DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/11/2026 has been entered.
Election/Restrictions
Claims 15 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/26/2022.
Response to Arguments
All of Applicants’ arguments and the declaration of Matthew Ehrman filed 11/19/2025 have been fully considered and are not persuasive for the reasons discussed below.
Applicant remarks that the newly filed data demonstrates that all the tested compositions have the same buffer capacity thus addressing the examiner’s comments that proper side-by-side comparisons were not presented.
The examiner would like to thank Applicant for the data presented in the new dec as it resolved the concern previously noted by the Examiner regarding proper side-by-side comparisons. However, Applicant has not addressed the examiner’s comments regarding the data not being commensurate in scope with the instant claims. The data is not commensurate in scope with the instant claim as a single data point (e.g. one single species of thickener and vitamin B3 compound in a single concentration) was presented and Applicant has not established a trend in the data showing that all compositions falling within the claimed genus would have the same effect. It is also noted that the data lacks a nexus the claimed invention. The data presented has a multitude of additional ingredients not required by the instant claims.
With regards to the DP rejection(s), as Applicant has not addressed the merits of the rejection(s), the double patenting rejection(s) is/are maintained for the reasons of record.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Claim 1 recite “pH of the composition from about…”, it should recite “pH of the composition is from about…”.
Claim 3 recites “Opacity” it should be “opacity”.
Appropriate correction is required.
Maintained/Modified 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 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 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.
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.
Claim(s) 1, 9-13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baca (US2018/0271760), KR20190038028, KR20120042280 and Richard (US 2012/0201767).
Baca discloses a skin care composition comprising one or more alpha hydroxy acids (AHAs), one or more salts of alpha hydroxyl acids, one or more tretinoin, retinols or retinol-like compounds,
and niacinamide or hydroquinone (Abs).
Regarding claims 1d and 11-12: Baca teaches the skin care composition to have a pH ranging from about 4 to about 6.5, this overlaps with the claimed “less than 4” as this embraces 3.99 and “about 4” embraces amounts slightly lower and higher than 4. In the alternative, Baca teaches a pH of 4 and the claimed “less than 4” embraces 3.99 and a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close and are expected to have similar properties absent factual evidence to the contrary.
Regarding claim 21: Baca teaches the skin care composition to have a pH ranging from about 4 to about 6.5, this embraces amounts slightly lower and higher than 4 such as about 3.8, which embraces amounts higher than 3.8. In the alternative, Baca teaches a pH of 4 and the claimed “about 3.8” a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close and are expected to have similar properties absent factual evidence to the contrary.
Regarding claim 1a and 10: Baca teaches the niacinamide to be used in amounts ranging from 0.5-5%. The niacinamide reduces transepidermal water loss and stimulates the brightening or clearing of the skin [0032].
Table 1 of Baca teaches exemplary compositions to comprise:
-- 1-5% niacinamide – reading on instant claims 1a and 10;
-- 1-5% polyacrylate-13 – Baca teaches that thickening agents can be effectively added and KR’028 demonstrates that polyacrylate-13 is water-based thickener for a cosmetics for topical application to skin (pg. 2 and 5) and KR’280 teaches that polyacrylate-13 is a copolymer formed with acryloyldimethyltaurate monomers (Abs);
-- 5-10% sodium lactate (salt of AHAs);
--less than 1% lactic acid – Baca also teaches that lactic acid can be used in amounts ranging from 0-30% [0017].
While in table 1 Baca exemplifies the use of lactic acid and lactate, Baca teaches preferred AHAs to include lactic acid and gluconic acid and these are used in amounts ranging from 0.05-30% [0027]. Baca further teaches that salts of AHAs act as humectants to bind and hold water in the stratum corneum and are natural moisturizers. Salts of AHAs include glycolate and lactate [0029]. Baca teaches gluconic acid and gluconate to be equivalent AHAs and salt of AHAs to lactic acid and lactate, therefore, the substitution of lactic acid and lactate with gluconic acid and gluconate is prima facie obvious absent evidence to the contrary. While the prior art doesn’t teach sodium gluconate specifically, Baca teaches that sodium forms of the salts of AHAs are suitable for use, therefore, the use of sodium gluconate is prima facie obvious. While Baca doesn’t specifically teach the use of AHAs consisting of gluconic acid and sodium gluconate, Baca teaches the composition to comprise one or more AHA and one or more salts of AHAs, thus the use of one AHA, such as gluconic acid, and the use of one salt of AHA such as sodium gluconate is prima facie obvious.
Regarding claim 9: Baca teaches the composition to comprise additional ingredients to enhance the composition performance, texture, viscosity and spreadability. Additional ingredients include moisturizing agents [0035].
However, the reference does not exemplify a composition having the specific combination of niacinamide, polymeric thickener, gluconic acid and sodium gluconate.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is... a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed ingredients including niacinamide, a polymeric thickener, gluconic acid and sodium gluconate for topical application to the skin from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Regarding the amounts of combination of gluconic acid and sodium gluconate, as discussed about the gluconic acid is taught to be used in amounts of 0-30% and the sodium gluconate in amounts of 5-10%, which provides a range that overlaps with the claimed ranges and overlapping ranges are prima facie obvious.
