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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/28/2021. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
The current 35 USC 101 analysis is based on the current guidance (Federal Register vol. 79, No. 241. pp. 74618-74633). The analysis follows several steps. Step 1 determines whether the claim belongs to a valid statutory class. Step 2A prong 1 identifies whether an abstract idea is claimed. Step 2A prong 2 determines whether any abstract idea is integrated into a practical application. If the abstract idea is integrated into a practical application the claim is patent eligible under 35 USC 101. Last, step 2B determines whether the claims contain something significantly more than the abstract idea. In most cases the existence of a practical application predicates the existence of an additional element that is significantly more.
The 35 USC 101 analysis between each element of claims and its combination is presented in the table below
Claim number and elements
Judicial exception (Step 2A Prong one)
Practical application (Step 2A Prong two)/ Significantly more (Step 2B)
Claim 1
Step 1: Yes, statutory class
Step 2A Prong two: No / Step 2B: No
A data processing device configured to execute the following processes of:
referring to data regarding measurement of a sample by an automatic analyzer;
Step2A Prong one: Yes
“referring to data ~” is insignificant extra-solution activity to gather routine data (the measurement data).
The automatic analyzer is high level of generality.
calculating a combination of values of a plurality of factors based on reaction process data among the data, the factors being predetermined variables or measured values representing characteristics of a reaction;
referring to a correspondence table including a distribution diagram and information regarding an abnormality cause candidate, the distribution diagram including a normal range region and a plurality of abnormal range regions that are generated by a combination of normal/abnormal ranges of the plurality of factors, and the abnormality cause candidate being associated with each of the abnormal range regions;
determining an abnormal range region in the correspondence table to which the combination of the values of the plurality of factors corresponds; and
abstract idea
mental process or mathematical concept
“calculating a combination of values~” is a math process. “a plurality of factors” are mathematical values/concept.
“referring ~” is a math or mental process.
“a correspondence table” is a math concept.
“determining an abnormal range region ~” is a math or mental process.
outputting the information regarding the abnormality cause candidate associated with the corresponding abnormal range region to a user.
“outputting the information~” is insignificant extra-solution activity.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-10 are directed to an abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as addressed below and presented in the above table.
Step 2A: Prong One
Regarding Claim 1, the limitations recited in Claim 1, as drafted, are processes that, under its broadest reasonable interpretation, cover performance of the limitation in the mathematical calculations and/or the mind, as presented in the above table. Nothing in the claim elements precludes the step from practically being performed in the mind and/or the mathematical calculations. For example, “calculating a combination of values of a plurality of factors based on reaction process data among the data, the factors being predetermined variables or measured values representing characteristics of a reaction” in the context of this claim may encompass mathematical calculations by calculating or inferring the combination of values of a plurality of factors based on the data (i.e., routine data) related the sample measurement, where the factors are indicative of mathematical values/concepts. For example, “referring to a correspondence table including a distribution diagram and information regarding an abnormality cause candidate, the distribution diagram including a normal range region and a plurality of abnormal range regions that are generated by a combination of normal/abnormal ranges of the plurality of factors, and the abnormality cause candidate being associated with each of the abnormal range regions” in the context of this claim may encompass manually calculating or inferring the abnormality cause candidate from the table including the distribution diagram and information, where the table including the distribution diagram and information is indicative of a mathematical concept.
Similarly, “determining an abnormal range region in the correspondence table to which the combination of the values of the plurality of factors corresponds” in the context of this claim may encompass manually calculating or inferring the abnormal range region based on the precedent mathematical and/or mental process.
