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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/11/2026 has been entered.
Status of Claims
Claim 1, 3-14 are pending with claims 1, 3-11 under examination and claims 12-14 withdrawn from consideration.
Claim 2 has been canceled.
Response to Amendment
Based on the amended claims and remarks received on 02/16/2026, the 101 rejection(s) have been modified to address the amended claims.
Based on the amended claims and remarks, the previous prior art rejection over Saros has been withdrawn and a new prior art rejection set forth (see below).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 3-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claim 1 is directed toward a device.
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract idea.
Claim 1 recites the abstract idea, “determine at least one of an aspiration amount of the first air gap and an aspiration amount of the second air gap based on an aspiration amount of the reagent” and “detect an abnormality at a time of pipetting the specimen based on the time-series data” could be performed by a human person by pen and paper or by a black box computer.
Step 2A, Prong Two: Has the abstract idea been integrated into a particular practical application?
No. After the determination is made and detection of an abnormality, no further action is taken, and therefore there is not a particular practical application.
The determination is performed by a control unit, and the detection is performed by a processor, which are just general-purpose computer(s). However, performing the abstract idea on a general purpose computer is not enough to integrate the exception into a practical application (MPEP 2106.04(a)(2) subsections (I) and (III), and 2106.05(b)(I)).
The claims also recite a pipette and a pressure source for pipetting fluid/air through a flow path, a pressure sensor to measure pressure in the flow path, a storage unit to store time-series pressure data, and a display to display the detection result of the abnormality. However, employing generic computer functions to execute the abstract idea, even when limiting the use of the idea to one particular environment, does not add significantly more, similar to how limiting the abstract idea in Flook to petrochemical and oil-refining industries was insufficient (see MPEP § 2106.05(h), Field of Use and Technological Environment). Additionally, these elements are interpreted as extra-solution activity which are incidental to the primary process and are mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity). Controlling the display based on detection of the abnormality amounts to mere instructions to apply the abstract idea on a generic computer, but does not integrate the abstract idea into a practical application (see MPEP § 2106.04(d) and § 2106.05(f), Mere Instructions To Apply An Exception). Further, displaying is not considered a practical application, such as improving the functioning of a computer, effecting a transformation, effecting a particular treatment, or applying the judicial exception in some other meaningful way. Indeed, the Court did not find that displaying information on a computer display without any limitations specifying how to achieve the desired result (information display) was not sufficient to show patent eligibility. Nor did the court find that arranging information on a graphical user interface in a manner that assists in processing information more quickly was sufficient to show patent eligibility. MPEP 2106.05(a)(I).
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
Claim 1 recites the additional elements a pipette and a pressure source for pipetting fluid/air through a flow path, a pressure sensor to measure pressure in the flow path, a storage unit to store time-series pressure data, and a display to display the detection result of the abnormality. However, these additional elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry (See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity) as evidenced by Ingenhoven et al. (US 2007/0020763; already of record - see [0063, 0065] and figs. 5 & 7-8), Yamazaki (US 2013/0121880; already of record - see [0032, 0034, 0036-0037, 0049] and figs. 1-5), and Tamezane et al. (US 2015/0362514; already of record - see [0025, 0034, 0037, 0074, 0091-0092] and figs. 1-3, 6, & 9-10). The control configured to aspirate a first air gap, a reagent, a second air gap, and a specimen in this order into the pipetting nozzle is also well-understood, routine, and conventional activities previously known to the industry as evidenced by Zebetakis (US Patent No. 5,268,147 – hereinafter “Zebetakis”) and Kumar et al. (US Patent No. 5,399,497 – hereinafter “Kumar”). See Zebetakis; figs. 4 & 7, “A2”, “R2”, “A3”, “S1”, col. 11 lines 48-61 & col. 13 lines 29-66 and Kumar; figs. 4 & 7, “A2, “R2, “A3”, “S1”, col. 9 lines 59-67).