However, Baca does not teach the composition to comprise sodium polyacryloyldimethyl taurate as recited by instant claims 1 and 22.
Richard teaches cosmetic compositions for application to the skin [0019] and teaches that suitable hydrophilic thickeners suitable for use include Simulgel 800 (CTFA name: sodium polyacyloyldimethyl taurate/polysorbate/sorbitan oleate) [0248].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baca with those of KR’028, KR’280 and Richard and substitute the polyacrylate-13 used in Baca with Simulgel 800 (CTFA name: sodium polyacyloyldimethyl taurate/polysorbate/sorbitan oleate) as these are taught by the prior art to be art recognized equivalents as they are each taught by the prior art to be used for the same purpose, as hydrophilic thickening agents comprising acyloyldimethyl taurate monomer(s) for use in cosmetics for application to skin. One of skill in the art would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
As recognized by MPEP §2144.06, it is prima facie obvious to substitute art-recognized equivalents, and an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Regarding claim 13: Since the composition of the combined prior art comprises the same components in same or similar amounts, the skilled artisan would reasonably expect the same properties to result, absent evidence to the contrary. This is supported by the instant specification that demonstrates that compositions having the claimed buffer system exhibit less than 5% TRPV1 activation.
Claim(s) 1, 2, 9-13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baca (US2018/0271760), KR20190038028, KR20120042280 and Richard (US 2012/0201767), as applied to claims 1, 9-13 and 21-22 above, and further in view of DE202004006865.
As discussed above, the prior art makes obvious the limitations of claims 1, 9-13 and 21-22, however, they do not teach the presence of a silicone emulsifier in the claimed amounts as recited by instant claim 2.
Baca teaches that additional ingredients to enhance the composition performance, texture, viscosity and spreadability can be added and these include emulsifiers [0035].
DE’865 teaches compositions for skin care comprising silicone emulsifiers which can further comprise AHAs. The silicone emulsifier is taught to be used in amounts of 0.5-5%, a preferred emulsifier for use is dimethicone copolyol and is used in amounts of 0.1-2% (DE’865 claims).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baca with those of DE’865. One of skill in the art would have been motivated to add 0.1-2% of dimethicone copolyol as an emulsifier into the composition of Baca as its prima facie obvious to combine prior art elements according to known methods to yield predictable results with a reasonable expectation of success as Baca teaches the emulsifier can be added and DE’865 teaches that dimethicone copolymer can be used in skin care compositions comprising AHAs.
Claim(s) 1, 3-4, 9-13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baca (US2018/0271760), KR20190038028, KR20120042280 and Richard (US 2012/0201767), as applied to claims 1, 9-13 and 21-22 above, and further in view of Tanner (WO 2008/112964).
As discussed above, the prior art makes obvious the limitations of claims 1, 9-13 and 21-22, however, they do not teach the opacity of the composition as required by instant claims 3-4.
Tanner teaches skin care compositions and teaches that skin care compositions can be opaque or translucent. The presence of colorants, insoluble particles, gas bubbles, large internal phase domains, and the like can affect the turbidity/translucency of a skin care composition. Opacity and translucency may be quantitatively determined by the percent transmission. Skin care compositions yielding a percent transmission of greater than or equal to 60% are considered translucent. Skin care composition yielding a percent transmission of less than 60%, 55%, 50%, 40%, or, alternatively, 30% are considered opaque. In one embodiment, the first skin care comprising is translucent and the second skin care composition is opaque.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baca with those of Tanner. As Tanner teaches skin care formulations that can be formulated as translucent or as opaque and teaches the percent transmission to vary, a skilled artisan would have been motivated to formulate the composition in one of these two well-known ways taking into account that the presence of colorants, insoluble particles, gas bubbles, large internal phase domains, and the like can affect the turbidity/translucency of a skin care composition which affects the percent transmission, thus a skilled artisan would have been motivated to monitor the presence of these types of ingredients to ensure the composition has the desired percent transmission (i.e. opacity). One of skill in the art would have a reasonable expectation of success as both Baca and Tanner teach skin care cosmetics.
Claim(s) 1, 5-7, 9-13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baca (US2018/0271760), KR20190038028, KR20120042280 and Richard (US 2012/0201767), as applied to claims 1, 9-13 and 21-22 above, and further in view of Zamyatin (US 2016/0000692) and Jensen (US 6,589,514).
As discussed above, the prior art makes obvious the limitations of claims 1, 9-13 and 21-22, however, they do not teach the composition to comprise an oil that reduces tackiness as recited by instant claims 5-7.
Baca teaches that dimethicone and feel modifiers, like silicone, can be effectively added (Table 1 and [0035]).
Zamyatin teaches cosmetic compositions for application to the skin [0017]. The compositions are taught to comprise an emollient such as <100 cst dimethicone [0005], which overlaps with the claimed “less than 100cst” and “less than 10cst” and overlapping ranges are prima facie obvious absent evidence of criticality. The emollient provides a softening, protecting and soothing effect in the skin surface [0025].
