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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/06/2026 has been entered.
Status of Claims
Claim 1 and 3-7 are under examination.
Claim 2 has been canceled.
Response to Amendment
Applicant’s amendments to the claims, received 01/06/2026, have overcome the 112(b) rejection(s) previously set forth in the Final Rejection mailed on 10/28/2025. Accordingly, the rejection(s) have been withdrawn.
The 101 rejection has been modified to address the amended claims.
In view of the amended claims and remarks received on 01/06/2026, the previous prior art rejection over Mimura has been modified to address the amended claims (see below). Further, an alternative rejection has been set forth over Kamihara (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 3-7 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 an automatic analysis device.
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract ideas, “acquire a variation amount of a measurement value of a quality control substance used for quality control”, “calculate a predicted variation amount based on a display difference value, which is a difference value between a first display value indicating a concentration of the first calibration solution used for calibration before a lot change and a second display value indicating a concentration of the second calibration solution used for calibration after the lot change and a measurement difference value which is a difference value between measurement values of the concentration of the first calibration solution and the second calibration solution”, “estimate a cause of variation occurring in the measurement value of the quality control substance based on a comparison result between the variation amount and the predicted variation amount”, “upon determining the cause of variation occurring in the measurement value of the quality control substance automatically correct the measurement value of the quality control substance according to the cause of variation”, and “estimate that the lot change of the calibration solution is the cause of variation upon determining the variation amount is within a range of the predicted variation amount” which are mental processes and/or mathematical concepts that could be performed by a human person by pen and paper or by a black box computer. The computer programmed to perform the recited steps/processes is merely a general-purpose computer for which to apply the abstract ideas, but does not preclude the steps from being considered an abstract idea. See MPEP 2106.04(a)(2) subsections (I) and (III).
Step 2A, Prong Two: Has the abstract idea been integrated into a particular practical application?
No. These judicial exceptions are not integrated into a practical application because upon estimating that the lot change of the calibration solution is the cause of variation upon determining the variation amount is within a range of the predicted variation amount, nothing further is performed with the estimated/determined variation or the correction. Therefore, there is no application of the abstract idea.
The abstract ideas are performed by a computer which is just a general-purpose computer. However, use of a conventional computer functions to apply the judicial exceptions does not qualify as a particular machine (MPEP § 2106(b)(I), MPEP § 2106(b)(II) and MPEP § 2106(b)(III)).
Acquire a variation amount of a measurement value of a quality control substance used for quality control is an abstract idea, however, if it is determined to not be an abstract idea the claim limitation is alternatively 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).
The recited functions “calculates the predicted variation amount … and a measurement difference value” and “estimate … the cause of variation” are mere instructions to implement the abstract idea or other exception on a computer (see MPEP 2106.05(f)). Accordingly, these elements amount to a machine that contributes only nominally or insignificantly to the execution of the claimed system and would not integrate a judicial exception or provide significantly more (see MPEP § 2106.05(b)(III), MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-understood, Routine, Conventional Activity). 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 “an automatic analysis device for analyzing a sample”, “a computer”, “a quality control substance”, a first calibration solution”, and “a second calibration solution”. However, these additional elements do not amount to significantly more as they are well-understood, routine, and convention (WURC) in the art as evidenced by Mimura et al. (US 2007/0217949 – hereinafter “Mimura”) and Satomura et al. (US 2007/0255756 – hereinafter “Satomura”). Mimura and Satomura teach an automatic analysis device for analyzing a sample (Mimura; [0002] and Satomura; fig. 1, #3a, [0046]), a computer (Mimura; fig. “dedicated terminal” and Satomura; fig. 1, #5, [0046]), a quality control substance, a first calibration solution and a second calibration solution (Mimura; fig. 1, [0007, 0050-0052] and Satomura; [0059-0060]).
The claims by-in-large do not contain any additional elements aside from a general-purpose computer to apply the judicial exception and therefore, comprises no additional claim elements that amount to significantly more.
