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 .
Priority
The instant application was filed 28 July 2022 and is the national stage entry of PCT/JP2021/003137 filed 29 January 2021. The Applicant claims priority to foreign application JP2020-015174 filed 31 January 2020. An English copy of the foreign document has not been provided. Therefore, the effective filing date of the instant application is 29 January 2021.
Claim Status
Claim 15 was withdrawn.
Claims 17-20 are newly added.
Claims 1-10, 12-14 and 16-20 are rejected.
No claims are allowed.
Examiner’s Note
The Applicant's amendments and arguments filed 26 May 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 26 May 2026, it is noted that no claims have been amended or canceled. Claims 17-20 have been newly added. Support for the new claims can be found Table 1 of the specification. No new matter has been added.
Declaration
The declaration under 37 CFR 1.132 filed 26 May 2026 is sufficient to overcome the rejection of claims 1-10, 12-14, 16-20 based upon the rejections over Fukui, Tomonari, and Smijs.
The Applicant argues that the composition of Additional Comparative Example B was inferior, in regards to the UV protection and whitishness.
Any alleged evidence of better UV protection and whitishness does not have a causal relationship with the merits and scope of the claimed invention, which is, broadly, an emulsion cosmetic composition comprising titanium dioxide surface-treated with any fatty acid and/or any alkylalkoxysilane, any amphiphilic substance solid at normal temperature, a linear silicone oil of any size, and any volatile hydrocarbon oil. As such, the data are not commensurate in scope with the claims.
“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
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.
Claims 1-10, 12-14 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fukui et al. (US 2012/0301523 A1) in view of Tomonari et al. (US 2020/0347256 A1), as evidenced by Draelos et al. (The Efficacy of a Ceramide-based Cream in Mild-to-moderate Atopic Dermatitis, JCAD, 2018) and atamanchemicals.com.
Regarding claim 1, Fukui teaches a W/O (i.e. water-in-oil) emulsion that includes: (A) 1 to 20% by weight of a plate-like powder which has been surface-treated with an alkylalkoxysilane; (B) 0.1 to 10% by weight of an oil that is solid at temperature of 25° C.; (C) 0.5 to 60% by weight of a hydrocarbon oil; and (D) water (abs). The plate-like powder of component (A) can be zinc oxide (i.e., hydrophobically-treated zinc oxide) or titanium dioxide ([0019]) and has an average particle diameter of 0.1 to 10 μm (i.e., 100nm to 10,000nm) ([0018]).
Regarding claim 2, (b) may be ceramides ([0063]).
Regarding claim 3, the composition further comprises (c), a silicone oil ([0039]), which is liquid at 25° C ([0040]), and includes dimethyl polysiloxane (i.e., linear silicone oil) ([0041]).
Regarding claim 4, (d) may be isododecane ([0034]).
Regarding claim 5, the amount of (d) isododecane may be 0.5-60% ([0036]).
Regarding claim 6, the cosmetic composition may contain an organic ultraviolet absorber having absorption in the UVA range, so that an ultraviolet ray protective effect can be further enhanced ([0048]) (i.e., sunscreen).
Regarding claim 7, the claim is a product-by-process claim. 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. See MPEP 2113. In the instant case, the final product disclosed in the instant application holds no patentably distinct structural differences from the final product disclosed by Fukui. Therefore, the claim is unpatentable. Furthermore, Fukui discloses a W/O (i.e. water-in-oil) cosmetic emulsion that includes: (a) a plate-like powder which has been surface-treated with an alkylalkoxysilane; (b) an oil that is solid at temperature of 25° C.; (c) dimethyl polysiloxane (i.e., linear silicone oil), and (d) a hydrocarbon oil wherein some oil components are heated and dissolved and the oil phase in its entirety is mixed and cooled to room temperature before being mixed into the aqueous phase component ([0136]). Fukui differs from the claim insofar as not reciting the exact order of mixing claimed. However, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04(IV)(C). Thus, the claim is also obvious.
Regarding claim 8, the composition may comprise ceramides ([0063]).
Regarding claim 9, the composition may comprise ceramides ([0063]).
Regarding claim 10, the composition further comprises (E), a silicone oil ([0039]), which is liquid at 25 °C ([0040]), and includes dimethyl polysiloxane (i.e., linear silicone oil) ([0041]), in an amount of 5 to 50% by weight based on a total weight of a cosmetic composition ([0042]).
Regarding claim 12, water is included in amounts of 10 to 60% by weight based on a total weight of a cosmetic composition ([0038]).
Regarding claims 13 and 14, as discussed above, Fukui discloses water is included in amounts of 10 to 60% by weight based on a total weight of a cosmetic composition, 1 to 20% by weight of a plate-like powder which has been surface-treated with an alkylalkoxysilane (i.e. component (a) of the instant application), and 0.1 to 10% of ceramides (i.e. component (b) of the instant application. Accordingly, the ratio of [(a)/water] is from 0.0167 to 2, which overlaps the claimed range in claim 13. Further, the ratio of [(b)/water] of the prior art is 0.00167 to 1, which overlaps the claimed range in claim 14. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claim 16, Fukui teaches hydrophobically-treated zinc oxide having an average particle diameter of 0.1 to 10 μm (i.e., 100nm to 10,000nm), which overlaps the claimed range of an average particle size of 5 nm or more and 100 nm or less. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claim 17, the composition may comprise ceramides, such as N-(2-hydroxy-3-hexadecyloxypropyl)-N-2-hydroxyethyl hexadecanamide ([0026]), which is an example of a pseudo-ceramide (evidenced by Draelos et al., pg. 5).
