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 .
Response to Arguments
All of Applicant’s argument filed 11/19/2025 have been fully considered.
In view of the amendments to claim 12, the 112(b) rejection over this claim is withdrawn as the issues have been resolved.
Patentability over Wakamatsu
Applicant argues that tromethamine provides unexpectedly superior results over inorganic alkali such as potassium anhydride, this is seen in Example 3 and comparative example 6 of the specification. Example 3 showed marked improvement in odor control and discoloration. Applicant also clarifies the results obtained in Ex. 6 and the meaning of “-“ and narrows the claims to be more commensurate in scope with the data presented as tables 3-1, 3-2 and 3-3 shows specific oils to provide unexpected effects.
The Examiner thanks Applicant for the clarification regarding comparative Ex. 6, however, the data presented remains unpersuasive as the data is still not commensurate in scope, as 1 single data point was provided and a single concentration points and a single pH (which determines how much tromethamine is present in the composition). A single data point is not sufficient to establish trend in the data such that all species claims would have the stated effect. Applicant has not provided any evidence that the differences shown were statistically significant. Applicant has not provided any error bars, suggesting a single experiment which does not rise to the level of statistical significance and it’s unclear of the studies are reproducible. Applicant’s remarks regarding the oils of table 3-1 and 3-3 are not persuasive as the data shows these oils, for example phytostearyl/behenyl/octydodecyl lauroyl glutamate and stearyl dimethicone, provide improved feel in use, however, these oils are known skin conditioning agents (see US 2019/0240134 [0021] and US2008/0159974, claim 7), as such as improved skin feel is expected. Regarding table 3-2, Applicant arguments are not persuasive as the examples do not comprise tromethamine as required by the instant claims, thus all examples in table 3-2 do not have a nexus to the claimed invention.
New 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.
Claim(s) 1-2, 5-6, 10, 12 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wakamatsu (US 2011/0112045), JP2014070063 and Harripersad (US 2008/0159974), as evidenced by Okubo (US 2012/0295989) and Okano (US 2008/0014231).
Wakamatsu discloses an O/W emulsion comprising components (A) to (F) (Abs) for the production of a skin cosmetic (Wakamatsu – claims 9-10). The emulsions preferably have a viscosity ranging from 20,000 to 30,000 cps (equivalent to 20,000 to 30,000 mPas), this overlaps with the viscosity as recited by instant claims 1, 6 and 10 [0059].
Examples 1-8 of Wakamatsu disclose O/W emulsion with viscosities ranging from 15000-33000 comprising adenosine monophosphate, oils such as liquid paraffin, glycerin, acrylic acid-alkyl methacrylate copolymer, pH adjuster, purified water, etc.
Regarding instant claims 1, 6 and 10, Ingredient (A): Wakamatsu teaches component (A) is an adenosine phosphate ester, preferred examples include adenosine monophosphate monosodium, adenosine monophosphate disodium, adenosine triphosphate monosodium, adenosine triphosphate disodium, adenosine triphosphate trisodium, and cyclic adenosine 3′,5′-monophosphate [0020]. This component is preferably used in amounts ranging from 0.5 to 7 wt. % [0022].
Regarding instant claims 1-2, 6 and 10, Ingredient (B): Wakamatsu teaches component (C) to be an acrylic acid-alkyl methacrylate copolymers which is preferably used in amounts ranging from 0.05-0.7wt%. [0027]. A preferred copolymers include Pemulen TR-1 and TR-2, selected from a finite number of options. As evidenced by Okubo, these polymers are acrylic acid/C10-30 alkyl acrylate crosspolymers having a molecular weight of 1,500,00 and 1,000,000 respectively (Table 1).
Regarding instant claims 1, 6, 10 and 14, Ingredient (E): Wakamatsu teaches component (H) to be an oil and teaches that the oil used in not particularly limited. Suitable oils include jojoba oil, petrolatum, and silicone oils such as modified silicones which are modified by polyoxyethylene or polyoxypropylene [0040], The use of any of these oils is prima facie obvious and expected to yield no more than expected from such an arrangement. One or more oils are taught to be used in amounts of 5-40wt% [0041].
Regarding claim 15: Wakamatsu teaches the inclusion of Component (E), polyhydric alcohol(s), these are added to improve the expression of the emulsification property of the polyglycerin fatty acid ester, etc. A preferred polyhydric alcohol is glycerin, as evidenced by Okano, glycerin is a water-soluble humectant [0061].
Regarding instant claims 1 and 6: Ingredient (F): Wakamatsu teaches ingredient (G) to be water [0038].
Regarding instant claims 1, 5-6 and 10, Ingredient (D): Wakamatsu teaches that the composition is for external use and generally has a pH from mildly acidic to neutral, however, to reduce skin irritation and ensure a pigmentation prevention effect, the pH preferably ranges from 5.5-7. To adjust the pH of the composition, a pH adjuster may be added to the composition. Examples of pH adjusting agents include arginine, selected from a finite number of options. All of the working examples of Wakamatsu include a pH adjusting agent, thus the addition of a pH adjusting agent as taught is prima facia obvious.
However, Wakamatsu does not teach ingredient (D), the pH adjuster, to be tromethamine.
JP’063 teaches a skin external agent comprising water, oils, etc. and pH adjusting agents. JP’063 teaches that from the standpoint of good applicability to skin preferred pH adjusting agents are arginine and tromethamine (selected from a finite number of options) [0008, 0027 and 0026].
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wakamatsu with those of JP’063. One of skill in the art would have recognized arginine and tromethamine to be art recognized equivalent pH adjusting agents suitable for use in skin cosmetics. It would have been prima facie obvious to substitute arginine in the composition of Wakamatsu with tromethamine with a reasonable expectation of success. One of skill in the art would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
As recognized by MPEP §2144.06, it is prima facie obvious to substitute art-recognized equivalents, and an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Regarding claim 12: The prior art makes obvious to use tromethamine as the sole pH adjuster as mixtures are not required by Wakamatsu, this reads on the composition not comprising a pH adjuster which is an inorganic alkali compound.
However, Wakamatsu does not teach the oil component to further comprise an ingredient (G), such as stearyl dimethicone, a silicone wax.
Harripersad teaches cosmetic compositions for application to the skin (Abs). Harripersad teaches that skin conditioning agents such as stearyl dimethicone, silica silylate and jojoba oil can be used (Harripersad – claim 6-7), and these are exemplified to be used in amounts of 0.01-50% (Harripersad – claim 19).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the above references with those of Harripersad. One of skill in the art would have been motivated to add 0.01-50% of a skin conditioning agent such as stearyl dimethicone, selected from a finite number of options, to improve the skin conditioning properties of the composition of Wakamatsu. One of skill in the art would have a reasonable expectation of success as Wakamatsu teaches oils such as jojoba oil, which is a skin conditioning agent can be effect used.
As discussed above, Wakamatsu makes obvious to use of ingredient (E) in amounts 5-40wt% [0041] and Harripersad makes obvious adding 0.01-50% of stearyl dimethicone (ingredient (G)), this provides amounts of ingredient (E) and ingredient (G) that overlap with the claimed ranges.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613