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 and Response to Amendments
The amendments filed July 27, 2026 have been acknowledged and entered. Claims 1, 4, 8, 19, 30, 32, 37, 39-40, 43, 48-51, 54 and 70-71 are pending.
Information Disclosure Statements
Acknowledgement is made of the Information Disclosure Statement filed July 27, 2026 . All references have been considered except where marked with a strikethrough.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Claim Objections and Allowable Subject Matter
Claim 48 is objected to for being in improper Markush format. A proper Markush claim recites a list of alternatively useable members (see MPEP 2117). In the present case the claim recites the phrase “or pharmaceutically acceptable salts thereof” which is improper. It is suggested that Applicant amend the claim to recite “or a pharmaceutically acceptable salt thereof” which is the same language used in claim 1.
Claims 49-51 and 54 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 48 would be allowable if amended to overcome the objection set forth herein.
The reasons for indicating allowable subject matter were set forth in the previous office action and are incorporated herein by reference.
Maintained Rejections
Claim Rejections - 35 USC § 102
Claim(s) 1, 4, 8, 19, 30, 37, 39-40, 43 and 70-71 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Taylor et al. (WO2022/174031 A1 (hereinafter “Taylor”).
Taylor teaches (1R,3S)-3-(3-(pyrimidin-2-ylamino)-1H-pyrazol-5-yl)cyclopentyl isopropylcarbamate (see page 504 and 507, Example 37, product of step 5; see also page 81; pictured below for convenience) which corresponds to instant Formula (I) wherein A is a 6-membered heteroaryl having two N ring atoms; n and m are each 0; R2 is C3 alkyl; and R3 is H.
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Taylor teaches compound 310 (see page 112; pictured below for convenience) which corresponds to instant Formula (I) wherein A is a 6-membered heteroaryl having one N ring atom; n is 1; R1 is 5-membered heteroaryl having two N heteroatoms substituted by 1 R1d wherein R1d is C1 alkyl; m is 0; R2 is C3 alkyl; and R3 is H.
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Taylor teaches compound 563 (page 157, pictured below for convenience) which corresponds to instant Formula (I) wherein A is a 6-membered heteroaryl having two N ring atoms; n is 1; R1 is C2 alkoxy; m is 0; R2 is C3 alkyl; and R3 is H. Regarding R1, Examiner notes that the instant specification teaches the alkoxy groups can be further substituted with a variety of substituents described within (see paragraph [0015]). In view of this teaching and that hydroxy is a substituent described in the specification (e.g. see paragraph [0005]), compound 563 of Taylor is regarded as being included with the scope of the claims.
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Taylor further teaches a pharmaceutical composition comprising the compound (see claim 20) and a method of using the compound to treat a CDK-mediated disorder wherein the CDK2-mediated disorder is breast cancer (claims 22-23)
Examiner notes that the abovementioned compounds, composition and method are disclosed at least in the specification of priority document 63/166,638 of Taylor filed March 26, 2021 at pages 48, 80 and 94-96 and priority document 63/250,473 of Taylor filed September 30, 2021 at page 155, both of which were filed prior to the effective filing date of the instant application, October 5, 2021. Taylor therefore anticipates the instant claims.
Claim Rejections - 35 USC § 103
Claim(s) 1 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (WO2022/174031 A1) (hereinafter “Taylor”).
Taylor teaches a generic group of compounds which embraces applicants’ claimed compounds for use as pharmaceuticals and compositions for the treatment of CDK2-mediated disorders including cancer (see page 2, Formula I-A, paragraph [0005], [0011] and [0012]). The claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. It has been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).”
In particular, Taylor teaches (1R,3S)-3-(3-(pyrimidin-2-ylamino)-1H-pyrazol-5-yl)cyclopentyl isopropylcarbamate (see page 504 and 507, Example 37, product of step 5; see also page 81; pictured below for convenience) which corresponds to instant Formula (I) wherein A is a 6-membered heteroaryl having two N ring atoms; n and m are each 0; R2 is C3 alkyl; and R3 is H.
Taylor does not disclose a compound wherein the position corresponding to ring A of the instant claims is substituted with an R1 as required by claim 32. However, Taylor further teaches a genus of Formula (V) which provides that the group corresponding to ring A of the claims can be substituted with a Me, -CN, -OCH3 or -CF3 group which corresponds to R1 of instant Formula (I) (see [0017], Formula V; [0123] definitions of CyC; [0113] in some embodiments RC is -OCH3; in some embodiments RC is CN; [0117] in some embodiments RC is -CH3, in some embodiments RC is CF3; Formula V and CyC pictured below for convenience).
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The difference between the prior art and the instant claims is that the instant claims require that the A ring is substituted by Me, -CN, -OCH3 or -CF3. However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant claims to modify (1R,3S)-3-(3-(pyrimidin-2-ylamino)-1H-pyrazol-5-yl)cyclopentyl isopropylcarbamate of Taylor with an R1 as is required by the instant claims, because Taylor disclosed that the position corresponding to ring A of the claims could be substituted with an R1 group as required by the claimed invention.
One would have been motivated as a matter of making additional compounds to treat cancer. One would have been especially motivated to make modifications that the reference explicitly taught, which in the present case includes wherein the position corresponding to R1 can be Me, -CN, -OCH3 or -CF3.
One would have had a reasonable expectation of success because Taylor had already disclosed the claimed modifications. Therefore there would have been an expectation that such a modification would result in a compound useful for treating cancer.
Response to Arguments
Applicant’s arguments filed July 27, 2026 have been fully considered but they are not persuasive.
Applicant states that Applicant has amended claim 1 to incorporate the limitations of allowable claim 33. Accordingly, Applicant submits that claim 1 is not anticipated by Taylor.
This amendment is not found persuasive because the compounds of Taylor are still embraced by the instant claims. Taylor teaches compounds 310, 563 and example 37 as noted in the rejection. Example 37 for instance still corresponds to instant Formula (I) wherein A is a 6-membered heteroaryl having two N ring atoms; n and m are each 0; R2 is C3 alkyl; and R3 is H.
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The amendment to incorporate the limitations of claim 33 into claim 1 is not sufficient to overcome the rejections over Taylor because original claim 33, which is canceled in the present claims, recited that R4 is hydrogen or C1-4 alkyl and therefore required that R4 is present (i.e. m is 1). Thus, Taylor was not art to claim 33. By contrast, broader claim 1 permits m to be 0 and therefore R4 can be absent, and the compounds of Taylor are still embraced by the claims.
The rejection is still deemed proper and thus maintained.
Conclusion
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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September 8, 2026
/K.S.M./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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