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 .
Withdrawn Objections/Rejections
The objection to claim 8 is withdrawn as the amended claim has addressed the informality.
The nonstatutory double patenting rejections over the claims of co-pending Application 16/916,380 are withdrawn in view of the amendments to the claims of the co-pending application. The claims of co-pending application 16/916,380 recite a composition free from fatty alcohols, required by the composition of the instant claims.
Claim Status
Applicants' amendments and arguments filed 01/05/2026 have been fully considered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The
following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application.
Claim 11 is cancelled.
Claim 20 is withdrawn.
Claims 1-10, 12-19, and 21-24 are under current examination.
Examiner’s Note
Claim 17, designated as “Previously presented”, recites “Pa.s” as underlined, indicating that the claim has been amended. The claim is consistent with the previously examined claims filed 05/28/2025; thus, the claim is being treated as “Previously presented”. The Examiner suggests that the underlining of “Pa.s” be omitted.
Claim Objections-Maintained
Claim 18 is objected to because of the following informalities: for readability of the claim, it is suggested that “miscellaneous emulsifiers/surfactants other than the nonionic emulsifiers of plurality of nonionic emulsifiers of (b)” in component “(h)” should read “miscellaneous emulsifiers/surfactants other than the nonionic emulsifiers of the plurality of nonionic emulsifiers of (b)”.
Claim 19 is objected to because of the following informalities: for consistency in the claim language, it is suggested that “and each of the one or more skin treatment compositions are separately contained” in line 3 should read “and each of the one or more additional skin treatment compositions are separately contained”.
Appropriate correction is required.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-10, 12-19, and 21-24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Independent claims 1, 18, and 24 recite “whereby the composition is chemically stabilized so that at least 70% of the retinol is preserved at 8 weeks in a sealed polyethylene terephthalate glycol container stored at 25 °C and/or 45 °C”. This renders the claims indefinite as it is unclear how a composition can be stored in a sealed container at both 25 °C and 45 °C simultaneously. It is suggested that Applicant recite “or” in place of “and/or”.
Claims 2-10, 12-17, 19, and 21-22 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 1 and failure to cure the deficiency noted above.
Claim 23 is rejected under 35 U.S.C. 112(b) by virtue of its dependency on indefinite claim 18 and failure to cure the deficiency noted above.
Rejections Maintained, Slightly Modified to Address Amended Claims
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 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.
Claims 1-10, 12-16, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Isoir-Ingrez et al. (WO 2021/123233 A1, published June 24, 2021; of record), hereafter “Isoir-Ingrez” in view of Norman (WO 2012/045081, published April 5, 2021; of record).
Applicant has provided a submission in this file that the claimed invention and the subject matter disclosed in the prior art reference WO 2021/123233 A1 were owned by, or subject to an obligation of assignment to, the same entity as L’Oreal not later than the effective filing date of the claimed invention, or the subject matter disclosed in the prior art reference was developed and the claimed invention was made by, or on behalf of one or more parties to a joint research agreement not later than the effective filing date of the claimed invention. However, although subject matter disclosed in the reference WO 2021/123233 A1 has been excepted as prior art under 35 U.S.C. 102(a)(2), it is still applicable as prior art under 35 U.S.C. 102(a)(1) that cannot be excepted under 35 U.S.C. 102(b)(2)(C).
Applicant may overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore, not prior art as set forth in 35 U.S.C. 102(b)(1)(A). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
Regarding instant claim 1, Isoir-Ingrez teaches a cosmetic composition for making up and/or caring for keratin materials, comprising retinol (abstract). The compositions of Isoir-Ingrez are preferably in the form of an oil-in-water emulsion (pg. 25, lines 19-20). Isoir-Ingrez teaches that the combination of at least one di-t-butyl pentaerythrityl tetrahydroxycinnamate compound, at least one ethylenediaminedisuccinic acid salt, and at least carnosine makes it possible to efficiently stabilize the retinol contained in a cosmetic composition, that losses of retinol compound contained in compositions of the invention are low over time, and that no degradation of odor or color occurs when using the composition (pg. 3, lines 21-30); the compositions of Isoir-Ingrez are thus interpreted as being stabilized.
Regarding instant claim 1(a), Isoir-Ingrez teaches the composition may comprise an amount of retinol of between 0.02% and 5.0% by weight (pg. 5, lines 4-9). Table 1 sets forth a composition that comprises 0.2 wt.% retinol (2.0 wt.% Retinol 10 SU, which is 10% by weight active material in soybean oil, see pg. 5, lines 12-17).
Regarding instant claim 1(b), Isoir-Ingrez teaches that the composition preferably comprises at least one nonionic surfactant (pg. 19, lines 16-17) and provides examples of suitable surfactants (pg. 19, line 18-pg. 20, line 31); surfactants are preferably present from 0.5% to 10% by weight (pg. 21, lines 22-24). The exemplified composition of Isoir-Ingrez comprises 2.9 wt.% of a plurality of nonionic emulsifiers (component (b)) including 2.0 wt.% PEG-40 stearate (an ethoxylated fatty acid, as provided in the instant specification, example 1; component (b)(i)) and 0.9 wt.% sorbitan tristearate (an additional nonionic emulsifier; component (b)(iv)). Isoir-Ingrez further teaches that the nonionic surfactant can include alkyl and polyalkylglucosides or polyglucosides containing an alkyl group including from 6 to 30 carbon atoms, such as laurylglucoside and arachidyl glucoside (pg. 20, lines 15-31), meeting the limitation of (b)(ii), one or more nonionic surfactants having a HLB from about 9 to about 12 (as provided in the instant specification paragraphs [0042] and example 1).
Regarding instant claim 1(c) and 1(d), the exemplified composition of Isoir-Ingrez further comprises 2.5 wt.% cetyl alcohol (a fatty alcohol, component (c)) and 13.0 wt.% other fatty compounds (combination of diisopropyl sebacate, isononyl isnononanoate, isohexadecane, and soybean oil from Retinol 10 SU; component (d)).
Regarding instant claim 1(e), the exemplified composition of Isoir-Ingrez further comprises the thickening polymers ammonium polyacryloyldimethyl taurate and sodium acrylate/sodium acryloyldimethyl taurate copolymer.
Regarding instant claim 1(f), the exemplified composition of Isoir-Ingrez comprises water. The composition of Isoir-Ingrez set forth in Table 1 comprises 10 wt.% water in Phase H, and water q.s. for 100 in Phase A. The other components of the composition comprise 39.924 wt.%, resulting in 60.076 wt.% water. Isoir-Ingrez further teaches that the aqueous phase comprises water and optionally a water-soluble solvent (pg. 8, line 8), and that the aqueous phase is preferentially from 50% to 80% by weight (pg. 8, lines 1-4).
