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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 18, 2025 has been entered.
Status of the Claims
Claim 9 has been amended; and claims 1-8, 12-17 and 19 have been withdrawn. Claims 9-11 and 18 are currently examined herein.
Status of the Rejection
Applicant’s amendments have partially overcome claim objection for claim 9.
Applicant’s amendments have overcome all claim rejections under 35 U.S.C. 112(b).
All 35 U.S.C. § 103 rejections from the previous office action are essentially maintained and modified in response to the amendment.
Claim Objection
Claim 9 is objected to because of the following informalities:
Claim 9: please amend “electrical signal(s)” in line 9 on page 5 to – the electrical signal(s)--; “electrical signals” in line 12 on page 5 to – the electrical signal(s)--.
Appropriate correction is required.
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 9, 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jang (KR 10-2016-0127310, a machine translation used for citation) in view of Neel (US 2009/0134024A1), Barton-Sweeney et al. (US2020/0209180A1), and Jedrusik et al. (Potassium to creatinine ratio in a spot urine sample is a reliable measure of 24-hour urinary potassium excretion in hypertensive patients, Journal of Hypertension, 2004, 22, S97-S98).
Regarding claim 9, Jang teaches a non-invasive point-of-care (POC) device (a portable one-stop smart sodium, potassium and creatinine digital measuring device 100 in Fig. 1 [para. 0070]); “for detecting a disorder of electrolyte balance in a patient’s body” is an intended use limitation. 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, Jang teaches the POC device for measuring the concentrations of sodium, potassium, and creatinine contained in urine, thus, the disclosed POC device is capable of performing the intended use. Said POC device comprising:
a readout-meter-device (see annotated Fig.1 in Jang); “for quantitative and selective measurement of cationic electrolyte concentration and creatinine concentration in a urine sample and for determining a ratio of cationic electrolyte-to-creatinine” 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, Jang teaches the readout-meter-device that is configured to measure concentrations of sodium, potassium and creatinine in urine [para. 0023, 0070-0075], thus the disclosed readout-meter-device is configured to quantitatively and selectively measure cationic electrolyte concentration such as potassium concentration and creatinine concentration in a urine sample for determining a ratio of cationic electrolyte-to-creatinine such as a ratio of the potassium concentration to the creatinine concentration, said readout-meter-device comprising:
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a single-use test strip (measurement strip 104 in Figs.2-4 [para. 0021, 0076]); “for quantitative and selective potentiometric determination of a concentration of a cationic electrolyte that is not sodium, and of creatinine concentration in a patient’s urine sample” 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, Jang teaches the measurement strip 104 as shown in Figs. 2-4 comprising independent electrode sensors such as potassium measuring electrode sensor 112b and the creatinine measuring electrode sensor 112c for measuring, respectively, the concentrations of potassium and creatinine in the urine [para. 0025, 0072]. Thus the disclosed single-use test strip is configured for quantitative and selective potentiometric determination of a concentration of a cationic electrolyte that is not sodium (measuring potassium concentration by using potassium measuring electrode sensor 112b [para. 0072]), and of creatinine concentration (measuring creatinine concentration by creatinine measuring electrode sensor 112c [para. 0072]) in a patient’s urine sample (in urine sample [para. 0072]), the single-use test strip comprising:
a substrate (a substrate of the measurement strip 104 in Fig.4),
an electrode assembly applied on said substrate (Fig. 4 shows an electrode assembly of electrode sensors 112 on the substrate of the measurement strip 104 [para. 0072]),
said electrode assembly comprising:
one working electrode that is selective for said cationic electrolyte (a potassium measuring electrode sensor 112b in Fig.4 [para. 0072]);
one creatinine-selective working electrode (a creatinine measuring electrode sensor 112c in Fig.4 [para. 0072]);
– a reference electrode for said cationic electrolyte-selective working electrode (a “Ref” electrode for the potassium measuring electrode sensor 112b in Fig. 4) and a separate reference electrode for said creatinine-selective working electrode (a “Ref” electrode for the creatinine measuring electrode sensor 112c in Fig.4); and
optionally, one or two neutral electrodes for measuring and eliminating interferences (this limitation is optional),
