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 .
Status of the claims
The amendment filed 03/05/26 is acknowledged and has been entered. Claims 1, 8-10, 13 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 Claims 8-17 and 22 remain withdrawn as being directed to non-elected inventions.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 Objections
Claim 2 is objected to because of the following informalities: Claim 2 the recitation “the at least two biomarkers” should be --the biomarkers—because claim 1 was amended to remove the at least two biomarkers. Appropriate correction is required.
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).
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).
Response to Arguments
Applicant's arguments and the Declaration under 37 CRF 1.132 filed 03/05/26 have been fully considered but they are not persuasive.
Applicant argues that claim 1 has been amended to be directed towards an in vitro method of diagnosing invasive cervical carcinoma (ICC) in a human subject that includes detecting the levels of CD40, CD27, and TIM-3 biomarkers in a CVL sample from the subject. Detection of the biomarkers includes physical steps. These physical steps constitute significantly more than an abstract idea and clearly tie the method to a technological improvement-namely, the ability to diagnose ICC from a non-invasive biological sample with enhanced accuracy and clinical utility. Applicant directs the Examiners attention to the Declaration under 37 CFR $1.132 by Dr. Melissa M. Herbst-Kralovetz and Dr. Pawel Laniewski, experts in the field of gynecological cancer, as evidenced by their curriculum vitae submitted as EXHIBIT A and EXHIBIT B, to support the subject matter eligibility of the presently claimed invention.
This argument and the Declaration have been considered but are insufficient and not found persuasive because the claim itself does not reflect the disclosed improvement in the technology. The current claim does not provide a step of medical intervention which applies the judicial exception in a manner which adds more to the claim. The current claims are not acting or using a practical application but are coming up with information of the naturally occurring biomarkers in a naturally occurring sample from patients with ICC. The claims do not have a step of using these higher levels in a manner that imposes a meaningful limit. Thus, the current steps are not acting on or using the judicial exception in a practical application and that the steps are merely coming up with information but not applying that information with medical intervention.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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