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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 1 has been entered.
Status of Objections and Rejections
The rejection of claim(s) 3 is/are obviated by Applicant’s cancellation.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection are necessitated by the amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-2 and 4-10 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites “wherein the measuring of each of the diluted reagents with known specific ion concentrations at multiple different concentrations further comprises obtaining the slope at a boundary concentration between the slope obtained from the curve of potential difference versus sample concentration of two concentrations in a high concentration range and the slope obtained from the curve of potential difference versus sample concentration of two concentrations in a low concentration range, and wherein the boundary concentration is a concentration at which an influence of the interference ions on measurement accuracy becomes unacceptable.” It is unclear what the boundary concentration is and how the slope at the boundary concentration is determined. In the specification, it seems that the boundary is between a concentration that the influence on measurement accuracy is allowable (e.g., a concentration in the higher concentration range) and a concentration that the influence is not allowable (e.g., a concentration in the lower concentration range) (Specification, ¶33). However, there are only two slopes shown in Fig. 2: one is in the higher concentration range and the other is in the lower concentration range. No slope at a boundary concentration is shown in Fig. 2 and there is no disclosure how the slope at the boundary is determined. Further, the specification discloses using the ratio of two slopes (SL2/SL1) to determine whether the influence on the measurement accuracy is allowable or not (specification, ¶38), which is not recited in the amended claim 1. Applicant is requested to particularly point out and distinctly claim the subject matter of the instant invention.
All subsequent dependent claims 2 and 4-10 are rejected due to their dependencies on rejected base claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2 and 4-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2012/0261260) in view of Kishioka (US 2019/0265187), and further in view of Amemiya (US 5,580,441).
Regarding claims 1, 4, and 10, Li teaches an electrolyte analyzer that measures the ion concentration in a liquid (¶23: an electrolyte analyzer that involves the use of ion-selective electrodes to measure patient samples, e.g., blood, urine), the analyzer comprising:
an electrolyte analysis unit including an ion-selective electrode used for measuring a specific ion (Fig. 1; ¶28: a sodium ion selective electrode 110, a potassium ion selective electrode 111, or a chlorine ion selective electrode 112) and a reference electrode (Fig. 1; ¶28: a comparative electrode 114);
a supply tank (Fig. 1; ¶27: a diluent bottle 103) that supplies a diluent via a dilution tank (Fig. 1; ¶27: a dilution tank 109) for diluting a reagent or a sample (¶27: from the diluent bottle 103 to the dilution tank 109, thereby diluting the sample); and
a processor (since the analyzer is capable of computing a balance ratio, comparing the fluctuation patterns, and determining the deterioration of the electrodes and the reagents (¶¶12-14), the analyzer must contain a process to perform the operation of the analyzer as shown in Fig. 2) configured to
measure each of the diluted reagents with known specific ion concentration at multiple different concentrations generated by diluting the reagents at known concentrations with diluent (Fig. 1; ¶23: a sample of known concentrations; high/low-concentration standard solutions; ¶27: causes a diluent to transfer from a diluent bottle 103 to the dilution tank 109, thereby diluting the sample); and
perform a water quality determination process of the dilute based on an obtained slope (¶11: the sample of known concentration is measured and the extracted fluctuation patterns of: slope values) obtained from a curve of potential difference versus sample concentration (e.g., ¶¶31: calculation of the slope sensitivity based on calibration using standard solutions of known concentrations); and
determine a water quality of the diluent to be abnormal (Fig. 3: fluctuation patterns are abnormal; estimated cause: deterioration of the ISE diluent; ¶46) due to a presence of interference ions based on the slope obtained from the curve of potential difference versus sample concentration (¶3: deterioration of the diluent or mixing of foreign substances into the diluent may result in abnormal measurement).
Li does not disclose the supply tank is a water supply tank (claim 1) or wherein the diluent is system water (claim 10).
However, Kishioka teaches an electrolyte concentration measurement device by ion selective electrode ([Abstract]). The internal standard liquid preparation unit 440 is provided with an internal standard liquid preparation container A441, an internal standard liquid preparation container B442, and a drug substance supply unit 448 that supplies a drug substance 447 (Fig. 4; ¶97). In addition, a pure water supply pump 481 that introduces pure water into each preparation container (¶97).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Li by substituting the diluent with pure water as taught by Kishioka. The suggestion for doing so would have been that pure water is a suitable material for diluent and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Li does not disclose the determination of abnormality is based on the slope exceeding a threshold.