Claim 3 recites the abstract idea of estimating the cause of variation (step 2A prong 1), but does not integrate the exception under 2A prong 2 because a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)). The function “estimates … the cause of variation” are mere instructions to implement the abstract idea or other exception on a computer (see MPEP 2106.05(f)). Accordingly, these elements amount to a machine that contributes only nominally or insignificantly to the execution of the claimed system and would not integrate a judicial exception or provide significantly more (see MPEP § 2106.05(b)(III), MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-understood, Routine, Conventional Activity).
Claim 4 recites the abstract ideas of determining the cause of variation (step 2A prong 1), but does not integrate the exception under 2A prong 2 because determining is interpreted as extra-solution activity incidental to the primary process as mere data gathering which is not considered significantly more than the abstract idea, 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, but does not amount to significantly more than the exception itself and cannot integrate the judicial exception into a practical application (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity and MPEP § 2106.05(h), Field of Use and Technological Environment). 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).
Claim 5 recites the additional elements of displaying the input value. However, 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).
Claim 6 recites the abstract idea of correcting the measurement value (step 2A prong 1), but does not integrate the exception under 2A prong 2 because a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)). The function of correcting a value is merely instructions to implement the abstract idea or other exception on a computer (see MPEP 2106.05(f)). Accordingly, these elements amount to a machine that contributes only nominally or insignificantly to the execution of the claimed system and would not integrate a judicial exception or provide significantly more (see MPEP § 2106.05(b)(III), MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-understood, Routine, Conventional Activity). 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).
Claim 7 recites the abstract idea of determining the cause of variation (step 2A prong 1), but does not integrate the exception under 2A prong 2 because determining is interpreted as extra-solution activity incidental to the primary process as mere data gathering which is not considered significantly more than the abstract idea, 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, but does not amount to significantly more than the exception itself and cannot integrate the judicial exception into a practical application (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity and MPEP § 2106.05(h), Field of Use and Technological Environment). 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).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mimura et al. (US 2007/0217949; already of record – hereinafter “Mimura”).
Regarding claim 1, Mimura disclose an automatic analysis device for analyzing a sample (Mimura; [0002]), the automatic analysis device comprising:
a computer (Mimura; fig. 1, “Dedicated Terminal”) programmed to:
acquire a variation amount of a measurement value of a quality control substance used for quality control (Mimura disclose acquiring an average (i.e. measurement value) and standard deviation value (i.e. variation amount) for each standard solution and control sample (i.e. quality control substances) used for quality control in a clinical laboratory through a network (i.e. acquires). An average value and standard deviation are predetermined by reagent manufacturers with respect to each lot of quality control substance, and provided to the clinical laboratory via the network; fig. 1, [0007, 0050-0052]),
calculate a predicted variation amount based on a display difference value, which is a difference value between a first display value indicating a concentration of the first calibration solution used for calibration before a lot change and a second display value indicating a concentration of the second calibration solution used for calibration after the lot change and a measurement difference value which is a difference value between measurement values of the concentration of the first calibration solution and second calibration solution, wherein a display value is the concentration value of the calibration solution provided by the reagent manufacturer (Mimura disclose calculating a predicted variation amount within ±3 standard deviations from an average value for a particular lot of calibration solution or quality control material, which is deemed to be acceptable and normal; [0010, 0162-0166]. The determination is made based on statistical calculations of measured results from each lot of calibration solution and quality control material with respect to the acquired average and standard deviation values provided by the reagent manufacturer; [0050-0052, 0162-0166]. The information display screens of the results of calibration, figs. 2-3, and superimposed results of control samples and standard solution, figs. 4-5, display a difference between the reagent lots, a difference between the reagent bottles, a difference between the standard solution lots, and a difference between the control sample lots which can be distinguished using several kinds of displaying methods including: displaying each lot with different color, and displaying lot numbers on the screen; [0178, 0181]. The examiner notes that each lot has a different average value and standard deviation determined by the manufacturer (i.e. measurement difference value). Thus, when a new lot is measured, the predicted variation amount of ±3 standard deviations from the acquired value changes on the display. See upper and lower bounds in figs. 2-3); and
