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 .
DETAILED ACTION
Claims 1, 3-11, and 13-18 are pending in the instant application.
Claims 1 and 11, and 13-14 are amended.
Claims 3, 4, 6, 9, 10, 13, 14, and 16 are cancelled.
Claims 1, 5, 7-8, 11, 15, and 17-18 are examined herein.
Priority
The instant application claims benefit of foreign priority to Japanese Patent No. 2018-240020, filed on 21 December 2018 and the benefit of priority to PCT/JP2019/050188, filed on 20 December 2019. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 21 December 2018.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 23 December 2021, 15 August 2022, and 02 April 2024 are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 19 September 2025 has been entered.
In view of applicant amendment to claim 1, the 102(a)(1) rejection of record is withdrawn.
With respect to the 103 rejection, Applicant amendment has been considered but is not found persuasive for at least the following reasons. Nogusa in view of Caldow teaches a composition of amino acids to improve physical capacity. In the absences of criticality, the recited weight ratio of amino acids is routine optimization. The rejection is maintained and amended below to reflect applicant amendments to claims.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS FACILLITATED BY AMENDMENT
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, 5, 7-8, 11, 15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Nogusa et al. (WO2017159741A1, publication date 21 September 2017. Note the references below are to the US published US20190070139A1, as the document is in English in view of Caldow et al. (Clin Nutr. 2016;35(5):1118-26).
Regarding claim 1, Nogusa discloses an agent for improving physical capacity, including muscle endurance (paragraph [0025]), comprising cystine (claim 1), isoleucine (claim 5), and glycine (paragraph [0100]). Nogusa discloses the ratio of cystine to isoleucine to be 1:0.01 to 100 (claim 7).
Nogusa does not disclose the weight ratio for an additional amino acid.
In the absence of criticality, determination of an appropriate weight ratio would be routine optimization. See MPEP 2144.05.II.A.
Nogusa also fails to teach a preferred embodiment wherein the additional amino acid is glycine.
Caldow teaches the muscle preserving effects of glycine.
It would be prima facie obvious to one of ordinary skill in the art to combine the teaching of Nogusa and Caldow and arrive at the instant invention. Nogusa teaches an agent for improving muscle quality comprising isoleucine and cystine and an additional amino acid. One would be guided to selecting glycine as the additional amino acid to be added to the agent from the list disclosed by Nogusa as Caldow teaches its muscle preserving effects.
Regarding claim 5, Nogusa does teach the agent can be used by adding to a high density liquid nutritional supplement can be mixed with a liquid (page 9, paragraph [0107]).
Nogusa does not teach a molar concentration of the amino acids.
In the absence of criticality, determination of the molar concentration required to deliver the appropriate amount of each amino acid would be routine optimization. See MPEP 2144.05.II.
Regarding claim 7, Nogusa discloses the agent can comprise an excipient, binder, disintegrant, lubricant, coating agent, base, solvent, diluent, solubilizing agent, solubilizer, emulsifier, dispersing agent, suspending agent, stabilizer, thickener, soothing agent, isotonicity agent, pH adjuster, antioxidant, antiseptic, preservative, corrigent, flavoring agent, sweetening agent, flavor, or colorant (paragraph [0106]).
Regarding claim 8, Nogusa discloses the agent can comprise of food additives, such as production agent, thickening stabilizer, gum base, emulsifier, preservation, antioxidant, gloss agent, pH adjuster, sweetener, bitter taste, acidulant, colorant, or flavor (paragraph [0154]).
Regarding claim 11, Nogusa discloses the method of improving physical capacity, including muscle endurance (paragraph [0025]), comprising cystine (claim 14), isoleucine (claim 17), and glycine (paragraph [0100]). Nogusa discloses the ratio of cystine to isoleucine to be 1:0.01 to 100 (claim 7).
Nogusa does not disclose the weight ratio for an additional amino acid.
In the absence of criticality, determination of an appropriate weight ratio would be routine optimization. See MPEP 2144.05.II.A.
Regarding claim 15, Nogusa does teach the agent can be used by adding to a high density liquid nutritional supplement can be mixed with a liquid (page 9, paragraph [0107]).
Nogusa does not teach a molar concentration of the amino acids.
In the absence of criticality, determination of the molar concentration required to deliver the appropriate amount of each amino acid would be routine optimization. See MPEP 2144.05.II.
Regarding claims 17 and 18, Caldow teaches improved insulin sensitivity related to the administration of glycine (page 1124 and 1125). It would be prima facie obvious to one of ordinary skill in the art that an agent comprising glycine would have this same effect.
Conclusion
Claims 1, 5, 7-8, 11, 15, and 17-18 are rejected.
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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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