Jensen teaches skin care compositions comprising emollients in amounts ranging from 5-30% (Jensen – claims 1 and 16).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baca with those of Zamyatin and Jensen. One of skill in the art would have been motivated to add 5-30% of an emollient such as >100cst dimethicone to the composition of Baca as Zamyatin teaches that >100cst dimethicone is an emollient that provides softening, protecting and soothing effect in the skin surface and Jensen teaches that emollients are known to be used in cosmetics in amounts ranging from 5-30%. One of skill in the art would have a reasonable expectation of success as Baca teaches that feel modifiers, such as silicones can be added and teaches dimethicone to be a suitable additive for use.
Claim(s) 1, 8, 9-13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baca (US2018/0271760), KR20190038028, KR20120042280 and Richard (US 2012/0201767), as applied to claims 1, 9-13 and 21-22 above, and further in view of Hakozaki (US 2017/0196795).
As discussed above, the prior art makes obvious the limitations of claims 1, 9-13 and 21-22, however, they do not teach the composition to comprise a stable fatty alcohol thickener as recited by instant claim 8.
Hakozaki teaches cosmetic compositions for improving the appearance and barrier function of skin. The composition has a low pH and combine a combination of niacinamide and saccharide (Abs). Hakozaki teaches that thickening agents, such as cetyl alcohol and stearyl alcohol, can be used. These thickening agents are stable at low pH and neutralized thickening agents may not impart the desired thickening or feel properties to the composition at low pH [0040].
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baca with those of Hakozaki. One of skill in the art would have been motivated to add cetyl alcohol and/or stearyl alcohol to the composition of Baca as thickening agents as Hakozaki teaches that these compounds function are stable in low pH conditions and can insure that the composition has the desired thickening and feel properties at a low pH. One of skill in the art would have a reasonable expectation of success as Baca teaches that thickening agents can be effectively added [0035].
Claim(s) 1, 9-13, 14 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baca (US2018/0271760), KR20190038028, KR20120042280 and Richard (US 2012/0201767), as applied to claims 1, 9-13 and 21-22 above, and further in view of EP0134483 and Pereira (US 4,981,948).
As discussed above, the prior art makes obvious the limitations of claims 1, 9-13 and 21-22, however, they do not teach the composition to be an essence and have a viscosity as recited by instant claim 14.
Claim 14 recites “the composition is in the form of an essence,” and the claim requires the composition to have ingredients (a)-(d) and have a viscosity ranging from 1-30,000 cP. Absent a definition in the specification as to what makes a composition an essence, a composition comprising the claimed ingredients (a)-(d) and having a viscosity ranging from 1-30,000 cP will be deemed to read on essence as claimed.
As discussed above, the prior art makes obvious a composition comprising thickening agents.
EP’483 teaches skin care composition and teaches that the amount of water or aqueous carrier to be included in the skin care compositions will vary, depending upon the desired consistency of the final product. By varying the amount of water, thickener and/or amphoteric surfactant present, it is possible to formulate a thick-flowing liquid or lotion, a semi-liquid thick cream, a paste, a stick, a gel, an alcoholic hydrogel, an emulsion, an alcoholic solution or a formulation suitable for use in an aerosol. In any event, the cosmetic composition should be provided in a form which can be uniformly spread on the skin [0037].
EP’483 teaches that preferred lotion formulations typically exhibit a viscosity from about 2000 to 20,000 centipoises (cps) at ambient temperature (approx. 25°C). The preferred facial creams exhibit a viscosity from about 25,000 to 60,000 cps and the heavier creams or pastes show viscosities from 70,000 to 170,000 cps [0050].
Pereira teaches skin cosmetics and teaches that viscosities of up to 2,000 mPas resemble milk, 2000-5000 a thin lotion, 5000-8000 normal pourable lotion and so forth (Col.7, ln. 10-25).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baca with those of EP’483 and Pereira. One of skill in the art would have recognize that the viscosity of the composition Baca could be optimized by varying the concentration of the thickening agents, in order obtain a desired viscosity required to control the topical application of the composition. One of skill in the art would further recognize that the viscosity of the composition is further modified dependent on the final texture of the composition, whether it be a milk, lotion, a facial cream or thicker heavier pastes or creams. Therefore, it would be obvious to modify the amounts of thickening agent to achieve a viscosity ranging from 2000-20,000 cps at 25°C, which reads on the claims 1-30,000 cP. One of skill in the art would have a reasonable expectation of success as both Baca, Pereira and EP’483 teach cosmetic compositions.
Claim(s) 1, 5-13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deckner (US 5,968,528), Baca (US2018/0271760) and Richard (US 2012/0201767).
Regarding claim 1a and 10: Deckner teaches stable skin care composition containing a vitamin B3 compound (particularly niacinamide) which generally improve the quality of the skin, particularly human facial skin (Abs and working examples). The compositions more preferably comprise from about 0.1% to about 10% of the vitamin B3 compound (col. 4, lines 27-35).
