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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 is indefinite since it is not clear how a coagulation factor concentration of a subject specimen is determined “based on” the measured blood coagulation time of the subject specimen measured by the method according to claim 1. It is not clear what steps or calculations must be performed in order to transform the blood coagulation time measured in the method of claim 1 into a coagulation factor concentration. Claim 8 is rejected under 35 USC 112(b) based upon its dependency from claim 7.
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 and 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claim(s) recite(s) a method for measuring blood coagulation time comprising acquiring information (i.e. a coagulation reaction P(i) and reaction velocity V(i) as a differential value of the reaction P(i)), and performing different mathematical calculations comprising a calculation start point Te using a ratio of V(i) to maximum reaction velocity and a time Tc according to the equation P(Tc)=P(Te) x N%. This judicial exception is not integrated into a practical application because the claims do not recite any application of the judicial exception (i.e. abstract ideas) after calculating the time Tc as the blood coagulation time. 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 acquiring information (i.e. a coagulation reaction P(i) and reaction velocity V(i) as a differential value of the reaction P(i) and measuring a coagulation factor concentration using the calculated blood coagulation time Tc in the method only amount to data gathering and well-understood, routine and conventional post solution activity.
When considering the claims under the 2019 Revised Patent Subject Matter Eligibility Guidance (January 2019), it is noted that the claims meet step 1 of the guidance since the claims are directed to one of the statutory categories of invention (i.e. are directed to a process). The claims meet prong one of revised step 2A since the claims recite a judicial exception comprising abstract ideas or mental processes including performing several calculations (i.e. a calculation start point Te using a ratio of V(i) to maximum reaction velocity and a time Tc according to the equation P(Tc)=P(Te) x N%). These calculation steps in the claims 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). Claims 1 and 5-6 only recite mathematical calculations, and claims 7-8 recite making a mental determination of a concentration of a coagulation factor based on the calculated blood coagulation time, which all fall under the judicial exception category of abstract ideas. Additionally, the Examiner notes that even if the claims recited performing the calculations and mental analysis steps using a computer or processor, this would also not make the claims patent eligible under 35 US C 101 since performing a mental process or mathematical calculations on a generic computer, or using a generic computer as a tool to perform a mental process or calculation represents abstract ideas when the computer is presented at a high level of generality. See MPEP 2106.04(a)(2) III and MPEP 2106.04(a)(2)(C).
The claims do not meet prong two of revised step 2A since the claims do not recite additional elements that integrate the judicial exception into a practical application, such as an improvement in the functioning of a computer or other technology, effecting a particular treatment or prophylaxis for a disease or medical condition, implementing the judicial exception with a particular machine or manufacture that is integral to the claim, effecting a transformation or reduction of a particular article to a different state or thing, or applying the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. The step of calculating the blood coagulation time Tc in the method (claims 1 and 5-6) constitutes a judicial exception (i.e. is an abstract idea), and the step of measuring a coagulation factor concentration using the calculated blood coagulation time Tc in the method (claims 7-8) is a mental analysis step and/or routine extra-solution activity which is incidental to the primary process and a nominal or tangential addition to the claims. See MPEP 2106.05(g).
The claims also do not meet step 2B of the guidance since the additional elements of the claims concerning acquiring information (i.e. a coagulation reaction P(i) and reaction velocity V(i) as a differential value of the reaction P(i)) (claims 1 and 5-6), and measuring a coagulation factor concentration using the calculated blood coagulation time Tc in the method (claims 7-8) only amount to data gathering, mental analysis steps, and/or well-understood, routine and conventional post solution activity rather than additional steps that provide an inventive concept to confer patent eligibility under 35 USC 101. The step of measuring a coagulation factor concentration using the calculated blood coagulation time is well known, conventional and routine in the prior art, as evidenced by the reference to Suzuki et al (US 2018/0306820) described in the last Office action mailed on October 24, 2025. According to MPEP 2106.05, “An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966)”. Therefore, the elements recited in the claims which are in addition to the judicial exception do not amount to an inventive concept that qualifies as significantly more to the judicial exception. For this reason, the claims are not patent eligible under step 2B of the 35 USC 101 analysis.
