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 .
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 1-11 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 1 recited the phrase “selected from:” throughout the claim. If Markush language is intended, the proper phrasing should read: selected from the group consisting of.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baek WO 2021212076 A1.
Baek teaches a topical formulation of an anhydrous emulsion, composed of a urea compound, non-aqueous skin-compatible solvents, and silicone compound are provided. The formulations are storage stable in a non-aqueous solution for an extended period of time without significant degradation of the urea in the composition and have desirable physical properties. The topical formulations can include concentrations of urea of 1 to 30% by weight. Topical compositions of this disclosure find use in treating or preventing a variety of cosmetic and/or dermatological conditions. See paragraph 0009. Baek also teaches the composition further comprises emulsifying agents include, but are not limited to, polysorbates, laureth-4, potassium cetyl sulfate, and silicone and silicone-elastomer-based emulsifiers and emulsifying blends. In some embodiments, a surfactant such as a monoglyceride, sorbitan fatty acid ester, or polyglycerine fatty acid ester, polyoxyethylene hardened castor oil, polyoxyethylene fatty acid ether, or combinations thereof, is added thereto in a small amount, and the stability is further improved. In some embodiments, the emulsifying agent is added to the formulation in an effective amount to improve the stability of the formulation. In some embodiments, the emulsifying agents include, but are not limited to: sorbitan laurate, sorbitan palmitate, sorbitan sesquiisostearate, sorbitan sesquioleate, sorbitan sesquistearate, sorbitan stearate, sorbitan oleate, sorbitan monoisostearate, sorbitan trisostearate, sorbitan trioleate, sorbitan tristearate; glyceryl behenate, glyceryl caprate, glyceryl caprylate, glyceryl caprylate/caprate, glyceryl cocoate, glyceryl erucate, glyceryl hydroxystearate, glyceryl isostearate, glyceryl lanolate, glyceryl laurate, glyceryl linoleate, glyceryl myristate, glyceryl oleate, glyceryl palmitate lactate, glyceryl sesquioleate, glyceryl stearate, glyceryl stearate citrate, glyceryl stearate lactate; polyglyceryl-4 isostearate, polyglyceryl-3 oleate, polyglyceryl-2 sesquioleate, triglyceryl diisostearate, diglyceryl monooleate, tetraglyceryl monooleate, glycol distearate, glycol hydroxystearate, glycol oleate, glycol ricinoleate, glycol stearate, propylene glycol isostearate, propylene glycol hydroxystearate, propylene glycol laurate, propylene glycol myristate, propylene glycol oleate, propylene glycol ricinoleate, propylene glycol stearate; sucrose cocoate, sucrose laurate; Methyl Glucose Sesquistearate, Methyl Glucose Dioleate; PEG-20 Methyl Glucose Sesquistearate; or mixtures thereof. See paragraphs 0065-0066. The composition further includes one or more optional additional components (e.g., as described herein). In some embodiments, the one or more optional additional components are selected from physiologic lipids, ascorbic acid, retinol, tocopherols, tocotrienols (e.g., alpha, beta, delta and gamma tocopherol s or alpha, beta, delta and gamma tocotrienols), ferulic acid, azelaic acid, hydroxy acids (e.g., salicylic acid), panthenol, pinus pinaster bark extract, emulsifying agent, hyaluronic acid complex, madecassoside, madecassoside asiaticoside, acetyl zingerone, bakuchiol, and bis-ethylhexyl hydroxydimethoxy benzylmalonate, zinc oxide, and titanium dioxide. See paragraph 0078. Additional component composed of up to 20% by weight based on the total weight of the composition. See paragraph 0079. In some embodiments, the composition further includes 10% or less by weight in total of one or more optional additional components selected from an antioxidant, a skin lightening agent, and a moisturizing agent. See paragraph 0080. In some embodiments, the second phase (e.g., external phase) solution of the subject composition includes one or more (optional) additional ingredients described herein. Each optional additional component (e.g., as described herein) may be present in the first phase (e.g., internal phase) in an amount of 20% or less by weight of the first phase (e.g., internal phase), such as 19% or less, 18% or less, 17% or less, 16% or less, 15% or less, 14% or less, 13% or less, 12% or less, 11% or less, 10% or less, 9% or less, 8% or less, 7% or less, 6% or less, 5% or less, 4% or less, 3% or less, 2% or less, 1% or less, 0.5% or less, 0.5% or less, 0.4% or less, 0.3% or less, 0.2% or less, or 0.1% or less by weight. In some embodiments the amount of the one or more optional additional components (e.g., as described herein) dissolved in the first phase (e.g., internal phase) is 