DETAILED ACTION
Applicant’s arguments, filed on 07/29/2025, 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 on 07/29/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the current claims hereby under examination.
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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 9-12, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Moein (US PG Pub 20120323098) in further view of Oja (WO 2019006413).
Regarding independent claim 1, Moein teaches a working electrode measuring the presence of a first analyte ([0007]: “Embodiments of the present disclosure relate to analyte monitoring and/or detection devices and systems which utilize one or more sensor connectors, e.g., one or more rivets, to physically connect an analyte sensor, e.g., an in vivo or in vitro analyte sensor having one or more electrodes to an electronics unit such as a sensor control unit”), comprising:
a working conductor (Figure 3, “first conductive layer” 32) having a first electrode reactive surface ([0087]: “a first conductive layer 32 which substantially covers the entirety of a first surface area”);
a first transport material that enables flux of the first analyte to a first reactive chemistry ([0093]: “a first membrane layer 36 may be provided solely over the sensing component or sensing layer 32A on the working electrode 32”; [0093]: “a first membrane layer 36 may be provided solely over the sensing component or sensing layer 32A on the working electrode 32 to modulate the rate of diffusion or flux of the analyte to the sensing layer”);
wherein the first reactive chemistry is responsive to the first analyte, the first reactive chemistry including a mediator ([0131]), an enzyme ([0133]: “One example of a suitable catalyst is an enzyme which catalyzes a reaction of the analyte”) and a cofactor ([0133]: “a catalyst, including a glucose oxidase, glucose dehydrogenase (e.g., pyrroloquinoline quinone (PQQ), dependent glucose dehydrogenase, flavine adenine dinucleotide (FAD) dependent glucose dehydrogenase, or nicotinamide adenine dinucleotide (NAD) dependent glucose dehydrogenase), may be used when the analyte of interest is glucose”),
wherein the enzyme and the cofactor form wired elements that are electrically connected to the working conductor ([0079]: “Wire sensors generally include a substrate (dielectric material) and electrodes (conductive material) and may include a core conductive wire that may be a working electrode, and one or more other conductive wires which may wrapped or coiled around at least a length of the core wire and serve as a reference electrode, counter electrode or reference/counter electrode.”).
Moein discloses a wire sensor used for the analyte sensor. Oja further adds information about the components of a wire sensor, which teaches on this limitation.
Oja discloses a method and apparatus for analyte detection using an electrochemical biosensor. Specifically, Oja teaches wherein the enzyme and the cofactor form wired elements that are electrically connected to the working conductor ([00100]: “the sensor is a wire, e.g., a working electrode wire inner portion with one or more other electrodes associated”; [00116]: “the analyte is detected by an enzyme protein that is capable of interacting directly with the analyte molecule. However, some enzymes (e.g., glucose oxidase) cannot exchange electrons directly with electrodes because their redox active sites are buried deep within the enzyme protein structure. Therefore, in order to transfer electrons between the redox active site of the enzyme and the electrodes, an electron transfer agent (i.e., a redox mediator) is used. Immobilization of the electron transfer agent and the analyte-specific enzyme on the sensing layer creates what is referred to as a "wire" as the immobilized molecules are capable of relaying electrons, and as such are "electrically wired." The analyte-specific enzyme is also referred to as a "wired enzyme."”). Moein and Oja are analogous arts as they are both related to wire sensors used to measure analytes.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure of Oja’s wire sensor into Moein’s wire sensor, as they are both wire sensors used to measure analytes and Oja further defines the components of this sensor.
The Moein/Oja combination teaches wherein the first reactive chemistry is located between the working conductor and the first transport material (Moein, Figure 3).
Regarding claim 2, the Moein/Oja combination teaches the working electrode described in claim 1, wherein the mediator is a conductive polymer (Moein, [0130]-[0132]).
