Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
A fifth 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 24, 2025 has been entered.
Claims 1, 3, 4, 6, 8-14, 18-24, 26 and 27 are pending.
Claims 2, 5, 7, 15-17 and 25 are cancelled.
Claims 1, 8, 24, 26 and 27 are currently amended.
Claims 12-14, 20 and 21 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 3, 4, 6, 8-11, 18, 19, 22-24, 26 and 27 as filed on January 28, 2025 are under consideration.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim objections are withdrawn, all previous claim rejections under 35 USC 112(b) are withdrawn, and all previous claim rejections under 35 USC 112(d) are withdrawn.
Applicant’s arguments 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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, 3, 4, 6, 8-11, 18, 19, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lambers (US 2003/0215414, published November 20, 2003, of record) as evidenced by The Derm Review “Ceramides” September 28, 2018, of record, in view of
De Paoli Ambrosi (US 2006/0063835, published March 23, 2006, of record);
Spada et al. “Skin hydration is significantly increased by a cream formulated to mimic the skin’s own natural moisturizing systems,” Clinical, Cosmetic and Investigational Dermatology 11:491-497, 2018, of record; Vielhaber (US 2008/0268077, published October 30, 2008, of record); and Ri et al. (JP 2001-199872 A, published July 24, 2001, as evidenced by the Google translation, of record) as evidenced by Ortiz-Tafoya et al. “Physicochemical characterization of sodium stearoyl lactylate (SSL), polyoxyethylene sorbitan monolaurate (Tween 20) and kappa-carrageenan,” Data in Brief 19:642-650, 2018, of record.
Lambers is applied herewith on the first emulsifier embodiment drawn to ionically uncharged molecules
Lambers teaches compositions comprising a combination of a sphingoid base and a ceramide (title; abstract; claims; paragraph [0010]). The sphingoid base and the ceramide may be present from 0.001 to 10 wt%, from 0.02 to 1 wt% (paragraph [0037]), as required by instant claims 9 and 27. 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). See MPEP 2144.05. The ratio of the sphingoid base to the ceramide may range from 1 to 10 to 10 to 1, from 1 to 5 to 1 to 1 (paragraph [0038]), as required by instant claims 6, 23 and 27.
The sphingoid base is preferably a sphingosine, a sphinganine or a phytosphingosine (claim 2; paragraph [0021]), as required by instant claims 3, 4 and 23. Creams I-IV and the liposomal formulation comprise phytosphingosine (paragraphs [0092]-[0108]).
The ceramide can be ceramide 1, 2, 3, 4, 5, 6I or/and 6II (claim 4; paragraphs [0023]-[0028]). Creams I-IV and the liposomal formulation comprise ceramide 3 (ceramide NP as evidenced by page 4 of The Review) and ceramide 6 (ceramide AP as evidenced by pages 6-7 of The Review) (paragraphs [0092]-[0108]). Cream I comprises 1 wt% ceramide 3 and 0.5 wt% ceramide 6 (ratio NP:AP of 2:1) (paragraph [0100]). The compositions may comprise an individual ceramide as well as a mixture of two or more different ceramides; a combination of ceramides may lead to increased ceramide solubility in comparison to individual ceramides which may tend to crystallize (compositions are physically stable as defined at page 8, lines 23-27 of the instant specification) (paragraphs [0024]-[0026]).
The compositions may further comprise one or more additional skin lipid compounds such as cholesterol (claim 5; paragraph [0029]). Creams II and III comprise 0.25 wt% or 1.25 wt% cholesterol (renders obvious a range of 0.25 to 1.25 wt%) (paragraphs [0101]-[0104]), as required by instant claims 10, 18, 23 and 27.
The compositions may be applied in combination with a conventional antiinflammatory and/or antimicrobial agent (claim 10; paragraph [0033]). Lambers further teaches the compositions are suitable for application to skin conditions associated with an infectious state inclusive of bacterial infections (abstract; paragraph [0088]).
