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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1, 3-23) and Species A-2 (Claims 14-16) in the reply filed on 11/19/2025 is acknowledged. Claims 1, 3-12, 14-16, and 18-23 are therefore pending.
Claims 13, 17, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-12, 14-16, 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shibata et al (US 2013/0047711) in view of Kimura et al (US 20220003745): WO2020196074A1 (published 10/1/2020).
Regarding claim 1, Shibata et al teach a specimen analyzer for analyzing an analyte in a specimen, the specimen analyzer comprising:
a measurement unit including a first reagent container storing a first reagent (Fig. 5: stain fluid supplied to C1; Para. 0065: reaction chambers C1 to C5 are supplied with stain fluid, hemolytic agent and diluted solution),
a second reagent container storing a second reagent (Fig. 5: stain fluid supplied to C2; Para. 0065: reaction chambers C1 to C5 are supplied with stain fluid, hemolytic agent and diluted solution),
a first reaction chamber configured to prepare a first measurement sample from a first specimen and the first reagent (Fig. 5: reaction chamber C1 for preparing a specimen for analysis ; Para. 0065: reaction chambers C1 to C5 are supplied with stain fluid, hemolytic agent and diluted solution, the "first" or "second" specimen is considered a material worked upon by an apparatus and does not patentably define the claimed apparatus over the prior art (see MPEP 2115) and Shibata is fully capable of using either blood or urine),
a second reaction chamber configured to prepare a second measurement sample from the first reagent and a second specimen different from the first specimen, (Fig. 5: reaction chamber C2 for preparing a specimen for analysis ; Para. 0065: reaction chambers C1 to C5 are supplied with stain fluid, hemolytic agent and diluted solution; Para. 0122 teach blood or urine can be used, the "first" or "second" specimen is considered a material worked upon by an apparatus and does not patentably define the claimed apparatus over the prior art (see MPEP 2115) and Shibata is fully capable of using either blood or urine).
a third reaction chamber configured to prepare a third measurement sample from the first specimen and the second reagent (Para. 0065: reaction chambers C1 to C5 are supplied with stain fluid, hemolytic agent and diluted solution; the "first" or "second" specimen is considered a material worked upon by an apparatus and does not patentably define the claimed apparatus over the prior art (see MPEP 2115) and Shibata is fully capable of using either blood or urine) , and
an optical detector (Fig. 5: D1; Para. 0064: D1 detectors for detecting specimen prepared in the reaction chamber C1-C5) configured
to obtain a first optical signal from the first measurement sample (Fig. 5: D1; Para. 0064: D1 detectors for detecting specimen prepared in the reaction chamber C1-C5),
obtain a second optical signal from the second measurement sample (Fig. 5: D1; Para. 0064: D1 detectors for detecting specimen prepared in the reaction chamber C1-C5), and
obtain a third optical signal from the third measurement sample (Fig. 5: D1; Para. 0064: D1 detectors for detecting specimen prepared in the reaction chamber C1-C5); and
an analysis unit configured to analyze first data corresponding to the first optical signal, analyze second data corresponding to the second optical signal, and analyze third data corresponding to the third optical signal (Para. 0034: information processing unit 4 performs analysis based on the measurement results)
Shibata teach execute analysis of a second measurement item different from the first measurement item with respect to the first measurement sample, through a second analysis operation of processing a first representative value obtained from the first data, the first representative value corresponding to a feature of the analyte, and execute analysis with respect to the third measurement sample, through a third analysis operation of processing a second representative value obtained from the third data, the second representative value corresponding to a feature of the analyte, wherein the second analysis operation and the third analysis operation do not use the Al algorithm, and wherein the first reaction chamber and the second reaction chamber execute, in parallel, preparation of the first measurement sample and the second measurement sample (Para. 0034, 0065: analysis of the measurement unit for different types of analysis).
Shibata is silent to wherein the analysis unit is configured to execute analysis of a first measurement item with respect to the first measurement sample, through a first analysis operation of processing the first data according to an artificial intelligence (AI) algorithm.
Kimura et al teach cell analysis using staining analysis such as WDF to detect different classes of cells such as classification of neutrophil (NEUT), lymphocyte (LYMPH), monocyte (MONO), eosinophil (EO), basophil (BASO), and immature granulocyte (IG) and using deep learning algorithm using matrix data for the cell analysis method (Para. 0227, 0067-0069: AI algorithm; Para. 0160: matrix AI). It is desirable to use deep learning algorithm is order to determine types of cells that cannot be determined by conventional cell analyzer (Para. 0010).
Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the AI algorithm of Kimura et al to the analysis unit of Shibata to provide the above advantage of determining types of cells that cannot be determined by conventional cell analyzer.
Regarding claim 3, Shibata/Kimura teach the second analysis operation, the analysis unit specifies the first representative value from the first data and processes the specified first representative value. (Para. C1 analysis provides the WPC)
Regarding claim 4, Shibata/Kimura teach the second analysis operation, the analysis unit specifies the first representative value from a magnitude of the first data (Kimura: Para. 0227: signal strength were used to generate training data).
