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 Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/28/2025 has been entered.
Status of Claims
Applicant's arguments, filed 10/28/2025, 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 10/28/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1-11, 13, and 16.
Applicants have left claims 12 and 17-23 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 14-15.
Claims 1-13 and 16-23 are the current claims hereby under examination.
Claim Objections - Newly Applied Necessitated by Applicant’s Amendments
Claims 16 and 21-23 are objected to because of the following informalities:
Regarding claim 16, the period in line 21 should be deleted.
Regarding claim 21, line 1 recites “the sensor electrode”, however it appears it should read --the glucose sensor-- (emphasis added) to maintain consistent claim language.
Regarding claim 22, line 1 recites “the sensor electrode”, however it appears it should read --the glucose sensor-- (emphasis added) to maintain consistent claim language.
Regarding claim 23, line 1 recites “the sensor electrode”, however it appears it should read --the glucose sensor-- (emphasis added) to maintain consistent claim language.
Claim Rejections - 35 USC § 103 - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments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 1, 8-13, 16, 18-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20120190950 A1) (previously cited), hereinafter referred to as Yang, in view of Yodfat et al. (US 20080214916 A1) (previously cited), hereinafter referred to as Yodfat, in view of Brister et al. (US 20060020192 A1), hereinafter referred to as Brister.
The claims are generally directed towards a glucose sensor comprising a sensor electrode, comprising: the sensor electrode comprising: a base substrate; a working electrode including an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode; and an analyte sensing layer coupled to the working electrode, the analyte sensing layer comprising glucose oxidase catalyzing a reaction between glucose and oxygen, from an external environment, to form a byproduct comprising hydrogen peroxide, the byproduct detectably altering an electrical current at the working electrode; and an analyte modulating layer comprising a polymer disposed over and in contact with the analyte sensing layer; and wherein the channels distribute the oxygen, after diffusion through a thickness of the analyte modulating layer to the analyte sensing layer, throughout the working electrode; and a processor coupled to the sensor electrode, the processor configured for determining a concentration from the electrical current by taking into account distribution of the oxygen by the channels, so as to obtain a more accurate reading of a concentration of the glucose as compared to a reading of the concentration using the working electrode without the arrangement of pillars.
Regarding claim 1, Yang discloses a glucose sensor comprising a sensor electrode (Abstract, “amperometric analyte sensor … electrodes … glucose sensors”, Fig. 2A), comprising:
the sensor electrode comprising:
a base substrate (Fig. 2A, element 102, para. [0096-0097], para. [0104-0105]);
a working electrode (Fig. 2A, element 104, para. [0096-0098], para. [0106]); and
an analyte sensing layer coupled to the working electrode (Fig. 2A, element 110, para. [0098-0099]), the analyte sensing layer comprising glucose oxidase catalyzing a reaction between glucose and oxygen, from an external environment, to form a byproduct comprising hydrogen peroxide, the byproduct detectably altering an electrical current at the working electrode (Fig. 1, para. [0006], para. [0098], para. [0109]); and
an analyte modulating layer (Fig. 2A, element 112) comprising a polymer disposed over and in contact with the analyte sensing layer (para. [0076-0078], para. [0100], para. [0101], “in direct contact with the analyte sensing layer”, para. [0116-0118]); and
a processor coupled to the sensor electrode, the processor configured for determining a concentration from the electrical current (para. [0085], “glucose oxidase is used to catalyze the reaction between glucose and oxygen … circuit current can be measured …”, para. [0098], “concentration of glucose can be determined by monitoring this modulation in current …”, para. [0120], “sensor electrodes and sensors … operatively coupled to … processors … a processor for analyzing the received signal …”).
Yang teaches the working electrode can be formed in a desired pattern of conductive paths (para. [0097]). However, Yang does not explicitly disclose the working electrode includes an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode, wherein the channels distribute the oxygen, after diffusion through a thickness of the analyte modulating layer to the analyte sensing layer, throughout the working electrode.