The compositions comprise a vehicle which may comprise water and other active ingredients inclusive of anti-oxidants and preservatives like sorbic acid or/and benzoic acid (paragraphs [0040]-[0041] and [0079]-[0081]). Cream IV is aqueous and comprises 0.6 wt% Phenonip mixed parabens in phenoxyethanol (preservative).
The compositions may comprise surfactants (surface active agents) / emulsifiers which may be nonionic or/and anionic in nature; emulsifiers impart the ability to form oil-in-water emulsions or/and are able to form a lamellar phase (paragraphs [0041] and [0043]-[0073]). Exemplary emulsifiers include glyceryl stearate, sodium stearoyl lactylate and sodium lauroyl lactylate (paragraphs [0052]-[0053], [0061]-[0065] and Table bridging pages 5 and 6), as required by instant claim 26. Lambers exemplifies a composition comprising sodium lauroyl lactylate as the only emulsifier, wherein the weight ratio of A and B to E is 1:9 (Table bridging pages 5 and 6), as required by instant claim 26.
The compositions may comprise emollients such as oils, waxes and hydrocarbons (paragraph [0042]).
Lambers does not teach C) triethyl citrate, E) an emulsifier comprising at least 50 mol% ionically uncharged molecules, the weight ratio [(A)+(B)]:(E) is 1:2 to 1:10, and a pH of 4 to 8 as required by claim 1.
Lambers does not teach C) triethyl citrate, E) 0.3 to 2 wt% emulsifier comprising at least 50 mol% ionically uncharged molecules, and a pH of 4 to 8 as required by claim 8.
Lambers does not teach the weight ratio (A):(B):(C) is (2-6):(1-2):(1-2) as required by claims 6 and 23.
Lambers does not teach the composition has a pH of 4.5 to 7.4 as required by claim 11.
Lambers does not teach the composition has a pH of 4 to 5.4 as required by claim 19.
Lambers does not teach the non-aqueous solvent consists of the triethyl citrate as required by claim 22.
These deficiencies are made up for in the teachings of De Paoli Ambrosi, Spada, Vielhaber and Ri.
De Paoli Ambrosi teaches triethyl citrate for the treatment of bacterial infections of the skin; triethyl citrate possesses antibiotic, antiseptic and disinfectant activities and does not generate bacterial resistance phenomena (title; abstract; claims; paragraph [0004]). Triethyl citrate may be present from 0.01 to 99 wt% of the final formulation (claims; paragraphs [0009], [0014]).
Spada teaches ceramide cream is formulated with an acidic pH (pH less than 7) which has been shown to be optimal for healthy skin (title; abstract; page 493, Table 1; page 496, rhc, 1st full paragraph; page 497, reference 24 “Formulating at pH 4-5”), as required by instant claims 11 and 19.
Vielhaber teaches ceramide compositions which may comprise 1 to 98 wt% surfactants inclusive of combinations of anionic and/or amphoteric (ionically charged) with one or more non-ionic; non-ionic surfactants do not form ions in the aqueous medium (title; abstract; claims; paragraphs [0054], [0165]-[0202]). Anionic surfactants include inter alia acyl lactylates (paragraph [0172]). Non-ionic surfactants include inter alia esters of carboxylic acids with glycerol or/and glycerol esters (paragraphs [0192], [0196], [0199]).