estimate a cause of variation occurring in the measurement value of the quality control substance based on a comparison result between the variation amount and the predicted variation amount (Mimura disclose a measured value within ±3 standard deviation (i.e. calculated predicted variation amount) from the acquired standard deviation (i.e. variation amount) is judged to be normal; [0162-0166]. If the concentration of a measured value deviates from the predicted concentration of ±3 standard deviations from the acquired value, the analyzer issues an alarm indicating the data is abnormal and an estimate is made as to whether or not the analyzer, the reagent, the standard solution, a condition of an electric circuit, etc., are abnormal; [0004, 0008, 0021-0022]),
upon determining the cause of variation occurring in the measurement value of the quality control substance automatically correct the measurement value of the quality control substance according to the cause of variation (Mimura disclose the predicted variation amount within ±3 standard deviations from the acquired value for a particular lot of calibration solution or quality control material is judged to be normal; [0010, 0162-0166]. The determination is made based on statistical calculations of measured results from each lot of calibration solution and quality control material with respect to the acquired average and standard deviation values provided by the reagent manufacturer; [0050-0052, 0162-0166]. The information display screens of the results of calibration, figs. 2-3, and superimposed results of control samples and standard solution, figs. 4-5, display a difference between the reagent lots, a difference between the reagent bottles, a difference between the standard solution lots, and a difference between the control sample lots which can be distinguished using several kinds of displaying methods including: displaying each lot with different color, and displaying lot numbers on the screen; [0178, 0181]. The examiner notes that each lot has a different average value and standard deviation determined by the manufacturer (i.e. measurement difference value). Thus, when a new lot is measured, the predicted variation amount of ±3 standard deviations from the acquired value is determined and changes on the display. See upper and lower bounds in figs. 2-3), and
estimate that the lot change of the calibration solution is the cause of variation upon determining that the variation amount is within a range of the predicted variation amount (Mimura; [0045]).
Regarding claim 3, Mimura disclose the automatic analysis device according to claim 1 above, wherein the computer is programmed to estimate that the lot change of the calibration solution is not the cause of variation upon determining the measurement value of the quality control substance and the measurement value of the concentration of the calibration solution have different variation directions (Mimura disclose the measurement value of the quality control material and calibration solution fluctuate in both positive and negative directions; figs. 4-5, [0173-0176]. The fluctuations are deemed acceptable within the predicted variation amount of ±3 standard deviations from the acquired value from each lot; [0051, 0162]).
Regarding claim 4, Mimura disclose the automatic analysis device according to claim 1 above, wherein the computer is programmed to, upon determining that the lot change of the calibration solution is the cause of variation, an input value of the concentration value of the second calibration solution calculated based on the predicted variation amount is displayed (Mimura disclose the information display screens of the results of calibration, figs. 2-3, and superimposed results of control samples and standard solution, figs. 4-5, display a difference between the reagent lots, a difference between the reagent bottles, a difference between the standard solution lots, and a difference between the control sample lots which can be distinguished using several kinds of displaying methods including: displaying each lot with different color, and displaying lot numbers on the screen; [0178, 0181]. The examiner notes that each lot has a different average value and standard deviation determined by the manufacturer (i.e. measurement difference value). Thus, when a new lot is measured, the predicted variation amount of ±3 standard deviations from the acquired value may change on the display. See upper and lower bounds in figs. 2-3. Further, the new information is transmitted to the automatic analyzer based on lot information and statistical processing and displayed with the predicted variation as an allowable width; figs. 2-3, [0050-0052, 0172]).
