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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed January 26th, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
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.
Claim 15 is 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.
Claim 15 recites a method for treating an HPK1-associated disease or disorder in a mammalian subject which further comprises administering to the subject an effective amount of a compound of Claim 1, or a pharmaceutically acceptable salt thereof in combination with another one or more second anti-cancer agent selected from the group consisting of vascular endothelial growth factor (VEGF) receptor inhibitors, topoisomerase II inhibitors, smoothen inhibitors, alkylating agents, anti-tumor antibiotics, anti-metabolites, retinoids, immunomodulatory agents. However, the claim is missing a conjunction between “the words “retinoids,” and “immunomodulatory agents;” as such claim 15 recites an open list of alternatives. As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of whether the method further comprises the administering of retinoids, and/or immunomodulatory agents or whether any anti-cancer agent falls within the scope of the invention. Therefore, given the uncertainty claim 15; claim 15 is rejected under 35 U.S.C. 112(b) as indefinite.
Moreover, newly amended claim 15 recites the term “further” in line 1 of the claim which is definite because it is unclear what required active step is before the “furthering” step. Additionally, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of what other active step is required for the method or what the administering of the compound is furthering. Therefore, given the uncertainty claim 15; claim 15 is rejected under 35 U.S.C. 112(b) as indefinite.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance: claims 1, 3, and 5 – 11 direct to a compound of the formula (Ib):
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. Moreover, claims 14, and 16 – 17 direct to a method for treating an HPK1-associated disease or disorder in a mammalian subject which comprises administering to the subject an effective amount of a compound of Claim 1, or a pharmaceutically acceptable salt thereof.
The closest prior art of International Publication Number WO 2012/145569 to Bennett et. al. (herein after Bennett’569; cited in the office action dated October 2nd, 2025) teach diaminocarboxamide pyrimidine compounds a condition treatable or preventable by inhibition of a JNK pathway (page 1 paragraph 0001). Furthermore, Bennett’569 teach that mitogen-activated protein kinases (MAPKs) are important mediators of signal transduction from the cell surface to the nucleus, using phosphorylation cascades to generate a coordinated response by a cell to an external stimulus by phosphorylation of selected intracellular proteins, including transcription factors (page 1 paragraph 0003). Additionally, Bennett’569 teach compounds having the following formula (I):
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(page 3 paragraph 0008). More specifically, Bennett’569 teach Compound B – 15 of chemical name 2-(2-methoxyphenylamino )-4-(phenylamino)pyrimidine-5-carboxamide and structure
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(page 310) wherein instant X and instant Y are bonds; instant Ring A is phenyl wherein instant R1a, instant R1b, and instant R1c are H; instant R3a and instant R3b are H; instant Ring B is phenyl where instant R2a and instant R2b are H, and instant R2c is -OCH3.
However, Bennett’569 fails to teach a compound of formula (Ib):
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(claim 1). Moreover, the prior rt fails to teach a motivation for modifying prior art compound B-15 to make reference R1 a tetrahydroisoquinoline ring. Therefore, given that the prior art of Bennett’569 fails to anticipate or render obvious the instant structure claims 1, 3, 5 – 11 are free of the prior art. Moreover, claims 14, and 16 – 17 which direct a method for treating an HPK1-associated disease or disorder in a mammalian subject which comprises administering to the subject an effective amount of a compound of Claim 1 are also free of the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claim 15 is rejected. Claims 1, 3, 5 – 11, 14, and 16– 17 are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682