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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07AUG2025 has been entered.
Status of Claims
The amendments and remarks filed on 07AUG2025 have been entered and considered.
Claims 1-20 are currently pending.
Claims 1, 11, 17, & 19 have been amended.
Claim 20 has been added.
No claims have been withdrawn or canceled.
No new matter has been added.
Claims 1-20 are under examination.
Response to Arguments
Applicant's arguments filed 07AUG2025 regarding the rejections under 35 U.S.C 102(a)(1) & 103 have been fully considered but are not persuasive. Parts deemed not persuasive discussed below:
Applicant argues (Page 6 of the Remarks):
“In connection with the claimed conductive film, the Office Action (at 4) relies on Wang’s substrate (e.g. substrate 3171 in Fig. 31E). However, Wang repeatedly requires that the substrate (allegedly corresponding to the claimed conductive film) is electrically insulative such as paper (e.g. paras. 0006, 0008, 0009, 0010, 0012, 0013, 0014, etc.)”
The examiner is not persuaded because the substrate was not cited to be the conductive film as stated by the applicant. Working electrode 3172 as stated in Wang was cited as a conductive layer which represented the conductive film. The combination of the sensing layer and working electrode stated in Wang Figure 31E forms a new working electrode. The configuration of the layers to create this sensing apparatus is further described in Figure 31a of Wang. The examiner maintains that the working electrode 3172 of Wang allows for electron transfer between he sensing layer and the external circuit and therefore, Wang discloses the configuration as claimed.
Applicant argues (Page 7 of the Remarks):
“Wang does not explicitly or implicitly teach that the substrate is conductive, much less that it is capable of electron transfer between the conductive film and the working electrode as is explicitly required by the claims. Rather, Wang teaches a configuration where all electrical connections are provided by electrodes that are patterned on the substrate (e.g. a single layer). Therefore, Wang at least does not teach or suggest a conductive film as required by the claims.”
”
The examiner is not persuaded because Wang Figure 31a shows that the configuration of the sensing electrode is formed of many layers during the manufacturing process, though it is not shown as the various layers throughout the disclosure. Figure 31a & e as compared to the instant application’s Figure 7 shows a similar design of layers which enable an analyte sensing system with the sensing layer, a layer that allows electron transfer (such as Wang’s working electrode 3172), and the adhesive layer. Therefore, the examiner maintains that Wang teaches the claimed invention.
Claim Rejections - 35 USC § 102
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 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, 9, 11, 14, & 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US Publication No 20170325724; Previously Cited).
Regarding claim 1, Wang discloses a disposable sensor for biofluid analysis (Wang ¶0004 “For example, a user can apply an exemplary single-use electrochemical sensor device to a selected skin area such that the device then quantifies a target chemical analyte in a biological fluid”), a conductive film (Wang Figure 31E illustrating the substrate on one side of the working electrode and the sensing layer directly on the other side of the working electrode where the working electrode may be interpreted as the conductive film in question) having a first major surface (Wang Figure 31E showing sensing layer 3174 disposed on the first major surface (skin facing portion of conductive film 3172); See Below)
PNG
media_image1.png
605
702
media_image1.png
Greyscale
and a second major surface opposite to the first major surface (Wang Figure 31E showing substrate layer 3171 disposed on the second major surface (non-skin facing portion of conductive film 3172); See Below) ;
PNG
media_image2.png
605
702
media_image2.png
Greyscale
a sensing layer disposed directly on the first major surface of the conductive film (Wang ¶0006 “in which the working electrode includes a electrochemical transducer layer including a catalyst to selectively catalyze a corresponding analyte in the ISF to cause a reaction detectable at the anodic and cathodic electrode assemblies”; Figure 31E illustrating sensing layer 3174 as show in the Figure 31E provided above), and an adhesive layer disposed on the second major surface of the conductive film (Wang Adhesive layer 3122 as shown in Figure 31A; ¶0219 “For example, in some implementations of the method, the adhesive sheet can include an outer coating layer on an external surface of the adhesive sheet not in contact with the electrode pattern. For example, the outer coating layer can include polyvinyl alcohol (PVA). In some implementations, for example, the method can further include removing the outer coating layer from the adhesive sheet to enable adhesion of the electrochemical sensor to the skin or the wearable item via the adhesive sheet.”¶0240), wherein the sensing layer is configured for in-situ analysis of sweat adjacent to the first major surface (Wang ¶0006 “in which the working electrode includes a electrochemical transducer layer including a catalyst to selectively catalyze a corresponding analyte in the ISF to cause a reaction detectable at the anodic and cathodic electrode assemblies”; where the first major surface is being interpreted as the working electrode portion that contacts the skin of a user) and for electron transfer between the conductive film and the sensing layer (Wang ¶0248 “For example, the electroactive redox mediator can facilitate the transfer of electrons between the working electrode 3172 and the active site of the catalyst.”; ¶0225; ¶0325); wherein the adhesive layer is configured to detachably couple the disposable sensor to a working electrode for electron transfer between the conductive film and the working electrode (Wang Figure 31A showing portion 3150b which shows adhesive layer 3122 positioned where the working electrode would attach to the sensing layer 3111 as shown in Figure 31E; ¶0237).
