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 .
Election/Restrictions
Applicant's election of Group II (drawn to a method of treating), in the reply filed on 07/01/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-7, and 12-23 are pending of which, claims 1-7 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 12-18 and 21-23 have been examined on the merits.
Please note, for clarity of the record, on 07/01/2025, Applicant elected the species, Compound (a); as shown below and recited in claim 12, having the following structure:
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Per MPEP 803.02, the Examiner determined that the elected species is not allowable over the prior art, therefore, the examination of the Markush claim was not extended. Additionally, claims 11, drawn to nonelected species, are withdrawn from further consideration.
Withdrawn Rejections
The rejection of claims 8-11 and 13-18 under 35 U.S.C. 112 (a) is withdrawn in view of the cancelled claims.
The rejection of claims 8-11 and 13-18 under 35 U.S.C. 103 is withdrawn in view of the cancelled claims.
The rejection of claims 8 and 9 are under 35 U.S.C. 103 as being unpatentable over Hodge et al. (US20050288347) is withdrawn in view of the cancelled claims.
The rejection of claims 10 and 12 under 35 U.S.C. 103 as being unpatentable over Hodge et al. (US20050288347) as applied to claim 8 and 9 above, in view of CAS Abstract RN 849534-66-3 (29 Apr 2005) is withdrawn in view of the cancelled claims.
New Grounds of Rejection due to claim amendment
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.
Claim 12-18 and 21-23 is 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 12 is drawn to a method of treating a MAP4K3-mediated disorder in a subject. The specification discloses data for compounds designated only by internal number (e.g., 3396, 2912, 2189, 4479; Figures 3, 4A-C), but fails to clearly identify which structural compound corresponds to each identifier number. As a result, a POSITA cannot reasonably determine which disclosed data correspond to which claimed compound, and thus, a POSITA cannot know which inhibitors is supported by the experimental data. This lack of clarity demonstrates that the Applicant did not possess the full scope of the claimed compound at the time of filing.
Furthermore, claims 14-17 recite treatment range of MAP4k3-mediated disorders, including numerous cancers and autoimmune disorder, as an example. The specification does not provide representative examples or data demonstrating efficacy of the claimed compounds in treating theses diseases. The biological data (Figure 4A-C) are limited to in vitro cellular models evaluating TFEB nuclear localization, LC3-II flux, and number of autolysosome markers. These assays only demonstrate modulation of cellular pathways associated with MAP4K3 activity and autophagy, and should not be viewed as evidence of treating cancer or autoimmune diseases. No in vivo studies, disease-relevant models, or cancer, or autoimmune-specific assays are provided to support the instant claim.
Therefore, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data to claim a method of treating a
MAP4K3-mediated disorder in a subject.
Subject Matter Free of the Art of Record
The subject matter of claim 12 is free of the art of record. The closest prior art is Hodge et al. US PG-PUB 2005/0288347. While Hodge teaches compounds of formula I, however there is no motivation for an ordinary skilled artisan in the art to modify the teachings of Hodge to arrive at the claimed compound. Since claims 13-18 and 21-23 are directly or indirectly dependent on claim 12, they are free of the art of record. These claims are not allowable until the 112 rejection is overcome.
Conclusion
Therefore, claims 12-18 and 21-23 are rejected.
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.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622