Regarding instant claim 2, as described above, Isoir-Ingrez teaches the composition may comprise an amount of retinol of between 0.02% and 5.0% by weight (pg. 5, lines 4-9). Table 1 sets forth a composition that comprises 0.2 wt.% retinol (2.0 wt.% Retinol 10 SU, which is 10% by weight active material in soybean oil, see pg. 5, lines 12-17).
Regarding instant claim 3, as noted above, Isoir-Ingrez teaches that the composition preferably comprises at least one nonionic surfactant (pg. 19, lines 16-17) and provides examples of suitable surfactants (pg. 19, line 18-pg 20, line 31). The exemplified composition of Isoir-Ingrez comprises sorbitan tristearate (an additional nonionic emulsifier; component (b)(iv)).
Regarding instant claim 4, as noted above, the exemplified composition of Isoir-Ingrez comprises 2.0 wt.% of the ethoxylated fatty acid PEG-40 stearate and the additional nonionic emulsifier of sorbitan tristearate. Isoir-Ingrez further teaches that the nonionic surfactant can include alkyl and polyalkylglucosides or polyglucosides containing an alkyl group including from 6 to 30 carbon atoms, such as laurylglucoside and arachidyl glucoside (lines 15-31), meeting the limitation of (b)(ii), one or more nonionic surfactants having a HLB from about 9 to about 12 (as provided in the instant specification paragraphs [0042] and example 1); surfactants are preferably present from 0.5% to 10% by weight (Isoir-Ingrez, pg. 21, lines 22-24).
Regarding instant claim 6, as described above, the composition of Isoir-Ingrez comprises PEG-40 stearate, which is an adduct of ethylene oxide with esters of stearic acid, comprising 40 oxyethylene groups.
Regarding instant claim 7, as described above, Isoir-Ingrez teaches that the nonionic surfactant can include alkyl and polyalkylglucosides or polyglucosides containing an alkyl group including from 6 to 30 carbon atoms, such as laurylglucoside and arachidyl glucoside (Isoir-Ingrez lines 15-31; provided in the instant specification as alkylpolyglucosides at paragraph [0042]).
Regarding instant claim 8, as described above, the exemplified composition of Isoir-Ingrez comprises cetyl alcohol, which is a fatty alcohol with 16 carbon atoms.
Regarding instant claim 9, as described above, the fatty compounds exemplified by Isoir-Ingrez are diisopropyl sebacate (a fatty ester), isononyl isnononanoate (a fatty ester), isohexadecane (a hydrocarbon-based oil), and soybean oil (a vegetable oil).
Regarding instant claim 10, as noted above, the compositions of Isoir-Ingrez are preferably in the form of an oil-in-water emulsion (pg. 25, lines 19-20). Isoir-Ingrez further teaches that when the composition includes an oily phase, oils of silicone origin are preferred (pg. 9, lines 23-24).
Regarding instant claims 12-13, the exemplified composition of Isoir-Ingrez comprises the taurate copolymer sodium acrylate/sodium acryloyldimethyl taurate copolymer as one of the thickening polymers.
Regarding instant claim 14, per the instant specification at paragraph [0157], the term “about” is understood to encompass a range of ± 10%; therefore, “about 65 to about 85 wt.% of water” is interpreted to encompass the range of 58.5 to 93.5 wt.% water. As noted above, the exemplified composition of Isoir-Ingrez comprises water. The composition of Isoir-Ingrez set forth in Table 1 comprises 10 wt.% water in Phase H, and water q.s. for 100 in Phase A. The other components of the composition comprise 39.924 wt.%, resulting in 60.076 wt.% water. Isoir-Ingrez further teaches that the aqueous phase is preferentially from 50% to 80% by weight (pg. 8, lines 1-4).
Regarding instant claim 15, Isoir-Ingrez teaches that the aqueous phase comprises water and optionally a water-soluble solvent (pg. 8, line 8). The exemplified composition of Isoir-Ingrez set forth in Table 1 comprises the water-soluble solvents of propanediol, glycerine, caprylyl glycol, and denat. alcohol. These components are present in a total of 14.35 wt.%.
Regarding instant claim 16, the exemplified composition of Isoir-Ingrez set forth in Table 1 further comprises the additional ingredients of trisodium ethylenediamine disuccinate, adenosine, phenoxyethanol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, hydroxyethylcellulose, silica, carnosine, and citric acid. These components are present in a total of 3.774 wt.%.
Regarding instant claim 21, as noted above, the exemplified composition of Isoir-Ingrez set forth in Table 1 comprises the water-soluble solvents of propanediol (a polyol), glycerine (glycerin), caprylyl glycol (a glycol), and denat. alcohol (a mono-alcohol).
Isoir-Ingrez does not teach that the plurality of nonionic emulsifiers comprises about 0.1 to about 5 wt.% of one or more glyceryl esters (instant claim 1(b)(iii)), that the one or more glyceryl esters are chosen from glyceryl behenate, glyceryl erucate, glyceryl hydroxystearate, glyceryl isostearate, glyceryl lanolate, glyceryl laurate, glyceryl linoleate, glyceryl myristate, glyceryl palmitate lactate, glyceryl stearate, glyceryl distearate, or a mixture thereof (instant claim 5), or that the one or more glyceryl esters are chosen from glyceryl stearate, glyceryl ricinoleate, and mixtures thereof (instant claim 22). Isoir-Ingrez further does not teach the kit of instant claim 19 comprising the composition and one or more additional skin treatment compositions separately contained.
Norman teaches a non-ionic oil-in-water emulsion comprising a combination of non-ionic emulsifiers and non-ionic emulsion stabilizers (abstract) for use in topical skin care compositions (paragraph [0002]). This combination includes glyceryl stearate (a glyceryl ester, and of those recited in instant claims 5 and 22), PEG-100 stearate (an ethoxylated fatty acid), arachidyl glucoside (a nonionic emulsifier having a HLB from about 9 to about 12, see instant specification paragraphs [0040]-[0041]), and arachidyl alcohol (a fatty alcohol, see instant specification paragraph [0008]). Norman exemplifies in Table 1 a composition that comprises 0.9 wt.% glyceryl stearate, 0.6 wt.% PEG-100 stearate, 0.165 wt.% arachidyl glucoside, and 0.605 arachidyl alcohol. Norman further teaches that moisturizing agents, including retinol, can be used with the compositions (paragraph [0048]-[0049]). Norman further teaches that the compositions can be contained in kits with additional components, including other compositions (paragraph [0064]-[0065]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the composition of Isoir-Ingrez with the combination of non-ionic emulsifiers and non-ionic emulsion stabilizers taught by Norman and package it in a kit as further suggested by Norman.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Norman teaches that such non-ionic emulsions can have a non-oily, non-greasy, non-sticky, non-tacky, and/or silky feel after being applied to skin (paragraph [0014]) and the combination of non-ionic emulsifiers and stabilizers works well to provide stable oil-in-water emulsions for compositions used to moisturize the skin and treat fine lines and wrinkles (paragraphs [0002]-[0004] and [0036]). Further, the kits of Norman are taught to be useful for dispensing a pre-determined and desired amount of the composition and can provide instructions for how to apply, use, and maintain multiple compositions (paragraph [0065]). There is a reasonable expectation of success as the compositions of Isoir-Ingrez are oil-in-water emulsions taught to be used for antiaging care of keratin materials, notably of the skin, particularly the appearance of wrinkles and fine lines (pg. 1, lines 5-21), and comprise a combination of nonionic emulsifiers and fatty alcohols; the emulsions of Norman are taught to be generally useful in cosmetic compositions, including anti-aging products (paragraph [0017]), are used to treat fine lines and wrinkles (paragraph [0002]), and are taught to be used with moisturizing agents, including retinol.