Yodfat teaches an analogous glucose sensor (Fig. 7, element 2000). Yodfat teaches the sensor electrodes includes a working electrode (Fig. 7, element 122, para. [0057]) and an analyte sensing layer (Fig. 7, element 230, para. [0057]). Yodfat further teaches the working electrode includes an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode (Fig 8b, para. [0058], “surface area can be enlarged by inclusion of one or more artificially created … cavities”). 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 working electrode disclosed by Yang to additionally include an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode, as taught by Yodfat. This is because Yodfat teaches the inclusion of cavities allows for the surface area to be increased, enhancing the enzyme-analyte interactions (para. [0058]).
However, modified Yang does not explicitly disclose the processor is configured for determining the concentration from the electrical current by taking into account distribution of the oxygen by the channels, so as to obtain a more accurate reading of a concentration of the glucose as compared to a reading of the concentration using the working electrode without the arrangement of pillars.
Brister teaches an analogous glucose sensor (Abstract, Fig. 3, Fig. 5C), comprising a sensor electrode comprising a working electrode, an analyte sensing layer, and an analyte modulating layer (Fig. 5C, para. [0130-0146]). Brister teaches a processor coupled to the sensor electrode, the processor configured for determining a concentration from the electrical current by taking into account distribution of the oxygen (para. [0113], “measure the concentration of an analyte …”, para. [0120], para. [0142-045], para. [0160-0163], “increase oxygen availability to the enzyme …”, para. [0226], “electronics associated with the sensor system … enable measurement of an current signal indicative of the analyte concentration …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor taught by modified Yang to additionally be configured for determining the concentration from the electrical current by taking into account distribution of the oxygen, as taught by Brister. This is because Brister teaches glucose sensors with additional elements, such as increased surface area and oxygen enhancing materials/structures allow for the sensor to be supplied with an excess of oxygen, so the processor can determining a glucose concentration more accurately (para. [0140], para. [0142-0143], para. [0226]).
Regarding “wherein the channels distribute the oxygen, after diffusion through a thickness of the analyte modulating layer to the analyte sensing layer, throughout the working electrode; and the oxygen being distributed by the channels, so as to obtain a more accurate reading of a concentration of the glucose as compared to a reading of the concentration using the working electrode without the arrangement of pillars”, because the claimed and prior art produces are identical/substantially identical in structure with regards to a base substrate, an electrode including an arrangement of pillars defining channels, an analyte sensing layer, an analyte modulating layer comprising a polymer disposed over and in contact with the analyte sensing layer, and the processor being configured to take into account distribution of oxygen, the claimed properties or functions are inherent (see MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”). Further, see Yodfat, para. [0058], and the cited portions of Brister above.
Regarding claim 8, modified Yang discloses the glucose sensor of claim 1, wherein the glucose oxidase is at least partially disposed in the channels in spaces between the pillars (Yang; para. [0098], “analyte sensing layer … disposed on one or more of the exposed electrodes …”, Yodfat; para. [0057], “working electrode … covered by an analyte sensing layer” - the glucose oxidase is disposed over the working electrode, which is in the form of cavities. Further, see the rejection of Claim 1).
Regarding claim 9, modified Yang discloses the glucose sensor of claim 1, wherein the channels increase diffusion of the hydrogen peroxide towards sidewalls of the pillars (Because the claimed and prior art produces are identical/substantially identical in structure with regards to a base substrate, a working electrode including an arrangement of pillars defining channels, an analyte sensing layer comprising a polymer disposed over and in contact with the analyte sensing layer, the claimed properties or functions are inherent (see MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”). Further, see Yodfat, para. [0058]).
Regarding claim 10, modified Yang discloses the glucose sensor of claim 1, wherein the pillars include a metal composition comprising at least one metal selected from platinum, gold, silver, copper, titanium, chromium, or iridium (para. [0106], “working electrode … platinum groups …”, Further, see the rejection of Claim 1).
