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 .
Status of the Claims
The Amendment filed December 9, 2025 has been entered. Claims 11-13 and 15-17 have been amended; claims 22-33 are new; and claims 1-10 and 18-20 have been cancelled. Claims 11-17 and 21-33 are currently pending and are examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed September 17, 2025.
The claim interpretation under 112(f) is withdrawn in view of the amendment.
New grounds of claim objection are necessitated by the amendment as outlined below.
New grounds of claim rejection under 112(b) are necessitated by the amendment as outlined below.
All 35 U.S.C. § 103 rejections for claims 11-17 and 21 from the previous office action are substantially maintained and modified only in response to the amendment.
New grounds of rejection for new claims 22 and 24-33 under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/20/2026 has been considered by the examiner.
Claim Objection
Claims 11, 13, 15-16, 21-22, 27-28, 30 and 33 are objected to because of the following informalities:
Claim 11: please amend “each of said working electrodes” to -- each of said one or more working electrodes--; “wherein the analyte ion measurement assembly is an electroanalytical measurement assembly” to -- wherein the analyte ion measurement assembly is [[an]] the electroanalytical measurement assembly--; “measuring one or more potential differences” to -- measuring the one or more potential differences--.
Claim 13: please amend “one or more concentrations” to –the one or more concentrations--.
Claim 15: please amend “the analyte ion” to -- the one or more analyte ions--.
Claim 16: please amend “one or more concentrations of one or more analyte ions in a sample” to –the one or more concentrations of the one or more analyte ions in [[a]] the sample--.
Claim 21: please amend “the analyte ion being a monovalent ion” to -- the one or more analyte ions being [[a]] the monovalent ion --.
Claim 22: please amend “each of said working electrodes” to -- each of said one or more working electrodes--; “determine one or more concentrations” to -- determine the one or more concentrations--; “wherein the analyte ion measurement assembly is an electroanalytical measurement assembly” to -- wherein the analyte ion measurement assembly is [[an]] the electroanalytical measurement assembly--.
Claim 27: please amend “the analyte ion” to -- the one or more analyte ions--.
Claim 28: please amend “one or more concentrations of one or more analyte ions in a sample” to –the one or more concentrations of the one or more analyte ions in [[a]] the sample--.
Claim 30: please amend “the analyte ion measurement” to -- the analyte ion measurement assembly--; “wherein the analyte ion measurement assembly is an electroanalytical measurement assembly” to -- wherein the analyte ion measurement assembly is [[an]] the electroanalytical measurement assembly--; “measuring one or more potential differences” to -- measuring the one or more potential differences--.
Claim 33: please amend “the analyte ion” to -- the one or more analyte ions--.
Appropriate correction is required.
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.
Claims 22-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Regarding claim 22, claim 22 recites “the one or more potential difference” in Ln 16, which lacks antecedent basis. Therefore, the scope of claim 22 is indefinite. Claims 23-29 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 22.
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.
Claims 11-16, 21-22, 24-28, 30, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Ye (US 20060025748 A1) in view of Low et al. (US 20190056329 A1).
Regarding claim 11, Ye teaches an apparatus for measuring one or more potential differences being indicative of one or more concentrations of one or more analyte ions in a sample (a system that determines an analyte potassium ion concentration as a function of a reference sodium ion concentration and a differential electric potential [0014]), comprising:
an analyte ion measurement assembly (ISE system 100 in Fig. 3 [0048]) comprising:
(i) one or more working electrodes, each of said one or more working electrodes comprising an ion-selective electrode, which is selective for an analyte ion (working ISE 102 in Fig. 3 is solid-state and selective for potassium ion [0018, 0048, Examples 1-2]), and
(ii) a reference electrode comprising an ion-selective electrode, which is selective for a reference ion (reference ISE 104 in Fig. 3 is solid-state and selective for sodium ion [0018, 0048-0049, Example 3]) such that the reference electrode is configured to perform a measurement based on the reference ion (since reference ISE 104 is selective for sodium ion, it is capable of performing a measurement based on the reference ion of sodium ion),
wherein the analyte ion measurement assembly is an electroanalytical measurement assembly (potassium ion measurement is dependent on differential electrical potential 126 produced between ISEs 102 and 104 in Fig. 3 [0049-0052], thus the analyte ion measurement assembly is an electroanalytical measurement assembly ),
and wherein the analyte ion measurement assembly is arranged for measuring one or more potential differences directly or indirectly between:
(i) each of the one or more working electrodes, and
(ii) the reference electrode (the measured differential electrical potential 126 is produced directly between working ISE 102 and reference ISE 104 in Fig. 3 [0049-0052]).