Claims 3 & 4 recites the abstract idea “determines at least one of the aspiration amount of the first air gap and the aspiration amount of the second air gap so that a total volume of all the fluids aspirated into the pipetting nozzle before the aspiration of the specimen is constant” and “determine the aspiration amount of the first air gap so that the total volume of all the fluids aspirated into the pipetting nozzle before the aspiration of the specimen is constant” (step 2A, prong 1), but does not integrate the exception under 2A prong 2 because data gathering is insignificant extra-solution activity and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception does not amount to significantly more than the exception itself. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(h), Field of Use and Technological Environment. Further, the additional elements are considered well-known and conventional in the art. See Zebetakis; fig. 4, line segment “PA”, col. 11 lines 40-61, col. 12 lines 63-66, col. 13 lines 42-49.
Claim 5 recites the abstract idea “calculate a determination index based on the pressure history and compare a preset determination threshold with the determination index to detect the abnormality at the time of pipetting the specimen” (Step 2A prong 1), but does not integrate the exception under 2A prong 2 because use of conventional computer functions does not qualify as a particular machine and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception does not amount to significantly more than the exception itself. See MPEP 2106.04(a)(2) subsections (I) and (III), and 2106.05(b)(I), MPEP § 2106.05(g), Insignificant Extra-Solution Activity, and 2106.05(h), Field of Use and Technological Environment. The processor is merely employing generic computer functions to execute the abstract idea, but does not add significantly more. (see MPEP § 2106.04(d), § 2106.05(f), Mere Instructions To Apply An Exception and § 2106.05(h), Field of Use and Technological Environment). The additional elements further limiting the time-series data to include a pressure history are interpreted as data gathering to be used in the abstract idea but does not integrate the judicial exception into a particular practical application because data gathering is insignificant extra-solution activity, and not a particular application (See MPEP 2106.05(g), Insignificant Extra-Solution Activity). Further, these elements are considered well-known and conventional in the art. See Yamazaki (US 2013/0121880) and Tamezane et al. (US 2015/0362514).
Claim 6 recites the abstract idea “calculate a difference between a pressure value before aspirating the specimen and a pressure value during aspirating the specimen as the determination index” which is math and/or a mental process. However, use of conventional computer functions does not qualify as a particular machine (MPEP 2106.04(a)(2) subsections (I) and (III), and 2106.05(b)(I)). The processor is merely employing generic computer functions to execute the abstract idea, but does not add significantly more. (see MPEP § 2106.04(d), § 2106.05(f), Mere Instructions To Apply An Exception and § 2106.05(h), Field of Use and Technological Environment). Further, these elements are considered well-known and conventional in the art. See Yamazaki (US 2013/0121880) and Tamezane et al. (US 2015/0362514).
Claim 7 recites “the control unit is further configured to control the pressure source so that the aspiration amount of the second air gap is equal to the aspiration amount of the specimen”. However, use of conventional computer functions does not qualify as a particular machine and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception does not amount to significantly more than the exception itself. See MPEP 2106.04(a)(2) subsections (I) and (III), and 2106.05(b), MPEP § Particular Machine, MPEP § 2106.05(g), Insignificant Extra-Solution Activity, and 2106.05(h), Field of Use and Technological Environment.
Claim 8 recites the abstract idea(s) of “calculate a difference between a pressure value when aspirating the second air gap and a pressure value when aspirating the specimen as the determination index and compares a preset determination threshold with the determination index to detect the abnormality” and “compares a preset determination threshold with the determination index”, but does not integrate the exception under 2A prong 2 because use of conventional computer functions does not qualify as a particular machine and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception does not amount to significantly more than the exception itself. See MPEP 2106.04(a)(2) subsections (I) and (III), and 2106.05(b)(I), MPEP § 2106.05(g), Insignificant Extra-Solution Activity, and 2106.05(h), Field of Use and Technological Environment. Further, the additional elements are considered well-known and conventional in the art. Yamazaki (US 2013/0121880) and Tamezane et al. (US 2015/0362514).