a receiving module (see annotated Figs. 2-3 in Jang) for receiving an interface of the single-use test-strip, wherein said receiving module is in other suitable form allowing to establish a connection to the interface of said single-use test-strip (see annotated Figs. 2-3 in Jang; the measurement strip 104 may be arranged to be electrically connected to the measurement strip that is connected to one end of the controller [para. 0021]; thus there must be a receiving module for the measurement strip to be inserted into, and the receiving module is in a suitable form allowing to establish a connection of the interface of the test strip to one end of the controller); “for quantitative and selective potentiometric determination of a concentration of a cationic electrolyte that is not sodium, and of creatinine concentration in a patient’s urine sample” 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, Jang teaches the measurement strip 104 as shown in Figs. 2-4 comprising independent electrode sensors such as potassium measuring electrode sensor 112b and the creatinine measuring electrode sensor 112c for measuring, respectively, the concentrations of potassium and creatinine in the urine [para. 0025, 0072]. Thus the disclosed single-use test strip is configured for quantitative and selective potentiometric determination of a concentration of a cationic electrolyte that is not sodium (measuring potassium concentration by using potassium measuring electrode sensor 112b [para. 0072]), and of creatinine concentration (measuring creatinine concentration by creatinine measuring electrode sensor 112c [para. 0072]) in a patient’s urine sample (in urine sample [para. 0072]),
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“said interface for electrically connecting said electrode assembly to said readout-meter-device and for establishing electrical contact between said readout-meter-device and said electrode assembly of said single-use test-strip, thus allowing the detection and transmission of electrical signal(s) from said single-use test-strip to said readout-meter-device” 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, Jang teaches the interface as shown in the annotated Figs. 2-3 in Jang. Jang further teaches the sensing unit 110 may be configured to be electrically connected to the measurement strip 104 that is connected to and exposed to the main body 102 including the control unit 120. At this time, the detection unit 110 is composed of an independent electrode sensor 112 for measuring the ion concentration of potassium and creatinine contained in the urine respectively as an electrical signal. The controller 120 amplifies the electrical signals, converting the amplified electrical signals into digital signals, and analyzing the changed digital signals [para. 0080-0081]. Since the electrode assembly of the single-use test-strip and the readout-meter-device can be electrically connected, the contact surface between them would be deemed to be the claimed interface. Thus, the interface is configured to perform the claimed functions above,
wherein said receiving module has electrical connectors for separately contacting each electrode via said interface of said single-use test-strip (Annotated Fig.4 in Jang indicating six contact pads connected to the electrodes via leads, and there must have corresponding electrical connectors in the receiving module of the readout-meter-device for separate electrical connection between each pair of the contact pad and the electrical connector),
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a multichannel amplifier (AMP 122 in Fig.1 [ para. 0072]) for amplifying the electrical signal(s) transmitted from said single-use test-strip (an amplifier [AMP] 122 for amplifying the electrical signal measured by each electrode sensor [para. 0072]),
a controller (the controller 120 in Fig.1 [para. 0072]) including an analog/digital converter (ADC 124 in Fig.1 [para. 0072]) and a storage memory (Memory 130 in Fig.1; the storage unit 130 [para. 0073]), wherein said controller is configured to convert the electrical signal(s) received from said single-use test strip into cationic electrolyte concentration measurement(s) and creatinine concentration measurement(s) (the controller converts the amplified electrical signals from electrical signals of electrode sensors 112 into digital signals; analyzes the measured value signal converted into a digital signal to calculate the urine content of potassium and creatinine by using the Kawasaki formula [para. 0072]),
an output display (Display 140 in Fig.1 [para. 0074]); “configured to indicate said ratio a user” 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, Jang teaches the display 140 functions to display the urine content of sodium, potassium and creatinine [para. 0074], thus the display 140 is capable of indicating said ratio a user by displaying the obtained result (which is the ratio).
As shown in Fig.4, the electrode assembly uses a three-electrode system comprising working (+), counter(-), and reference (Ref) electrodes for each electrochemical cell of sodium, potassium and creatinine [para. 0072].
Jang is silent to the following limitations: (1) a power supply; (2) the substrate is either electrically insulating or has an electrically insulating layer applied thereon, wherein said substrate is made of a material selected from plastic, ceramic, alumina, paper, cardboard, rubber, textile, carbon-based polymers, fluoropolymers, silicon-based substrates, quartz, silicon nitride, silicon oxide, silicon based polymers, semiconducting materials, organic dielectric materials, and inorganic dielectric materials, and wherein said electrically insulating layer, if present, is made of a dielectric material; (3) the electrode assembly uses a two-electrode system consisting of a working electrode and a reference electrode for each of potassium and creatinine, wherein the reference electrodes for potassium and creatinine are shared as one joint reference electrode; (4) the controller configured to subsequently determine a ratio of cationic electrolyte concentration to creatinine concentration based on said cationic electrolyte concentration measurement(s) and creatinine concentration measurement(s).