Regarding claim 9, the Moein/Oja combination teaches the working electrode described in claim 2, wherein a printing process is used to apply the first reactive chemistry to the first electrode reactive surface (Moein, [0109]: “The identifier may in some embodiments be made from the same conductive material as one or more of the conductive layers of the analyte sensor and may, in some embodiments, be applied or formed in the same manner as one or more of the conductive layers of the analyte sensor, via a printing or ablation method”), the mediator within the first reactive chemistry being dispersed within a printable electrically conductive ink or paste (Moein, [0102]: “working electrode 502 is applied in the form of a carbon ink.”). Furthermore, this limitation is a product-by-process claim. How the first reactive chemistry is applied is not critical to the apparatus itself, as patentability of an apparatus lies in the structure of the apparatus rather than how the structure is made. See MPEP Section 2113. The structure of the electrode in Moein is the same, therefore the 103 rejection of claim 2 teaches on claim 9 as well.
Regarding independent claim 10, Moein teaches an electrochemical sensor for measuring in-vivo analyte concentration within in subject ([0117]: “ Embodiments relate to the continuous and/or automatic in vivo monitoring of the level of one or more analytes using a continuous analyte monitoring system that includes an analyte sensor at least a portion of which is to be positioned beneath a skin surface of a user for a period of time and/or the discrete monitoring of one or more analytes using an in vitro blood glucose ("BG") meter and an analyte test strip”), comprising:
a working electrode ([0007]: “Embodiments of the present disclosure relate to analyte monitoring and/or detection devices and systems which utilize one or more sensor connectors, e.g., one or more rivets, to physically connect an analyte sensor, e.g., an in vivo or in vitro analyte sensor having one or more electrodes to an electronics unit such as a sensor control unit”) that includes
a working conductor (Figure 3, “first conductive layer” 32) having an electrode reactive surface ([0087]: “a first conductive layer 32 which substantially covers the entirety of a first surface area”);
a reactive chemistry being response to an analyte, the reactive chemistry including a mediator ([0131]), an enzyme ([0133]: “One example of a suitable catalyst is an enzyme which catalyzes a reaction of the analyte”) and a cofactor ([0133]: “a catalyst, including a glucose oxidase, glucose dehydrogenase (e.g., pyrroloquinoline quinone (PQQ), dependent glucose dehydrogenase, flavine adenine dinucleotide (FAD) dependent glucose dehydrogenase, or nicotinamide adenine dinucleotide (NAD) dependent glucose dehydrogenase), may be used when the analyte of interest is glucose”), the reactive chemistry being applied over the electrode reactive surface ([0124]: “the sensing elements are deposited on the conductive material of a working electrode”), wherein the enzyme and the cofactor form wired elements that are electrically connected to the working conductor ([0079]: “Wire sensors generally include a substrate (dielectric material) and electrodes (conductive material) and may include a core conductive wire that may be a working electrode, and one or more other conductive wires which may wrapped or coiled around at least a length of the core wire and serve as a reference electrode, counter electrode or reference/counter electrode.”).
Moein discloses a wire sensor used for the analyte sensor. Oja further adds information about the components of a wire sensor, which teaches on this limitation.
Oja discloses a method and apparatus for analyte detection using an electrochemical biosensor. Specifically, Oja teaches wherein the enzyme and the cofactor form wired elements that are electrically connected to the working conductor ([00100]: “the sensor is a wire, e.g., a working electrode wire inner portion with one or more other electrodes associated”; [00116]: “the analyte is detected by an enzyme protein that is capable of interacting directly with the analyte molecule. However, some enzymes (e.g., glucose oxidase) cannot exchange electrons directly with electrodes because their redox active sites are buried deep within the enzyme protein structure. Therefore, in order to transfer electrons between the redox active site of the enzyme and the electrodes, an electron transfer agent (i.e., a redox mediator) is used. Immobilization of the electron transfer agent and the analyte-specific enzyme on the sensing layer creates what is referred to as a "wire" as the immobilized molecules are capable of relaying electrons, and as such are "electrically wired." The analyte-specific enzyme is also referred to as a "wired enzyme."”). Moein and Oja are analogous arts as they are both related to wire sensors used to measure analytes.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure of Oja’s wire sensor into Moein’s wire sensor, as they are both wire sensors used to measure analytes and Oja further defines the components of this sensor.
