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 .
Reopening of Prosecution After Appeal Brief
In view of the appeal brief filed on 09/02/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejections are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below.
Status of Claims
Claims 1-9 remain cancelled.
Claims 10-20 are pending and being examined on the merits herein.
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Withdrawn Objections/Rejections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the previous Office action (mailed 04/02/2026) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of appellant’s appeal brief filed on 09/02/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 10-12 and 15-17 each uses indefinite article “a” or “an” defining compound “glycine”, “tranexamic acid”, “mycosporine-glycine” (or “MG”), “shinorine”, “mycosporine-glycine-alanine”, and/or “porphyra-334”. Because each of the agent is a specific compound, not a class of compounds, it is unclear what exact compound species are included in the claim scope(s) with the meaning of indefinite article. For example, glycine, it is just glycine itself, it cannot be a glycine out of glycine; while claim reads “a glycine”, implying many different glycine species.
Claims 13 and 14 recites “pH” for the composition. However, claim 10, which claims 13 and 14 directly or indirectly depends upon, comprising only MAA and another compound, does not recite a solvent or indicate the composition being aqueous. It is unclear how the composition has a pH without aqueous status of the composition.
Claim 18 recites “MAA is stabilized”. The term “stabilized” in claim is a relative term which renders the claim indefinite. The term “stabilized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear under what conditions, e.g., how long or what proportion of MAA not being decomposed, or what degree of discoloration, MAA is considered as “stabilized”.
Claims 19-20 are rejected accordingly because they depend on claim 10 and 15 respectively, and each does not further clarify the issue addressed above in claims 10 and 15.
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 Matsumoto et al. (JP2017197475, 11/02/2017, IDS of 04/18/2024) in view of Ehlis et al. (US20180092819, 04/05/2018).
Matsumoto throughout the reference directs to a solution composition comprising a stabilized mycosporine-like amino acid (MAA) with one or more substances (e.g., [Overview]; Claim 1) that can solve the problems related to stability of MAA in the composition, i.e., (1) coloration of the MAA, (2) decomposition of MAA, and (3) reduction in the UV absorption capacity of MAA (e.g., [0013]; [0023]).
For Claims 10 and 15, Matsumoto teaches a solution composition comprising MAA that contains stabilized MAA with one or more substances including aspartic acid, glutamic acid, arginine, cysteine, methionine, serine (as amino acids), lysine hydrocholoride, glutathione, ergothioneine (as amino acid derivatives), etc. (e.g., Claim 3; [Overview]). Matsumoto teaches the method mixing MAA with the one or more substances including the amino acids and amino acid derivatives as mentioned above (e.g., [Overview]; Claims 7 and 9; [0014-0015]). Matsumoto specifies that the method comprising adding the one or more substances as described can stabilize MAA in solving problems of coloration, decomposition, and reduction of UV absorption capacity (e.g., [0023]; [0058-0059]).
For Claims 11-12 and 16-17, Matsumoto teaches the MAA compounds represented by chemical formula 1 [0030], resulting in many species depending on Q1 and Q2 variations in the formula [0030-0032]. Matsumoto indicates that MAA can be shinorine, porphyra-334, mycosporine-glycine, mycosporine-glycine-alanine, etc. (e.g., [0033]).
For Claims 13 and 14, since instant claim 10, upon which claims 13 and 14 depend directly or indirectly, does not indicate the composition comprising solvent, therefore, the composition in claims comprising solid materials does not constitute pH value. For the purpose of compact prosecution, the pH is interpreted as the composition being in aqueous form. Matsumoto teaches the composition is used for cosmetics for skin, hair, eyes, and nails in the form of milky lotion, gel, serum, cream, sunscreen cream, etc. (e.g., [0046-0047]). MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). The cosmetic products being used on human skin would motivate artisans to apply pH range around neutral to slightly acidic to slightly basic ranges. Matsumoto exemplifies in Example 1 [0074] using shinorine with one or more other substances dissolved in pH 7 phosphate buffer for the composition, falling within the pH ranges from 5.0 to 9.0 in instant claim 13, or from 5.4 to 8.0 in instant claim 14. MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
For Claim 18, Matsumoto teaches that the composition comprising stabilized MAA (e.g., [0023]; [0058-0059]) with one or more specified substances such as aspartic acid, glutamic acid, arginine, cysteine, methionine, serine (as amino acids), lysine hydrocholoride, glutathione, ergothioneine (as amino acid derivatives), etc. (e.g., Claim 3; [Overview]), as discussed above in detail.
