Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
MAINTAINED REJECTION
2. 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 prostate cancer and expression of a panel of genes, which is a judicial exception. This judicial exception is not integrated into a practical application because data gathering steps 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 step is ‘detecting in a prostate tumor sample…expression of a panel of genes…normalized to one or more housekeeping genes,’ which was 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.
REPLY TO ARGUMENTS
3. The arguments of the response filed 01/07/26 on pages 6-8 have been fully considered, but are not found persuasive. On page 6 the response argues that independent claims 27 and 34 have been amended such that no judicial exception is recited. The Office disagrees and notes that these claims are drawn to a method ‘for assessing gene expression in a prostate cancer sample’ wherein ‘the patient has a poor prognosis when the CCP score exceeds a threshold value, and the patient has a good prognosis when the CCP score is less than the threshold value’. Thus, a natural correlation or judicial exception is clearly recited. Regarding independent claim 43, the Office notes that it recites at the end, ‘wherein the expression level of the panel of genes determines whether cancer will recur or result in cancer-specific death’; thus, a natural correlation or judicial exception is clearly recited.
Regarding the arguments of the response filed 05/02/25 on pages 9-15, first, the response points to M.P.E.P. 2106.05(c) and argues that the claims recite a transformation of a particular article to a different state or thing, the transformation being a conversion of RNA to cDNA. This is unconvincing because the claims are not drawn to a method of transforming RNA to cDNA, which has long been routine and conventional in the prior art of molecular biology, but rather to a method of prognosing prostate cancer based on a judicial exception – a correlation between prostate cancer and expression of a panel of specific genes. Thus, the routine and conventional step of ‘reverse transcribing RNA…to obtain cDNA’ has nothing to do with the key element of the claimed method, which is a prognostic correlation between prostate cancer and certain gene expression. In other words, the response is applying the ‘transformation’ aspect of the eligibility guidelines in a way that does not pertain to the claimed methods. Second, the response points to M.P.E.P. 2106.04(d)(1) and argues that the claims, as a whole, are directed to a practical application of improved methods of prognosing a prostate cancer patient who has undergone radical prostatectomy. Similar to what is stated above regarding the ‘transformation’ argument, again the response is applying the eligibility guidelines in a manner that is not germane to the claimed method. The guidelines refer to an improvement in, for example, the functioning of a computer, or other technology or technical field. However, the pending claims are drawn to a prognostic correlation between prostate cancer and certain gene expression; the guidelines do not mention improvements to diagnostic correlations, which are judicial exceptions. The claimed method does not require any improvement in, for example, the technology or technical field of diagnosis or prognosis, involving, for example, an improved way of obtaining a sample from a patient, or an improved way of reverse transcribing RNA to obtain cDNA. Finally, the response argues that the claimed methods amount to significantly more than the judicial exception, and points to Ex parte Lee, Appeal 2017-011014 for support. However, the Office does not agree that the particulars of that appeal are relevant to the claimed methods. Other than the steps and limitations directly pertaining to the judicial exception of correlating prostate cancer with expression of particular genes, the claims merely require reverse transcribing RNA to obtain cDNA, and detecting expression of a panel of genes, which general methodology the Office has shown to be routine and conventional in the prior art. In other words, there is no coordinated elements or combination of steps in the claims that are sufficient to amount to significantly more than the judicial exception. Analysis under the guidelines for ‘routine and conventional’ pertains to the general methodology in claims other than the judicial exception. While the Office has found that detection of the particular gene panel required in the claims in relation to prostate cancer and radical prostatectomy was not taught or suggested in the prior art, this is not a consideration for determining eligibility under the guidelines; rather, it is a consideration regarding prior art.
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. THIS ACTION IS MADE FINAL. 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.
6. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached on 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
03/09/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681