Regarding claim 11, modified Yang discloses the glucose sensor comprising the sensor electrode of claim 1 (para. [0008-0009], “glucose sensor …”), wherein the processor determines the concentration of glucose by associated the electrical current as being proportional to the concentration of glucose (para. [0073], para. [0085], para. [0098], “concentration of glucose can be determined by monitoring this modulation in current …”, para. [0120]).
Regarding claim 12, modified Yang discloses the glucose sensor of claim 11, wherein the arrangement of pillars is such that the electrical current has increased stability, as characterized by a reduced decay of the electrical current as: a concentration of the oxygen is increased, and as compared to the glucose sensor without the pillars (Because the claimed and prior art produces are identical/substantially identical in structure with regards to a base substrate, a working electrode including an arrangement of pillars defining channels, an analyte sensing layer comprising a polymer disposed over and in contact with the analyte sensing layer, the claimed properties or functions are inherent (see MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”). Further, see Yodfat, para. [0058]).
Regarding claim 13, Yang discloses a glucose sensor comprising a sensor electrode (Abstract, “amperometric analyte sensor … electrodes … glucose sensors”, Fig. 2A), comprising:
the sensor electrode comprising:
a base substrate (Fig. 2A, element 102, para. [0096-0097], para. [0104-0105]);
an electrode (Fig. 2A, element 104, para. [0096-0098], para. [0106]); and
an analyte sensing layer (Fig. 2A, element 110, para. [0098-0099]), wherein the analyte sensing layer comprises glucose oxidase for catalyzing a reaction between glucose and oxygen to form hydrogen peroxide altering an electrical current at the electrode (Fig. 1, para. [0006], para. [0098], para. [0109]);
an analyte modulating layer (Fig. 2A, element 112) comprising a polymer contacting the electrode and the analyte sensing layer across the electrode (para. [0076-0078], para. [0100], para. [0101], “in direct contact with the analyte sensing layer”, para. [0116-0118]); and
a processor coupled to the sensor electrode for determining a concentration of the glucose as being proportional to the electrical current (para. [0073], “amount of hydrogen peroxide generated by the oxidoreductase is proportional to the amount of substrate exposed to the oxidoreductase …”, para. [0085], “glucose oxidase is used to catalyze the reaction between glucose and oxygen to yield gluconic acid and hydrogen peroxide … hydrogen peroxide then reacts electrochemically with an electrode within an electrical circuit of the sensor, so that the resultant alterations in circuit current can be measured”, para. [0098], “concentration of glucose can be determined by monitoring this modulation in current …”, para. [0117], para. [0120], “sensor electrodes and sensors … operatively coupled to … processors … a processor for analyzing the received signal …”).
Yang teaches the working electrode can be formed in a desired pattern of conductive paths (para. [0097]). However, Yang does not explicitly disclose the electrode includes an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the electrode, the analyte sensing layer is disposed in spaces between the pillars, the analyte modulating layer is disposed across the spaces between the pillars, wherein the channels increase diffusion of the hydrogen peroxide to sidewalls of the pillars.
Yodfat teaches an analogous glucose sensor (Fig. 7, element 2000). Yodfat teaches the sensor electrodes includes a working electrode (Fig. 7, element 122, para. [0057]) and an analyte sensing layer disposed over the working electrode (Fig. 7, element 230, para. [0057]). Yodfat further teaches the electrode includes an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the electrode (Fig 8b, para. [0058], “surface area can be enlarged by inclusion of one or more artificially created … cavities”), and the analyte sensing layer is disposed in spaces between the pillars (para. [0057]). 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 sensor electrode disclosed by Yang to additionally include an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the electrode, such that the analyte sensing layer is disposed in spaces between the pillars, and the analyte modulating layer is disposed across the spaces between the pillars, as taught by Yodfat. This is because Yodfat teaches the inclusion of cavities allows for the surface area to be increased, enhancing the enzyme-analyte interactions (para. [0058]).
However, modified Yang does not explicitly disclose the processor for determining the concentration of the glucose as being proportional to the electrical current by taking into account the diffusion of the hydrogen peroxide resulting from the arrangement of pillars.
