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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/20/2026 has been entered.
Priority
This application is a continuation of international Patent Application of PCT/US20/22294 filed on 03/12/2020 which claims priority to U.S. Provisional Application 62/929,459 filed on 11/01/2019 and to U.S. Provisional Application 62/818,017 filed on 03/13/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/13/2026 and 04/20/2026 have been received. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner and all references are considered except where they were lined through.
Claim Status
The Applicant amended claims 1 and 25 and noted that no new matter is added. The Applicant cancelled claims 2, 7-8, 10, 15-16, 18-24, 26-49 and 52-54. Claims 3-6, 9 and 17 are original. The Applicant previously presented claims 11-14. Claims 50-51 remain withdrawn from consideration as being drawn to a nonelected invention as noted in the Office action of 03/25/2025.
Thus, claims 1, 3-6, 9, 11-14, 17 and 25 are under examination.
Withdrawn Objections and Rejections
The previous objection to the specification, regarding antecedent basis for the claimed subject matter of “VECTRA”, is withdrawn in light of Applicant’s amendments of the specification.
The previous rejection of claim 18 under 35 U.S.C. 101, regarding the claim directed to at least one judicial exception without significantly more, is withdrawn in light of Applicant’s cancellation of the claim.
Maintained Rejections
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, 3-6, 9, 11-14, 17 and 25 are rejected under 35 U.S.C. 101 because the claimed invention is for a process or a method that is directed to at least one judicial exception without significantly more. The claims recite a mere collection of information in the form of data that is compared to a cutoff value from which the applicant or doctor will be able to predict the possibility of a patient with inflammatory disease of having cardiovascular disease. Such an inference is not sufficient to transform the abstract idea of a mental process (assessing risk of cardiovascular disease (CVD) in a subject with an inflammatory disease), the law of nature (correlating selected biomarkers with CVD risk) and the abstract idea of a mathematical calculation (calculating the CVD risk score for the subject with an interpretation function) into a patentable application.
The claims are ineligible because the claims recite at least one judicial exception, i.e., abstract idea of a mathematical calculation (calculating the CVD risk score for the subject with an interpretation function), an abstract idea of a mental process (assessing risk of cardiovascular disease (CVD) in a subject with an inflammatory disease) and a law of nature (correlating selected biomarkers with CVD risk). Moreover, the claims as a whole do not integrate the judicial exceptions into a practical application nor do they provide an inventive concept.
Furthermore, the step of “recommending a therapy” is not actually a therapeutic step because of the term “recommending”. Also, any therapy appears to be conditional on the test result, and it is also recited at a high level of generality rather than being a specific therapy directed to the disease. Therefore, this limitation does not integrate the judicial exceptions into a practical application. Claim 1 also does not recite limitations that amount to significantly more than the judicial exception.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?)
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03.
Example 43 of 2019 Revised Patent Subject Matter Eligibility Guidance (PEG) is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims (Subject matter eligibility | USPTO).
Regarding claim 1 of example 43 of PEG and per Step 1, the claim is directed to a process, which is one of the statutory categories of invention as the claim recites “A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype; (b) administering a treatment to the patient having a non-responder phenotype.” (Step 1: YES).
Similarly, claim 1 of the instant application is also directed to a statutory class of a method for assessing risk of cardiovascular disease (CVD) in a subject having an inflammatory disease as it recites “measuring in a sample from the subject protein levels for three or more biomarkers … calculating a CVD risk score for the subject using the following formula … identifying the subject having an inflammatory disease and at risk of CVD based on the CVD risk score exceeding a threshold level” (Step 1: YES).
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?)
Regarding claim 1 of example 43 of PEG and per Step 2A, prong 1, the claim recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” and according to broadest reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent phenotype.
Specifically, limitation (a) in claim 1 of Example 43 of PEG recites “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype,” which has a BRI that requires performing an arithmetic calculation (division) in order to obtain the ratio of C11 to C13 levels, and then using this ratio to identify whether the patient has the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or greater and thus is not responding, or will not respond, to glucocorticoids). This limitation therefore recites a mathematical calculation. The grouping of “mathematical concepts” in PEG includes “mathematical calculations” as an exemplar of an abstract idea. PEG Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be practically performed in the human mind, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract ideas.
