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 .
Detailed Action
Claims 1, 3, 8, 11, 13, 17, 19, 23, 26-27, 31, 35, 40, 59-62, 67, 71, and 81 are currently pending.
Election/Restriction
Applicant’s election of Group I and compound
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in the reply filed on 11/12/2025 is acknowledged. Because applicant did not distinctly and specifically point out the errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 31, 60, 62, 67, and 71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II or unelected species, there being no allowable generic or linking claim. Thus, Claims 1, 3, 8, 11, 13, 17, 19, 23, 26-27, 35, 40, 59, 61, and 81 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
The elected species was found to be free of the art. Search and examination was broadened to encompass compounds in which the L group was C=O-alkylene rather than a C=O-biphenylene.
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.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3, 8, 11, 13, 17, 19, 23, 26-27, 35, 40, 59, 61, and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (WO2020035049, published 2/20/2020, Google Patent English translation cited herein) in view of Mikochik (US20200131189, published 4/30/2025, claiming priority to US provisional application No. 16667027 filed 10/29/2019, cited in 4/14/2023 IDS).
Chen teaches compounds for targeting and degrading CDKs (Abstract). Specifically, Chen teaches compounds which are PROTACS or chimeric bifunctional compounds comprising a CDK(7 and/or 9) inhibitor moiety and a degron (cereblon) moiety to overcome shortcomings of other small molecule inhibitors (Translation Doc: Page 24, Para 1-2). For example, compound 157 is taught as such a bifunctional compound on Page 98:
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.
Chen does not teach that
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may instead be a single saturated cycle sans methylene or an alternative CDK9 inhibitor moiety similar to that of the elected compound.
Mikochik also teaches compounds which function as CDK9 inhibitors (Abstract; Title; Page 6, Compound 48). Mikochik teaches Compound 35,
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, as a potent CDK9 inhibitor (Page 45, Table).
Both Chen and Mikochik teach CDK inhibitors comprising a bicyclic core comprising 3 nitrogen ring heteroatoms and two substituents (an alkyl and substituted heterocyclyl) at the same position. Using Chen’s teaching that the bifunctional compounds possess the degron moiety to efficiently target CDK9s for degradation, one of ordinary skill in the art would find it obvious to substitute one inhibitor moiety for the CDK9 inhibitor moiety taught by Mikochik and expect greater CDK9 activity reduction compared to the Mikochik inhibitor alone. One of skill in the art would reasonably expect to be able to attach the Mikochik moiety to the degron moiety through the N-C(=O)- motif of the Chen PROTAC to form the following heterobifunctional CDK9 degrader:
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in which the following definitions of examined Formula (I) apply: R1 is alkyl; DR2, R3, R4, R5, and R6 are H; A is
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(Claim 13); L is
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(Claims 19 and 23); and E is
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(Claims 26-27 and 35). The modified compound is the same as the first compound listed on Page 13 of instant Claim 59. Other particular combinations of appropriate moieties in Mikochik and Chen would be expected to yield similar biheterofunctional PROTACS, encompassed within Formula (I), which degrade CDK9 more efficiently than any particular CDK9 inhibitor moiety alone.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627