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
Election of Species and Status of the Claims
Applicant’s election without traverse of compound I-35,
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in the response filed on January 16th 2026 is acknowledged. Claims 1-21 are pending. Claims 6-14 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1-7 and 15-21 are examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 based on the date of the provisional applications 63/373,014 filed on August 19th 2022 and 63/383,042 filed on November 9th 2022.
Information Disclosure Statement
The Information Disclosure Statements filed on January 16th 2026 and September 18th 2025 are in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
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 15 and 19 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.
Claim 15 is indefinite for the reference to Table 1. See MPEP 2173.05(s):
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claim 19 is indefinite for the phrase “an CDK2-mediated disorder, disease, or condition,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim from the claim language. Specifically, the term “CDK2-mediated disorder, disease, or condition” is not defined in the specification further than, “disorders, diseases, and/or conditions as used herein means any disease or other deleterious condition in CDK2 or a mutant thereof, are known to play a role” (Specification, paragraph [00184]). While a particular subset of CDK2-mediated disorders would be recognized by one of ordinary skill in the art, the term “CDK2-mediated disorder, disease, or condition,” is unclear, as one of ordinary skill in the art could not reasonably determine the full scope of disorders “mediated by” CDK2 activity.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim recites a method of inhibiting CDK2 in a biological sample comprising contacting said biological sample with a compound of claim 1. This judicial exception is not integrated into a practical application because only the contact of the sample with the compound (i.e. a natural phenomenon) and the results of said contact are recited. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only further limitation beyond the natural phenomenon is the intended response of the sample (the inhibition of CDK2) to the compound.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7 and 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Winterton (WO2020168178 published on August 20th 2020).
The claims are directed towards a compound of formula I-a’:
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One such compound is applicant’s compound I-255:
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Compound I-255 is taught by Winterton (Winterton, pg. 130, Example B7). Winterton thereby anticipates claims 1-7 and 15.
Claim 16 is directed towards a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutical adjuvant. Winterton teaches the compound as part of an adjuvant therapy with additional active agents (Winterton, pg. 94), anticipating claim 16.
Claim 17 requires that the pharmaceutical composition of claim 16 comprises additional active agents. As Winterton teaches additional active agents (Winterton, pg. 94), Winterton anticipates claim 17.
Claims 18 and 19 are directed towards a method of treating a CDK2 associated disorder in a patient via administration of a compound of claim 1. Winterton teaches such a method (Winterton, pg. 153, claim 23), anticipating claims 18 and 19.
Claim 20 requires that the disease in the method of claim 19 is cancer. Winterton teaches the treatment of cancer with the compounds (Winterton, pg. 180, claim 49), anticipating claim 21.
Claim 21 requires that the cancer of claim 20 is characterized by overexpression of CCNE1. Winterton teaches the treatment of cancer characterized by CCNE1 overexpression (Winterton, pg. 181, claim 56), anticipating claim 21.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629