DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 13 April 2026, is acknowledged.
Claim 1 has been amended.
Claims 1-3 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the acryl-silicone copolymer is a copolymer of methacryloxypropyl polydimethylsiloxane, butyl methacrylate, 2-ethylhexyl acrylate, and methyl methacrylate; and
the diluent is undecane and tridecane.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 103
The rejection of claims 1-3 under 35 U.S.C. § 103 is withdrawn in view of Applicant’s amendment to claim 1 and in favor of the new grounds of rejection below.
New Grounds of Objection
Claim Objections
Claim 1 is objected to for reciting “have a viscosity” in line 6 because line 5 recites the object having the viscosity to be “the cosmetic composition”. Because the object is singular, the phrase in line 6 should read “has a viscosity” (bold added for emphasis).
Appropriate correction is required.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 was amended to recite a viscosity of the claimed cosmetic composition from 210-6,000 cP. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”). While the Applicant did not specifically cite the support for the amendment in the original disclosure, support for the viscosity limitation was found in para. [57] and [70-71] and Table 2 of the instant spec. However, in each instance the viscosity is stated to be “at 25 °C”, which is not recited in instant claim 1. As a result, the newly added limitation to claim 1 includes viscosities at all temperatures which is not supported by the original disclosure and is considered new matter. Claims 2-3 depend from claim 1, incorporate all of its limitations, and are therefore also rejected for introducing new matter. Applicant may overcome this rejection by amending claim 1 to recite “at 25 °C” after the range of viscosity values.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Hideyuki Yamaki et al. (Japanese Patent Application Publication No. JP 2018-24591 A, published on 15 February 2018, references to English translation, provided by Applicant in the IDS filed on 19 May 2023, hereafter referred to as H-Y) in view of Rollat et al. (U.S. Patent Application Publication No. US 2003/0017128 A1, published on 23 January 2003, hereafter referred to as Rollat) and Bochniak et al. (U.S. Patent Application Publication No. US 2003/0211159 A1, published on 13 November 2003, hereafter referred to as Bochniak).
H-Y teaches a composition for external application which contains an acrylic silicone graft copolymer and various oily components (Title and Abstract). The composition for external application is taught to be suitable as a skin cosmetic and is therefore interpreted as equivalent to a cosmetic composition as recited in the instant claims (pg. 2, lines 24-29 and claims 6-7). The silicone graft copolymer is taught to contain three units represented by formulas (I), (II), and (III), as well as other units that (pg. 2, lines 32-34 and pg. 3, lines 5-8).
In one embodiment, the unit of formula (II) is specifically a unit of formula (IIa) in which the end opposite R1 terminates in a methacrylate group, R2 is a C2-10 alkyl group, preferably C2-6 and may be propylene, and R1 is an alkyl group including methyl, which is equivalent to the elected methacryloxypropyl polydimethylsiloxane unit (pg. 2, lines 57-62 and pg. 3, lines 13-14). The additional units in the acrylic silicone-based graft copolymer are taught to be methacrylic acid and alkyl methacrylates (pg. 3, lines 5-8).
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Formulas (I), (II), and (III) reproduced from H-Y (JP 2018-24591 A).
H-Y further teaches that the composition comprises one or more oily components in combination with the acrylic silicone-based graft copolymer, which allows the function of the copolymer to be more effective (pg. 3, lines 38-40). In one embodiment, the oily component is a hydrocarbon oil and may be undecane and tridecane (pg. 3, lines 41-51). H-Y teaches that the preferable viscosity of the oily component of their composition be “10,000 mPa•s or less, more preferably 5,000 mPa•s or less, and further preferably 500 mPa•s or less” (pg. 4, lines 6-9). The units mPa•s and cP are equivalent, so the viscosity ranges taught by H-Y are equivalent to <10,000 cP, <5,000 cP, and <500 cP, respectively.
The composition is also taught to contain an aqueous component which may include water and/or a water-soluble organic solvent, examples of the latter being lower alcohols such as methanol, ethanol, and isopropanol (pg. 4, lines 20-25). The content of the acrylic silicone graft copolymer is taught to be 0.1-20% by mass, preferably 1-5% by mass (pg. 3, lines 31-37), and the content of the oily component is taught to be 20-90% by mass (pg. 4, lines 12-14), resulting in a ratio of 1:1 to 900, preferably 1:4 to 90, which significantly overlaps with the range of ratios recited in instant claim 3. Finally, in Examples 4-5, H-Y teaches that the ratio of oily components in the compositions (in Examples 4-5 hydrogenated coconut fatty acid and coconut alkyl) may be ~1:0.2, which falls within the range of ratios recited in instant claim 2.
