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 . Claims included in the prosecution are claims 1-4, 8, 9, 11-27, 30, 32, 34, 37, 39, 41, 43, 45, 47, 48, 50, 52, 53 and 81.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/20/226 has been entered.
Applicants' arguments, filed 04/20/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17, 22, 25, 27, 30, 32, 34, 37, 39, 41, 43, 45, 47, 50 and 52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "first phase" in the second line. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite wherein the composition comprises a first phase. Claim 1 recites wherein the composition comprises an internal phase and an external phase. As such, the scope of first phase is unclear.
Claims 22, 25, 27, 30, 32, 34, 37, 39, 41, 43, 45, 47, 50 and 52 recite the limitation "the additional component.” There is insufficient antecedent basis for this limitation in the claim. Claim 17 recites one or more additional components. It is unclear whether the additional component is referencing to all or some of the one or more additional components. To obviate this issue, it is suggested for “the additional component’ to be recited as --- the one or more additional component ---.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
This rejection is modified from the previous Office Action in view of the amendments to the claims.
1. Claims 1, 2, 4, 8-9, 11, 13-24, 27, 32, 34, 50, 52 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman).
Friedman discloses a topical composition (abstract). The composition may be in the form of an emulsion comprising a discontinuous phase and a continuous phase. An emulsion is a preparation of one liquid distributed in small globules throughout the body of a second liquid. The discontinuous phase or the continuous phase may be an oil phase. Either or both of the continuous phase and the discontinuous phase may contain one or more excipients such as surfactants, emulsifiers, emulsion stabilizers, anti-oxidants, emollients, humectants, chelating agents, suspending agents, thickening agents, occlusive agents, preservatives, stabilizing agents, pH modifying agents, solubilizing agents, penetration enhancers, and other excipients ([0072]). Antioxidants include all forms of Vitamin E including a-tocopherol. Antioxidants may be present in amounts from about 1% to about 90% ([0064]). The emulsion can be anhydrous ([0090]). Humectants include glycerin (i.e. glycerol), polyols, and urea and mixtures thereof ([0049]). The humectants may be present in amounts from about 5% to about 50% ([0061]). The composition may comprise from about 5% to about 20% urea ([0032]). The urea is introduced into a mixture comprising the humectant, wherein such mixture is then heated and mixed until the urea is dissolved ([0091]). Emollients include cholesterol ([0081]) soybean oil (i.e., non-silicone oil agent), silicone oils, polyethylene glycol, dimethicones, oleic acid, and mixtures thereof in amounts from about 10% to about 90% ([0059]). Hydroxyethyl Urea is highly hygroscopic and offers excellent moisturizing benefit, and may also be beneficially included in the composition ([0048]). Ascorbic acid may be included in amounts ranging from about 5 to about 50% by weight of the formulation ([0042]). Retinol may be included from about 1% to about 60% ([0044]). Azelaic acid may be included in amounts ranging from about 1% to about 60% by weight ([0044]). The composition is physically and chemically stable at room temperature, meaning the physical state of the composition upon packaging remains substantially constant over the shelf life of the product at room temperature and the components of the compositions do not chemically degrade to an unacceptable extent during the shelf life of the product at room temperature ([0053]). Shelf life may range from 6 months to 5 years ([0066]). The compositions comprise one or more components that aid in hydration (e.g., urea) and/or one or more active agents that have keratolytic activity (e.g., salicylic acid), in a suitable pharmaceutically acceptable topical carrier ([0031]).
The prior art discloses a storage stable ([0053]) topical (abstract) emulsion ([0072]) containing urea ([0049]), glycerin (i.e. glycerol) (i.e., non-aqueous skin-compatible solvent) ([0049]) and dimethicone ([0059]), wherein the components may be included in either or both of the continuous phase and the discontinuous phase ([0072]). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding claim 1 reciting wherein the internal phase is homogenous, as discussed above, Friedman discloses in paragraph [0091] mixing the humectant (e.g., glycerol) and urea. Thus, it would have been obvious to one of ordinary skill in the art that if the humectant and urea were to be incorporated into the discontinuous phase (i.e., internal phase) that the phase would be homogenous since the components are mixed.