Claim 9 recites the abstract idea of “calculate a determination index based on the pressure history and compare a preset determination threshold and the determination index to detect the abnormality” and “the determination threshold in the acquired aspiration amount of the reagent is compared with the determination index” (step 2A prong 1), but does not integrate the exception under 2A prong 2 because use of conventional computer functions does not qualify as a particular machine and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception does not amount to significantly more than the exception itself. See MPEP 2106.04(a)(2) subsections (I) and (III), and 2106.05(b)(I) and 2106.05(f), Mere Instructions To Apply an Exception. The additional elements further limiting the time-series data to include a pressure history and acquiring the aspiration amount of the reagent are interpreted as data gathering to be used in the abstract idea and does not integrate the judicial exception into a particular practical application because data gathering is insignificant extra-solution activity, and not a particular application. See MPEP 2106.05(g). Further, these elements are considered well-known and conventional in the art. See Yamazaki (US 2013/0121880) and Tamezane et al. (US 2015/0362514).
Claim 10 recites the abstract idea of “calculate a determination index based on the pressure history and compare a preset determination threshold and the determination index to detect the abnormality” and “the determination threshold in the acquired property value of the reagent is compared with the determination index” (step 2A prong 1), but does not integrate the exception under 2A prong 2 because use of conventional computer functions does not qualify as a particular machine and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception does not amount to significantly more than the exception itself. See MPEP 2106.04(a)(2) subsections (I) and (III), and 2106.05(b)(I) and 2106.05(f), Mere Instructions To Apply an Exception. The additional elements further limiting the time-series data to include a pressure history and acquiring the aspiration amount of the reagent are interpreted as data gathering to be used in the abstract idea and does not integrate the judicial exception into a particular practical application because data gathering is insignificant extra-solution activity, and not a particular application. See MPEP 2106.05(g). Further, these elements are considered well-known and conventional in the art. See Yamazaki (US 2013/0121880) and Tamezane et al. (US 2015/0362514).
Claim 11 recites “the control unit is further configured to control the pipetting nozzle and the pressure source so that the reagent and the specimen are alternatively aspirated into the pipetting nozzle a plurality of times”. However, this is interpreted as mere instructions to implement the abstract idea or other exception on a computer (see MPEP 2106.05(f)).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zebetakis (US Patent No. 5,268,147 – hereinafter “Zebetakis”), and further in view of Yamazaki (US 2013/0121880; already of record – hereinafter “Yamazaki”).
Regarding claim 1, Zebetakis disclose an automatic analysis device (Zebetakis; figs. 5-12, #20, col. 6 lines 42-68) comprising:
a pipetting nozzle configured to pipette a fluid (Zebetakis; fig. 7, #40, col. 7 lines 15-33 and 58-64),
a pressure source configured to generate a pressure fluctuation for pipetting the fluid by the pipetting nozzle (Zebetakis; figs. 1, 2 & 7, #31 in “aspirate position”, col. 9 lines 26-40),
a flow path connecting the pipetting nozzle and the pressure source (Zebetakis; fig. 7, #38, #50, in “aspirate position”, col. 9 lines 26-40),
a storage unit configured to store time-series data (Zebetakis disclose the control system as a general purpose computer with a stored system program for controlling operational functions of the system; fig. 4, col. 10, lines 61-62 and col. 11 lines 60-61),
a control unit configured to control driving of the pipetting nozzle and the pressure source (Zebetakis; figs. 3 & 7, #36, #52, #153, col. 10 line 55 through col. 11 line 32), wherein the control unit is configured to:
control the pipetting nozzle and the pressure source to aspirate a first air gap, a reagent, a second air gap, and a specimen in this order into the pipetting nozzle (Zebetakis; figs. 4 & 7, “A2”, “R2”, “A3”, “S1”, col. 11 lines 48-61 & col. 13 lines 29-66), and