Neel teaches a system for measuring a body fluid constituent including a test strip and a meter [para. 0045]. The meter may be battery powered and may stay in a low-power sleep mode when not in use in order to save power [para.0049]. Test strip 10 is formed with a base layer 16 extending along the entire length of test strip 10. Base layer 16 is preferably composed of an electrically insulating material and has a thickness sufficient to provide structural support to test strip 10. Base layer 16, for example, may be polyester [para. 0054]. Thus, Neel teaches: (1) a power supply (battery); and (2) the substrate is electrically insulating and made of plastic (base layer 16 is preferably composed of an electrically insulating material, and may be polyester which is a type of plastic).
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 POC device in Jang by adding a battery as the power source, as taught by Neel, because the battery would not only power the meter but would save power by staying in a low-power sleep mode when not in use [0049 in Neel]. 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).
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 material of the substrate of the test strip in modified Jang to an electrically insulating material of polyester, as taught by Neel, because Neel teaches it would be preferable to use an electrically insulating material such as polyester as the base layer of the test strip in which electrons or ions cannot be moved easily, hence preventing the flow of electric current [para. 0054]. Furthermore, 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].
Regarding the limitations of a receiving module and/or an interface of the test strip, wherein said receiving module has electrical connectors for separately contacting each electrode via said interface of said test-strip, and wherein said receiving module is in the form of a slit, recess or well or other suitable form allowing to establish a connection to the interface of said single-use test-strip, which are inherently present in the POC device of Jang as outlined in the rejection above. Even if Jang does not explicitly disclose a receiving module and/or an interface of the test strip, wherein said receiving module has electrical connectors for separately contacting each electrode via said interface of said test-strip, and wherein said receiving module is in the form of a slit, recess or well or other suitable form allowing to establish a connection to the interface of said single-use test-strip, these limitations are alternatively rejected in view of Neel in the following.
Neel teaches a system for measuring a body fluid constituent including a test strip and a meter [para. 0045]. Figure 2 shows a test strip 10 inserted within a meter strip connector 30 [para. 0033, 0060]. The meter connector 30 includes channel 32 for receiving the test strip 10 [para. 0060]. The connector further includes a first plurality of connector contacts 38 and a second plurality of connector contacts 40 to make contact with distinct portions of the distal strip contact region 26 (Fig. 2; [para. 0061]). Thus, Neel teaches a receiving module (connector 30 with the channel 32 in Fig.2) and an interface of a test strip (distal strip contact region 26 in Fig.2), wherein said receiving module has electrical connectors (connector contacts 38 and 40 in Fig.2) for separately contacting each electrode via said interface of said single-use test-strip (Fig. 2 indicating each pair of connector contacts 38 and 40 are separately contacted each electrode via the distal strip contact region 26 [para. 0061, 0063]), and wherein said receiving module is in the form of a slit (the meter connector 30 includes channel 32 for receiving the test strip 10 [para. 0060]) allowing to establish a connection to the interface of said single-use test-strip (see Figs. 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 modify the POC device in modified Jang by incorporating a receiving module for receiving an interface of the test strip to form the electrical connection, wherein the receiving module is in the form of a slit allowing to establish a connection to the interface of single-use test-strip, and wherein the receiving module has electrical connectors for separately contacting each electrode via the interface of the single-use test strip, as taught by Neel, because the receiving module is suitable to receive a test strip and would enable the connection between the test strip and the meter to function. 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).
Modified Jang is silent to the following limitations: (3) the electrode assembly uses a two-electrode system consisting of a working electrode and a reference electrode for each electrochemical cell of potassium and creatinine, wherein the reference electrodes for potassium and creatinine are shared by one joint reference electrode; (4) the controller configured to subsequently determine a ratio of cationic electrolyte concentration to creatinine concentration based on said cationic electrolyte concentration measurement(s) and creatinine concentration measurement(s).
Jang teaches the electrode assembly comprising independent electrode sensors 112 including the sodium measuring electrode sensor 112a, potassium measuring electrode sensor 112b, and creatinine measuring electrode 112c [para. 0072]. Fig.4 shows that each electrochemical cell for sodium, potassium, and creatinine is a three-electrode system including a working electrode, a counter electrode, and a reference electrode.