Ri teaches an additive for ceramide capable of suppressing the precipitation of ceramide with age comprising (B) alkyloyllactic acid and or its salt (ionically charged) and (C) glycerin and/or its polyglycerin fatty acid ester (title; abstract; claims). The weight ratio of (B):(C) is 1:20 to 20:1 (claim 9). The additive is an emulsifier (claim 10). Cosmetics prepared with the additive have no storage of ceramide crystals under a microscope and have excellent storage stability at at least 40 ºC for 8 weeks (page 5, last full paragraph). Example 1 comprises ceramide 3, monoglyceryl stearate (MW ~359 g/mol) and sodium stearoyl lactate (MW ~451 g/mol) (paragraph bridging pages 5 and 6). As evidenced by Ortiz-Tafoya, sodium stearoyl lactylate (lactate) has a surface tension less than 40 mN/m above the cmc of 0.05 wt% at 25 ºC (Figure 4; page 647, last full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Lambers inclusive of the exemplary compositions to further comprise 0.01 to 99 wt% of triethyl citrate as taught by De Paoli Ambrosi because triethyl citrate possesses antibiotic, antiseptic and disinfectant activities and does not generate bacterial resistance phenomena. There would be a reasonable expectation of success because Lambers, as a whole, is drawn to compositions suitable for application to skin conditions associated with an infectious state inclusive of bacterial infections and because the compositions of Lambers may be applied in combination with antimicrobial agents. Therefore, the combined teachings of Lambers in view of De Paoli Ambrosi render obvious amounts of triethyl citrate which overlap the relative amounts set forth in claims 6 and 23 because the compositions of Lambers comprise 0.001 to 10 wt% of the ceramide and the sphingoid base, the ratio of the sphingoid base to the ceramide ranging from 1 to 10 to 10 to 1. An overlapping range is sufficient for a finding of prima facie obviousness. See MPEP 2144.05. The combined teachings of Lambers in view of De Paoli Ambrosi also render obvious compositions wherein triethyl citrate is the only nonaqueous solvent as set forth in claim 22.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ceramide compositions of Lambers in view of De Paoli Ambrosi to have an acidic pH (pH less than 7) as taught by Spada such as a pH of 4 to 5 because ceramide cream formulated with an acidic pH has been shown to be optimal for healthy skin. There would be a reasonable expectation of success because neither Lambers nor De Paoli Ambrosi delimit the pH of the compositions thereof and because Lambers teaches and exemplifies ceramide creams which are intended to improve skin condition as set forth in the abstract thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of the surfactant / emulsifier of the ceramide compositions of Lambers in view of De Paoli Ambrosi and Spada to comprise 1 to 98 wt% of the composition as taught by Vielhaber because this amount of surfactant / emulsifier is suitable for formulating ceramide compositions. There would be a reasonable expectation of success because Lambers does not delimit the amount of surfactant / emulsifier. Regarding claim 1 which recites a ratio of (A+B):emulsifier, Lambers teaches the sphingoid base and the ceramide (B+A) from 0.001 to 10 wt% and Vielhaber teaches 1 to 98 wt% emulsifier, therefore, the combined teachings render obvious ratios as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surfactant / emulsifier of the ceramide compositions of Lambers in view of De Paoli Ambrosi, Spada and Vielhaber to comprise combinations of alkyloyllactic acid and salts thereof such as sodium stearoyl lactate (charged) and glycerin fatty acid esters such as glyceryl stearate (uncharged) in weight ratios of 1:20 to 20:1 as taught by Ri because such combinations suppress precipitation of ceramides with age and yield cosmetics with excellent storage stability. There would be a reasonable expectation of success because Lambers teaches suitable emulsifiers include glyceryl stearate and sodium stearoyl lactylate. Regarding the surface tension of the emulsifier, Ortiz-Tafoya evidences sodium stearoyl lactylate (lactate) as taught / exemplified by Ri has a surface tension less than 40 mN/m above the cmc of 0.05 wt% at 25 ºC. It is presumed that the combination of additional surface active agents inclusive of glyceryl stearate would not increase the surface tension because by definition surfactants reduce the surface tension of water. Therefore, the combined teachings of the prior art render obvious emulsifiers having properties as instantly claimed in amounts as instantly claimed in combination with ceramides in weight ratios as instantly claimed.
Regarding the property / result achieved after six months of storage at 25 ºC, Lambers expressly teaches mixtures of different ceramides to increase solubility / decrease crystallization and Ri expressly teaches emulsion vehicles wherein ceramides are combined with specific emulsifiers and ratios thereof have excellent storage stability. As such, the compositions rendered obvious by the combined teachings of the prior art are physically stable as instantly claimed.
