DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on xxx, 2025. Claims 1-15 are pending in the application.
Status of Objections and Rejections
All objections and rejections from the previous office action are withdrawn in view of Applicant’s amendment.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 § 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 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2012/0261260) in view of Kishioka (US 2019/0265187).
Regarding claims 1 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).
Regarding claim 2, Li teaches wherein the reagent having the known concentration is an internal standard solution (¶11).
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 and Kishioka 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 and Kishioka determines abnormality based on a fluctuation pattern, e.g., correction coefficients (¶Li, ¶24), 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 and Kishioka 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.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Kishioka, and further in view of Amemiya (US 5,580,441).
Regarding claims 3-4, Li and Kishioka disclose all limitations of claim 1, but fails to teach 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 (claim 3) 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. 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 slope is the selectivity coefficient, i.e., the linear calibration curve, and another range that the slope is zero and thus is out of the linear calibration curve. 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 and Kishioka 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), so that the measurement could be determined whether it is off the linear calibration curve or not and useful for determination of the ion concentration within the linear calibration concentration range.
The designations “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” and “wherein the concentration in the high concentration range is 10 times or more the concentration in the low concentration range” are functional limitations in apparatus claims. MPEP 2114 (II). They do 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).
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.
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues Li teaches using fluctuation patterns and calculating an electromotive force balance ratio to be compared against atypical fluctuation pattern (Response, p. 24), and thus does not teaches the determination is based on a slope that exceeds a threshold (p. 26). This argument is unpersuasive because Li teaches the fluctuation patterns include slope values (Li, ¶11). When the slope value matches with the atypical patten that must be a different value from that of the typical pattern, which is deemed to be the threshold value.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (p. 28), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, the instant uses a ratio of the slope SL2 to the slope SL1, the slope SL1 as a criteria, is (SL2/SL1 X 100) = 100 (%). If the slope SL2 to the slope SL1 is 92 (%) or less, it is determined that the water quality of the system water is abnormal (Spec. ¶38), which indicates that these four concentrations are not in a linear calibration curve, as disclosed in Amemiya (Fig. 1). Thus, one of skilled in the art would modify Li and Kishioka by using the method of Amemiya to determine an abnormality based on the slopes of the curve of multiple concentrations within high/low ranges, as the fluctuation patterns (Li, ¶11). Examiner notes here using the determined slopes of the curve over a concentration range to determine the linear calibration curve is well-known in the art (Amemiya, Fig. 1 labeled as Prior Art).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 M-F: 8:30am - 5:30pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571-272-8521. 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. SUN/Primary Examiner, Art Unit 1795