Regarding claims 1d, 11-12 and 21: Deckner teaches the compositions are preferably formulated to have a pH of about 10.5 or below, more preferably from about 3 to about 8 (col. 10, lines 11-14). Therefore, it would be within the purview of the skilled artisan to formulate the composition of Deckner having a pH within the claimed ranges, with a reasonable expectation of success.
Regarding claim 1b: Deckner teaches that that organic hydroxy acids such as lactic acid are also useful in the composition in amounts ranging from 0.1-10% and are effective at enhancing the skin appearance (col. 31, lines 1-10). Deckner also teaches lactate salts to be useful in the composition (col. 33, lines 5-10).
However, Deckner does not teach the composition to have gluconic acid and sodium gluconate in the claimed amounts.
Baca discloses a skin care composition comprising one or more alpha hydroxy acids (AHAs), one or more salts of alpha hydroxyl acids, one or more tretinoin, retinols or retinol-like compounds,
and niacinamide or hydroquinone (Abs).
Baca teaches preferred AHAs to include lactic acid and gluconic acid and their derivatives (i.e. salts) these are used in amounts ranging from 0.05-30% and act as wrinkle-smoothers, help clear blemishes, hydrate the skin and lighten pigment spots [0027]. Baca further teaches that salts of AHAs act as humectants to bind and hold water in the stratum corneum and are natural moisturizers. Salts of AHAs include glycolate and lactate [0029].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Deckner with those of Baca. One of skill in the art would have been motivated to use gluconic acid as the organic hydroxy acid in Deckner as this is taught to be equivalent to lactic acid and is effective at enhancing skin appearance. One of skill in the art would have also been motivated to add a salt of AHAs, such as gluconate, as this act as humectants to bind and hold water in the stratum corneum and are natural moisturizers. One of skill in the art would have a reasonable expectation of success as Deckner teaches that organic hydroxy acids include C1-C18 hydroxy acid, preferably C8 or below (gluconate is a C6 hydroxy acid).
Regarding the claimed 0.1-10% of sodium gluconate and gluconic acid, as discussed the prior art teaches amounts that overlap with these ranges. Baca teaches amounts of 0.5-30%.
While the prior art doesn’t teach sodium gluconate specifically, Baca teaches that sodium forms of the salts of AHAs are suitable for use (working examples teach sodium lactate), therefore, the use of sodium gluconate is prima facie obvious.
Regarding claim 1c: Deckner teaches the inclusion of thickening agents in amounts of 0.1-5%, these include carbomers and acrylates/C10-C30 alkyl acrylate crosspolymers (col. 19, lines 35-40 and col. 20, lines 45-55), thus the inclusion of a carbomer is prima facie obvious.
However, Deckner does not teach the composition to comprise sodium polyacryloyldimethyl taurate as recited by instant claims 1 and 22.
Richard teaches cosmetic compositions for application to the skin [0019] and teaches that suitable hydrophilic thickeners suitable for use include carbomers, acrylates/C10-C30 alkyl acrylate copolymers, etc. and Simulgel 800 (CTFA name: sodium polyacyloyldimethyl taurate/polysorbate/sorbitan oleate) [0248].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the above references with those of Richard and substitute the carbomer used in Deckner with Simulgel 800 (CTFA name: sodium polyacyloyldimethyl taurate/polysorbate/sorbitan oleate) as these are taught by the prior art to be art recognized equivalents as they are each taught by the prior art to be used for the same purpose, as thickening agents for use in cosmetics for application to skin. One of skill in the art would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
As recognized by MPEP §2144.06, it is prima facie obvious to substitute art-recognized equivalents, and an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Regarding claims 5-7: Deckner teaches that preferred compositions may also comprise a hydrophobic component, such as organopolysiloxane (silicone) oils, including dimethicones having viscosities of 0.65-50 cSt (col. 11, line 66 – col. 12, line 34), as this silicone oil has the viscosity as claimed it is expected to reduce tackiness.
Regarding claim 8: Deckner teaches fatty alcohols (such as cetyl alcohol, stearyl alcohol, and behenyl alcohol) may be present as structuring agents (Deckner - claim 1).
Regarding claim 9: Deckner teaches that sunscreen or sunblocks can be added to the composition to protect against exposure to UV light (col. 28, lines 35-45).
Regarding claim 13: Since the composition of the combined prior art comprises the same components in same or similar amounts, the skilled artisan would reasonably expect the same properties to result, absent evidence to the contrary. This is supported by the instant specification that demonstrates that compositions having the claimed buffer system exhibit less than 5% TRPV1 activation.
Claim(s) 1, 2, 5-13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deckner (US 5,968,528), Baca (US2018/0271760) and Richard (US 2012/0201767), as applied to claims 1, 5-13 and 21-22 above, and further in view of DE202004006865.
As discussed above, the prior art makes obvious the limitations of claims 1, 5-13 and 21-22, however, they do not teach the presence of a silicone emulsifier in the claimed amounts as recited by instant claim 2.