For Claims 19-20, Matsumoto throughout the reference does not use tranexamic acid in the composition or the method for MAA stability.
Matsumoto does not teach the one or more substances in the composition can be selected from the group consisting of a nucleobase or its derivative (excluding thymine and adenine), a nucleoside, glycine, a tranexamic acid, and a combination thereof as specified in instant claims 10 and 15.
Ehlis throughout the refence teaches ultraviolet radiation absorbing polymer composition (e.g., Abstract).
Ehlis specifies that ultraviolet radiation absorbing polymer compositions comprising the polymer compound of formula (3) as sunscreen actives for the protection of organic materials that are sensitive to ultraviolet light, especially human and animal skin and hair, against the action of UV radiation; Such UV filters are therefore suitable as light-protective agents in cosmetic and pharmaceutical applications (e.g., [0045]). Ehlis teaches that suitable UV filter substances and adjuvants include mycosporines and/or mycosporine-like amino acids (MAA) (e.g., [0087], Table 3). Ehlis further teaches that in addition to the primary light-protective substances it is also possible to use secondary light-protective substances of the antioxidant type which interrupt the photochemical reaction chain triggered when UV radiation
penetrates the skin or hair; Typical examples of such antioxidants are amino acids ( e.g. glycine, histidine, tyrosine, tryptophan) and derivatives thereof [0125].
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate Ehlis teaching to select additional light-protective substance such as antioxidant amino acid glycine as a component in the MAA composition taught by Matsumoto to arrive at current invention. Because both references teach UV light absorbing and filtering sunscreen agents, especially Matsumoto teaches natural amino acids including aspartic acid, glutamic acid, arginine, cysteine, methionine, serine are suitable for the composition, especially Matsumoto states that UV absorbers can have problems including being easily decomposed by light and having poor stability, and chemically synthesized substance giving a poor image to user (e.g., [0007]), it would have motivated artisans in the field to experiment and explore other amino acids, as additional suitable UV absorber for increasing the UV absorbing capacity and sharing the burden of UV absorbers’ instability upon exposure to UV light,
while Ehlis teaches that glycine and other amino acid species are antioxidants that can help UV light protection along with MAA. Therefore, the claimed invention is a simple combination of reagents known to be obvious materials that all already taught in prior art and discussed above. The idea for combining them flows logically from them having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Further regarding instant claim 15, it is interpreted as the following options:
Option 1) product-by-process claim, MPEP 2113. I. states "[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). For this instance, prior art teaches the composition comprising MAA and glycine and the method of mixing MAA with the other substances such as glycine, therefore, the patentability relies on the product that is already taught by prior art.
Option 2) intended use claim, because the claim does not provide structural method steps, while “for stabilizing” is intended use. By applying the composition comprising MAA and glycine as taught by prior art, the intended use would be capable of being achieved in prior art. Especially as discussed above, MAA and glycine both are UV light protective agents, therefore combining them together would share the burden of instability under UV light exposure, and thereby stabilizing each other in the composition and providing UV screening effect on the user. MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
Response to Arguments
Appellant’s arguments with respect to claims 10-20 in appeal brief filed on 09/02/2026 have been fully considered, but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Please refer to the entire office action presented above as the full response to the appeal.
Conclusion
No claims are allowed.
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/DX.Z./Examiner, Art Unit 1616
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
