DETAILED CORRESPONDENCE
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/11/25 has been entered.
Response to Amendment
As to the claim amendments filed on 10/30/25, the previous 101 rejection has been modified to address the claim amendments.
Based on the clam amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Status
Claims 1-2, 4-7 are pending.
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 1-2, 4-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract ideas of “predict and notify” which are done “by predictive analysis based on a progress of deterioration of reagent based on an approximation line or an approximate curve”, and “perform calibration…”. The prediction is an abstract idea of estimating. Further, the notification is also paired with the prediction and it is done by “predictive analysis” which is a mental process and/or math. The predictive analysis is based on an approximation curve which is also either an evaluation or math. Additionally, performing calibration by generating standard curves is an abstract idea in the form of mental process and/or math, or could be done by pencil and paper. MPEP 2106.04(a)(2)III is clear that using pencil and paper or a computer to perform the abstract idea does not preclude the steps from being considered an abstract idea.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No. Once the computer predicts and notifies an expiration date and performs calibration, then nothing happens. Therefore, there is no application, much less a particular practical application. Even if the notifying was not an abstract idea, just sending a notification does not integrate the exception into a practical application because notifying is insignificant post-solution activity and not a particular practical application, similar to the alarm in Parker v. Flook. See MPEP 2106.04(d) and 2106.05(g). Additionally, the displaying could be considered just generally linking the use of the judicial exception to a particular technological environment or field of use. See MPEP 2106.05(h).
Also, the abstract ideas are done by a general-purpose computer. A general-purpose computer coupled with a generic analyzer is not a particular machine, and performing the abstract idea on a general-purpose computer is not enough to integrate the exception into a practical application (See MPEP 2106.05(b)I.).
The claim also recites an automatic analyzer to perform analysis by causing a sample to react with a reagent and measuring absorbance. However, this is just using the analyzer to gather data to be used in the abstract idea. However, data gathering to be used in the abstract idea does not integrate the judicial exception into a practical application because data gathering is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Additionally, this is recited at such a high level of generality that it amounts to just generally applying the abstract idea per MPEP 2106.05(f), and also is just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements are an automatic analysis device comprising: a sample dispensing mechanism; a reagent dispensing mechanism; a reaction disk on which a reaction container, in which a sample reacts with a reagent, is set; a photometer that measures an absorbance in the reaction container; a sample disk on which the sample is set; a reagent disk on which the reagent is set; and a computer that controls the automatic analysis device, where the computer includes ASIC or FPGA. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Li et al (US 20130151189; hereinafter “Li”; already of record) or Gemperle et al (US 20180252737; hereinafter “Gemperle”) which teach an automatic analysis device (Li teaches an analyzer; Fig. 1, [2, 16, 17, 29-34, 48, 58]) comprising: a sample dispensing mechanism (Li; #5, Fig. 1); a reagent dispensing mechanism (Li; #10, Fig. 1); a reaction disk on which a reaction container, in which a sample reacts with a reagent, is set (Li; #6/9, Fig. 1); a photometer that measures an absorbance in the reaction container (Li; #15, Fig. 1); a sample disk on which the sample is set (Li; #1, Fig. 1); a reagent disk on which the reagent is set (Li; #12, Fig. 1); and a computer that controls the automatic analysis device (Li; #3, Fig. 1), and also where computer control function via software programming or ASIC for controllers are well-known in the art (Gemperle; [31]).
Dependent claims 2, 4-7 are similarly rejected because they do not resolve any of the above issues. Claim 2 just recites calibration being performed and recorded, where calibration is an abstract idea under step 2A prong 1, and even if the calibration was not abstract it is just data gathering under step 2A prong 2, and where recording/storing is just insignificant extra-solution activity or generally linking the exception to the field of use (See MPEP 2106.04(d) and 2106.05(g), and MPEP 2106.05(h)). Claim 4 just recites the details of creating an approximation line which is just math and/or a mental process, or can be done via pencil and paper, under step 2A prong 1, and after the determination then there is no action taken or integration under step 2A prong two. Claim 5 does not appear to recite any other elements and therefore remains ineligible under 101 for the reasons discussed above with respect to claim 1. Claims 6-7 do not appear to recite other elements and remain ineligible under 101 for the reasons discussed above with respect to claim 1. Further, even if claims 5-7 did positively recite the determination and selection steps, then these processes are still mental processes under step 2A prong 1 with no corresponding application.
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 (i.e., changing from AIA to pre-AIA ) 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 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 1-2, 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US 20130151189; hereinafter “Li”; already of record) alone, or alternatively in view of Gemperle et al (US 20180252737; hereinafter “Gemperle”).
