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 .
Response to Amendment
The Amendment filed 05/26/2026 has been entered. Claims 1-8 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 02/24/2026. New grounds of rejections necessitated by amendments are discussed below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 recites “the sensor monitors, as monitoring objects, the plurality of channels having different properties, concurrently,” and “analogue monitoring data common to the plurality of channels”. The specification discloses the sensor continuously measured the channels and analogue reference data continuously measured by the sensor beforehand before monitoring (paragraph [0008]) and the sensor sends continuously measured analogue data (paragraph [0044]). However, the disclosure is silent on the sensor monitoring the plurality of channels “concurrently”. Additionally, the disclosure is silent on the analogue monitoring data “common to the plurality of channels”. Furthermore, applicant has not pointed out where the new claim limitation is supported (Remarks filed 05/26/2026). See MPEP 2163.04 (I). Therefore the claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-8 are rejected by virtue of their dependency on all of the limitations and the written description issues of claim 1.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Duan et al. (US 20070191990 A1) in view of Bauwens et al. (WO 2019014306 A2) and Kodama (JP 2017133970 A; cited in the IDS filed 08/29/2023; see machine translation).
Regarding claim 1, Duan teaches an automatic analyzer (abstract and Fig. 1 teaches a system for liquid flow sensing and control; paragraphs [0041],[0053]-[0054] teaches a controller programmed for controlling elements; therefore, the system is interpreted as an automatic analyzer), comprising:
a channel through which liquid flows (Fig. 1 and paragraph [0037] teaches conduit 104 through which liquid flows);
a sensor (Fig. 1, liquid flow meter 110) that monitors the channel (paragraph [0037; Fig. 1); and
a control unit (Fig. 1, controller 120 and bubble detection module 124) that determines abnormality in the liquid flowing through the channel based on measurement results of the sensor (paragraph [0039] teaches the bubble detection module analyzes signals from the flow meter for the presence of a bubble prior to passing information to the controller; paragraph [0056] teaches signaling an abnormal or disrupted flow condition where a bubble appears to have become stuck in the sensor conduit; therefore, the controller and bubble detection module determines abnormality, i.e. bubble or disrupted flow condition, in the liquid flowing based on the flow meter measurements),
wherein the control unit determines the channel an abnormality has occurred based on analogue monitoring data continuously measured by the sensor during monitoring and analogue reference data continuously measured by the sensor beforehand before monitoring (paragraph [0038] teaches real-time feedback from the flow meter signal; paragraph [0065] teaches a bubble detection process by comparing received amplitude of signals, i.e. analogue monitoring data continuously measured, to previously received and stored amplitudes, i.e. analogue reference data continuously measured beforehand; paragraph [0067] teaches amplitude of received signal are periodically sampled; paragraph [0067] teaches predetermined value of amplitude during calibration may be employed as a reference).
While Duan teaches abnormality and bubble detection of one channel (Fig. 1 and paragraphs [0037]-0039],[0065]), Duan fails to teach: a plurality of channels through which liquid flows; the sensor that monitors the plurality of channels; the control unit that determines abnormality in the liquid flowing through the plurality of channels based on measurement results of the sensor; wherein the sensor monitors, as monitoring objects, the plurality of channels having different properties, concurrently, and the control unit determines in which of the plurality of channels has an abnormality has occurred based on analogue monitoring data common to the plurality of channels continuously measured by the sensor during monitoring and analogue reference data common to the plurality of channels continuously measured by the sensor beforehand before monitoring.
Bauwens teaches systems for automated processing of samples (abstract). Bauwens teaches a need for automated systems for processing materials and samples (paragraphs [0005]-[0006]). Bauwens teaches input conduits can be attached to a bubble sensor assembly (paragraph [0114], bubble sensor assembly 50), i.e. sensor, that includes a plurality of parallel channels configured to hold respective conduits (paragraph [0114]). Bauwens teaches conduits of different bags can have different colors, i.e. different properties, wherein different colors in the channels of a container assembly facilities proper assembly (paragraph [0134]). Bauwens teaches the system can be configured to direct light to emit light if a bubble is detected by a bubble sensor for a respective conduit (paragraph [0146]).
