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 .
Status of the Claims
Claims 1-20 are pending and currently under examination.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on 03/21/2025 and 05/01/2025 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Foley et al. (US20150352017A1, Published 12/10/2015; cited in the IDS filed 05/01/2025).
Applicant’s Invention
The Applicants claims are drawn to a method of protecting skin, the method comprising topically applying to skin of a person a decamethylcyclopentasiloxane (D5)-free composition comprising: Salix nigra (willow) bark extract; niacinamide; and octocrylene, wherein the composition does not comprise D5.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1-2, 7, 13-14 and 20, Foley teaches a water-in-silicone emulsion and methods for its use that includes 5% to 8% w/w of octinoxate, 1% to 3% w/w of niacinamide, 0.01% to 0.1% w/w of Salix nigra bark extract, 0.01% to 0.1% w/w of adenosine, and 0.001% to 0.01% w/w of Silybum marianum extract (abstract). Foley also teaches UV absorption agents such as octocrylene (paragraph [0042]). Foley further teaches the compositions can also include any number of combinations of additional ingredients described throughout this specification (e.g., pigments, or additional cosmetic or pharmaceutical ingredients). The concentrations of any ingredient within the compositions can vary. For example, at least about 0.0001% to 99%. A person of ordinary skill in the art would understand that the concentrations can vary depending on the addition, substitution, and/or subtraction of ingredients in a given composition (paragraph [0036]). Foley also teaches the composition is formulated for topical application to facial skin (paragraph [0007]), wherein topical application means to apply or spread a composition onto the surface of lips or keratinous tissue (i.e., lips, skin, and nails) (paragraph [0014]). With regards to the limitation wherein the composition does not comprise D5, the examiner points out that although Foley does teach cyclopentasiloxane (i.e., D5) in some embodiments, it is not required in Foley’s cosmetic composition, and Foley does teach other alternatives of silicone oils that can be present in the composition further showing that cyclopentasiloxane (i.e., D5) is not required in the composition. (See e.g. para 0007 and claim 1, each of which describe embodiments that do not require cyclopentasiloxane.)
Regarding claims 3-4 and 15-16, Foley teaches the compositions of the present invention can also include any one of, any combination of, or all of the following additional ingredients: water, a chelating agent, a moisturizing agent, a preservative, a thickening agent, a silicone containing compound, an essential oil, a structuring agent, a vitamin, a pharmaceutical ingredient, a pigment, or an antioxidant, or any combination of such ingredients or mixtures of such ingredients, wherein the amounts of such ingredients can range from 0.0001% to 99.9% by weight or volume of the composition (paragraph [0009]). Foley further teaches silicone containing compounds that can be used in the present invention include silicone oils such dimethicone (paragraph [0053]).
Regarding claims 8 and 19, Foley teaches the compositions of the present invention can also include any one of, any combination of, or all of the following additional ingredients: water, a chelating agent, a moisturizing agent, a preservative, a thickening agent, a silicone containing compound, an essential oil, a structuring agent, a vitamin, a pharmaceutical ingredient, a pigment, or an antioxidant, or any combination of such ingredients or mixtures of such ingredients (paragraph [0009]). Foley also teaches cosmetic ingredients such as film formers, humectants, pH adjusters, and exfoliating agents can be present (paragraph [0040]).
Regarding claims 9 and 19, Foley teaches the compositions of the present invention can be incorporated into all types of vehicles. Non-limiting examples include emulsions (e.g., water-in-oil, water-in-oil-in-water, oil-in-water, silicone-in-water, water-in-silicone, oil-in-water-in-oil, oil-in-water-in-silicone emulsions), creams, lotions, gels, and ointments (paragraph [0037]).
