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 species A (figures 1-5) in the reply filed on 05/21/2026 is acknowledged.
Claims 10-13 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/21/2026.
Status of Claims
Claims 1-20 remain pending in the application, with claims 1-9, 14-15, 18-20 being examined and claims 10-13 and 16-17 being withdrawn pursuant to the election filed 05/21/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “wherein the processing circuitry is further configured to associate the state of the liquid with a result of a test for a mixture liquid of the sample and the reagent conducted prior to the measuring.” where it is unclear what “conducted prior to the measuring.” is referring to. Is it associating the state of the liquid with a result of a test that is being conducted prior to the measuring, or is it the test that is conducted prior to the measuring?
[0100] of the instant specification recites “More specifically, and for example, the control circuitry 9 associates each abnormal state with the result of a test for a mixture liquid of a sample and a reagent, conducted prior to the measurement of an electrical potential of the washing liquid.”
Therefore, for examination it will be interpreted that it is the test that is conducted prior to the measuring.
It is suggested to amend claim 3 to recite “associate the state of the liquid with a result of a test for a mixture of liquid of the sample and the reagent, the test conducted prior to the measuring.”
Claim 5 recites “provide a notification of one of a plurality of abnormal states” on lines 7-8, where it is unclear if one of a plurality of abnormal states includes the abnormal state described in claim 2, or if the plurality of abnormal states are different from the one described in claim 2.
Further, if the plurality of abnormal states includes the abnormal state described in claim 2, it is then unclear if the notification described in claim 5 is the same or different.
For examination, it will be interpreted that the notification is the same, and that the plurality of abnormal states includes the one described in claim 2.
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.
Claim(s) 1-3, 5-6, 8-9, 14-15, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over translated Nonaka (JP-2015/121427-A) in view of Du (US-2010/0259397-A1) and translated Pang (WO-8606167-A1).
Regarding claim 1, Nonaka teaches an automatic analyzing apparatus (Figure 1) comprising processing circuitry (control unit 104) configured to ([0017], Figure 1):
measure pertaining to a contact between a probe (probe 201) for dispensing a sample or a reagent and a liquid surface, and output as a measurement value ([0022] see CPU 108 calculates the capacitance value around probe 201 acquired from liquid level detection mechanism 202 via liquid level detection ADC 203 (analog to digital converter), Figure 2);
determine whether or not the measurement value is within a specific range, and output a determination result ([0022] see CPU 108 determines whether the appropriate amount of cleaning liquid can be discharged and is appropriate after cleaning it can be determined whether or not a certain amount of cleaning liquid has been discharged, [0039], [0040]); and
provide a notification on a state of a liquid related to the liquid surface according to the determination result ([0032] [0039], [0040], [0041], [0042] all describe various notifications due to sensing of capacitance).
While Nonaka does describe measuring the capacitance to determine the liquid level, this is not an electrical potential.
In the same problem solving area of liquid level detecting, Du teaches a converting unit that receives and converts a capacitance signal from a sampling needle and converts it to a voltage signal (Du; abstract).
Specifically, Du describes that a liquid level detecting device converts capacitance change in the sampling needle into voltage or potential change and determines whether the sampling needle contacts the liquid level based on at least in part on this change in capacitance (Du; [0004]).
Pang teaches that converting a capacitance value into a voltage signal is particularly suitable for further electronic processing (Pang; [0031], and see claim 6 that describes a converter that converts capacitance value to a voltage signal).
It would have been obvious to one skilled in the art to modify the control unit of Nonaka such that it has the conversion unit that converts the measured capacitance into a voltage as taught by Du because it is taught by Pang that converting a capacitance value into a voltage signal is particularly suitable for further electronic processing (Pang; [0031], and see claim 6 that describes a converter that converts capacitance value to a voltage signal).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., adding the conversion unit to the control unit), and that in combination, each element merely would have performed the same function as it did separately (i.e., the conversion unit would still convert capacitance to voltage, the control unit would still measure the changes in incoming singals), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the control unit of reference Nonaka with the conversion unit of reference Du, since the result would have been predictable.
Regarding claim 2, modified Nonaka teaches the automatic analyzing apparatus according to claim 1. Nonaka further teaches wherein the processing circuitry (104) is further configured to provide a notification of a normal state as the state of the liquid if the measurement value is within the specific range, and provide a notification of an abnormal state as the state of the liquid if the measurement value is not within the specific range (Nonaka; [0032], [0037], [0039], [0041], [0042] all describe notifications to the operator of potential errors which would be an abnormal state, [0040] describes where the display outputs that the cleaning liquid has discharged the appropriate amount which would be a normal state).