Brister teaches an analogous glucose sensor (Abstract, Fig. 3, Fig. 5C), comprising a sensor electrode comprising an electrode, an analyte sensing layer, and an analyte modulating layer (Fig. 5C, para. [0130-0146]). Brister further teaches a processor coupled to the sensor electrode for determining a concentration of the glucose as being proportional to the electrical current by taking into account the diffusion of the hydrogen peroxide (para. [0113], “measure the concentration of an analyte …”, para. [0160-0163], “glucose molecule reacted there is a proportional change in the product, hydrogen peroxide, one can monitor the change in hydrogen peroxide to determine glucose concentration …. increase oxygen availability to the enzyme …”, para. [0226], “electronics associated with the sensor system … enable measurement of an current signal indicative of the analyte concentration …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor taught by modified Yang to additionally determine a concentration of the glucose as being proportional to the electrical current by taking into account the diffusion of the hydrogen peroxide, as taught by Brister. This is because Brister teaches the conversion of oxygen and glucose to hydrogen peroxide, when oxygen is in excess, yields a glucose signal that is proportional to the hydrogen peroxide concentration, resulting in a more accurate glucose concentration (para. [0140], para. [0142-0143], para. [0160-0163], para. [0226]).
Regarding, “wherein the channels increase diffusion of the hydrogen peroxide to sidewalls of the pillars, and the diffusion of the hydrogen peroxide resulting from the arrangement of pillars”, because the claimed and prior art produces are identical/substantially identical in structure with regards to a base substrate, an electrode including an arrangement of pillars defining channels, an analyte sensing layer, and an analyte modulating layer comprising a polymer disposed over and in contact with the analyte sensing layer, the claimed properties or functions are inherent (see MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”). Further, see Yodfat, para. [0058], and the cited portions of Brister above.
Regarding claim 16, Yang discloses a method of making a sensor electrode (Abstract, “amperometric analyte sensor”, Fig. 2A, para. [0003]), comprising:
providing a base substrate (Fig. 2A, element 102, para. [0096-0097], para. [0104-0105]);
forming a working electrode (Fig. 2A, element 104, para. [0096-0098], para. [0106]); and
coupling an analyte sensing layer to the working electrode (Fig. 2A, element 110, para. [0098-0099]), the analyte sensing layer comprising glucose oxidase catalyzing a reaction between glucose and oxygen to form a byproduct comprising hydrogen peroxide, the byproduct detectably altering an electrical current at the working electrode (Fig. 1, para. [0006], para. [0098], para. [0109]); and
disposing an analyte modulating layer comprising a polymer in contact with the analyte sensing layer, for diffusion of the glucose and the oxygen through a thickness of the analyte modulating layer to the analyte sensing layer (Fig. 2A, element 112, para. [0076-0078], para. [0100], para. [0101], “in direct contact with the analyte sensing layer”, para. [0116-0118]); and
coupling a processor to the sensor electrode and configuring the processor to determine a concentration of the glucose as being proportional to the electrical current (para. [0085], “glucose oxidase is used to catalyze the reaction between glucose and oxygen … circuit current can be measured …”, para. [0098], “concentration of glucose can be determined by monitoring this modulation in current …”, para. [0120], “sensor electrodes and sensors … operatively coupled to … processors … a processor for analyzing the received signal …”).
Yang teaches the working electrode can be formed in a desired pattern of conductive paths (para. [0097]). However, Yang does not explicitly disclose the working electrode is formed including an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode, and wherein the channels distribute the oxygen, after the diffusion through the thickness, throughout the working electrode.
Yodfat teaches an analogous method of making a sensor electrode (Fig. 7, element 2000). Yodfat teaches the sensor electrodes includes a working electrode (Fig. 7, element 122, para. [0057]) and an analyte sensing layer (Fig. 7, element 230, para. [0057]). Yodfat further teaches the working electrode includes an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode (Fig 8b, para. [0058], “surface area can be enlarged by inclusion of one or more artificially created … cavities”). 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 of making a sensor disclosed by Yang to additionally include an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode, as taught by Yodfat. This is because Yodfat teaches the inclusion of cavities allows for the surface area to be increased, enhancing the enzyme-analyte interactions (para. [0058]).