Regarding claim 5, Shibata/Kimura teach the first optical signal has a region corresponding to each of analytes in the first specimen, and the analysis unit is configured to specify the first representative value from the first data corresponding to each of the regions of the first optical signal. (Kimura: Para. 0096, 0227: waveform data were used to generate training data including predetermined thresholds and time points at certain intervals).
Regarding claim 6, Shibata/Kimura teach the analysis unit is configured to specify, as the first representative value, a peak value in the region of the first data (Kimura: Para. 00096; 0227: waveform data including peak value were used to generate training data).
Regarding claim 7, Shibata/Kimura teach the first optical signal has a region corresponding to each of analytes in the first specimen, and in the first analysis operation, the analysis unit is configured to input, to the AI algorithm, the first data corresponding to each of the regions of the first optical signal. (Kimura: Para. 00096; 0227: waveform data were used to generate training data).
Regarding claim 8, Shibata/Kimura teach the measurement unit is configured to obtain the first data from a signal that is greater than a predetermined threshold and corresponding to intensity of the first optical signal. (Kimura: Para. 0227: threshold exceeded defined as the measurement start time point).
Regarding claim 9, Shibata/Kimura teach the measurement unit is configured to obtain the first representative value from the first optical signal, and in the second analysis operation, the analysis unit is configured to process the first representative value obtained by the measurement unit. (Kimura: Para. 0096, 0227: waveform data were used to generate training data from the optical signal)
Regarding claim 10, Shibata/Kimura teach the first optical signal is a signal that reflects presence of an analyte in the first specimen (Kimura: Abstract: determining the type of cell for which the signal strength has been obtained).
Regarding claim 11, Shibata/Kimura teach the optical detector includes a light source, a flow cell, and a photodetector, wherein the optical detector is configured to apply light to the flow cell, and detect light generated from analytes in the first and second specimens flowing in the flow cell. (Shibata: Para. 0066: flow cell and an optical detector for performing flow cytometry using a semiconductor laser)
Regarding claim 12, Shibata/Kimura teach the first data and the second data respectively correspond to the first optical signal and the second optical signal obtained while the analyte passes through an application position of the light (Para. 0066: WPC, WDF performed in detector D1).
Regarding claim 14, Shibata/Kimura teach the analysis unit is configured to analyze the first data through a matrix operation according to the AI algorithm (Para. 0160: matrix operation).
Regarding claim 15, Shibata/Kimura teach the analysis unit is configured to execute the matrix operation according to the AI algorithm, through parallel processing performed by a parallel-processing processor (Kimura Para. 0143: parallel arithmetic processing).
Regarding claim 16, Shibata/Kimura teach the analysis unit is configured to execute the first analysis operation by the parallel- processing processor and execute the second analysis operation and the third analysis operation by a host processor of the parallel-processing processor. (Kimura Para. 0143: parallel arithmetic processing).
Regarding claim 18, Shibata/Kimura teach the first reaction chamber is configured to prepare the first measurement sample from the first specimen and the first reagent that is used in order to classify white blood cells in the first specimen (Shibata: Para.0065: WDF analysis in C2) , and the second reaction chamber is configured to prepare the second measurement sample from the second specimen and the first reagent that is used in order to classify white blood cells in the second specimen (Shibata: Para. 0065: C1 white blood cells in WPC).
Regarding claim 19, Shibata/Kimura teach the first reaction chamber is configured to prepare the first measurement sample from the first specimen and the first reagent that is used in order to classify cells in the first specimen into neutrophils, lymphocytes, monocytes, and eosinophils (Shibata para. 0065: WDF channel).
Regarding claim 20, Shibata/Kimura teach analysis of the first measurement sample according to the Al algorithm, the analysis unit is configured to perform classification as to whether or not a cell in the first specimen corresponds to at least either of a nucleated red blood cell and a basophil (Kimura: para. 0072).
Regarding claim 21, Shibata/Kimura teach the analysis unit is configured to classify cells in the first specimen into nucleated red blood cells and basophils through the first analysis operation from the first data obtained from the first measurement sample, and classify cells in the first specimen into neutrophils, lymphocytes, monocytes, and eosinophils through the second analysis operation from the first data obtained from the first measurement sample (Shibata Para. 0065; Kimura Para. 0072).
Regarding claim 22, Shibata/Kimura teach the analysis unit is configured to execute, through the first analysis operation, analysis of the first measurement item with respect to the first measurement sample, and analyze the second measurement item by determining, through the second analysis operation, a type of an analyte that has not corresponded to the first measurement item as a result of the first analysis operation (Shibata Para. 0065: different cells analyzed in the different chambers; Kimura Para. 0072).
Regarding claim 23, Shibata/Kimura teach the analysis unit is configured to execute, through the second analysis operation, analysis of the second measurement item with respect to the first measurement sample, and analyze the first measurement item by determining, through the first analysis operation, a type of an analyte that has not corresponded to the second measurement item as a result of the second analysis operation. (Shibata Para. 0065: different cells analyzed in the different chambers; Kimura Para. 0072)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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