Claims 1, 3, 4, 6, 8-11, 18, 19, 22-24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lambers (US 2003/0215414, published November 20, 2003, of record) as evidenced by The Derm Review “Ceramides” September 28, 2018, of record, in view of De Paoli Ambrosi (US 2006/0063835, published March 23, 2006, of record); Spada et al. “Skin hydration is significantly increased by a cream formulated to mimic the skin’s own natural moisturizing systems,” Clinical, Cosmetic and Investigational Dermatology 11:491-497, 2018, of record; Vielhaber (US 2008/0268077, published October 30, 2008, of record); and Ri et al. (JP 2001-199872 A, published July 24, 2001, as evidenced by the Google translation, of record) as evidenced by Ortiz-Tafoya et al. “Physicochemical characterization of sodium stearoyl lactylate (SSL), polyoxyethylene sorbitan monolaurate (Tween 20) and kappa-carrageenan,” Data in Brief 19:642-650, 2018, of record as applied to claims 1, 3, 4, 6, 8-11, 18, 19, 22 and 23 above, and further in view of Sakulowski (WO 2019/077039, published April 25, 2019, of record).
The teachings of Lambers, De Paoli Ambrosi, Spada, Vielhaber and Ri have been described supra.
They do not teach a preservative selected from (i) methylpropanediol, caprylyl glycol and phenylpropanol, (ii) sodium levulinate and potassium sorbate, and (iii) caprylyl glycol and benzoic acid as required by claim 24.
This deficiency is made up for in the teachings of Sakulowski.
Sakulowski teaches a preservative comprising 1,2-octanediol (caprylyl glycol) and benzoic acid useful for preservation of cosmetic products (title; abstract; claims; pages 4-5, Germ count Reduction test). The preservative exhibits antimicrobial activity against S. aureus, E. coli and P. aeruginosa and is better than either 1,2-octanediol or benzoic acid alone (page 5, Table 1c; page 6, lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the preservative taught by Sakulowski for the preservative in the compositions of Lambers because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary. There would be a reasonable expectation of success because the compositions of Lambers may comprise preservatives inclusive of benzoic acid. One would have been motivated to do so because the preservative combination of Sakulowski is better than benzoic acid alone.
Regarding the wherein clause of claim 27 drawn to passing preservation stress tests, because the combined teachings of the prior art render obvious compositions as instantly claimed, it is presumed that the compositions of the prior art are capable of passing preservation stress testing, absent evidence to the contrary. In further support of this presumption, Sakulowski teaches compositions comprising 1,2-octanediol (caprylyl glycol) and benzoic acid exhibit antimicrobial activity against S. aureus, E. coli and P. aeruginosa.
Claims 1, 3, 4, 6, 8-11, 18, 19, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lambers (US 2003/0215414, published November 20, 2003, of record) as evidenced by The Derm Review “Ceramides” September 28, 2018, of record, in view of
De Paoli Ambrosi (US 2006/0063835, published March 23, 2006, of record);
Spada et al. “Skin hydration is significantly increased by a cream formulated to mimic the skin’s own natural moisturizing systems,” Clinical, Cosmetic and Investigational Dermatology 11:491-497, 2018, of record; and Dahms (WO 98/53797, published December 3, 1998, IDS reference filed March 23, 2020, as evidenced by the Google translation, of record).
Zhang is applied herewith on the second / new emulsifier embodiment drawn to sodium lauroyl lactylate as introduced into the claims on January 28, 2025
The teachings of Lambers have been described supra.
Lambers does not specifically teach C) triethyl citrate, E) an emulsifier that is sodium lauroyl lactylate, and a pH of 4 to 8 as required by claim 1.
Lambers does not specifically teach C) triethyl citrate, E) 0.3 to 2 wt% sodium lauroyl lactylate, and a pH of 4 to 8 as required by claim 8.
Lambers does not teach the weight ratio (A):(B):(C) is (2-6):(1-2):(1-2) as required by claims 6 and 23.
Lambers does not teach the composition has a pH of 4.5 to 7.4 as required by claim 11.
Lambers does not teach the composition has a pH of 4 to 5.4 as required by claim 19.