The Moein/Oja combination teaches a pseudo-reference electrode that includes a combined counter-reference conductor (Moein, [0079]: “one or more other conductive wires which may wrapped or coiled around at least a length of the core wire and serve as a reference electrode”); and
a transport material enables flux of the analyte to the reactive chemistry (Moein, [0093]: “a first membrane layer 36 may be provided solely over the sensing component or sensing layer 32A on the working electrode 32”; [0093]: “a first membrane layer 36 may be provided solely over the sensing component or sensing layer 32A on the working electrode 32 to modulate the rate of diffusion or flux of the analyte to the sensing layer”), the transport material being applied over the reactive chemistry and the pseudo-reference electrode (Moein, [0093]: “a single, homogenous membrane may be coated over the entire sensor surface area”).
Regarding claim 11, the Moein/Oja combination teaches the electrochemical sensor described in claim 10, wherein the pseudo-reference electrode further includes a counter-reference surface treatment (Moein, [0089]: “conductive layer 33 is configured to include a reference electrode which includes a secondary layer of conductive material 33A, e.g., Ag/AgCl, disposed over a distal portion of conductive layer 33”).
Regarding claim 12, the Moein/Oja combination teaches the electrochemical sensor described in claim 11, wherein the mediator is a conductive polymer (Moein, [0130]-[0132]).
Regarding claim 14, the Moein/Oja combination teaches the electrochemical sensor described in claim 11, wherein a printing process is used to apply the reactive chemistry to the electrode reactive surface (Moein, [0109]: “The identifier may in some embodiments be made from the same conductive material as one or more of the conductive layers of the analyte sensor and may, in some embodiments, be applied or formed in the same manner as one or more of the conductive layers of the analyte sensor, via a printing or ablation method”), the mediator within the reactive chemistry being a printable electrically conductive ink or paste (Moein, [0102]: “working electrode 502 is applied in the form of a carbon ink.”).
Regarding claim 20, the Moein/Oja combination teaches the electrochemical sensor described in claim 10, wherein the pseudo-reference electrode is located on a side opposite the working electrode (Moein, Figure 10, working electrode 502 and reference electrode 504).
Claims 3-6, 8, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over the Moein/Oja combination as applied to claim 2 and 12 above, and further in view of Hampp (US Patent Publication No. 5783056).
Regarding claim 3, the Moein/Oja combination teaches the working electrode described in claim 2 wherein the first reactive chemistry is formed by electropolymerization of the mediator in the presence of the enzyme and the cofactor. This limitation is a product-by-process claim. How the first reactive chemistry is formed is not critical to the apparatus itself, as patentability of an apparatus lies in the structure of the apparatus rather than how the structure is made. See MPEP Section 2113. The structure of the electrode in Moein is the same, therefore the 103 rejection of claim 2 teaches on claim 3 as well.
Moreover, , the Moein/Oja combination is silent on the formation of the first reactive chemistry. Hampp discloses an electrochemical enzyme biosensor that contains electrodes for sensing. Specifically, Hampp teaches the working electrode wherein the first reactive chemistry is formed by electropolymerization of the mediator in the presence of the enzyme and the cofactor (Column 2, lines 46-56: “the microporous noble metal electrodes are modified by coating them with electropolymerizable, conductive polymers, in particular with polypyrrole and poly(methylene blue). This modification can be utilized for the immobilization of enzymes and other selectivity-conferring biocomponents. In the process, the disperse surface of the noble metal electrodes enables homogeneous growth of the polymer during the electropolymerization, since many reactive sites, uniformly distributed over the entire macroscopic electrode surface, are generated.”) . Moein, Oja, and Hampp are analogous arts as they all relate to sensors that measure analytes in a subject.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the formation technique from Hampp in the electrode from , the Moein/Oja combination, as , the Moein/Oja combination is silent of the formation technique of the first reactive chemistry, and Hampp discloses a formation technique that is suitable for the electrode.