Deckner teaches that emulsifiers/surfactants can be added and preferred emulsions contain a silicone containing emulsifier or surfactant (col. 16, lines 64-67)
DE’865 teaches compositions for skin care comprising silicone emulsifiers which can further comprise AHAs. The silicone emulsifier is taught to be used in amounts of 0.5-5%, a preferred emulsifier for use is dimethicone copolyol and is used in amounts of 0.1-2% (DE’865 claims).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Deckner with those of DE’865. One of skill in the art would have been motivated to use 0.1-2% of dimethicone copolyol as an emulsifier into the composition of Deckner as its prima facie obvious to combine prior art elements according to known methods to yield predictable results with a reasonable expectation of success as Deckner teaches silicone emulsifiers can be added and DE’865 teaches that dimethicone copolymer can be used in skin care compositions comprising AHAs.
Claim(s) 1, 3-4, 5-13 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deckner (US 5,968,528), Baca (US2018/0271760) and Richard (US 2012/0201767), as applied to claims 1, 5-13 and 21-22 above, and further in view of Tanner (WO 2008/112964).
As discussed above, the prior art makes obvious the limitations of claims 1, 5-13 and 21-22, however, they do not teach the opacity of the composition as required by instant claims 3-4.
Tanner teaches skin care compositions and teaches that skin care compositions can be opaque or translucent. The presence of colorants, insoluble particles, gas bubbles, large internal phase domains, and the like can affect the turbidity/translucency of a skin care composition. Opacity and translucency may be quantitatively determined by the percent transmission. Skin care compositions yielding a percent transmission of greater than or equal to 60% are considered translucent. Skin care composition yielding a percent transmission of less than 60%, 55%, 50%, 40%, or, alternatively, 30% are considered opaque. In one embodiment, the first skin care comprising is translucent and the second skin care composition is opaque.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Deckner with those of Tanner. As Tanner teaches skin care formulations that can be formulated as translucent or as opaque and teaches the percent transmission to vary, a skilled artisan would have been motivated to formulate the composition in one of these two well-known ways taking into account that the presence of colorants, insoluble particles, gas bubbles, large internal phase domains, and the like can affect the turbidity/translucency of a skin care composition which affects the percent transmission, thus a skilled artisan would have been motivated to monitor the presence of these types of ingredients to ensure the composition has the desired percent transmission (i.e. opacity). One of skill in the art would have a reasonable expectation of success as both Deckner and Tanner teach skin care cosmetics.
Claim(s) 1, 5-13, 14 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deckner (US 5,968,528), Baca (US2018/0271760) and Richard (US 2012/0201767), as applied to claims 1, 5-13 and 21-22 above, and further in view of EP0134483 and Pereira (US 4,981,948).
As discussed above, the prior art makes obvious the limitations of claims 1, 5-13 and 21-22, however, they do not teach the composition to be an essence and have a viscosity as recited by instant claim 14.
Claim 14 recites “the composition is in the form of an essence,” and the claim requires the composition to have ingredients (a)-(d) and have a viscosity ranging from 1-30,000 cP. Absent a definition in the specification as to what makes a composition an essence, a composition comprising the claimed ingredients (a)-(d) and having a viscosity ranging from 1-30,000 cP will be deemed to read on essence as claimed.
As discussed above, the prior art makes obvious a composition comprising thickening agents.
EP’483 teaches skin care composition and teaches that the amount of water or aqueous carrier to be included in the skin care compositions will vary, depending upon the desired consistency of the final product. By varying the amount of water, thickener and/or amphoteric surfactant present, it is possible to formulate a thick-flowing liquid or lotion, a semi-liquid thick cream, a paste, a stick, a gel, an alcoholic hydrogel, an emulsion, an alcoholic solution or a formulation suitable for use in an aerosol. In any event, the cosmetic composition should be provided in a form which can be uniformly spread on the skin [0037].
EP’483 teaches that preferred lotion formulations typically exhibit a viscosity from about 2000 to 20,000 centipoises (cps) at ambient temperature (approx. 25°C). The preferred facial creams exhibit a viscosity from about 25,000 to 60,000 cps and the heavier creams or pastes show viscosities from 70,000 to 170,000 cps [0050].
Pereira teaches skin cosmetics and teaches that viscosities of up to 2,000 mPas resemble milk, 2000-5000 a thin lotion, 5000-8000 normal pourable lotion and so forth (Col.7, ln. 10-25).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Deckner with those of EP’483 and Pereira. One of skill in the art would have recognize that the viscosity of the composition Deckner could be optimized by varying the concentration of the thickening agents, in order obtain a desired viscosity required to control the topical application of the composition. One of skill in the art would further recognize that the viscosity of the composition is further modified dependent on the final texture of the composition, whether it be a milk, lotion, a facial cream or thicker heavier pastes or creams. Therefore, it would be obvious to modify the amounts of thickening agent to achieve a viscosity ranging from 2000-20,000 cps at 25°C, which reads on the claims 1-30,000 cP. One of skill in the art would have a reasonable expectation of success as both Deckner, Pereira and EP’483 teach cosmetic compositions.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deckner (US 5,968,528), Baca (US2018/0271760) and Seppic (“Sepimax™ Zen”, 2015). Deckner and Seppic are newly cited by the Examiner but were both cited by Applicant on the IDS filed 12/2/2021.