However, Li teaches the operation of the analyzer includes extracting of fluctuation patterns and comparing the extracted fluctuation pattern against atypical fluctuation patterns (stored on the analyzer in advance) (Fig. 2; ¶44). When any of the extracted pattern matches any of the atypical patterns, the analyzer activates an alarm (Fig. 2: Step 204; ¶44). Here, the fluctuation patterns include the fluctuation patterns of slope values (¶11). Thus, Li teaches determination of abnormality is based on a fluctuation pattern, e.g., slope values, which are compared with the predetermined fluctuation patterns, and when the extracted fluctuation pattern matches with the atypical patterns, i.e., exceeding a threshold representative of the typical pattern, the abnormality is determined and an alarm is given (Fig. 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Li by using the slope values to determine the abnormality as suggested because when the fluctuation pattern matches with the stored atypical fluctuation pattern (i.e., the atypical slope value), it would exceed a threshold, i.e., the typical fluctuation pattern (i.e., the typical slope value). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Li does not disclose wherein the processor is further configured to measure the diluted reagents having four different concentrations and performs the water quality determination process of the diluent based on the slope obtained from the curve of potential difference versus sample concentration of two concentrations in a high concentration range and the slope obtained from the curve of potential difference versus sample concentration of two concentrations in the low concentration range, wherein the measuring of each of the diluted reagents with known specification concentration at multiple different concentrations further comprises obtaining the slope at a boundary concentration between the slope obtained from the curve of potential difference versus sample concentration of two concentration in a high concentration range and the slope obtained from the curve of potential difference versus sample concentration of two concentrations in a low concentration, and wherein the boundary concentration is a concentration at which an influence of the interference ions on measurement accuracy becomes unacceptable (claim 1) or wherein the concentration in the high concentration range is 10 times or more the concentration in the low concentration range (claim 4).
However, Amemiya teaches the measurements of standard solutions with different concentrations different for determination of the selectivity coefficient on the basis of output potentials over the whole potential response curves (Fig. 1: points from A to I; col. 2, ll. 46-53). Fig. 1 shows a low concentration range (e.g., A, B, C), a medium concentration range (e.g., D, E, F), and a high concentration range (e.g., G, H, I), which are the entire response curve for the object ion. The tangent of a region of the curve indicating a change in the output potential in proportion to the change in the measuring ion concentration is determined without being influenced by the interfering ion, and at the same time the tangent of a region of the curve indicating no change of the output potential due to the influence from the interfering ion is determined (col. 2, ll. 20-26). Therefore, the junction of these tangents is determined, and at the same time the concentration of the measuring ion corresponding to the junction is determined (col. 2, ll. 27-29). Thus, Amemiya teaches measuring four different concentrations, e.g., two concentrations in the high concentration range (e.g., G, H) and two concentrations in the low concentration range (e.g., B,C), which indicates a range that the measuring ion concentration is determined without being influenced by the interfering ion (col. 2, ll. 20-23) and a region indicating no change of the output potential due to the influence from the interfering ion (col. 2, ll. 24-26). Here, the concentration corresponding to the junction is Cx, which is read as the boundary concentration and below this boundary concentration, the influence of the interference ions on measurement accuracy becomes unacceptable. Further, since the x axis is log(object ion concentration) in Fig. 1, the concentration in the high concentration range is 10 times or more than the concentration in the low concentration range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Li by including four different concentrations for the water quality determination process based on the slope of the curve within two concentration ranges in which the concentration high concentration range is 10 times or more than the concentration in the low concentration range as taught by Amemiya because the broad concentration range would cover the entire response curve (col. 2, ll. 50-51) and the measurement would be used to determine whether the concentration range is influenced by the interfering ion or not (col. 2, ll. 20-26).
Regarding claim 2, Li teaches wherein the reagent having the known concentration is an internal standard solution (¶11).
Regarding claim 5, the designation “wherein as the specific ion, the concentration range in the low concentration range for chlorine ion (Cl-) is 8 to 12 (mmol/l), the concentration range in the low concentration range for potassium ion (K+) is 0.3 to 0.7 (mmol/l), and the concentration range in the low concentration range for sodium ion (Na+) is 12 to 16 (mmol/l)” is functional limitations in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, the combined Li, Kishioka, and Amemiya determines the water quality based on slopes obtained from the curves of potential difference versus sample concentration obtained from results of measuring at multiple concentrations, e.g., two concentrations in a high concentration range and another two in a low concentration range, and thus is capable of obtaining the slopes of the ion concentration range for specific ions as recited.