Regarding claim 4, the Moein/Oja/Hampp combination of claim 3 teaches the working electrode described in claim 3, wherein the first reactive chemistry includes free elements of the enzyme and the cofactor entrapped within the polymerized mediator (Hampp, Column 2, lines 46-56: “the microporous noble metal electrodes are modified by coating them with electropolymerizable, conductive polymers, in particular with polypyrrole and poly(methylene blue). This modification can be utilized for the immobilization of enzymes and other selectivity-conferring biocomponents. In the process, the disperse surface of the noble metal electrodes enables homogeneous growth of the polymer during the electropolymerization, since many reactive sites, uniformly distributed over the entire macroscopic electrode surface, are generated.”).
Regarding claim 5, the Moein/Oja/Hampp combination teaches the working electrode described in claim 4, wherein the mediator participates in transferring electrons (Moein, [0079]: “Wire sensors generally include a substrate (dielectric material) and electrodes (conductive material) and may include a core conductive wire that may be a working electrode, and one or more other conductive wires which may wrapped or coiled around at least a length of the core wire and serve as a reference electrode, counter electrode or reference/counter electrode.”; Oja, [00100]: “the sensor is a wire, e.g., a working electrode wire inner portion with one or more other electrodes associated”; [00116]: “the analyte is detected by an enzyme protein that is capable of interacting directly with the analyte molecule. However, some enzymes (e.g., glucose oxidase) cannot exchange electrons directly with electrodes because their redox active sites are buried deep within the enzyme protein structure. Therefore, in order to transfer electrons between the redox active site of the enzyme and the electrodes, an electron transfer agent (i.e., a redox mediator) is used. Immobilization of the electron transfer agent and the analyte-specific enzyme on the sensing layer creates what is referred to as a "wire" as the immobilized molecules are capable of relaying electrons, and as such are "electrically wired." The analyte-specific enzyme is also referred to as a "wired enzyme."”).
Regarding claim 6, the Moein/Oja/Hampp combination teaches the working electrode described in claim 5, wherein reaction of the analyte with free enzyme generates an intermediary and reaction of the free enzyme with the cofactor generates a reacted cofactor (Moein, [0134]: “a catalyst may be attached to a polymer, cross linking the catalyst with another electron transfer agent, which, as described above, may be polymeric. A second catalyst may also be used in certain embodiments. This second catalyst may be used to catalyze a reaction of a product compound resulting from the catalyzed reaction of the analyte. The second catalyst may operate with an electron transfer agent to electrolyze the product compound to generate a signal at the working electrode. Alternatively, a second catalyst may be provided in an interferent-eliminating layer to catalyze reactions that remove interferents.”).
Regarding claim 8, the Moein/Oja/Hampp combination teaches the working electrode described in claim 4, wherein the enzyme is a dehydrogenase enzyme (Moein, [0133]: “One example of a suitable catalyst is an enzyme which catalyzes a reaction of the analyte. For example, a catalyst, including a glucose oxidase, glucose dehydrogenase”) and the cofactor is an electron acceptor (Moein, [0133]: “for example, a catalyst, including a glucose oxidase, glucose dehydrogenase (e.g., pyrroloquinoline quinone (PQQ), dependent glucose dehydrogenase, flavine adenine dinucleotide (FAD) dependent glucose dehydrogenase, or nicotinamide adenine dinucleotide (NAD) dependent glucose dehydrogenase), may be used when the analyte of interest is glucose.”).
Regarding claim 13, the Moein/Oja combination teaches the electrochemical sensor described in claim 12, wherein the reactive chemistry is formed by electropolymerization of the mediator in the presence of the enzyme and the cofactor. This limitation is a product-by-process claim. How the reactive chemistry is formed is not critical to the apparatus itself, as patentability of an apparatus lies in the structure of the apparatus rather than how the structure is made. See MPEP Section 2113. The structure of the sensor in Moein is the same, therefore the 103 rejection of claim 12 teaches on claim 13 as well.