10% or less by weight, such as 9% or less, 8% or less, 7% or less, 6% or less, 5% or less, 4% or less, 3% or less, 2% or less, 1% or less, 0.5% or less, 0.4% or less, 0.3% or less, 0.2% or less, or 0.1% or less by weight. In some embodiments, the composition includes an optional additional component that is a physiologic lipid. In some embodiments, the physiologic lipid is a ceramide, cholesterol, cholesterol ester, a free fatty acid, and combinations thereof. See paragraphs 0082-0083. In some embodiments, the tocopherol or tocotrienol agent is present in the composition in an amount of 2% or less by weight, such as 1.5% or less, 1% or less, 0.5% or less, 0.4% or less, 0.3% or less, 0.2% or less, or 0.1% or less by weight. [0093] In some embodiments of any one of the formulations described herein, the formulation excludes tocopherol or tocotrienol agents, e.g., or precursors thereof having vitamin E activity. In certain embodiments of any one of the formulations described herein, the formulation excludes vitamin E acetate. See paragraph 0092. The composition further comprises a secondary antioxidant including bakuchiol (10309-37-2) a natural terpenoid antioxidant. See paragraph 0096. Baek further teaches the amount of the secondary antioxidant is in the range of 0.1 to 3%. See paragraphs 0097-0098 and 0117. As used herein, the term “non-aqueous” refers to compositions that are substantially anhydrous. Non-limiting examples of substantially anhydrous compositions include, for example, 1% or less water in the subject compositions, such as 0.5% or less, 0.4% or less, 0.3% or less, 0.2% or less, or 0.1% or less water. See paragraph 0127. Baek further teaches the composition comprises 5% or less of C10-C30 cholesterol/lanosterol esters. See Claims 39-40, paragraphs 0177-0178.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Baek WO 2021212076 A1, in view of Grabenhofer (Cosmetics & Toiletries).
Baek is relied upon for the reason stated above. While Baek teaches a cosmetic composition comprises at least one or more antioxidants, it is noted that Baek does not teach using turmeric as an antioxidant. However, turmeric is a known skin cosmetic component having an antioxidant property. See for example the teaching in Grabenhofer, which teaches nature-based ingredients in skin care comprising the potent antioxidant-rich botanical turmeric. The Grabenhofer reference further teaches bakuchiol and turmeric are proven to be powerful yet gentle nature-based ingredients that are key to helping to improve the condition of the skin and lips.
As such, it would have been prima facie obvious to one of ordinary skills in the art to optimize the teaching in Baek to include turmeric as an antioxidant in combination with bakuchiol with the expectation to obtain a skin care composition useful in the art. This is because Gravenhofer teaches antioxidant such as turmeric significantly increase hydration, significantly and progressively improved fine lines thus, defend and restore healthier-looking skin. This is because Baek teaches the desirability for using one or more antioxidants in the skin care composition that also comprises bakuchiol.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Baek WO 2021212080 A1, in view of Grabenhofer (Cosmetics & Toiletries).
Baek teaches a topical formulation of azelaic acid dissolved in a combination of a urea agent and a non-aqueous skin-compatible solvent. The formulations are storage stable for an extended period of time without undesirable discoloration or significant degradation of the azelaic acid in the composition. This disclosure provides particular topical formulations which have been developed and optimized to provide skin compatibility and desirable physical properties. See paragraphs 0011-0014. Non-aqueous skin compatible solvent is found in paragraphs 0035-0036. The formulation further comprising one or more additional components such as the one or more optional additional components in the first phase solution, and one or more optional additional components are added in the second phase solution. In some embodiments, the one or more optional additional components are selected from tocopherols, tocotrienols (e.g., alpha, beta, delta and gamma tocopherols or alpha, beta, delta and gamma tocotrienols), ferulic acid, azelaic acid, hydroxy acids (e.g., salicylic acid), panthenol, pinus pinaster bark extract, emulsifying agent, hyaluronic acid complex, madecassoside, acetyl zingerone, bakuchiol, and bis-ethylhexyl hydroxydimethoxy benzylmalonate. See paragraphs 0086-0087. Formulation comprising less than 2% tocopherol as the first antioxidant is found in paragraphs 0099-0101. Formulation comprising bis-ethylhexyl hydroxydimethoxy benzylmalonate as the secondary antioxidant is found in paragraph 0105. The amounts of first and second antioxidant that fall within the claimed range can be found