Regarding claim 3, modified Nonaka teaches the automatic analyzing apparatus according to claim 1. Nonaka further teaches wherein the processing circuitry (104) is further configured to associate the state of the liquid with a result of a test for a mixture liquid of the sample and the reagent conducted prior to the measuring (Nonaka; [0023] see CPU 108 calculates the necessary discharge amount of cleaning liquid from the total amount of the sample and the reagent which is an analysis target which is previously performed in the reaction container 118 for cleaning, where based on this information the CPU calculates the cleaning liquid discharge height position of the probe, [0024] where after probe 201 moves to the cleaning liquid discharge height the cleaning liquid is discharged and the CPU senses the capacitance value until the capacitance value greatly fluctuates which stops the discharge of cleaning liquid, [0025] describes a confirmation process where after the discharge of cleaning liquid is stopped, the probe is lifted up before being lowered again to check for if the capacitance value has a fluctuation that is the same as the peak of capacitance value when the cleaning liquid is discharged to determine if the appropriate cleaning liquid is used).
From the paragraphs of Nonaka above, the total amount of sample and reagent that was previously performed in the reaction container is a result of a test for a mixture liquid, where the confirmation of the cleaning operation by discharging the appropriate amount relates to the state of the liquid, thus the total amount of sample and reagent from the test previously performed is associated with the confirmation of the cleaning operation (where it is later described in [0032] [0039], [0040], [0041], [0042] that these are various notifications on the cleaning operation see claim 1 supra).
Regarding claim 5, modified Nonaka teaches the automatic analyzing apparatus according to claim 2. Nonaka further teaches wherein the processing circuitry (104) is further configured to
compare, if the measurement value is not within the specific range, the measurement value to one or more thresholds to output the determination result (Nonaka; [0027], [0036], [0039] describe capacitance values in relation to a threshold value), and
provide a notification of one of a plurality of abnormal states according to the determination result (Nonaka; [0032] describes a notification that a possibility that the cleaning operation has not been properly performed, [0039] describes where an operator is notified of the possibility of the cleaning liquid amount shortage, [0041] describes a notification where there may be bubbles contained in the liquid container which as discharged the cleaning liquid).
Regarding claim 6, modified Nonaka teaches the automatic analyzing apparatus according to claim 1.
The limitations of claim 6 are directed to the material worked upon by the apparatus, all the structural limitations of the claim have been disclosed by modified Nonaka and the apparatus of modified Nonaka is capable of working on a washing liquid for washing a reaction container. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Nonaka (see MPEP §2115).
Further, please note that the liquid has not been positively recited in the claim, and is therefore not part of the claimed system.
Please note that Nonaka does teach a cleaning liquid discharged into a reaction container and monitoring the amount of cleaning liquid discharged during cleaning (Nonaka; [0016]).
Regarding claim 8, modified Nonaka teaches the automatic analyzing apparatus according to claim 6. Nonaka further teaches wherein the processing circuitry (104) is further configured to provide a notification on a state of a mechanism for preparing the washing liquid, according to the determination result (Nonaka; [0039] where this describes an operator to be notified of the possibility of the cleaning liquid amount shortage, where when the fluctuation of capacitance value is not detected within a predetermined time it is considered that the pump and solenoid valve have a defect, where these two components discharge the cleaning liquid as described in [0024] and thus prepare the cleaning liquid).
Regarding claim 9, modified Nonaka teaches the automatic analyzing apparatus according to claim 2. Nonaka further teaches wherein the processing circuitry (104) is further configured to determine, if the measurement value is not within the specific range, whether or not a number of times of the determining has reached a predetermined number, and provide the notification of the abnormal state if the number of times of the determining has reached the predetermined number (Nonaka; [0039]).
As described in [0039] of Nonaka, in this scenario the CPU 108 detects whether the capacitance value changes within a predetermined time, for example whether the capacitance value becomes equal to or more than a predetermined threshold, where if the capacitance value does not change within a predetermined time the operator is notified of the possibility of the cleaning liquid amount shortage.
One skilled in the art would recognize that the first instance where the capacitance value is not within the predetermined range is indication that the measurement value is not within the specific range, where continuous testing for the capacitance value within a set time period will be testing for this range a specific number of times, and that after the set time if the value still does not meet the specific range outputs the notification.