Regarding claim 1 reciting wherein the composition does not comprise salicylic acid or ammonium lactate, as discussed above, Friedman teaches that the compositions comprise one or more components that aid in hydration (e.g., urea) and/or one or more active agents that have keratolytic activity (e.g., salicylic acid), in a suitable pharmaceutically acceptable topical carrier. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the composition of Friedman wherein the composition does not comprise salicylic acid or ammonium lactate since although salicylic acid may be included as an alternative to urea, the composition only requires the presence of one component that aids in hydration (e.g., urea) in a suitable pharmaceutically acceptable topical carrier. This is also supported in paragraph [0018] of Friedman, which discloses wherein the topically active agent is selected from the group consisting of urea, salicylic acid, ammonium lactate, and combinations thereof. Therefore, one of ordinary skill in art may select just urea instead of a combination thereof. Thus, the composition of Friedman does not require salicylic acid and ammonium lactate and a composition free of those compounds would have been obvious.
Regarding the limitation of claim 1 reciting wherein the composition is storage stable for 12 months at 25°C ± 2°C in a sealed container, as discussed above, Friedman discloses a storage stable topical (abstract) emulsion containing urea, glycerin (i.e. glycerol) (i.e., non-aqueous skin-compatible solvent), and dimethicone, wherein the components may be included in either or both of the continuous phase and the discontinuous phase, which provides a composition substantially the same as claimed in instant claim 1. Accordingly, because the composition of claim 1 is storage stable for 12 months at 25̊ C ± 2̊ C in a sealed container, the composition of Friedman would necessarily be storage stable for 12 months at 25̊ C ± 2̊ C in a sealed container.
Regarding claim 9 reciting wherein the 1% to 30% urea agent of claim 1 is hydroxyethyl urea, Friedman does not disclose the amount of hydroxyethyl urea. However, as discussed above, Friedman discloses wherein the hydroxyethyl urea is a moisturizing agent. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of hydroxyethyl urea through experimentation based on the level of moisturization desired. Where 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. See MPEP 2144.05(II)(A).
Regarding claim 13, since the emulsion of Friedman comprises a discontinuous phase (i.e., internal phase) and a continuous phase (i.e., external phase), the composition of Friedman necessarily exhibits a urea agent degradation rate that is less than the urea agent degradation rate of a homogenous internal phase solution in the absence of the external phase emulsion when stored in a sealed container at 25°C ± 2°C.
Regarding claim 16, as discussed above, either or both the discontinuous phase and the continuous phase may comprise the humectants (e.g., glycerol and urea) and the emollients (i.e., dimethicone). Thus, one may have the discontinuous phase comprise the humectants and the continuous phase comprise the emollients. Friedman discloses wherein the composition comprises from about 5% to about 20% urea (i.e. humectant), about 10% to about 90% dimethicone (i.e., emollient), and about 5% to about 50% glycerin (i.e., humectant). The claimed percent by weight ratio of the internal phase to the external phase would have been obvious from these ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
2. Claims 12 and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Zhang (US 2007/0172436 A1, July 26, 2007) (cited by applicant on IDS 03/21/2023) (hereinafter Zhang).
The teachings of Friedman are discussed above. Friedman does not teach wherein the composition comprises 1,3 propanediol or a ceramide.
However, Zhang teaches a nonaqueous ascorbic acid composition in an alcohol solvent comprising a solubilization enhancer and an oleaginous skin protectant ([0002]). Polyols suitable for preparing the nonaqueous compositions include 1,3-propanediol, diglycerin, and combinations thereof and they may serve as a nonaqueous alcohol solvent or a thickener to adjust the viscosity of the nonaqueous compositions ([0035]). The nonaqueous alcohol solvents may be present in an amount of 20 to 90% by weight ([0037]). The composition may comprise ceramide VI (i.e. ceramide AP) ([0077]). Ceramides help with restoration of damaged skin barrier ([0082]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Friedman discloses wherein the composition may comprise polyols and thickening agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 1,3 propanediol into the emulsion of Friedman since this is a known and effective polyol and thickening agent for topical compositions as taught by Zhang.
Additionally, it would have been obvious to one of ordinary skill in the art to have incorporated ceramide AP into the composition of Friedman motivated by the desire to formulate the composition to help with restoration of damaged skin barrier as taught by Zhang.
In regards to the amount of ceramide recited in claim 17, since Zhang discloses wherein ceramide help with restoration of damaged skin barrier, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of restoration of damaged skin barrier desired. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
3. Claims 30, 37 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Albrecht (US 2018/0071190 A1, March 15, 2018) (hereinafter Albrecht).
The teachings of Friedman are discussed above. Friedman does not teach wherein the composition comprises bis-ethylhexyl hydroxydimethoxy benzylmalonate, bakuchiol, or glycyrrhetinic acid.
