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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/16/26 has been entered. Claims 1, 4, 11-13, 18, 22 and 24 have been amended. Claims 5 and 7 have been amended. Claims 2, 6 and 10 were previously canceled. Claim 9 remains withdrawn as being directed to a non-elected invention. Accordingly, claims 1, 3-4, 8 and 11-25 are 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Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.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 1, 3-4, 8 and 11-21 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 the sFRP4 in a female human subject with adenomyosis as compared to a reference or to an abstract idea of determining the amount or concentration of sFRP4.
Step 2A, Prong 2
The additional elements of determining the amount or concentration of sFRP4 by contacting the body fluid with at least one antibody that specifically binds to sFRP4 and comparing to a reference 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 recitations “assessing whether the female human patient has adenomyosis”, “monitoring the female human subject”, “wherein an elevated amount or concentration of sFRP4 relative to the reference is indicative of the presence of adenomyosis or the risk of developing adenomyosis in the female human patient” and “wherein a decreasing amount or concentration of sFRP4 relative to the reference is indicative of the therapy being effective, and wherein an unaltered or increasing amount or concentration of sFRP4 relative to the reference is indicative of persisting or recurring adenomyosis”. The “assessing”, “monitoring” and “wherein” statements 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 the value of sFRP4 or observation of the patient and values without any medical intervention. No active method steps are invoked or clearly required; the “assessing” and “monitoring” 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.
With respect to the recitation “selecting a therapy..” (as recited in claim 3). The “selecting” reads on a mental step or thinking of what therapy to use and also allows for verbal communication and does not provide a positive medical intervention of the patient.
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 Schuitemaker et al (US 2018/0059122) it is well known routine and conventional in the art to measure the amount of sRFP4 in a sample by immunoassay and compare it to a reference (e.g. para’s 0004, 0011, 0013, 0025, 0029, 0036, 0052, 0066). As shown by Zanut et al (Nature Communications, May 29, 2020, pages 1-9) it is well known, routine and conventional to use electrochemiluminescence sandwich assays for detecting a desired antigen by using a biotinylated antibody specific for the antigen and an ruthenium labeled antibody also specific for the antigen (e.g. page 7, Fig 5).
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 filed 09/16/26 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues that amended claims 1 and 4 recite the sample is a blood, serum, or plasma sample, and to specify the directional relationship between the determined amount of sFRP4 and the assessment made and that the amended claims apply the recited relationship to achieve a capability that the specification identifies as previously unavailable, namely the assessment of adenomyosis from a blood, serum or plasma sample, without recourse to imaging or to surgical pathology.
This argument is not found persuasive because the directional relationship of the level of sFRP4 in subjects having or at risk of having adenomyosis is the naturally occurring correlation.
Applicant argues that the recited determination is performed in vitro, on a blood, serum, or plasma sample, by contacting that sample with at least one antibody, or antigen-binding fragment thereof, that specifically binds sFRP4.
This argument is not found persuasive because the steps of contacting the sample with at least one antibody, or antigen-binding fragment thereof is considered to be an additional element that does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. As shown by Schuitemaker et al (US 2018/0059122) contacting a sample with antibodies specific for sFRP4 are known and conventional in the art. Thus, the step is considered to be insignificant extra-solution activity for gathering information. The current claim does not provide a particular treatment or prophylaxis which would add more than the judicial exception.
Applicant further argues that the amended claims recite that an elevated amount or concentration of sFRP4 relative to the reference is indicative of the presence of adenomyosis or the risk of developing adenomyosis. Amended claim 4 recites that a decreasing amount or concentration relative to the reference is indicative of the therapy being effective, and that an unaltered or increasing amount or concentration is indicative of persisting or recurring adenomyosis. The claims therefore no longer read on any and all increases, decreases, or equal amounts, and instead tie the recited determination to a specified clinical output. Taken with the recitation of a blood, serum, or plasma sample and of antibody-based in vitro determination, the amended claims impose a meaningful limit that does not preempt the recited relationship.
This argument is not found persuasive because (1) the “wherein” statements 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 the value of sFRP4 or observation of the patient and values without any medical intervention. No active method steps are invoked or clearly required; the “assessing” and “monitoring” 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; and (2) the any and all decreases was part of written description rejection and not 101 rejections; (3) as stated supra the correlation of the recited biomarker in the sample of subjects having or suspected of having adenomyosis is the judicial exception and the detection of the biomarker by the use of antibodies is considered to be an additional element which does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Allowable Subject Matter
Claims 1, 3-4, 8 and 11-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action. The prior art of record does not teach nor fairly suggest detecting the amount or concentration of sFRP4 in blood, serum or plasma by contacting the blood, serum or plasma sample with at least one antibody, or antigen-binding fragment thereof , that specifically binds sFRP4; comparing the amount or concentration to a reference and correlating elevated levels with adenomyosis in the female subject.
Claims 22-25 are considered allowable. The prior art of record does not teach nor fairly suggest providing the blood, serum or plasma sample from the female human patient having adenomyosis; and detecting the level of sFRP4 by contacting the blood, serum or plasma sample with at least one antibody, or antigen-binding fragment thereof , that specifically binds sFRP4.
Conclusion
Claims 1, 3-4, 8 and 11-21.
Claims 22-25 are considered allowable.
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.
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, Gregory Emch can be reached at 571-272-8149. 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.
/GARY COUNTS/ Primary Examiner, Art Unit 1678