Ye further teaches that a reference ion measurement assembly, being arranged for measuring a parameter indicative of a concentration of a reference ion would provide more accurate calculations of the analyte ion concentration (measurement of a reference sodium ion concentration is obtained periodically via a method separate from the ion-selective electrode [ISE] system 100 in Fig. 3 to calculate an accurate target potassium ion concentration [0017, 0048, 0054]).
Ye is silent to a reference ion measurement assembly being arranged for measuring a parameter indicative of a concentration of a reference ion, wherein the reference ion measurement assembly is different from an electroanalytical measurement assembly.
Low teaches an apparatus for measuring one or more potential differences being indicative of one or more concentrations of one or more analyte ions in a sample (analyzer system 100 in Fig. 1 including sensor chip 800 in Fig. 8A, which can include a potentiometric sensor for sensing ionic species [0013, 0084, 0087]), comprising:
an ion measurement assembly (first sensor 805 in Fig. 8A [0084]), being arranged for measuring a parameter indicative of a concentration of an ion (the first sensor identifies the concentration of an analyte in the specimen [0088]; The analytes/properties to which the sensors respond may be selected from among human chorionic gonadotropin, pH, partial pressure CO2, partial pressure O2, glucose, lactate, creatinine, urea, sodium [para. 0059]), wherein the ion measurement assembly is different from an electroanalytical measurement assembly (first sensor 805 is an optical sensor [0088]), and
an analyte ion measurement assembly (second sensor 810 in Fig. 8A [0084]) comprising:
i. one or more working electrodes (second sensor 810 includes an array of electrodes [0087]), each of said working electrodes selective for an analyte ion (the second sensor may be a potentiometric sensor for detecting ionic species [0087]), and
ii. a reference electrode (a potential is applied to the second sensor 810 and a reference electrode [0098]),
wherein the analyte ion measurement assembly is an electroanalytical assembly (second sensor 810 is a potentiometric sensor [0087]).
Low further teaches that combining an optical and electrochemical assay into a single device enables point-of-care testing without requiring independent hardwired circuitry for each type of assay [0006].
Ye and Low are both considered analogous to the claimed invention because they are in the same field of ion measurement apparatuses. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in Ye by integrating the electroanalytical analyte ion measurement assembly into the combined analyzer with an optical reference ion measurement assembly taught in Low, such that the reference ion measurement assembly suggested by Ye is different from an electroanalytical measurement assembly, since this would enable point-of-care testing [0006 in Low] and provide measurement of the reference ion concentration to calculate an accurate analyte ion concentration [0017, 0054 in Ye]. Furthermore, Low teaches the claimed improvement as a known technique that is applicable to the base device in Ye. One skilled in the art could have applied the combined optical/electrochemical measuring device in Low in the same way to the base device in Ye, yielding predictable results (MPEP 2143(I)(D)).
The added reference ion measurement assembly is configured to perform a measurement based on the reference ion (the first sensor identifies the concentration of an analyte in the specimen [0088 in Low]; The analytes/properties to which the sensors respond may be sodium [para. 0059 in Low]).
Regarding claim 12, modified Ye teaches the apparatus according to claim 11, wherein the reference ion measurement assembly comprises an optical sensor (as stated in the rejection of claim 11, the reference ion measurement assembly is an optical sensor [0088 in Low]).