However, Albrecht teaches a cosmetic product which has a particularly high activity with respect to the prevention or elimination of barrier disorders of the skin ([0003]). The composition comprises at least one antioxidant such as bakuchiol and bis-ethylhexyl hydroxydimethoxy benzylmalonate in an amount between 0.01% by weight and 10% by weight ([0016]). The composition may comprise glycyrrhetinic acid as an anti-inflammatory active substance ([0036]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition may comprise antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated bakuchiol and bis-ethylhexyl hydroxydimethoxy benzylmalonate into the composition of Friedman since they are known and effective antioxidants as taught by Albrecht.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated glycyrrhetinic acid into the composition of Friedman motivated by the desire to formulate the composition to have anti-inflammatory effects as taught by Albrecht.
In regards to the amount of glycyrrhetinic acid recited in claim 17, since Albrecht discloses wherein glycyrrhetinic acid is an anti-inflammatory agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of anti-inflammation desired. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
4. Claims 25-26 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Maruyama (US 2019/0336421 A1, Nov 7, 2019) (hereinafter Maruyama).
The teachings of Friedman are discussed above. Friedman does not teach wherein the composition comprises 0.1% to 2% by weight of ferulic acid or a pinus pinaster bark extract.
However, Maruyama discloses a cosmetic composition (abstract) for facial skin ([0453]) comprising an antioxidant agent such as polyphenols ([0345]) derived from pinus pinaster (bark extract) ([0347]) or a lipophilic antioxidant (c) such as ferulic acid ([0359]). The amount of ingredient(s) (c) in the composition according to the present invention may range from 0.01 to 20% by weight ([0362])
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated ferulic acid or pinus pinaster bark extract into the composition of Friedman since they are known and effective antioxidants as taught by Maruyama.
5. Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Revolution (Good Vibes Lip Balm, Dec. 29, 2019) (hereinafter Revolution).
The teachings of Friedman are discussed above. Friedman does not teach wherein the composition comprises C10-C30 cholesterol/lanosterol esters.
However, Revolution discloses a tinted lip balm comprising C10-C30 cholesterol/lanosterol esters and teaches that C10-30 Cholesterol/Lanosterol Esters, aka Super Sterol Liquid is an extremely efficient emollient that can repair dry hands or cracked lips and is great at maintaining a healthy skin barrier (Ingredients Explained, C10-30 Cholesterol/Lanosterol Esters).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises emollients in amounts from about 10% to about 90%. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated C10-C30 cholesterol/lanosterol esters into the composition of Friedman since they are known and effective emollients as taught by Revolution.
6. Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Nurlaily et al., (Comparative Antioxidant and Anti-inflammatory Activity of Different Extracts of Centella asiatica (L.) Urban and Its Active Compounds, Asiaticoside and Madecassoside, January 2012) (hereinafter Nurlaily).
The teachings of Friedman are discussed above. Friedman does not teach wherein the composition comprises madecassoside.
However, Nurlaily teaches madecassoside and asiaticoside are bioactive compounds of Centella asiatica (CA) and showed considerable antioxidant activity (Abstract). Centella asiatica is a medicinal herb used in Ayurvedic and Chinese traditional medicines to treat various ailments such as wounds, ulcer and leprosy (page 64, first and second column).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated madecassoside into the composition of Friedman since it is a known and effective antioxidant as taught by Nurlaily.
7. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Kwon et al. (US 2012/0277313, Nov. 1, 2012) (hereinafter Kwon).
The teachings of Friedman are discussed above. Friedman does not teach wherein the composition comprises dimethicone/polyethylene glycol (PEG)-10/15 crosspolymer and lauryl PEG-9 polydimethylsiloxyethyl dimethicone.
However, Kwon discloses wherein lauryl PEG-9 polydimethylsiloxyethyl dimethicone and dimethicone PEG-10/15 crosspolymer are silicone-based emulsifiers (¶ [0013]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises emulsifiers. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated lauryl PEG-9 polydimethylsiloxyethyl dimethicone and dimethicone PEG-10/15 crosspolymer into the composition of Friedman since they are known and effective emulsifiers as taught by Kwon.
