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 Claims
Applicant's arguments, filed 02/06/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/06/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 11, 12, and 17.
Applicants have left claims 2-8, 13-16, and 18-20 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 9-10.
Claims 1-8 and 11-20 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/06/2026 are being considered by the examiner.
Claim Objections - Newly Applied
Claim 18 is objected to because of the following informalities:
Regarding claim 18, line 2 recites “the interference layer”, however it appears the claim should read --the interference zapping layer-- (emphasis added) to maintain consistent claim language.
Claim Rejections - 35 USC § 102 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simpson et al. (US 20100185071 A1) (previously cited), hereinafter referred to as Simpson.
The claims are generally directed towards an electrochemical probe comprising: an electrode; an enzyme layer arranged over the electrode and comprising an enzyme configured to convert an analyte to a chemical species measurable by the electrode; and an interference zapping layer arranged over the enzyme layer, the interference zapping layer comprising a conductive nanowire network embedded within a polymer matrix, wherein the polymer matrix allows diffusion of the analyte therethrough, the polymer matrix comprising a hydrogel.
Regarding claim 1, Simpson discloses an electrochemical probe (Abstract, Fig. 1B, para. [0007]) comprising:
an electrode (Fig. 1B, element 16, para. [0310], “glucose-measuring working electrode …”);
an enzyme layer arranged over the electrode and comprising an enzyme configured to convert an analyte to a chemical species measurable by the electrode (Fig. 2A-2B, element 28, para. [0167], “enzyme domain …”, para. [0295-0296], “enzyme domain provides an enzyme to catalyze the reaction of the analyte and its co-reactant …”, para. [0310], “glucose-measuring working electrode 16 measures the hydrogen peroxide produced by the enzyme catalyzed reaction …”); and
an interference zapping layer arranged over the enzyme layer, the interference zapping layer comprising a conductive nanowire network embedded within a polymer matrix, wherein the polymer matrix allows diffusion of the analyte therethrough, the polymer matrix comprising a hydrogel (Fig. 1B, element 18, para. [0160], “working electrodes … formed from a fine wire …”, para. [0162], “auxiliary (additional) working electrode is configured to measure a background signal …”, para. [0171], “hydrogel film”, para. [0273-0275], “auxiliary electrode configured to electrochemically modify electrochemical interferents … auxiliary electrode is located within or adjacent to the membrane system … placed anywhere between the electroactive sensing surface and the outside fluid … plurality of spaced wires or conductive polymers … designed to allow analytes to penetrate therethrough”).
Regarding claim 2, Simpson discloses the probe of claim 1, further comprising an analyte limiting layer (Fig. 2B, element 30, para. [0167], “resistance domain …”, para. [0300], “resistance domain … controls the flux of oxygen and glucose to the underlying enzyme domain …”).
Regarding claim 3, Simpson discloses the probe of claim 2, wherein the analyte limiting layer is a glucose limiting layer (Fig. 2B, element 30, para. [0167], “resistance domain …”, para. [0300], “resistance domain … controls the flux of oxygen and glucose to the underlying enzyme domain …”).
Regarding claim 4, Simpson discloses the probe of claim 1, wherein the electrode is configured to measure glucose concentration (para. [0317-0318], “sensing region comprises electroactive surfaces … determine glucose concentration …”, para. [0322]).
Regarding claim 5, Simpson discloses the probe of claim 1, wherein the enzyme layer is configured to convert glucose to hydrogen peroxide and gluconic acid (para. [0317-0318], “glucose oxidase catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate …”).
Regarding claim 6, Simpson discloses the probe of claim 5, wherein the enzyme layer comprises a glucose oxidase (para. [0317-0318], “sensing region comprises electroactive surfaces … glucose oxidase … determine glucose concentration …”, para. [0322]).
Regarding claim 7, Simpson discloses the probe of claim 1, further comprising a blocking layer (Fig. 2B, element 26, element 30, para. [0167], “resistance domain …”, para. [0177], “interference domain is provided that substantially restricts or blocks the flow of one or more interfering species …”, para. [0300], “resistance domain … controls the flux of oxygen and glucose to the underlying enzyme domain …”).
Regarding claim 8, Simpson discloses the probe of claim 1, comprising: a first voltage source configured to set the electrode to a first applied potential (Fig. 4, element 36, para. [0310], para. [0433], “a first potentiostat is provided that is operatively associated with the glucose-measuring working electrode …”) and a second voltage source configured to set the interference zapping layer to a second applied potential (Fig. 4, element 37, para. [0310], para. [0433], “second potentiostat is provided that is operatively associated with the optional auxiliary electrode …”), wherein the second applied potential is equal to or higher than the first applied potential (para. [0273-0275], “auxiliary electrode is set at a potential of from about 0.6 to about 1.2 V …”, para. [0448-0453], “first sensor can be biased at a voltage of about 0.4V and the second sensor can be biased at a voltage about 0.6V …”).