Regarding claim 13, modified Ye teaches the apparatus according to claim 11, further comprising:
a data processing device comprising a processor (as stated in the rejection of claim 11, the analyte ion measurement assembly of Ye is integrated into the analyzer of Low as the potentiometric sensing component of the analyzer. The analyzer includes a processor [0022 in Low]) configured to determine the one or more concentrations of the one or more analyte ions in the sample based on: the concentration of the reference ion, and the one or more potential differences (the processor is configured to perform the integrated optical and potentiometric assays to determine a quantitative value proportional to the amount of target analyte [0009, 0022, 0088 in Low], wherein the potential difference between the working and reference ISEs is used to directly calculate the ratio of potassium to sodium concentration [0050, 0054 in Ye], and then a separately determined concentration of sodium [e.g., the reference measurement from the optical assay] is multiplied by said ratio to arrive at the concentration of potassium ions [0054 in Ye]).
Regarding claim 14, modified Ye teaches the apparatus according to claim 11, further comprising a sample handling system (as stated in the rejection of claim 11, the analyte ion measurement assembly of Ye is integrated into the analyzer of Low. The analyzer includes a sample entry orifice 115 in Fig. 1 leading to a sample receiving chamber, which is fluidically connected to conduit 845 in Fig. 8A [0037, 0040, 0088 in Low]) comprising: a sample inlet (sample entry orifice 115 in Fig. 1 [0037 in Low]), a measurement chamber (the sample fluidically contacts sensors 805 and 810 in conduit 845 in Fig. 8A [0088 in Low]), and one or more fluidic channels fluidically connecting the sample inlet and the measurement chamber (the sample receiving chamber fluidically connects orifice 115 to the conduit [0037, 0040, 0088 in Low]).
Regarding claim 15, modified Ye teaches the apparatus according to claim 11.
The limitation “wherein an accuracy is lower than 20 % for the one or more analyte ions being a monovalent ion” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Ye teaches an apparatus that is configured to perform the functional limitations above (as demonstrated in the rejection of claim 11 above, modified Ye teaches all of the structural limitations of the apparatus, such that modified Ye is capable of performing the above functional limitation. The recitation of the accuracy of the apparatus as claimed does not impart a particular structural difference from the prior art).
Regarding claim 16, modified Ye teaches the apparatus according to claim 11.
The limitation “wherein the apparatus enables determining the one or more concentrations of the one or more analyte ions in the sample based on the more or more potential differences, with an accuracy with respect to one or more true concentrations, being lower than 20 % for the one or more analyte ions each being a monovalent ion” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Ye teaches an apparatus that is configured to perform the functional limitations above (as demonstrated in the rejection of claim 11 above, modified Ye teaches all of the structural limitations of the apparatus, such that the apparatus enables determining the one or more concentrations of the one or more analyte ions in the sample based on the one or more potential differences [the system in Ye determines an analyte potassium ion concentration as a function of a reference sodium ion concentration and a differential electric potential, para. 0014 in Ye]. Therefore, modified Ye is capable of performing the above functional limitations. The recitation of the accuracy of the apparatus as claimed does not impart a particular structural difference from the prior art).
Regarding claim 21, modified Ye teaches the apparatus according to claim 15.
The limitation “wherein the accuracy is lower than 7% for the one or more analyte ions being the monovalent ion” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Ye teaches an apparatus that is configured to perform the functional limitations above (as demonstrated in the rejection of claims 11 and 15 above, modified Ye teaches all of the structural limitations of the apparatus, such that modified Ye is capable of performing the above functional limitation. The recitation of the accuracy of the apparatus as claimed does not impart a particular structural difference from the prior art).