determine at least one of an aspiration amount of the first air gap and an aspiration amount of the second air gap based on an aspiration amount of the reagent (Zebetakis disclose the first gap A2, reagent R2, and second air gap A3 are determined through driving the pump piston 34 of the pump 31 through different and readily adjustable strokes in the pump cylinder 32. Accordingly, an aspiration amount of the first air gap A2 is determined based on a beginning position of the cylinder for the reagent, and an aspiration amount of second air gap A3 is determined based on an ending position of the cylinder for the reagent; fig. 4, line segment “PA”, col. 11 lines 40-61, col. 12 lines 63-66, col. 13 lines 42-49),
a processor (Zebetakis; fig. 3, #153, col. 10 lines 59-61), and a display (Zebetakis disclose a user console 167; fig. 3, col. 11 lines 18-26) configured to:
receive a determination result, and display the determination result (Zebetakis disclose a general purpose computer instructs, controls, monitors, and synchronizes the operations of system 20, as well as calculate and monitor the sample liquid analysis results and output the same in a variety of formats; col. 11 lines 26-32).
Zebetakis does not teach a pressure sensor configured to measure pressure in the flow path when the pipetting nozzle pipettes the fluid, the storage unit configured to store time-series data of the pressure measured by the pressure sensor, or the processor detects an abnormality based on the time-series data and displays a determination result based on the detection of the abnormality.
However, Yamazaki teach the analogous art of an automatic analysis device (Yamazaki; fig. 1, [0031]) comprising a pipetting nozzle configured to pipette a fluid (Yamazaki; figs. 1 & 2, #15, [0032]), a pressure source configured to generate a pressure fluctuation for pipetting the fluid by the pipetting nozzle (Yamazaki; figs. 1 & 2, #25, [0032]), a flow path connecting the pipetting nozzle and the pressure source (Yamazaki; fig. 1 & 2, #24, [0032]), a pressure sensor configured to measure pressure in the flow path when the pipetting nozzle pipettes the fluid (Yamazaki; fig. 2, #26, [0034]), a control unit configured to control driving of the pipetting nozzle and the pressure source (Yamazaki; fig. 1, #60, #76, [0032, 0035-0037]), a storage unit configured to store time-series data of the pressure measured by the pressure sensor (Yamazaki; figs. 1, 3 & 5, #61, #76, [0006, 0037, 0049]), a processor configured to detect an abnormality (Yamazaki; fig. 2, #76, [0036]), and a display configured to display a determination result based on detection of the abnormality (Yamazaki; fig. 1, #61, [0032, 0036])
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the automatic analysis device and control unit of Zebetakis to include a pressure sensor that measures the pressure in the flow path, a storage unit configured to store time-series data of the pressure measured by the pressure sensor, and to modify the processor and display of Zebetakis to be configured to detect and send an abnormality signal to the display, as taught by Yamazaki, because Yamazaki teach storing and comparing the time-series pressure data with a data table having “normal”, “air-sucking”, and “clogging” conditions allows the automatic analyzer to determine if an abnormal state has occurred during the pipetting process and stops the operation to alert an operator (Yamazaki; [0036, 0037, 0039, 0049]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Zebetakis and Yamazaki both teach analysis systems configured to aspirate a predetermined amount of sample for analysis.
Regarding claim 3, modified Zebetakis teach the automatic analysis device according to claim 1 above, wherein the control unit determines at least one of the aspiration amount of the first air gap and the aspiration amount of the second air gap so that a total volume of all the fluids aspirated into the pipetting nozzle before the aspiration of the specimen is constant (Zebetakis disclose the aspiration amount of the first gap A2, reagent R2, and second air gap A3 are determined through driving the pump piston 34 of the pump 31 through different and readily adjustable strokes in the pump cylinder 32. Accordingly, an aspiration amount of all the fluids aspirated into the pipetting nozzle before aspiration of the specimen is constant; fig. 4, line segment “PA”, col. 11 lines 40-61, col. 12 lines 63-66, col. 13 lines 42-49).