Regarding claim 9, Claim 1 is anticipated by Wang. Wang additionally discloses wherein the sensing layer includes an enzyme (Wang ¶0010 “And, the method includes detecting the electrical signal at the electrochemical sensor electrodes, in which the electrical signal is associated with a parameter of the analyte, and in which the detecting includes the oxidation or reduction of the analyte by the catalyst (for example, enzyme) to generate electrical signal”; ¶0099).
Regarding claim 11, Wang discloses a disposable sensor array for biofluid analysis (Wang ¶0004 “For example, a user can apply an exemplary single-use electrochemical sensor device to a selected skin area such that the device then quantifies a target chemical analyte in a biological fluid”), a conductive film (Wang Figure 31E illustrating the substrate on one side of the working electrode and the sensing layer directly on the other side of the working electrode where the working electrode may be interpreted as the conductive film in question)having a first major surface (Wang Figure 31E showing sensing layer 3174 disposed on the first major surface (skin facing portion of conductive film 3172))
PNG
media_image1.png
605
702
media_image1.png
Greyscale
and a second major surface opposite to the first major surface (Wang Figure 31E showing substrate layer 3171 disposed on the second major surface (non-skin facing portion of conductive film 3172); See Below) ;
PNG
media_image2.png
605
702
media_image2.png
Greyscale
; a first sensor disposed directly on the first major surface of the conductive film (Wang ¶0006 “in which the working electrode includes a electrochemical transducer layer including a catalyst to selectively catalyze a corresponding analyte in the ISF to cause a reaction detectable at the anodic and cathodic electrode assemblies”; Figure 31E illustrating sensing layer 3174 as show in the Figure 31E provided above); a second sensor disposed directly on the first major surface of the conductive (Wang ¶0006 “In one aspect, a non-invasive epidermal electrochemical sensor device includes a flexible substrate including an electrically insulative material structured to adhere to skin of a user; an anodic electrode assembly and a cathodic electrode assembly each formed and separately arranged on the substrate and each including a working electrode,.”;); and an adhesive layer disposed on the second major surface of the conductive film (Wang Adhesive layer 3122 as shown in Figure 31A; ¶0219 “For example, in some implementations of the method, the adhesive sheet can include an outer coating layer on an external surface of the adhesive sheet not in contact with the electrode pattern. For example, the outer coating layer can include polyvinyl alcohol (PVA). In some implementations, for example, the method can further include removing the outer coating layer from the adhesive sheet to enable adhesion of the electrochemical sensor to the skin or the wearable item via the adhesive sheet.”¶0240), wherein the first and second sensors are both configured for in-situ analysis of sweat adjacent to the first major surface (Wang ¶0006 “in which the working electrode includes a electrochemical transducer layer including a catalyst to selectively catalyze a corresponding analyte in the ISF to cause a reaction detectable at the anodic and cathodic electrode assemblies”; where the first major surface is being interpreted as the working electrode portion that contacts the skin of a user) and for electron transfer between the conductive film and the sensors (Wang ¶0248 “For example, the electroactive redox mediator can facilitate the transfer of electrons between the working electrode 3172 and the active site of the catalyst.”; ¶0225; ¶0325); wherein the adhesive layer is configured to detachably couple the disposable sensor array to a working electrode for electron transfer between the conductive film and the working electrode (Wang Figure 31A showing portion 3150b which shows adhesive layer 3122 positioned where the working electrode would attach to the sensing layer 3111 as shown in Figure 31E where the adhesive layer; ¶0237).