H-Y does not teach the alky groups in the alkyl methacrylates to be methyl, butyl, and 2-ethyl hexyl nor the amount of organic solvent in their aqueous component. These deficiencies are offset by the teachings of Rollat and Bochniak.
Rollat teaches a hair styling composition comprising methacrylic copolymers and additional components (Title and Abstract). The methacrylic copolymer is taught to comprise four or more different methacrylate monomers, among which are methacrylate esters with C1-30 branched and strain chain alkyl alcohols such as methyl methacrylate, t-butyl methacrylate, isobutyl methacrylate, and 2-ethylhexyl methacrylate (para. [0021] and claims 1 and 5-6). The composition is additionally taught to comprise one or more other constituents, such as fixing polymers and long chain hydrocarbons (para. [0051-0052]). In one embodiment, the fixing polymer is a grafted silicone polymer containing a silicone polymer, such as polydimethylsiloxanes (PDMS), and a non-silicone organic chain such as t--butyl acrylate, acrylic acid, poly(methacrylate), and poly(alkyl methacrylates) (para. [0150-0156]).
Bochniak teaches a method for reducing the level of residual organic solvent in polymers following production and compositions comprising the low level organic solvent polymer (Abstract and claims 19-21 and 28-35). Polymers are taught to be widely used, including cross-linked, acrylic-based polymers, but often possess residual organic solvents as a result of manufacturing conditions (para. [0003-0004]). Examples of residual organic solvents include lower alcohols such as methanol, ethanol, and isopropanol, which may be necessary for synthetic procedures, but because they provide no therapeutic benefit and may be harmful at higher level Bochniak teaches that “all residual organic solvents should be removed to the lowest extent practicable” (para. [0004]). Bochniak teaches that an acceptable level of residual organic solvents is less than 30 ppm and preferably less than 2 ppm (para. [0036-0037] and claims 19-21 and 25-27). Conversion of ppm units to % can be performed by dividing by 10,000, resulting in Bochniak teaching the equivalent of <0.003% or <0.0002%.
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “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). These guidelines apply to the weight ratios of diluents and copolymer: diluents, the viscosity, and the quantity of residual organic solvents. The weight ratios taught by H-Y fall within the ranges of ratios recited in instant claims 2-3, the viscosity ranges taught by H-Y encompass and/or significantly overlap with the range recited in amended claim 1, and the range taught by Bochniak significantly overlaps with the range recited in instant claim 1, rendering the ranges prima facie obvious.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Rollat and Bochniak with the invention of H-Y to arrive at the invention of instant claims 1-3 because combining prior art elements in similar inventions according to known methods produces predictable results. H-Y teaches a cosmetic composition comprising the diluents undecane and tridecane in amounts that fall within the recited ratio range, an acryl-silicone copolymer that can contain the elected methacryloxypropyl polydimethylsiloxane and the genus alkyl methacrylates, and optionally comprising organic solvents such as methanol, ethanol, and isopropanol. In addition, H-Y teaches appropriate viscosity ranges for the oily component of their composition which significantly overlap with and/or encompass the range recited in instant claim 1. The oil component comprises 20-90% by mass of the composition taught by H-Y and it would have been obvious to apply the viscosity range taught by H-Y to the entire composition in the absence of additional teachings, particularly when the taught range can apply to 90% w/w of the composition.
In view of the teachings of Rollat, a person of ordinary skill would be motivated to use methyl, isobutyl/t-butyl, and 2-ethylhexyl methacrylates because Rollat teaches their use in copolymers in cosmetic compositions and provides missing information an ordinary artisan would need to complete the invention of H-Y. Further, the cosmetic composition taught by Rollat contains long chain hydrocarbons and alkyl methacrylate polymers alongside grafted silicone-acrylate polymers and demonstrates to one of ordinary skill that the components are compatible in cosmetic compositions.