However, modified Yang does not explicitly disclose configuring the processor to determine the concentration of the glucose by taking into account distribution of the oxygen by the channels, so as to obtain a more accurate reading of a concentration of the glucose as compared to a reading of the concentration using the working electrode without the arrangement of pillars.
Brister teaches an analogous method of making a glucose sensor (Abstract, Fig. 3, Fig. 5C), comprising a sensor electrode comprising a working electrode, an analyte sensing layer, and an analyte modulating layer (Fig. 5C, para. [0130-0146]). Brister teaches configuring the processor to determine the concentration of the glucose by taking into account distribution of the oxygen (para. [0113], “measure the concentration of an analyte …”, para. [0120], para. [0142-045], para. [0160-0163], “increase oxygen availability to the enzyme …”, para. [0226], “electronics associated with the sensor system … enable measurement of an current signal indicative of the analyte concentration …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor taught by modified Yang to additionally be configured for determining the concentration of the glucose by taking into account distribution of the oxygen, as taught by Brister. This is because Brister teaches glucose sensors with additional elements, such as increased surface area and oxygen enhancing materials/structures allow for the sensor to be supplied with an excess of oxygen, so the processor can determining a glucose concentration more accurately (para. [0140], para. [0142-0143], para. [0226]).
Regarding “wherein the channels distribute the oxygen, after the diffusion through the thickness, throughout the working electrode, and the oxygen being distributed by the channels, so as to obtain a more accurate reading of a concentration of the glucose as compared to a reading of the concentration using the working electrode without the arrangement of pillars”, because the claimed and prior art produces are identical/substantially identical in structure with regards to a base substrate, an electrode including an arrangement of pillars defining channels, an analyte sensing layer, an analyte modulating layer comprising a polymer disposed over and in contact with the analyte sensing layer, and the processor being configured to take into account distribution of oxygen, the claimed properties or functions are inherent (see MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”). Further, see Yodfat, para. [0058], and the cited portions of Brister above.
Regarding claim 18, modified Yang discloses the method of claim 16, wherein the glucose oxidase is at least partially disposed in the channels in spaces between the pillars (Yang; para. [0098], “analyte sensing layer … disposed on one or more of the exposed electrodes …”, Yodfat; para. [0057], “working electrode … covered by an analyte sensing layer” - the glucose oxidase is disposed over the working electrode, which is in the form of cavities. Further, see the rejection of Claim 1).
Regarding claim 19, modified Yang discloses the method of claim 16, wherein the channels are configured to increase diffusion of the hydrogen peroxide towards sidewalls of the pillars (Because the claimed and prior art produces are identical/substantially identical in structure with regards to a base substrate, a working electrode including an arrangement of pillars defining channels, an analyte sensing layer comprising a polymer disposed over and in contact with the analyte sensing layer, the claimed properties or functions are inherent (see MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”). Further, see Yodfat, para. [0058]).
Regarding claim 20, modified Yang discloses the method of claim 16, further comprising providing the sensor electrode in a glucose sensor (para. [0008-0009], “glucose sensor …”).
Regarding claim 22, modified Yang discloses the sensor electrode of claim 1, wherein the polymer comprises: a hydrophilic comb-copolymer having a central chain and a plurality of side chains coupled to the central chain, wherein at least one side chain comprises a silicone moiety (para. [0136]), a blended mixture of a linear polyurethane/polyurea polymer, and a branched acrylate polymer (para. [0059]), a first polymer formed from a mixture comprising a diisocyanate; at least one hydrophilic diol or hydrophilic diamine; and a siloxane; that is blended with a second polymer formed from a mixture comprising a 2-(dimethylamino) ethyl methacrylate; a methyl methacrylate; a polydimethyl siloxane monomethacryloxypropyl; a poly(ethylene oxide) methyl ether methacrylate; and a 2- hydroxyethyl methacrylate (para. [0084]), or a high-density amine layer.