Regarding claim 14, Claim 11 is anticipated by Wang. Wang additionally discloses wherein the first sensor and the second sensor are spatially segregated from one another on the first major surface of the conductive film. (Wang Figure 31E showing the two distinct sensors on the same surface).
Regarding claim 20, Claim 1 is anticipated by Wang. Wang additionally discloses wherein the conductive film, the sensing layer, and the adhesive layer form a vertical stack of layers having a top layer corresponding to the sensing layer and a bottom layer corresponding to the adhesive layer (Wang Figure 31A showing adhesive layer 3122 in portion 3140a), and wherein the top layer is configured for contact with the sweat and the bottom layer is configured for contact with the working electrode (Wang Figure 31A as described in ¶0239).
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.
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.
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.
Claims 17 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Publication No 20170325724; Previously Cited) in view of Yamamoto et al. (US Publication US 20020148726; Previously Cited).
Regarding claim 17, Wang discloses a method of forming a disposable sensor for biofluid analysis, comprising a coating composition (Wang ¶0004 “For example, a user can apply an exemplary single-use electrochemical sensor device to a selected skin area such that the device then quantifies a target chemical analyte in a biological fluid”); wherein the coating composition is configured for in-situ analysis of sweat (Wang ¶0315 “Exemplary implementations were performed using the disclosed enzymatic T3 electrochemical sensor devices applied to skin of human subjects for in-situ sweat lactate profile recordings and analysis.; Figure 1D); providing a coating composition including an enzyme (Wang ¶0313 “The working electrode of the exemplary T3 sensor can be functionalized with monolayers, ligands, enzyme catalysts and/or electroactive redox mediators, among other molecules or substances to enhance the detectability of the target enzyme…. FIG. 41B shows a schematic illustrating an exemplary modified working electrode including the transducer layer coated by biocompatible polymer (e.g., chitosan).”) ; applying the coating composition on a conductive film to form a sensing layer directly disposed on the conductive film (Wang ¶0006 “and in which the working electrode includes a electrochemical transducer layer including a catalyst to selectively catalyze a corresponding analyte in the ISF to cause a reaction detectable at the anodic and cathodic electrode assemblies;”; Figure 31E illustrating the substrate on one side of the working electrode and the sensing layer directly on the other side of the working electrode where the working electrode may be interpreted ad the conductive film in question); wherein the sensing layer is configured for electron transfer between the conductive film and the sensing layer (Wang ¶0248 “For example, the electroactive redox mediator can facilitate the transfer of electrons between the working electrode 3172 and the active site of the catalyst.”; ¶0225; ¶0325); and disposing an adhesive layer on the conductive film (Wang Adhesive layer 3122 as shown in Figure 31A; ¶0240 “Subsequently, the method 3100 then includes implementing a process 3140b to apply the electrochemical sensor device 3125 to the skin 3141 via the attachment of the adhesive sheet 3122 to the skin 3141 such that the external surface of the electrode structures 3111 are in contact with the surface of the skin 3141.”), wherein the adhesive layer is configured to detachably couple the disposable sensor to a working electrode for electron transfer between the conductive film and the working electrode (Wang Figure 31A showing portion 3150b which shows adhesive layer 3122 positioned where the working electrode would attach to the sensing layer 3111 as shown in Figure 31E where the adhesive layer; ¶0237).
Wang does not disclose freeze-drying the coating to form a sensing layer. Yamamoto in a similar field of endeavor of biosensor design teaches freeze-drying the coating to form a sensing layer (Yamamoto ¶0076 “The enzyme/surface active agent layer 23 was formed by the freeze drying method”; ¶0077-¶0078; ¶0073). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Wang with the methods for freeze-drying the coating to form a sensing layer, as taught in Yamamoto to enhances the solubility of the reaction reagents (Yamamoto ¶0078).