Regarding the limitation of instant claim 1 that the composition “is chemically stabilized so that at least 70% of the retinol is preserved at 8 weeks in a sealed polyethylene terephthalate glycol container stored at 25°C and/or 45°C”, as noted above, Isoir-Ingrez teaches stabilized compositions such that losses of retinol are low over time (chemically stabilized retinol). Isoir-Ingrez demonstrates that the percentage degradation of inventive compositions is 20% or less upon storage at 45 °C for 1 month (pg. 34, Table 4). While the prior art does not exemplify the exact storage and stability conditions claimed, the combination of Isoir-Ingrez and Norman arrives at the structural components of the claimed cosmetic composition and a retinol-containing composition that is stable upon storage at 45 °C. There is no evidence of record that compares the stability of compositions consistent with the instant invention to those outside the instant claims, and no evidence of record that the claimed stability properties structurally limit the composition. It is interpreted that, absent evidence to the contrary, stabilized compositions which meet the structural limitations of the claims will possess the claimed properties. Per MPEP 2142 (emphasis added), “If, however, the examiner does produce a prima facie case, the burden of coming forward with evidence or arguments shifts to the applicant who may submit additional evidence of nonobviousness, such as comparative test data showing that the claimed invention possesses properties not expected by the prior art, or rebuttal arguments.”
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Isoir-Ingrez in view of Norman as applied to claims 1-16, 19, and 21-22 above and further in view of Shiloach et al. (US 2005/0227880 A1, published October 13, 2005; of record), hereafter “Shiloach”.
The teachings of the modified Isoir-Ingrez are described above. Regarding instant claim 17, Isoir-Ingrez teaches that one or more thickeners and/or gelling agents may be incorporated to obtain a desired viscosity (pg. 21, lines 27-29). Norman teaches that the viscosity of topical skin care compositions can be selected to achieve a desired result or type of composition, and can range from about 1cps to well over a million cps, as measured at 25 °C (paragraph [0013]); 1 cP=0.1 Pa.s.
The combination of Isoir-Ingrez and Norman do not teach the limitation of instant claim 17 of a shear rate of 1 s-1 at 25 °C.
Shiloach teaches an aqueous isotropic liquid cleansing and moisturizing composition with a viscosity in the range of about 1,000 to 300,000 cps @1/sec shear rate at 25 °C (abstract, claim 1). The composition can include active agents (paragraph [0162]) including retinol as an anti-wrinkle, anti-skin atrophy and skin repair active (paragraph [0166]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to routinely optimize the viscosity and shear rate of the composition of the modified Isoir-Ingrez to reach that recited in instant claim 17. Isoir-Ingrez teaches that the viscosity of retinol-containing compositions can be modified by the use of thickeners and/or gelling agents and Norman teaches that the viscosity of such compositions can be selected to achieve a desired type of composition and a range of viscosities overlapping those of the instant claim. Further, Shiloach teaches compositions having a viscosity overlapping the range of the instant claim @1/sec shear rate at 25 °C are suitable for cleansing and moisturizing compositions comprising retinol. From MPEP 2144.05 II. A.: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, From MPEP 2144.05 I.: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Independent claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Isoir-Ingrez et al. (WO 2021/123233 A1, published June 24, 2021; of record), hereafter “Isoir-Ingrez” as evidenced by Johnson et al. (“Safety Assessment of Pentaerythrityl Tetra-Di-t-Butyl Hydroxyhydrocinnamate as Used in Cosmetics” https://www.cir-safety.org/sites/default/files/pentae032014final.pdf; of record), hereafter “Johnson” and Reddy et al. (“Carnosine: A Versatile Antioxidant and Antiglycating Agent” Science of Aging Knowledge Environment 4 May 2005, Vol 2005, Issue 18; of record), hereafter “Reddy”.
Applicant has provided a submission in this file that the claimed invention and the subject matter disclosed in the prior art reference WO 2021/123233 A1 were owned by, or subject to an obligation of assignment to, the same entity as L’Oreal not later than the effective filing date of the claimed invention, or the subject matter disclosed in the prior art reference was developed and the claimed invention was made by, or on behalf of one or more parties to a joint research agreement not later than the effective filing date of the claimed invention. However, although subject matter disclosed in the reference WO 2021/123233 A1 has been excepted as prior art under 35 U.S.C. 102(a)(2), it is still applicable as prior art under 35 U.S.C. 102(a)(1) that cannot be excepted under 35 U.S.C. 102(b)(2)(C).
Applicant may overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore, not prior art as set forth in 35 U.S.C. 102(b)(1)(A). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
Regarding instant claim 18, Isoir-Ingrez teaches a cosmetic composition for making up and/or caring for keratin materials, comprising retinol (abstract). The compositions of Isoir-Ingrez are preferably in the form of an oil-in-water emulsion (pg. 25, lines 19-20). Isoir-Ingrez teaches that the combination of at least one di-t-butyl pentaerythrityl tetrahydroxycinnamate compound, at least one ethylenediaminedisuccinic acid salt, and at least carnosine makes it possible to efficiently stabilize the retinol contained in a cosmetic composition, that losses of retinol compound contained in compositions of the invention are low over time, and that no degradation of odor or color occurs when using the composition (pg. 3, lines 21-30); the compositions of Isoir-Ingrez are thus interpreted as being stabilized.
Regarding instant claim 18(a), Isoir-Ingrez teaches the composition may comprise an amount of retinol of between 0.02% and 5.0% by weight (pg. 5, lines 4-9).
