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 .
Election/Restrictions
Applicant’s election without traverse of group I and level of ARID1A in the reply filed on 12/08/2025 is acknowledged.
Claims 2-3 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/8/2025.
Drawings
The drawings filed 05/08/2023 are acceptable.
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.
Claims 1, 4-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea and law of nature without significantly more.
The claims recite a method for predicting the responsiveness of a subject towards a PLK1 inhibitor and this step encompasses a law of nature and an abstract. The claim sets forth determining the level of PLK1 and predicting responsiveness to PLK1 inhibiting therapy. This is an abstract idea which can be practiced in the mind by making a determination of the measured levels of ARID1A and determining responsiveness to therapy.
Claims 4 further limit the judicial exception of responsiveness of PL1 inhibiting therapy by reciting an increase level as compared to a reference indicates a likelihood of resistance to PLK1. Claim 5 recites decreased level of ARID1A as compared to a reference indicates likelihood of sensitivity to PLK1. These limitations both encompass an abstract idea and sets forth the natural correlation of level of ARID1A with response to PLK1 inhibiting therapy. The abstract idea encompassed by the claims is a mental step, which encompasses critical thinking and analysis to compare the level of ARID1A in a sample to a reference and make the conclusion of likelihood of resistance or sensitivity to PLK1 inhibitor.
These judicial exception are not integrated into a practical application because the steps in addition to the judicial exceptions are data gathering steps that do not apply or integrate the judicial exceptions in any way. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to the judicial exception are data gathering steps recited at a high level of generality employing techniques that were well-established, routine and conventional at the time of the invention. The courts have recognized that amplifying and sequencing nucleic acid sequences is among the well-understood, routine, conventional activity in the life science arts when claimed in a merely generic matter. Here, the claims include steps of determining the level of ARID1A in a sample. Prior to the invention, Wang (PLoS ONE, vol 7, e40364, pp. 1-9)
teaches determining ARID1A mRNA and protein levels in cancer cells. This provides evidence that these steps were conventional at the time of the invention.
Claims 4-5 further define the level of ARID1A and encompass a mental processes and thus only limit the judicial exceptions.
Claims 6 limits the PLK1 inhibitor, Claim 7-8 limit the subject. Claim 9-10 limit the sample. These limitations are a field of use limitation which does not amount to significantly more.
The claims as a whole does not amount to significantly more than the judicial exceptions. Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
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, 4-7, 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (2018, cited on IDS).
Wu teaches administering AURKAi to mice bearing ARID1A tumors comprising WT or loss of ARID1A. Wu teaches AURKAi treatment significantly inhibited the growth of tumors in mice with a loss of ARID1A and did not affect the growth of tumors in mice with WT ARID1A (see fig 2 and pg. 4) (claim 4-5, 7, 9-10) (determining level of ARID1A in a sample from subject) (increased level resistance toward PLK1 inhibiting therapy, decreased level sensitive toward PLK1 inhibiting therapy). Wu teaches that AURKAi is a target pathway of PLK1 (PLK1 inhibiting therapy) and teaches CDC25C and PLK1 siRNA inhibit the growth of tumors in ARID1A negative cells (see pg. 9, 2nd column). (claim 6 and 11)
Claims 1, 4-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (PLoS ONE, vol 7, e40364, pp. 1-9).
Wang teaches decreased mRNA and protein expression of ARID1A in gastric cancer (see figure 1 and 2). Wang teaches the subject has gastric cancer (see human tissue samples) (claims 7-8). While the claim recites “for predicting the responsiveness of a subject toward a Polo-like kinase 1 (PLK1) inhibiting therapy” the preamble simply states what is indicated by the result of determining the level of ARID1A as this claim language does not require steps to be performed, it is not limiting of claim scope (see MPEP 2111.04). Additionally the requirement of the wherein clause in claims 4-5 are inherently met as a result of the performance of the active step of determining the expression level of ARID1A in the sample and the predicting referenced in the wherein clause and preamble constitute instructional limitations added to a method known in the art. The preamble in the context of the present claim does not result in any manipulative difference as the recitation of for predicting responsiveness simply states a conclusion regarding the subject that results from the active “determining” of the claim (see MPEP 2111.02 (II)).
Conclusion
No claims are allowable.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
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