Regarding claim 22, Ye teaches an apparatus for measuring one or more potential differences being indicative of one or more concentrations of one or more analyte ions in a sample (a system that determines an analyte potassium ion concentration as a function of a reference sodium ion concentration and a differential electric potential [0014]), comprising:
an analyte ion measurement assembly (ISE system 100 in Fig. 3 [0048]) comprising:
(i) one or more working electrodes, each of said one or more working electrodes comprising an ion-selective electrode, which is selective for an analyte ion (working ISE 102 in Fig. 3 is solid-state and selective for potassium ion [0018, 0048, Examples 1-2]), and
(ii) a reference electrode being arranged for measuring a concentration of the reference ion and comprising an ion-selective electrode, which is selective for the reference ion (reference ISE 104 in Fig. 3 is solid-state and selective for sodium ion [0018, 0048-0049, Example 3]),
wherein the analyte ion measurement assembly is an electroanalytical measurement assembly (potassium ion measurement is dependent on differential electrical potential 126 produced between ISEs 102 and 104 in Fig. 3 [0049-0052], thus the analyte ion measurement assembly is an electroanalytical measurement assembly),
and wherein the analyte ion measurement assembly is arranged for measuring one or more potential differences directly or indirectly between:
(i) each of the one or more working electrodes, and
(ii) the reference electrode (the measured differential electrical potential 126 is produced directly between working ISE 102 and reference ISE 104 in Fig. 3 [0049-0052]).
Ye further teaches that a reference ion measurement assembly, being arranged for measuring a parameter indicative of a concentration of a reference ion would provide more accurate calculations of the analyte ion concentration (measurement of a reference sodium ion concentration is obtained periodically via a method separate from the ion-selective electrode [ISE] system 100 in Fig. 3 to calculate an accurate target potassium ion concentration [0017, 0048, 0054]).
Ye further teaches wherein the potential difference between the working and reference ISEs is used to directly calculate the ratio of potassium to sodium concentration [0050, 0054], and then a separately determined concentration of sodium is multiplied by said ratio to arrive at the concentration of potassium ions [0054].
Ye is silent to: (1) a reference ion measurement assembly being arranged for measuring a parameter indicative of a concentration of a reference ion, wherein the reference ion measurement assembly is different from an electroanalytical measurement assembly; and (2) a data processing device comprising a processor configured to determine one or more concentrations of the one or more analyte ions in the sample based on the concentration of the reference ion, the one or more potential differences, and a measurement from the reference ion measurement assembly of the parameter indicative of the concentration of the reference ion.
Low teaches an apparatus for measuring one or more potential differences being indicative of one or more concentrations of one or more analyte ions in a sample (analyzer system 100 in Fig. 1 including sensor chip 800 in Fig. 8A, which can include a potentiometric sensor for sensing ionic species [0013, 0084, 0087]), comprising:
an ion measurement assembly (first sensor 805 in Fig. 8A [0084]), being arranged for measuring a parameter indicative of a concentration of an ion (the first sensor identifies the concentration of an analyte in the specimen [0088]; The analytes/properties to which the sensors respond may be selected from among human chorionic gonadotropin, pH, partial pressure CO2, partial pressure O2, glucose, lactate, creatinine, urea, sodium [para. 0059]), wherein the ion measurement assembly is different from an electroanalytical measurement assembly (first sensor 805 is an optical sensor [0088]), and
an analyte ion measurement assembly (second sensor 810 in Fig. 8A [0084]) comprising:
i. one or more working electrodes (second sensor 810 includes an array of electrodes [0087]), each of said working electrodes selective for an analyte ion (the second sensor may be a potentiometric sensor for detecting ionic species [0087]), and
ii. a reference electrode (a potential is applied to the second sensor 810 and a reference electrode [0098]),
wherein the analyte ion measurement assembly is an electroanalytical assembly (second sensor 810 is a potentiometric sensor [0087]).
Low further teaches that combining an optical and electrochemical assay into a single device enables point-of-care testing without requiring independent hardwired circuitry for each type of assay [0006]. The analyzer includes a processor [0022] configured to perform the integrated optical and potentiometric assays to determine a quantitative value proportional to the amount of target analyte [0009, 0022, 0088].
Ye and Low are both considered analogous to the claimed invention because they are in the same field of ion measurement apparatuses. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in Ye by integrating the electroanalytical analyte ion measurement assembly into an combined analyzer with an optical reference ion measurement assembly taught in Low, such that the reference ion measurement assembly suggested by Ye is different from an electroanalytical measurement assembly, since this would enable point-of-care testing [0006 in Low] and provide measurement of the reference ion concentration to calculate an accurate analyte ion concentration [0017, 0054 in Ye]. Furthermore, Low teaches the claimed improvement as a known technique that is applicable to the base device in Ye. One skilled in the art could have applied the combined optical/electrochemical measuring device in Low in the same way to the base device in Ye, yielding predictable results (MPEP 2143(I)(D)).
