laurate and sucrose dilaurate in this ratio. However, it would have been obvious for one of ordinary skill in the art to be directed to substitute the sucrose stearate with sucrose laurate and substitute the methyl glucose sesquisterate with sucrose dilaurate. One would be motivated to make these substitutions because Pham discloses an emulsifier system having a hydrophile-lipophile balance (HLB) of 1.5 to 13.0 (page 5, line 31). HLB values for commonly used surfactants are readily available in the literature and are well known in the art (page 6, lines 5-7). One of ordinary skill in the art would distinguish the HLB value for sucrose stearate as being considerably higher than that of methyl glucose sesquisterate. Thus, 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 is considered to be a suitable ingredient of lower HLB value. Therefore, 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 thereby obtaining an improvement in 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 because Pham attributes the emulsifier system consisting of at least one sucrose fatty acid ester (e.g., sucrose dilaurate, sucrose dilaurate) and the ratios thereof to providing the surprising result of achieving the desired “low-soaping effect” without having silicone or dimethicone present (page 5, 12). This surprising result would thereby improve upon the art without a clear showing of evidence to the contrary. A skilled artisan would know that the nonionic surfactant of Pham indicates a sugar derived emulsifier and thus 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]).
With respect to the instability index value limitations of instant claims 2-3, and 15, these are not provided per se but 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 contribute to the patentability of the claims. In other words just 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 8, while Gujraty mentions linear or branched type silicone emulsifiers may also be used and identifies polyether modified silicones in paragraph ([0064]), Gujraty does not make them a requirement. 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) to read on the limitation.
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 (i.e.,, Gujraty (claims 12-13) and Pham (page 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, 13, 22, and 27-28 are rejected under 35 U.S.C. § 103 as being unpatentable over Gujraty and Pham evidenced by Lubrizol above, further in view of Ikeda et al. (US 20170087064 B2) evidenced by Making Cosmetics (https://www.makingcosmetics.com/Z-EMF-STEARETH21-01-16000.html?lang=en_US).
The teachings of Gujraty and Pham as evidenced by Lubrizol above are incorporated herein. Gujraty and Pham do not teach steareth-2/-21, or PEG-100 stearate; serum/essence.
Ikeda discloses a cosmetic composition comprising at least one oil; at least one polyglyceryl fatty acid ester, preferably with a polyglyceryl moiety derived from 2 to 6 glycerin; at least one compound selected from the group consisting of resorcinol and resorcinol derivatives; and water (abstract, claim 21). Ikeda provides examples of nano- or micro-emulsion form or lamellar structure or have a lamellar phase with improved transparency and stability ([0517] see Examples, claim 22). 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 (claim 25).
Regarding claims 6 and 13, Gujraty discloses stearic derived fatty acids (claim 5) that share primary functions as the species recited of instant claim 6. Ikeda discloses “(CTFA name: Steareth-2” in paragraph [0366] (“Brij 72”)to read on the limitation. Ikeda teaches polyglyceryl monooleate ([0016], [0521] polyglyceryl-5 oleate) to overlap with the glyceryl monooleate disclosed in claims 5 and 7 of Gujraty.
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 the 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) and Pham teaches lotions and face creams (page 3, lines 6-7). As taught in Ikeda, oil-in-water (O/W) or water-in-oil (W/O) emulsions are well known in the field of cosmetics and dermatology, particularly in the preparation of cosmetic products, such as serums ([0081], [0083]) to meet the limitation of claim 22. Ikeda provides a composition with better transparency and can be used for cosmetics such as a lotion and a serum ([0074], [0081]-[0083]).
Regarding claim 27, i.e., about 0.1% to about 3% by weight of a sucrose ester, as mentioned above, Pham provides example formulations (I.-IX.) in which a sucrose ester is present (0.5% to 2.0%) in an oil-in-water emulsion (page 14). Regarding the about 0.5% to about 5% by weight of a non-ionic emulsifier system (e.g., steareth-2), as mentioned above Gujraty discloses as emulsion the composition has from about 0.05% to about 20% emulsifier ([0062]). Ikeda discloses Steareth-2” in paragraph [0366] and polyglyceryl monooleate ([0016], [0521] polyglyceryl-5 oleate) to overlap with the glyceryl monooleate disclosed in claims 5 and 7 of Gujraty. It would be obvious for one skilled in the art to incorporate the steareth-2 taught by Ikeda at or within the claimed range because given taught and known HLB values in the prior art could reasonably expect an improvement in the ability to improve upon the stability of the emulsion. For instance Ikeda provides HLB values in the examples that reflect the disclosure of different HLB values in claim 25 and provide amounts at about 5% by weight (e.g., Example 5 of Ikeda, Table 7). Evidence from Making Cosmetics shows that the recommended use level for steareth-21 is 1-5% in emulsions for skin and hair care products (see page 1). 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 attributes the stability of the systems by the “crown of the (b) polyglyceryl fatty acid ester” ([0502]) and thereby contributes to the art, absent a clear showing of evidence to the contrary.
Regarding claim 28, instability index value limitations are not provided per se but the prior art clearly teaches 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 contribute to the patentability of the claims. In other words just 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.
For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Response to Arguments
Applicants’ arguments have been fully considered but they are not persuasive.
Applicants argue that based on the instability index going from 0.3% to 14.4% with the introduction of 1% sucrose ester in a base formula. Applicants argue that the composition of claim 27 overcomes this instability with the 0.1% to about 3% sucrose laurate and sucrose dilaurate blend, the 0.01-1% rheology modifier, and 0.5%-5% non-ionic emulsifier system with PEG-100 stearate, glycereth-25, steareth-2/-21. Applicants argue that the hydrophobically modified rheology modifier and stearic acid derivative emulsifier is what unexpectedly suitably stabilized the emulsion. Applicants argue that with Gujraty and Pham an unstable emulsion would be created.
The Examiner respectfully disagrees and asserts that these ingredients are well known and widely used in the art. With respect to the results of achieve “suitable stability” by applicants, such adjustments in amounts and HLB balance is well within the purview of a person of ordinary skill in this art. Pham discloses an emulsifier system having a hydrophile-lipophile balance (HLB) of 1.5 to 13.0 (page 5, line 31). HLB values for commonly used surfactants are readily available in the literature and are well known in the art (page 6, lines 5-7). Importantly "emulsifier system" of Pham refers to the combination of both the sucrose fatty acid ester and nonionic surfactant (page 5, lines 22-30). Pham’s teaching of emulsifier system ratio of non-ionic surfactant and sucrose FA ester leading to surprising results albeit not the same unexpected “suitably stabilized” emulsion of the instant disclosure, nevertheless, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Ikeda teaches Steareth-2 and is focused on HLB balance. The cited prior art teaches the structure of the claimed invention and as such one skilled in the art would reasonably expect the suitable stability observed by applicants.
Further, the current record does not support a finding that the specific combination and amounts as applicants argued from instant claim 27 is critical. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990). See MPEP § 716.02 - § 716.02(g).
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
All claims under consideration remain rejected; no claims are allowed. Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no case, 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 Karen A. Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached M-F, 9-5.
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/Karen A Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