Regarding the composition comprising both lauryl PEG-9 polydimethylsiloxyethyl dimethicone and dimethicone PEG-10/15 crosspolymer, since Kwon discloses the use of various emulsifiers individually, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by Kwon to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
8. Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al., (US 2010/0189761 A1, July 29, 2010) (hereinafter Friedman) in view of Zhang (US 2007/0172436 A1, July 26, 2007) (cited by applicant on IDS 03/21/2023) (hereinafter Zhang), Nurlaily et al., (Comparative Antioxidant and Anti-inflammatory Activity of Different Extracts of Centella asiatica (L.) Urban and Its Active Compounds, Asiaticoside and Madecassoside, January 2012) (hereinafter Nurlaily), Maruyama (US 2019/0336421 A1, Nov 7, 2019) (hereinafter Maruyama), Kwon et al. (US 2012/0277313, Nov. 1, 2012) (hereinafter Kwon), Revolution (Good Vibes Lip Balm, Dec. 29, 2019) (hereinafter Revolution), and Albrecht (US 2018/0071190 A1, March 15, 2018) (hereinafter Albrecht).
The teachings of Friedman are discussed above. Friedman does not teach wherein the composition comprises 1,3-propanediol.
However, Zhang teaches a nonaqueous ascorbic acid composition in an alcohol solvent comprising a solubilization enhancer and an oleaginous skin protectant ([0002]). Polyols suitable for preparing the nonaqueous compositions include 1,3-propanediol, diglycerin, and combinations thereof and they may serve as a nonaqueous alcohol solvent or a thickener to adjust the viscosity of the nonaqueous compositions ([0035]). The nonaqueous alcohol solvents may be present in an amount of 20 to 90% by weight ([0037]). The composition may comprise ceramide VI (i.e. ceramide AP) ([0077]). Ceramides help with restoration of damaged skin barrier ([0082]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Friedman discloses wherein the composition may comprise polyols and thickening agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 1,3 propanediol and diglycerin into the emulsion of Friedman since these are known and effective polyols and thickening agents for topical compositions as taught by Zhang.
The combined teachings of Friedman and Zhang do not teach wherein the composition comprises madecassoside.
However, Nurlaily teaches madecassoside and asiaticoside are bioactive compounds of Centella asiatica (CA) and showed considerable antioxidant activity (Abstract). Centella asiatica is a medicinal herb used in Ayurvedic and Chinese traditional medicines to treat various ailments such as wounds, ulcer and leprosy (page 64, first and second column).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated madecassoside into the composition of Friedman since it is a known and effective antioxidant as taught by Nurlaily.
The combined teachings of Friedman, Zhang, and Nurlaily do not teach wherein the composition comprises ferulic acid and pinus pinaster bark extract.
However, Maruyama discloses a cosmetic composition (abstract) for facial skin ([0453]) comprising an antioxidant agent such as polyphenols ([0345]) derived from pinus pinaster (bark extract) ([0347]) or a lipophilic antioxidant (c) such as ferulic acid ([0359]). The amount of ingredient(s) (c) in the composition according to the present invention may range from 0.01 to 20% by weight ([0362])
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated ferulic acid and pinus pinaster bark extract into the composition of Friedman since they are known and effective antioxidants as taught by Maruyama.
The combined teachings of Friedman, Zhang, Nurlaily, and Maruyama do not teach wherein the composition comprises dimethicone/PEG-10/15 crosspolymer and lauryl PEG-9 polydimethylsiloxyethyl dimethicone.
However, Kwon discloses wherein lauryl PEG-9 polydimethylsiloxyethyl dimethicone and dimethicone PEG-10/15 crosspolymer are silicone-based emulsifiers (¶ [0013]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises emulsifiers. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated lauryl PEG-9 polydimethylsiloxyethyl dimethicone and dimethicone PEG-10/15 crosspolymer into the composition of Friedman since they are known and effective emulsifiers as taught by Kwon.
The combined teachings of Friedman, Zhang, Nurlaily, Maruyama, and Kwon do not teach wherein the composition comprises C10-30 cholesterol/lanosterol esters.
However, Revolution discloses a tinted lip balm comprising C10-C30 cholesterol/lanosterol esters and teaches that C10-30 Cholesterol/Lanosterol Esters, aka Super Sterol Liquid is an extremely efficient emollient that can repair dry hands or cracked lips and is great at maintaining a healthy skin barrier (Ingredients Explained, C10-30 Cholesterol/Lanosterol Esters).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition comprises emollients in amounts from about 10% to about 90%. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated C10-C30 cholesterol/lanosterol esters into the composition of Friedman since they are known and effective emollients as taught by Revolution.
