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 .
Status of the Claims
Pursuant to the amendment dated 12/10/2025, claims 7-10 and 15 have been cancelled. Claims 3, 5, 6, 11, 12, and 14 have been cancelled.
Claims 1, 2, 4, and 13 are pending and under current examination.
All rejections not reiterated have been withdrawn.
A terminal disclaimer is on file for copending applications 17/601,704; 17/601,317; 17/601,252; 17/601,341; 17/601,347; 17/796,584; 17/796,580; 17/796,578; and 17/796,577.
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, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Fukushima et al. (WO2017069157A1, published 27 April 2017; of record) in view of Wang et al. (Semin Cutan Med Surg 30:210-213; publication year: 2011; of record) and further in view of Tsai et al. (Journal of Nanoparticles Vol 2016; article ID 6539581; publication year: 2016; of record) and Ono et al. (JPH05117127A, published 14 May 1993; of record).
Fukushima et al. is directed to a cosmetic composition for external application to the skin [Lines 663-664; limitation of instant claim 1]. The composition comprises an ultraviolet absorber such as zinc oxide and a water-soluble thickener [Claim 1; limitation of instant claim 1], xanthan gum [Line 249; limitation of instant claim 1]. Fukushima et al. further discloses including vitamins such as B2 the use of the alkyl-modified carboxyvinyl polymer acrylates/alkyl acrylate (C10-C30) [Line 259; limitation of instant claim 7], and the polymer PEG-240/Decyltetradeceth-20/HDI, a hydrophobically modified polyether urethane [Line 251; limitations of instant claims 8-9].
Fukushima et al. does not teach including sodium hexametaphosphate, as required by instant claim 1. However, this deficiency is cured by Ono et al.
Wang, in the analogous art of sunscreen compositions, discloses that titanium dioxide and zinc oxide particles lose their efficacy as sunscreen agents when they agglomerate into larger particles (page 211, left col).
Tsai, in the analogous art of metal oxide particle suspensions that may be used for sunscreens (title, page 1, left col), discloses that sodium hexametaphosphate is an effective dispersant for titanium oxide nanoparticles (abstract).
Ono et al. is directed to fluorescent cosmetics [0001] that are highly light-resistant and safe. Ono et al. discloses the use of the inorganic phosphor, zinc oxide phosphor ([0006]; limitations of claims 2-3). In addition, Ono et al. discloses the use of sodium hexametaphosphate ([0020]; limitations of claim 1) in their cosmetic compositions.
It would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine add sodium hexametaphosphate to Fukushima’s sunscreen composition. The skilled artisan would have been motivated to do so in order to improve the dispersion of the zinc oxide particles within the composition to maintain their efficacy as sunscreen agents. The skilled artisan would have had reasonable expectation of success in view of Ono, who discloses a similar sunscreen composition containing sodium hexametaphosphate. In view of Ono, one of ordinary skill would have understood that sodium hexametaphosphate is compatible with topical sunscreen compositions containing zinc oxide phosphor.
With regard to the quantity of sodium hexametaphosphate required by instant claim 1, the examiner considers it merely a matter of routine for one of ordinary skill to have tested several concentrations of dispersant in order to sufficiently disperse the metal oxide particles in Fukushima’s invention. See MPEP 2144.05.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fukushima et al. (WO2017069157A1, published 27 April 2017; of record) in view of Wang et al. (Semin Cutan Med Surg 30:210-213; publication year: 2011; of record), Tsai et al. (Journal of Nanoparticles Vol 2016; article ID 6539581; publication year: 2016; of record), and Ono et al. (JPH05117127A, published 14 May 1993; of record) as applied to claims 1, 2, and 13 above, and further in view of Chae et al. (KR20190005369A; publication date: 01/16/2019; citing the English machine translation).
The relevant disclosures of Fukushima, Wang, Tsai, and Ono are set forth above. Fukushima discloses further that the composition may be contain anti-wrinkle agents; however, none of these references disclose including phycocyanin C in the composition.
Chae discloses that phycocyanin C has anti-wrinkle effects (e.g. page 2).
It would have been prima facie obvious to add phycocyanin C to Fukushima’s composition containing anti-wrinkle agents because they were both known for the same purpose as of the instant effective filing date. See MPEP 2144.06.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
On pages 4-5, Applicant points out the amendment to claim 1, narrowing the scope of component B.
The examiner notes that the identity of the thickeners has been narrowed to those used in the examples reported in tables 1-3.