The added reference ion measurement assembly is arranged for measuring a parameter indicative of a concentration of a reference ion (the first sensor identifies the concentration of an analyte in the specimen [0088 in Low]; The analytes/properties to which the sensors respond may be sodium [para. 0059 in Low]).
Furthermore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus by providing a processor configured to determine the one or more concentrations of the one or more analyte ions in the sample based on the concentration of the reference ion, the one or more potential differences, and a measurement from the reference ion measurement assembly of the parameter indicative of the concentration of the reference ion (the processor is configured to perform the integrated optical and potentiometric assays to determine a quantitative value proportional to the amount of target analyte [0009, 0022, 0088 in Low], wherein the potential difference between the working and reference ISEs is used to directly calculate the ratio of potassium to sodium concentration [0050, 0054 in Ye], and then a separately determined concentration of sodium [e.g., the reference measurement from the optical assay] is multiplied by said ratio to arrive at the concentration of potassium ions [0054 in Ye]).
Regarding claim 24, modified Ye teaches the apparatus according to claim 22, and Ye teaches wherein a first working electrode of the one or more working electrodes comprises an internal electrode and a membrane (working electrode 102 comprises an internal electrode 110 and an ISE membrane 114 as shown in Fig.3 [0048]), wherein the internal electrode and the membrane are separated by a gap (Fig.3 in Ye shows the internal electrode 110 and the membrane 114 are separated by a gap filed with a hydrogel layer 112 [para. 0048]).
Regarding claim 25, modified Ye teaches the apparatus according to claim 22, and Ye is silent to wherein the reference ion measurement assembly is configured to measure a pH sensitive luminescent indicator of the sample.
Low further teaches wherein the analytes/properties to which the sensors respond may be selected from among human chorionic gonadotropin, pH, partial pressure CO2, partial pressure O2, glucose, lactate, creatinine, urea, sodium, potassium [para. 0059].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reference ion measurement assembly such that the modified reference ion measurement assembly is further configured to measure pH, as taught by Low, which teaches the suitable sensors to be integrated in the analyzer [para. 0059 in Low].
With the above modification, the modified reference ion measurement assembly is capable of measuring a pH sensitive luminescent indicator of the sample since it is configured to measure pH of the sample.
Regarding claim 26, modified Ye teaches the apparatus according to claim 22, and Ye is silent to further comprising a sample handling system comprising: a sample inlet, a measurement chamber containing at least one of the reference ion measurement assembly or the analyte ion measurement assembly, and one or more fluidic channels, fluidically connecting the sample inlet and the measurement chamber.
Low teaches the analyzer comprising a sample handling system comprising: a sample inlet (sample entry orifice 115 in Fig. 1 [0037]), a measurement chamber containing at least one of the reference ion measurement assembly or the analyte ion measurement assembly (the sample fluidically contacts sensors 805 and 810 in conduit 845 in Fig. 8A [0088]), and one or more fluidic channels fluidically connecting the sample inlet and the measurement chamber (the sample receiving chamber fluidically connects orifice 115 to the conduit [0037, 0040, 0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus by providing a sample handling system comprising: a sample inlet, a measurement chamber containing at least one of the reference ion measurement assembly or the analyte ion measurement assembly, and one or more fluidic channels, fluidically connecting the sample inlet and the measurement chamber, as taught by Low, since Low teaches the suitable sample handing system for measuring the amount of target analyte inside the environment of a measurement chamber [para.0094].
Regarding claim 27, modified Ye teaches the apparatus according to claim 22, and “wherein an accuracy is lower than 7%, for the analyte ion being a monovalent ion” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Ye teaches an apparatus that is configured to perform the functional limitations above (as demonstrated in the rejection of claim 22 above, modified Ye teaches all of the structural limitations of the apparatus, such that modified Ye is capable of performing the above functional limitation. The recitation of the accuracy of the apparatus as claimed does not impart a particular structural difference from the prior art).
