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 .
This office action is in response to the amendment filed on March 27th, 2026. Claim 3 was cancelled.
Claims 1, 2, and 4-15 are pending and were examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objections or rejections not reiterated below are hereby withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 27th, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Although there is some illegible text in Figures 1-7 of the submitted copy of Sandri et al. (Cell 2004 117 (3) 399-412), this illegibility may be an unavoidable result of soft scanning of an electronic copy of the document and a fully legible copy is available at https://doi.org/10.1016/S0092-8674(04)00400-3.
Specification
The use of the terms Labogene, Hitachi, Thermo Fisher Scientific, PepMap, MiniBest, Takara, Bio-Rad, ATCC, Gibco, and Abcam, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed March 27th, 2026, with respect to the objection to claim 3 have been fully considered and are persuasive. The objection to claim 3 has been withdrawn. Claim 3 has been cancelled, and claim 1 has been amended to recite “lactic acid bacterium of the genus Lactiplantibacillus”, specifying the taxonomic classification of the lactic acid bacterium.
The rejection of claim 3 under 35 U.S.C. 112 (b) is withdrawn based on the applicant’s amendment to cancel claim 3.
The rejection of claim 3 under 35 U.S.C. 112 (a) is withdrawn based on the applicant’s amendment to cancel claim 3.
The rejection of claim 3 under provisional double patenting over copending Application No. 18/515,425; US-20240189386-A1 (reference application) is withdrawn based on the applicant’s amendment to cancel claim 3.
The rejection of claim 3 under provisional double patenting over copending Application No.
18/618,666; US-20240350576-A1 (reference application) is withdrawn based on the applicant’s amendment to cancel claim 3.
The rejection of claim 3 under provisional double patenting over copending Application No.
18/515,599; US-20240181002-A1 (reference application) is withdrawn based on the applicant’s amendment to cancel claim 3.
Applicant’s arguments, filed March 27th, 2026, with respect to the rejection of claims 1 have been fully considered and are persuasive. The rejection of claims 1-14 under 35 U.S.C. 112 (b) has been withdrawn. Claims 1, 12, and 14 have been amended to recite the term “alleviating” instead of the term “improving”. The term “alleviating” implies that the instantly claimed method is acting against the muscle loss, rendering definite the effect of the instantly claimed method on muscles loss.
Pending Objections and Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, and 4-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for making a green tea peptide composition, and using the composition to achieve specified effects on , does not reasonably provide enablement for the preventing, improving, or treating of muscle loss in a living subject organism, such as a human or other animal. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claims 1, 2, and 4-15 are rejected under 35 U.S.C. 112(a)
Applicant's arguments filed March 27th, 2026 regarding the rejection of claims 1, 2, and 4-15 under 35 U.S.C. 112(a) have been fully considered but they are not fully persuasive. The applicant has presented information from both the prior art and MPEP 2164.02 which supports a correlation between the in vitro muscle tissue models of the instant disclosure and in vivo muscle tissue of a subject organism (Experimental examples 1-3). As such, one of skill in the art would have a reasonable expectation of success at using the present invention for alleviating or treating muscle loss. However, the examples within the instant disclosure do not support preventing muscle loss, but rather inhibiting muscle loss (Experimental examples 1-3). The cited reference Sandri et al. (Cell 2004, 117 (3), 399-412) discloses RNAi blocking the function of Foxo1 and Foxo3 preventing the induction of the atrogin-1 promoter 24 hours after food deprivation in mice. However, this experiment disclosed by Sandri et al. relates to a method using RNAi, not the instantly disclosed method of using a peptide composition; and relates specifically to the induction of the atrogin-1 promoter during starvation, not other factors that can contribute to muscle loss. The cited reference Bodine et al. (Nature Cell Biology 2001, 3, 1014-1019) supports Akt expression (where Akt activates p70S6K) preventing muscle loss resulting from denervation, but not starvation or infection. Moreover, the instant disclosure does not support increasing p70S6K activity to the level in the control untreated with DEX (Figure 3B). Therefore, while inhibiting, treating, and alleviating muscle loss is enabled by the present disclosure and prior art, preventing muscle loss is not. To clarify the problem: the examiner interprets the term "preventing" as implying prevention in an absolute sense, whereas the applicant appears to interpret the term "prevention" as synonymous with the term "inhibition" (instant specification page 26, line 6 from the bottom). The examiner suggests amending claims 1, 12, 14, and 15 to recite the term "inhibiting" instead of the term "preventing".
Pending claims 1 and 4-15 still refer to a green tea peptide composition obtained by fermenting any green tea protein, but it is not certain that the instant disclosure enables the method of using any green tea peptide composition obtained by fermenting any green tea protein (any protein native to the green tea plant) as currently claimed.
Double Patenting
Claims 1, 2, and 4-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/515,425; US-20240189386-A1 (reference application).
Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them. The rejection is still pending.
Claims 1, 2, and 4-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No.
18/618,666; US-20240350576-A1 (reference application).
Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them. The typographical error pointed out by the applicant in the listing of the reference application number is acknowledged and corrected above. The rejection is still pending.
Claims 1, 2, and 4-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No.
18/515,599; US-20240181002-A1 (reference application).
Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them. The rejection is still pending.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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