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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/2025 has been entered.
Claim Status
Claim 15 is withdrawn.
Claims 1-10, 12-14 and 16 are rejected.
No claims are allowed.
Maintained 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.
Claims 1-10, 12-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Fukui et al., (US 2012/0301523 A1, Nov. 29, 2012) (cited by applicant on IDS 07/28/2022) (hereinafter Fukui) in view of Tomonari et al., (US20200347256A1, filed Jan. 28, 2019) (hereinafter Tomonari).
Fukui discloses 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 (Abstract). 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]). One or more types of component (A) may be used ([0024]). Component (B) is ceramides ([0063]). Component (C) can be isododecane ([0034]). 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]). Water is included in amounts of 10 to 60% by weight based on a total weight of a cosmetic composition ([0038]). 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). The W/O cosmetic emulsion method comprises mixing component (B), a solid oil, and component (C), an oil, and dissolving with heat, then cooled to room temperature. Component (A) was mixed into a solution of component (E) methyl polysiloxane, N-propionyl polyethylene imine-methyl polysiloxane copolymer, then added to the oil phase. The oil phase was then added to the aqueous phase and stirred at high speed ([0136]).
Fukui differs from the instant claims insofar as not teaching the titanium dioxide having an average particle size of 5 nm to 50 nm.
However, 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.
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 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.
Response to Applicant’s Arguments
Applicant argues that there would have been no motivation for the skilled artisan to combine the teachings of Fukui et al. with those of Tomonari et al. because in paragraph [0005] of Fukui et al., it is disclosed that the use of titanium oxide power causes problems, such as the skin appearing white and a bad feeling to the touch and therefore the use of titanium oxide of Tomonari would be a disincentive.
Applicant’s argument has been fully considered but found not to be persuasive. The office action does not suggest the use of the titanium oxide of Tomonari in the composition of Fukui. Rather, as discussed above, the composition of Fukui comprises titanium dioxide which has been surface-treated with an alkylalkoxysilane, meeting the limitation of the component (a) in claim 1. However, the titanium dioxide of Fukui does not have an average particle size of 5 nm to 50 nm. Tomonari teaches that titanium dioxide particles having a particle size 5 to 100 nm have high visible light transparency and a favorable ultraviolet shielding range. Thus, it would have been obvious to one of ordinary skill in the art to adjust the particle size of 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.
Applicant argues that there would have been no motivation for the skilled artisan to combine the teachings of Fukui et al. with those of Tomonari et al. because the composition of Fukui is a water-in-oil emulsified cosmetic composition with a nonionic surfactant having HLB of 8 or less and the composition of Tomonari uses a nonionic surfactant having an HLB value of 10 or more, therefore, if titanium dioxide in the aqueous dispersion is blended in the water-in oil emulsified cosmetic composition of Fukui et al., it is clear that the stability would be bad.
Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above as the office action asserts that the composition of Fukui would be modified, not the composition of Tomanari, and it would have been obvious to one of ordinary skill in the art to adjust the particle size of 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 and does not suggest the use of the titanium dioxide of Tomonari in the composition of Fukui.
Applicant argues that instantly claimed titanium oxide particles having a particle size from 5 to 50 nm may be uniformly applied and have a superior ultraviolet protective effect, which is an unexpected result. Applicant cites the Additional Comparative Example as being comparable to that of the Comparative Examples, in particular the results of Comparative Example 5 found in Table 2.
Applicant’s argument has been fully considered but found not to be persuasive. The results do not appear to be unexpected. The Additional Comparative Example submitted by Applicant is compared to Example 1 of the instant specification. The difference in the compositions is the type of component (a) used, as plate-like octylsilyated zinc oxide is used in the Additional Comparative Example and stearic acid treated titanium dioxide is used in Example 1. The results show that Example 1 and Additional Comparative Example only differ in terms of ultraviolet protection ability. Example 1 has a score of b and Additional Comparative Example has a score of d. As noted in paragraph [0059] of the instant specification, a score of b means an SPF value of 60-less than 100. A score of d means an SPF value of less than 40. According to MPEP 716.02, any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Thus, since different (a) components are used, one would expect different results. As evidenced by Taglia (What Do the SPF Numbers Mean?, May 2025) (hereinafter Taglia), SPF 30 blocks 97% UVB rays, while SPF 100 blocks 99% UVB rays (page 1, Assessing SPF). Taglia concludes that, as a general rule, everyone should use an SPF of at least 30 (page 1, third heading). Thus, the difference in results does not appear to be of statistical and practical significance since a difference of 3% does not appear to be of statistical and practical significance according to Taglia. Thus, Applicant’s showing does not appear to be unexpected.
Furthermore, with regards to the comparative examples disclosed in instant Table 2, it is unclear how they differ from the claimed invention. As discussed above, one would expect different compositions to have different results. Therefore, unexpected results with regards to the claimed invention cannot be determined from the comparative examples. Therefore, the comparative examples having an unfavorable result for spreadability and whitishness is not persuasive.
Applicant argues that the claimed particle size of component (a) being 5 nm to 50 nm is critical to achieving the unexpected results.
Applicant’s argument has been fully considered but found not to be persuasive. Applicant has not shown wherein the claimed particle size is critical. The zinc oxide powder of Fukui had an average particle diameter of 0.25 μm (i.e., 250 nm) ([0128]), which is outside of the claimed range of 5 to 50 nm. Thus, when comparing the Additional Comparative Example to the instantly claimed invention having a different component (a) and particles within the instantly claimed range, it is unclear if the difference in observed results is due the compositions comprising different compounds or is due to the difference in particle size. Further, it is not shown in the Examples or Comparative Examples that compositions having component (a) with a particle size outside of the claimed range would not result in the composition being uniformly applied and having a superior ultraviolet protection. Thus, the data provided by the Applicant does not show that the claimed particle size is critical to achieving the unexpected results.
Applicant argues that a combination of component (a) and component (b) is necessary achieving the unexpected results.
Applicant’s argument has been fully considered but found not to be persuasive. Applicant has not shown wherein a combination of the components is critical. All of the disclosed Comparative Examples in instant Table 2, and including the Additional Comparative Example as well, comprise component (b). Thus, because Applicant has not shown wherein a composition that does not comprise a combination of component (a) and component (b) would not result in uniform application and superior ultraviolet protection, Applicant has not shown wherein a combination of the components is critical.
Applicant argues that claim 15 should be rejoined since claim 1 is now allowable.
Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above regarding the rejection of claim 1.
For the foregoing reasons, the rejection is maintained.
Response to Declaration/Affidavit
The Declaration submitted 10/24/2025 is acknowledged and has been fully considered. The Examiner submits that Declarant’s arguments are addressed above and are unpersuasive. Therefore, the rejections are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./
Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614