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 electrode assembly of the test strip in modified Jang by removing the sodium measuring electrode sensor 112a and its corresponding counter and reference electrodes for measuring sodium, which would obtain the electrode assembly consisting of the potassium measuring electrode sensor 112b and its corresponding counter and reference electrodes for measuring potassium concentration, and the creatinine measuring electrode sensor 112c and its corresponding counter and reference electrodes for measuring creatinine concentration. Omission of an element and its function is obvious if the function of the element is not desired [see MPEP § 2144.04 (II)(A)]. With the above modification, the electrode assembly consists of the cationic electrolyte-selective working electrode for potassium and its corresponding counter and reference electrode, and the creatinine-selective working electrode and its corresponding counter and reference electrode.
Barton-Sweeney teaches solid state electrodes used in biosensing, environmental analysis (e.g., soil analysis, or water analysis), pharmaceutical analysis, and food analysis (abstract). For the differences between electrodes, such as the differential between the working and reference electrodes, can be used to determine an analyte level. Additional electrodes may be used in the analysis of the level of the analyte, by providing an additional measurement value of the same analyte. For example, what would normally be a two-electrode system may utilize additional electrodes, such as a counter electrode to monitor fluctuations in current [para. 0059]. While many of the examples involve a two-electrode system (working and reference solid state electrodes), and other embodiments may include an electrode system that uses any number of electrodes. For example, the biosensor for the ions can have a working electrode, a reference electrode, and a counter electrode. In an embodiment, the electrode system comprises multiple electrochemical cells with one or more than one, such as 1 to 5, or 1 to 15, or 1 to 25 electrodes for each cell. The electrode system can have multiple electrochemical cells that share electrodes. In an embodiment, the electrode system can have an array of electrochemical cells each with their own working electrodes, and a shared reference electrode wherein the cells can sense separate analytes in the same sample that is in contact with the cells and electrodes [para. 0061]. Detection can be done using potentiometric sensing or amperometric sensing depending on the species being detected, for any of the devices described herein [para. 0091]. Thus, Barton-Sweeney teaches the electrode system (corresponding to the claimed electrode assembly) can have an array of electrochemical cells each with their own working electrodes, and a shared reference electrode wherein each electrochemical cell is a two-electrode system consisting of a working electrode and a shared reference electrode.
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 electrode assembly of the test strip and the POC device in modified Jang such that the modified electrode assembly consists of two electrochemical cells for potassium and creatinine, each consisting of its own working electrode and a shared reference electrode, as taught by Barton-Sweeney, since Barton-Sweeney teaches suitable alternative configurations of biosensors for ions, such as a two-electrode system (working and reference solid state electrodes), a three-electrode system (a working electrode, a reference electrode, and a counter electrode); and an array of electrochemical cells each with their own working electrodes and a shared reference electrode wherein the cells can sense separate analytes in the same sample that is in contact with the cells and electrodes [para. 0061].
With the above modification, the electrode assembly consists of the cationic electrolyte-selective working electrode (the potassium measuring electrode sensor 112b), the creatinine-selective working electrode (the creatinine measuring electrode 112c), and a shared/joint reference electrode for both the cationic electrolyte-selective working electrode and the creatinine-selective working electrode.
Modified Jang is silent to the following limitations: (4) the controller configured to subsequently determine a ratio of cationic electrolyte concentration to creatinine concentration based on said cationic electrolyte concentration measurement(s) and creatinine concentration measurement(s).
Jedrusik teaches elevated urinary potassium excretion is a hallmark of primary hyperaldosteronism (PHA), a disorder that is increasingly commonly recognized as one of the most prevalent forms of secondary hypertension. The potassium to creatinine ratio (K/creat) in a spot urine sample would represent a useful measure of 24-hour urinary potassium excretion (Background). Potassium to creatinine ratio in a spot urine sample correlates closely with the same ratio for 24-hour urine collection, thus representing a potentially useful measure of 24-hour urinary potassium excretion without the need for lengthy urine collections. In the future it might emerge as a useful screening test for primary hyperaldosteronism (Conclusions).
Given the teachings of Jang regarding measuring the concentrations of potassium and creatinine in the urine [para. 0072]; and the teachings of Jedrusik regarding potassium to creatinine ratio in a spot urine sample representing a potentially useful measure of 24-hour urinary potassium excretion and might emerge as a useful screening test for primary hyperaldosteronism, 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 controller in modified Jang to determine a ratio of potassium concentration to creatinine concentration based on the potassium concentration measurement(s) and the creatinine concentration measurement(s), since the potassium to creatinine ratio would represent a useful measure of 24-hour urinary potassium excretion, and serve as useful screening test for primary hyperaldosteronism (conclusions in Jedrusik).