Moreover, the Moein/Oja combination is silent on the formation of the reactive chemistry. Hampp discloses an electrochemical enzyme biosensor that contains electrodes for sensing. Specifically, Hampp teaches the electrochemical sensor wherein the first reactive chemistry is formed by electropolymerization of the mediator in the presence of the enzyme and the cofactor (Column 2, lines 46-56: “the microporous noble metal electrodes are modified by coating them with electropolymerizable, conductive polymers, in particular with polypyrrole and poly(methylene blue). This modification can be utilized for the immobilization of enzymes and other selectivity-conferring biocomponents. In the process, the disperse surface of the noble metal electrodes enables homogeneous growth of the polymer during the electropolymerization, since many reactive sites, uniformly distributed over the entire macroscopic electrode surface, are generated.”) . Moein, Oja, and Hampp are analogous arts as they both relate to sensors that measure analytes in a subject.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the formation technique from Hampp in the electrode from the Moein/Oja combination, as the Moein/Oja combination is silent of the formation technique of the reactive chemistry, and Hampp discloses a formation technique that is suitable for the sensor.
Regarding claim 15, the Moein/Oja/Hampp combination of claim 13 teaches the electrochemical sensor described in claim 13, wherein the reactive chemistry includes free elements of the enzyme and the cofactor entrapped within the polymerized mediator (Hampp, Column 2, lines 46-56: “the microporous noble metal electrodes are modified by coating them with electropolymerizable, conductive polymers, in particular with polypyrrole and poly(methylene blue). This modification can be utilized for the immobilization of enzymes and other selectivity-conferring biocomponents. In the process, the disperse surface of the noble metal electrodes enables homogeneous growth of the polymer during the electropolymerization, since many reactive sites, uniformly distributed over the entire macroscopic electrode surface, are generated.”).
Regarding claim 16, the Moein/Oja/Hampp combination teaches the electrochemical sensor described in claim 15, wherein the mediator participates in transferring electrons (Moein, [0079]: “Wire sensors generally include a substrate (dielectric material) and electrodes (conductive material) and may include a core conductive wire that may be a working electrode, and one or more other conductive wires which may wrapped or coiled around at least a length of the core wire and serve as a reference electrode, counter electrode or reference/counter electrode.”; Oja, [00100]: “the sensor is a wire, e.g., a working electrode wire inner portion with one or more other electrodes associated”; [00116]: “the analyte is detected by an enzyme protein that is capable of interacting directly with the analyte molecule. However, some enzymes (e.g., glucose oxidase) cannot exchange electrons directly with electrodes because their redox active sites are buried deep within the enzyme protein structure. Therefore, in order to transfer electrons between the redox active site of the enzyme and the electrodes, an electron transfer agent (i.e., a redox mediator) is used. Immobilization of the electron transfer agent and the analyte-specific enzyme on the sensing layer creates what is referred to as a "wire" as the immobilized molecules are capable of relaying electrons, and as such are "electrically wired." The analyte-specific enzyme is also referred to as a "wired enzyme."”).
Regarding claim 17, the Moein/Oja/Hampp combination teaches the electrochemical sensor described in claim 16, wherein reaction of the analyte with free enzyme generates an intermediary and reaction of the free enzyme with the cofactor generates a reacted cofactor (Moein, [0134]: “a catalyst may be attached to a polymer, cross linking the catalyst with another electron transfer agent, which, as described above, may be polymeric. A second catalyst may also be used in certain embodiments. This second catalyst may be used to catalyze a reaction of a product compound resulting from the catalyzed reaction of the analyte. The second catalyst may operate with an electron transfer agent to electrolyze the product compound to generate a signal at the working electrode. Alternatively, a second catalyst may be provided in an interferent-eliminating layer to catalyze reactions that remove interferents.”).
Claims 7, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over the Moein/Oja/Hampp combination as applied to claim 6 and 17 above, and further in view of Feldman (US Patent Application Publication No. 20210059587).
