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 Claims
Amendment filed on 02/26/2026 is acknowledged.
Claims 1-9 remain cancelled. Claims 10-11 and 13-15 are amended.
Claims 10-20 are pending and being examined herein on merits.
Priority
This instant application 18291346, filed on 01/23/2024, is a 371 of PCT/JP2022/028940, filed on 07/27/2022, which claims foreign priority of Japan 2021-131709, filed on 08/12/2021.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 11/28/2025) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 02/26/2026.
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.
Claims 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Misonou et al. (Marine Biotechnology, 2003, record of 11/28/2025), in view of Coba et al. (Marine Drugs, 01/14/2019, IDS of 04/18/2024) and Baschong et al. (US20120328541, 12/27/2012).
Misonou teaches water-soluble UV-absorbing substances (UVAS) mycosporine-like amino acids (MAAs) found in red algae inhibits the degradation of UV-irradiated thymine, and the inhibitory effect of MAAs is significantly greater than that of exogenously added adenine or guanine (e.g., Abstract; Pg. 195, left col. 1st paragraph). As evidenced by instant specification [0043], guanine, adenine, and thymine are known as nucleobases or bases in nucleic acids.
Regarding instant claims 10-12 and 19, Misonou teaches compositions in the “mixed” experiment (A), various concentrations of UVAS are mixed with a thymine solution (Pg. 196, 1st paragraph of Effect of UVAS on Dimer Production). Consequently, comparison is carried out with adenine or guanine is being added to the same molar concentration to a thymine solution (Pg. 196, left bottom paragraph) to compare with thymine solution with UVAS material MAAs (Fig. 6). Misonou specifies that UVAS are identified on HPLC system as authentic MAAs, porphyra-334, shinorine (corresponding to instant claims 11-12), and palythine (e.g., Pg. 195, right col. 2nd paragraph; Pg. 196, right col. 3rd paragraph). Thus, Misonou teaches a composition comprising MAAs (palythine, shinorine, and prophyra-334), and a compound of nucleobases, e.g., thymine, wherein does not comprise tranexamic acid (corresponding to instant claim 10 and 19).
Misonou suggests that red algal UVAS might have a strong quenching activity against the excited state of thymine in addition to acting as a UV filter in the algal tissue, and this ability might have some relation to the antioxidant activity of several MAAs, e.g., mycosporine-glycine or prophyra-334 (Pg. 199, right Col. 4th paragraph), and UVAS absorbs UV energy and emits visible light providing protection of DNA from UV light (Pg. 199, end paragraph-Pg. 200, left).
Misonou does not teach the composition comprising a compound selected from the group consisting of a nucleobase excluding thymine and adenine, a nucleoside, glycine, a tranexamic acid, and a combination thereof as recited in instant claim 10, Misonou does not teach the composition has pH from 5.0 to 9.0 as recited in instant claim 13, or from 5.4 to 8.0 as recited in instant claim 14, or the method for stabilizing MAA as recited in instant claim 15-18 and 20.
Coba throughout the reference teaches influence of pH and temperature stressors on the stability of MAAs (e.g. Abstract). Coba teaches throughout the reference MAAs including porphyra-334, shinorine, asternia-330, mycosporine-serinol, palythine (e.g., Pg. 3 of 19, 3rd paragraph).
Regarding instant claims 13-14, Coba teaches that MAAs are highly stable at room temperature during 24 hr at pH 4.5-8.5 (e.g., Abstract ), overlapping with pH of from 5.0 to 9.0 in instant claim 13 and from 5.4 to 8.0 in instant claim 14. Coba teaches that a MAA analogous to M-Ser, mycosporine glycine shows high resistance to various pH conditions for up to 24 hr (Pg. 8 of 19, bottom paragraph), which constitutes high activity in scavenging hydrosoluble radicals, inhibition of beta-carotene oxidation, and superoxide radical scavenging relative to ascorbic acid and vitamin E (e.g., Pg. 11 of 19, end of 3rd paragraph).
Baschong teaches anti-radical agents for dermatological compositions (e.g., [0002]). Baschong teaches using the compounds for the treatment of radical induced impairments such as inflammatory or allergic conditions, collagen damages, DNA-damage, or reperfusion-damage (use as anti-aging) (e.g., [0002]), and adjuvants including mycosporines, mycosporine-like-amino acid (MAA) from the red alga [0321], antioxidants such as amino acids including glycine that can interrupt the photochemical reaction chain triggered when UV radiation penetrates the skin or hair [0268] are suitable for the anti-radical composition (corresponding to instant claim 10).
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate Coba and Baschong’s teaching with Misonou to arrive at current invention. Because Misonou teaches that MAAs show a significant inhibitory effect on the production of thymine (as DNA component in skin cells) photodimers, suggesting its ability of DNA protection from UV radiation and mycosporine-glycine having antioxidant activity, while Coba teaches that pH as well as glycine stabilizes mycosporine and Baschong teaches both mycosporine and glycine are anti-radical agents suitable for the skin care composition providing protection from inflammatory or allergic conditions, collagen damages, DNA-damage, or reperfusion-damage, an artisan in the field would have motivation to combine these elements taught by Misonou, Coba, and Baschong into the composition for reasonable expectation of success for maximizing the benefit of UVAS material can provide. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Regarding instant claims 15-18 and 20, Misonou, Coba and Baschong teaches the composition comprising MAAs, e.g., mycosporine-glycine, shinorine, porphyra-334 (corresponding to instant claims 16-17), and glycine, without a tranexamic acid (corresponding to instant claim 20), as discussed above. A method “for stabilizing …” in instant claim 15 is considered an “intended use” limitation, which does not create structural difference over the prior art teaching of making and using the composition in the study. Therefore, evidently prior art teaches the method for stabilizing MAA comprising mixing MAA with glycine, and the “intended use” of stabilizing MAA as instantly claimed would necessarily present in the composition which has been taught by prior art. Similarly, the property of that MAA is stabilized, as claimed in instant claim 18, is also evidently present in prior art because the composition of instant claim 10 has been taught by prior art. Moreover, MPEP 2145 II. states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, pH of the composition overlaps with that taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Response to Arguments
Applicant's arguments filed on 02/26/2026 have been fully considered.
Applicant asserts that the amended claims are not anticipated by Misonou et al.
Examiner has thoroughly examined the amended claims and found this assertion persuasive. Therefore, previous art rejections under 35 U.S.C. 102 (a)(1) has been withdrawn.
Applicant asserts that the amended claims are not obvious over Misonou et al. and Coba et. al. because thymine nucleobase is excluded from the amended claims and Misonou does not describe a composition containing guanine.
In response, examiner finds the assertion persuasive over amended claims. Therefore, new reference Baschong has combined with Misonou and Coba to address the amended limitation scope. Baschong teaches using MAA and glycine in the composition for skin protection.
Applicant asserts that combination of Misonou and Coba is based on hindsight analysis because the subject matter and problem are different from each other and the combination is not proper.
The new ground of rejections over Misonou, Coba, and Baschong has been presented in this office action. Please refer to the entire office action as a complete response to the remarks/arguments. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant points out that the stabilizing effect of the claimed invention has been specifically confirmed by the examples in the present specification.
The stabilizing effect is the property of the composition, since prior art Misonou, Coba and Baschong teaches the invention, the specifically confirmed stabilizing effect would necessarily present in the composition which has been taught by prior art.
In conclusion, prior art Misonou, Coba and Baschong combined teaching teaches the instant invention.
Please refer to the entire office action as presented above as a complete response to the remarks/arguments.
Conclusion
No claim is 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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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616