Lambers does not teach the non-aqueous solvent consists of the triethyl citrate as required by claim 22.
These deficiencies are made up for in the teachings of De Paoli Ambrosi, Spada, and Dahms.
The teachings of De Paoli Ambrosi have been described supra.
The teachings of Spada have been described supra.
Dahms teaches encapsulation of water insoluble substances inclusive of ceramides with surfactants inclusive of sodium lauroyl lactylate (title; abstract; claims; Example 12). The preferred quantitative ratios are 0.1 to 15, particularly preferably 0.3 to 12, in particular 0.5 to 10 parts by weight of active ingredient per 1 to 5 parts by weight of surfactant and 0.1 to 15 parts by weight of active ingredient / surfactant mixture to 1 to 5 parts by weight of water (page 3, 1st full paragraph). Example 12 comprises 3 parts sodium lauroyl lactylate and 1 part ceramide. Encapsulation increases stability (page 1, last full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Lambers inclusive of the exemplary compositions to further comprise 0.01 to 99 wt% of triethyl citrate as taught by De Paoli Ambrosi because triethyl citrate possesses antibiotic, antiseptic and disinfectant activities and does not generate bacterial resistance phenomena. There would be a reasonable expectation of success because Lambers, as a whole, is drawn to compositions suitable for application to skin conditions associated with an infectious state inclusive of bacterial infections and because the compositions of Lambers may be applied in combination with antimicrobial agents. Therefore, the combined teachings of Lambers in view of De Paoli Ambrosi render obvious amounts of triethyl citrate which overlap the relative amounts set forth in claims 6 and 23 because the compositions of Lambers comprise 0.001 to 10 wt% of the ceramide and the sphingoid base, the ratio of the sphingoid base to the ceramide ranging from 1 to 10 to 10 to 1. An overlapping range is sufficient for a finding of prima facie obviousness. See MPEP 2144.05. The combined teachings of Lambers in view of De Paoli Ambrosi also render obvious compositions wherein triethyl citrate is the only nonaqueous solvent as set forth in claim 22.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ceramide compositions of Lambers in view of De Paoli Ambrosi to have an acidic pH (pH less than 7) as taught by Spada such as a pH of 4 to 5 because ceramide cream formulated with an acidic pH has been shown to be optimal for healthy skin. There would be a reasonable expectation of success because neither Lambers nor De Paoli Ambrosi delimit the pH of the compositions thereof and because Lambers teaches and exemplifies ceramide creams which are intended to improve skin condition as set forth in the abstract thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ceramide compositions of Lambers in view of De Paoli Ambrosi and Spada to comprise surfactants inclusive of sodium lauroyl lactylate as taught by Dahms in an amount of 1 to 5 wt% or/and in an amount of 1 to 5 parts per 0.1 to 15 parts of the actives such as in an amount of 3 parts per 1 part of the actives in order to encapsulate the ceramide and sphingoid base actives. There would be a reasonable expectation of success because Lambers exemplifies an embodiment of encapsulation within sodium lauroyl lactylate (table bridging pages 5 and 6).
Regarding the property / result achieved after six months of storage at 25 ºC, Lambers expressly teaches mixtures of different ceramides to increase solubility / decrease crystallization and Dahms expressly teaches encapsulation increases stability. As such, the compositions rendered obvious by the combined teachings of the prior art are physically stable as instantly claimed.
Claims 1, 3, 4, 6, 8-11, 18, 19, 22-24, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lambers (US 2003/0215414, published November 20, 2003, of record) as evidenced by The Derm Review “Ceramides” September 28, 2018, of record, in view of
De Paoli Ambrosi (US 2006/0063835, published March 23, 2006, of record);
Spada et al. “Skin hydration is significantly increased by a cream formulated to mimic the skin’s own natural moisturizing systems,” Clinical, Cosmetic and Investigational Dermatology 11:491-497, 2018, of record; and Dahms (WO 98/53797, published December 3, 1998, IDS reference filed March 23, 2020, as evidenced by the Google translation, of record) as applied to claims 1, 3, 4, 6, 8-11, 18, 19, 22 and 23 above, and further in view of Sakulowski (WO 2019/077039, published April 25, 2019, of record).