Regarding claim 19, Claim 17 is obvious over Wang in view of Yamamoto. Wang additionally discloses wherein the coating composition is applied on a first major surface of the conductive film (Wang Figure 31E showing sensing layer 3174 disposed on the first major surface (skin facing portion of conductive film 3172))
PNG
media_image1.png
605
702
media_image1.png
Greyscale
, and the adhesive layer is disposed on a second major surface of the conductive film that is opposite to the first major surface. (Wang Adhesive layer 3122 as shown in Figure 31A; ¶0219 “For example, in some implementations of the method, the adhesive sheet can include an outer coating layer on an external surface of the adhesive sheet not in contact with the electrode pattern. For example, the outer coating layer can include polyvinyl alcohol (PVA). In some implementations, for example, the method can further include removing the outer coating layer from the adhesive sheet to enable adhesion of the electrochemical sensor to the skin or the wearable item via the adhesive sheet.”¶0240).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Publication No 20170325724; Previously Cited) in view of Yamamoto et al. (US Publication US 20020148726; Previously Cited) and Bernstein et al. (US Publication No 20160015267; Previously Cited).
Regarding claim 18, Claim 17 is obvious over Wang in view of Yamamoto. Neither Wang nor Yamamoto disclose wherein the conductive film has an anisotropic electrical conductivity. Bernstein in a similar field of endeavor of biofluid analysis sensors teaches wherein the conductive film has an anisotropic electrical conductivity (Bernstein ¶0134 “In certain embodiments, the conductive film 530 may include anisotropic conductive adhesive film.”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang combined with Yamamoto with the conductive film having an anisotropic electrical conductivity as taught by Bernstein to create a system with the ability for channeling the flux of substances in a preferential direction to maximize analyte readings in the system.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Publication No 20170325724; Previously Cited) in view of Wogoman (US Publication No. 4938860; Previously Cited; Previously Cited).
Regarding claim 10, Claims 1 & 9 are obvious over Wang. Wang does not disclose wherein the sensing layer includes a polymeric material, and the enzyme is dispersed within the polymeric material. Wogoman in an analogous field of endeavor of analyte detection teaches wherein the sensing layer includes a polymeric material, and the enzyme is dispersed within the polymeric material (Woogman Column 5 Lines 27-45 “(Woogman Column 5 Lines 25-31 “In the preferred electrode 10, a layer of enzyme 28 (FIG. 5), such as glucose oxidase, is bonded or immobilized on anode 12 at the working area 20… In accordance with an important feature of the present invention it has been found that a dispersion of a polymerizable silicon-containing compound applied in an incompletely cured form as a silicon compound dispersed phase in a liquid carrier, the carrier being essentially insoluble in the dispersed phase and removable from the dispersion during curing, will dry and cure as a continuous layer, film or membrane having unexpectedly high glucose-permeability to function as a single membrane 30.”)”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system in Wang with items in Wogoman by integrating the enzyme into the sensing layer, as dispersed through the material to create a system with a conductive film that has an accurate sensor reading of analytes that can be directly analyzed for correlations in the body as through sweat.
Claims 2, 4-5, 12-13, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Publication No 20170325724; Previously Cited) in view of Bernstein et al. (US Publication No 20160015267; Previously Cited).
Regarding claim 2, Claim 1 is anticipated by Wang. Wang does not additionally disclose wherein the conductive film has an anisotropic electrical conductivity. Bernstein in a similar field of endeavor of biofluid analysis sensors (Bernstein Abstract, ¶0022, ¶0023) teaches wherein the conductive film has an anisotropic electrical conductivity (Bernstein ¶0134 “In certain embodiments, the conductive film 530 may include anisotropic conductive adhesive film.”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with the conductive film having an anisotropic electrical conductivity, as taught by Bernstein. The motivation to integrate this into the system of Wang would be to create a system with the ability for channeling the flux of substances in a preferential direction to maximize analyte readings in the system.
