Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/26 has been entered.
NON-PRIOR ART REJECTION
3. 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 27, 30-34, 37-39, and 43-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or correlation without significantly more. The claims recite a natural correlation between expression of a panel of genes and clinical risk of recurrence for prostate cancer, which is a judicial exception. This judicial exception is not integrated into a practical application because data gathering steps, which includes the recited step of ‘preparing a nomogram’, required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only physical steps are ‘reverse transcribing RNA…to obtain cDNA’ and ‘detecting in the cDNA expression of a panel of genes…normalized to one or more housekeeping genes,’ which were routine and conventional in the prior art as evidenced by Bibikova et al., see pages 666-671, especially Abstract, Fig. 1 and results on page 667, and Materials and Methods on pages 670-671.
According to the 2019 Revised Patent Subject Matter Eligibility Guidance, an initial two step analysis is required for determining statutory eligibility.
According to the Manual of Patent Examination Procedure (MPEP) sections 2103 through 2106.07(c), which now incorporates the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), October 2019 Patent Eligibility Guidance Update (October 2019 Update), and the Berkheimer Memo, an initial two step analysis is required for determining statutory eligibility.
Step Analysis
Step 1 requires a determination of whether the claims are directed to a process, machine,
manufacture, or a composition of matter. In the instant case, the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2 The Step 2 analysis is a two-part analysis, Step 2A and Step 2B.
Step 2A. prong 1 Step 2A, prong 1 requires a determination of whether the claims are directed towards a judicial exception, i.e. a law of nature, natural phenomenon, or an abstract idea, while step 2A, prong 2 requires an analysis of whether the judicial exception integrated into a practical application if the claim recites a judicial exception under Prong 1.
Step 2A. prong 2
Step 2A, prong 2 requires an analysis of whether the judicial exception is integrated into a practical application if the claim recites a judicial exception under Prong 1.
Step 2B
The second part, Step 2B of the two-step analysis is drawn to determining whether any element or combination of elements, in the instant claims is/are sufficient to ensure that the claims as a whole amount to significantly more than the judicial exception.
Following the analysis below the claims are not patent eligible under 35 U.S.C. 101.
Concerning Step 1: YES. Claims 27, 30-34, 37-39, and 43-45 are directed to methods, therefore the claims are directed to a process, which is a statutory category.
Concerning Step 2A: NO. Claims 27, 30-34, 37-39, and 43-45 do not require any physical step such that the judicial exception is integrated into a practical application.
Concerning Step 2A, prong 1, claims 27, 30-34, 37-39, and 43-45 are directed towards a judicial exception, i.e. a natural correlation, as noted above. These claims recite abstract ideas of comparing and parsing data (preparing a nomogram), as these claims recite steps of calculating a level/quantity in a manner that could be achieved as a mental step.
The step of determining the expression of certain genes falls within the grouping of abstract ideas as it merely instructs a user to analyze various target sequences (analyze natural law/natural sequences) and to draw a conclusion that one is or is not at risk of recurrence of prostate cancer.
Concerning Step 2A, prong 2, the judicial exception recited in claims 27, 30-34, 37-39, and 43-45 is not integrated into a practical application because of the following.
A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. When the exception is so integrated, then the claim is not directed to a judicial exception.
Claims 27, 30-34, 37-39, and 43-45 do not recite steps beyond the recited steps of reverse transcribing RNA and determining expression level of certain genes (routine and conventional steps to obtain the judicial exception or natural correlation), preparing a nomogram which is a compilation of data, and providing an output of the compiled data. Thus, these claims do not recite steps/elements that are construed to be a practical application that apply, rely on, or use the judicial exceptions. The steps of reverse transcribing RNA and detecting the level of certain target genes is not a practical application as these steps must be applied to realize the judicial exception.
Concerning Step 2B, claims 27, 30-34, 37-39, and 43-45 do not recite any additional elements that ensure that the claims as a whole amount to significantly more than the judicial exception. The recited ‘preparing’ and ‘providing’ steps only involve compiling and outputting data relating to the judicial exception.
Based on the above analysis, claims 27, 30-34, 37-39, and 43-45 are rejected as being ineligible under 35 U.S.C. 101.
CONCLUSION
4. Claims 27, 30-34, 37-39, and 43-45 are free of the prior art, but they are rejected for another reason. No claims are allowable.
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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07/21/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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