Regarding claim 4, modified Zebetakis disclose the automatic analysis device according to claim 3 above, wherein the control unit is further configured to determine the aspiration amount of the first air gap so that the total volume of all the fluids aspirated into the pipetting nozzle before the aspiration of the specimen is constant (Zebetakis disclose the aspiration amount of the first gap A2, reagent R2, and second air gap A3 are determined through driving the pump piston 34 of the pump 31 through different and readily adjustable strokes in the pump cylinder 32. Accordingly, an aspiration amount of the first air gap is determined so that the total volume of all the fluids aspirated into the pipetting nozzle before aspiration of the specimen is constant; fig. 4, line segment “PA”, col. 11 lines 40-61, col. 12 lines 63-66, col. 13 lines 42-49).
Regarding claim 5, modified Zebetakis disclose the automatic analysis device according to claim 1 above, wherein: the time-series data includes a pressure history at the time of aspiration of the specimen, and the processor is further configured to calculate a determination index based on the pressure history and compare a preset determination threshold with the determination index to detect the abnormality at the time of pipetting the specimen (The modification of the automatic analysis device and control unit of Zebetakis to include a pressure sensor that measures the pressure in the flow path, a storage unit configured to store time-series data of the pressure measured by the pressure sensor, and the processor and display of Zebetakis to be configured to detect and send an abnormality signal to the display, as taught by Yamazaki, has previously been discussed in claim 1 above. Yamazaki further teach the measured pressure readings are compared with data tables having thresholds to determine an abnormality; [0006, 0049]).
Regarding claim 6, modified Zebetakis teach the automatic analysis device according to claim 5 above, wherein the processor is further configured to calculate a difference between a pressure value before aspirating the specimen and a pressure value during aspirating the specimen as the determination index (The modification of the automatic analysis device and control unit of Zebetakis to include a pressure sensor that measures the pressure in the flow path, a storage unit configured to store time-series data of the pressure measured by the pressure sensor, and the processor and display of Zebetakis to be configured to detect and send an abnormality signal to the display, as taught by Yamazaki, has previously been discussed in claim 1 above. Yamazaki teach “the pressure sensor 26 detects the change of pressure”; [0036]).
Regarding claim 7, modified Zebetakis teach the automatic analysis device according to claim 1 above, wherein the control unit is further configured to control the pressure source so to aspiration an amount of the second air gap and aspiration an amount of the specimen (Zebetakis; figs. 4 & 7, “A2”, “R2”, “A3”, “S1”, col. 11 lines 48-61 & col. 13 lines 29-66).
Modified Zebetakis does not teach the aspiration amount of the second air gap and the specimen are equal.
However, Zebetakis does teach controlling the aspiration amount of air and sample based on driving the pump piston 34 of the pump 31 through different and readily adjustable strokes in the pump cylinder 32; fig. 4, line segment “PA”, col. 11 lines 40-61, col. 12 lines 63-66, col. 13 lines 42-49.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the aspiration amount of either the second air gap or the specimen to be equal, because modifying the second air gap and the specimen to be equal would create sufficient spacing between liquid aspiration operation to keep the liquids separated and/or provide an appropriate reagent amount to carry out the reaction of the specimen and reagent during detection. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Zebetakis teach adjustable strokes in the pump cylinder for controlling an amount of aspiration for the air gap and liquid.