As to claim 1, Li teaches an automatic analysis device (Li teaches an analyzer; Fig. 1) comprising:
a sample dispensing mechanism (Li; #5, Fig. 1);
a reagent dispensing mechanism (Li; #10, Fig. 1);
a reaction disk on which a reaction container, in which a sample reacts with a reagent, is set (Li; #6/9, Fig. 1);
a photometer that measures an absorbance in the reaction container (Li; #15, Fig. 1);
a sample disk on which the sample is set (Li; #1, Fig. 1);
a reagent disk on which the reagent is set (Li; #12, Fig. 1); and
a computer that controls the automatic analysis device (Li; #3, Fig. 1); wherein the computer is configured to perform analysis by causing the sample to react with the reagent, and predict and notify an expiration date of the reagent by performing predictive analysis based on a progress of deterioration of the reagent based on an approximation line or an approximate curve by using past and current absorbance values of a calibration result; and wherein the computer is configured to perform calibration that generates a standard curve a plurality of times for each lot is executed by using a property in absorption spectroscopic analysis pertaining to a standard liquid, the approximation line is created by using at least one of measurement date and time and measured absorbance data of each of first to (N + 1)th (N = 1, 2, and so on) calibration at a stage where the calibration in any lot is implemented (N + 1) times, and a date and time when the measured absorbance data is beyond a predetermined limit absorbance is predicted and notified based on the approximation line (Li teaches an analyzer that performs quality control measurement to determine whether a reagent is deteriorated based on changes in absorbance, where the standard lines are compared to a threshold control range to determine if the reagent is deteriorated (i.e. expired); [2, 16, 17, 29-34, 48, 58]. Li teaches that absorbance values of the regents are measured, then statistical processing (predictive analysis) is performed to predict the degree of reagent deterioration, where the k-factor as the confidence interval can be used, and would be indicative of the interval constraints on when the reagent is ok and when it has deteriorated; [16, 17]. Given that the reagents are measured at predetermined time intervals, and that the reagents can be measured at various time intervals to account for day-to-day variation then this means that there are multiple measurements created using both current and previous results; [2, 16]. Measuring the reagent over time as recited in [2, 16, 30] would create an approximate line/curve since the curve/line is just based on 2 measured values, and then using that information to perform statistical processing to determine intervals (time/date) in which calibration should be performed [16] would mean that the predictive analysis was performed to predict deterioration date as the report of the “interval at which calibration should be performed” is the newly predicted “expiration date”. Li also teaches that based on the measurement data, that a pattern (approximation line/curve) is extracted and then the range (date) of variation is determined, where a warning is notified to indicate optimum/predicted intervals/dates where calibration may be expired; [29, 32, 48]. Further, Li teaches that reagent is known to drift/deteriorate over time, which is why calibration is updated at various intervals; [48]. Li teaches that when the calibration shows that the reagent is deteriorated/varies past a limit then a note to indicate necessity for additional calibration is provided, where the note is the display and the necessity for additional calibration could be interpreted as the expiration date; [29]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”, “to…”, “using…”, etc). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Li does not specifically teach that the computer is a computer, including an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA). However, one of ordinary skill in the art would have found it obvious to have modified the computer program of Li to have been an ASIC or FPGA as an obvious variant because one of ordinary skill in the art would know that these are substitutable equivalents to computer programs and easily selectable from a small list of alternative variants that achieve the same function of programming a computer. Alternatively, Gemperle teaches the analogous art of a sample analyzer (Gemperle; [70]) where the computer controller function is known to be controlled by an ASIC (Gemperle; [31]). It would have been obvious to one of ordinary skill in the art to have substituted the computer controller function of Li to have been performed by an ASIC as in Gemperle because Gemperle teaches that these are obvious variants of software and hardware programming for controllers that are known in the art (Gemperle; [31]).
As to claim 2, modified Li teaches the automatic analysis device according to claim 1, wherein the computer is configured to record the measured absorbance during the calibration for each reagent bottle, and when there is a calibration result of the reagent in a same lot, and to provide expiration date information of a reagent bottle on which the calibration is not performed based on the expiration date determined based on the calibration result (Li teaches performing calibration on each bottle; [16, 32]. Li also teaches providing the expiration date (see above in claim 1). This expiration would apply to all bottles in the same lot if a user decided on a lot-to-lot calibration instead of a bottle-to-bottle calibration).