Regarding claim 18, the composition may comprise dimethyl polysiloxane ([0041]), which is interpreted as the same as dimethicone (evidenced by atamanchemicals.com, pg. 1).
Regarding claim 19, the composition may comprise hydrogenated polyisobutene ([0034]).
Fukui does not teach titanium dioxide having an average particle size of 5 nm to 50 nm in claim 1.
Tomonari discloses a titanium dioxide aqueous dispersion having high dispersibility and little aggregation or coarse particles wherein the titanium dioxide particles have a hydrophobic compound such as a higher fatty acid or a salt thereof on the surface (i.e., surface treated) (Abstract). The average primary particle size of titanium dioxide particles is preferably 5 to 100 nm. Titanium dioxide particles having such a particle size have high visible light transparency and a favorable ultraviolet shielding range ([0020]). The aqueous dispersion medium in the present invention contains water as a main component ([0033]). The titanium dioxide aqueous dispersion of the invention can be used in cosmetics comprising ultraviolet shielding agents and in the form of an emulsion ([0058]).
Fukui discloses cosmetic emulsions comprising surface-treated titanium dioxide and having an ultraviolet ray protective effect, as discussed above. Tomonari discloses surface treated titanium dioxide particles, having an average primary particle size 5 to 100 nm, suitable for use in cosmetic emulsions comprising ultraviolet shielding agents. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to formulate the surface treated titanium dioxide of Fukui to have an average particle size of 5 nm to 50 nm, because titanium dioxide particles having such a particle size have a favorable ultraviolet shielding range, as taught by Tomonari.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Fukui in view of Tomonari, as applied to claims 1-10, 12-14, 16-19 above, and further in view of Smijs et al. (Titanium dioxide and zinc oxide nanoparticles in sunscreens: focus on their safety and effectiveness, Nanotechnol Sci Appl., 2011), as evidenced by Draelos et al. (The Efficacy of a Ceramide-based Cream in Mild-to-moderate Atopic Dermatitis, JCAD, 2018) and atamanchemicals.com.
In regards to claim(s) 1-10, 12-14, 16-19, Fukui and Tomonari, as applied supra, is herein applied in its entirety for its teachings of a water-in-oil emulsion cosmetic composition.
Fukui does not specify that the SPF coverage in their cosmetic composition is in the range of 60-100 in claim 20.
Smijs teaches examples of titanium dioxide nanoparticles in sunscreen formulations. For example, titanium dioxide with a particle size of 12-60 nm, such as Anthelios XL SPF 60, provides SPF 60. The titanium dioxide allegedly penetrated deeper in the skin layers (Table 1).
Since Fukui does not specify that the SPF coverage in their cosmetic composition is in the range of 60-100 in claim 20, one of ordinary skill in the art would have been led to combine the teachings with a reasonable expectation of success. A skilled artisan would have been motivated to use Smijs’ teaching because the nanoparticle sized titanium dioxide is able to better penetrate the skin layers, which would have been useful in Fukui’s sunscreen cosmetic composition. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Response to Arguments
Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive.
The Applicant argues that Fukui teaches away from adjusting the surface treated titanium dioxide to have an average particle size of 5 nm to 50 nm (Remarks, pgs. 8-9).
Applicant’s argument is not found persuasive. The Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). In response to the Applicant's argument that the references fail to show certain features of applicant’s invention, it is reminded that to properly teach away, the prior art reference must criticize, discredit, or otherwise discourage the solution sought. Merely teaching alternatives does not do this (see MPEP 2145 (X)(D)).
The Applicant argues that the Second Declaration shows unexpected results regarding the UV protection and whitishness (Remarks, pg. 9).
Applicant’s argument is not found persuasive. Any alleged evidence of better UV protection and whitishness does not have a causal relationship with the merits and scope of the claimed invention, which is, broadly, an emulsion cosmetic composition comprising titanium dioxide surface-treated with any fatty acid and/or any alkylalkoxysilane, any amphiphilic substance solid at normal temperature, a linear silicone oil of any size, and any volatile hydrocarbon oil. As such, the data are not commensurate in scope with the claims.
“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
The Applicant argues that Fukui teaches that component (A) is added in the oil phase and cooled to room temperature, whereas in the claimed invention, component (a) is dispersed in the oil phase in which the non-volatile oil is heated for dissolution (Remarks, pg. 10).
Applicant’s argument is not found persuasive. The composition claims as written, such as instant claim 1, allow for component (A) to be added in the oil phase and cooled to room temperature. Furthermore, "[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).
Conclusion
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 Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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