Regarding instant claim 18(b), Isoir-Ingrez teaches that the composition preferably comprises at least one nonionic surfactant (pg. 19, lines 16-17) and provides examples of suitable surfactants (pg. 19, line 18-pg 20, line 31). The exemplified composition of Isoir-Ingrez comprises 2.9 wt.% of a plurality of nonionic emulsifiers (component (b)) including 2.0 wt.% PEG-40 stearate (an ethoxylated fatty acid, as provided in the instant specification, example 1; component (b)(i)) and 0.9 wt.% sorbitan tristearate (an additional nonionic emulsifier; component (b)(iv)). Isoir-Ingrez further teaches that the nonionic surfactant can include alkyl and polyalkylglucosides or polyglucosides containing an alkyl group including from 6 to 30 carbon atoms, such as laurylglucoside and arachidyl glucoside (Isoir-Ingrez pg. 20, lines 15-31), meeting the limitation of (b)(ii), one or more nonionic surfactants having a HLB from about 9 to about 12 (as provided in the instant specification paragraphs [0042] and example 1); surfactants are preferably present from 0.5% to 10% by weight (pg. 21, lines 22-24).
Regarding instant claim 18(c), the exemplified composition of Isoir-Ingrez further comprises 2.5 wt.% cetyl alcohol (a fatty alcohol having 16 carbon atoms).
Regarding instant claim 18(d), the exemplified composition of Isoir-Ingrez comprises other fatty compounds (combination of diisopropyl sebacate, isononyl isnononanoate, isohexadecane, and soybean oil from Retinol 10 SU; component (d)). While Isoir-Ingrez exemplifies 13 wt.% of these fatty compounds, they further teach that the content of the oily phase may be present from 5% to 50% by weight (pg. 16, lines 1-3).
Regarding instant claim 18(e), the exemplified composition of Isoir-Ingrez further comprises the thickening polymers ammonium polyacryloyldimethyl taurate and sodium acrylate/sodium acryloyldimethyl taurate copolymer.
Regarding instant claim 18(f), the exemplified composition of Isoir-Ingrez comprises water. The composition of Isoir-Ingrez set forth in Table 1 comprises 10 wt.% water in Phase H, and water q.s. for 100 in Phase A. The other components of the composition comprise 39.924 wt.%, resulting in 60.076 wt.% water. Isoir-Ingrez further teaches that the aqueous phase is preferentially from 50% to 80% by weight (pg. 8, lines 1-4).
Regarding instant claim 18(g), Isoir-Ingrez teaches that the aqueous phase comprises water and optionally a water-soluble solvent (pg. 8, line 8). The exemplified composition of Isoir-Ingrez set forth in Table 1 comprises the water-soluble solvents of propanediol, glycerine, caprylyl glycol, and denat. alcohol. These components are present in a total of 14.35 wt.%.
Regarding instant claim 18(h), the compositions of Isoir-Ingrez require the inclusion of di-t-butyl pentaerythrityl tetrahydroxycinnamate (or tetra-di-t-butyl pentaerythrityl hydroxyhydrocinnamate, CAS number 6683-19-8, see pg. 5, lines 24-26), an ethylenediaminedisuccinic acid salt, and carnosine (claim 1). These components are exemplified in Table 1 to be present at 0.3 wt.%, 0.2 wt.%, and 0.5%, respectively (1.0 wt.% total). As evidenced by Johnson, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate functions as an antioxidant in cosmetic products (abstract). An ethylenediaminedisuccinic acid salt is a salt. As evidenced by Reddy, carnosine is a naturally occurring antioxidant (abstract). The di-t-butyl pentaerythrityl tetrahydroxycinnamate, ethylenediaminedisuccinic acid salt, and carnosine taught by Isoir-Ingrez are therefore as interpreted as consistent with the antioxidant and salt miscellaneous ingredients of instant claim 18(h).
Isoir-Ingrez does not teach the wt.% of retinol, wt.% of fatty compounds, or wt.% of nonionic emulsifier having a HLB from about 9 to about 12 of instant claim 18 with sufficient specificity to anticipate, but rather renders obvious, the instant claims. However, Isoir-Ingrez teaches the inclusion of these components in ranges overlapping those of the instant claim. From MPEP 2144.05: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding the limitation of instant claim 18 that the composition “is chemically stabilized so that at least 70% of the retinol is preserved at 8 weeks in a sealed polyethylene terephthalate glycol container stored at 25°C and/or 45°C”, as noted above, Isoir-Ingrez teaches stabilized compositions such that losses of retinol are low over time (chemically stabilized retinol). Isoir-Ingrez demonstrates that the percentage degradation of inventive compositions is 20% or less upon storage at 45 °C for 1 month (pg. 34, Table 4). While the prior art does not exemplify the exact storage and stability conditions claimed, the teachings of Isoir-Ingrez arrive at the structural components of the claimed cosmetic composition and a retinol-containing composition that is stable upon storage at 45 °C. There is no evidence of record that compares the stability of compositions consistent with the instant invention to those outside the instant claims, and no evidence of record that the claimed stability properties structurally limit the composition. It is interpreted that, absent evidence to the contrary, stabilized compositions which meet the structural limitations of the claims will possess the claimed properties. Per MPEP 2142 (emphasis added), “If, however, the examiner does produce a prima facie case, the burden of coming forward with evidence or arguments shifts to the applicant who may submit additional evidence of nonobviousness, such as comparative test data showing that the claimed invention possesses properties not expected by the prior art, or rebuttal arguments.”
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Isoir-Ingrez as evidenced by Johnson and Reddy as applied to claim 18 above and further in view of Norman (WO 2012/045081, published April 5, 2021; of record).
The teachings of Isoir-Ingrez are described above.
Isoir-Ingrez does not teach the limitation of instant claim 23 that the cosmetic composition contains about 0.1 to about 5 wt.% of one or more glyceryl esters wherein the one or more glyceryl esters are chosen from glyceryl behenate, glyceryl erucate, glyceryl hydroxystearate, glyceryl isostearate, glyceryl lanolate, glyceryl laurate, glyceryl linoleate, glyceryl myristate, glyceryl palmitate lactate, glyceryl stearate, glyceryl distearate, or a mixture thereof.
Norman teaches a non-ionic oil-in-water emulsion comprising a combination of non-ionic emulsifiers and non-ionic emulsion stabilizers (abstract) for use in topical skin care compositions (paragraph [0002]). This combination includes glyceryl stearate (a glyceryl ester, and of those recited in instant claims 23), PEG-100 stearate (an ethoxylated fatty acid), arachidyl glucoside (a nonionic emulsifier having a HLB from about 9 to about 12, see instant specification paragraphs [0040]-[0041]), and arachidyl alcohol (a fatty alcohol, see instant specification paragraph [0008]). Norman exemplifies in Table 1 a composition that comprises 0.9 wt.% glyceryl stearate, 0.6 wt.% PEG-100 stearate, 0.165 wt.% arachidyl glucoside, and 0.605 arachidyl alcohol. Norman further teaches that moisturizing agents, including retinol, can be used with the compositions (paragraph [0048]-[0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the composition of Isoir-Ingrez with the combination of non-ionic emulsifiers and non-ionic emulsion stabilizers taught by Norman.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Norman teaches that such non-ionic emulsions can have a non-oily, non-greasy, non-sticky, non-tacky, and/or silky feel after being applied to skin (paragraph [0014]) and the combination of non-ionic emulsifiers and stabilizers works well to provide stable oil-in-water emulsions for compositions used to moisturize the skin and treat fine lines and wrinkles (paragraphs [0002]-[0004] and [0036]). There is a reasonable expectation of success as the compositions of Isoir-Ingrez are oil-in-water emulsions taught to be used for antiaging care of keratin materials, notably of the skin, particularly the appearance of wrinkles and fine lines (pg. 1, lines 5-21), and comprise nonionic emulsifiers and fatty alcohols; the emulsions of Norman are taught to be generally useful in cosmetic compositions, including anti-aging products (paragraph [0017]), are used to treat fine lines and wrinkles (paragraph [0002]), and are taught to be used with moisturizing agents, including retinol.