Regarding claim 28, modified Ye teaches the apparatus according to claim 22, “wherein the apparatus is configured to enable determining one or more concentrations of one or more analyte ions in a sample based on the one or more potential differences, with an accuracy with respect to one or more true concentrations, being lower than 20% for the one or more analyte ions each being a monovalent ion” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Ye teaches an apparatus that is configured to perform the functional limitations above (as demonstrated in the rejection of claim 22 above, modified Ye teaches all of the structural limitations of the apparatus, such that the apparatus enables determining the one or more concentrations of the one or more analyte ions in the sample based on the one or more potential differences [determines an analyte potassium ion concentration as a function of a reference sodium ion concentration and a differential electric potential, para. 0014 in Ye]. Therefore, modified Ye is capable of performing the above functional limitations. The recitation of the accuracy of the apparatus as claimed does not impart a particular structural difference from the prior art.
Regarding claim 30, Ye teaches an apparatus for measuring one or more potential differences being indicative of one or more concentrations of one or more analyte ions in a sample (a system that determines an analyte potassium ion concentration as a function of a reference sodium ion concentration and a differential electric potential [0014]), comprising:
an analyte ion measurement assembly (ISE system 100 in Fig. 3 [0048]) comprising:
(i) one or more working electrodes, each of said one or more working electrodes comprising an ion-selective electrode, which is selective for an analyte ion (working ISE 102 in Fig. 3 is solid-state and selective for potassium ion [0018, 0048, Examples 1-2]), and
(ii) a reference electrode being comprising an ion-selective electrode, which is selective for the reference ion (reference ISE 104 in Fig. 3 is solid-state and selective for sodium ion [0018, 0048-0049, Example 3]),
wherein the analyte ion measurement assembly is an electroanalytical measurement assembly (potassium ion measurement is dependent on differential electrical potential 126 produced between ISEs 102 and 104 in Fig. 3 [0049-0052], thus the analyte ion measurement assembly is an electroanalytical measurement assembly),
and wherein the analyte ion measurement assembly is arranged for measuring one or more potential differences directly or indirectly between:
(i) each of the one or more working electrodes, and
(ii) the reference electrode (the measured differential electrical potential 126 is produced directly between working ISE 102 and reference ISE 104 in Fig. 3 [0049-0052]).
Ye further teaches that a reference ion measurement assembly, being arranged for measuring a parameter indicative of a concentration of a reference ion would provide more accurate calculations of the analyte ion concentration (measurement of a reference sodium ion concentration is obtained periodically via a method separate from the ion-selective electrode [ISE] system 100 in Fig. 3 to calculate an accurate target potassium ion concentration [0017, 0048, 0054]). The potential difference between the working and reference ISEs is used to directly calculate the ratio of potassium to sodium concentration [0050, 0054], and then a separately determined concentration of sodium is multiplied by said ratio to arrive at the concentration of potassium ions [0054].
Ye is silent to: (1) a reference ion measurement assembly being arranged for measuring a parameter indicative of a concentration of a reference ion, wherein the reference ion measurement assembly is different from an electroanalytical measurement assembly; and (2) a data processing device comprising a processor
configured to account for measurement error from the analyte ion measurement assembly, wherein the accounting includes accumulating the measurement error and is based on a measurement of the parameter indicative of the concentration of the reference ion.
Low teaches an apparatus for measuring one or more potential differences being indicative of one or more concentrations of one or more analyte ions in a sample (analyzer system 100 in Fig. 1 including sensor chip 800 in Fig. 8A, which can include a potentiometric sensor for sensing ionic species [0013, 0084, 0087]), comprising:
an ion measurement assembly (first sensor 805 in Fig. 8A [0084]), being arranged for measuring a parameter indicative of a concentration of an ion (the first sensor identifies the concentration of an analyte in the specimen [0088]; The analytes/properties to which the sensors respond may be selected from among human chorionic gonadotropin, pH, partial pressure CO2, partial pressure O2, glucose, lactate, creatinine, urea, sodium [para. 0059]), wherein the ion measurement assembly is different from an electroanalytical measurement assembly (first sensor 805 is an optical sensor [0088]), and
an analyte ion measurement assembly (second sensor 810 in Fig. 8A [0084]) comprising:
i. one or more working electrodes (second sensor 810 includes an array of electrodes [0087]), each of said working electrodes selective for an analyte ion (the second sensor may be a potentiometric sensor for detecting ionic species [0087]), and
ii. a reference electrode (a potential is applied to the second sensor 810 and a reference electrode [0098]),
wherein the analyte ion measurement assembly is an electroanalytical assembly (second sensor 810 is a potentiometric sensor [0087]).