Regarding claim 8, modified Zebetakis teach the automatic analysis device according to claim 7 above, wherein the processor is further configured to: calculate a difference between a pressure value when aspirating the second air gap and a pressure value when aspirating the specimen as a determination index and compares a preset determination threshold with the determination index to detect the abnormality (The modification of the automatic analysis device and control unit of Zebetakis to include a pressure sensor that measures the pressure in the flow path, a storage unit configured to store time-series data of the pressure measured by the pressure sensor, and the processor and display of Zebetakis to be configured to detect and send an abnormality signal to the display, as taught by Yamazaki, has previously been discussed in claim 1 above. Yamazaki additionally teach aspirating an air gap 78; fig. 2, [0036, 0049] and “the pressure sensor 26 detects the change of pressure” with respect to the aspiration operation; [0036] to compare with a threshold to detect the abnormality; figs. 3 & 5, [0004, 0037, 0049]. Accordingly, modified Zebetakis would be configured to calculate the pressure values when aspirating the second air gap and the pressure value when aspirating the specimen to detect the abnormality by comparing against the predetermined threshold in the data table).
Regarding claim 9, modified Zebetakis teach the automatic analysis device according to claim 1 above, wherein: the time-series data includes a pressure history at the time of aspiration of the specimen, the processor is further configured to calculate a determination index based on the pressure history and compare a preset determination threshold and the determination index to detect the abnormality (The modification of the automatic analysis device and control unit of Zebetakis to include a pressure sensor that measures the pressure in the flow path, a storage unit configured to store time-series data of the pressure measured by the pressure sensor, and the processor and display of Zebetakis to be configured to detect and send an abnormality signal to the display, as taught by Yamazaki, has previously been discussed in claim 1 above. Yamazaki further teach the measured pressure readings are compared with data tables having thresholds to determine an abnormality; [0006, 0049]), the determination threshold is a function that changes based on the aspiration amount of the reagent (Yamazaki teach the determination threshold is a function that changes based on an aspiration amount based on air-sucking, excessive bubble, and clogging, which are a function of the aspiration amount of liquid; [0049]. Accordingly, modified Zebetakis would be configured to calculate the determination index as a function that changes based on the aspiration amount of the reagent.), and the aspiration amount of the reagent is acquired from the control unit and the determination threshold in the acquired aspiration amount of the reagent is compared with the determination index (Yamazaki; [0036, 0049, 0051]).
Regarding claim 10, modified Zebetakis teach the automatic analysis device according to claim 1 above, wherein: the time-series data includes a pressure history at the time of aspiration of the specimen, the processor is further configured to calculate a determination index based on the pressure history and compare a preset determination threshold and the determination index to detect the abnormality (The modification of the automatic analysis device and control unit of Zebetakis to include a pressure sensor that measures the pressure in the flow path, a storage unit configured to store time-series data of the pressure measured by the pressure sensor, and the processor and display of Zebetakis to be configured to detect and send an abnormality signal to the display, as taught by Yamazaki, has previously been discussed in claim 1 above. Yamazaki further teach the measured pressure readings are compared with data tables having thresholds to determine an abnormality; [0006, 0049]), the determination threshold is a function that changes based on a property value of the reagent (Yamazaki teach the determination threshold is a function that changes based on an aspiration amount based on air-sucking, excessive bubble, and clogging, which are a function of the aspiration amount of first liquid; [0037, 0049, 0051, 0064]. Accordingly, modified Zebetakis would be configured to calculate the determination index as a function that changes based on a property value of the reagent.), and the property value of the reagent is acquired from the control unit and the determination threshold in the acquired property value of the reagent is compared with the determination index (Yamazaki teach a “normal 1” and “normal 2” data set to compare the liquid with where “normal 1” corresponds to a case that liquid having a viscosity substantially same as the lower limit of a conceivable viscosity range of a normal samples and “normal 2” corresponds to a case that liquid having a viscosity substantially same as the conceivable average viscosity of normal samples; [0037]).
Regarding claim 11, modified Zebetakis teach the automatic analysis device according to claim 1 above, wherein the control unit is further configured to control the pipetting nozzle and the pressure source so that the reagent and the specimen are alternately aspirated into the pipetting nozzle a plurality of times (Zebetakis; figs. 10-14, “TP1”, “TP2”, “TP3”, col. 16 line 3 through col. 17 line 25).