Regarding claim 5, Mimura disclose the automatic analysis device according to claim 4 above, wherein the input value is displayed in a daily difference variation graph indicating a shift in the measurement value of the quality control substance (Mimura disclose the information display screens of the results of calibration, figs. 2-3, and superimposed results of control samples and standard solution, figs. 4-5, display a difference between the reagent lots, a difference between the reagent bottles, a difference between the standard solution lots, and a difference between the control sample lots which can be distinguished using several kinds of displaying methods including: displaying each lot with different color, and displaying lot numbers on the screen; [0178, 0181]. The examiner notes that each lot has a different average value and standard deviation determined by the manufacturer (i.e. measurement difference value). Thus, when a new lot is measured, the predicted variation amount of ±3 standard deviations from the acquired value may change on the display. See upper and lower bounds in figs. 2-3. Further, the new information is transmitted to the automatic analyzer based on lot information and statistical processing and displayed with the predicted variation as an allowable width; figs. 2-3, [0050-0052, 0172]. The data is processed to check for changes from the previous day; [0050]).
Regarding claim 6, Mimura disclose the automatic analysis device according to claim 1 above, wherein the measurement value of the quality control substance is corrected based on the display difference value and the measurement difference value (Mimura disclose if the concentration of a measured value deviates from the predicted concentration of ±3 standard deviation from the acquired value, the analyzer issues an alarm indicating the data is abnormal and a check is made as to whether or not the analyzer, the reagent, the standard solution, a condition of an electric circuit, etc., are abnormal; [0004, 0008, 0021-0022]. the information display screens of the results of calibration, figs. 2-3, and superimposed results of control samples and standard solution, figs. 4-5, display a difference between the reagent lots, a difference between the reagent bottles, a difference between the standard solution lots, and a difference between the control sample lots which can be distinguished using several kinds of displaying methods including: displaying each lot with different color, and displaying lot numbers on the screen; [0178, 0181]. The examiner notes that each lot has a different average value and standard deviation determined by the manufacturer (i.e. measurement difference value). Thus, when a new lot is measured, the predicted variation amount of ±3 standard deviations from the acquired value may change on the display. See upper and lower bounds in figs. 2-3. Further, the new information is transmitted to the automatic analyzer based on lot information and statistical processing and displayed with the predicted variation as an allowable width; figs. 2-3, [0050-0052, 0172]. The data is processed to check for changes from the previous day; [0050]).
Regarding claim 7, Mimura disclose the automatic analysis device according to claim 1 above, wherein the computer is programmed to, upon determining the lot change of the calibration solution is not the cause of variation, the measurement difference value is displayed in a daily difference variation graph indicating a shift in the measurement value of the quality control substance (Mimura disclose if the concentration of a measured value deviates from the predicted concentration of ±3 standard deviation from the acquired value, the analyzer issues an alarm indicating the data is abnormal and a check is made as to whether or not the analyzer, the reagent, the standard solution, a condition of an electric circuit, etc., are abnormal; [0004, 0008, 0021-0022]. the information display screens of the results of calibration, figs. 2-3, and superimposed results of control samples and standard solution, figs. 4-5, display a difference between the reagent lots, a difference between the reagent bottles, a difference between the standard solution lots, and a difference between the control sample lots which can be distinguished using several kinds of displaying methods including: displaying each lot with different color, and displaying lot numbers on the screen; [0178, 0181]. The examiner notes that each lot has a different average value and standard deviation determined by the manufacturer (i.e. measurement difference value). Thus, when a new lot is measured, the predicted variation amount of ±3 standard deviations from the acquired value may change on the display. See upper and lower bounds in figs. 2-3. Further, the new information is transmitted to the automatic analyzer based on lot information and statistical processing and displayed with the predicted variation as an allowable width; figs. 2-3, [0050-0052, 0172]. The data is processed to check for changes from the previous day; [0050]).
Claim(s) 1 and 3-7 are alternatively rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamihara et al. (US 2013/0266484 – hereinafter “Kamihara”).
