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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 statement (IDS) submitted on 10/03/2025 has been received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and all references are considered except where they were lined through.
Claim Status
The Applicant amended claims 1, 11-14 and 21-22 and noted that no new matter is added. The Applicant cancelled claims 2, 7-8, 10, 15-16, 19-20, 23-24, 26-49 and 52-54. Claims 3-6, 9 and 17 are original. The Applicant previously presented claims 18 and 25. Claims 50-51 remain withdrawn from consideration.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, 17-18, 21-22 and 25 are under examination.
Withdrawn Objections and Rejections
The previous objection to the specification, regarding antecedent basis for the claimed subject matter of DAS, DMARD, MBDA and MTX, is withdrawn in light of Applicant’s amendments of the specification. The Applicant notes that no new matter is added.
The previous objection to claims 13-14 and 21-22, regarding informalities is withdrawn in light of the Applicant’s amendments of claims.
The previous rejection of claims 1 and 11-12 under 35 U.S.C. 112(b), regarding indefiniteness, is withdrawn in light of Applicant’s amendments of claims.
The previous rejection of claims 2, 8 and 15-16 under 35 U.S.C. 101, regarding the claims being directed to at least one judicial exception without significantly more, is withdrawn in light of Applicant’s cancellation of the claims.
The previous rejections of claims 2, 8 and 15-16 under 35 U.S.C. 103, regarding obviousness, are withdrawn in light of Applicant’s cancellation of the claims.
The previous rejections of claims 1, 3-6, 9, 11-14, 17-18, 21-22 and 25 under 35 U.S.C. 103, regarding obviousness, are withdrawn in light of Applicant’s amendments of claims.
The previous rejection of claims 1,3, 6, 11-13, 17 and 22 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10, 14 and 16-17 of U.S. Patent No. US 10,962,552 B2 in view of Curtis et al. (Ann Rheum Dis 2018;77:386–392), is withdrawn in light of Applicant’s amendments of claims.
Maintained Objection
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter of “VECTRA”. See 37 CFR 1.75(d)(1), MPEP § 608.01(o) and MPEP § 608.01(v).
The term “VECTRA” is a registered trademark for a multi-biomarker blood test used to assess rheumatoid arthritis (RA) disease activity. The term “VECTRA” appears in the specification without any description of the trademark.
The use of the term [VECTRATM], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Per MPEP 608.01(v), although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification recites the term “VECTRA” without any indication of what the term could be. Proper correction is required.
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, 17-18 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.
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 PEG” is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims.
Regarding claim 1 of example 43 of the “2019 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 the “2019 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 the “2019 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 the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 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 the “2019 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 “2019 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 the “2019 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 the “2019 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 the “2019 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 the “2019 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 the “2019 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 18, 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 claim 18 does not integrate the judicial exceptions into a practical application. Claim 18 also does not recite limitations that amount to significantly more than the judicial exception.
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 09/25/2025 have been fully considered but they are not persuasive regarding the rejection of claims 1, 3-6, 9, 11-14, 17-18 and 25 under 35 U.S.C. 101 for the following reasons.
Step 2A- prong 1
The Applicant alleged that the claims of the instant application do not recite a judicial exception. The Applicant alleged that to determine that the claim recites a judicial exception, "it is not enough to merely identify a patentineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is 'directed to'." Rapid Litigation Management Ltd v. CellzDirect, Inc., 827 F.3d 1042, 1050 (Fed. Cir. 2016) (emphasis added).
This argument is not persuasive because when the claims are examined as a whole, and the claims are directed to judicial exceptions that are not integrated or significantly more. Unlike the case law of Rapid Litigation Management, claim 1 of the instant application does not improve a process such as preserving hepatocytes and offer instead a mathematical formula to calculate the risk of cardiovascular risk (CVD) in a subject without requiring the Doctor or the skilled artisan to do any action. Thus, claim 1 does not offer much more than the judicial exception itself of an abstract idea of a mathematical calculation of a CVD risk formula without integrating it into a practical application nor is it amounted to significantly more.
The Applicant respectfully contends that the claims are not directed to a mental process, a law of nature, or an abstract idea, but are drawn to methods for assessing and treating rheumatoid arthritis in a subject. Instead, Applicant alleges that independent claim 1 recites multiple steps which cannot be performed in the mind such as "measuring in a sample from the subject protein levels for three or more biomarkers" and calculating a CVD risk score using the recited formula which requires measurement of protein levels to generate the Adjusted MBDA, and separately measuring leptin, TNFR1, and MMP3. These steps cannot be performed in the mind and do not correspond to a law of nature.