Regarding claim 24a: Deckner teaches stable skin care composition containing a vitamin B3 compound (particularly niacinamide) which generally improve the quality of the skin, particularly human facial skin (Abs and working examples). The compositions more preferably comprise from about 0.1% to about 10% of the vitamin B3 compound (col. 4, lines 27-35).
Regarding claim 24d: Deckner teaches water to be a preferred carrier for use (col. 8, lines 10-15).
Regarding claim 24e: Deckner teaches the compositions are preferably formulated to have a pH of about 10.5 or below, more preferably from about 3 to about 8 (col. 10, lines 11-14). Therefore, it would be within the purview of the skilled artisan to formulate the composition of Deckner having a pH within the claimed ranges, with a reasonable expectation of success.
Regarding claim 24b: Deckner teaches that that organic hydroxy acids such as lactic acid are also useful in the composition in amounts ranging from 0.1-10% and are effective at enhancing the skin appearance (col. 31, lines 1-10). Deckner also teaches lactate salts to be useful in the composition (col. 33, lines 5-10).
However, Deckner does not teach the composition to have gluconic acid and sodium gluconate in the claimed amounts.
Baca discloses a skin care composition comprising one or more alpha hydroxy acids (AHAs), one or more salts of alpha hydroxyl acids, one or more tretinoin, retinols or retinol-like compounds,
and niacinamide or hydroquinone (Abs).
Baca teaches preferred AHAs to include lactic acid and gluconic acid and their derivatives (i.e. salts) these are used in amounts ranging from 0.05-30% and act as wrinkle-smoothers, help clear blemishes, hydrate the skin and lighten pigment spots [0027]. Baca further teaches that salts of AHAs act as humectants to bind and hold water in the stratum corneum and are natural moisturizers. Salts of AHAs include glycolate and lactate [0029].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Deckner with those of Baca. One of skill in the art would have been motivated to use gluconic acid as the organic hydroxy acid in Deckner as this is taught to be equivalent to lactic acid and is effective at enhancing skin appearance. One of skill in the art would have also been motivated to add a salt of AHAs, such as gluconate, as this act as humectants to bind and hold water in the stratum corneum and are natural moisturizers. One of skill in the art would have a reasonable expectation of success as Deckner teaches that organic hydroxy acids include C1-C18 hydroxy acid, preferably C8 or below (gluconate is a C6 hydroxy acid).
Regarding the claimed 0.1-10% of sodium gluconate and gluconic acid, as discussed the prior art teaches amounts that overlap with these ranges. Baca teaches amounts of 0.5-30%.
While the prior art doesn’t teach sodium gluconate specifically, Baca teaches that sodium forms of the salts of AHAs are suitable for use (working examples teach sodium lactate), therefore, the use of sodium gluconate is prima facie obvious.
Regarding claim 24c: Deckner teaches the inclusion of thickening agents in amounts of 0.1-5%, these include crosslinked polyacrylate polymers, however, Deckner does not specifically teach the use of polyacrylate crosspolymer-6.
Seppic teaches SepimaxTM Zen (INCI name (polyacrylate crosspolymer-6) is an “excellent thickener and stabilizer even in very specific conditions” (page 2). The thickener creates transparent gels, and provides a rich, elegant touch, with a velvety after-feel (id.). Seppic teaches the polymer is efficient even at low viscosity, citing examples of 1400 mPa.s (cP) and 1000 mPa.s (e.g., page 3). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to select and/or include polyacrylate crosspolymer-6 as a thickener in the composition of Deckner; thus arriving at the claimed invention. One skilled in the art would be motivated to do so, with a reasonable expectation of success, because said thickener provides the benefits of transparency along with a rich, elegant touch, with a velvety after-feel, as taught by Seppic and Deckner teaches that crosslinked polyacrylate polymers can be added.
New Claim Rejections - 35 USC § 103
Claim(s) 1, 5-13, 21-22 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deckner (US 5,968,528), Baca (US2018/0271760) and Richard (US 2012/0201767), as applied to claims 1, 5-13 and 21-22 above, and further in view of Favre (US 2012/0148645).
As discussed above, the prior art makes obvious the limitations of claims 1, 5-13 and 21-22, however, they do not teach the composition to comprise 0.01-1% of an emulsifier as recited by instant claim 25.
Deckner teaches that silicone emulsifiers can be added (col. 14, lines 5-10) and these include polydimethylsiloxanes modified with polyethylene oxide chains or those containing moieties derived from ethylene oxide or propylene oxide, this can be used in amounts ranging from 0.05-1% (col. 17, lines 1-15).
Favre teaches cosmetic compositions and teaches PEG-11 methyl ether dimethicone to be a suitable emulsifier for use [0053].
It would have been prima facie obvious to modify the teachings of the above references with those of Favre and use PEG-11 methyl ether dimethicone as the silicone emulsifier for use in the composition of Deckner as Deckner teaches that silicone emulsifiers including those polydimethylsiloxanes modified with polyethylene oxide and Favre teaches PEG-11 methyl ether dimethicone (i.e. a polydimethylsiloxanes modified with polyethylene oxide) to be a suitable emulsifier for use and its prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended purpose (MPEP 2144.07).
