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 .
Claim Rejections - 35 USC § 102
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 1-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Tahara et al. (US 2019/0128907).
Regarding claim 1, Tahara discloses a calibration curve generation method for generating a calibration curve in an automatic clinical analyzer that quantifies a concentration of a component to be measured contained in a specimen, the method comprising:
irradiating, with light, a mixed liquid containing one standard solution in which a concentration of the component to be measured is not zero and also containing a reagent reacting with the component to be measured, thereby measuring a time course in which the component to be measured in the one standard solution reacts (para 46-51, 86-101);
extracting pieces of calibration data which are a plurality of pieces of light amount data in a plurality of different times from a fitting line for time course data representing the time course in which the component to be measured in the one standard solution reacts (para 44-51); and
generating the calibration curve indicating a relationship between the concentration and the light amount data by converting the plurality of different times into a plurality of concentrations of the component to be measured (para 45-47, 86-101).
Regarding claim 2, the calibration curve generation method according to claim 1, wherein the converting the plurality of different times into the plurality of concentrations of the component to be measured includes: generating data for converting photometric points to concentrations representing a relationship between a photometric point for extracting a plurality of pieces of light amount data from the fitting line and the concentration of the component to be measured, the plurality of pieces of light amount data being pieces of light amount data corresponding to pieces of calibration data of a standard solution group having a plurality of known concentrations (para 38); and
converting the time into the concentration by using the generated data for converting photometric points to concentrations (para 38).
Regarding claim 3, the calibration curve generation method according to claim 2, wherein the concentration of the one standard solution corresponds to a concentration of a standard solution having a highest concentration in the standard solution group (para 47).
Regarding claim 4, the calibration curve generation method according to claim 2, wherein the concentration of the one standard solution corresponds to a concentration of a standard solution other than a highest concentration in the standard solution group, and calibration data of a standard solution having a highest concentration is generated by extrapolating the time course data of the one standard solution (para 47).
Regarding claim 5, the calibration curve generation method according to claim 2, wherein the concentration of the one standard solution corresponds to a concentration of a standard solution of any one of the standard solution group, and in a case where, both the concentrations thereof are different from each other, concentrations of all standard solutions of the standard solution group are corrected by using the concentration of the one standard solution used when the calibration curve is generated (para 116).
Regarding claim 6, the calibration curve generation method according to claim 2, wherein, in the converting the plurality of different times into the plurality of concentrations of the component to be measured, pieces of separately acquired ones of the data for converting photometric points to concentrations are read out to the automatic clinical analyzer and are used (para 91-95).
Regarding claim 7, the calibration curve generation method according to claim 6, wherein the data for converting photometric points to concentrations is stored in an external storage medium (para 49, 87).
Regarding claim 8, the calibration curve generation method according to claim 2, wherein, in the converting the plurality of different times into the plurality of concentrations of the component to be measured, the data for converting photometric points to concentrations inputted on a user interface is used (input interface 5, para 41).
Regarding claim 9, the calibration curve generation method according to claim 2, wherein light amount data obtained by actually measuring a standard solution having a zero concentration is used for light amount data corresponding to a standard solution in which the component to be measured has a zero concentration among the plurality of pieces of light amount data (fig. 8 shows zero concentration).
Regarding claim 10, the calibration curve generation method according to claim 1, wherein the calibration curve is generated by a tool independent of the automatic clinical analyzer (analysis circuitry 3 generates the calibration data, and executes programs stored in the storage circuitry 8 which is a separate structure).
Regarding claim 11, the calibration curve generation method according to claim 1, further comprising: performing error check by comparing the generated calibration curve with calibration curve data acquired in the past; and reporting an error for the generated calibration curve and displaying a screen for selecting whether or not to use the calibration curve in a case where the error is deviated from a configured threshold in the error check (para 164).
Regarding claim 14, a non-transitory storage medium storing thereon a calibration curve generation program causing a computer to execute processing of generating a calibration curve in an automatic clinical analyzer that quantifies a concentration of a component to be measured contained in a specimen (para 39,49), the program causing the computer to execute:
irradiating, with light, a mixed liquid containing one standard solution in which a concentration of the component to be measured is not zero and also containing a reagent reacting with the component to be measured, thereby measuring a time course in which the component to be measured in the one standard solution reacts (para 46-51, 86-101);
extracting pieces of calibration data which are a plurality of pieces of light amount data in a plurality of different times from a fitting line for time course data representing the time course in which the component to be measured in the one standard solution reacts (para 44-51); and
generating the calibration curve indicating a relationship between the concentration and the light amount data by converting the plurality of different times into a plurality of concentrations of the component to be measured (para 45-47, 86-101).
Response to Arguments
Applicant's arguments filed 12/9/26 have been fully considered but they are not persuasive. Applicant argues, “On the other hand, Tahara requires "a plurality of standard samples each containing a detection target in a known concentration" as defined in claim 1 of Tahara and shown in paragraph [0124] and Figs. 11 and 12 of Tahara. Using Tahara's method, it is not possible to generate a calibration curve with just a single standard solution that is equivalent to a calibration curve generated using a plurality of standard solutions each with a different known concentration.” Claim 1 does not specifically claim detection of unknown component concentration. Claim 1 was rejected based upon target concentration detection, generation of calibration curved based upon the detected target concentration and the light amount data by converting the plurality of different times into a plurality of concentrations of the target component to be measured. Claim 1 does not distinguish a component to be measured contained in a specimen from a known or unknown component to be detected.
Applicant argues, “The above referenced feature allows for the generation of a calibration curve using a single standard solution (with a known concentration) that is equivalent to a calibration curve generated using multiple standard solutions each with a different known concentration. This is advantageous because it allows for the reduction of reagent consumption and reduction of time to generate calibration curves.” Claim 1 does not specifically claim detection of unknown component concentration. Claim 1 was rejected based upon target concentration detection, generation of calibration curved based upon the detected target concentration and the light amount data by converting the plurality of different times into a plurality of concentrations of the target component to be measured. Claim 1 does not distinguish a component to be measured contained in a specimen from a known or unknown component to be detected.
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 SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758