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 .
DETAILED ACTION
Response to Amendment
Applicants’ amendment of the claims filed 10 December 2025 has been entered. Applicants’ remarks filed 10 December 2025 are acknowledged.
Claims 1-17, 19, 21-29, 32-36, 40 and 42-44 are cancelled. Claims 18, 20, 30-31, 37-39 and 41 are pending and under examination.
Claim Rejections Maintained
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.
Amended claims 18, 20, 30-31, 37-39 and 41 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding Step 2A-Prong 1, Applicants argue that the claims do not recite a judicial exception. Applicants argue that the claims are not directed to a law of nature, but are drawn to methods for generating a protein level score (claim 18), for providing a quantitative measure of PsA disease activity (claim 30), and for recommending a therapeutic regimen in a subject previously diagnosed with PsA (claim 37). Applicants argue that each independent claim involves obtaining protein expression levels from a sample and manipulating the protein expression data to obtain either a protein level score or a disease activity score, and such obtaining and manipulation render the claims directed to significantly more than a law of nature. Applicants also argue that the claims are not directed to an abstract idea because the steps of performing at least one immunoassay on a blood sample to generate protein level data as recited in each of the independent claims cannot be performed in the mind or by a human with pen and paper.
Applicants’ arguments have been fully considered but have not been found to be persuasive.
Step 2A-Prong 1 evaluates whether the claims are directed to a judicial exception, i.e. whether the claims recite a law of nature, natural phenomenon, or abstract idea.
Independent claim 18 recites “combining the protein level data for each protein marker to generate the protein level score, wherein the protein level score correlates with a PsA disease activity in said subject as measured by a body surface area (BSA) assessment”;
independent claim 30 recites “performing at least one immunoassay on a first blood sample from the subject to generate a first dataset … applying an algorithm to said first dataset to determine a first disease activity score, wherein said first disease activity score correlates with a PsA disease activity in said subject as measured by a body surface area (BSA) assessment”; and
independent claim 37 recites: “A method for recommending a therapeutic regimen … comprising: a) performing, at a first time point, a first immunoassay on a first blood sample from the subject to generate a first disease activity score based on a first set of quantitative data, … wherein the first disease activity score correlates with a PsA disease activity in said subject as measured by a body surface area (BSA) assessment; b) performing, at a second time point that is a time period after the first time point, a second immunoassay on a second blood sample from the subject to generate a second disease activity score based on a second set of quantitative data … wherein the second disease activity score correlates with a PsA disease activity in said subject as measured by a body surface area (BSA) assessment; and d) recommending a therapeutic regimen, or modifying an existing therapeutic regimen, based on the difference between the first and second disease activity scores”.
As shown above (particularly the underlined portions), the independent claims recite the correlation between the expression levels of the protein markers in a biological/blood sample obtained from a subject diagnosed with psoriatic arthritis (PsA) and the disease activity in the subject. This type of correlation is a consequence of natural processes, i.e., a law of nature. Applicants cites Illumina, Inc. v. Ariosa Diagnostics, Inc., 967 F.3d 1319, 1325 (Fed. Cir. 2020) for support of the arguments, however, the instant case is not analogous to Illumina because the claims in Illumina do not recite a judicial exception.
Further, the claims recite the steps of analyzing, evaluating, and recommending a therapeutic regimen, e.g., “applying an algorithm to said first dataset to determine a first disease activity score”, and “recommending a therapeutic regimen, or modifying an existing therapeutic regimen”. These are types of mental processes, which also belong to a judicial exception, i.e., an abstract idea.
Since the claims recite a judicial exception (i.e., an abstract idea, a law of nature, or a natural phenomenon), the answer to Step 2A-Prong 1 is Yes.
Regarding Step 2A-Prong 2, Applicants argue that even if assuming that the claims are directed to a judicial exception, the judicial exception is integrated fully into a practical application thereof. Applicants argue that the claimed methods provide an improvement to existing assessment methods such that one can determine an appropriate treatment or change in treatment for a subject with greater accuracy and efficiency using readily available clinical data. Applicants argue that the claims as a whole are not a drafting effort designed to monopolize any alleged exception, and the scope of the independent claims is limited by, e.g., the specifically recited protein markers and the steps for obtaining the protein level data.
Applicants’ arguments have been fully considered but have not been found to be persuasive.
Step 2A-Prong 2 evaluates whether the judicial exception is integrated into a practical application. i.e., whether the claims recite additional elements that integrate the judicial exception into a practical application.
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. “One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A, because they are not "directed to" the recited judicial exception.” See MPEP 2106.04(d)(2). Further, “The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s).” (ibid.) In the instant claims, however, there is no additional element that integrates the exception into a practical application (i.e., to apply, rely on, or use the judicial exception). Therefore, the answer to Step 2A-Prong 2 is No.
Regarding Step 2B, Applicants argue that even if assuming that the claims are directed to a judicial exception, the claims are still patent eligible as they provide an inventive concept. Applicants argue that the lack of any present prior art rejection proves that the presently claimed detection technique is not well-understood, conventional, or routine, and it meets the "significantly more" and "inventive concept" thresholds laid out in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
Applicants’ arguments have been fully considered but have not been found to be persuasive.
Step 2B evaluates whether the claims provide an inventive concept. MPEP 2106.05 states: “an “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception” (emphasis added). Further, “patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101” (ibid.). The instant claims do not recite additional element(s) that are sufficient to amount to significantly more than the judicial exception. The additional elements, e.g., detecting the protein levels of the biomarkers using an immunoassay, such as a multiplex assay, are well-understood, routine and conventional to one skilled in the art. These additional elements do not provide an inventive concept, and therefore, the answer to Step 2B is NO.
For the foregoing reasons, the instant claims are directed to non-statutory subject matter.
Double Patenting
Amended claims 18, 20, 30-31, 37-39 and 41 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,656,227.
Applicants indicated that Applicants are prepared to file a terminal disclaimer over U.S. Patent No. 11,656,227, if appropriate in view of the allowed subject matter.
Conclusion
NO CLAIM IS ALLOWED.
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 Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674