Modified/Maintained Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-14, 21-22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,959,933 in view of Baca (US 2018/0271760), Richard (US 2012/0201767) and KR20190058950.
US’933 teaches a skin care essence, comprising: a) about 0.1% to 10% of a vitamin B3 compound; b) about 0.1% to 5% of a pH buffer comprising lactic acid and sodium lactate; c) about 0.1% to 5% of a polymer thickener comprising polyacrylate crosspolymer-6; d) about 0.1% to 10% of a silicone fluid having a viscosity of 100 cSt or less at 25° C.; and e) wherein the composition has a pH of about 2.0 to about 5.0, an opacity of about 60 to about 85 and a viscosity of about 1 cP to about 15000 cP at 25° C. The skin care essence further comprises about 0.01% to about 1% of a silicone emulsifier and the silicone fluid is dimethicone with a viscosity of 10 cSt or less. The composition further comprises a stable fatty alcohol thickener selected from the group consisting of cetyl alcohols, stearyl alcohols, behenyl alcohols and combinations thereof and at least one additional skin care active selected from the group consisting of vitamins, minerals, peptides, sugar amines, sunscreens, oil control agents, flavonoid compounds, anti-oxidants, protease inhibitors, tyrosinase inhibitors, anti-inflammatory agents, moisturizing agents, exfoliating agents, skin lightening agents, anti-acne agents, anti-wrinkle agents, phytosterols, N-acyl amino acid compounds, antimicrobials, antifungals, and combinations thereof. The vitamin B3 compound is niacinamide and the pH is about 3.5 to about 3.9. The composition exhibits a TRPV1 activation of less than about 10% according to the TRPV1 assay.
However, the composition comprises lactic acid and sodium lactate instead of gluconic acid and sodium gluconate and does not comprise sodium polyacyloyldimethyl taurate as a thickening polymer.
The teachings of Baca are discussed above and are incorporated into this rejection and the claims are obvious for the same reasons of equivalency between lactic acid/sodium lactate and gluconic acid/sodium gluconate as discussed above.
Richard teaches cosmetic compositions for application to the skin [0019] and teaches that suitable hydrophilic thickeners suitable for use include Simulgel 800 (CTFA name: sodium polyacyloyldimethyl taurate/polysorbate/sorbitan oleate) [0248].
KR’950 teaches cosmetic compositions and teaches polyacrylate crosspolymer-6 to be a suitable thickening agent for application to skin.
It would have been prima facie obvious to substitute polyacrylate crosspolymer-6 for Simulgel 800 as they are each taught by the prior art to be used for the same purpose, as polymeric thickening agents for use in cosmetics for application to skin.
Claims 1-2, 5-13, 21-22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 of US Patent US 11,911,498 (copending Application No. 17/215988), in view of Baca (US 2018/0271760), Richard (US 2012/0201767) and KR20190058950.
US‘498 teaches a skin care composition, comprising: a) about 0.1% to 10% of a niacinamide; b) about 0.1% to 5% of a pH buffer comprising lactic acid and sodium lactate; c) about 0.1% to 5% of a polymer thickener comprising polyacrylate crosspolymer-6; d) about 0.1% to 10% of a silicone fluid having a viscosity of 100 cSt or less at 25° C.; and e) wherein the composition has a pH of about 2.0 to about 5.0. The skin care composition further comprises about 0.01% to about 1% of a silicone emulsifier and the silicone fluid is dimethicone with a viscosity of 10 cSt or less. The composition further comprises a stable fatty alcohol thickener selected from the group consisting of cetyl alcohols, stearyl alcohols, behenyl alcohols and combinations thereof and at least one additional skin care active selected from the group consisting of vitamins, minerals, peptides, sugar amines, sunscreens, oil control agents, flavonoid compounds, anti-oxidants, protease inhibitors, tyrosinase inhibitors, anti-inflammatory agents, moisturizing agents, exfoliating agents, skin lightening agents, anti-acne agents, anti-wrinkle agents, phytosterols, N-acyl amino acid compounds, antimicrobials, antifungals, and combinations thereof. The pH is about 3.5 to about 3.9. The composition exhibits a TRPV1 activation of less than about 10% according to the TRPV1 assay.
However, the composition comprises lactic acid and sodium lactate instead of gluconic acid and sodium gluconate and does not comprise sodium polyacyloyldimethyl taurate as a thickening polymer.
The teachings of Baca are discussed above and are incorporated into this rejection and the claims are obvious for the same reasons of equivalency between lactic acid/sodium lactate and gluconic acid/sodium gluconate as discussed above.
Richard teaches cosmetic compositions for application to the skin [0019] and teaches that suitable hydrophilic thickeners suitable for use include Simulgel 800 (CTFA name: sodium polyacyloyldimethyl taurate/polysorbate/sorbitan oleate) [0248].
KR’950 teaches cosmetic compositions and teaches polyacrylate crosspolymer-6 to be a suitable thickening agent for application to skin.
It would have been prima facie obvious to substitute polyacrylate crosspolymer-6 for Simulgel 800 as they are each taught by the prior art to be used for the same purpose, as polymeric thickening agents for use in cosmetics for application to skin.
