DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claim 1, 3-14 are pending with claims 1, 3-11 under examination and claims 12-14 withdrawn from consideration.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
The 101 rejection(s) have been modified to address the amended claims.
Based on the amended claims and remarks, received 07/07/2026, the previous prior art rejection over Zebetakis has been modified to address the amended claims (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, a display to receive and display the detection result of the abnormality, and terminate pipetting in response to detection of the abnormality by the processor. 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 and pipette 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). Lastly, although “terminating” is an action, this is interpreted as just the result of the abstract idea and is nothing more than insignificant post solution activity, and would not be considered a particular practical application since many automatic analysis devices would aim to stop/terminate pipetting/processing when an abnormality is detected. See MPEP 2106.05(g) , Insignificant Extra-Solution Activity.
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, a display to display the detection result of the abnormality, and terminate pipetting in response to detection of the abnormality by the processor. 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.
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”) 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, or wherein the control unit is further configured to, in response to detection of the abnormality by the processor, terminate pipetting of the specimen.
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]), and wherein the control unit is further configured to, in response to detection of the abnormality by the processor, terminate pipetting of the specimen (Yamazaki; [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 and terminate pipetting in response to detection of the abnormality, 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 07/07/2026, have been considered but were not found persuasive.
Applicant argues, see pages 7-10 of their remarks towards the 101 rejection that the claims are directed to a physical and structural device that is far from abstract, and there is nothing about abstract about a device including structures such as a pipetting nozzle, a pressure source, a flow path, and a pressure sensor. Applicant cites MPEP 2106.06(a) with reference to the robotic arm assembly example, and argues the claims are clearly not an attempt to tie up any judicial exception.
The examiner respectfully disagrees. Although the claim recites physical structure including a pipetting nozzle, a pressure source, a flow path, and a pressure sensor, these elements do not preclude the claim from reciting an abstract idea. In this case, the claims recite the abstract idea(s) “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” which could be performed by a human person by pen and paper or by a black box computer. Further, the additional elements in the claims, including the pipetting nozzle, pressure source, flow path, and pressure sensor do not recite a meaningful limitation along with the judicial exception such that the claim integrates the abstract idea into a particular practical application under Step 2A Prong 2, or recite any additional elements which are significantly more than the abstract idea itself under step 2B, which are required under the Alice/Mayo test described in MPEP 2106 (see 101 rejection above).
Applicant argues on page 10 of their remarks towards step 2A prong one of the 101 rejection that claim 1 does not recite a mental process because amended claim 1 cannot be practically performed in the human mind including the claimed operations “in response to detection of the abnormality by the processor, terminate pipetting of the specimen”. Applicant cites MPEP 2106.04(a)(2)(III)(A) and argue “claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, for instance when the human mind is not equipped to perform the claimed limitations”.
The examiner respectfully disagrees. The cited MPEP reference makes clear that “claims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind”. However, in the instant application, the claims do recite a mental process that can practically be performed in the human mind including “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” which could be performed by a human person by pen and paper or by a black box computer. Regarding applicant’s argument towards the claimed operation “in response to detection of the abnormality by the processor, terminate pipetting of the specimen”, MPEP 2106.05(d)(II) states “Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking)”. In this case, the claimed operation 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). Although “terminating” is an action, this is interpreted as just the result of the abstract idea and is nothing more than insignificant post solution activity, and would not be considered a particular practical application since many automatic analysis devices would aim to stop/terminate pipetting/processing when an abnormality is detected. See MPEP 2106.05(g) , Insignificant Extra-Solution Activity.
Regarding applicants argument on pages 11-12 of their remarks towards step 2A prong two of the 101 rejection that MPEP 2106.04(d)(1) states “a claim reciting a judicial exception is not directed to the judicial exception if it also recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application … one way to demonstrate the integration is when the claimed invention improves the functioning of a computer or improves another technology or technical field”, and that paragraphs [0047] and [0073] of the present invention describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Specifically, the cited paragraphs discuss a device for detecting an abnormality at a time of pipetting the specimen and terminate pipetting of the specimen in response to an abnormality being detected.
The examiner respectfully disagrees. The alleged improvements in paragraphs [0047] and [0073] of applicant’s disclosure are directed towards terminating the pipetting operation to reduce loss of reagent. The argued improve amounts to nothing more than an instruction to apply the abstract idea on a generic computer which do not render the abstract idea eligible under Step 2A Prong Two. Further, the alleged improvement does not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more. See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(f), Mere Instructions To Apply An Exception. In this case, the alleged improvement cannot be considered an improvement to the function of a computer as many automatic analyzer would aim to terminate pipetting/processing upon detection of an abnormality.
Applicant argues on page 12 of their remarks towards Step 2B of the 101 analysis that the claim integrates the alleged abstract idea into a practical application by “in response to detection of the abnormality by the processor, terminate pipetting of the specimen” which amounts to significantly more than the abstract idea.
The examiner respectfully disagrees. The argued practical application amounts to nothing more than an instruction to apply the abstract idea on a generic computer which do not render the abstract idea eligible under Step 2A Prong Two. Further, the alleged practical application does 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 as evidenced by Yamazaki (US 2013/0121880; already of record - see [0032, 0034, 0036-0037, 0049] and figs. 1-5). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity and MPEP § 2106.04(d) and § 2106.05(f), Mere Instructions To Apply An Exception. In this case, the practical application cannot be considered significantly more as it does not provide an improvement over the prior art.
Applicant argues on pages 12-14 of their remarks towards the 103 rejection over Zebetakis in view of Yamazaki that the Zebetakis does not disclose “an aspiration amount of the first air gap is determined based on the aspiration amount of the reagent” or “determining the aspiration amount of the second air gap A3 based on the aspiration amount of the reagent R2” as recited in claim 1. Applicant cites column 9 lines 65-69, col. 10 lines 1-2, and col. 14 lines 40-43 of Zebetakis which discuss a vanish zone and argues the volume of the second air gap A3 is determined in accordance with the vanish zone.
The examiner respectfully disagrees and believes applicant has mischaracterized the prior art. 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. Further, the vanish zone applicant argues towards is downstream of the pipetting operation as part of the detection means 30, and is distinct from the controlled pipetting operation upstream of the device.
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.
Conclusion
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 extension fee 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 date of this final action.
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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
Prosecution Insights