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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 May 2026 been entered.
Status of the Claims
Claims 1, 5, 7-8, 11, 15, and 17-18 are pending in the instant application.
Claims 1 and 11 are amended.
Claims 19-22 are new.
Claims 1, 5, 7-8, 11, 15, and 17-22 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 30 March 2026 has been entered.
With respect to the 103 rejection Applicant’s amendments and arguments have been considered but are not found persuasive for the following reasons. Nogusa discloses a composition for improving physical capacity, including muscle endurance (paragraph [0025]), comprising cystine (claim 1), isoleucine (claim 5), and glycine (paragraph [0100]). The skilled artisan is guided to isoleucine from a list of 3 amino acids where Nogusa discloses the preferable amino acid in addition to cystine is leucine, isoleucine, or valine (paragraph [0080]). Nogusa then discloses other amino acids, essential or non-essential, may be added to the composition. Regarding the non-essential amino acids three examples are listed, aspartic acid, glycine and tyrosine (paragraph [0100]). The skilled artisan is presented with a finite list of options to pair with cystine and an example which contains both cysteine and isoleucine in which physical endurance is improved. In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. In this case at least prong E of KSR applies- “Obvious to try” choosing from a finite number of identified, predictable solutions. From Nogusa it is known that a composition containing both cysteine and isoleucine will improve muscle endurance. Isoleucine is presented from a finite list as a pairing with cystine, as is glycine. While Nogusa does not provide an embodiment with glycine, from Caldow et al. it is also known that glycine demonstrates muscle preserving effects. Therefore, with the guidance of Caldow and the limited list of amino acids presented by Nogusa, to the skilled artisan it would be “obvious to try” the combinations presented by Nogusa, which would lead to the instant invention.
Additionally, by the teaching of Caldow, the skilled artisan is motivated to add glycine to the first preferred embodiment of Nogusa. It would be expected that results of improved muscle endurance would be similar, if not better. The instant specification does not demonstrate improved physical endurance with a composition comprising only cysteine, isoleucine, and glycine in comparison to a composition including these three amino acids and additional amino acids. The contrasting composition of Table 3 contains neither cystine nor glycine. Therefore the Applicant has not demonstrated that additional amino acids would hinder the muscle improving effects of cystine, isoleucine, and glycine, which would render the instant composition more efficacious over the prior art. As it stands, the instant composition is the expected result of additivity. Therefore the rejection is maintained and revised below to reflect the claim amendments.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
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 17-22 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 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 and 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.
Regarding claims 19-22, 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.
Conclusion
Claims 1, 5, 7-8, 11, 15, and 17-22 are rejected.
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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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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