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 .
Claim Interpretation
Regarding limitations recited in claims 1-9 which are directed to a manner of operating the disclosed chemical analysis device, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115.
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) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishii et al. (US 2015/0198579 A1, cited in IDS filed 01/30/2024).
Regarding claim 1, Ishii discloses a chemical analysis device including a plurality of reaction cells into which specimens and reagents are dispensed (Fig. 1, see: reaction cells 21), and performs absorbance measurement by a photometric system that emits light onto a mixed liquid of the specimens and the reagents contained in the reaction cell and measures the light passing through the mixed liquid (Fig. 1, see: photometry mechanism 8), the chemical analysis device comprising:
a diagnosis unit that performs failure diagnosis (Fig. 1, see: judgement unit 103), in which the diagnosis unit creates a population of photometric data for failure diagnosis for each predetermined reaction cell, and compares the photometric data of the population of photometric data created for each predetermined reaction cell with a preset threshold to perform failure diagnosis (Fig. 3, see: absorbance data used for abnormality judgement based on a threshold value).
Regarding claim 2, Ishii further discloses the diagnosis unit accumulates time-series photometric data measured using a sample specimen for failure diagnosis and a reagent for failure diagnosis, and creates a population of photometric data for failure diagnosis for each predetermined reaction cell based on the accumulated photometric data ([0025]-[0026], see: storage unit 12 includes a time-variation of a measurement value for each of the measurement items for a sample and reagent of each analysis item).
Regarding claim 3, Ishii further discloses the photometric data to be compared with the threshold is the amount of difference between a measured value and an average value of the photometric data ([0036], see: absorbance data of one measurement or the average of multiple measurements for two types of wavelengths is used to output a difference between the respective absorbance data).
Regarding claim 4, Ishii further discloses the photometric data to be compared with the threshold is a coefficient of variation obtained by dividing a standard deviation of measured values of the photometric data by an average value ([0037], see: approximation parameter calculation uses the existing least-squares method for calculation of the parameter values, minimizing the square error by means of the steepest descent method).
Regarding claim 5, Ishii further discloses the diagnosis unit acquires time-series data of mechanisms that configure the chemical analysis device, and when a failure is determined by comparing the photometric data of the population of photometric data created for each predetermined reaction cell with the preset threshold, estimates the failure location by matching the photometric data with the time-series data of the mechanism ([0032]-[0033], see: determining is abnormality has occurred in a measurement value if an approximation parameter exceeds the threshold value and notifying the operator through the notification unit and display unit).
Regarding claim 6, Ishii further discloses the mechanism configuring the chemical analysis device is a sample dispensing mechanism or a reagent dispensing mechanism, and the time-series data of the mechanism configuring the chemical analysis device is a pressure value in a dispensing path configuring the sample dispensing mechanism or the reagent dispensing mechanism, or a current value during pressure control of a syringe pump ([0046]-[0048], see: reagent pipettor has been judged as an abnormality factor).
Regarding claim 7, Ishii further discloses the mechanism configuring the chemical analysis unit is a stirring mechanism that stirs the specimen and the reagent, and the time-series data of the mechanism configuring the chemical analysis device is a sound pressure value of an output ultrasound of an ultrasonic element configuring the stirring mechanism or a current value when driving the ultrasonic element ([0023], see: piezoelectric element driver controlled by the stirring mechanism).
Regarding claim 8, Ishii further discloses the diagnosis unit accumulates photometric data ([0025]-[0026], see: storage unit 12 includes a time-variation of a measurement value for each of the measurement items for a sample and reagent of each analysis item) and determines a new threshold using the accumulated data ([0032], see: control unit reads out a threshold value from the storage unit).
Regarding claim 9, Ishii further discloses the location and the number of reaction cells used for failure diagnosis are set according to the total number of reaction cells (Fig. 10, see: unit number and cell number).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 5712721254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT J EOM/Primary Examiner, Art Unit 1797
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