Independent claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Isoir-Ingrez et al. (WO 2021/123233 A1, published June 24, 2021; of record), hereafter “Isoir-Ingrez” in view of Norman (WO 2012/045081, published April 5, 2021; of record).
Applicant has provided a submission in this file that the claimed invention and the subject matter disclosed in the prior art reference WO 2021/123233 A1 were owned by, or subject to an obligation of assignment to, the same entity as L’Oreal not later than the effective filing date of the claimed invention, or the subject matter disclosed in the prior art reference was developed and the claimed invention was made by, or on behalf of one or more parties to a joint research agreement not later than the effective filing date of the claimed invention. However, although subject matter disclosed in the reference WO 2021/123233 A1 has been excepted as prior art under 35 U.S.C. 102(a)(2), it is still applicable as prior art under 35 U.S.C. 102(a)(1) that cannot be excepted under 35 U.S.C. 102(b)(2)(C).
Applicant may overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore, not prior art as set forth in 35 U.S.C. 102(b)(1)(A). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
Regarding instant claim 24, Isoir-Ingrez teaches a cosmetic composition for making up and/or caring for keratin materials, comprising retinol (abstract). The compositions of Isoir-Ingrez are preferably in the form of an oil-in-water emulsion (pg. 25, lines 19-20). Isoir-Ingrez teaches that the combination of at least one di-t-butyl pentaerythrityl tetrahydroxycinnamate compound, at least one ethylenediaminedisuccinic acid salt and at least carnosine makes it possible to efficiently stabilize the retinol contained in a cosmetic composition, that losses of retinol compound contained in compositions of the invention are low over time, and that no degradation of odor or color occurs when using the composition (pg. 3, lines 21-30); the compositions of Isoir-Ingrez are thus interpreted as being stabilized.
Regarding instant claim 24(a), Isoir-Ingrez teaches the composition may comprise an amount of retinol of between 0.02% and 5.0% by weight (pg. 5, lines 4-9). From MPEP 2144.05: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding instant claim 24(b), Isoir-Ingrez teaches that the composition preferably comprises at least one nonionic surfactant (pg. 19, lines 16-17) and provides examples of suitable surfactants (pg. 19, line 18-pg 20, line 31); surfactants are preferably present from 0.5% to 10% by weight (pg. 21, lines 22-24). The exemplified composition of Isoir-Ingrez comprises 2.9 wt.% of a plurality of nonionic emulsifiers (component (b)) including 2.0 wt.% PEG-40 stearate (an ethoxylated fatty acid, as provided in the instant specification, example 1; component (b)(i)) and 0.9 wt.% sorbitan tristearate (an additional nonionic emulsifier; component (b)(iv). Isoir-Ingrez further teaches that the nonionic surfactant can include alkyl and polyalkylglucosides or polyglucosides containing an alkyl group including from 6 to 30 carbon atoms, such as laurylglucoside and arachidyl glucoside (lines 15-31), meeting the limitation of (b)(ii), one or more nonionic surfactants having a HLB from about 9 to about 12 (as provided in the instant specification paragraphs [0042] and example 1).
Regarding instant claim 24(c), the exemplified composition of Isoir-Ingrez further comprises 2.5 wt.% cetyl alcohol (a fatty alcohol having 16 carbon atoms).
Regarding instant claim 24(d), the exemplified composition of Isoir-Ingrez comprises other fatty compounds (combination of diisopropyl sebacate, isononyl isnononanoate, isohexadecane, and soybean oil from Retinol 10 SU). They further teach that the content of the oily phase may be present from 5% to 50% by weight (pg. 16, lines 1-3).
Regarding instant claim 24(e), the exemplified composition of Isoir-Ingrez further comprises the thickening polymers ammonium polyacryloyldimethyl taurate and sodium acrylate/sodium acryloyldimethyl taurate copolymer.
Regarding instant claim 24(f), per the instant specification at paragraph [0157], the term “about” is understood to encompass a range of ± 10%; therefore, “about 65 to about 85 wt.% of water” is interpreted to encompass the range of 58.5 to 93.5 wt.% water. As noted above, the exemplified composition of Isoir-Ingrez comprises water. The composition of Isoir-Ingrez set forth in Table 1 comprises 10 wt.% water in Phase H, and water q.s. for 100 in Phase A. The other components of the composition comprise 39.924 wt.%, resulting in 60.076 wt.% water. Isoir-Ingrez further teaches that the aqueous phase is preferentially from 50% to 80% by weight (pg. 8, lines 1-4).
Isoir-Ingrez does not teach that the plurality of nonionic emulsifiers comprises about 0.1 to about 5 wt.% of one or more glyceryl esters chosen from glyceryl behenate, glyceryl erucate, glyceryl hydroxystearate, glyceryl isostearate, glyceryl lanolate, glyceryl laurate, glyceryl linoleate, glyceryl myristate, glyceryl palmitate lactate, glyceryl stearate, glyceryl distearate, or a mixture thereof (instant claim 24(b)(iii)).
Norman teaches a non-ionic oil-in-water emulsion comprising a combination of non-ionic emulsifiers and non-ionic emulsion stabilizers (abstract) for use in topical skin care compositions (paragraph [0002]). This combination includes glyceryl stearate (a glyceryl ester, and of those recited in instant claims 24(b)(iii)), PEG-100 stearate (an ethoxylated fatty acid), arachidyl glucoside (a nonionic emulsifier having a HLB from about 9 to about 12, see instant specification paragraphs [0040]-[0041]), and arachidyl alcohol (a fatty alcohol, see instant specification paragraph [0008]). Norman exemplifies in Table 1 a composition that comprises 0.9 wt.% glyceryl stearate, 0.6 wt.% PEG-100 stearate, 0.165 wt.% arachidyl glucoside, and 0.605 arachidyl alcohol. Norman further teaches that moisturizing agents, including retinol, can be used with the compositions (paragraph [0048]-[0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the composition of Isoir-Ingrez with the combination of non-ionic emulsifiers and non-ionic emulsion stabilizers taught by Norman.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Norman teaches that such non-ionic emulsions can have a non-oily, non-greasy, non-sticky, non-tacky, and/or silky feel after being applied to skin (paragraph [0014]) and the combination of non-ionic emulsifiers and stabilizers works well to provide stable oil-in-water emulsions for compositions used to moisturize the skin and treat fine lines and wrinkles (paragraphs [0002]-[0004] and [0036]). There is a reasonable expectation of success as the compositions of Isoir-Ingrez are oil-in-water emulsions taught to be used for antiaging care of keratin materials, notably of the skin, particularly the appearance of wrinkles and fine lines (pg. 1, lines 5-21), and comprise nonionic emulsifiers and fatty alcohols; the emulsions of Norman are taught to be generally useful in cosmetic compositions, including anti-aging products (paragraph [0017]), are used to treat fine lines and wrinkles (paragraph [0002]), and are taught to be used with moisturizing agents, including retinol.