On page 5, applicant describes the instant invention as converting UV light to provide a preferable action on skin that is surprising and leads to an improvement in the quality of life such that those who have avoided ultraviolet as much as possible for a reason of beauty or health may feel like going out actively. On page 6, Applicant cites para 9 of the specification and argues that in light of the examples of the present application, take into account the unexpected effects regarding the cell activation effect of the cosmetic according to amended claim 1. Applicant also describes the increased fluorescent integrated value, and states that this increase makes it possible to utilize ultraviolet rays in a beneficial manner to activate cells producing beneficial effects on skin. On page 6, Applicant argues that the specification describes in 0022 that the cell activation effect may be measured by measuring for example the viability, reducing ability, or proliferation of living cells using AlamarBlue as in the examples and figure 2 depicts a method for measuring cell activity and results obtained when using the specific UV wavelength conversion substance recited in claim 1. Applicant cites examples 1-3 and figure 2.
As an initial matter, the alleged benefits such as quality of life or feeling like going out actively are abstract and not clearly linked to the difference between the claimed invention and the closest prior art. With regard to the argument that protocols exist to evaluate the effect of the composition on tangible benefits like viability or proliferation does not meet the requirement that the claimed composition actually possesses these attributes.
The examiner has fully evaluated the data presented in the specification, and found the burden to overcome an obviousness rejection has not been met, as described in the Office action mailed on 09/10/2025. The examiner’s position is replicated here, noting that the claims have been amended to limit the identity of the thickener.
Please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Although the UV wavelength absorber has been narrowed to only those three substances described in the examples of the specification, the unexpected nature of the results, as well as the practical significance of the data are not clear from the record. Applicant has described the benefit as “activating skin cells” and “preferrable action on the skin”; however, these are, at best, totally abstract and ambiguous effects. The examiner notes that the UV wavelength conversion substances have been shown to have a protective effect on cells by Alamar Blue assay, when they are added to a cell growth medium in a tissue culture experiment (see examples 1-1 to 1-3 of the instant specification). However, this benefit is an inherent property of the known substances and is not, itself, unexpected. The data, cited by Applicant in the remarks and presented in tables 1-3 of the instant specification shows that combining sodium hexametaphosphate with the various UV wavelength conversion substances (zinc oxide, phycocyanin-C, or riboflavin) causes an increase in the amount of UV energy that is converted to a different wavelength by the phosphors noted above. The extent of this increase is highly variable among the tested formulations, indicating that the selection of water-soluble thickener may also be relevant to the effect. In table 2, formulations containing phycocyanin-C and sodium hexametaphosphate increase fluorescence integrated value (i.e. “UV wavelength conversion” as described in the instant application) from 100% as measured for the control P0 to 109% in formulation P1 or 119% in example P8. The record does not address whether an increase as small as 19% has any meaningful impact on tangible factors such as keratinocyte or fibroblast viability. No statistical analysis of the effect has been presented on the record. The examiner maintains that the result is not unambiguously unexpected and the practical and statistical significance of the data is unclear.
In addition to these comments made by the examiner in the previous Office action, the examiner would like to emphasize the differences among the various compositions according to the invention, i.e. having one of the claimed thickeners, one of the claimed UV conversion substances, and sodium hexametaphosphate vs. compositions outside the scope of the invention. Applicant has argued that they consider adding sodium hexametaphosphate to provide unexpectedly superior performance; however, in Table 1, the composition G2, lacking sodium hexametaphosphate performs better than e.g. composition G5, which does have sodium hexametaphosphate. It’s unclear why G5 would be considered unexpectedly superior to e.g. G4, when objectively the fluorescence integrated value for “unexpectedly superior G5” is markedly lower than the fluorescence integrated value for G2. In an nutshell, it is unclear what is unexpected, and it is unclear what causes any allegedly unexpectedly superior property.
On page 7, Applicant points to EXHIBIT 1, a press release published by the applicant and demonstrates the effects of the presently claimed cosmetic, for example showing that the claimed cosmetics efficiently convert UV light into visible light, which restores skin damage caused by UV light and enhances the production of collagen and hyaluronic acid. The instant cosmetics also are stated to suppress inflammation and reduce skin redness when skin is exposed to UV light.
The examiner notes that increased collagen and hyaluronic acid production would have practical significance; however, the record does not currently support that there is any nexus between this increase and difference between the claimed invention and the closest prior art (i.e. the inclusion of sodium hexametaphosphate) as sodium hexametaphosphate does not appear to be discussed in the press release. The suppression of inflammation and redness is expected of any UV protection agent, and therefore cannot be relied upon to overcome the obviousness rejection. Moreover, a publication cannot be relied upon to overcome an obviousness rejection. Accordingly this information is considered to be Applicant opinion, and does not constitute evidence on the record. Please refer to MPEP 716.01(C)(II) regarding probative value of objective evidence and MPEP 2145(I) regarding weight given to Applicant opinion.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617