DETAILED ACTION
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
101 Rejection
The previously set forth 101 rejection has been withdrawn based on applicant’s filed amendments to claim 1 that integrate the abstract idea into a practical application.
112 Rejections
The 112(a) and (b) rejections of claim 12 are moot based on the cancellation of claim 12.
102/103 Rejection
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-5, 7, 8, 10-11 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.
With respect to claim 1, the examiner is unsure how “k represents a series of integers from 1 to n, n denotes an integer equal to or larger than 2” is considered to be a series of integers. A description of quantity or a sequence is a list of numbers in a specific order or pattern, such as 1, 3, 5, 7, 9. If n=2, then there are only two integers and therefore, not a quantity or a sequence of numbers in a specific order or pattern. The examiner is unclear regarding the scope of the claim 1.
Claim 2, line 2 recites limitations in parathesis. The examiner is unsure if this portion is positively recited. To further prosecution, the examiner has interpreted the claim that this portion is positively recited, however, clarification is required.
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, 2-4, 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 k represents a series of integers from 1 to n, n denotes an integer equal to or larger than 2, and 0 <Xk<Vmax (as Kawabe teaches selecting points, before and after, to aid in selecting a maximum value; [0007]); 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 the Xk is specified by Vmax x Sk%, wherein Sk ranges from 0.5 to 99 (Note: insofar as what is positively recited, Vmax is capable of being x Sk%, wherein Sk ranges from 0.5 to 99, as Vmax is dependent of the data collected and therefore, capable of being x Sk%, wherein Sk ranges from 0.5 to 99.
With respect to claim 3, Kawabe teaches the method further comprising calculating statistics thereof (as Kawabe teaches calculating a weighted average value using points on the curve; [0025]).
With respect to claim 4, Kawabe teaches the method further comprising 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); 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) insofar as what is positively recited).
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.
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.
/MATTHEW G MARINI/ Primary Examiner, Art Unit 2853
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