in paragraph 0107. In some embodiments, formulation contains an anti-inflammatory agent as an additional ingredient. In some embodiments, the anti-inflammatory agent is madecassoside, madecassoside asiaticoside, or madecassic acid. The anti-inflammatory agent, when included, is preferably present in an amount in the range of 0.1 to 2%, more preferably 0.1 to 1% by weight of the composition, such as 0.1 to 0.5% by weight, or 0.1 to 0.2% by weight. Any convenient oils and lipids can be utilized in the oil component of the subject emulsions. An oil component or oil phase refers to any phase that is immiscible with the non-aqueous liquid composition. In some embodiments, the oil component is silicone-based, e.g., includes a silicone polymer. In some embodiments, the oil component includes a silicone oil or silicone elastomer, such as a polyorganosiloxane. In some embodiments, the silicone polymers have dual characteristics, and can be used as emulsifiers and/or act as the continuous/dispersed phase of the emulsion composition. Oils and lipids of interest include, but are not limited to, silicone oils, linseed oil, tsubaki oil, macadamia nut oil, com oil, mink oil, olive oil, avocado oil, sasanqua oil, castor oil, safflower oil, apricot oil, cinnamon oil, jojoba oil, grape oil, sunflower oil, almond oil, rapeseed oil, sesame oil, wheat germ oil, rice germ oil, rice bran oil, cottonseed oil, soybean oil, peanut oil, teaseed oil, evening primrose oil, eggyoke oil, neetsfoot oil, liver oil, triglycerine, glycerine trioctanate, pentaerythritol tetraoctanate, glycerine triisopalmitate, cholesterol, free fatty acids, and combinations thereof. Any convenient emulsifying agents or emulsifiers can be utilized in the preparation of the subject emulsions to stabilize the composition and prevent separation of the oil component from the solvent solution (e.g., the non-aqueous liquid composition). Exemplary emulsifying agents include but are not limited to polysorbates, laureth-4, potassium cetyl sulfate, and silicone and silicone-elastomer-based emulsifiers and emulsifying blends. In some embodiment, a surfactant such as a monoglyceride, sorbitan fatty acid ester, or polyglycerine fatty acid ester, polyoxyethylene hardened castor oil, polyoxyethylene fatty acid ether, is added thereto, e.g. 5% by weight or more, and the stability is further improved. See paragraphs 0119-0121. In some embodiments, the emulsifying agents include, but are not limited to: sorbitan laurate, sorbitan palmitate, sorbitan sesquiisostearate, sorbitan sesquioleate, sorbitan sesquistearate, sorbitan stearate, sorbitan oleate, sorbitan monoisostearate, sorbitan trisostearate, sorbitan trioleate, sorbitan tristearate; glyceryl behenate, glyceryl caprate, glyceryl caprylate, glyceryl caprylate/caprate, glyceryl cocoate, glyceryl erucate, glyceryl hydroxystearate, glyceryl isostearate, glyceryl lanolate, glyceryl laurate, glyceryl linoleate, glyceryl myristate, glyceryl oleate, glyceryl palmitate lactate, glyceryl sesquioleate, glyceryl stearate, glyceryl stearate citrate, glyceryl stearate lactate; polyglyceryl-4 isostearate, polyglyceryl-3 oleate, polyglyceryl-2 sesquioleate, triglyceryl diisostearate, diglyceryl monooleate, tetraglyceryl monooleate, glycol distearate, glycol hydroxystearate, glycol oleate, glycol ricinoleate, glycol stearate, propylene glycol isostearate, propylene glycol hydroxystearate, propylene glycol laurate, propylene glycol myristate, propylene glycol oleate, propylene glycol ricinoleate, propylene glycol stearate; sucrose cocoate, sucrose laurate; Methyl Glucose Sesqui stearate, Methyl Glucose Dioleate; PEG-20 Methyl Glucose Sesquistearate; or mixtures thereof. See paragraph 0125.
Baek does not teach using turmeric in the cosmetic composition herewith. However, turmeric is a known skin cosmetic component having an antioxidant property. See for example the teaching in Grabenhofer, which teaches nature-based ingredients in skin care comprising the potent antioxidant-rich botanical turmeric. The Grabenhofer reference further teaches bakuchiol and turmeric are proven to be powerful yet gentle nature-based ingredients that are key to helping to improve the condition of the skin and lips.
As such, it would have been prima facie obvious to one of ordinary skills in the art to optimize the teaching in Baek to include turmeric and bakuchiol with the expectation to obtain a skin care composition useful in the art. This is because Gravenhofer teaches the effect of turmeric to reduce inflammation to significantly increase hydration, significantly and progressively improved fine lines thus, defend and restore healthier-looking skin. This is because Baek teaches the desirability for using one or more components having an anti-inflammatory property.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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