Response to Arguments
Applicant’s arguments filed on 03/11/2026 have been fully considered.
Applicant argues, see pages 7-9 of their remarks, that the eligibility of claim 1 under MPEP 2106.06(a) is self-evident because the claim is not an attempt to tie up any judicial exception. The examiner respectfully disagrees as the claim fails the full eligibility analysis (the Alice/Mayo test) described in MPEP 2106, subsection III. See the 101 rejection above.
Applicant argue, see page 9-10 of their remarks, that claim 1 is patentable under Step 2A Prong One of the 101 rejection because claim 1 simply cannot reasonably be performed in the human mind using pen and paper or by a black box computer. Applicant argues the claimed features of the pipetting nozzle, pressure sensor, flow path, display simply cannot be performed in the human mind because the human mind does not reasonably function in accordance with the operations outlined by the claimed features.
The examiner respectfully disagrees. Step 2A prong One is directed toward identifying the law of nature/natural phenomenon/abstract idea in the claims. Independent claim 1 recites the abstract idea “determine at least one of an aspiration amount of the first air gap and an aspiration amount of the second air gap based on an aspiration amount of the reagent”, and “detect an abnormality at a time of pipetting the specimen based on the time-series data”. The abstract idea(s) is/are of the type that is in the grouping of “mathematical concepts” and/or “mental process” (See MPEP 2106.04(a)(2) subsections (I) and (III)) because determining an amount of fluid could be performed in the mind and detecting is a mathematical relationship between variable or numbers. Specifically, a user or laboratory technician could easily, in their mind, look at an amount of liquid aspirated and determine an spiration amount of a first air gap or an aspiration amount of a second air gap based on the aspiration amount of the liquid or detect an influence of a physical property value of a reagent on a pressure history using a mathematical concepts with pen and paper.
Applicant argues, see pages 10-11 of their remarks, that claim 1 is patentable under Step 2A Prong Two of the 101 rejection because the claimed invention improves the functioning of a computer or improves another technology or technical field. Applicant argues paragraphs [0010-0011] of their present application discuss a device for detecting an abnormality at a time of pipetting and therefore the analysis result of the automatic device is improved.
The examiner respectfully disagrees. The additional elements in the claims are merely employing generic computer functions to execute the abstract idea, even when limiting the use of the idea to one particular environment, does not add significantly more, similar to how limiting the abstract idea in Flook to petrochemical and oil-refining industries was insufficient (see MPEP § 2106.05(h), Field of Use and Technological Environment). Additionally, these elements are interpreted as extra-solution activity which are incidental to the primary process and are mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity). Controlling the display based on detection of the abnormality amounts to mere instructions to apply the abstract idea on a generic computer, but does not integrate the abstract idea into a practical application (see MPEP § 2106.04(d) and § 2106.05(f), Mere Instructions To Apply An Exception). Further, displaying is not considered a practical application, such as improving the functioning of a computer, effecting a transformation, effecting a particular treatment, or applying the judicial exception in some other meaningful way. Indeed, the Court did not find that displaying information on a computer display without any limitations specifying how to achieve the desired result (information display) was not sufficient to show patent eligibility. Nor did the court find that arranging information on a graphical user interface in a manner that assists in processing information more quickly was sufficient to show patent eligibility. MPEP 2106.05(a)(I). Additionally, detecting an abnormality with “high accuracy” alone does not lead to an alleged improvement because all analyzers would aim to be accurate, and the abstract idea (determining/detecting) itself cannot be the alleged improvement in a particular technology. See MPEP 2106.05(a) paragraphs 4-7. The alleged improvements in paragraphs [0010] and [0072] of applicant’s disclosure are directed towards a determination index calculated based on pressure history in normal pipetting conditions and abnormal pipetting conditions, but are not recited in independent claim 1. The claim itself must reflect the disclosed improvement in technology and include all of the limitations that lead to the improvement. See MPEP 2106.05(a)(II).