Regarding claim 23, modified Yang discloses the sensor electrode of claim 13, wherein the polymer comprises: a hydrophilic comb-copolymer having a central chain and a plurality of side chains coupled to the central chain, wherein at least one side chain comprises a silicone moiety (para. [0136]), a blended mixture of a linear polyurethane/polyurea polymer, and a branched acrylate polymer (para. [0059]), a first polymer formed from a mixture comprising a diisocyanate; at least one hydrophilic diol or hydrophilic diamine; and a siloxane; that is blended with a second polymer formed from a mixture comprising a 2-(dimethylamino) ethyl methacrylate; a methyl methacrylate; a polydimethyl siloxane monomethacryloxypropyl; a poly(ethylene oxide) methyl ether methacrylate; and a 2- hydroxyethyl methacrylate (para. [0084]), or a high-density amine layer.
Claims 2-4, 7, 17, and 21 rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20120190950 A1) (previously cited), hereinafter referred to as Yang, in view of Yodfat et al. (US 20080214916 A1) (previously cited), hereinafter referred to as Yodfat, in view of Brister et al. (US 20060020192 A1), hereinafter referred to as Brister as applied to claims 1 and 16 above, and further in view of Adalian et al. (US 20190307378 A1) (previously cited), hereinafter referred to as Adalian.
Regarding claims 2, modified Yang discloses the glucose sensor of claim 1.
However, modified Yang does not explicitly disclose wherein the pillars have a diameter in a range of 0.001-1000 micrometers, a height in a range of 0.001-1000 micrometers, and a spacing in a range of 0.001-1000 micrometers.
Adalian teaches an analogous enzyme-based sensor (Abstract, Fig. 9, para. [0014]). Adalian teaches the sensor includes a working electrode including an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode (para. [0025-0026], para. [0034], para. [0038]). Adalian further teaches the pillars have a diameter in a range of 0.001-1000 micrometers (para. [0026]), and a spacing in a range of 0.001-1000 micrometers (para. [0026]). 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 pillars disclosed by modified Yang to explicitly have a diameter in a range of 0.001-1000 micrometers and a spacing in a range of 0.001-1000 micrometers, as taught by Adalian. This is because Adalian teaches the small dimensions of the pillars allows for an increase in surface area of the electrode (para. [0026]).
However, modified Yang does not explicitly disclose a height in a range of 0.001-1000 micrometers.
Adalian and Yodfat clearly teach the variability of the dimensions and dimensional relationships of the components (Yodfat, para. [0058]; Adalian, para. [0026]), which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Adalian and Yodfat as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 3, modified Yang discloses the glucose sensor of claim 1.
However, modified Yang does not explicitly disclose wherein the pillars have a diameter in a range of 10-15 micrometers, a height in a range of 10-15 micrometers, and a spacing in a range of 10-15 micrometers.
Adalian teaches an analogous enzyme-based sensor (Abstract, Fig. 9, para. [0014]). Adalian teaches the sensor includes a working electrode including an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode (para. [0025-0026], para. [0034], para. [0038]). Adalian further teaches the pillars have a diameter in a range of 10-15 micrometers (para. [0026]), and a spacing in a range of 10-15 micrometers (para. [0026]). 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 pillars disclosed by modified Yang to explicitly have a diameter in a range of 10-15 micrometers and a spacing in a range of 10-15 micrometers, as taught by Adalian. This is because Adalian teaches the small dimensions of the pillars allows for an increase in surface area of the electrode (para. [0026]).
However, modified Yang does not explicitly disclose a height in a range of 10-15 micrometers.
Adalian and Yodfat clearly teach the variability of the dimensions and dimensional relationships of the components (Yodfat, para. [0058]; Adalian, para. [0026]), which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Adalian and Yodfat as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 4, modified Yang discloses the glucose sensor of claim 1.
