DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on January 13, 2026. Claims 1-13 are pending in the application.
Status of Objections and Rejections
All objections from the previous office action are withdrawn in view of Applicant’s amendment.
All rejections under 35 U.S.C. §112 from the previous office action are withdrawn in view of Applicant’s amendment.
All other rejections from the previous office action are maintained.
Claim Rejections - 35 USC § 102
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, 5-10, and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feldman (US 2010/0213057).
Regarding claim 1, Feldman teaches a method for measuring a concentration of an analyte using an electrochemical analyte sensor (Fig. 1; ¶4: electrochemical analyte monitoring system; a current directly proportional to analyte concentration) having a first electrode (Fig. 1: working electrode) and a second electrode (Fig. 1: counter electrode), the first electrode being configured to react with the analyte for generating an electrical signal (¶30: the redox polymer 102 disposed on the working electrode passes electrons, or a current, between the primary reactant and the working electrode), the method comprising:
applying a modulated voltage signal between the first electrode and the second electrode (Fig. 1: a voltage is applied between the working electrode and the counter electrode; Fig. 9: P-stat powered and self-powered; Fig. 11: when R = 4.67 Mohm, the currents of P-stat powered and self-powered over time; Fig. 14: the current and potential vary with different R values; ¶142: coupled together with a variety of resistors, ranging in resistance from 0 MΩ to 100 MΩ; thus the applied voltage would be modulated with varying resistance of the resistors);
determining a current signal in response to the applied modulated voltage signal (¶105: measure the sensor current; Fig. 14; ¶142: resulting spontaneous steady state current was measured for sensors configured with different R values);
determining an electric potential working point of the analyte sensor based on the determined current signal (Fig. 14; ¶142: the range of R values from 0 to 10 MΩ is the range of R values for which the sensor output, at an analyte concentration at the top of its physically relevant range, is independent of R; thus, the potential corresponding to the constant current output within the range of R values (0 to 10 MΩ) would be the electric potential working point; e.g., Fig. 11, 13: using R = 4.67 Mohm);
operating the analyte sensor at the determined electric potential working point (¶142: an R value of 0 to 10 MΩ would be selected; e.g., Fig. 11, 13: using R = 4.67 Mohm); and
measuring the concentration of the analyte based on the electrical signal generated by the first electrode (¶4: a current directly proportional to analyte concentration).
Regarding claim 5, Feldman teaches wherein the first electrode is a working electrode and/or wherein the second electrode is selected from the group consisting of a counter electrode (Fig. 1: working electrode; counter electrode).
Regarding claim 6, Feldman teaches harvesting energy released by the electrochemical reaction of the analyte with the first electrode and using the energy to power the operation of the analyte sensor (¶4: the self-powered analyte determining device spontaneously passes a current directly proportional to analyte concentration in the absence of an external power source; ¶8: the self-powered analyte sensor leads to measure the current flow and calculate the analyte level).
Regarding claim 7, Feldman teaches wherein the analyte is glucose (Fig. 1; ¶7: electrocatalystic oxidation of glucose) and the concentration of the glucose is measured and outputted on a display (¶28: a current proportional to an analyte concentration, such as glucose; Fig. 2; ¶8: a hand-held display).
Regarding claim 8, Feldman teaches an analyte sensor (Fig. 1; ¶4: electrochemical analyte monitoring system) for measuring an analyte concentration (¶4: a current directly proportional to analyte concentration), the analyte sensor comprising a first electrode (Fig. 1: working electrode) and a second electrode (Fig. 1: counter electrode), the first electrode being configured to electrochemically react with an analyte for generating an electrical signal (¶30: the redox polymer 102 disposed on the working electrode passes electrons, or a current, between the primary reactant and the working electrode) and the analyte sensor being configured for measuring the analyte concentration according to claim 1 (as described in claim 1).
Further, the limitation “the analyte sensor being configured for measuring the analyte concentration according to claim 1” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Feldman teaches all structural limitations of the presently claimed analyte sensor, and thus it is capable of measuring the analyte concentration by the method of claim 1.
Regarding claim 9, Feldman teaches wherein the first electrode is a working electrode (Fig. 1: working electrode).
Regarding claim 10, Feldman teaches wherein the first electrode comprises at least one of enzyme, glucose oxidase (¶75: a glucose electrode having a sensing layer containing a catalyst, e.g., glucose oxidase).
Regarding claim 12, the designation “wherein the second electrode is configured to measure an oxygen saturation in the environment of the second electrode” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Feldman teaches all structural limitations of the presently claimed analyte sensor, and oxygen is electroreduced to H2O on the counter electrode (Fig. 1; ¶31, Equation 2). Thus, the counter electrode of Feldman is capable of measuring an oxygen saturation in the environment of the second electrode.
Regarding claim 13, Feldman teaches wherein the first electrode and second electrode are arranged on opposing sides of a/the substrate of the analyte sensor (Fig. 8A; ¶67: the electrodes 801 and 803 on the substrate; here, electrodes 801 and 803 are arranged on the opposing sides of the substrate)
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman in view of Goode (US 2005/0043598).
Regarding claim 2, Feldman discloses all limitations of claim 1 and the modulated voltage signal applied between the first electrode and the second electrode. Feldman does not disclose wherein the modulated voltage signal is applied in time-discrete steps.
However, Goode teaches pulse amperometric detection of an electrochemical flow cell, including a controller that applies the potentials and monitors current generated by the electrochemical reactions (¶263). The cell can include one working electrode at different applied potentials (¶263), e.g., using pulsed amperometric detection (¶14). Thus, Goode teaches the modulated voltage signal is applied in time-discrete steps.
