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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/26 has been entered. Claim 13 has been amended. Claims 1-12, 14 and 16 were previously canceled. New claim 33 has been added. Accordingly, claims 13, 15 and 17-33 are pending and under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
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 13, 15 and 17-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims are directed to a naturally occurring correlation between the expression levels of the recited markers on immune cells and the ratio of the immune cells compared to a threshold in subjects with estrogen receptor positive cancer.
Step 2A, Prong 2
The additional elements of detecting expression level of the recited markers presenting on the immune cells and comparing to a threshold do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the abstract idea.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
Also, as shown by Jenks et al (J Lab Precis Medl, 2018 Feb 3, pages 1-4) it is well known, routine and conventional in the art to detect the ratios of biomarkers of immune cells and compare to that of a threshold. Chan et al (Int J Biol Markers, 2012; 27(4) pages e295-e204) also shows that it is well known, routine and conventional to determine the levels of markers presenting on immune cells and determining a change compared to a baseline/threshold (e.g. abstract, pgs 296, 298) (submitted in the listing of reference by Examiner 07/14/25).
With respect to the “administering to the subject a checkpoint modulator agent…” as recited in claim 13. Although the claim invokes administering a treatment to the subject the claim currently recites and alternative scenario in reciting “if at least one ratio of the immune cells is above a threshold”, and thus the claim allows for an embodiment wherein the subject is determined not to have a ratio above the threshold and no treatment is administered. Therefore, the claims as currently recited do not recite something significantly more than the judicial exception.
Also, with respect to the “administering to a subject presenting with the ratio above a threshold a checkpoint modulator agent” as recited in new claim 33. Although the claim invokes administering a treatment to the subject the claim as currently recited allows for a determination wherein the subject is not presenting the ratio. The claim does not positively detect a ratio above the threshold and administer the treatment to the subject having the detected ratio above the threshold.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies and also fails to provide active method steps.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678