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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/01/26 has been entered. Claims 1-2, 8 and 22 have been amended. Currently, claims 1-3, 5, 7-17 and 22 are pending. Claims 8-17 and 22 remain withdrawn as being directed to non-elected inventions. Accordingly, claims 1-3, 5 and 7 are under examination.
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 and 7 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 levels of CD40, CD27 and TIM-3 in a cervicovaginal lavage (CVL) sample of a subject with invasive cervical carcinoma (ICC) as compared to a predetermined threshold.
Step 2A, Prong 2
The additional elements of obtaining a CVL sample from a patient and measuring the levels of the recited biomarkers in the sample and comparing to a predetermined threshold does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “wherein a higher level[[s]] of the at least two biomarkers in the CVL sample, as determined in step (b), compared to above a predetermined threshold is indicative of the presence of ICC in the human subject; wherein the predetermined threshold is the biomarker concentration over a defined threshold or fold change, or specific concentration in pg/ml”. The “wherein” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of a higher level of the biomarkers being correlated with ICC. No active method steps are invoked or clearly required; the “wherein” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
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).
As shown by Pepin et al (The Journal of Immunology, Volume 200, Issue Supplement 1, May 2018, page 174.43) it is well known, routine and conventional to obtain a sample from a patient and measure the expression of CD40, and CD27 and TIM-3 compare to that of control patients (predetermined threshold) (e.g. page 174.43).
As shown by Churchman et al (Journal of Chromatography B, 1017-1018 (2016), pages 75-81) it is well known, routine and conventional to rinse the lower reproductive tract and collect the components of the mucosal surface of the vagina for collection of proteins (e.g. abstract).
With respect to the “administering a treatment to the human subject diagnosed with ICC” as recited in claim 1. Although the claim invokes administering a treatment to the subject the claim as currently recites “diagnosing the human subject with ICC when the biomarkers in the CVL sample, as determined in step (b) are at a higher level compared to a predetermined threshold”” The recitation of “when” allows for the scenario when the level is lower level and thus allows for an embodiment wherein no treatment is administered. Therefore, this scenario does not recite something significantly more than the judicial exception. Also, the claim currently recites a treatment step that is generic and allows for anything already known and conventional such as telling the subject to rest or someone to change their diet. Thus, the current treatment step does not recite something significantly more than the judicial exception.
Further, with respect to the sample being a cervicovaginal lavage (CVL). In the instant case, the claims are directed to a method that starts with the recited biomarkers measured in CVL sample which are naturally occurring markers found in a naturally occurring sample. The method therefore begins and ends with naturally occurring markers and thus the claims are directed to a matter that is naturally occurring. Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed Cir, 2014-1139, 2014-1144, 06/12/15).
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
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.
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).
NOTE: It is recommended to positively recite a step of diagnosing the subject (as pointed out in the interview summary filed 08/18/26) and treating the subject with a specific treatment (such as provide in paragraphs 0004-0005 of the specification) and not a generic treatment.
Response to Arguments
Applicant's arguments filed 09/01/26 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues that amended claim 1 now recites "administering a treatment to the human subject diagnosed with ICC." Accordingly, as amended, claim 1 includes additional limitations that integrate the alleged natural phenomenon into a practical application and amount to significantly more. Thus, Applicant respectfully requests reconsideration and withdrawal of the rejections under 35 U.S.C. § 101.
This argument is not found persuasive because although the claim invokes administering a treatment to the subject the claim as currently recites “diagnosing the human subject with ICC when the biomarkers in the CVL sample, as determined in step (b) are at a higher level compared to a predetermined threshold”” The recitation of “when” allows for the scenario when the level is lower level and thus allows for an embodiment wherein no treatment is administered. Therefore, this scenario does not recite something significantly more than the judicial exception. Also, the claim currently recites a treatment step that is generic and allows for anything already known and conventional such as telling the subject to rest or someone to change their diet. Thus, the current treatment step does not recite something significantly more than the judicial exception.
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
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