Step 2A: Prong Two
This judicial exception is abstract ideal itself and not integrated into a practical application. In particular, the specification details use of processor to perform mathematical calculations of “calculating a combination of values of a plurality of factors based on reaction process data among the data, the factors being predetermined variables or measured values representing characteristics of a reaction”, “referring to a correspondence table including a distribution diagram and information regarding an abnormality cause candidate, the distribution diagram including a normal range region and a plurality of abnormal range regions that are generated by a combination of normal/abnormal ranges of the plurality of factors, and the abnormality cause candidate being associated with each of the abnormal range regions” and “determining an abnormal range region in the correspondence table to which the combination of the values of the plurality of factors corresponds”. The automatic analyzer is recited at a high-level of generality to merely gather routine data (i.e., data regarding measurement of a sample) of the sample. The limitations of “referring to data regarding measurement of a sample by an automatic analyzer” and “outputting the information regarding the abnormality cause candidate associated with the corresponding abnormal range region to a user” are insignificant extra-solution activities necessary to merely gather data to be used for performing the abstract idea and to merely perform a generic computer function of a generic computer component to output the information. See MPEP 2106.05(g). There is no showing of integration into a practical application such as an improvement to the functioning of a computer, or to any other technology or technical field, or use of a particular machine.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “referring to data regarding measurement of a sample by an automatic analyzer” in the context of this claim is an insignificant pre-solution activity to merely gather data to be used for performing the abstract idea. The limitation of “outputting the information regarding the abnormality cause candidate associated with the corresponding abnormal range region to a user” in the context of this claim are an insignificant post-solution activity to merely perform a generic computer function of a generic computer component to output the information. See MPEP 2106.05(g). As discussed above, with respect to integration of the abstract idea into a practical application, using the processing circuity of the sensor to perform “referring to data regarding measurement of a sample by an automatic analyzer”, “calculating a combination of values of a plurality of factors based on reaction process data among the data, the factors being predetermined variables or measured values representing characteristics of a reaction”, “referring to a correspondence table including a distribution diagram and information regarding an abnormality cause candidate, the distribution diagram including a normal range region and a plurality of abnormal range regions that are generated by a combination of normal/abnormal ranges of the plurality of factors, and the abnormality cause candidate being associated with each of the abnormal range regions”, “determining an abnormal range region in the correspondence table to which the combination of the values of the plurality of factors corresponds” and “outputting the information regarding the abnormality cause candidate associated with the corresponding abnormal range region to a user” amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept cannot provide statutory eligibility. Claim 1 is not patent eligible.
Regarding Claims 2-9, the limitations are further directed to an abstract idea, as described in claim 1. The business operator in claim 3 and the screen in claim 9 are high level of generalities merely recited to perform a generic computer function of a generic computer component. The limitation of “the distribution diagram of the correspondence table is displayed on a screen” in claim 9 is an insignificant extra-solution activity to merely perform a generic computer function of a generic computer component. For the reasons described above with respect to Claim 1, the judicial exceptions are not meaningfully integrated into a practical application, or amount to significantly more than the abstract idea.
Regarding Claim 10, it is a device type claim having similar limitations as of claim 1 above. Therefore, it is rejected under the same rationale as of claim 1 above.
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 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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makino et al. (US 20140356964 A1, hereinafter referred to as “Makino”, US PG Publication of US 9506942 B2 cited in IDS dated 08/12/2024).
Regarding Claim 1, Makino teaches a data processing device (Fig. 1, 50), configured to execute the following processes of:
referring to data regarding measurement of a sample by an automatic analyzer (Fig. 1, the automatic analyzer 1) (Figs. 1-5; Para 0048, “The reaction mixture of the sample and reagent in each reaction cell 11 is measured photometrically every time it passes in front of the photometer 41”);
calculating a combination of values of a plurality of factors based on reaction process data among the data, the factors being predetermined variables or measured values representing characteristics of a reaction (the scattered light)(Fig. 4 and 9; Para 0065; Para 0078, “a concentration calculation unit 501 that calculates concentrations based on the detection signals from the detectors 44, 45A and 45B”);
referring to a correspondence table (Fig. 10, an acceptable fluctuation range table 504) including a distribution diagram and information regarding an abnormality cause candidate, the distribution diagram including a normal range region and a plurality of abnormal range regions that are generated by a combination of normal/abnormal ranges of the plurality of factors, and the abnormality cause candidate being associated with each of the abnormal range regions (Fig. 4 and 9; Para 0064-0066, “diagram explaining a sudden fluctuation (1) at a single point of measurement …. diagram explaining sudden fluctuations (2) at multiple points of measurement … diagram explaining gradual fluctuations throughout the entire reaction process”; Para 0074-0075, “FIG. 7 is a graph showing typical dispersion of normal results of measurement … FIG. 8 is a graph showing typical dispersion of abnormal results of measurement”; Para 0078, “FIG. 9 is an operation flowchart of checks for measurement value abnormalities performed by the automatic analyzer … an acceptable fluctuation range table 504”);
determining an abnormal range region in the correspondence table to which the combination of the values of the plurality of factors corresponds (Para 0078 -0080, “FIG. 9 is an operation flowchart of checks for measurement value abnormalities performed by the automatic analyzer … a fluctuation range calculation and judgment unit 505 … when the checks for measurement value abnormalities are started (step (a)), the determination range judgment unit 502 checks to judge whether the results of concentration calculation”); and
outputting the information regarding the abnormality cause candidate associated with the corresponding abnormal range region to a user (Para 0092, “FIG. 12 is a diagram showing a typical measurement value abnormality alarm display screen … The measurement value abnormality alarm display screen on the display 59 indicates an abnormality level, an alarm description of the nature of the abnormality, the time of occurrence, and details (explanation and countermeasures)”).