In view of the teachings of Bochniak, a person of ordinary skill would be motivated to have the content of lower alcohol organic solvents in their cosmetic composition at the equivalent of <0.003% w/w because Bochniak teaches this level to be suitable for compositions that will contact humans and will not be hazardous to the user or environment. An ordinary artisan would desire their cosmetic product not be hazardous and would therefore be motivated to use this range for the lower alcohols in the composition of H-Y. Further, H-Y does not teach the quantity of lower alcohols to be used in their composition and Bochniak teaches missing information that an ordinary artisan would require to complete their invention.
Lines 7-9 of instant claim 1 are interpreted as product-by-process limitations and this claim is “not limited to the manipulations of the recited steps, only the structure implied by the steps.” See MPEP § 2113.I. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Because the product recited in instant claims 1-3 is obvious in view of the teachings above, the limitation in instant claim 1 regarding the process by which the composition is prepared does not render the invention patentable. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-3 in view of the teachings of H-Y, Rollat, and Bochniak.
Response to Arguments
The Applicant’s arguments, filed on 13 April 2026, have been fully considered but are not persuasive.
In para. 2 of the section titled “The Pending Claims Are Not Obvious” on pg. 4 of the remarks, Applicant argues that the H-Y and Rollat references fail to teach the content of the organic solvent recited in amended claim 1 or the viscosity of the composition. The argument regarding the content of the organic solvent has been rendered moot in view of the new grounds of rejection, specifically in view of the teachings of Bochniak which motivate the levels of organic solvents, including lower alcohols, be the equivalent of 0.003% w/w or less. Regarding the viscosity of the composition, this was rendered obvious by the teachings of H-Y and is included in the new grounds of rejection above. As a result, Applicant’s arguments are not found to be persuasive.
In para. 3 of the section titled “The Pending Claims Are Not Obvious” on pg. 4, Applicant claims to have shown “unobvious or unexpected advantageous properties” in their invention with Tables 1 and 2 of the instant spec. Guidelines on determining whether results are expected or unexpected are provided in MPEP § 716.02. To demonstrate that results are unexpected and significant, the Applicant has the responsibility of presenting evidence that establishes “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). “Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims” (bold added for emphasis). See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e).
The comparisons presented in Tables 1 and 2 are not a persuasive demonstration of unexpected and surprising results. The only data presented in Table 1 are the distillation pressure, temperature, and time and the identity and ratio of the diluent. Further, a direct comparison of any Example 1-5 of the inventive composition and a Comparative Example 1-10 is not allowed by Table 1 because more than one variable changes in each instance (e.g., Comparative Example 1 was distilled at 760 torr and 95 °C for 2 hours with a diluent of undecane and tridecane at a ratio of 1:2.3 and no example of the inventive composition was distilled at 760 torr or for 2 hours). Table 2 allows a comparison of the viscosity, appearance, organic solvent content, subjective feeling, and amount of diluent lost during distillation as a result of changing distillation conditions. However, as stated above and repeated here in brief, "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP § 2113.I. Therefore, a comparison of the process by which the acryl-silicone copolymer is prepared is not a persuasive demonstration of unexpected and surprising results.
The Applicant has not demonstrated unexpected results commensurate in scope with the claimed invention. “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.” In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP § 716.02(d). All of the inventive Examples 2-10 and Comparative Examples 1-5 were “prepared in the same manner as in Example 1 except that vacuum distillation or distillation was carried out under the same conditions as described in Table 1, and the type of the diluent was changed” (instant spec. para. [0059]). No examples were presented outside the claimed range of ratios for copolymer: diluent and therefore Tables 1 and 2 do not demonstrate the criticality of the claimed range.
Finally, the Applicant also has not compared their invention with the closest prior art. See MPEP § 716.02(e). The comparison provided in Tables 1 and 2 of the instant specification are comparisons of distillation conditions for preparing the claimed acryl-silicone copolymer. Hideyuki Yamaki et al., which was provided by Applicant in the IDS filed on 19 May 2023, and used in a rejection under 35 U.S.C. § 103 in the previous Office Action, teach cosmetic compositions that comprise the diluents undecane and tridecane in amounts that fall within the recited ratio range, an acryl-silicone copolymer that can contain the elected methacryloxypropyl polydimethylsiloxane and the genus alkyl methacrylates, and optionally comprise organic solvents such as methanol, ethanol, and isopropanol. Therefore, a comparison with the closest subject matter in the prior art should include a comparison to Hideyuki Yamaki et al.
Conclusion
No claims are allowed.
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.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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