This argument is not persuasive because while claim 1 has measurement steps that are not done in the human mind, there is a good portion of steps that are done in the human mind such as “identifying the subject having an inflammatory disease and at risk of CVD”. Also, when measuring the different biomarkers, not much is achieved beyond uncovering a judicial exception of a natural law that will be used in a mathematical formula which is by itself a judicial exception of an abstract idea of a mathematical calculation. Thus, there is no real improvement in the measurements of the biomarkers for example. The measurement steps are directed to simple data gathering steps in order to uncover the judicial exception and therefore cannot be relied upon to provide a practical application or significantly more than the judicial exception itself.
The Applicant alleged that the Examiner has simply identified certain concepts which are allegedly patent ineligible but has not performed an assessment of what the claims are directed to as required under 3 5 USC § 101. It is respectfully noted that the presently claimed subject matter mirrors the facts underlying Illumina. Illumina, Inc. v. Ariosa Diagnostics, Inc., 967 F.3d 1319, 1325 (Fed. Cir. 2020). Specifically, the steps of measuring protein levels to use in the Adjusted MBDA and subsequent CVD risk score calculation render the claims patent-eligible under the standards discussed above. For these reasons, Applicant respectfully requests withdrawal of the rejection as the claims do not recite a judicial exception under step 2A.
This argument is not persuasive because unlike the case law of Illumina, the measured results are not different from the natural products and there isn’t a discovery method for preparing a mixture or product. The instant case is about a mathematical calculation which is by itself a judicial exception.
Also, the claims recite at least one judicial exception, i.e., abstract idea of a mathematical calculation (calculating the cardiovascular disease (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 as noted in the following discussions.
Step 2A- prong 2
The Applicant alleged that if there is a judicial exception of an abstract idea, the judicial exception is clearly integrated into a practical application. First, the Applicant alleged that the claimed methods of the disclosure provide an improvement to the technical field. As noted in the specification, the claimed methods and specific algorithms show superior accuracy over conventional methods for determining CVD risk in patients having inflammatory diseases. The application's numerous examples show the advantages of the claimed methods, especially Example 3 (starting at para. [00448] of the PCT application as published) and Example 4 (starting at para. [00460]). The methods of assessing risk of CVD in a subject having an inflammatory disease claimed herein provide a technical improvement to existing CVD risk assessment as one can determine an appropriate treatment or change in treatment for a subject with greater accuracy and efficiency using readily available clinical data.
This argument is not persuasive because there is no integration of the different judicial exceptions into a practical application. Specifically, the mathematical formula is by itself a judicial exception of an abstract idea of a mathematical calculation. Also, the measured biomarkers are used to uncover a Judicial exception.
Second, the Applicant alleged that the claims as a whole are not a drafting effort designed to monopolize any alleged exception. In particular, the scope of the independent claims is limited by at least calculating the CVD risk score with the specific formula recited. For example, others are not foreclosed from using alternate formulas besides the one listed to CVD risk.
This argument is not persuasive because the Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena, even if the judicial exception is narrow (e.g., a particular mathematical formula such as the Arrhenius equation). See, e.g., Mayo, 566 U.S. at 79-80, 86-87, 101 USPQ2d at 1968-69, 1971 (claims directed to "narrow laws that may have limited applications" held ineligible).
In the instant case, the claims are attempting to claim the judicial exceptions of a natural law, an abstract idea of a mathematical calculation and a mental process; and the measurement steps in the claims are simply data-gathering steps to use in making the judicial exceptions without any integration of the judicial exceptions into a practical application nor significantly more. Thus, the judicial exceptions are not clearly integrated into a practical application in the claims as a whole.
Step 2B:
The Applicant alleged that if the claims recite judicial exceptions, the claims recite “significantly more” than the judicial exceptions. The Applicant alleged that the instant claims provide an inventive concept in the field of cardiovascular disease (CVD) risk assessment. The Applicant further alleged that here, the claimed methods recite or depend from a claim which recites the formula used to calculate the CVD risk score. The Applicant alleged that the prior art only does not disclose or suggest the recited formula used in the present methods. For at least this reason, the presently claimed subject matter, when viewed as a whole, meets the "significantly more" and "inventive concept" thresholds laid out in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) and, therefore, constitutes patent-eligible subject matter.
The argument is not found persuasive because when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court; in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965).
In the instant case, the method of claim 1 is not asking the doctor or skilled artisan to provide an action if the subject has been identified as having an inflammatory disease and at risk of CVD. The claim recites a single additional element in calculating the CVD formula and determining the risk of CVD, 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. Claim 1 of the instant case does not teach providing a specific treatment to lower the CVD risk in a patient.
Thus, the previous rejection of claims 1, 3-6, 9, 11-14, 17-18 and 25 under 35 U.S.C. 101, regarding the claims being directed to at least one judicial exception without significantly more, is maintained and is made final.
Allowable Subject Matter
Claims 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are 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.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678