Regarding claim 10, Foley teaches a water-in-silicone emulsion and methods for its use that includes 5% to 8% w/w of octinoxate, 1% to 3% w/w of niacinamide, 0.01% to 0.1% w/w of Salix nigra bark extract, 0.01% to 0.1% w/w of adenosine, and 0.001% to 0.01% w/w of Silybum marianum extract (abstract). Foley also teaches UV absorption agents such as octocrylene (paragraph [0042]). Claim 10 requires the limitation wherein the composition is formulated to be sweat and/humidity resistant. Foley teaches the active method steps of a topically applying a composition comprising Salix nigra bark extract, niacinamide, and octocrylene, but does not explicitly disclose wherein the composition is formulated to be sweat and/humidity resistant. However, such property must necessarily be present. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Regarding claim 11, Foley teaches a water-in-silicone emulsion and methods for its use that includes 5% to 8% w/w of octinoxate, 1% to 3% w/w of niacinamide, 0.01% to 0.1% w/w of Salix nigra bark extract, 0.01% to 0.1% w/w of adenosine, and 0.001% to 0.01% w/w of Silybum marianum extract (abstract). Foley also teaches UV absorption agents such as octocrylene (paragraph [0042]). Claim 11 requires the limitation wherein the composition protects skin from ultraviolet (UV) radiation. Foley teaches the active method steps of a topically applying a composition comprising Salix nigra bark extract, niacinamide, and octocrylene, but does not explicitly disclose wherein the composition protects skin from ultraviolet (UV) radiation. However, such property must necessarily be present. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Regarding claim 12, the claim requires the limitation wherein the composition reduces an immune response in skin triggered by heat exposure as compared to a second composition that is the same as the D5-free composition except that the second composition comprises D5 and/or does not comprise Salix nigra (willow) bark extract, niacinamide, and/or octocrylene. Foley teaches the active method steps of a topically applying a composition comprising Salix nigra bark extract, niacinamide, and octocrylene. The Examiner points out that the instant specification states that Salix nigra (willow) bark extract, niacinamide, and octocrylene—can be used to protect skin from UV radiation (e.g., sun light) and soothe skin by reducing an immune response in skin triggered by heat exposure (paragraph [0038]). Therefore, such property must necessarily be present in Foley’s cosmetic composition. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Foley does not disclose a single embodiment or example where every limitation recited in the instant claims are taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art because
Foley teaches all of the claimed elements. It would have been prima facie obvious at the time
of filing to have a method of protecting skin, the method comprising topically applying to skin of a person a decamethylcyclopentasiloxane (D5)-free composition comprising: Salix nigra (willow) bark extract; niacinamide; and octocrylene, wherein the composition does not comprise D5 because Foley teaches these elements as components of their invention.
With regards to the limitation wherein the composition comprises 1 to 20% by weight of octocrylene and 2 to 20% by weight of dimethicone, it would have been obvious to optimize the amounts of octocrylene and dimethicone in Foley’s cosmetic composition. Foley teaches the compositions can also include any number of combinations of additional ingredients described throughout this specification (e.g., pigments, or additional cosmetic or pharmaceutical ingredients). The concentrations of any ingredient within the compositions can vary. For example, at least about 0.0001% to 99%. A person of ordinary skill in the art would understand that the concentrations can vary depending on the addition, substitution, and/or subtraction of ingredients in a given composition (paragraph [0036]). Therefore, it would have been obvious to optimize the amounts of octocrylene and dimethicone in Foley’s cosmetic composition because Foley teaches that The concentrations of any ingredient within the compositions can vary. For example, at least about 0.0001% to 99% (paragraph [0036]), therefore, one of ordinary skill in the art can use the teachings of Foley as a starting point using routine experimentation for the desired results of the cosmetic composition. 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. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Claims 5-6 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Foley et al. (US20150352017A1, Published 12/10/2015; cited in the IDS filed 05/01/2025) as applied to claims 1-4, 7-16, and 19-20 above in view of Brouard et al. (US20150190326A1, Published 07/09/2015) further in view of Inokuchi et al. (US20150118320A1, Published 04/30/2015) further in view Cunningham l et al. (US20090035234A1, Published 02/05/2009).