Regarding claim 1, Kamihara disclose an automatic analysis device for analyzing a sample (Kamihara; fig. 1, [0033-0043]), the automatic analysis device comprising:
a computer (Kamihara; figs. 1 & 3, #33, [0050]) programmed to:
acquire a variation amount of a measurement value of a quality control substance used for quality control (Kamihara disclose acquiring variable parameter data 38/48 which include a standard solution absorbance range; figs. 2-3 & 5, steps 5 & 6, [0046, 0054-0057, 0082]),
calculate a predicted variation amount based on a display difference value which is a difference value between a first display value indicating a concentration of the first calibration solution used for calibration before a lot change and a second display value indicating a concentration of the second calibration solution used for calibration after the lot change and a measurement difference value which is a difference value between measurement values of the concentration of the first calibration solution and the second calibration solution, wherein a display value is the concentration value of the calibration solution provided by reagent manufacturer (Kamihara disclose calculating a relative ratio 55 (predicted variation amount) between lots of reagents using a difference in upper and lower limit values of the standard solution absorbance range provided by the reagent manufacturer, and a measured value of the standard solution for each lot; figs. 5-6, Steps 10-16 [0058-0064, 0082, 0087-0093, 0099-0101]),
estimate a cause of variation occurring in the measurement value of the quality control substance based on a comparison result between the variation amount and the predicted variation amount (Kamihara disclose reagent-derived value alarms that use the variation amount and relative ratio 55 to estimate apparatus-derived abnormalities or an abnormal data from the batch/lot; [0076, 0094, 0104]),
upon determining the cause of variation occurring in the measurement value of the quality control substance automatically correct the measurement value of the quality control substance according to the cause of variation (Kamihara disclose the variable parameters 38/48 are automatically replaced by newly registered ones each time the reagent batch is changed or may be edited by a user; fig. 5, [0067, 0071-0074]), and
estimate that the lot change of the calibration solution is the cause of variation upon determining the variation amount is within a range of the predicted variation amount (Kamihara teach the change in batch of the calibration solution is the cause of variation in the allowable range; fig. 6; [0090-0094].
Regarding claim 3, Kamihara disclose the automatic analysis device according to claim 1 above, wherein the computer is programmed to estimate that the lot change of the calibration solution is not the cause of variation upon determining the measurement value of the quality control substance and the measurement value of the concentration of the calibration solution have different variation directions (Kamihara; [0076, 0094, 0104]).
Regarding claim 4, Kamihara disclose the automatic analysis device according to claim 1 above, wherein the computer is programmed to, upon determining that the lot change of the calibration solution is the cause of variation, an input value of the concentration value of the second calibration solution calculated based on the predicted variation amount is displayed (Kamihara; figs. 4-6, “calculated value”).
Regarding claim 5, Kamihara disclose the automatic analysis device according to claim 4 above, wherein the input value is displayed in a daily difference variation graph indicating a shift in the measurement value of the quality control substance (Kamihara; fig. 6B, [0090-0094]).
Regarding claim 6, Kamihara disclose the automatic analysis device according to claim 1 above, wherein the measurement value of the quality control substance is corrected based on the display difference value and the measurement difference value (Kamihara disclose the variable parameters 38/48 are automatically replaced by newly registered ones each time the reagent batch is changed or may be edited by a user; fig. 5, [0067, 0071-0074]).
Regarding claim 7, Mimura disclose the automatic analysis device according to claim 2 above, wherein the computer is programmed to, upon determining the lot change of the calibration solution is not the cause of variation, the measurement difference value is displayed in a daily difference variation graph indicating a shift in the measurement value of the quality control substance (Kamihara; fig. 6, [0087-0094]).
Response to Arguments
Applicant’s arguments, filed 01/06/2026, have been fully considered.
Applicant argues on pages 5-6 of their remarks toward the 101 rejection over claim 1 that the claim sets forth an improvement to automatic analyzers by automatically estimating a cause of variation occurring in the measurement value of the quality control substance, and that the alleged abstract idea is integrated into a practical application of the abstract idea demonstrated by the particular improvement. The examiner respectfully disagrees. Outside of the abstract idea(s), the claim is generally an automatic analyzer comprising a computer for analyzing a sample where any conventional automatic analyzer performs these functions. The analyzer and computer are not particular machines and are not being transformed into a particular machine, but rather are being used in their ordinary capacity. In this case, the analyzer and computer are solely being used to gather data which is extra-solution activity (see MPEP 2106.05(c)). The abstract idea “estimating a cause of variation occurring in the measurement value of the quality control substance” alone does not lead to an alleged improvement because the abstract idea (estimating) itself cannot be the alleged improvement in a particular technology. See MPEP 2106.05(a) paragraphs 4-7.
