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 Arguments
Applicant's arguments filed December 11, 2025 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. 112(b), the Examiner notes that Applicant has amended claim 1 to include a step in which the second mixed specimen is prepared. As such, the Examiner has removed the rejections under 35 U.S.C. 112(b).
With respect to the rejections under 35 U.S.C. 101, Applicant has argued that the claims when considered as a whole are not directed to an abstract idea without significantly more. Specifically, Applicant has argued that the steps of obtaining a blood specimen from a subject, heating the sample, and performing coagulation tests are more than data gathering and mental steps, thus the claims are directed to eligible subject matter. The Examiner respectfully disagrees.
As stated in the previous Office Action, the steps of calculating first and second parameters related to first and second coagulation reaction curves, and determining a measurement of a titer of a coagulation factor inhibitor based on a ratio or difference between the first and second parameters. The calculating steps are abstract ideas in that they can be performed in the human mind, by a person using a pen and paper, or with a generic computer. With respect to the computer, the Examiner notes that mental processes performed on a computer are abstract ideas as performing a mental process on a generic computer, or using a computer as a tool to perform a mental process represents an abstract idea when the computer is presented at a high level of generality (MPEP 2106.04(a)(2) III, MPEP 2106.04(a)(2) C). The determining step is also an abstract idea as it only requires mental analysis of the data generated from the coagulation tests performed on the samples. As such, the Examiner maintains that the claims are directed to an abstract idea. Independent claim 1 does not recite a practical application of the abstract ideas as nothing occurs after the titer of the coagulation factor is determined. As such, the Examiner maintains that the claims do not recite a practical application of the step of determining the titer or a coagulation factor. Additionally, the Examiner maintains that the claims do not provide significantly more as the additional steps are directed to routine data gathering, well-understood, routine, and conventional steps. As set forth in the MPEP, determining the level of a biomarker in blood by any means is considered as well-understood, routine, and conventional activity (MPEP 2106.05(d) II). Additionally, the Examiner has cited reference to Matsuo et al., (US 2008/0183431) for showing that heating a sample prior to acquiring a coagulation reaction curve is known in the art. As such, the Examiner contends that the additional limitations recited in the claims do not provide significantly more than the judicial exceptions. Therefore, based on the arguments provided here, the Examiner contends that the instant claims do not comply with 35 U.S.C. 101 as they are directed to a judicial exception without significantly more.
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) the abstract ideas of calculating first and second parameters related to first and second coagulation reaction curves, and determining a measurement of a titer of a coagulation factor inhibitor based on a ratio or difference between the first and second parameters. The calculating and determining steps are abstract ideas in that they can be performed in the human mind, or by a person using a pen and paper (MPEP 2106.04(a)(2) III). For example, the Examiner notes that the determining step is an abstract idea in that it requires the mental process of considering a ratio or difference between the first and second parameters, and making a mental determination of a concentration of the coagulation factor inhibitor based on the analysis of data pertaining to the first and second parameters. Additionally, the Examiner notes that claims reciting a mental process performed on a computer are abstract ideas as performing a mental process on a generic computer, or using a computer as a tool to perform a mental process represents abstract ideas when the computer is presented at a high level of generality (MPEP 2106.04(a)(2) III, MPEP 2106.04(a)(2) C). As such, the claimed calculations being performed on a processor are nothing more than an abstract idea in that it can be considered as performing a mental process on a generic computer, or using a generic computer as a tool to perform a mental process. Given these views, the Examiner contends that the calculating and determining steps of claim 1 are abstract ideas. This judicial exception is not integrated into a practical application because the claim does not recite any application of the judicial exception after determining a concentration of the coagulation factor inhibitor. Claim 1 does not recite any application with respect to the titer of the coagulation factor inhibitor after it is determined, thus the claim does not provide a practical application of the step of determining the titer of a coagulation factor inhibitor. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps of preparing a mixed sample, heating the mixed sample, and acquiring first and second coagulation curves are routine data gathering, well-understood, routine, and conventional steps that do not provide significantly more. In support of this view, the Examiner points to reference to Matsuo et al., (US 2008/0183431) who teach a sample analyzing method in which a sample is heated (paragraph 0047) prior to acquiring a coagulation reaction curve (paragraph 0058). As such, the Examiner contends that the steps of preparing a mixed sample, heating the mixed sample, and acquiring first and second coagulation curves does not provide significantly more to the instant claims. Therefore, based on the rationale provided above, the Examiner contends that the instant claims do not comply with 35 U.S.C. 101 as the claims are directed to an abstract idea without significantly more.
Conclusion
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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/DWAN A GERIDO/ Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797