As to claim 4, modified Li teaches the automatic analysis device according to claim 1, wherein the computer is configured to create the approximation line by using an initial calibration result, a second calibration result, and respective calibration implementation timings, and to automatically determine a predicted expiration date of the reagent by using a point corresponding to a point of intersection of an extension line of the approximation line and a preliminarily set limit absorbance line (Li teaches creating calibration lines; Figs. 1-5, and see claim 1 above. The expiration date is determined by comparing whether the calibration lines to a threshold control range to determine if the reagent is deteriorated (i.e. expired); [2, 16, 17, 29-34, 48, 58]).
As to claim 5, modified Li teaches the automatic analysis device according to claim 1, wherein accuracy of a determined expiration date and time is improved by increasing the number of adopted calibration results in accordance with the number of calibration implementations (Li teaches the analyzer structure. How the accuracy is improved is functional and intended use language that does not further define the apparatus structure beyond that of a capability. Li also teaches increasing number of calibrations so that intervals are shorter to improve accuracy; [48]).
As to claim 6, modified Li teaches the automatic analysis device according to claim 1, wherein one or more conditions are set for determining the expiration date of the reagent (Li teaches the analyzer structure. What settings are used, and how the conditions are set, and the determinations made are functional and intended use language that does not further define the apparatus structure beyond that of a capability. Li teaches the analyzer running analysis where various conditions are set within an analyzer; [2, 30]).
As to claim 7, modified Li teaches the automatic analysis device according to claim 6, wherein setting of the one or more conditions includes setting of a limit absorbance, selection of a calibrator to be used, and selection of a main wavelength which is a measurement wavelength/a sub wavelength/a difference in two wavelengths are performed (Li teaches the analyzer structure. What settings are used, and how the conditions are set, and the determinations and selections made are functional and intended use language that does not further define the apparatus structure beyond that of a capability. Li teaches the analyzer running analysis where various conditions are set within an analyzer; [2, 30]).
Claims 1-2, 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al (Translation of JP2009168730; hereinafter “Tanaka”; already of record) alone, or alternatively in view of Gemperle et al (US 20180252737; hereinafter “Gemperle”).
As to claim 1, Tanaka teaches an automatic analysis device (Tanaka teaches an analyzer; Fig. 2, [36]) comprising:
a sample dispensing mechanism (Tanaka; #2-7, Fig. 2);
a reagent dispensing mechanism (Tanaka; #2-10, Fig. 2);
a reaction disk on which a reaction container, in which a sample reacts with a reagent, is set (Tanaka; #2-1, Fig. 2);
a photometer that measures an absorbance in the reaction container (Tanaka; #2-12, Fig. 2);
a sample disk on which the sample is set (Tanaka; #2-5, Fig. 2);
a reagent disk on which the reagent is set (Tanaka; #2-9, Fig. 2); and
a computer that controls the automatic analysis device (Tanaka; #2-15, Fig. 2); wherein the computer is configured to perform analysis by causing the sample to react with the reagent, and predict and notify an expiration date of the reagent by performing predictive analysis based on a progress of deterioration of the reagent based on an approximation line or an approximate curve by using past and current absorbance values of a calibration result; and wherein the computer is configured to perform calibration that generates a standard curve a plurality of times for each lot is executed by using a property in absorption spectroscopic analysis pertaining to a standard liquid, the approximation line is created by using at least one of measurement date and time and measured absorbance data of each of first to (N + 1)th (N = 1, 2, and so on) calibration at a stage where the calibration in any lot is implemented (N + 1) times, and a date and time when the measured absorbance data is beyond a predetermined limit absorbance is predicted and notified based on the approximation line (Tanaka teaches obtaining and displaying a calibration curve based on absorbance values [19, 21], and then predict/determining future expiration date of reagents [5, 6, 7, 10-12, 34]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”, “to…”, “using…”, etc). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Tanaka does not specifically teach that the computer is a computer, including an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA). However, one of ordinary skill in the art would have found it obvious to have modified the computer program of Tanaka to have been an ASIC or FPGA as an obvious variant because one of ordinary skill in the art would know that these are substitutable equivalents to computer programs and easily selectable from a small list of alternative variants that achieve the same function of programming a computer. Alternatively, Gemperle teaches the analogous art of a sample analyzer (Gemperle; [70]) where the computer controller function is known to be controlled by an ASIC (Gemperle; [31]). It would have been obvious to one of ordinary skill in the art to have substituted the computer controller function of Tanaka to have been performed by an ASIC as in Gemperle because Gemperle teaches that these are obvious variants of software and hardware programming for controllers that are known in the art (Gemperle; [31]).