However, modified Yang does not explicitly disclose wherein the pillars have a diameter in a range of 5-25 micrometers, a height in a range of 5-25 micrometers, and a spacing in a range of 5-25 micrometers.
Adalian teaches an analogous enzyme-based sensor (Abstract, Fig. 9, para. [0014]). Adalian teaches the sensor includes a working electrode including an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode (para. [0025-0026], para. [0034], para. [0038]). Adalian further teaches the pillars have a diameter in a range of 5-25 micrometers (para. [0026]), and a spacing in a range of 5-25 micrometers (para. [0026]). 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 pillars disclosed by modified Yang to explicitly have a diameter in a range of 5-25 micrometers and a spacing in a range of 5-25 micrometers, as taught by Adalian. This is because Adalian teaches the small dimensions of the pillars allows for an increase in surface area of the electrode (para. [0026]).
However, modified Yang does not explicitly disclose a height in a range of 5-25 micrometers.
Adalian and Yodfat clearly teach the variability of the dimensions and dimensional relationships of the components (Yodfat, para. [0058]; Adalian, para. [0026]), which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Adalian and Yodfat as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 7, modified Yang discloses the glucose sensor of claim 1.
However, modified Yang does not explicitly disclose wherein the analyte modulating layer is disposed directly on top of the pillars and over the analyte sensing layer across a width of the channels.
Adalian teaches an analogous enzyme-based sensor (Abstract, Fig. 9, para. [0014]). Adalian teaches the sensor includes a working electrode including an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode (para. [0025-0026], para. [0034], para. [0038]). Adalian further teaches an analyte modulating layer is disposed directly on top of the pillars and over an analyte sensing layer across a width of the channels (Fig. 9, element 930, para. [0025]). 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 analyte modulating layer and analyte sensing layer taught by modified Yang to explicitly be disposed directly on top of the pillars and over the analyte sensing layer across a width of the channels, as taught by Adalian. This is because Adalian teaches the arrangement of the analyte modulating layer on top of the pillars allows for the capturing of escaping ions, increasing the electrical measurement reliability (para. [0024]).
Regarding claim 17, modified Yang discloses the method of claim 16.
However, modified Yang does not explicitly disclose wherein the analyte modulating layer is disposed directly on top of the pillars and over the analyte sensing layer in the channels.
Adalian teaches an analogous method of making an enzyme-based sensor (Abstract, Fig. 9, para. [0014]). Adalian teaches the sensor includes a working electrode including an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode (para. [0025-0026], para. [0034], para. [0038]). Adalian further teaches an analyte modulating layer is disposed directly on top of the pillars and over an analyte sensing layer across a width of the channels (Fig. 9, element 930, para. [0025]). 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 analyte modulating layer and analyte sensing layer taught by modified Yang to explicitly be disposed directly on top of the pillars and over the analyte sensing layer across a width of the channels, as taught by Adalian. This is because Adalian teaches the arrangement of the analyte modulating layer on top of the pillars allows for the capturing of escaping ions, increasing the electrical measurement reliability (para. [0024]).
Regarding claim 21, modified Yang discloses the sensor electrode of claim 1, wherein the analyte modulating layer comprises a glucose limiting membrane contacting the analyte sensing layer across a spacing between the pillars (Fig. 2A, element 112, para. [0100-0101], “glucose limiting membrane … in direct contact with the analyte sensing layer …” - Further, see the rejection of claim 1).
However, modified Yang does not explicitly disclose the glucose limiting membrane contacts the working electrode.
Adalian teaches an analogous enzyme-based sensor (Abstract, Fig. 9, para. [0014]). Adalian teaches the sensor includes a working electrode including an arrangement of pillars defining channels disposed on the base substrate, wherein the pillars form an electroactive surface of the working electrode (para. [0025-0026], para. [0034], para. [0038]). Adalian further teaches a glucose limiting membrane contacts the working electrode (Fig. 9, element 930, para. [0025], para. [0039-0040]). 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 glucose limiting membrane taught by modified Yang to explicitly be contacting the working electrode, as taught by Adalian. This is because Adalian teaches the arrangement of the analyte modulating layer on top of the pillars allows for the capturing of escaping ions, but allowing passage of select chemical species, increasing the electrical measurement reliability (para. [0024], para. [0039]).