Kodama teaches an automated analyzer that dispenses a sample and reagent for measurement (paragraph [0001]), and the automatic analyzer can quickly find an abnormal flow path among multiple flow paths through which cleaning liquid flows (paragraph [0006]). Kodama teaches a cleaning mechanism includes a plurality of tubes that form flow paths (paragraph [0003]). Kodama teaches an analysis control unit diagnoses whether there are any abnormalities in the flow paths of each tube, which could be from damage or leakage (paragraph [0085]). Kodama teaches when an input to start calibration, testing, or cleaning is made, a simple diagnosis is made to determine whether there are any abnormalities in the flow paths of cleaning units of the analysis units (paragraph [0085]). Kodama teaches identifying the abnormal flow paths based on pre-set path diagnosis parameters (paragraph [0086]), wherein if a diagnostic quantity is not within an allowable range, the flow path is diagnosed as being abnormal (paragraph [0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the channel, sensor, and control unit of Duan to incorporate Bauwens’s teachings of automated systems with parallel channels and conduits having different properties and a bubble sensor assembly to detect bubbles in parallel conduits (paragraphs [0114],[0134],[0146]) and Kodama’s teachings of an automated analyzer with multiple flow paths and quickly finding an abnormal flow path among multiple flow paths based on pre-set diagnosis parameters (paragraphs [0003],[0006],[0085]-[0096],[0091]) to provide: a plurality of channels through which liquid flows; the sensor that monitors the plurality of channels; the control unit that determines abnormality in the liquid flowing through the plurality of channels based on measurement results of the sensor; wherein the sensor monitors, as monitoring objects, the plurality of channels having different properties, concurrently, and the control unit determines in which of the plurality of channels has an abnormality has occurred based on analogue monitoring data common to the plurality of channels continuously measured by the sensor during monitoring and analogue reference data common to the plurality of channels continuously measured by the sensor beforehand before monitoring. Doing so would have a reasonable expectation of successfully improving flexibility and throughput of the automated analyzer to monitor multiple different channels for abnormalities, therefore improving the capability of the automated analyzer to monitor and process multiple materials and samples as desired by Bauwens (paragraphs [0005]-[0006],[0114]). Furthermore, doing so would have a reasonable expectation of successfully improving throughput and parallel monitoring of a plurality of different channels of the automated analyzer, therefore ensuring quick and parallel or concurrent diagnosis of abnormalities in each channel by the sensor.
Regarding claim 7, modified Duan fails to teach: the automatic analyzer according to claim 1, further comprising: a reaction disc holding a plurality of reaction containers each containing a mixed liquid of a sample and a reagent; and a cleaning mechanism including a plurality of nozzles to discharge a cleaning liquid to the reaction containers, wherein the sensor monitors, as monitoring objects, a plurality of channels connected to the respective nozzles.