Regarding the limitation of instant claim 24 that the composition “is chemically stabilized so that at least 70% of the retinol is preserved at 8 weeks in a sealed polyethylene terephthalate glycol container stored at 25°C and/or 45°C”, as noted above, Isoir-Ingrez teaches stabilized compositions such that losses of retinol are low over time (chemically stabilized retinol). Isoir-Ingrez demonstrates that the percentage degradation of inventive compositions is 20% or less upon storage at 45 °C for 1 month (pg. 34, Table 4). While the prior art does not exemplify the exact storage and stability conditions claimed, the combination of Isoir-Ingrez and Norman arrives at the structural components of the claimed cosmetic composition and a retinol-containing composition that is stable upon storage at 45 °C. There is no evidence of record that compares the stability of compositions consistent with the instant invention to those outside the instant claims, and no evidence of record that the claimed stability properties structurally limit the composition. It is interpreted that, absent evidence to the contrary, stabilized compositions which meet the structural limitations of the claims will possess the claimed properties. Per MPEP 2142 (emphasis added), “If, however, the examiner does produce a prima facie case, the burden of coming forward with evidence or arguments shifts to the applicant who may submit additional evidence of nonobviousness, such as comparative test data showing that the claimed invention possesses properties not expected by the prior art, or rebuttal arguments.”
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-10, 12-18, and 21-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 12-13, and 17-22 of copending Application No. 16/916,742 in view of Isoir-Ingrez et al. (WO 2021/123233 A1, published June 24, 2021; of record), hereafter “Isoir-Ingrez”, Norman (WO 2012/045081, published April 5, 2021; of record), and Shiloach et al. (US 2005/0227880 A1, published October 13, 2005; of record), hereafter “Shiloach”.
Similar to the instant claims, the claims of copending Application No. 16/916,742 are directed to an oil-in-water emulsion cosmetic composition comprising retinol, sodium polyacrylate (a thickening polymer), one or more nonionic emulsifiers, a fatty phase comprising one or more fatty compounds, water, and one or more polyols (water-soluble solvents). The one or more nonionic emulsifiers are chosen from polyglyceryl-based emulsifiers, polyol esters, glycerol ethers, oxyethylenated ether, oxypropylenated ethers, ethylene glycol polymers, sorbitan esters, polysorbate, and mixtures thereof. The one or more fatty compounds are chosen from fatty alcohols, fatty acids, fatty esters, oils, waxes, derivatives thereof, and mixtures thereof. The composition further comprises one or more thickening agents other than sodium polyacrylate chosen from acrylates copolymers. The wt.% of the retinol, one or more nonionic emulsifiers, fatty compounds, and water-soluble solvents of copending Application No. 16/916,742 are overlapping with those of the instant claims. from MPEP 2144.05: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
The claims of copending Application No. 16/916,742 differ from the instant claims in that they do not recite that the composition is stabilized, the specific plurality of nonionic emulsifiers, that the thickening polymer is chosen from taurate copolymers, that the composition comprises one or more miscellaneous ingredients, the wt.% of water, or the viscosity and shear rate of the composition.
Isoir-Ingrez teaches a composition (Table 1) that comprises 0.2 wt.% retinol (2.0 wt.% Retinol 10 SU, which is 10% by weight active material in soybean oil, see pg. 5, lines 12-17), 2.0 wt.% PEG-40 stearate, (an ethoxylated fatty acid), and 0.9 wt.% sorbitan tristearate (an additional nonionic emulsifier). This results in 2.9 wt.% of a plurality of nonionic emulsifiers. Isoir-Ingrez further teaches that the nonionic surfactant can include alkyl and polyalkylglucosides or polyglucosides containing an alkyl group including from 6 to 30 carbon atoms, such as laurylglucoside and arachidyl glucoside (pg. 20, lines 15-31) one or more nonionic surfactants having a HLB from about 9 to about 12 (as provided in the instant specification paragraphs [0042] and example 1); surfactants are preferably present from 0.5% to 10% by weight (Isoir-Ingrez, pg. 21, lines 22-24).The composition of Isoir-Ingrez further comprises 2.5 wt.% cetyl alcohol (a fatty alcohol) and 13.0 wt.% other fatty compounds (combination of diisopropyl sebacate, isononyl isnononanoate, isohexadecane, and soybean oil from Retinol 10 SU. The composition of Isoir-Ingrez further comprises the thickening polymers ammonium polyacryloyldimethyl taurate and sodium acrylate/sodium acryloyldimethyl taurate copolymer and water 60.076 wt.% water. The composition further comprises 3.774 wt.%. miscellaneous ingredients including fillers (silica), pH adjusters (citric acid), and further skin active agents (adenosine). The compositions of Isoir-Ingrez are preferably in the form of an oil-in-water emulsion (pg. 25, lines 19-20). Isoir-Ingrez teaches that one or more thickeners and/or gelling agents may be incorporated to obtain a desired viscosity (pg. 21, lines 27-29). Isoir-Ingrez teaches that the combination of at least one di-t-butyl pentaerythrityl tetrahydroxycinnamate compound, at least one ethylenediaminedisuccinic acid salt and at least carnosine makes it possible to efficiently stabilize the retinol contained in a cosmetic composition, that losses of retinol compound contained in compositions of the invention are low over time, and that no degradation of odor or color occurs when using the composition (pg. 3, lines 21-30); the compositions of Isoir-Ingrez are thus interpreted as being stabilized.