As to claim 2, modified Tanaka teaches the automatic analysis device according to claim 1, wherein the computer is configured to record the measured absorbance during the calibration for each reagent bottle, and when there is a calibration result of the reagent in a same lot, and to provide expiration date information of a reagent bottle on which the calibration is not performed based on the expiration date determined based on the calibration result (Tanaka teaches performing calibration on each bottle; [9]. Tanaka also teaches providing the expiration date (see above in claim 1). This expiration would apply to all bottles in the same lot if a user decided on a lot-to-lot calibration instead of a bottle-to-bottle calibration).
As to claim 4, modified Tanaka teaches the automatic analysis device according to claim 1, wherein the computer is configured to create the approximation line by using an initial calibration result, a second calibration result, and respective calibration implementation timings, and to automatically determine a predicted expiration date of the reagent by using a point corresponding to a point of intersection of an extension line of the approximation line and a preliminarily set limit absorbance line (Tanaka teaches obtaining and displaying a calibration curve based on absorbance values [19, 21], and then predict/determining future expiration date of reagents [5, 6, 7, 10-12, 31, 34])
As to claim 5, modified Tanaka teaches the automatic analysis device according to claim 1, wherein accuracy of a determined expiration date and time is improved by increasing the number of adopted calibration results in accordance with the number of calibration implementations (Tanaka teaches the analyzer structure. How the accuracy is improved is functional and intended use language that does not further define the apparatus structure beyond that of a capability. Tanaka also teaches that a user can add a calibration; [11, 14, 34]).
As to claim 6, modified Tanaka teaches the automatic analysis device according to claim 1, wherein one or more conditions are set for determining the expiration date of the reagent (Tanaka teaches the analyzer structure. What settings are used, and how the conditions are set, and the determinations made are functional and intended use language that does not further define the apparatus structure beyond that of a capability. Tanaka teaches the analyzer running analysis where various conditions are set within an analyzer; [19, 31]).
As to claim 7, modified Tanaka teaches the automatic analysis device according to claim 6, wherein setting of the one or more conditions includes setting of a limit absorbance, selection of a calibrator to be used, and selection of a main wavelength which is a measurement wavelength/a sub wavelength/a difference in two wavelengths are performed (Tanaka teaches the analyzer structure. What settings are used, and how the conditions are set, and the determinations and selections made are functional and intended use language that does not further define the apparatus structure beyond that of a capability. Tanaka teaches the analyzer running analysis where various conditions are set within an analyzer; [19, 31]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Shiba et al (US 20190072576; hereinafter “Shiba”; already of record) teaches determining a calibration curve result of a reagent.
Nakasawa et al (US 20150044096; hereinafter “Nakasawa”; already of record) teaches performing calibration with a reagent and then performing quality control [11] where results from quality control are used to determine condition of reagent and new reagents use previous calibrations when previous calibration curves are determined to not have deteriorated [29]. See also [49, 54, 56-58] and Fig 3 which discuss quality control which would be the validation of the calibration reagents. Also discusses making calibration curve by an approximation, thereby creating an approximation curve; [56].
Kamihara et al (US 20130266484; hereinafter “Kamihara”; already of record) teaches an analyzer that does quality control to check the calibration values; [58-65] Fig. 3. When the calibration values are not within a threshold then an alarm is sent indicating the expiration of the reagent; [70, 94].
Hiramatsu et al (US 20040086429; hereinafter “HIramatsu”; already of record) teaches obtaining expiration date of reagent and then gathering deterioration correction data to correct calibration curve; Fig. 7. Given that Hiramatsu likely used calibration and various data points to create a correction table, then Hiramatsu likely made determinations on whether the reagent was expired to determine the expiration dates of the reagent based on reagent data variability from what the reagent should normally be measured as.
Mezei et al (US 4873633; hereinafter “Mezei”; already of record) teaches quality control data of reagents includes expiration data and associated absorbances; Col. 4 lines 12-18. Mezei teaches checking reagents over time (col. 12 line 33-43) and that quality control tests show acceptable ranges where if the QC test value is out of acceptable threshold then the determination is made that the reagent is expired/deteriorated (col. 14 line 9-50). Mezei teaches that shifting in the absorbance shows a deterioration in the reagent quality which would indicate the reagent is expired; col. 18 line 54-55.
Nozawa et al (US 20090269242; hereinafter “Nozawa”; already of record) teaches determining calibration based on lot or bottle; Fig. 6.
Response to Arguments
Applicant's arguments filed 10/30/25 have been fully considered.
With respect to the arguments towards the prior art rejection on pages 6-8 of their remarks, the arguments have been considered, but are moot because the arguments are towards the amended claims and not the current grounds of rejection.