Kodama teaches the automated analyzer (Fig. 2) comprises a reaction disc (4) holding a plurality of reaction containers (3) each containing a mixed liquid of a sample and a reagent (paragraph [0017]); and a cleaning mechanism (22) including a plurality of nozzles to discharge a cleaning liquid to the reaction containers (Figs. 3,5-9; paragraphs [0039]-[0043] teaches cleaning tanks with discharge nozzles 25 into which cleaning liquid is supplied; paragraph [0019] teaches cleaning nozzle for cleaning the inside of the reaction vessel after measurement). Kodama teaches diagnosing the presence or absence of abnormality in each flow path of the cleaning liquid (paragraph [0026]). Kodama teaches an analysis control unit diagnoses whether there are any abnormalities in the flow paths of each tube, which could be from damage or leakage (paragraph [0085]). Kodama teaches when an input to start calibration, testing, or cleaning is made, a simple diagnosis is made to determine whether there are any abnormalities in the flow paths of cleaning units of the analysis units (paragraph [0085]). Kodama teaches identifying the abnormal flow paths based on pre-set path diagnosis parameters (paragraph [0086]), wherein if a diagnostic quantity is not within an allowable range, the flow path is diagnosed as being abnormal (paragraph [0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the automatic analyzer of modified Duan to incorporate the teachings of an automated analyzer with a reaction disc and cleaning mechanism and quickly finding an abnormal flow path among multiple cleaning flow paths based on pre-set diagnosis parameters of Kodama (paragraphs [0003],[0006],[0085]-[0096],[0091]) to provide: the automatic analyzer according to claim 1, further comprising: a reaction disc holding a plurality of reaction containers each containing a mixed liquid of a sample and a reagent; and a cleaning mechanism including a plurality of nozzles to discharge a cleaning liquid to the reaction containers, wherein the sensor monitors, as monitoring objects, a plurality of channels connected to the respective nozzles. Doing so would have a reasonable expectation of successfully improving automation, throughput, monitoring of a plurality of channels for cleaning reaction containers, therefore ensuring diagnosis of abnormalities in each channel.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the claimed reaction disc and cleaning mechanism) by known methods with no change in their respective functions (i.e. allowing for automated sample analysis and fluid flow), and the combinations yielded nothing more than predictable results (i.e. providing the claimed reaction disc and cleaning mechanism would yield nothing more than the obvious and predictable result of improving automation, throughput, monitoring of a plurality of channels for cleaning reaction containers). See MPEP 2143(A).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Bauwens and Kodama as applied to claim 1 above, and further in view of Hara et al. (US 20200225254 A1; effectively filed 09/23/2016).
Regarding claim 2, modified Duan fails to teach wherein the sensor monitors, as monitoring objects, the plurality of channels having different diameters.
Hara teaches automatic analyzers (abstract). Hara teaches contamination of the reagent or the sample due to the carry-over may occur when dispensing the next reagent or sample (paragraph [0005]), thereby causing a possibility that an analysis result is not normally determined (paragraph [0038]). Hara teaches the automatic analyzer having higher reliability of analysis performance can be provided on the market by reducing the risk of contamination (paragraph [0042]). Hara teaches the control unit 103 can determine abnormality of the cleaning flow path 106 based upon a difference between a measured value of the pressure sensor 102 and measured values of the probe pressure sensors 111, 112, 113, and 114 of the sample or the reagent (paragraph [0054]). Hara teaches embodiments comprising a plurality of flow paths, wherein the plurality of flow paths may respectively have the same pipe diameter or different pipe diameters (paragraph [0109]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor and the plurality of channels of modified Duan to incorporate the teachings of an automated analyzer that monitors abnormalities in a flow path and an embodiment of a plurality of flow paths with different diameters of Hara to provide: wherein the sensor monitors, as monitoring objects, the plurality of channels having different diameters. Doing so would have a reasonable expectation of successfully improving monitoring for abnormalities of various different channels, such as channels with different diameters.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. channels having different diameters) by known methods with no change in their respective functions (i.e. monitoring channels and allowing for fluid flow), and the combinations yielded nothing more than predictable results (i.e. providing the channels with different diameters would yield nothing more than the obvious and predictable result of monitoring for abnormalities of various different channels). See MPEP 2143(A).
Regarding claim 3, Duan further teaches wherein the sensor is an ultrasonic sensor (paragraph [0012]).
Modified Duan fails to teach: the control unit specifies a range of each of the plurality of channels using a difference in time interval between reflected waves existing in the reference data, and determines in which of the plurality of channels an abnormality has occurred depending on which range a reflected wave belongs to, wherein the reflective wave exists only in the monitoring data.