The teachings of Lambers, De Paoli Ambrosi, Spada and Dahms have been described supra.
They do not teach a preservative selected from (i) methylpropanediol, caprylyl glycol and phenylpropanol, (ii) sodium levulinate and potassium sorbate, and (iii) caprylyl glycol and benzoic acid as required by claim 24.
This deficiency is made up for in the teachings of Sakulowski.
The teachings of Sakulowski have been described supra.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the preservative taught by Sakulowski for the preservative in the compositions of Lambers because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary. There would be a reasonable expectation of success because the compositions of Lambers may comprise preservatives inclusive of benzoic acid. One would have been motivated to do so because the preservative combination of Sakulowski is better than benzoic acid alone.
Regarding the wherein clause of claim 27 drawn to passing preservation stress tests, because the combined teachings of the prior art render obvious compositions as instantly claimed, it is presumed that the compositions of the prior art are capable of passing preservation stress testing, absent evidence to the contrary. In further support of this presumption, Sakulowski teaches compositions comprising 1,2-octanediol (caprylyl glycol) and benzoic acid exhibit antimicrobial activity against S. aureus, E. coli and P. aeruginosa.
Claims 1, 3, 4, 6, 8-11, 18, 19, 22-24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Korevaar et al. (US 2010/0184733, published July 22, 2010, of record) in view of Schmitt et al. “Investigation of a CER[NP]- and [AP]-based stratum corneum modeling membrane system: using specifically deuterated CER together with a neutron diffraction approach,” Langmuir 34:1742-1749, 2018, of record; Yu et al. (US 5,686,489, published November 11, 1997, of record); Clemente et al. (US 2011/0195036, published August 11, 2011, of record); and Sakulowski (WO 2019/077039, published April 25, 2019, of record).
Korevaar teaches skin treatment compositions comprising (title; abstract; claims; paragraphs [0024]-[0032]):
0.1 to 10 wt% of a mixture able to mimic skin identical structures comprising:
10 to 80 wt% of ceramide(s) (0.01 to 8 wt% of the total composition A+B) inclusive of at least one of ceramide NS, NP or/and NH (paragraphs [0026], [0053]-[0055]) as well as sphingoid base(s) inclusive of phytosphingosine (paragraphs [0041]-[0046], [0057]) and ceramides such as ceramide AP (paragraphs [0058]-[0059], [0068]-[0069]), as required by instant claims 3, 4, 9, 23 and 27;
10 to 45 wt% cholesterol (0.01 to 4.5 wt% of the total composition D), as required by instant claims 10, 18, 23 and 27;
10 to 45 wt% of free fatty acids;
0.5 to 10 wt% of nonionic emulsifier(s) (ionically uncharged E) with a combined HLB of 12 to 19; and
at least 40 wt% water.
The compositions show no crystallization of ceramides upon storage for up to 1 year at temperatures between -5 and 40 ºC (physically stable, no separation or inhomogeneity) (paragraphs [0035], [0037]-[0038]; also [0010]). The compositions may optionally further comprise auxiliaries and additives inclusive of additional biogenic active ingredients inclusive of anti-aging actives like alpha hydroxy acids or/and buffers or/and UV filters or/and preservatives (paragraphs [0032], [0084], [0091]-[0101]). The compositions may be incorporated into cosmetic formulations inclusive of emulsions in an effective amount between 0.001 and 20 wt% (paragraphs [0036], [0085], [0089]-[0090]).
Regarding the ratio by weight of (A+B):E of 1:2 to 1:10 as required by claim 1, Korevaar renders obvious a range of 0.01/4.5 to 8/0.01 which overlaps the claimed range, sufficient for prima facie obviousness. See MPEP 2144.05.