Regarding claim 11, Simpson discloses a method of using an electrochemical probe (Abstract, para. [0044]), comprising:
applying a first potential to an interference zapping layer, the first potential sufficient to oxidize at least one electrochemical interferent and a target analyte (para. [0154-0158], para. [0273-0275], “auxiliary electrode is set at a potential of from about 0.6 to about 1.2 V … both oxygen-generation and electrochemical interferant modification can be achieved”, para. [0318], “one or more potentiostat … applies a constant potential to the working electrode … determine the current produced …”, para. [0371]), the interference zapping layer arranged over a first electrode and a second electrode (para. [0161], para. [0273-0275], “auxiliary electrode is located within or adjacent to the membrane system … placed anywhere between the electroactive sensing surface and the outside fluid … polymer coating is chosen to selectively allow interferants to pass through the coating and electrochemically react with the auxiliary electrode” - the polymer coating being the interference zapping layer, the first electrode being the first working electrode and the second electrode being the auxiliary electrode);
measuring a first background current of the first electrode, wherein an enzyme layer is arranged above the first electrode (para. [0161], “first working electrode measures the hydrogen peroxide produced by an enzyme catalyzed reaction of the analyte … electronic current being detected …”, para. [0433]);
measuring a second background current of the second electrode (para. [0157], “measure a signal associated with the baseline …”, para. [0433]);
applying a second potential to the interference zapping layer, the second potential sufficient to oxidize at least one electrochemical interferent but not oxidize the target analyte (para. [0273-0275], “electrochemically modify interferants”, para. [0433], “a first potentiostat is provided that is operatively associated with the glucose-measuring working electrode …”, para. [0447-0453], “biased at a voltage of about 0.4V”);
measuring a first current of the first electrode (para. [0161], “electronic current being detected …”, para. [0433]);
measuring a second current of the second electrode (para. [0157], “measure a signal associated with the baseline …”, para. [0433]);
determining an estimate of a concentration of the target analyte based, at least in part, on measurements of the first background current, the second background current, the first current, and the second current (para. [0157], “sensing region is configured to measure changes in the amount of background noise … baseline signal is subtracted from the glucose signal to obtain the signal contribution substantially only due to glucose …”, para. [0371], para. [0472-0476], para. [0483]).
Regarding claim 12, Simpson discloses the method of claim 11, the target analyte comprising glucose (para. [0157], “sensing region is configured to measure changes in the amount of background noise … baseline signal is subtracted from the glucose signal to obtain the signal contribution substantially only due to glucose …”).
Regarding claim 13, Simpson discloses the method of claim 11, wherein the first potential is within +0.5 to +1.5 V (para. [0273-0275], “auxiliary electrode is set at a potential of from about 0.6 to about 1.2 V).
Regarding claim 14, Simpson discloses the method of claim 13, wherein the first potential is within +0.6 to +1.1V (para. [0273-0275], “auxiliary electrode is set at a potential of from about 0.6 to about 1.2 V).
Regarding claim 15, Simpson discloses the method of claim 11, wherein the second potential is within +0.3 to +1.1V (para. [0433], “a first potentiostat is provided that is operatively associated with the glucose-measuring working electrode …”, para. [0447-0453], “biased at a voltage of about 0.4V”).
Regarding claim 16, Simpson discloses the method of claim 15, wherein the second potential is within +0.4 to 0.7V (para. [0433], “a first potentiostat is provided that is operatively associated with the glucose-measuring working electrode …”, para. [0447-0453], “biased at a voltage of about 0.4V”).
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive.
Applicants have argued on page 5 of Remarks, filed 02/06/2026, that “the Office Action has failed to establish that Simpson anticipates at least the above emphasized portion of Claim 1”.
As recited above, Simpson teaches newly amended claim 1. The Examiner cannot find a reason to withdraw the rejection.
Applicants have argued on page 6 of Remarks, filed 02/06/2026, that “the Office Action appears to be interpreting the steps of “applying a first potential to an interference zapping layer” and “measuring a second background current of a second electrode” as being performed by Simpson’s auxiliary electrode, even through different components are claimed to perform these steps”.
As recited above in a different interpretation, Simpson teaches “applying a first potential to an interference zapping layer, the first potential sufficient to oxidize at least one electrochemical interferent and a target analyte, the interference zapping layer arranged over a first electrode and a second electrode … measuring a second background current of the second electrode”.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 20100185071 A1) (previously cited), hereinafter referred to as Simpson, in view of Gottlieb et al. (US 20100025238 A1) (previously cited), hereinafter referred to as Gottlieb.
