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 .
Priority
The present Application, filed June 22, 2023, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/US2022/018892, filed March 4, 2022, which claims the benefit of U.S. Provisional Patent Application Publication No. 63/156,880, filed March 4, 2021.
Status of the Claims
In the amendment filed July 2, 2025, claims 18, 20-21, 25-26, 29-41, and 47 are canceled. Claims 3-4, 8, 22-23, 42, and 46 are amended. Claims 1-17, 19, 22-24, 27-28, and 42-46 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 15, 2025 is acknowledged.
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.
Claims 1-17, 19, 22-24, 27-28, and 42-46 are indefinite:
Claims 1-17, 19, 22-24, 27-28, and 42-46 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 1 is indefinite for reciting a method of treating a disorder “characterized by amplification or overexpression of cyclin E, amplification or overexpression of CDK2, amplification or overexpression of cMYC, or a KRAS mutation in a subject,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. As a first matter, it would be unclear what it means for a disorder to be “characterized by” the attribute in question (e.g. amplification or overexpression of CDK2). For example, this recitation could mean that a general correlation has been shown between the disorder and amplification or overexpression of CDK2 (i.e. in population studies, people having the disorder also often have amplified or overexpressed CDK2), or it could mean that the specific subject of the method, who has the disorder, has been evaluated as having amplified or overexpressed CDK2. Or it could potentially mean something else.
If “characterized by” means that a general correlation has been shown in the art, this would be specifically construed as requiring only that the disorder has been described somewhere in the art as being characterized with, associated with, or otherwise correlated with overexpression. If “characterized by” means that the individual subject must be evaluated for “amplification or overexpression,” it would be unclear how one would determine if the gene in question is overexpressed. In particular, in the absence of any specified measurement method or standard cutoff (baseline, normal expression, against which the subject’s expression is compared), one of ordinary skill in the art could not reasonably determine with any certainty whether a given subject displayed overexpression of the protein within the scope of instant claim 1. Claims 2-17, 19, and 22-24 are indefinite for depending from claim 1 without curing this indefiniteness.
Similarly, claim 27 is indefinite for reciting “a cancer having a diagnosis of an elevated CDK2 expression in tumor cells of the subject,” because a person of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. Similar to claim 1, in the absence of any guidelines on the detailed basis and criteria for such a diagnosis, such as measurement method or comparative baseline for normal expression, one could not determine with any certainty whether a given subject had elevated CDK2 expression in all cases. If the term “diagnosis” indicates that this element solely depends on a clinician’s subjective opinion, then such subjectivity is inherently indefinite. Claims 28 and 42-26 are indefinite for depending from claim 27 without fully curing this indefiniteness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629