Duan teaches the flow signal comprises an ultrasonic time-of-flight difference flow signal and determining whether the signal deviates from a prior signal by more than a threshold value, i.e. range; and the magnitude of the ultrasonic time-of-flight difference flow signal may be used in combination with detection of a bubble based upon the ultrasonic flow signal amplitude to provide early detection of the presence of a bubble in the sensor conduit (paragraph [0012]). Duan teaches liquid flow rate can be determined from time difference of ultrasonic signals propagating along a flow direction compared to those propagating against the flow direction to establish a time-of-flight (paragraph [0059]). Duan teaches measuring reflected waves (paragraph [0063]). teaches bubble detection process takes advantage of characteristic time evolution of the detected signal amplitude to detect the presence of the bubble, where time evolution for the detected signals reflects measurements over a particular range of flow rates (paragraph [0064]); wherein bubble detection process may be adapted to reflect the characteristic signature from measurements (paragraph [0064]), which can be compared to stored measurements (paragraph [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit of modified Duan to incorporate the teachings of measuring and comparing ultrasonic time-of-flight difference flow signals with thresholds and stored measurements of Duan (paragraphs [0012],[0059],[0064],[0065]) to provide: the control unit specifies a range of each of the plurality of channels using a difference in time interval between reflected waves existing in the reference data, and determines in which of the plurality of channels an abnormality has occurred depending on which range a reflected wave belongs to, wherein the reflective wave exists only in the monitoring data. Doing so would have a reasonable expectation of successfully improving detection of the presence of an abnormality in each channel based on time-of-flight difference data and predetermined thresholds.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Bauwens and Kodama as applied to claim 1 above, and further in view of Tay et al. (US 20190376013 A1).
Regarding claim 4, modified Duan fails to teach wherein the sensor monitors, as monitoring objects, the plurality of channels including different materials.
Tay teaches a microfluidic device and system for investigating cells (abstract). Tay teaches the device includes a plurality of channels to direct fluids (paragraph [0010]). Tay teaches the multiplexer and controller are configured to deliver different fluid compositions to different channels and their respective wells (paragraph [0026]). Tay teaches a robust and streamed lined automated microfluidic investigations under dynamic conditions where an automated control program guides fluidic supplies to create individual experimentation conditions by supplying different fluid compositions via channels (paragraph [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor and the plurality of channels of modified Duan to incorporate the teachings of an automated device with a plurality of channels including different materials, i.e. different fluid compositions, of Tay (paragraphs [0026],[0053]) to provide: wherein the sensor monitors, as monitoring objects, the plurality of channels including different materials. Doing so would have a reasonable expectation of successfully improving varying of conditions for different experiments for each channel, therefore improving streamed lined automated investigations as discussed by Tay (paragraph [0053]).
Regarding claim 5, Duan further teaches wherein the sensor is an ultrasonic sensor (paragraph [0012]).
Modified Duan fails to teach: the control unit specifies a range of each of the plurality of channels using a difference in signal intensity between reflected waves existing in the reference data, and determines in which of the plurality of channels an abnormality has occurred depending on which range a reflected wave belongs to, wherein the reflected wave exists only in the monitoring data.
Duan teaches the flow signal comprises an ultrasonic time-of-flight difference flow signal and determining whether the signal deviates from a prior signal by more than a threshold value, i.e. range; and the magnitude of the ultrasonic time-of-flight difference flow signal may be used in combination with detection of a bubble based upon the ultrasonic flow signal amplitude to provide early detection of the presence of a bubble in the sensor conduit (paragraph [0012]). Duan teaches liquid flow rate can be determined from time difference of ultrasonic signals propagating along a flow direction compared to those propagating against the flow direction to establish a time-of-flight (paragraph [0059]). Duan teaches measuring signal levels of reflected waves (paragraph [0063]). teaches bubble detection process takes advantage of characteristic time evolution of the detected signal amplitude to detect the presence of the bubble, where time evolution for the detected signals reflects measurements over a particular range of flow rates (paragraph [0064]); wherein bubble detection process may be adapted to reflect the characteristic signature from measurements (paragraph [0064]), which can be compared to stored measurements (paragraph [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit of modified Duan to incorporate the teachings of measuring and comparing ultrasonic time-of-flight difference flow signal amplitudes and levels with thresholds and stored measurements of Duan (paragraphs [0012],[0059],[0064],[0065]) to provide: the control unit specifies a range of each of the plurality of channels using a difference in signal intensity between reflected waves existing in the reference data, and determines in which of the plurality of channels an abnormality has occurred depending on which range a reflected wave belongs to, wherein the reflected wave exists only in the monitoring data. Doing so would have a reasonable expectation of successfully improving detection of the presence of an abnormality in each channel based on signal amplitudes or levels of time-of-flight difference data and predetermined thresholds.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Bauwens and Kodama as applied to claim 1 above, and further in view of Braig et al. (US 20070179436 A1).