Applicant argues, see pages 11-12 of their remarks, that claim 1 is patentable under Step 2B of the 101 rejection(s) because the claimed limitations “control the pipetting nozzle and the pressure source to aspirate a first air gap, a reagent, a second air gap, and a specimen in this order into the pipetting nozzle”, “determining at least one of an aspiration amount of the first air gap and an aspiration amount of the second air gap based on an aspiration amount of the reagent” and “a processor configured to detect an abnormality at a time of a pipetting the specimen based on the time-series data” are not well-understood, routine, and conventional activity, and that the limitations of independent claim 1 add a combination of additional elements that are not well-understood, routine, conventional activity.
The examiner respectfully disagrees. Step 2B examines the additional elements (aside from the abstract idea) be considered as to whether they are well-understood routine and conventional in the art. In this case, the additional elements include a pipette and a pressure source for pipetting fluid/air through a flow path, a pressure sensor to measure pressure in the flow path, a storage unit to store time-series pressure data, and a display to display the detection result of the abnormality. However, these additional elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry (See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity) as evidenced by Ingenhoven et al. (US 2007/0020763; already of record - see [0063, 0065] and figs. 5 & 7-8), Yamazaki (US 2013/0121880; already of record - see [0032, 0034, 0036-0037, 0049] and figs. 1-5), and Tamezane et al. (US 2015/0362514; already of record - see [0025, 0034, 0037, 0074, 0091-0092] and figs. 1-3, 6, & 9-10). The control configured to aspirate a first air gap, a reagent, a second air gap, and a specimen in this order into the pipetting nozzle is also well-understood, routine, and conventional activities previously known to the industry as evidenced by Zebetakis (US Patent No. 5,268,147 – hereinafter “Zebetakis”) and Kumar et al. (US Patent No. 5,399,497 – hereinafter “Kumar”). See Zebetakis; figs. 4 & 7, “A2”, “R2”, “A3”, “S1”, col. 11 lines 48-61 & col. 13 lines 29-66 and Kumar; figs. 4 & 7, “A2, “R2, “A3”, “S1”, col. 9 lines 59-67). Therefore, the claims do not integrate the abstract idea(s) into a particular practical application nor do the physical actions that cannot be performed mentally amount to more than well-understood, routine, and conventional activities in the art.
Applicant argues, see pages 13-14 of their remarks, that the prior art does not teach the amended limitations “control the pipetting nozzle and the pressure source to aspirate a first air gap, a reagent, a second air gap, and a specimen in this order into the pipetting nozzle”. The examiner agrees and notes that applicant’s arguments are towards the amended claim limitations. The examiner has withdrawn the previous prior art rejection of Saros and set forth a new prior art rejection over Zebetakis in view of Yamazaki which the disclose all the limitations of amended claim 1. Specifically, Zebetakis teach controlling a nozzle and pressure source to aspirate a first air gap, a reagent, a second air gap, and a specimen in this order. Zebetakis; figs. 4 & 7, “A2”, “R2”, “A3”, “S1”, col. 11 lines 48-61 & col. 13 lines 29-66 and Kumar; figs. 4 & 7, “A2, “R2, “A3”, “S1”, col. 9 lines 59-67.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Isreeli (US Patent No. 3,643,689) disclose pipetting multiple samples and air gaps simultaneously.
Shiono (US Patent No. 4,457,184) disclose pipetting a plurality of liquid and an air gap separating the liquids.
Kumar et al. (US 5,399,497) disclose pipetting an air gap, a reagent, a second air gap, and a sample in this order.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CURTIS A THOMPSON whose telephone number is (571) 272-0648. The examiner can normally be reached on M-F: 7:00 a.m. - 5:00 p.m..
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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