Regarding claim 17, Simpson discloses a method of using an electrochemical probe comprising an interference zapping layer overlaying a working electrode (Abstract, Fig. 1B, Fig. 2A-B, para. [0044], para. [0162], para. [0273-0275], para. [0310]), the method comprising:
applying a first potential to the interference zapping layer, thereby selectively oxidizing certain electrochemical interferents (Fig. 4, element 37, para. [0273-0275], “electrochemically modifies electrochemical interferants …”, para. [0310], para. [0433], “second potentiostat is provided that is operatively associated with the optional auxiliary electrode …”, para. [0448-0453], “first sensor can be biased at a voltage of about 0.4V and the second sensor can be biased at a voltage about 0.6V …”);
applying a second potential to the working electrode (Fig. 4, element 36, para. [0310], para. [0433], “a first potentiostat is provided that is operatively associated with the glucose-measuring working electrode …”, para. [0448-0453], “first sensor can be biased at a voltage of about 0.4V and the second sensor can be biased at a voltage about 0.6V …”);
measuring a plurality of currents of the working electrode, each of the plurality of currents measured while the interference zapping layer is set to one of the first potential and while the working electrode is set to one of the second potential (para. [0273-0275], para. [0371], “first and second signals that are used to generate glucose concentration data … sensor electronics area configured to measure the current to provide the first and second signals …”, para. [0433], “measures a current value at the glucose-measuring working electrode … measures a current value at the auxiliary working electrode …”, para. [0448-0453]); and
determining, with a hardware processor, an estimate of a concentration of an analyte based, at least in part, on the measured plurality of currents (para. [0371], “electrodes are configured to provide the first and seconds signals that are used to generate glucose concentration data … first and second signals are used to determine the glucose concentration …”).
However, Simpson does not explicitly disclose the first and second potentials are a first plurality of potentials and a second plurality of potentials, and measuring the plurality of currents based on the plurality of potentials.
Gottlieb teaches of an analogous method of using an electrochemical probe for analyte sensing (Abstract, para. [0008]). Gottlieb teaches the electrochemical probe comprises a plurality of electrodes (para. [0010]). Gottlieb further teaches applying a first plurality of potentials to a first electrode, applying a second plurality of potentials to a second electrode, and measuring a plurality of currents as a result of the plurality of potentials (Fig. 4D, para. [0010], para. [0020], para. [0032], para. [0136], para. [0151]). 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 method disclosed by Simpson to explicitly apply a first plurality of potentials, applying a second plurality of potentials, and measure the plurality of currents as a result of the plurality of potentials, as taught by Gottlieb. This is because Gottlieb teaches a pulsed voltage allows lower concentrations of glucose to be detected more efficiently (para. [0151]).
Regarding claim 18, modified Simpson discloses the method of claim 17.
However, modified Simpson does not explicitly disclose wherein applying the first plurality of potentials to the interference layer comprises sequentially applying the first plurality of potentials.
Gottlieb further teaches sequentially applying the first plurality of potentials (Fig. 4D, para. [0010], para. [0020], para. [0032], para. [0136], para. [0151]). 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 method taught by modified Simpson to additionally sequentially apply the first plurality of potentials, as taught by Gottlieb. This is because Gottlieb teaches sequentially applying pulses allows lower concentrations of analytes to be detected more efficiently (para. [0151]).
Regarding claim 19, modified Simpson discloses the method of claim 17.
However, modified Simpson does not explicitly disclose wherein applying the second plurality of potentials to the working electrode comprises sequentially applying the second plurality of potentials.
Gottlieb further teaches sequentially applying the second plurality of potentials (Fig. 4D, para. [0010], para. [0020], para. [0032], para. [0136], para. [0151]). 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 method taught by modified Simpson to additionally sequentially apply the second plurality of potentials, as taught by Gottlieb. This is because Gottlieb teaches sequentially applying pulses allows lower concentrations of analytes to be detected more efficiently (para. [0151]).
Regarding claim 20, modified Simpson discloses the method of claim 17, wherein each of the plurality of currents is measured at a different combination of one of the first plurality of potentials and one of the second plurality of potentials (para. [0371], “provide the first and second signals …”, para. [0405], para. [0433]).
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 7-9 of Remarks, filed 02/06/2026, that “Gottlieb neither discloses nor suggests varying potential of an interference zapping layer …”.
The Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As recited above, Simpson teaches measuring a plurality of currents of the working electrode, each of the plurality of currents measured while the interference layer is set to the first potential and while the working electrode is set to a second potential. Gottlieb further teaches to one or ordinary skill in the art that applying a plurality of potentials allows for more efficient glucose concentration detection (para. [0151]), and it would have been obvious to one of ordinary skill in the art to apply the same technique to improve the method of Simpson in the same way.
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 KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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