Applicant states on page 7 that the improvement can be provided by the additional element(s) in combination with the recited judicial exception, and that the improvement set forth in claim 1 is not to the alleged abstract idea itself. The examiner agrees that the improvement can be in the additional elements; however, outside of the abstract idea(s), the additional elements recited in the claims include “an automatic analysis device for analyzing a sample”, “a computer”, “a quality control substance”, a first calibration solution”, and “a second calibration solution”. These additional elements do not amount to significantly more as they are well-understood, routine, and convention (WURC) in the art as evidenced by Mimura et al. (US 2007/0217949 – hereinafter “Mimura”) and Satomura et al. (US 2007/0255756 – hereinafter “Satomura”). Mimura and Satomura teach an automatic analysis device for analyzing a sample (Mimura; [0002] and Satomura; fig. 1, #3a, [0046]), a computer (Mimura; fig. “dedicated terminal” and Satomura; fig. 1, #5, [0046]), a quality control substance, a first calibration solution and a second calibration solution (Mimura; fig. 1, [0007, 0050-0052] and Satomura; [0059-0060]). The claims by-in-large do not contain any additional elements aside from a general-purpose computer to apply the judicial exception and therefore, comprises no additional claim elements that amount to significantly more. The analyzer and computer are not particular machines and are not being transformed into a particular machine, but rather are being used in their ordinary capacity. In this case, the analyzer and computer are solely being used to gather data which would not provide significantly more (see MPEP 2106.05(c)).
Applicant further argues on pages 7-8 that the limitations are not insignificant post-solution activities because these activities directly relate to improving the automatic analyzer by maintaining the quality of sample analysis. The examiner respectfully disagrees. The computer programmed to perform the recited steps/processes is merely a general-purpose computer for which to apply the abstract ideas, but does not preclude the steps from being considered an abstract idea. See MPEP 2106.04(a)(2) subsections (I) and (III). The additional elements recited in the claim 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). The recited functions “calculates the predicted variation amount … and a measurement difference value” and “estimate … the cause of variation” are mere instructions to implement the abstract idea or other exception on a computer (see MPEP 2106.05(f)). Accordingly, these elements amount to a machine that contributes only nominally or insignificantly to the execution of the claimed system and would not integrate a judicial exception or provide significantly more (see MPEP § 2106.05(b)(III), MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-understood, Routine, Conventional Activity). Further, the analyzer and computer are not particular machines and are not being transformed into a particular machine, but rather are being used in their ordinary capacity. In this case, the analyzer and computer are solely being used to gather data which is extra-solution activity (see MPEP 2106.05(c)).
Applicant argues on pages 8-12 that Mimura does not at all disclose estimating a cause of variation occurring in the measurement value of the quality control substance, and that Mimura is silent to disclosing “calculating a predicted variation amount…” as set forth in claim 1. The examiner respectfully disagrees. Mimura disclose calculating a predicted variation amount within ±3 standard deviations from an average value for a particular lot of calibration solution or quality control material, which is deemed to be acceptable and normal; [0010, 0162-0166], and if the concentration of a measured value deviates from the predicted concentration of ±3 standard deviations from the acquired value, the analyzer issues an alarm indicating the data is abnormal and an estimate is made as to whether or not the analyzer, the reagent, the standard solution, a condition of an electric circuit, etc., are abnormal; [0004, 0008, 0021-0022]. Mimura further disclose automatically updating the predicted variation amount of ±3 standard deviations from the acquired value on the display when a lot is changed, as depicted by the upper and lower bounds in figs. 2-3. However, if it is deemed that Mimura does not teach the argued limitations, a new grounds of rejection over Kamihara has been set forth in an alternative rejection.
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:
Yundt-Pacheco (US 2004/0220761) disclose a QC program to receive test results and determine whether the test result falls within a calculated control range.
Yamaguchi et al. (US 2011/0090066) disclose a method for checking whether calibration information is within quality control data range.
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..
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