Response to Arguments
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive.
The previous rejection of the claims under 35 USC 112(a) made in the last Office action mailed on October 24, 2025 has been withdrawn in view of the amendments made to the claims. Most of the previous rejections of the claims under 35 USC 112(b) made in the last Office action have also been withdrawn in view of the amendments made to the claims. However, claims 7-8 remain rejected under 35 USC 112(b) for the reasons set forth above. The previous rejections of the claims under 35 USC 102(a)(1) and 35 USC 103 as being either anticipated by or obvious over Kishimoto et al (US 4,252,536, submitted in the IDS filed on March 12, 2024) have been withdrawn in view of the amendments made to the claims and Applicant’s persuasive arguments.
Applicant argues the rejection of the claims under 35 USC 101 by stating that the claims are not directed to a law of nature or an abstract idea, but specifically apply the abstract ideas (i.e. calculations) recited in the claims in a specific useful method for measuring blood coagulation using a particular machine (i.e. an automated analyzer) that detects scattered light and performs specific calculations. This argument is not persuasive because the instant claims do not recite any application of the various calculations recited (both a calculation of a coagulation start point Te and a calculation of a blood coagulation time Tc) after performing the calculations. There are no steps of the method recited beyond or after performing both calculations of the coagulation start point Te and the blood coagulation time Tc, and therefore, there is no practical application of the abstract ideas (i.e. the various mathematical calculations) recited in the claims. The claims simply recite a step of calculating the blood coagulation time Tc (claims 1 and 5-6), which constitutes a judicial exception (i.e. is an abstract idea), and a step of measuring a coagulation factor concentration using the calculated blood coagulation time Tc (claims 7-8), which is also a mental analysis step and/or routine extra-solution activity which is incidental to the primary process and a nominal or tangential addition to the claims. See MPEP 2106.05(g). The recitation of performing the method on an “automated analyzer” does not provide a practical application of using a particular machine to perform the judicial exceptions recited in the claims since an automated analyzer is simply a generic apparatus for performing chemical and biological assays that is well-known, understood and routine in the prior art. The use of a generic automated analyzer to perform the method recited in the instant claims does not make the claims patent eligible under 35 US C 101 since performing a mental process or mathematical calculations on a generic automated analyzer, or using a generic automated analyzer as a tool to perform a mental process or calculation represents abstract ideas when the analyzer is presented at a high level of generality. See MPEP 2106.04(a)(2) III and MPEP 2106.04(a)(2)(C). Therefore, the claims do not recite a practical application of the abstract ideas under prong two of revised step 2A of the 35 USC 101 analysis because the claims only recite generic data gathering and mathematical calculations to obtain a blood coagulation time with no further steps of using the calculated blood coagulation time.
Applicant also argues that the claims as a whole are directed to significantly more than a judicial exception (i.e. abstract calculations) under Step 2B of the 35 USC 101 analysis since the claims are directed to a specific improvement over previous methods. This argument is not persuasive since the alleged “improvement” recited in the claims comprises abstract ideas (i.e. mathematical calculations) which are not patent eligible under 35 USC 101. The claims do not meet step 2B of the guidance since the additional elements of the claims beyond the abstract ideas concerning acquiring information (i.e. a coagulation reaction P(i) and reaction velocity V(i) as a differential value of the reaction P(i)) (claims 1 and 5-6), and measuring a coagulation factor concentration using the calculated blood coagulation time Tc in the method (claims 7-8) only amount to data gathering, mental analysis steps, and/or well-understood, routine and conventional post solution activity rather than additional steps that provide an inventive concept to confer patent eligibility under 35 USC 101. According to MPEP 2106.05, “An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966)”. The Examiner maintains that the elements recited in the claims which are in addition to the judicial exception do not amount to an inventive concept that qualifies as significantly more to the judicial exception.
For all of the above reasons, Applicant’s arguments are not persuasive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 March 25, 2026