The combined teachings of Friedman, Zhang, Nurlaily, Maruyama, Kwon, and Revolution do not teach wherein the composition comprises bakuchiol and bis-ethylhexyl hydroxydimethoxy benzylmalonate.
However, Albrecht teaches a cosmetic product which has a particularly high activity with respect to the prevention or elimination of barrier disorders of the skin ([0003]). The composition comprises at least one antioxidant such as bakuchiol and bis-ethylhexyl hydroxydimethoxy benzylmalonate in an amount between 0.01% by weight and 10% by weight ([0016]). The composition may comprise glycyrrhetinic acid as an anti-inflammatory active substance ([0036]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Friedman discloses wherein the composition may comprise antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated bakuchiol and bis-ethylhexyl hydroxydimethoxy benzylmalonate into the composition of Friedman since they are known and effective antioxidants as taught by Albrecht.
Regarding the amounts of 1,3-propanediol and diglycerin, as discussed above, these compounds are polyols, which are humectants. Friedman discloses wherein the total amount of humectants is from about 5% to about 50%. The claimed amounts would have been obvious from this range.
Regarding the amounts of madecassoside, ferulic acid, pinus pinaster bark extract, tocopherol, bakuchiol, and bis-ethylhexyl hydroxydimethoxy benzylmalonate, as discussed above, these compounds are antioxidants. Friedman discloses wherein the total amount of antioxidants is from about 1% to about 90%. The claimed amounts would have been obvious from this range.
Regarding the amounts of dimethicone, C10-30 cholesterol/lanosterol esters, and soybean oil, as discussed above, these compounds are emollients. Friedman discloses wherein the total amount of emollients is from about 10% to about 90%. The claimed amounts would have been obvious from this range.
Regarding the amounts of dimethicone/PEG-10/15 crosspolymer and lauryl PEG-9 polydimethylsiloxyethyl dimethicone, as discussed above, these compounds are surfactants. Thus, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount based on its known function.
Regarding the composition comprising multiple humectants, emollients, antioxidants, and surfactants, since the prior art discloses the use of various humectants, emollients, antioxidants, and surfactants individually, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
Response to Arguments
Applicant argues that Friedman does not identify the presently claimed allocation of materials into the two recited phases, nor does Friedman disclose the presently claimed phase relationship.
The Examiner does not find Applicant’s argument to be persuasive. Because Friedman discloses wherein the claimed components may be in the continuous and/or discontinuous phases, the claimed allocation of materials into the two recited phases would have been obvious. This is supported by MPEP 2143(I)(A) stating wherein a conclusion of obviousness is supported when all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. In the instant case, all the claimed elements were known and one of ordinary skill in the art could have combined the elements into either phase from Friedman disclosing wherein the claimed components may be in the continuous and/or discontinuous phases. Moreover, Applicant has not shown wherein the claimed architecture is critical such that the claimed allocation of materials into the two recited phases is not arbitrary. As such, Applicant’s argument is unpersuasive.
Applicant argues that Friedman repeatedly emphasizes urea used with salicylic acid and/or ammonium lactate.
The Examiner does not find Applicant’s argument to be persuasive. A prior art is evaluated for all that it reasonably suggests and is not limited to preferred embodiments or working examples. As discussed in the rejection, paragraph [0018] of Friedman discloses wherein the topically active agent is selected from the group consisting of urea, salicylic acid, ammonium lactate, and combinations thereof. Therefore, one of ordinary skill in art may select just urea instead of a combination thereof. Thus, the composition of Friedman does not require salicylic acid and ammonium lactate and a composition free of those compounds would have been obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that a general disclosure that a composition may be stable over shelf life does not establish that Friedman necessarily exhibits Applicant’s specific comparative urea-degradation behavior for the presently claimed composition.
The Examiner does not find Applicant’s argument to be persuasive. The rejection never said that claimed property is established from Friedman disclosing wherein the composition may be stable over shelf life. The rejection states wherein the claimed property would necessarily be present since the composition of Friedman is substantially the same as the claimed composition with substantially the same compounds in the same phases. As such, Applicant’s argument is unpersuasive.
With regards to Applicant’s argument that the secondary references do not cure the deficiencies of Friedman, arguments regarding Friedman have been addressed above and are unpersuasive. Therefore, the rejections with the secondary references are maintained.
Conclusion
Claims 1-4, 8, 9, 11-27, 30, 32, 34, 37, 39, 41, 43, 45, 47, 48, 50, 52, 53 and 81 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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