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 .
Application Status
2. Applicant’s amendment and response, submitted March 5, 2026 has been reviewed by the examiner and entered of record in the file. Claims 1-8 are canceled, and claims 9-12 are newly added.
3. Claims 9-12 are pending, under examination, and are the subject of this office action.
Priority
4. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d), a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Specification
5. Applicant’s corrected abstract, submitted March 5, 2026, is sufficient to overcome the previous objection.
Previous Claim Rejections - 35 USC § 101
6. Claims 1-4, 7 and 8 were previously rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
7. In view of the cancellation of claims 1-4, 7 and 8, the previous rejections under 35 U.S.C. 101 are withdrawn.
Previous Claim Rejections - 35 USC § 112(b)
8. Claim 3 was previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite regarding the limitation "muscle gain" in line 2.
9. In view of the cancellation of claim 3, the previous indefiniteness rejection is withdrawn.
Previous Claim Rejections - 35 USC § 102
10. Claims 1-8 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harris and Wise, WO 2012024611 A1.
11. In view of the cancellation of claims 1-8, the previous anticipation rejection is withdrawn.
12. Claims 1-4, 7 and 8 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kendrick et al., Eur J Appl Physiol 2009.
In view of the cancellation of claims 1-4, 7 and 8, the previous anticipation rejection is withdrawn.
13. Claims 1-4, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spradley et al., Nutrition & Metabolism 2012.
14. In view of the cancellation of claims 1-4, 7 and 8, the previous anticipation rejection is withdrawn.
Previous Claim Rejections - 35 USC § 103
15. Claims 5 and 6 were previously rejected under 35 U.S.C. 103 as being unpatentable over Kendrick et al., Eur J Appl Physiol 2009, as applied to claims 1-4, 7 and 8, above, and further in view of Harris and Wise, WO 2012024611 A1.
16. In view of the cancellation of claims 5 and 6, the previous obviousness rejection is withdrawn.
17. Claims 5 and 6 were previously rejected under 35 U.S.C. 103(a)(1) as being unpatentable over Spradley et al., Nutrition & Metabolism 2012, as applied to claims 1-4, 7 and 8 above, and further in view of Harris and Wise, WO 2012024611 A1.
18. In view of the cancellation of claims 5 and 6, the previous obviousness rejection is withdrawn.
Claim Rejections - 35 USC § 103
19. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
20. Claims 9-12 are rejected under 35 U.S.C. 103(a)(1) as being unpatentable over Ishibashi et al., Nutrients (2023), in view of Harris and Wise, WO 2012024611 A1 (cited on Applicant’s IDS of November 17, 2025).
21. Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim 9 is drawn to a method for promoting the differentiation of myoblasts into myotube cells, comprising a step of administrating an effective amount of b- alanine or a salt thereof to a subject.
Claim 10 is drawn to a method for promoting the differentiation of myoblasts into slow muscle cells or fast muscle cells, comprising a step of administrating an effective amount of b-alanine or a salt thereof to a subject.
Claim 11 is drawn to a method for increasing myotube cells, comprising a step of administrating an effective amount of b-alanine or a salt thereof to a subject.
Claim 12 is drawn to a method for promoting the expression of MyHCI, MyHCIIa, MyHCIIb, or MyHCIIx, comprising a step of administrating an effective amount of b-alanine or a salt thereof to a subject.
22. Ishibashi et al. teach that carnosine induces myoblast (C2C12 cell) differentiation in Figure 1:
“Expression of differentiation marker gene. C2C12 cells were differentiated in the presence of indicated amount of carnosine.”
(page 4 of 13, Figure 1 caption), i.e., carnosine promotes the differentiation of myoblasts into myotube cells. Ishibashi et al. teach the effects of carnosine on muscle fiber type, including both slow (MyHC1) and fast (MyHC2a, MyHC2x, and MyHC2b) muscle markers, wherein:
“MyHC1 levels decreased and MyHC2a, MyHC2x, and MyHC2b levels were increased in C2C12 cells differentiated in the presence of carnosine (Figures 2A- D). The changes in MyHC expression indicated that carnosine induces fast-twitch synthesis in C2C12 cells.”
(page 4, section 3.2 “Effects of Carnosine on Muscle Fiber Type Change,” first paragraph). As such, Ishibashi et al. teach that carnosine promotes the expression of McHCIIa, MyHCIIb, and MyHCIIx.
23. Ishibashi et al. go on to teach that carnosine induces fast-twitch synthesis in C2C12 cells, such that “carnosine treatment increased the percentage of fast-twitch myotubes,” (page 4, section 3.2 “Effects of Carnosine on Muscle Fiber Type Change,” first paragraph-second paragraph).
24. Ishibashi et al. also teach that carnosine has an effect on fast-twitch muscles and on slow-twitch muscles, and test the effect of carnosine on mitochondrial activity, a characteristic of slow-twitch muscles, wherein carnosine can induce the biogenesis of mitochondria in myotubes. (page 6, section 3.4 “Effects of Carnosine on Mitochondria in Myotube Cells”).
25. As such, Ishibashi et al. teach the effects of carnosine, i.e., the limitations of promoting differentiation of myoblasts into myotubes, increasing the number of fast-twitch muscle cells, increasing the percentage of myotubes, and promoting the expression of McHCIIa, MyHCIIb, and MyHCIIx, but do not teach the administration of beta-alanine.
26. Yet, Harris teaches that supplementation with an effective amount of beta-alanine in a subject increases the level of carnosine in the muscle tissue of said subject (see in particular Example 1, Conclusions at page 65, and Figure 1). Therefore, one skilled in the art would reasonably expect that administering an effective amount of beta-alanine to a subject would result in an increase in carnosine levels in the muscle tissue of said subject.
27. As Applicant has not defined or limited the patient population in the claims, any subject would benefit from the recited method of administration. Harris goes on to recite the dosage amount of beta-alanine:
“The method of any one of claims 1-26, wherein the beta-alanine is administered in a dose of between 0.1 g and 16 g per day”.
(see Harris Claim 27), which meets the limitation of “an effective amount” required by claims 9-12, because Applicant defines the effective amount as: “…in the case of an adult, the intake amount of the composition for increasing muscle of the present invention is preferably 0.01 to 100 mg/ kg per day as beta-alanine,” (Specification at paragraph [0032]). That is, assuming an average 62 kg adult, 100 mg/kg is equivalent to an amount of 6200 mg or 6.2 g, which is within the range of between 0.1 g and 16 g per day taught by Harris.
28. Thus, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention that by virtue of administering an effective amount of beta-alanine in a subject, thereby increasing levels of carnosine in the muscle tissue of said subject, one is necessarily promoting differentiation of myoblasts into myotubes, increasing the number of fast-twitch muscle cells, increasing the percentage of myotubes, and promoting the expression of McHCIIa, MyHCIIb, and MyHCIIx. In view of the combined art of record, one of skill in the art would have been motivated to administer an effective amount of beta-alanine in a subject in order to increase the levels of carnosine in the muscle tissue of said subject, thereby promoting differentiation of myoblasts into myotubes, increasing the number of fast-twitch muscle cells, increasing the percentage of myotubes, and promoting the expression of McHCIIa, MyHCIIb, and MyHCIIx, with a reasonable expectation of success.
As such, claims 9-12 are prima facie obvious.
Conclusion
29. Claims 9-12 are pending in the application. Claims 9-12 are rejected. No claim is allowed.
30. 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.
31. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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