Norman teaches a non-ionic oil-in-water emulsion comprising a combination of non-ionic emulsifiers and non-ionic emulsion stabilizers (abstract) for use in topical skin care compositions (paragraph [0002]). This combination includes glyceryl stearate (a glyceryl ester, and of those recited in instant claims 5, 22, and 24), PEG-100 stearate (an ethoxylated fatty acid), arachidyl glucoside (a nonionic emulsifier having a HLB from about 9 to about 12, see instant specification paragraphs [0040]-[0041]), and arachidyl alcohol (a fatty alcohol, see instant specification paragraph [0008]). Norman exemplifies in Table 1 a composition that comprises 0.9 wt.% glyceryl stearate, 0.6 wt.% PEG-100 stearate, 0.165 wt.% arachidyl glucoside, and 0.605 arachidyl alcohol. Norman further teaches that moisturizing agents, including retinol, can be used with the compositions (paragraph [0048]-[0049]). Norman teaches that the viscosity of topical skin care compositions can be selected to achieve a desired result or type of composition, and can range from about 1cps to well over a million cps, as measured at 25 °C (paragraph [0013]); 1 cP=0.1 Pa.s.
Shiloach teaches an aqueous isotropic liquid cleansing and moisturizing composition with a viscosity in the range of about 1,000 to 300,000 cps @1/sec shear rate at 25 °C (abstract, claim 1). The composition can include active agents (paragraph [0162]) including retinol as an anti-wrinkle, anti-skin atrophy and skin repair active (paragraph [0166]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the composition of copending Application No. 16/916,742 with the taurate copolymer, wt.% of water, and stabilizing miscellaneous ingredients of Isoir-Ingrez and the combination of non-ionic emulsifiers and non-ionic emulsion stabilizers taught by Norman.
Substituting the sodium acrylate/sodium acryloyldimethyl taurate copolymer of Isoir-Ingrez into the composition of copending Application No. 16/916,742 would have been prima facie obvious, as copending Application No. 16/916,742 recites thickening agents other than sodium acrylates chosen from acrylates copolymers. Simple substitution of one known thickening agent for another is within the purview of the skilled artisan and would yield predictable results (see MPEP 2141 III). Adjusting the wt.% of water of an oil-in-water emulsion as taught by the prior art could be accomplished by routine optimization. From MPEP 2144.05 "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The addition of miscellaneous ingredients would be prima facie obvious, as Isoir-Ingrez teaches that such additives are conventionally used in the cosmetic field and can be used for advantageous effects such as combating greasy skin (pg. 25, lines 21-25) and ingredients of at least one di-t-butyl pentaerythrityl tetrahydroxycinnamate compound, at least one ethylenediaminedisuccinic acid salt and at least carnosine makes it possible to efficiently stabilize the retinol contained in a cosmetic composition and minimize losses of retinol over time.
Further, the non-ionic emulsions of Norman are taught to have a non-oily, non-greasy, non-sticky, non-tacky, and/or silky feel after being applied to skin (paragraph [0014]) and the combination of non-ionic emulsifiers and stabilizers works well to provide stable oil-in-water emulsions (paragraph [0036]), providing motivation for one of ordinary skill in the art to incorporate them into the oil-in-water emulsion of copending Application No. 16/916,742.
It would further have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to routinely optimize the viscosity and shear rate of the composition of copending Application No. 16/916,742 to reach those of instant invention. Isoir-Ingrez teaches that the viscosity of retinol-containing compositions can be modified by the use of thickeners and/or gelling agents and Norman teaches that the viscosity of such compositions can be selected to achieve a desired type of composition and a range of viscosities overlapping those of the instant claim. Further, Shiloach teaches compositions having a viscosity overlapping the range of the instant claim @1/sec shear rate at 25 °C are suitable for cleansing and moisturizing compositions comprising retinol. From MPEP 2144.05 II. A.: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, From MPEP 2144.05 I.: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding the limitation of the instant claims that the composition “is chemically stabilized so that at least 70% of the retinol is preserved at 8 weeks in a sealed polyethylene terephthalate glycol container stored at 25°C and/or 45°C”, as noted above, Isoir-Ingrez teaches stabilized compositions such that losses of retinol are low over time (chemically stabilized retinol). Isoir-Ingrez demonstrates that the percentage degradation of inventive compositions is 20% or less upon storage at 45 °C for 1 month (pg. 34, Table 4). While the prior art does not exemplify the exact storage and stability conditions claimed, the modification of the composition of copending Application No. 16/916,742 described above arrives at the structural components of the claimed cosmetic composition and a retinol-containing composition that is stable upon storage at 45 °C. There is no evidence of record that compares the stability of compositions consistent with the instant invention to those outside the instant claims, and no evidence of record that the claimed stability properties structurally limit the composition. It is interpreted that, absent evidence to the contrary, stabilized compositions which meet the structural limitations of the claims will possess the claimed properties.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject
matter of copending Application No. 16/916,742, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants’ arguments filed 01/05/2026 have been fully considered, but are not persuasive.
Applicant reiterates the arguments that persons of ordinary persons of ordinary skill in the art would not have been motivated to modify Isoir-Ingrez to address the instability problem of retinol in cosmetic compositions since this problem, according to Isoir-Ingrez, was its focus and solved by the compositions disclosed therein. Applicant argues that the problem solved according to the Office Action is illusory or non-existent, and that Example 3 of MPEP § 2143 I. points out that adding an additional component to a known, successfully marketed formulation amounted to extra work and greater expense for no apparent reason which is not the same as combining known prior art elements. Applicant further argues that persons of ordinary skill in the art would not have even looked to Norman for a solution to the issues related to providing stabilized cosmetic compositions containing high amounts of retinol that are addressed by the present invention and also discussed by Isoir-Ingrez as Norman is not concerned with problems associated when employing retinol and even less so with the stability problem. The present invention provides a solution to the stability problem that is an alternative to the solution provided by Isoir-Ingrez or any other cited art, and the present invention has been distinguished over the prior art. Applicant argues that when formulating a composition and especially a cosmetic composition it is important to keep in mind that the more complex the composition becomes the more difficult it is to avoid negative interactions between the components.
These arguments are unpersuasive. The instant claims recite “A stabilized cosmetic composition…” and the instant specification suggests that stability can refer to physical stability (i.e., lack of visual separation and particulate formation) and/or chemical stability (i.e., resistance of retinol to degradation) (see particularly paragraphs [0017], [0129], and Examples 1-2 of the instant specification). While Norman is not primarily concerned with the chemical stability of retinol, Norman is concerned with providing physically stable water-in-oil emulsions (i.e., storage stable, color stable or both) in moisturizing compositions for the treatment of fine lines and wrinkles (see abstract, paragraphs [0002]-[0004], [0013]). Norman reasonably suggests to one of ordinary skill in the art that the particular combination of emulsifiers and stabilizers are what contribute to the physical stability of the oil-in-water emulsion (paragraphs [0035]-[0036]), motivating the skilled artisan to employ this combination to impart physical stability to the oil-in-water emulsions of Isoir-Ingrez, similarly taught for use in treating the signs of skin aging. The fact that Norman teaches that the emulsifier and stabilizer combination can be used in retinol-containing emulsions speaks to the reasonable expectation of success that an ordinary skilled artisan would have had in making this modification. The Examiner respectfully maintains the position that the test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding the reference to Example 3 of MPEP § 2143 I.A, the Examiner notes that the above rejection does not rely on a rationale of combining known prior art elements, but rather the rationale that there is a teaching, suggestion, or motivation in the prior art of Norman to modify the prior art of Isoir-Ingrez (see MPEP 2143 I.G.). The cited MPEP section further does not appear relevant to the issues at hand as Applicant does not provide evidence that the composition taught by Isoir-Ingrez is a successfully marketed product.