Regarding claim 7, the Moein/Oja/Hampp combination teaches the working electrode described in claim 6, wherein the generated intermediary diffuses to a wired element and results in direct electron transfer from the first electrode reactive surface to the cofactor generating reacted cofactor (Moein, [0126]: “ a glucose, lactate, or oxygen electrode may be formed having sensing elements which contain a catalyst, including glucose oxidase, glucose dehydrogenase, lactate oxidase, or laccase, respectively, and an electron transfer agent that facilitates the electrooxidation of the glucose, lactate, or oxygen, respectively.”; [0133]: “The catalyst may also, in some embodiments, act as an electron transfer agent.”). However, the Moein/Oja/Hampp combination does not teach the reacted cofactor further enabling a reversible reaction of the intermediary back to the analyte.
Feldman discloses an apparatus to measure an analyte concentration of an individual, specifically alcohol concentration. Specifically, Feldman teaches the reacted cofactor further enabling a reversible reaction of the intermediary back to the analyte ([0073]: “alcohol dehydrogenases do not only catalyze the forward conversion of alcohol to an aldehyde (generally referred to herein as acetaldehyde, although other aldehydes having higher or lower carbon content may be produced), but also perform the reaction reversibly”). Moein, Oja, Hampp, and Feldman are analogous arts as they all relate to sensors that measure analytes in a subject.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the action of reversing the reaction from Feldman into the electrode from the Moein/Oja/Hampp combination, as it allows the electrode to be used repeatedly, since it allows the analyte to separate from the electrode. Being able to use the electrode to sense the analytes more than once allows it to be more effective, since it will not have to be removed from the patient after each detection.
Regarding claim 18, the Moein/Oja/Hampp combination teaches the electrochemical sensor described in claim 17, wherein the generated intermediary diffuses to a wired element and results in direct electron transfer from the first electrode reactive surface to the cofactor generating reacted cofactor (Moein, [0126]: “ a glucose, lactate, or oxygen electrode may be formed having sensing elements which contain a catalyst, including glucose oxidase, glucose dehydrogenase, lactate oxidase, or laccase, respectively, and an electron transfer agent that facilitates the electrooxidation of the glucose, lactate, or oxygen, respectively.”; [0133]: “The catalyst may also, in some embodiments, act as an electron transfer agent.”). However, the Moein/Hampp combination does not teach the reacted cofactor further enabling a reversible reaction of the intermediary back to the analyte.
Feldman discloses an apparatus to measure an analyte concentration of an individual, specifically alcohol concentration. Specifically, Feldman teaches the reacted cofactor further enabling a reversible reaction of the intermediary back to the analyte ([0073]: “alcohol dehydrogenases do not only catalyze the forward conversion of alcohol to an aldehyde (generally referred to herein as acetaldehyde, although other aldehydes having higher or lower carbon content may be produced), but also perform the reaction reversibly”). Moein, Oja, Hampp, and Feldman are analogous arts as they all relate to sensors that measure analytes in a subject.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the action of reversing the reaction from Feldman into the sensor from the Moein/Oja/Hampp combination, as it allows the electrode to be used repeatedly, since it allows the analyte to separate from the sensor. Being able to use the sensor to sense the analytes more than once allows it to be more effective, since it will not have to be removed from the patient after each detection.
Regarding claim 19, the Moein/Oja/Hampp/Feldman combination teaches the electrochemical sensor described in claim 18, wherein the enzyme is a dehydrogenase enzyme (Moein, [0133]: “One example of a suitable catalyst is an enzyme which catalyzes a reaction of the analyte. For example, a catalyst, including a glucose oxidase, glucose dehydrogenase”) and the cofactor is an electron acceptor (Moein, [0133]: “for example, a catalyst, including a glucose oxidase, glucose dehydrogenase (e.g., pyrroloquinoline quinone (PQQ), dependent glucose dehydrogenase, flavine adenine dinucleotide (FAD) dependent glucose dehydrogenase, or nicotinamide adenine dinucleotide (NAD) dependent glucose dehydrogenase), may be used when the analyte of interest is glucose.”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
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/E.K.M./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791