DETAILED ACTION
This office action is in response to applicant’s filing dated March 6, 2026.
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 .
Status of claims
Claims 45 - 56 are pending in the instant application.
Election/Restrictions
Applicant's election with traverse of compound of formula:
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where R is hydroxyalkyl as a result of species election requirement in the reply filed on March 6, 2026 is acknowledged. The traversal is on the ground(s) that the compound taught by prior art and instantly claimed compounds have different substituents, and thus, patentable distinct. This is not found persuasive because compounds taught by prior art and instantly claimed compounds share common structural elements such as core, as shown in the Restriction requirement office action, mailed 11/07/2025. Thus, the structures of instantly claimed compounds do not constitute a structurally distinctive portion in view of prior art.
The requirement is still deemed proper and is therefore made FINAL.
The elected species are found to be free of art, thus, examination was expanded to include nonelected species, compound of formula:
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(claim 51).
Claims 48 - 50 and 54 – 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 6, 2026.
Claims 45 – 47 and 51 – 53 are under consideration in the present office action, as they relate to the elected and expanded species (see structures above).
Priority
The present application is a 371 of PCT/CN2021/115078, filed August 27, 2021 and claims the benefits of priority to Chinese application No. CN202011552478.7, filed December 24, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/05/2023, 10/08/2024 and 09/16/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 52 and 53 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 45 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Marineau et al (WO 2019/143730 A1, cited in IDS, filed 12/05/2023, hereinafter Marineau).
Instant claims are drawn to a compound of formula:
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or a pharmaceutically acceptable salt or a solvate hereof. Compounds of instant claims act as CDK7 inhibitors.
Marineau teaches compounds, acting as CDK7 inhibitors, and having a Formula Ia-2:
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, or a pharmaceutically acceptable salt thereof where X is N or CH; Y is CH; R1 is CN; R2 is -CF3; A is cyclopentyl, p is 0; R5 is -CH3; R6 is -C1-C4 alkyl; R7 is halo, -CN, -OH, etc., n is 0 - 4 (pages 25 – 26, [74], [75] and [77]).
The compound of Formula Ia-2, taught by Marineau, where X is N, R6 is -CH3 (-C1 alkyl) and n is 0, is equivalent or positional isomer of the compound
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of instant claims. Compounds that are similar in structure, presumably would have similar properties. MPEP 2144.09. II states: Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
Thus, since Marineau teaches compound of the same or similar (positional isomer) structure, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to try to make various structurally similar compounds, presumably possessing similar properties, to arrive at claimed compound. The one of ordinary skills would be motivated to do so in search of an agent effectively inhibiting CDK7 the reasonable expectation of success.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
Claims 45 and 51 are rejected.
Claims 52 and 53 are objected to.
Claims 46 and 47 are free of art.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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