DETAILED ACTION
Claims 1-6, 8-9, 11, 14-17, 20, and 23-28, submitted 23 December 2025, are pending in the application. Claims 1-4, 6, 8-9, 11, 17, 20, and 23-27 are withdrawn. Claims 5 and 14-16 have been rejected.
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 .
Rejections – Withdrawn and New
The status of the previously rejected claims, in the Office Action dated 23 September 2025, are detailed below.
Rejections under 35 U.S.C. § 103
The Applicant’s arguments, found in the Remarks filed 23 December 2025, are sufficient to overcome the rejection in the previous Office Action.
Response to Arguments
Applicant’s arguments, see pages 6-9 of Applicant Arguments/Remarks, filed 23 December 2025, with respect to the rejection of claims 5 and 14-16 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
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 5 and 14-16 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.
Claim 5 recites “a CtBP expression inhibitor”, for which the specification does not provide an adequate written description to convey that the inventors were in possession of the scope of the claimed invention. The functional property of the genus of compounds does not permit one to envisage which compounds would have the desired biological function.
In Example 9, found in paragraphs 106-108 of the instant specification, the Applicant demonstrates the inhibition of the expression of the CtBP target gene of a mouse model using 2-oxo-4-methylthiobutanoic acid (MTOB). However, the applicant recites in paragraph 53, “In some embodiments, a small molecule for inhibiting or blocking or reducing a CtBP activity can be 2-oxo-4-methylthiobutanoic acid “MTOB” or its derivatives thereof”. Yet, in the description of the drawings of Fig. 11 found in paragraph 41, the Applicant recites “Fig. 11 illustrates an exemplary MTOB post-treatment inhibiting expression of several CtBP target genes…”. Consequently, it is unclear whether the compound MTOB possesses the capability of both inhibiting the activity of CtBP and inhibiting the expression of CtBP or if it only possesses one of these functions.
Additionally, claims 14 and 16 recite the use of a CtBP activity inhibitor of which different compounds are listed (e.g., NSC 95397 of claim 14 and MTOB, phenylpyruvate, and HIPP of claim 16). The prior art, Chen ("The transrepression and transactivation roles of CtBPs in the pathogenesis of different diseases." Journal of Molecular Medicine 99.10 (2021): 1335-1347.), teaches the structures of the above mentioned CtBP inhibitor compounds, shown below.
Fig. 3 taught by Chen
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(pg. 1341, Figure 3, Bottom of Page)
Chen teaches that the derivatives of MTOB, phenylpyruvate and HIPP, showed higher binding affinity to CtBPs in vitro but continues to report that the in vivo effect of phenylpyruvate on inhibiting CtBP-mediated transcription is still unknown. Moreover, there appears to be a lack of the structure-activity relationship to further support that the compounds of the invention would achieve the same results. While the structures of MTOB, phenylpyruvate, and HIPP are similar in that each share a hydroxyl group, the structures are distinct enough to warrant experimentation to support the derivatives of claim 16 functionality in inhibiting the expression of CtBP. Finally, as there is uncertainty of which compound is presented to be the CtBP expression inhibitor, the instantly claimed invention is not described in such a way as to reasonably convey that the inventor, at the time the application was filed, had possession of the instantly claimed invention.
Regarding the requirement to adequate written description, the Applicant is directed to MPEP 2163 which states “An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)”. Based on the language of the specification and the absence of supporting material, the Examiner concludes that the Applicant does not have possession of the claimed invention.
Claim 15 is rejected as it is dependent of a rejected independent claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 is drawn to “the method according to claim 5, wherein the CtBP activity inhibitor comprises a small molecule and the small molecule comprises MTOB, phenylpyruvate, HIPP...”. As mentioned above, the instant specification describes MTOB as both an activity inhibitor, in paragraph 53, and an expression inhibitor of CtBP, found in Example 9. As a result, it is unclear whether the compound MTOB possesses the capability of both inhibiting the activity of CtBP and inhibiting the expression of CtBP or if only possesses one of these functions.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622