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 Feldman by substituting the applied modulated voltage with pulsed voltage as taught by Goode because the pulsed amperometric detection is suitable for an electrochemical cell to detect glucose (¶¶263, 345). Here, the substitution of one known element for another would yield nothing more than predictable results is prima facie obvious. MPEP 2141(III)(B).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman in view of Roy (US 2012/0108932).
Regarding claim 3, Feldman discloses all limitations of claim 1 but fails to teach wherein the step of determining a current signal in response to the applied modulated voltage signal comprises: determining the amplitude of the current signal and the average current signal at the first electrode in response to the applied modulated voltage signal and in response to the electrical signal generated at the first electrode from the reaction with the analyte.
However, Roy teaches an electro-chemical glucose sensor may generate current at a nanoAmp level, and an amplitude of such current may change based on a glucose level in the body fluid (¶138). Further, Roy teaches when determining at least one metric, it would ascertain the at least one sensor signal based on at least in part on the series of samples of the at least one sensor signal, i.e., the characteristic comprising one or more values descriptive of how data are distributed with respect to an average of the data (¶14).
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 Feldman by employing the current amplitude as the current signal as taught by Roy because the current amplitude changes based on a glucose level detected by an electro-chemical sensor (¶138). Here, the substitution of one known element for another would yield nothing more than predictable results is prima facie obvious. MPEP 2141(III)(B). Further, 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 Feldman by using average current signal in response to the applied modulated signal and generated at the first electrode from the reaction with the analyte (Feldman, ¶30) because the averaged value is a descriptive of how data are distributed to ascertain the value (Roy, ¶14). Here, use of averaged current signal would yield nothing more than predictable results.
Regarding claim 4, Feldman teaches wherein the step of determining the electric potential working point of the analyte sensor based on the determined current signal comprises: regulating the applied modulated voltage signal (Fig. 14; ¶142: the resulting spontaneous steady state current was measured for sensors configured with different R values).
The designation “such that the ratio of the determined amplitude of the current signal at the first electrode to the determined average current signal falls within a predetermined range to determine an electric potential working point of the first electrode” is deemed to be the intended result of the step “regulating the applied modulated voltage signal” and does not to require an active step of the method. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. In method claims, it is the overall method steps that are given patentable weight not the intended result thereof because the intended result does not materially alter the overall method. Here, this designation is not given patentable weight when it simply expresses the intended result of a process step positively recited. MPEP 2111.04.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman in view of Liu (US 2012/0132525).
Regarding claim 11, Feldman discloses all limitations of claim 10 and wherein the first electrode comprising at least one transition metal complex (Fig. 1; ¶30: the working electrode electrocatalyst layer 102 and 103; redox polymer 102) comprising a modified poly(vinylpyridine) backbone (¶87: a mass transport limiting layer is a membrane composed of crosslinked polymers such as polymers of polyvinylpyridine) loaded with Os complexes covalently coupled through a bidentate linkage (¶85: the sensing element is a redox active component including Osmium-based mediator molecules that include (bidente) ligands).
Feldman does not disclose the Os complexes is poly(bi-imidizyl) Os complexes.
However, Liu teaches polymers for use as redox mediators in electrochemical biosensors including polymeric backbones attached with transition metal complexes ([Abstract]). The redox polymer has a modified poly(vinylpyridine) backbone loaded with poly(bi-imidizyl) Ox complexes via bidentate linkage (¶171).
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 Feldman by substituting the Os complexes loaded into the polyvinylpyridine with one formed of poly(bi-imidizyl) Os complexes as taught by Liu. The suggestion for doing so would have been that poly(bi-imidizyl) Os complexes loaded polyvinylpyridine is a suitable material for the redox mediators in electrochemical sensors 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.
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues Feldman does not teach “a modulated voltage signal” and Examiner’s interpretation of Fig. 14 and ¶142 is incorrect (Response, pp. 5-6). This argument is unpersuasive. Feldman teaches a self-powered glucose sensor, and the voltage drop across the resistance R (i.e., the voltage between the working and counter electrode as shown in Fig. 1) of the self-powered analyte sensor can range from about 0 volts to about 1.2 volts, and typically, from about 0 volts and about 0.3 volts (¶35), which means the applied voltage is a modulated one. As indicated in Fig. 14, the open circuit potential remains at 474 mV (¶143), but the potential, i.e., potential drop across the resistor R, is different over the different R values.
Applicant explains how Ewp is identified (Specification, Fig. 1; ¶¶117-120) and argues Feldman fails to teach “determining an electric potential working point (Ewp)” (pp. 6-7). This argument is unpersuasive. Examiner notes the recited limitations, e.g., “modulated” voltage, determined “electric potential working point,” are broad and the method of determining Ewp has not been particularly pointed out and distinctly claimed. Here, Feldman teaches when the range of R values from 0 to 10 MΩ is the range of R values for which the sensor output, at an analyte concentration at the top of its physically relevant range, is independent of R, and thus the electric potential working point is determined, i.e., using R within the range from 0 to 10 MΩ.
Applicant argues the designation “such that the ratio of the determined amplitude of the current signal at the first electrode to the determined average current signal falls within a predetermined range to determine an electric potential working point of the first electrode” is not intended result but defines the manner in which the applied modulated voltage is regulated (p. 8, para. 2). Examiner disagrees because the step “regulating the applied modulated voltage signal” is an active step of the method, and as a result, the ratio of the current signal to the average current signal would naturally fall until it eventually falls within a predetermined range. Examiner suggests Applicant to amend the claims to detail the steps of determining the Ewp and provide the extent of the ratio.
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.
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/C. SUN/Primary Examiner, Art Unit 1795