Regarding the ratio by weight of A:B of (2 to 6) : (1 to 2) as required by claims 6, 23 and 27, Korevaar teaches the at least one of ceramide NS, NP or/and NH should form at least 40 wt% of the ceramides (paragraph [0055]) which implies the relative amount of the at least one ceramide to additional ceramides inclusive of phytosphingosine is at least 4:6 to 10:0 (e.g., Examples) which overlaps the claimed range, sufficient for prima facie obviousness.
Korevaar does not teach A) a ceramide NP and ceramide AP ratio of 1.5 to 2.5 ceramide NP : 1 ceramide AP, C) triethyl citrate, the emulsifier lowers the surface tension of water to less than 45 mN/m, a pH of 4 to 8, and a preservative selected from methylpropanediol, caprylyl glycol, phenylpropanol, sodium levulinate, potassium sorbate and benzoic acid as required by claims 1 and 8.
Korevaar does not teach the weight ratio (A):(B):(C) is (2-6):(1-2):(1-2) as required by claims 6, 23 and 27.
Korevaar does not teach a pH of 4.5 to 7.4 as required by claim 11.
Korevaar does not teach a pH of 4 to 5.4 as required by claim 19.
Korevaar does not teach the non-aqueous solvent consists of the triethyl citrate as required by claim 22.
Korevaar does not teach a preservative selected from (i) methylpropanediol, caprylyl glycol and phenylpropanol, (ii) sodium levulinate and potassium sorbate, and (iii) caprylyl glycol and benzoic acid as required by claim 24.
These deficiencies are made up for in the teachings of Schmitt, Yu, Clemente and Sakulowski.
Schmitt teaches the native ratio of ceramide NP to ceramide AP within skin is about 2:1 (abstract; page 1748, “Conclusions”).
Yu teaches alpha hydroxyacid esters inclusive of triethyl citrate are beneficial for treatment of aging related integumental changes (title; abstract; column 2, lines 63-67; Example 1; claims). The concentration of the ester may range from minimum of about 1% or 2% to a maximum of 100% (paragraph bridging columns 9 and 10).
Clemente teaches aqueous compositions including a discontinuous oil phase containing a UV absorber (title; abstract; claims). Clemente further teaches emulsifiers may be capable of lowering the surface tension of water to 45 dyne/cm (mN/m) (paragraph [0052]). Clemente further teaches the composition may have a pH from about 4.0 to 8.0 (paragraph [0073]).
Sakulowski teaches a preservative comprising 1,2-octanediol (caprylyl glycol) and benzoic acid useful for preservation of cosmetic products (title; abstract; claims; pages 4-5, Germ count Reduction test). The preservative exhibits antimicrobial activity against S. aureus, E. coli and P. aeruginosa and is better than either 1,2-octanediol or benzoic acid alone (page 5, Table 1c; page 6, lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ceramide component of the skin mimetic mixture (A) of Korevaar to comprise ceramide NP and ceramide AP in a ratio of about 2:1 as taught by Schmitt because this is the ratio found in native skin. There would be a reasonable expectation of success because the mixture (A) of Korevaar comprises at least one of inter alia ceramide NP and additional ceramides such as ceramide AP.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the skin treatment compositions or/and the cosmetic formulations of Korevaar in view of Schmitt to further comprise at least about 1% alpha hydroxy acid ester inclusive of triethyl citrate as taught by Yu because such esters are beneficial for treatment of aging related integumental changes. There would be a reasonable expectation of success because the compositions of Korevaar may optionally further comprise auxiliaries and additives inclusive of additional biogenic active ingredients inclusive of anti-aging actives like alpha hydroxy acids and the ester of Yu is a species falling within this genus. The combined teachings of Korevaar, Schmitt and Yu also render obvious compositions wherein triethyl citrate is the only nonaqueous solvent as set forth in claim 22. And the combined teachings Korevaar, Schmitt and Yu also render obvious amounts of triethyl citrate which overlap the relative amounts set forth in claims 6, 23 and 27 because the compositions of Korevaar comprise 0.01 to 8 wt% of the ceramide and the sphingoid base. An overlapping range is sufficient for a finding of prima facie obviousness. See MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the nonionic emulsifier(s) of the compositions of Korevaar are capable of lowering the surface tension of water to 45 dyne/cm (mN/m) as taught by Clemente because this is an art-recognized property of emulsifiers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Korevaar or/and the compositions of Korevaar in view of Schmitt and Yu to have a pH from about 4.0 to 8.0 as taught by Clemente because pH values within this range are suitable for aqueous compositions intended to be applied to the skin. There would be a reasonable expectation of success because Korevaar does not delimit the pH of the compositions and because the compositions of Korevaar may further comprise buffers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the preservative taught by Sakulowski for the preservative in the compositions of Korevaar because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary. There would be a reasonable expectation of success because the compositions of Korevaar may comprise preservatives.