The arguments towards the 101 rejection on page 5 of their remarks has been considered, but are they are not persuasive.
Applicants argue on page 5 of their remarks that the device is particular. The examiner respectfully disagrees. In step 2A Prong Two, as required in MPEP 2106.05(b), in evaluating integration into a particular practical application we also evaluate whether the judicial exception is applied with or used by a particular machine. Applicants argue on page 5 of their remarks that the analysis device has specific hardware elements that are particular. The examiner disagrees that the recited hardware is particular because all automated analysis devices would have the components sample/reagent dispensers, a reaction disk with a photometer, and sample/reagent disks thereby making the analyzer structure a generic analyzer and not a particular machine. Most analysis devices have these structures, and therefore these structures do not amount to a particular machine (see for example the prior art rejection and other references cited section). See MPEP 2106.05(b)I which discusses why the antenna was considered particular (included details such as shape of the antenna, length, conductors, etc) and why a Fourdrinier machine was particular.
Applicants argue on page 5 of their remarks that claim 1 recites a technological improvement because it makes it possible to save check time and that a state of deterioration can be accurately ascertained. Applicants also highlight that the improvement is in performing the predictive calibration/analysis, which is the abstract idea itself. In step 2A Prong Two, as required in MPEP 2106.04(d)(1) and 2106.05(a)II, we evaluate any potential improvements in technology, and make sure that the claims reflect all of the elements that lead to the improvement. However, it’s important to note that the judicial exception alone cannot provide the improvement (i.e. that the improvement cannot be in the abstract idea). See MPEP 2106.05(a), fifth paragraph. In this case, applicants cite to [23, 38] of the specification which state that the predictive calibration process is what leads to the improvement (see page 5 of their arguments). This argument is not persuasive because in order to overcome the 101 rejection, the improvement cannot be the abstract idea but must be in a particular technology (See paragraphs 4-7 of MPEP 2106.05(a)). See also MPEP 2106.05(a)II, which states that standard laboratory techniques, or gathering and analyzing information are not sufficient to show an improvement in technology, and the examiner notes that calibration is both a standard laboratory technique and a conventional data gathering method because no automated analytical devices operate without being properly calibrated.
Applicants argue on page 6 that the “computer…configured to” language is not merely functional language and that the control function is a structural limitation in the claims. Although the argued language is newly amened, the examiner agrees and has interpreted the claims as such for purposes of examination.
Applicants argue on page 7 of their remarks that Li does not disclose “wherein the computer is configured to perform calibration that generates a standard curve a plurality of times for each lot is executed by using a property in absorption spectroscopic analysis pertaining to a standard liquid, the approximation line is created by using at least one of measurement date and time and measured absorbance data of each of first to (N + 1)th (N = 1, 2, and so on) calibration at a stage where the calibration in any lot is implemented (N + 1) times, and a date and time when the measured absorbance data is beyond a predetermined limit absorbance is predicted and notified based on the approximation line”. The examiner respectfully disagrees. Li teaches an analyzer that performs quality control measurement to determine whether a reagent is deteriorated based on changes in absorbance, where the standard lines are compared to a threshold control range to determine if the reagent is deteriorated (i.e. expired); [2, 16, 17, 29-34, 48, 58]. Li teaches that absorbance values of the regents are measured, then statistical processing (predictive analysis) is performed to predict the degree of reagent deterioration, where the k-factor as the confidence interval can be used, and would be indicative of the interval constraints on when the reagent is ok and when it has deteriorated; [16, 17]. Given that the reagents are measured at predetermined time intervals, and that the reagents can be measured at various time intervals to account for day-to-day variation then this means that there are multiple measurements created using both current and previous results; [2, 16]. Measuring the reagent over time as recited in [2, 16, 30] would create an approximate line/curve since the curve/line is just based on 2 measured values, and then using that information to perform statistical processing to determine intervals (time/date) in which calibration should be performed [16] would mean that the predictive analysis was performed to predict deterioration date as the report of the “interval at which calibration should be performed” is the newly predicted “expiration date”. Li also teaches that based on the measurement data, that a pattern (approximation line/curve) is extracted and then the range (date) of variation is determined, where a warning is notified to indicate optimum/predicted intervals/dates where calibration may be expired; [29, 32, 48]. Further, Li teaches that reagent is known to drift/deteriorate over time, which is why calibration is updated at various intervals; [48]. Li teaches that when the calibration shows that the reagent is deteriorated/varies past a limit then a note to indicate necessity for additional calibration is provided, where the note is the display and the necessity for additional calibration could be interpreted as the expiration date; [29].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571)272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798