Regarding claim 11, modified Jang teaches the non-invasive point-of-care (POC) device according to claim 9, and Jang teaches wherein said POC device further comprises a connection interface (telecommunication Unit 150 in Fig.1 [para. 0075]) for transferring and/or exchanging data with an external computer or external network (the communication unit 150 may further include transmitting a result of the analysis process to the remote Personal Health Records (PHR) server 10 by wire or wirelessly [para. 0043, 0075]).
Regarding claim 18, modified Jang teaches the non-invasive point-of-care (POC) device according to claim 11, and Jang teaches wherein the connection interface is a wireless interface (transmitting to the remote PHR server 10 wirelessly [para. 0043]; wireless communication network [para. 0075]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jang, Neel, Barton-Sweeney and Jedrusik, as applied to claim 9 above, and further in view of Dietze et al. (US5393391A).
Regarding claim 10, modified Jang teaches the non-invasive point-of-care (POC) device according to claim 9, said electrode assembly consisting of:
said one working electrode that is selective for said cationic electrolyte (the potassium measuring electrode sensor 112b in Jang, as outlined in the rejection of claim 9 above);
said one creatinine-selective working electrode (the creatinine measuring electrode sensor 112c in Jang, as outlined in the rejection of claim 9 above);
said one joint reference electrode for both said cationic electrolyte-selective working electrode and said creatinine-selective working electrode (a shared/joint reference electrode for both the cationic electrolyte-selective working electrode and the creatinine-selective working electrode, as outlined in the rejection of claim 9 above); and
said interface for electrically connecting said electrode assembly to said readout-meter- device inserted into said receiving module of said readout-meter-device by way of said interface of said single-use test-strip, thus establishing the electrical contact between said electrode assembly of said single-use test-strip and said readout-meter device (as outlined in the rejection of claim 9 above, Jang or Jang in view of Neel teaches these limitations).
Modified Jang is silent to the one or two neutral electrodes for measuring and eliminating interferences.
Dietze teaches an electrode arrangement for the electrochemical analysis of components of a liquid (abstract), and Fig.16 shows an electrode assembly (an electrode unit 191) consisting of two ion-selective electrodes 195, and two reference electrodes 197 and 199. FIG. 16 shows schematically a voltage measurement device 213 connected between the reference electrode 197 and one of the ion-selective measurement electrodes. Between the other measurement electrode 195, selective for another kind of ion, and the reference electrode 197, there is connected another voltage measurement device 215. Between the reference electrodes 199 and 197 is connected a further voltage measurement device 217, the potential difference measured by this voltage measurement device providing a control value for the correction of the measurement values of the voltage measurement devices 213, 215. The reference electrode 199 can be constructed corresponding to the reference electrode 197 with the use of a porous membrane which is ion non-specific (Col. 14 Ln 11-60). Thus, Dietze teaches an electrode assembly consisting of a first ISE 195 selective for a first kind of ion, a second ISE 195 selective for a second kind of ion, a shared reference electrode 197, and a neutral electrode (reference electrode 199 which is ion non-specific).
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 electrode assembly and the POC device in modified Jang by providing a second reference electrode which is ion non-specific, as taught by Dietze, since the potential difference between the added second reference electrode and the shared reference electrode would provide a control value for the correction of the measurement values (Col. 14 Ln 52-57 in Dietze). The claimed limitations of one neutral electrode 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).
The limitation “for measuring and eliminating interferences” 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 Jang teaches the neutral electrode which is ion non-specific, and a potential difference between the neutral electrode and the shared reference electrode provides a control value for the correction of the measurement values of the potassium measuring electrode sensor 112b and the creatinine measuring electrode sensor 112c, thus, the disclosed neutral electrode is configured to perform the claimed functions of measuring and eliminating interferences.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 10-14, filed 9/18/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered, but are not persuasive in view of the modified rejection in response to the amendments.