Applicant’s Invention
Foley renders obvious all the limitations of instant claim 1. Applicants claim 5 further adds the limitation wherein the D5-free composition further comprises: magnesium sulfate; glycerin; xanthan gum; butylene glycol; ascorbyl glucoside; caprylyl methicone; butyloctyl salicylate; octisalate ethylhexyl salicylate; and silica. Applicants claim 6 further adds the limitation wherein the D5-free composition comprises: 0.01 to 3% by weight of magnesium sulfate; 1 to 10% by weight of glycerin; 0.01 to 3% by weight of xanthan gum; 1 to 20% by weight of butylene glycol; 0.01 to 3% by weight of ascorbyl glucoside; 1 to 10% by weight of caprylyl methicone; 1 to 15% by weight of butyloctyl salicylate; 1 to 15% by weight of octisalate ethylhexyl salicylate; and 0.01 to 3% by weight of silica. Applicants claim 17 further adds the limitation wherein the D5-free topical skin composition further comprises: magnesium sulfate; glycerin; xanthan gum; butylene glycol; ascorbyl glucoside; caprylyl methicone; butyloctyl salicylate; octisalate ethylhexyl salicylate; and silica. Applicants claim 18 further adds the limitation wherein the D5-free topical skin composition comprises: 0.01 to 3% by weight of magnesium sulfate; 1 to 10% by weight of glycerin; 0.01 to 3% by weight of xanthan gum; 1 to 20% by weight of butylene glycol; 0.01 to 3% by weight of ascorbyl glucoside; 1 to 10% by weight of caprylyl methicone; 1 to 15% by weight of butyloctyl salicylate; 1 to 15% by weight of octisalate ethylhexyl salicylate; and 0.01 to 3% by weight of silica.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 5-6 and 17-18, Foley teaches the formulation in Table 1 is formulated as a water-in-silicone emulsion, wherein magnesium sulfate in an amount 1.0%, butylene glycol in an amount of 6.0%, and glycerin in an amount of 3.5% (paragraph [0074]). Foley also teaches gums that can be xanthan gum, and silica (paragraph [0063]). Foley also teaches moisturizing agents such as octyl salicylate (i.e., octisalate ethylhexyl salicylate) (paragraph [0045]). Foley further teaches the compositions can also include any number of combinations of additional ingredients described throughout this specification (e.g., pigments, or additional cosmetic or pharmaceutical ingredients). The concentrations of any ingredient within the compositions can vary. For example, at least about 0.0001% to 99%. A person of ordinary skill in the art would understand that the concentrations can vary depending on the addition, substitution, and/or subtraction of ingredients in a given composition (paragraph [0036]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Foley does not teach 0.01 to 3% by weight of ascorbyl glucoside; 1 to 10% by weight of caprylyl methicone; 1 to 15% by weight of butyloctyl salicylate. However, these deficiencies are taught by Brouard et al., Inokuch et al., and Cunningham et al.
In the analogous art of cosmetic compositions, Brouard teaches anti-ageing or biogenic agents which are antioxidants such as ascorbyl glucoside, ascorbyl acetate, magnesium ascorbyl phosphate, distearyl thiodipropionate, tocopheryl acetate, etc. (paragraph [0155]).
In the analogous art of a cosmetic composition for skin, Inokuchi teaches the present invention is to provide an aqueous dispersion of silicone elastomer particles to provide a stable emulsion (abstract). Inokuchi also teaches it is desired to incorporate a silicone oil (paragraph [0068]), wherein examples of silicone oils include dimethylpolysiloxane, caprylyl methicone, phenyl trimethicone etc. (paragraph [0085]).
In the analogous art of sunscreen compositions, Cunningham teaches a sunscreen composition that is suitable for topical application to human skin (abstract). Cunningham also teaches suitable waterproofing agents well-known in the art include emollient esters (paragaraph [0071]). Cunningham further teaches that many emollients may also exhibit a film forming function in that they provide a water-resistant barrier on the skin, wherein a particularly preferred emollient is butyloctyl salicylate in amounts of from 0.1% to 10.0% by total weight of the composition (paragraph [0072]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to add ascorbyl glucoside in Foley’s cosmetic composition. Foley teaches the compositions of the present invention can also include any one of, any combination of, or all of the following additional ingredients: or an antioxidant, or any combination of such ingredients or mixtures of such ingredients (paragraph [0009]), wherein such antioxidants can be magnesium ascorbyl phosphate, distearyl thiodipropionate, tocopheryl acetate, etc. (paragraph [0047]). One would have understood in view of Brouard that a cosmetic composition can have antioxidants present for anti-ageing such as ascorbyl glucoside, ascorbyl acetate, magnesium ascorbyl phosphate, distearyl thiodipropionate, tocopheryl acetate, etc. (paragraph [0155]). It would have been obvious to add ascorbyl glucoside in Foley’s cosmetic composition because Foley teaches that antioxidants can be present in the composition such as magnesium ascorbyl phosphate, distearyl thiodipropionate, tocopheryl acetate, etc. (paragraph [0047]) and Brouard teaches antioxidants such as ascorbyl glucoside, ascorbyl acetate, magnesium ascorbyl phosphate, distearyl thiodipropionate, tocopheryl acetate, etc. Therefore, ascorbyl glucoside is known for the purpose of being an antioxidant agent in a cosmetic composition for the skin. See MPEP 2144.06(II).