Regarding the wherein clause of claim 27 drawn to passing preservation stress tests, because the combined teachings of the prior art render obvious compositions as instantly claimed, it is presumed that the compositions of the prior art are capable of passing preservation stress testing, absent evidence to the contrary. In further support of this presumption, Sakulowski teach compositions comprising 1,2-octanediol (caprylyl glycol) and benzoic acid exhibit antimicrobial activity against S. aureus, E. coli and P. aeruginosa.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant’s traversal at page 11 of the Remarks over the length of the rejections and reliance on too much picking and choosing is acknowledged but not found persuasive because length is not a factor in the determination of obviousness (e.g., reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991)) and because it is not seen how the extensive evidencing of facts constitutes picking and choosing (e.g., it is self- evident that that the emulsifiers of the compositions of Lambers are present in some amount, that the aqueous compositions of Lambers are characterized by some pH, etc.). Nonetheless, the new rejections applied infra over the new embodiment drawn to sodium lauroyl lactylate employ fewer references.
Applicant’s citation to the examples within the instant specification drawn to results using triethyl citrate remains unpersuasive because triethyl citrate is an art-recognized anti-bacterial (e.g., de Paoli Ambrosi) and because the composition of the proffered example (e.g., Table 1):
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220
742
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184
746
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is essentially the same as the liposomal formulation of Lambers (e.g., paragraph [0108]):
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134
366
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108
356
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and because it is understood from Lambers that crystallization of the ceramide is undesirable (e.g., outside the scope of Lambers).
Therefore, the rejections of record are properly maintained in modified form as necessitated by Applicant’s amendments and new rejections are applied infra over the new embodiment of emulsifier.
Many of the difficulties encountered in the prosecution of patent applications may be alleviated if each applicant includes, at the time of filing or no later than the first reply, claims varying from the broadest to which they believe they are entitled to the most detailed that they are willing to accept.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang et al. (CN 102579297 A, as evidenced by the Google translation, of record)
teaches aqueous compositions comprising (title; abstract; claims):
0.01 to 0.1 wt% ceramide 3 (ceramide NP),
0.01 to 0.1 wt% ceramide 6 (ceramide AP),
0.01 to 0.2 wt% phytosphingosine,
0.1 to 1 wt% cholesterol, and
0.5 to 2 wt% sodium lauroyl lactylate;
Zhang is considered cumulative to the art applied infra with respect to the new sodium lauroyl lactylate embodiment, particularly with respect to claims 8 and 9.
Liu et al. (CN 108451893 A, as evidenced by the Google translation) teaches aqueous compositions comprising a long-acting moisturizing complex comprising (title; abstract; claims):
0.5 to 5 wt% ceramide NP,
0.5 to 5 wt% ceramide AP,
0.5 to 5 wt% phytosphingosine,
0.5 to 5 wt% cholesterine (cholesterol), and
10 to 20 wt% lauroyl dilactic acid sodium salt (sodium lauroyl lactylate),
and further teaches compositions comprising 4 to 12 wt% of the complex, pH adjusting agent sufficient to achieve a pH from 5.5 to 6.5, and preservative; Liu is considered cumulative to the art applied infra with respect to the new sodium lauroyl lactylate embodiments.
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/ALISSA PROSSER/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner , Art Unit 1600