DETAILED ACTION
This action is in response to the amendment filed 03/17/2026.
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 .
Status of the Claims
Upon entry of the amendment, claims 1, 3-5, 10, 12-15, 18-19 are pending.
Claims 10, 12-15, 18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/28/2023.
Claims 1, 3-5, 19 are examined herein.
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, 3-5, 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon as well as an abstract idea without significantly more.
Claim 1 has been amended to add limitations requiring that the microRNA (miR) comprising one or more of miR-21, miR-17, let-17a, or miR-200c, and to require that the cancer is pancreatic cancer (see amended claim 1). The amendment does not overcome the rejection under 35 USC 101. The amendment does not add any active method steps to the claimed method accordingly, the only active method step of the claims is step (v) treating the pancreatic cancer in the subject by administering to the subject by administering to the subject the anticancer agent indicated in part (iv).
Here, the natural phenomenon is the natural correlation between the modification information of a microRNA (here any of the four specific miRs) and pancreatic cancer in a subject, and the abstract idea is the fact that the method steps are drawn to “analyzing” microRNA modification and a pancreatic both of which do not necessarily require any active method steps and can be performed mentally by merely looking at information (obtaining modification information) and thinking about the information (analyzing). Although step (iii) is drawn to “analyzing the responsiveness of the pancreatic cancer determined in step (ii) to an anticancer agent that has been administered to the subject based on the modification assessed in step (i)” and thus requires administering an anticancer agent to the subject, the claim broadly encompasses administering any anticancer agent and then “analyzing” natural events that occur in the subject. Furthermore “indicating an anticancer agent for treating the subject…” amounts to insignificant extra-solution activity. Although claim 1 also include the step of treating the pancreatic cancer in the subject by administering to the subject the anticancer agent indicated in (iv), the claimed method amounts to merely gathering information related to a natural phenomenon (identifying an agent) and then essentially applying the natural phenomenon (e.g., providing instruction on how to apply the exceptions; see MPEP 2106.05(f)).
Accordingly, the claimed method is based on a judicial exceptions (an natural phenomenon and an abstract idea), specifically the correlation between a modified miR form of any of the four specific miRs and pancreatic cancer and analyzing miR modification and indicating pancreatic cancer, without adding significantly to the judicial exceptions. Therefore, a rejection under 35 USC 101 is appropriate.
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered but they are not persuasive. Applicant argues that the claims have been amended to specify that the medical condition comprises pancreatic cancer and the miRNA must be one or more of miR-21, miR-17, let-17a, or miR-200c, and asserts that the amended claims define a specific, integrated method of diagnosing and treating pancreatic cancer using specific miRNA biomarkers and that the specific combination goes well beyond a mere observation of a natural phenomenon, and the claims are integrated into a practical application.
The arguments have been fully considered but are not persuasive. First, it is noted that the claims do not “use a specific agent” as asserted by Applicant. Rather, the claims explicitly encompass analyzing responsiveness of the pancreatic cancer to “an anticancer agent” that has been administered to the subject (see step (iii)), and treating the pancreatic cancer by administering to the subject “the anticancer agent” (see step (v)). Thus, the claims do not require the use of a specific agent, but broadly encompass analyzing the responsiveness of pancreatic cancer to any anticancer agent, and then administering the indicated anticancer agent to a subject that has pancreatic cancer. Utilizing any anticancer agent does not integrate the judicial exceptions into a practical application., Furthermore, the claims rely on the judicial exceptions without adding significantly to the judicial exception. Therefore, Applicant’s arguments are not persuasive.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
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