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to add caprylyl methicone in Foley’s cosmetic composition. Foley teaches the compositions of the present invention can also include any one of, any combination of, or all of the following additional ingredients: a silicone containing compound or any combination of such ingredients or mixtures of such ingredients (paragraph [0009]), wherein the silicone containing compound can be silicone oils such as dimethicone, phenyl trimethicone (paragraph [0053]). One would have understood in view of Inokuchi an aqueous dispersion of silicone elastomer particles to provide a stable emulsion (abstract). Inokuchi also teaches it is desired to incorporate an silicone oil (paragraph [0068]), wherein examples of silicone oils include dimethylpolysiloxane, caprylyl methicone, phenyl trimethicone etc. (paragraph [0085]). It would have been obvious to add caprylyl methicone in Foley’s cosmetic composition because Foley teaches the present invention can also include any one of, any combination of, or all of the following additional ingredients: a silicone containing compound or any combination of such ingredients or mixtures of such ingredients (paragraph [0009]), wherein the silicone containing compound can be silicone oils such as dimethicone, phenyl trimethicone (paragraph [0053]). And Inokuchi teaches it is desired to incorporate an silicone oil (paragraph [0068]), wherein examples of silicone oils include dimethylpolysiloxane, caprylyl methicone, phenyl trimethicone etc. (paragraph [0085]). Therefore, caprylyl methicone is known for the purpose of being a silicone oil in a cosmetic composition for the skin. See MPEP 2144.06(II).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to add butyloctyl salicylate in Foley’s cosmetic composition. Foley teaches a wide variety of non-limiting cosmetic ingredients that can be used in the context of the present invention. Examples of these ingredient classes include emollients (paragraph [0040]). The skilled artisan would have been motivated to add butyloctyl salicylate in Foley’s cosmetic composition because Cunningham teaches a sunscreen composition that is suitable for topical application to human skin (abstract), wherein waterproofing agents well-known in the art include emollient esters (paragaraph [0071]), and that many emollients may also exhibit a film forming function in that they provide a water-resistant barrier on the skin, wherein a particularly preferred emollient is butyloctyl salicylate in amounts of from 0.1% to 10.0% by total weight of the composition (paragraph [0072]). The skilled artisan would have had an reasonable expectation of success because Foley teaches that the cosmetic composition can have cosmetic ingredients such as emollients and Cunningham teaches that emollients provide the benefit of water-proofing and a film forming function in that the emollient provides a water-resistant barrier on the skin, wherein the preferred emollient is butyloctyl salicylate.
With regards to the limitation wherein the composition comprises 0.01 to 3% by weight of magnesium sulfate; 1 to 10% by weight of glycerin; 0.01 to 3% by weight of xanthan gum; 1 to 20% by weight of butylene glycol; 0.01 to 3% by weight of ascorbyl glucoside; 1 to 10% by weight of caprylyl methicone; 1 to 15% by weight of butyloctyl salicylate; 1 to 15% by weight of octisalate ethylhexyl salicylate; and 0.01 to 3% by weight of silica, it would have been obvious to optimize the amounts of in Foley’s cosmetic composition. Foley teaches the compositions can also include any number of combinations of additional ingredients described throughout this specification (e.g., pigments, or additional cosmetic or pharmaceutical ingredients). The concentrations of any ingredient within the compositions can vary. For example, at least about 0.0001% to 99%. A person of ordinary skill in the art would understand that the concentrations can vary depending on the addition, substitution, and/or subtraction of ingredients in a given composition (paragraph [0036]). Therefore, it would have been obvious to optimize the amounts of magnesium sulfate, glycerin, xanthan gum, butylene glycol, ascorbyl glucoside, caprylyl methicone, butyloctyl salicylate, octisalate ethylhexyl salicylate, and silica in Foley’s cosmetic composition because Foley teaches that The concentrations of any ingredient within the compositions can vary. For example, at least about 0.0001% to 99% (paragraph [0036]), therefore, one of ordinary skill in the art can use the teachings of Foley as a starting point using routine experimentation for the desired results of the cosmetic composition. 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. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Conclusion
No claims are allowed.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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