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 .
Applicant’s amendments and remarks filed on 08/05/2026 have been fully considered.
Claims 1-7 and 10 are pending for examination. Claims 8-9 are cancelled.
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 1-7 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-7 and 10 recite a method, which fall within one of statutory categories (i.e. process) (Step 1: YES).
Step 2A Prong One analysis: Claim 1 recites “acquiring a first derivative V(i) of a coagulation reaction up to a latest measurement point… calculating areas under the curve (AUCs) before the peak (pre-peak AUC) and after the peak (post-peak AUC) of V(i)… detecting cVmax(k) as Vmax which is a true maximum value of V(i)… calculating a blood coagulation time of the subject blood specimen based on k corresponding to the true maximum value Vmax, under a condition where the Vmax is detected” and claims 2-7 and 10 recite additional calculation steps or parameters or conditions. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations and/or mental process, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claims 1-7 and 10 do not recite any element(s). This judicial exception is not integrated into a practical application because the recited “measuring a blood coagulation reaction of a subject blood specimen (claim 1)” and “obtaining the coagulation reaction up to the latest measurement point as a reaction P(i) (Claim 8)” are considered as data gathering steps to be insignificant extra-solution activity. The abstract idea (mental process) is directed as “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea” (see MPEP 2106.04(a)(2).III.B). (Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no element(s) is/are recited. The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation/ analysis (Step 2B: No). Dependent claims do not recite additional elements/ features and do not add significantly more (i.e. an “inventive concept”) to the exception.
For these reasons, there is no inventive concept in the claims, and thus claims 1-7 and 10 are ineligible.
Response to Arguments
Applicant’s arguments, see page 9 of Remarks, filed on 08/05/2026, with respect to claims 1-10 have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-10 has been withdrawn.
Applicant's arguments filed on 08/05/2026 have been fully considered but they are not persuasive. In regard to the 35 USC 101 rejection, applicant first alleged that the claims do not recite a mathematical concept. In response, the claims contain mathematical relationships/ calculations. The applicant also mentioned example 38 of the 2019 Revised Guidance, however the recited claims are not even related/ similar to the claims of example 38. Secondly, applicant alleged that the claims are not directed to mental process because a person cannot practically measure a blood coagulation reaction of a subject blood specimen and perform the calculations. In response, it is noted that “measuring a blood coagulation reaction of a subject blood specimen (claim 1)” and “obtaining the coagulation reaction up to the latest measurement point as a reaction P(i) (Claim 8)” are considered as data gathering steps to be insignificant extra-solution activity (see above). MPEP 2106.04(a)(2).III.B indicates “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea”. Thus the claims are also directed to “mental process”. Third of applicant alleged that the claims are directed to a “practical application” and “significantly more” due to technical improvement. In response, the improvement cannot be within the judicial exception by itself, according to MPEP 2106.05(a), “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The claims do not recite any element(s). If the invention comprises any element with detail/ sufficient structure(s) and associated step(s) for measuring the blood coagulation reaction of a subject blood specimen, these features should be set forth in the claims. Thus, the 35 USC 101 rejection is maintained for the reasons of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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