Regarding Claim 2, Makino teaches wherein the correspondence table is set such that each of the abnormal range regions or each of the abnormality cause candidates is associated with information regarding a countermeasure (Para 0092, “FIG. 12 is a diagram showing a typical measurement value abnormality alarm display screen … The measurement value abnormality alarm display screen on the display 59 indicates an abnormality level, an alarm description of the nature of the abnormality, the time of occurrence, and details (explanation and countermeasures)”).
Regarding Claim 3, Makino teaches wherein the correspondence table is set in advance as default setting information by a business operator of the automatic analyzer (Para 0086, “FIG. 11 is a schematic diagram showing a typical screen through which default fluctuation ranges are input to check measurement value abnormalities”).
Regarding Claim 4, Makino teaches wherein the correspondence table is updated by displaying information regarding the correspondence table on a screen and adding or modifying the information regarding the abnormality cause candidate based on an operation of the user on the screen (Para 0059, “the operator registers various parameters and samples necessary for analysis and measurement via an operation screen on the CRT display 59”).
Regarding Claim 5, Makino teaches wherein the reaction process data is data representing a time change in absorbance, and as the variable that is one of the factors, a variable configuring an approximate expression of the reaction process data is used (At least paragraphs 0064-0066 and Figs. 3-5 teach points of measurement to show a time change in absorbance during the reaction time).
Regarding Claim 6, Makino teaches wherein the reaction process data is data representing a time change in absorbance, and as the variable that is one of the factors, a mean square error regarding a difference between an approximate expression and an absorbance in the reaction process data is used (At least paragraphs 0064-0066 and Figs. 3-5 teach points of measurement to show a time change in absorbance during the reaction time, where Makino teaches points of measurement to show a difference between an approximate expression and an absorbance).
Regarding Claim 7, Makino teaches wherein the reaction process data is data representing a time change in absorbance, and as the measured value that is one of the factors, a concentration or an activity value of a component of the sample is used (At least paragraphs 0064-0066 and Figs. 3-5 teach points of measurement during the reaction time to show a time change in absorbance and a concentration or an activity value of the measurement points during the reaction time).
Regarding Claim 8, Makino teaches wherein the distribution diagram includes the normal range region, a first abnormal range region, a second abnormal range region, and a third abnormal range region that are generated by at least a combination of a normal range and an abnormal range of a first factor and a normal range and an abnormal range of a second factor, the normal range region being configured by the normal range of the first factor and the normal range of the second factor, the first abnormal range region being configured by the normal range of the first factor and the abnormal range of the second factor, the second abnormal range region being configured by the abnormal range of the first factor and the normal range of the second factor, and the third abnormal range region being configured by the abnormal range of the first factor and the abnormal range of the second factor (At least paragraphs 0064-0066, and Figs. 4 and 7-9 teach the distribution diagram explaining a sudden fluctuation normal and abnormal results of measurements).
Regarding Claim 9, Makino teaches wherein the distribution diagram of the correspondence table is displayed on a screen (Para 0092, a diagram showing a typical measurement value abnormality alarm display screen given by the embodiment of the present invention. The measurement value abnormality alarm display screen on the display 59 indicates an abnormality level”).
Regarding Claim 10, it is device type claim and has similar limitations as of a part of claim 1 above. Therefore, it is rejected under the same rationale as of claim 1 above.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ishii et al. (US 20150198579 A1) teaches a data processing device for processing data acquired in measurement of a sample, where an abnormality judgment unit 103a which judges the presence/absence of an abnormality in a measurement value of each measurement item on the basis of an approximation formula and approximation formula parameters stored in an approximation formula storage unit 12a; and a factor judgment unit 103b which refers to the results of the judgment by the abnormality judgment unit 103a in a preset order.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BYUNG RO LEE whose telephone number is (571)272-3707. The examiner can normally be reached on Monday-Friday 8:30am-4:00pm.
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/BYUNG RO LEE/Examiner, Art Unit 2858
/LEE E RODAK/Supervisory Patent Examiner, Art Unit 2858