Regarding claim 6, modified Duan fails to teach: wherein the sensor is an optical sensor, and monitors, as monitoring objects, the plurality of channels having different transparencies, and the control unit determines in which of the plurality of channels an abnormality has occurred depending on the degree of attenuation of intensity of transmitted light.
Duan teaches attenuation of a signal due to a bubble (paragraph [0063]).
Braig teaches a system for analyzing bodily fluid (abstract). Braig teaches the system includes bubble sensors, including ultrasonic and optical sensors (paragraph [0138]). Braig teaches a bubble detector may operate on the principle that the air is clear and hence when an air bubble pass by a detector, a maximum amount of light would be transmitted, while blood is darker than air and a minimum amount of light would be transmitted; wherein bubble detectors are very well known in the art and many types can be employed (paragraph [0508]).
Since Braig teaches ultrasonic and optical sensors and their functions are well known in the art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor of modified Duan to provide: wherein the sensor is an optical sensor, and monitors, as monitoring objects, the plurality of channels and the control unit determines in which of the plurality of channels an abnormality has occurred depending on the degree of attenuation of intensity of transmitted light. Doing so would have a predictable result of allowing for determining of an abnormality, e.g. bubbles, in the channels based on transmission of light. See MPEP 2413(I)(B).
Modified Duan fails to teach: the plurality of channels having different transparencies.
Bauwens teaches systems for automated processing of samples (abstract). Bauwens teaches input conduits can be attached to a bubble sensor assembly that includes a plurality of parallel channels configured to hold respective conduits (paragraph [0114]). Bauwens teaches conduits of different bags can have different colors, i.e. transparencies, wherein different colors in the channels of a container assembly facilities proper assembly (paragraph [0134]). Bauwens teaches the system can be configured to direct light to emit light if a bubble is detected by a bubble sensor for a respective conduit (paragraph [0146]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of channels of modified Duan to incorporate the teachings of automated systems with conduits and bubble sensors, where conduits have different colors of Bauwens (paragraphs [0114],[0134],[0146]) to provide: the plurality of channels having different transparencies. Doing so would have a reasonable expectation of successfully improving differentiation between different channels for improved assembly and analysis.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Bauwens and Kodama as applied to claim 1 above, and further in view of Kishioka et al. (US 20190265187 A1).
Regarding claim 8, Duan fails to teach: the automatic analyzer according to claim 1, further comprising: a flow-type electrolyte analysis mechanism using an ion selective electrode, wherein the electrolyte analysis mechanism includes a dilution bottle containing a diluted solution, and a reference electrode liquid bottle containing a reference electrode liquid, and the sensor monitors, as monitoring objects, a channel connected to the dilution bottle and a channel connected to the reference electrode liquid bottle.
Duan teaches the system for use with a variety of types of liquid flow measurement systems (abstract).
Kodama teaches an analysis control unit diagnoses whether there are any abnormalities in the flow paths of each tube, which could be from damage or leakage (paragraph [0085]). Kodama teaches when an input to start calibration, testing, or cleaning is made, a simple diagnosis is made to determine whether there are any abnormalities in the flow paths of cleaning units of the analysis units (paragraph [0085]). Kodama teaches identifying the abnormal flow paths based on pre-set path diagnosis parameters (paragraph [0086]), wherein if a diagnostic quantity is not within an allowable range, the flow path is diagnosed as being abnormal (paragraph [0091]).