In addition, limitation (a) describes a naturally occurring relationship between the ratio of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls within the mathematical concept and mental process groupings in PEG, and a law of nature), and the analysis must therefore proceed to Step 2A Prong Two.
Similarly, claim 1 of the instant application recites a judicial exception of “calculating the CVD risk score for the subject with an interpretation function” after measuring the protein levels for three or more biomarkers by using a formula. This limitation therefore recites a mathematical calculation which falls under an abstract idea as noted above in PEG.
Furthermore, claim 1 is also reciting an abstract idea of a mental process of assessing risk of cardiovascular disease (CVD) in a subject with an inflammatory disease “identifying the subject having an inflammatory disease and a risk of CVD based on the CVD risk score exceeding the threshold level, and a law of nature of correlating selected biomarkers with CVD risk “at risk of CVD based on the CVD risk score exceeding a threshold level”.
Accordingly, claim 1 of the instant application recites three judicial exceptions of an abstract idea that falls within the mathematical concept, a mental process and a law of nature, and the analysis must therefore proceed to Step 2A Prong Two.
(Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?)
Regarding claim 1 of example 43 of PEG and per Step 2A, prong 2, the claim as a whole does not integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the abstract idea, claim 1 of example 43 of PEG recites the additional element of “(b) administering a treatment to the patient having a non-responder phenotype”. Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s
phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Thus, limitation (b) of example 43 of PEG fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, limitation (b) of example 43 of PEG does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception.
Similarly, claim 1 of the instant application does not have additional elements that would integrate the judicial exceptions cited above into a practical application. The claim has steps of measuring proteins levels of three or more biomarkers and calculating a CVD risk score for the subject with inflammatory disease using a formula to compare to a threshold level to identify a subject with inflammatory disease of being at risk of having cardiovascular disease, and these steps do not integrate the judicial exception into a practical application because they are data gathering steps to use in the calculation and comparison, which do not add a meaningful limitation to the method as they are insignificant extra-solution activity. These steps do not integrate the judicial exceptions into a practical application because they do not amount to more than the judicial exceptions themselves, analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claims do not act on or use the judicial exceptions in any further steps as required by MPEP 2106.04(d).
Therefore, claim 1 does not integrate the judicial exception into a practical application.
(Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?)
Regarding claim 1 of example 43 of PEG and per Step 2B, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claim recites a single additional element in limitation (b), which does not require any particular application of the recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.
Similarly, claims 1 of the instant application simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, such as measuring the protein levels of three or more biomarkers by an immunoassay (Specification, page 49, [00343]). Furthermore, the claim itself is recited at a high level of generality in which any assay can be used as the measurement method for claim 1.
Thus, claim 1 is not eligible and is rejected under 35 USC 101.
Regarding claim 3, the claim teaches the type of sample to use for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claim 4, the claim teaches the age of the subject for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claim 5, the claim teaches prior history of the subject for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claim 6, the claim teaches the type of inflammatory disease for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claim 9, the claim defines the reference group for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claims 11 and 12, the claims further select biomarkers to use with the method which do not integrate the judicial exceptions into a practical application, nor do they amount to significantly more.
Regarding claim 13, the claim validates the CVD score for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claim 14, the claim calculates the CVD score for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claim 17, the claim teaches how to measure the protein levels of biomarkers for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Regarding claim 25, the claim teaches threshold level for the method which does not integrate the judicial exceptions into a practical application, nor does it amount to significantly more.
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive regarding the rejection of claims 1, 3-6, 9, 11-14, 17 and 25 under 35 U.S.C. 101, as the claims are directed to a judicial exception without significantly more.
The Applicant amended claim 1 to include a treatment recommendation step to overcome the 101 rejection. the step of “recommending a therapy” is not actually a therapeutic step because of the term “recommending”. Also, any therapy appears to be conditional based on the test result. Therefore, this limitation does not integrate the judicial exceptions into a practical application. And claim 1 does not recite limitations that amount to significantly more than the judicial exception itself. Therefore, claims 1, 3-6, 9, 11-14, 17 and 25 are still rejected under 35 U.S.C. 101.
Conclusion
No claims are allowed.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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