Applicant’s Argument #1:
Regarding claim 9, Applicant argues at pages 10-13 that the combined prior art does not teach or suggest 1) simultaneous, quantitative, and selective potentiometric measurement of both a cationic electrolyte (not sodium) and creatinine in urine using a single-use test strip; 2) configuration of the device to determine and report the ratio of cationic electrolyte-to-creatinine; and 3) use of a joint reference electrode for both the cationic electrolyte-selective and creatinine-selective working electrodes. Even if ion-selective electrodes, creatinine sensors, and electronic readout devices may be individually known, the specific arrangement as claimed in the Applicant's claims has not been taught or suggested by the cited references. The cited references do not provide any suggestion to one skilled in the art with respect to a POC device for potentiometrically measuring a ratio of cationic electrolyte-to-creatinine. Nor do the cited references teach or suggest a device architecture capable of simultaneously and selectively potentiometrically measuring both a cationic electrolyte and creatinine on a single-use test strip and reporting their ratio at the point of care. Rather, the cited references measure analytes individually and do not suggest a unified platform for this specific combination that provides a ratio of cationic electrolyte-to-creatinine. The use of a joint reference electrode for both working electrodes of a potentiometric set-up is not obvious in view of the cited references because none of the cited references teaches or suggest the advantages (e.g., simple, cost-effective, and consistent) of using a joint reference electrode in the potentiometric set-up. Barton-Sweeney does not teach shared reference electrodes in potentiometric measurements that use voltage for the analysis of ion concentration. The person skilled in the art would not expect to arrive at the electrode assembly applied on the substrate. as currently recited in the Applicant's claims
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. Firstly, “quantitative and selective potentiometric measurement of both a cationic electrolyte (not sodium) and creatinine concentration in a urine sample” is a functional limitation, and as outlined in the rejection of claim 9 above, the read-out-meter-device of Jang is capable of performing the claimed functions since the measurement strip 104 as shown in Figs. 2-4 in Jang comprises independent electrode sensors such as potassium measuring electrode sensor 112b and the creatinine measuring electrode sensor 112c for measuring, respectively, the concentrations of potassium and creatinine in the urine [para. 0025, 0072]. Thus, Jang teaches a unified platform which can simultaneously measure a cationic electrolyte (potassium) and creatinine concentration.
Secondly, Barton-Sweeney teaches suitable alternative configurations of biosensors for ions, such as a two-electrode system (working and reference solid state electrodes), a three-electrode system (a working electrode, a reference electrode, and a counter electrode); and an array of electrochemical cells each with their own working electrodes and a shared reference electrode wherein the cells can sense separate analytes in the same sample that is in contact with the cells and electrodes [para. 0061]. Detection can be done using potentiometric sensing or amperometric sensing depending on the species being detected, for any of the devices described herein [para. 0091]. The differences between electrodes, such as the differential between the working and reference electrodes, can be used to determine an analyte level [para. 0059]. Thus, Barton-Sweeney does teach a shared reference electrode in potentiometric measurements. Therefore, the POC device as modified by Barton-Sweeney is capable of performing the functions of quantitative and selective potentiometric measurement of cationic electrolyte concentration (potassium) and creatinine concentration.
Thirdly, since Jang teaches measuring the concentrations of potassium and creatinine in the urine [para. 0072]; and Jedrusik teaches potassium to creatinine ratio in a spot urine sample representing a potentially useful measure of 24-hour urinary potassium excretion and might emerge as a useful screening test for primary hyperaldosteronism, 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 controller in modified Jang to determine/calculate a ratio of potassium concentration to creatinine concentration based on the measured potassium and creatinine concentrations, since the potassium to creatinine ratio would represent a useful measure of 24-hour urinary potassium excretion, and serve as useful screening test for primary hyperaldosteronism (conclusions in Jedrusik). Furthermore, the display 140 in Jang is capable of indicating the determined ratio to a user since the display unit 140 functions to display the obtained results such as urine content of sodium, potassium and creatinine [para. 0074 in Jang] and can display the determined ratio in the same way as displaying urine content.
Applicant’s Argument #2:
Regarding claim 10, Applicant argues at page 13 that Dietze et al. reference does not cure the deficiencies of the Jang, Neel, Barton-Sweeney et al., and Jedrusik et al. references. Thus, the Jang, Neel, Barton-Sweeney et al., Jedrusik et al., and Dietze et al. references, either taken alone or in combination, do not teach or suggest the claimed invention.
Examiner’s Response #2:
As explained in the Examiner’s Response #1 above, claim 9 is still unpatentable over Jang, Neel, Barton-Sweeney, and Jedrusik.
Conclusion
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.
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/SHIZHI QIAN/Examiner, Art Unit 1795