Please note that under a different interpretation, the capacitance significantly fluctuating before reaching the proper cleaning position described in [0032], the probe detecting a capacitance that does not change within a predetermined time described in [0039], when the peak of fluctuation of the capacitance is smaller than the peak of fluctuation of the capacitance in the liquid amount described in [0041], would all meet the limitations of claim 9 because the number of times that the determining has reached a predetermined number may be one. In other words, the number of times that determining is required is a single time.
Regarding claim 14, modified Nonaka teaches the automatic analyzing apparatus according to claim 1. Nonaka further teaches further comprising
the probe (probe 201) (Nonaka; [0022], Figure 1), and
a liquid level detector (liquid level detection mechanism 202) electrically connected to the probe (201) and configured to detect the contact between the probe (201) and the liquid surface (Nonaka; [0021], [0022], where the control unit 104 is electrically connected to the probe 201 and the liquid level detection mechanism 202 and therefore the probe and detection mechanism are electrically connected).
Regarding claim 15, modified Nonaka teaches the automatic analyzing apparatus according to claim 2.
The limitations of claim 15 are directed to the material worked upon by the apparatus, all the structural limitations of the claim have been disclosed by modified Nonaka and the apparatus of modified Nonaka is capable of working on a washing liquid for washing a reaction container. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Nonaka (see MPEP §2115).
Further, please note that the liquid has not been positively recited in the claim, and is therefore not part of the claimed system.
Please note that Nonaka does teach a cleaning liquid discharged into a reaction container and monitoring the amount of cleaning liquid discharged during cleaning (Nonaka; [0016]).
Regarding claim 18, modified Nonaka teaches the automatic analyzing apparatus according to claim 2. Nonaka further teaches further comprising
the probe (probe 201) (Nonaka; [0022], Figure 1), and
a liquid level detector (liquid level detection mechanism 202) electrically connected to the probe (201) and configured to detect the contact between the probe (201) and the liquid surface (Nonaka; [0021], [0022], where the control unit 104 is electrically connected to the probe 201 and the liquid level detection mechanism 202 and therefore the probe and detection mechanism are electrically connected).
Regarding claim 19, modified Nonaka teaches the automatic analyzing apparatus according to claim 9. Nonaka further teaches further comprising
the probe (probe 201) (Nonaka; [0022], Figure 1), and
a liquid level detector (liquid level detection mechanism 202) electrically connected to the probe (201) and configured to detect the contact between the probe (201) and the liquid surface (Nonaka; [0021], [0022], where the control unit 104 is electrically connected to the probe 201 and the liquid level detection mechanism 202 and therefore the probe and detection mechanism are electrically connected).
Regarding claim 20, Nonaka teaches an automatic analyzing method comprising:
measuring pertaining to a contact between a probe (probe 201) for dispensing a sample or a reagent and a liquid surface, and outputting as a measurement value ([0031], [0036], [0039] each describe the measurement of capacitance in relation to liquid amount);
determining whether or not the measurement value is within a specific range, and outputting a determination result ([0022], [0031], [0036], [0039]); and
providing a notification on a state of a liquid related to the liquid surface according to the determination result ([0032], [0039], [0040], [0041], [0042] all describe various notifications due to the sensing of capacitance).
While Nonaka does describe measuring the capacitance to determine the liquid level, this is not an electrical potential.
In the same problem solving area of liquid level detecting, Du teaches a converting unit that receives and converts a capacitance signal from a sampling needle and converts it to a voltage signal (Du; abstract).
Specifically, Du describes that a liquid level detecting device converts capacitance change in the sampling needle into voltage or potential change and determines whether the sampling needle contacts the liquid level based on at least in part on this change in capacitance (Du; [0004]).
It would have been obvious to one skilled in the art to modify the control unit of Nonaka such that it has the conversion unit that converts the measured capacitance into a voltage as taught by Du because it is taught by Pang that converting a capacitance value into a voltage signal is particularly suitable for further electronic processing (Pang; [0031], and see claim 6 that describes a converter that converts capacitance value to a voltage signal).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., adding the conversion unit to the control unit), and that in combination, each element merely would have performed the same function as it did separately (i.e., the conversion unit would still convert capacitance to voltage, the control unit would still measure the changes in whatever signal is incoming), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the control unit of reference Nonaka with the conversion unit of reference Du, since the result would have been predictable.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over translated Nonaka (JP-2015/121427-A), Du (US-2010/0259397-A1) and translated Pang (WO-8606167-A1), and in further view of translated Ishii (JP-2001/041963-A).
