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 .
Response to Amendment
The amendment received on 10/28/2025 is acknowledged. Claim 29 and 43 have been amended. Claim 44-45 have been cancelled. Claims 29-43 are currently pending and have been treated on the merits.
Response to Arguments
Applicant argues that the amendment to make the step read “if there is a hemorrhagic risk, administering an anti-DOA compound to said patient, wherein the amount of anti-DOA compound administered to the patient is determined as a function of the amount…” makes the method significantly more than the judicial exception. This argument has been fully considered but is not persuasive as this step is not required to be practiced as it only applies to some patients, i.e. those having a risk. And thus for those without risk the method is not significantly more than the judicial exception. An interview may be beneficial for determining ways to incorporate the abstract idea into a practical application. Applicant may consider amending the claims to specifically be a method of treating patients having hemorrhagic risk.
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 29-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (abstract ideas – mathematical calculations and mental processes) without significantly more.
The claim(s) recite(s) a method for estimating risk. The method recited is a mathematical calculation that results in a further mental designation, i.e. that a patient does or does not have risk. recite active method steps of mixing solutions of enzymes and measuring physical properties, thus the claims are directed to a process (Step 1: Yes).
The claims set forth judicial exceptions which are abstract ideas. Claim 29 sets forth that the method is a method of estimating risk, the abstract idea is the concept of risk as well as the mental steps of comparing values and using mathematical equations. The claim further provides in an optional form that based on the abstract concept of risk, a number maybe calculated, i.e. the amount of an anti-DOA compound. The claim provides enzymatic activity method steps, however this type of enzymatic assay is known in the art and used to assay Factor Xa activity, and are used to obtain the data which is used in the method. The claim further recites using a “universal calibration curve” which is claimed using product by process language, “is obtained by a method comprising steps of”, and thus does not require the active practicing of these method steps, it refers to abstract idea produced from the steps, i.e. the universal calibration curve. Further these steps of analysis can be performed mentally. The claims are directed to a judicial exception (abstract ideas, Step 2A – Yes).
Dependent claims further provide specific mathematical formula, and require the sample which is analyzed to be from certain bodily fluids and the DOA and anti-DOA, as well as identifying patients. Claims 44 and 45 further describe that anti-DOA compound is administered; however, the claims do not provide an active step of administration, only a determination of an amount.
The judicial exceptions are not integrated into a practical application. Claim 29 requires are mixing solutions of enzymes, labeled substrates of the enzymes having a detectable physical property and the enzyme that can be used in the instant methods. The additional limitations in claim 29 are used to obtain the data which is a data-gathering step, mathematical calculations on how to plot the gathered data on a graph and the types of inhibitors that can be assayed using the calibration curves obtained in the instant method. Further, the additional limitations are recited at a high-level of generality and does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claims do not include any additional elements that are sufficient to amount significantly more than the judicial exception. The claims do recite active method steps of mixing enzymes and labeled substrates of enzymes and measuring the physical properties of the labels. The claims also recite the enzyme, different inhibitors and the different substrates that can be used in the instant methods to obtain the data. However, the enzyme, inhibitors and substrates and methods to create calibration curves are well known, routine and conventional activities in the art before the filing of the instant invention. Hoffman (EP 2818871; Applicant IDS) teaches methods and apparatus for universal calibration of anti-Factor Xa tests using analyzing units that can perform mixing of samples and/or reagents (see abstract, par. [0057]). Hoffman teaches quantifying factor Xa inhibition by mixing two reagents, enzyme Factor Xa and a peptide substrate with a detectable label (chromogen or fluorophore) that is released when the substrate is split by factor Xa (see par. [0009]). Hoffman teaches preparing universal calibrator samples for blood coagulation factor inhibitors such low molecular weight heparin, unfractionated heparin, danaparoid, rivaroxaban, pentasaccharide and apixaban (see [0027]). Similarly, Trevigen (Colorimetric assay kit, Cat# 4677-096-K; Applicant IDS) teaches colormetric kits to assay for inhibitors of PARP (an enzyme). Trevigen teaches plotting the PARP standard curve by serially diluting the PARP-HSA standard (the colorimetric substrate) in different mixtures. Bauer et al. (Comp. Clin. Pathol., 2012, 21:1605-1616/IDS submitted) teaches performing coagulation screening tests using commercial reagents including chromogenic substrate MAPA-Gly-Arg-p-nitroaniline (pNA) to assay for anti-factor Xa activity (see pg. 1608 col. 1 Coagulation times, anti-FXa activity and AT). The method provides for treatment for patients with elevated risk; however, such steps are not practiced for patients that aren’t at risk. The claims limit the different types of enzymes, chromogenic substrates and coagulation factor inhibitors that can be used in the instant methods; however, these are routine, conventional and well-understood as discussed above, and they do not add “significantly more” to the claimed method (Step 2B – No).
Therefore, the instant invention recited in claims 29-43 are not patent eligible under 35 U.S.C. 101.
An interview may be beneficial to applicant to discuss how the abstract idea may be integrated into a practical application.
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.
/CHARLES Z CONSTANTINE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657