The suggestion that the claimed invention provides an unexpected solution to the retinol stability problem and has been distinguished over the prior art is unpersuasive. The evidence of record does not provide any comparison to compositions of the prior art or even any comparisons to compositions outside the scope of the claimed invention, and thus, no unexpected results can be concluded. Further, the instant specification exemplifies only two narrow embodiments of the claimed compositions (see Example 1), and from these examples, it is unclear that any alleged unexpected stability results would extend to the full scope of the independent claims.
Regarding the argument that the more complex the composition becomes the more difficult it is to avoid negative interactions between the components, the Examiner respectfully maintains that should Applicants be suggesting that the combination would render the prior art inoperable, arguments of counsel cannot take the place of evidence in the record (see MPEP 2145).
Applicant continues to argue that use of 50% by weight or less of water is critical to and required by the invention of Norman. Applicant argues that it is improper to combine references where the references teach away from their combination, and a showing that the prior art teaches away from the claimed invention argues against the obviousness of the invention. Applicant argues that that even if Norman were properly combinable with Isoir-Ingrez, the present invention would not be achieved since the independent claims specify greater amounts of water and the cited art fails to teach all the claim recitations. Applicant argues that Norman does not attribute that beneficial effects mentioned therein are achieved only or merely because of the combination of non-ionic emulsifiers and stabilizers and rather requires a combination of non-ionic emulsifiers and non-ionic emulsion stabilizers, a combination of humectant skin conditioning agents, and a combination of UV absorbing agents to produce a stable oil-in-water emulsion having less than 50% (w/w) of water. Applicant argues that it is improper to selectively rely on only certain teachings of a reference to find obviousness while ignoring and disregarding the teachings as a whole and the inferences a skilled artisan might draw from them, and the rejection of the claims is predicated on improper hindsight. Applicant argues that is imperative that secondary considerations also be evaluated in determining patentability even where the claimed invention involves only relatively simple mechanical concepts, as in the invention in McLaughlin.
The Examiner respectfully maintains the position previously set forth in prior Office Actions that the rejection is not suggesting the bodily incorporation of the features of Norman into the composition of Isoir-Ingrez, but rather the modification of the composition of Isoir-Ingrez with the combination of non-ionic emulsifiers and non-ionic emulsion stabilizers taught by Norman to achieve the beneficial effects suggested by Norman. Per MPEP 2145 III., “("The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art."); In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983)”.
As noted above, Norman reasonably suggests to one of ordinary skill in the art that the particular combination of emulsifiers and stabilizers are what contribute to the physical stability of the oil-in-water emulsion (paragraphs [0035]-[0036]), motivating the skilled artisan to employ this combination to impart physical stability to the oil-in-water emulsions of Isoir-Ingrez. It is further noted that Norman teaches that water can be included in any amount in the compositions (paragraph [0041]), and suggests to the skilled artisan that the exemplified oil-in-water emulsions are able to remain stable in spite of lower amounts of water. From Norman, paragraph [0034] (emphasis added), “In one non-limiting aspect of the present invention, the oil-in-water emulsions can include less than 50% (w/w) of water, yet still remain stable and produce a cosmetically elegant feel when applied to skin.” Per MPEP 2123 I., patents are relevant as prior art for all they contain, and a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.
Regarding the argument that the prior art teaches away from the combination of the prior art, the Examiner notes that, per MPEP 2123 II., “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” As set forth above, while Norman may exemplify emulsions with less than 50% (w/w) of water, this example is non-limiting. Norman provides a broad teaching that water can be included in any amount in the compositions (paragraph [0041]), and does not teach away from the claimed invention.
Regarding the argument that the rejection is predicated improper hindsight, the Examiner respectfully maintains the position set forth in previous Office Actions regarding this point. Primarily, the Examiner submits that the rejection only takes into account knowledge from the teachings of the prior art which was within the level of ordinary skill before the effective filing date of the instant invention, and the rejections do not include knowledge gleaned only from the disclosure.
Applicant continues to argue that claim 18 excludes the combination of di-t-butyl pentaerythrityl tetrahydroxycinnamate; an ethylenediaminedisuccinic acid salt; and carnosine required according to the invention of lsoir-Ingrez.
The Examiner respectfully disagrees and maintains the position that the di-t-butyl pentaerythrityl tetrahydroxycinnamate, an ethylenediaminedisuccinic acid salt required by Isoir-Ingrez are consistent with the limitation of claim 18 (emphasis added), “(h) about 8 wt.% of one or more miscellaneous ingredients chosen from miscellaneous emulsifiers/surfactants other than the nonionic emulsifiers of plurality of nonionic emulsifiers of (b), preservatives, fragrances, pH adjusters, salts, antioxidants, vitamins, botanical extracts, UV filtering agents, soybean proteins, protein hydrolysates and/or isolates, hydrotropes, pearlescent agents, fillers, colorants, mattifying agents, further skin active agents, buffers, and mixtures thereof”. The Examiner maintains the position that ethylenediaminedisuccinic acid salt is a salt and, as evidenced by Johnson and Reddy, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate and carnosine are known antioxidants. These components are exemplified by Isoir-Ingrez in an amount of 1.0 wt.% total, and thus these required components are consistent with the miscellaneous ingredients of claim 18(h). The fact that a compound may be used for various purposes does not change the identity of that compound; i.e., a salt remains a salt whether it is being used as a stabilizing agent or for another purpose. Further, Isoir-Ingrez teaches that antioxidants are known for use in the stabilization of retinol in a cosmetic composition (pg. 2, lines 10-25).
In view of the forgoing, and as further detailed in the above rejections, the Examiner maintains that the instant claims are prima facie obvious over the teachings of the modified Isoir-Ingrez.
Regarding the non-statutory double patenting rejections over co-pending Application Nos. 16/916,742 and 16/916,380 in view of the cited art, Applicant submits that for the reasons set forth above that the independent claims of the present invention are patentable over Isoir-Ingrez, Norman, and Shiloach and the cited art does not cure the deficiencies of the claims of co-pending applications.
As noted above, the nonstatutory double patenting rejections over the claims of co-pending Application 16/916,380 are withdrawn in view of the amendments to the claims of the co-pending application. The arguments regarding the cited art are addressed above. Accordingly, the Examiner respectfully maintains that the claims are unpatentable over the claims co-pending Application No. 16/916,742, in view of the cited art, for the reasons set forth above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611