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 .
Withdrawn rejections
Rejection of claims 1-4 under 35 USC 101 as being directed to non-statutory class of invention is withdrawn in view of amendments to claims filed on 1/14/26.
Rejection of claims 1-4 under 35 USC 112(b) as reciting a use without reciting nay positive steps is withdrawn in view of amendments filed on 1/14/26.
Maintained rejections
Rejection of claims 1-4 under 35 USC 112(a) as lacking written description is maintained. Reply to applicant’s remarks follows repeated text of the rejection of record.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are directed to administration of a TMAVA antagonist. TMAVA antagonist has not been described in the specification in such a way as to reasonably convey to one skilled in the art that the inventor had possession of a TMAVA antagonist at the time the application was filed. Specification provides guidance regarding TMAVA antagonist in paragraph [0031] (page 30 of the specification filed on 12/8/22). In paragraph [0031] applicants describe various types activities that are deemed as being antagonistic to function of TMAVA. These include:
Reagent capable of inhibiting activity of TMAVA
Reagent capable of eliminating TMAVA
Reagent capable of reducing production of TMAVA
Reagent capable of promoting metabolism of TMAVA
However, no reagent capable of performing any of the above listed functions is identified in the specification as a TMAVA antagonist. Examples found in the specification support the hypothesis that TMAVA activity is involved in development of fatty liver and cardiovascular disease. Example 7 is directed to counteracting the effect of TMAVA by supplementation of exogenous carnitine. Reduction in carnitine production is an effect of TMAVA activity. However, carnitine supplementation does not antagonize the function of TMAVA but rather supplements endogenous carnitine whose levels are reduced due to TMAVA activity. Carnitine has not been shown either by applicants or in the art submitted with IDS to inhibit activity, eliminate, reduce production or promote metabolism of TMAVA. Therefore, carnitine is not an antagonist of TMAVA. For the reasons stated above, applicants failed to satisfy the written description requirement because there is no evidence that at the time of filing applicants had possession of a product that meets the definition of the term TMAVA antagonist.
Reply to applicant’s remarks
Remarks filed on 1/14/26 have been fully considered and found to be not convincing.
Arguments directed to the rejection under 35 USC 112(a) begin on page 6 of the remarks. In the first paragraph of page 6, applicants argue that specification clearly defines the core inventive concept and the detailed mechanism of action for treatment of fatty liver or heart failure. The rejection of record is does not argue that antagonism of TMAVA would not be beneficial in reducing lipid accumulation in liver and heart. The rejection argues that applicants have not exemplified a single TMAVA antagonist that is capable of carrying out the claimed function.
The specification provides 4 definitions for the term “TMAVA antagonist” and in the reply applicants expand on all 4 definitions. However, the only example of TMAVA antagonist provided in the reply is y-BB, which like TMAVA is a substrate of BBOX. Examiner maintains that specification fails to identify agents that applicant intends to administer as part of a treatment regiment in order to treat fatty liver and heart failure.
New Rejection
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bae et al (Diabetes Care, 2015, 38(7), 1245-1252; abstract).
Bae discloses administration of L-carnitine to subjects with NAFLD (Research and methods).
Conclusion
Claims 1-4 are rejected
Claims 5-10 are withdrawn
THIS ACTION IS MADE FINAL. 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 YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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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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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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