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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/16/26 has been entered.
Response to Arguments
112 Rejections
The 112(b) rejections of claim 1 and 2 are withdrawn based on applicant’s filed amendments.
102/103 Rejection
Applicant argues Kawabe makes no mention or suggestion of obtaining the recited pre-Ave, the post-Ave, the pre-SD, the post-SD, the pre-CV, the post-CV, the pre-post average difference, the pre-post SD ratio, the distortion index, and the peakedness index which are statistics of pk or qk calculated using n-number of pk or qk (where k represents a series of integers from 1 to n).
As an initial point, the claim recites “calculating at least one selected from the group consisting of a pre-Ave, a post-Ave, a pre-SD, a post-SD, a pre-CV, a post-CV, a pre-post average difference, a pre-post SD ratio, a distortion index, and a peakedness index” (emphasis added). Therefore, under the broadest reasonable interpretation, the claim only requires at least one of the argued “statistics”.
As detailed below, Kawabe teaches calculating a peak apex in paragraph [0009], which the examiner considered to read on the claimed “peakedness index.” Notably, the limitations describing the other calculated elements of the “at least one” statement do not further define the examiner's elected alternative.
Further, under the broadest reasonable interpretation of the claim, the peakedness index “representing (sum or average value of Wk with respect to lower part of peak of V(i))/(sum or average value of Wk with respect to upper part of peak of V(i)), Wk representing qk-pk” is not an active step defining the calculation of the peakedness index. Therefore, insofar as what is structurally recited, the peakedness index is capable of representing the sum or average value of Wk with respect to lower part of peak of V(i))/(sum or average value of Wk with respect to upper part of peak of V(i), Wk representing qk-pk insofar as what is positively recited.
The examiner suggests further defining an active step of calculating the argued “statistics” with positively defined calculative steps and involved variables.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 7, 8, 10 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawabe (JP 2019086518A).
With respect to claim 1, Kawabe teaches a method of measuring blood coagulation characteristics of a subject (as read in the abstract), the method comprising: isolating a plasma test sample (i.e. a test sample composed of a reaction liquid containing of plasma a reagent; [0009]) from the blood of the subject (step 1; [0009]), measuring a blood coagulation reaction of the isolated subject plasma test sample (as Kawabe teaches in [0009], a step of acquiring coagulation reaction curve data of the reaction liquid, X axis: reaction time, Y axis: coagulation reaction amount) and acquiring a coagulation reaction curve Ri (step 2; [0009]), where i time (as the X axis is disclosed as time where a coagulation reaction amount is plotted against), of the subject specimen (i.e. the test sample composed of a reaction liquid containing of plasma a reagent; [0009]) and second data for estimating a blood coagulation abnormality factor of the subject (i.e. a reaction rate is considered to read on the claimed “second data”; [0025]), calculating a blood coagulation time from the coagulation reaction curve R(i) (using equation 3; [00025]), obtaining a first derivative V(i) of the coagulation reaction curve R(i) (as para. [00026] details a first derivative is calculated from the curve); determining a point Pk where V(i) assumes Xk before reaching a maximum value of V(i), Vmax, and a point qk where V(i) assumes Xk after reaching Vmax, where Xk is a variable specified by Vmax x Sk%, wherein 0< Sk<100 (S reads as an adjustable percentage coefficient falling within the recited range; [0019]), k represents a series of integers with an increment of 1 from 1 to n, n denotes an integer ranging from 5 to 50, and 0 <Xk<Vmax (as Kawabe teaches selecting points, before and after, to aid in selecting a maximum value; [0007]); calculating at a peakedness index (as Kawabe teaches in [0009] calculating a peak apex), the peakedness index (is capable of) representing (sum or average value of Wk with respect to lower part of peak of V(i))/(sum or average value of Wk with respect to upper part of peak of V(i)), Wk representing qk-pk; as the limitation does not reads as an active step, therefore, the peakedness index is capable of representing sum or average value of Wk with respect to lower part of peak of V(i))/(sum or average value of Wk with respect to upper part of peak of V(i), Wk representing qk-pk insofar as what is positively recited) and performing an estimation of a blood coagulation abnormality factor characteristic of the plasma test sample (as Kawabe teaches using the disclosed method for estimating a blood coagulation abnormality factor characteristic more accurately; [00010]): wherein the method does not comprise combining the isolated plasma test sample with a reference plasma sample (as Kawabe does discloses combining the patient’s plasma with a reagent while not mixing in a reference/normal plasma sample; abstract).
With respect to claim 2, Kawabe teaches the method wherein Sk ranges from 0.5 to 99 (as S being an adjustable percentage coefficient and is taught in [0019] falls into the recited range).
With respect to claim 7, Kawabe teaches the method further comprising a point R(E), E denoting a coagulation reaction end point (as Kawabe discloses a coagulation reaction end point being Te; [0018]; Fig. 1), on the coagulation reaction curve R(i); as determined [0025]).
With respect to claim 8, Kawabe teaches the method, wherein the method comprises continuing measurement of the blood coagulation reaction until an end of the coagulation reaction (as Kawabe teaches measurements occur until coagulation has been reached; [0004]).
With respect to claim 10, Kawabe teaches the method wherein the estimating of the blood coagulation abnormality factor comprises estimating a type of the blood coagulation abnormality factor of the subject specimen (as Kawabe teaches the blood coagulation comprises estimating effects caused by coagulation inhibitor factors; [0002]), and the type of the blood coagulation abnormality factor is a coagulation factor inhibitor [0002]).
With respect to claim 11, Kawabe teaches the method, wherein the estimating of the blood coagulation abnormality factor comprises estimating a presence or absence of the blood coagulation abnormality factor of the subject specimen (as Kawabe teaches determining the presence of coagulation inhibitors, which could indicate hemophilia A conditions; [0002-0003]).
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawabe (JP 2019086518A).
With respect to claim 5, Kawabe et al. teaches all that is claimed in the above rejection of claim 4, but remains silent regarding the blood coagulation reaction analysis method wherein the acquiring of the second data further comprises calculating, as the second data, a standard deviation interval of an objective parameter with respect to the subject specimen, wherein the SDI of the objective parameter with respect to the subject specimen = (α-β) ÷ γ, wherein
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The statistical process of calculating a standard deviation of a data set to indicate how spread-out values are around a mean is a well-known statistical method in engineering. In addition, Kawabe et al. discloses using statistical processing of the data set to understand or determine how “normal” a particular data point is relative to an average of an objective parameter from a subject and reference values.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing the instant invention to derive the claimed equation based on the variables taught in Kawabe et al., as there are only a finite number of predictable solutions, with a reasonable expectation of deriving the claimed equation from the taught variables of the prior art. MPEP 2141 III.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Das et al. (2016/0364536) which teaches using machine learning to predict patient conditions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW G MARINI whose telephone number is (571)272-2676. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephen Meier can be reached at 571-272-2149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW G MARINI/Primary Examiner, Art Unit 2853
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