Low further teaches that combining an optical and electrochemical assay into a single device enables point-of-care testing without requiring independent hardwired circuitry for each type of assay [0006]. The analyzer includes a processor [0022] configured to perform the integrated optical and potentiometric assays to determine a quantitative value proportional to the amount of target analyte [0009, 0022, 0088].
Ye and Low are both considered analogous to the claimed invention because they are in the same field of ion measurement apparatuses. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in Ye by integrating the electroanalytical analyte ion measurement assembly into an combined analyzer with an optical reference ion measurement assembly taught in Low, such that the reference ion measurement assembly suggested by Ye is different from an electroanalytical measurement assembly, since this would enable point-of-care testing [0006 in Low] and provide measurement of the reference ion concentration to calculate an accurate analyte ion concentration [0017, 0054 in Ye]. Furthermore, Low teaches the claimed improvement as a known technique that is applicable to the base device in Ye. One skilled in the art could have applied the combined optical/electrochemical measuring device in Low in the same way to the base device in Ye, yielding predictable results (MPEP 2143(I)(D)).
The added reference ion measurement assembly is arranged for measuring a parameter indicative of a concentration of a reference ion (the first sensor identifies the concentration of an analyte in the specimen [0088 in Low]; The analytes/properties to which the sensors respond may be sodium [para. 0059 in Low]).
Furthermore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus by providing a processor configured to determine the one or more concentrations of the one or more analyte ions in the sample based on the concentration of the reference ion, the one or more potential differences, and a measurement from the reference ion measurement assembly of the parameter indicative of the concentration of the reference ion (the processor is configured to perform the integrated optical and potentiometric assays to determine a quantitative value proportional to the amount of target analyte [0009, 0022, 0088 in Low], wherein the potential difference between the working and reference ISEs is used to directly calculate the ratio of potassium to sodium concentration [0050, 0054 in Ye], and then a separately determined concentration of sodium [e.g., the reference measurement from the optical assay] is multiplied by said ratio to arrive at the concentration of potassium ions [0054 in Ye]).
Ye further teaches in addition to protein absorption caused potential drift and/or signal error, when the ion sensor is in contact with blood or is implanted inside the body, thrombosis formation and tissue encapsulation may cause sensor unreliability and even malfunction. Thus, poor stability is a large problem, and should be significantly improved in order for ion sensors to be used long term in complex media like blood or urine, particularly in vivo [para. 0046].
Since there is a problem of sensor signal drift or error [para. 0046 in Ye], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor to account for measurement error from the analyte ion measurement assembly, wherein the accounting includes accumulating the measurement error and is based on a measurement of the parameter indicative of the concentration of the reference ion, since it would provide more accurate calculations of the analyte ion concentration [0017, 0048, 0054 in Ye].
Regarding claim 32, modified Ye teaches the apparatus according to claim 30, and Ye teaches wherein a first working electrode of the one or more working electrodes comprises an internal electrode and a membrane, wherein the internal electrode and the membrane are separated by a gap (working electrode 102 comprises an internal electrode 110 and an ISE membrane 114 as shown in Fig.3 [0048]), wherein the internal electrode and the membrane are separated by a gap (Fig.3 in Ye shows the internal electrode 110 and the membrane 114 are separated by a gap filed with a hydrogel layer 112 [para. 0048]).
