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 .
Claim Objections
Claim 20 is objected to because of the following informalities: the claim recites “the sunscreen” while the parent claim recites “organic sunscreen”. Consistent terminology should be employed in the claims when referencing a particular component. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-6, 8-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tomita et al. (JP 2003137716 – English translation referenced for citations) in view of Oyama et al. (US Patent No. 6,117,434).
Tomita et al. teach a cosmetic emulsion composition for melanin production inhibition and skin whitening that comprises a 1, 4-quinone derivative or a 1, 4-hydroxyquinone derivative as active ingredients (see abstract and paragraphs 4-6 and 58). Vitamin K2 compounds also known as menaquinone 4, menaquinone 5, menaquinone 6, and menaquinone 7 are particular examples of these derivatives that Tomita et al. envision (see paragraph 6; instant claims 2 and 14). Tomita et al. teach the 1, 4-quinone derivative or a 1, 4-hydroxyquinone derivative preset at 0.01 to 1 wt% of the composition (see paragraph 9). They also explicitly detail application of the composition to the skin (see paragraph 10). Tomita et al. further teach of the inclusion of UV screening compounds in the composition and particular envisioned compounds include a butyl methoxy dibenzoyl methane (see paragraph 13; instant claim 20). Moisturizing ingredients may also be present (see paragraph 16). They additionally detail an example of their composition as an oil-in-water essence (lotion) (see example 7). This formulation has an oil phase containing cholesteryl-12-hydroxystearate at 3 wt%, menaquinone 6 (vitamin K2; MK6) at 0.1 wt%, stearic acid at 3 wt%, liquid paraffin at 5 wt%, surfactants/emulsifiers, and ultraviolet absorbers, while the water phase contains 1, 3-butylene glycol (see instant claims 1-2, 5-6, 9-12, and 18). This emulsion configuration yields the vitamin K2 compound encapsulated in the oil dispersed phase (see instant claim 1). Another example provides a lower proportion of oils of about 0.5 wt% for a microemulsion while a cream form cream is generated from higher proportions of oils (see examples 4 and 5). While the cholesteryl-12-hydroxystearate is an ester of 12-hydroxystearic acid the acid itself is not explicitly taught as a component.
Oyama et al. teach a topical composition for moisturizing skin (see abstract). They teach the composition as an oil-in-water composition with an oily substance mixed with water and desired moisturizing ingredients (see column 2 lines 1-15). They contemplate stearic acid, liquid petrolatum (paraffin liquid), cholesteryl-12-hydroxystearate and 12-hydroxystearic acid as the oily substances employed separately or in combination in such compositions (see column 4 lines 35-47; instant claims 1 and 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the composition in example 7 of Tomita et al. where the proportion of the menaquinone 6 is adjusted within the range envisioned for the 1, 4-quinone derivative/1, 4-hydroxyquinone derivative. The result is a range of ratios of vitamin K2 to hydroxystearic acid compound that spans from 0.01:3 (1:300) to 1:3, where the example provides a ratio of 1:30 ratio. It also would have been obvious to exchange 12-hydroxystearaic acid for the cholesteryl-12-hydroxystearate in the example as known alternative oily substances for topical oil-in-water emulsion compositions. This modification would have been obvious in light of Oyama et al. as the simple substitution of one known element for another in order to yield a predictable outcome. The range of ratios of 12-hydroxystearic acid to vitamin K2 would then overlap or embrace those instantly claimed, thereby rendering the claimed ranges obvious (see instant claims 8, 16-17). “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). Adjusting the proportion of the hydroxystearic acid oily component upward or downward would have been obvious as a design choice to generate the desired product consistency/configuration in light of other examples detailed by Tomita et al. This implied range overlaps or embraces the instantly claimed range thereby rendering the range of hydroxystearic acid proportion obvious (see MPEP 2144.05; instant claim 19). It additionally would have been obvious to exchange the envisioned butyl methoxy dibenzoyl methane UV screening compound for the UV screening compound in the example as the simple substitution of one known element for another in order to yield a predictable outcome (see instant claim 20). The exchange of another envisioned menaquinone for the menaquinone 6 (e.g., menaquinone 7) also would have been obvious for the same reason (see instant claim 14). The application of the modified compositions to skin would follow (see instant claim 13). Therefore claims 1-2, 4-6, 8-14 and 16-20 are obvious over Tomita et al. in view of Oyama et al.
Claims 1-2 and 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tomita et al. in view of Oyama et al. as applied to claims 1-2, 4-6, 8-14 and 16-20 above, and further in view of Bartolone et al. (CN 1227098 – English translation referenced for citations).
Tomita et al. in view of Oyama et al. render obvious the limitations of instant claims 1-2, 4-6, 8-14 and 16-20, where the composition is a topical composition for inhibiting melanin production. The presence of niacinamide is not explicitly detailed.
Bartolone et al. teach a composition for skin whitening (see abstract and paragraph 10-14). They additionally teach niacinamide as a skin whitening active (see paragraph 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add nicotinamide to the composition of Tomita et al. in view of Oyama et al. in light of Bartolone et al. This modification would have been obvious because both the modified compositions of Tomita et al. and that of Bartolone et al. function as skin whitening compositions. “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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06). Therefore claims 1-2 and 4-20 are obvious over Tomita et al. in view of Oyama et al. and Bartolone et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615