Claims 5 and 6 rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20120190950 A1) (previously cited), hereinafter referred to as Yang, in view of Yodfat et al. (US 20080214916 A1) (previously cited), hereinafter referred to as Yodfat, in view of Brister et al. (US 20060020192 A1), hereinafter referred to as Brister as applied to claim 1 above, and further in view of Fukuda et al. (US 20110042237 A1) (previously cited), hereinafter referred to as Fukuda.
Regarding claim 5, modified Yang discloses the glucose sensor of claim 1.
However, modified Yang does not explicitly disclose wherein the arrangement comprises a hexagonal pattern.
Fukuda teaches of an analogous electrochemical sensor device including a plurality of conductive protrusion portions (Abstract, para. [0012]). Fukuda further teaches the arrangement of the conductive protrusion portions comprises a hexagonal pattern (Fig. 5, pillars 51 are arranged in a hexagonal pattern). 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 arrangement to comprise a hexagonal pattern, as taught by Fukuda. This is because Fukuda teaches different arrangements of the pillars allow for efficient contacting between the pillars and the analyte being measured (para. [0107]).
Alternatively and/or additionally, Fukuda clearly teach the variability of the pillar arrangements (Fukuda; Fig. 5, Fig. 7), which suggests that the arrangements can be optimized based on manufacturing, design, and use applications. As such, the arrangements of the pillars are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the arrangement of the pillars, using the teachings of Fukuda as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 6, modified Yang discloses the glucose sensor of claim 1.
However, modified Yang does not explicitly disclose wherein the arrangement comprises a serpentine pattern.
Fukuda teaches of an analogous electrochemical sensor device including a plurality of conductive protrusion portions (Abstract, para. [0012]). Fukuda further teaches the arrangement of the conductive protrusion portions comprises a serpentine pattern (Fig. 7, pillars 51b are arranged in a serpentine pattern). 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 arrangement to comprise a serpentine pattern, as taught by Fukuda. This is because Fukuda teaches different arrangements of the pillars allow for efficient contacting between the pillars and the analyte being measured (para. [0107]).
Alternatively and/or additionally, Fukuda clearly teach the variability of the pillar arrangements (Fukuda; Fig. 5, Fig. 7), which suggests that the arrangements can be optimized based on manufacturing, design, and use applications. As such, the arrangements of the pillars are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the arrangement of the pillars, using the teachings of Fukuda as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 10/28/2025, with respect to the rejection(s) of claim(s) 1, 8-13, 16, 18-20, and 22-23 under 35 USC 103 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejection moot. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Brister et al. (US 20060020192 A1), hereinafter referred to as Brister.
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
Applicants have argued on page 9 of Remarks, filed 10/28/2025, that “Adalian requires the formation of a platinum/enzyme/platinum sandwich layer for the operation of his device. However, this configuration is significantly different from that in Yodfat and therefore the combination with Yodfat would not be predictable or obvious”.
In response to applicant's argument that “the combination with Yodfat would not be predictable or obvious”, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
That is, Adalian suggests to one of ordinary skill in the art the specifics regarding the dimensions of the pillars, the arrangement of the pillars, and the location of the analyte modulating layer.
Applicants have argued on pages 9-10 of Remarks, filed 10/28/2025, that “Fukuda’s lateral flow teaches away from the combination with the flow through the thickness of the analyte sensing layer in Yang, providing further evidence that the combination of Yang and Fukuda is not obvious”.
As recited above, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Specifically, Fukuda suggests to one of ordinary skill in the art the specifics regarding the arrangement of the pillars. Further, Fukuda does not explicitly teach away from lateral flow, as argued.
Conclusion
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791