Regarding claim 33, modified Ye teaches the apparatus according to claim 30, and “wherein an error is lower than 1.35%, for the analyte ion being a monovalent ion” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Ye teaches an apparatus that is configured to perform the functional limitations above (as demonstrated in the rejection of claim 30 above, modified Ye teaches all of the structural limitations of the apparatus, such that modified Ye is capable of performing the above functional limitation. The recitation of the accuracy of the apparatus as claimed does not impart a particular structural difference from the prior art).
Claims 17 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Ye in view of Low, as applied to claims 11 and 22 above, and further in view of Chon et al. (US 20230116505 A1).
Regarding claim 17, modified Ye teaches the apparatus according to claim 11, but is silent to the limitation wherein a distance between: each of the one or more working electrodes, and the reference electrode is equal to or less than 10 mm.
Chon teaches an electrochemical sensor based on a working and reference electrode system [0003], wherein the distance between the working and reference electrodes is between 50 µm and 5 mm [0033-0034], which is within the claimed range. Chon further teaches that this distance range between the working and reference electrodes prevents short circuits between the working and reference electrodes while maintaining measurement accuracy [0034].
Modified Ye and Chon are both considered analogous to the claimed invention because they are in the same field of electrochemical sensors based on working and reference electrodes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between the working electrode and reference electrode in modified Ye to be between 50 µm and 5 mm, as taught in Chon, since this would prevent short circuits between the working and reference electrodes while maintaining measurement accuracy [0033-0034 in Chon]. Furthermore, Chon teaches the claimed improvement as a known technique that is applicable to the base device in modified Ye. One skilled in the art could have applied the distance between the working and reference electrodes in Chon in the same way to the base device in modified Ye, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 29, modified Ye teaches the apparatus according to claim 22, but is silent to wherein a distance between each of the one or more working electrodes and the reference electrode is equal to or less than 10 mm.
Chon teaches an electrochemical sensor based on a working and reference electrode system [0003], wherein the distance between the working and reference electrodes is between 50 µm and 5 mm [0033-0034], which is within the claimed range. Chon further teaches that this distance range between the working and reference electrodes prevents short circuits between the working and reference electrodes while maintaining measurement accuracy [0034].
Modified Ye and Chon are both considered analogous to the claimed invention because they are in the same field of electrochemical sensors based on working and reference electrodes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between each working electrode and the reference electrode in modified Ye to be between 50 µm and 5 mm, as taught in Chon, since this would prevent short circuits between the working and reference electrodes while maintaining measurement accuracy [0033-0034 in Chon]. Furthermore, Chon teaches the claimed improvement as a known technique that is applicable to the base device in modified Ye. One skilled in the art could have applied the distance between the working and reference electrodes in Chon in the same way to the base device in modified Ye, yielding predictable results (MPEP 2143(I)(D)).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Ye in view of Low, as applied to claim 30 above, and further in view of Kim et al. (Effect of adsorption-induced surface stress change on the stiffness of a microcantilever used as a salinity detection sensor, Appl. Phys. Lett., 2008, 93, 081911).
Regarding claim 31, modified Ye teaches the apparatus according to claim 30, and is silent to wherein the reference ion measurement assembly comprises a mechanical stress sensor.
Kim teaches a mechanical stress sensor to measure to concentration of sodium ions (a microcantilever used as a salinity detection sensor [title]; Table 1 shows the adsorbed mass of sodium ions of cantilevers; Table II shows the spring constant changes of the microcantilevers for different NaCl concentrations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the optical sensor for measuring sodium ions with a mechanical stress sensor to measure concentration of sodium ions, as taught by Kim, which teaches a suitable alternative mechanical stress sensor for the measurement of the concentration of sodium ions (abstract and title in Kim).
Allowable Subject Matter
Claim 23 would be allowable if they are rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 23, the prior art of the record does not teach and/or suggest
wherein the reference ion measurement assembly comprises a magnetic field sensor.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 7-8, filed 12/9/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered.
Applicant’s Argument #1:
Applicant argues at page 8 that the amendments constitute a narrowing of the claims, which should not be construed as an admission as to the merits of the prior rejection.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection above.
Examiner suggests applicant to incorporate the limitations of claim 23 into each independent claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) 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 SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V 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.
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/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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