Regarding claim 4, modified Nonaka teaches the automatic analyzing apparatus according to claim 1. While Nonaka does describe a scenario where if the capacitance value does not change within a predetermined time, the operator is notified of the possibility of the cleaning liquid amount shortage via a display (Nonaka; [0039]), Nonaka does not teach wherein the processing circuitry is further configured to suspend, if the measurement value is not within the specific range, a test for a mixture liquid of the sample and the reagent conducted after the measuring.
In the same problem solving area of autoanalyzers issuing warnings due to abnormalities of a cleaning solution, Ishii teaches where the operation of the automatic analyzer is stopped when the concentration of cleaning liquid is abnormal (Ishii; abstract, page 6 paragraph 10).
Specifically, Ishii teaches a method where the concentration of a cleaning liquid is determined to be in the normal concentration range, where if determined to be normal the control proceeds to continue the analysis (Ishii; page 6 paragraphs 5-6). However, if the concentration is abnormal the automatic analyzer is stopped when the concentration of the cleaning liquid is abnormal and an “alarm for invoking replacement of the consumables of the cleaning liquid preparation mechanism” is generated (Ishii; page 6 paragraph 10).
It would have been obvious to one skilled in the art to modify the CPU of Nonaka such that when the operator is notified of the possibility of the cleaning liquid amount shortage as described by [0039] of Nonaka, that the analysis of the sample be halted until the problem is resolved as taught by Ishii because Ishii teaches that it is desirable to stop the analysis until the issue regarding the cleaning liquid is resolved by the user (Ishii; page 6 paragraph 6).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over translated Nonaka (JP-2015/121427-A), Du (US-2010/0259397-A1) and translated Pang (WO-8606167-A1), and in further view of Veening (US-2021/0255129-A1) and translated Ishii (JP-2001/041963-A).
Regarding claim 7, modified Nonaka teaches the automatic analyzing apparatus according to claim 6. Nonaka has been modified with Du such that the control unit includes the conversion unit that converts capacitance into voltage.
However, Nonaka nor Du teach wherein the state of the liquid relates to a concentration of a detergent contained in the washing liquid.
In the analogous art of processors measuring a solution and comparing the measurement to a threshold, Veening teaches where the solution sensor can be a sensor to monitor voltage of the solution (Veening; abstract, [0023]).
Specifically, Veening teaches that by measuring the voltage of the solution, the concentration of cleaning or disinfection chemicals in the solution can be monitored (Veening; [0029]).
It would have been obvious to one skilled in the art to modify the control unit of modified Nonaka such that the voltage correlates with concentration because it is taught by Ishii that changes in the concentration of a cleaning solution affects the cleaning ability, where lower concentration leads to the decrease in washing ability and an increase in contamination between samples or reagents, and when the concentration is higher than normal it can cause abnormal reactions due to carry-over of the washing liquid into the reaction system (Ishii; [0003]). Therefore, the teachings of Ishii would motivate one skilled in the art to monitor the concentration of the cleaning solution.
Please note that the liquid, and therefore detergent in washing liquid, have not been positively recited and are therefore not part of the claimed system.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Translated Umehara (JP-2010/002237-A) teaches where a reagent dispensing device includes a capacitive liquid detection mechanism, where the liquid level detection mechanism 10 includes a means for detecting the liquid in reaction vessel 5, and includes an oscillation circuit 101, differentiation circuit 102, and voltage detection circuit 103 (Umehara; [0023], [0025], [0026], [0027], [0045]).
Yokota (US-2023/0067353-A1) teaches where if it is determined that the amount of cleaning water is outside the range of predetermined criterion, an alarm is output to a display unit, where then the amount of cleaning water may be adjusted by either closing a water amount adjusting valve or opening it (Yokota; [0087], Figure 12).
Takayama (US-2009/0114538-A1) teaches where a process includes measuring an absorbance, and if it falls in the appropriate range the quality of cleaning solution is regarded as appropriate and the automatic analyzer starts a sample analysis process and the information regarding the cleaning solution falls within the appropriate range is recorded as a log (Takayama; [0050]). Further, Takayama teaches where if the measured absorbance falls outside the appropriate value range, the controller causes a display unit to display a message, where the sample analysis process is stopped and the information regarding the absorbance of the cleaning solution falling outside the appropriate range and the analysis of the sample to be tested is stopped is recorded as a log (Takayama; [0051]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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