Kishioka teaches an automated analyzer for flow electrolyte measurement (paragraph [0015]; abstract). Kishioka teaches a flow-type electrolyte analysis mechanism (Fig. 1) using an ion selective electrode (ion selective electrode unit 110), wherein the electrolyte analysis mechanism includes a dilution bottle (151,152) containing a diluted solution (paragraph [0041],[0045]), and a reference electrode liquid bottle (161,162) containing a reference electrode liquid (paragraph [0038]); and a channel connected to the dilution bottle (Fig. 1) and a channel connected to the reference electrode liquid bottle (Fig. 1). Kishioka teaches ion measurement of a sample is widely used in the field of analysis where a flow ion selective electrode is provided with a detection unit in a flow path and ion concentrations of samples can be qualified continuously (paragraph [0002]). Kishioka teaches known problems in the art of sample measurement and discusses the invention provides a simplified device (paragraphs [0011]-[0013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the automated analyzer of Duan to incorporate Duan’s teachings of the system for use with a variety of types of liquid flow measurement systems (abstract), Kodama’s teachings of diagnosing whether there are any abnormalities in the flow paths of each tube, which could be from damage or leakage (paragraphs [0003],[0006],[0085]-[0096], [0091]), and Kishioka’s teachings of analyzing ion concentrations of samples using a flow-type electrolyte analysis mechanism (Fig. 1; paragraphs [0002], [0038],[0041],[0045]) to provide: the automatic analyzer according to claim 1, further comprising: a flow-type electrolyte analysis mechanism using an ion selective electrode, wherein the electrolyte analysis mechanism includes a dilution bottle containing a diluted solution, and a reference electrode liquid bottle containing a reference electrode liquid, and the sensor monitors, as monitoring objects, a channel connected to the dilution bottle and a channel connected to the reference electrode liquid bottle. Doing so would have a reasonable expectation of successfully improving analysis of samples for known parameters, e.g. ion concentrations, and improving diagnosing abnormalities in the channels of the analyzer.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the claimed flow-type electrolyte analysis mechanism and sensor) by known methods with no change in their respective functions (i.e. analyzing a sample and monitoring abnormalities in channels of the analyzer), and the combinations yielded nothing more than predictable results (i.e. providing the combination of the automatic analyzer with the flow-type mechanism would yield nothing more than the obvious and predictable result of enabling improved sample analysis for ions while diagnosing any abnormalities in the channels of the analyzer). See MPEP 2143(A).
Response to Arguments
Applicant’s arguments, see page 5, filed 05/26/2026, with respect to the claim objections and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The claim objections and rejections under 35 U.S.C. 112(b) of 02/24/2026 has been withdrawn.
Applicant’s arguments, see pages 5-7, filed 05/26/2026, with respect to the rejection(s) of claims 1-8 under 35 U.S.C. 103, specifically regarding claim 1, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Duan et al. (US 20070191990 A1) in view of Bauwens et al. (WO 2019014306 A2) and Kodama (JP 2017133970 A; cited in the IDS filed 08/29/2023; see machine translation).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Remarks, pages 6-7, “plurality of flow paths are monitored simultaneously by a single sensor…”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Note that the BRI of “sensor” of claim 1 can include the interpretation of the sensor comprising multiple sensor elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Manz et al. (US 6540896 B1) teaches microfluidic devices that including multiple parallel channels (abstract). Manz teaches a sensor is an optical sensor or sensor array, that is capable of detecting signals from all of the analysis channels simultaneously or substantially contemporaneously; and examples of such detectors are capable of imaging or otherwise detecting optical signals from multiple parallel channels, simultaneously (column 10, lines 48-54).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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