Regarding claim 6, Li in view of Kishioka teaches wherein the water quality determination process of the diluent is performed based on the slope obtained from the curve of potential difference versus sample concentration obtained from results of measuring at multiple concentrations. The designation “the diluted reagents having ion concentrations selected from the range of 8-12 (mmol/l) in the case of chlorine ion (Cl-), 0.3 to 0.7(mmol/l) in the case of potassium ion (K+), and 12 to 16 (mmol/l) in the case of sodium ion (Na+) as the specific ion” is functional limitations in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, the combined Li Kishioka, and Amemiya determines the water quality based on slopes obtained from the curves of potential difference versus sample concentration obtained from results of measuring at multiple concentrations, and thus is capable of obtaining the slopes of the ion concentration range for specific ions as recited.
Regarding claim 7, the designation “wherein if the water quality of the diluent is determined to be abnormal in the water quality determination process, the processor is further configured to correct the measurement of the sample concentration by the ion-selective electrode by using a predetermined correction coefficient according to the ion concentration of the diluent” is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, the combined Li, Kishioka, and Amemiya determines abnormality based on a fluctuation pattern, e.g., correction coefficients (¶Li, ¶24) or the slopes within different concentration range (Amemiya, col. 2, ll. 20-29), which are compared with the predetermined fluctuation patterns, and when the extracted fluctuation pattern matches with the atypical patterns, i.e., exceeding a threshold representative of the typical pattern. Thus, it is capable of correcting the measurement of the sample concentration by the ion-selective electrode by using a predetermined correction coefficient according to the ion concentration of the diluent
Regarding claim 8, Li teaches wherein an alarm is issued when the water quality of the diluent is determined to be abnormal in the water quality determination process (¶47: an alert icon is displayed on the screen).
Regarding claim 9, Li teaches wherein the water supply tank stores the diluent (Fig. 1: ¶27: a diluent bottle 103; a diluent to transfer from a diluent bottle 103 to the dilution tank 109, thereby diluting the sample).
The designation “if the water quality of the diluent is determined to be abnormal in the water quality determination process after a cleaning step including the cleaning of the water supply tank with a detergent and the rinsing, it is determined that the detergent remains” is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, the combined Li Kishioka, and Amemiya determines abnormality based on an extracted fluctuation pattern compared with the predetermined atypical fluctuation patterns, for judging diluent deterioration (Li, claim 4). Thus, it is capable of determining that the detergent remains after a cleaning step of the water supply tank if an abnormality is determined.
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant cited the specification (¶¶33, 38) (Response, pp. 10-11) to support the amended claim 1. However, it is unclear how to determine an inclination (i.e., slope) at the boundary (Specification ¶33) and there are only two slopes within the higher concentration range and the lower concentration range as shown in Fig. 2. The disclosure in the specification ¶38 is to use the ratio of two slopes, not a slope at the boundary, to determine whether the influence on the measurement accuracy is allowable or not. Examiner suggests to recite the subject matter of the instant application, for example, the ratio of the two slopes instead of a slope at the boundary. Further search and consideration would be required based upon any further amendments.
Applicant argues Amemiya disclose taking measurements of standard solutions with different concentrations different for determination of the selectivity coefficient on the basis of output potentials (Response, pp. 14-15). Applicant asserts that Amemiya does not teach that Cx is used as a “boundary concentration” as a concentration at which an influence of the interference ions on measurement accuracy becomes unacceptable (p. 16, para. 2 to p. 17, para. 2). These arguments are unpersuasive. Amemiya explicitly discloses the tangent of a region of the curve indicating a change in the output potential in proportion to the change in the measuring ion concentration is determined without being influenced by the interfering ion, and at the same time the tangent of a region of the curve indicating no change of the output potential due to the influence from the interfering ion is determined (col. 2, ll. 20-26). Therefore, the junction of these tangents is determined, and at the same time the concentration of the measuring ion corresponding to the junction is determined (col. 2, ll. 27-29). Thus, the concentration Cx corresponds to the junction and is read as the boundary concentration. The determination of Cx is a concentration between the higher concentration range and the lower concentration range, in which the measurements is not influenced by the interfering ion and influenced by the interfering ion respectively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached on M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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