Claims 1-7, 9-13 and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,583,488 in view of Richard (US 2012/0201767).
US’488 discloses a method of treating skin by applying to the skin a low pH composition comprising 0.01% to about 3%, by weight, of the vitamin B3 compound, about 0.1% to 5% of a pH buffering system comprising an acid buffering agent and a salt buffering agent; about 0.1% to 5% of a polymer thickener comprising a low-pH tolerant thickener; and about 0.1% to 10% of a tack-reducing silicone oil having a viscosity of 10 cSt or less at 25° C, (reading on instant claim 1 and 5-7). The vitamin B3 compound is taught to be niacinamide (reading on instant claim 10), the acid buffering agent can be gluconic acid and the salt buffering agent can be sodium gluconate. The pH of the composition is taught to range from about 2-4.5 (reading on instant claims 1, 11-12 and 21). The composition further includes 0.01-1% of a silicone emulsifier (reading on instant claim 2). The composition is taught to have an opacity ranging from 15-75 and exhibits a TRPV1 activation of less than 10% according to the TRPV1 assay (reading on instant claims 3-4 and 13).
However, US’488 does not teach the composition to have sodium polyacyloyldimethyl taurate.
Richard teaches cosmetic compositions for application to the skin [0019] and teaches that suitable hydrophilic thickeners suitable for use include Simulgel 800 (CTFA name: sodium polyacyloyldimethyl taurate/polysorbate/sorbitan oleate) [0248].
It would have been prima facie obvious to add Simulgel 800 as a thickening agents to the composition of US’488 as its taught to be well-known cosmetic thickening agent.
Claims 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,583,488 in view of Seppic (“Sepimax™ Zen”, 2015).
US’488 discloses a method of treating skin by applying to the skin a low pH composition comprising 0.01% to about 3%, by weight, of the vitamin B3 compound, about 0.1% to 5% of a pH buffering system comprising an acid buffering agent and a salt buffering agent; about 0.1% to 5% of a polymer thickener comprising a low-pH tolerant thickener; and about 0.1% to 10% of a tack-reducing silicone oil having a viscosity of 10 cSt or less at 25° C, (reading on instant claim 1 and 5-7). The vitamin B3 compound is taught to be niacinamide (reading on instant claim 10), the acid buffering agent can be gluconic acid and the salt buffering agent can be sodium gluconate. The pH of the composition is taught to range from about 2-4.5 (reading on instant claims 1, 11-12 and 21). The composition further includes 0.01-1% of a silicone emulsifier (reading on instant claim 2). The composition is taught to have an opacity ranging from 15-75 and exhibits a TRPV1 activation of less than 10% according to the TRPV1 assay (reading on instant claims 3-4 and 13).
However, US’488 does not teach the composition to have polyacrylate-6 crosspolymer.
The teachings of Seppic are discussed above and are incorporated into this rejection.
It would have been prima facie obvious to use polyacrylate crosspolymer-6 as a thickening agents to the composition of US’488 as its taught to be well-known cosmetic thickening agent with improved benefits.
Claims 1, 3-8, 10-14, 21-22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-11 and 21-22 of copending Application No. 18/413546 in view of Baca (US 2018/0271760), Richard (US 2012/0201767) and Seppic (“Sepimax™ Zen”, 2015).
US‘546 teaches a skin care essence composition, comprising: a) about 0.1% to 10% of a niacinamide; b) about 0.1% to 5% of a pH buffer comprising lactic acid and sodium lactate; c) about 0.1% to 5% of a polymer thickener d) about 0.1% to 10% of a silicone fluid having a viscosity of 100 cSt or less at 25° C.; and e) wherein the composition has a pH of about 2.0 to about 5.0. The composition further comprises a stable fatty alcohol thickener selected from the group consisting of cetyl alcohols, stearyl alcohols, behenyl alcohols and combinations thereof and comprises polyacrylate crosspolymer-6 as a thickening agent. The pH is about 3.5 to about 3.9. The composition exhibits a TRPV1 activation of less than about 10% according to the TRPV1 assay and had an opacity of 60-85.
However, the composition comprises lactic acid and sodium lactate instead of gluconic acid and sodium gluconate and does not comprise sodium polyacyloyldimethyl taurate as a thickening polymer.
The teachings of Baca are discussed above and are incorporated into this rejection and the claims are obvious for the same reasons of equivalency between lactic acid/sodium lactate and gluconic acid/sodium gluconate as discussed above.
Richard teaches cosmetic compositions for application to the skin [0019] and teaches that suitable hydrophilic thickeners suitable for use include Simulgel 800 (CTFA name: sodium polyacyloyldimethyl taurate/polysorbate/sorbitan oleate) [0248].
It would have been prima facie obvious to substitute polyacrylate crosspolymer-6 for Simulgel 800 as they are each taught by the prior art to be used for the same purpose, as polymeric thickening agents for use in cosmetics for application to skin.
Regarding claim 24: US’546 teaches that the polymeric thickener can be polyacrylate crosspolymer-6.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowable.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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