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 .
According to a preliminary amendment filed on Dec. 3, 2024, the applicants have amended claims 4-26, 28, 31-34 and 37.
Claims 1-37 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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.
Claims 1, 34 and 37 are 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.
In claim 1, variables X and R3 are defined. However, these variables are not present in compounds of formula (Ia).
In claim 34, specific diseases associated with either hyperactivity or hypoactivity of CDK12, are not defined.
Claim 37 recites the limitation "cancer" in claim 34. There is insufficient antecedent basis for this limitation in the claim.
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.
8. 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.
9. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Benoit (WO 2023/091726 A1, cited on applicant’s form 1449).
Benoit discloses CDK 12 inhibitors for treating cancer. The compounds disclosed in examples 238-241 (see pages 353-355) by Benoit meet all the limitations of instant claims when variable W represents N, variable X represents CH, n is 1 and Z is absent in the instant compounds of formula (Ia) except that the bicyclic ring (instant moiety AB) is attached to the cyclohexyl ring by a carbon atom instead of instant N atom. However, Benoit teaches this interchangeability since the compound in example 270 (see page 381) has bicyclic ring (instant moiety AB) attached to the cyclohexyl ring by N atom. Therefore, it would have been obvious to one skilled in the art to prepare instant compounds without affecting their utility of treating cancer with reasonable expectation of success.
Allowable Subject Matter
10. The following is a statement of reasons for the indication of allowable subject matter: The instant claims 2-33 directed to compounds of formula (I) are allowed since they are neither disclosed nor obvious over the prior art. In the prior art, Benoit discloses CDK 12 inhibitors for treating cancer. The most closely related compounds disclosed in examples 238-241 (see pages 353-355) by Benoit differ from the instant compounds by having different bicyclic ring (instant moiety AB) attached to the cyclohexyl ring by a carbon atom instead of instant N atom. Furthermore, there is no teaching, suggestion or motivation in the prior art to modify the compounds of Benoit to prepare instant compounds.
11. Claims 35 and 36 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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