Regarding claim 4, claim 1 is anticipated by Wang. Wang does not disclose wherein the conductive film includes conductive fillers dispersed therein. Bernstein in a similar field of endeavor of biofluid analysis sensors teaches wherein the conductive film includes conductive fillers dispersed therein (Bernstein ¶0134 “In certain embodiments, the conductive film 530 may include anisotropic conductive adhesive film, e.g., such as those available from 3M Corporation, St. Paul, Minn., which is heat bondable, electrically conductive and include a thermosetting epoxy/acrylate adhesive matrix with conductive particles that allow interconnection of circuit lines through the adhesive thickness after bonding while providing sufficient space or gap for electrical insulation in the plane of the adhesive”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with the conductive fillers including metallic particles, as taught by Bernstein. The motivation to integrate this into the system of Wang would be to create a system with a conductive film that has a uniform composition for consistent reading capabilities, which will be filled with metal that can aid in conductivity to further increase signal production.
Regarding claim 5, claims 1 & 4 are obvious over Wang in view of Bernstein. Wang does not disclose wherein the conductive fillers include metallic particles. Bernstein in a similar field of endeavor of biofluid analysis sensors teaches wherein the conductive fillers include metallic particles (Bernstein ¶0134 “adhesive matrix with conductive particles” can be interpreted as metallic particles, since metallics can be conductive). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with the conductive fillers including metallic particles, as taught by Bernstein to create a system with a conductive film that has a uniform composition for consistent reading capabilities, which will be filled with metal that can aid in conductivity to further increase signal production.
Regarding claim 12, claim 11 is anticipated by Wang. Wang does not additionally disclose wherein the conductive film has an anisotropic electrical conductivity. Bernstein in a similar field of endeavor of biofluid analysis sensors teaches wherein the conductive film has an anisotropic electrical conductivity (Bernstein ¶0134 “In certain embodiments, the conductive film 530 may include anisotropic conductive adhesive film.”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with the conductive film having an anisotropic electrical conductivity, as taught by Bernstein to create a system with the ability for channeling the flux of substances in a preferential direction to maximize analyte readings in the system.
Regarding claim 13, claim 11 is anticipated by Wang. Wang does not additionally disclose wherein the conductive film includes conductive fillers dispersed therein. Bernstein in a similar field of endeavor of biofluid analysis sensors teaches wherein the conductive film includes conductive fillers dispersed therein (Bernstein ¶0134 “In certain embodiments, the conductive film 530 may include anisotropic conductive adhesive film, e.g., such as those available from 3M Corporation, St. Paul, Minn., which is heat bondable, electrically conductive and include a thermosetting epoxy/acrylate adhesive matrix with conductive particles that allow interconnection of circuit lines through the adhesive thickness after bonding while providing sufficient space or gap for electrical insulation in the plane of the adhesive”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with the conductive film includes conductive fillers dispersed therein, as taught by Bernstein to create a system with a conductive film that has a uniform composition for consistent reading capabilities.
Regarding claim 16, claim 1 is anticipated by Wang. Wang does not additionally disclose a method for biofluid analysis, comprising: attaching the disposable sensor onto an electrode contact of a wearable device exposing the disposable sensor to a biofluid during a sensing operation and detaching the disposable sensor from the electrode contact subsequent to the sensing operation. Bernstein in a similar field of endeavor of biofluid analysis sensors teaches attaching the disposable sensor onto an electrode contact of a wearable device (Bernstein ¶0071 “As described, embodiments include in vivo analyte sensors and on body electronics that together provide body wearable sensor electronics assemblies. In certain embodiments, in vivo analyte sensors are fully integrated with on body electronics (fixedly connected during manufacture), while in other embodiments they are separate but connectable post manufacture (e.g., before, during or after sensor insertion into a body).”); exposing the disposable sensor to a biofluid during a sensing operation (Bernstein ¶0086 “Also shown in FIG. 1 is insertion device 150 that, when operated, transcutaneously positions a portion of analyte sensor 101 through a skin surface and in fluid contact with ISF,”); and detaching the disposable sensor from the electrode contact subsequent to the sensing operation (Bernstein ¶0071 “As described, embodiments include in vivo analyte sensors and on body electronics that together provide body wearable sensor electronics assemblies. In certain embodiments, in vivo analyte sensors are fully integrated with on body electronics (fixedly connected during manufacture), while in other embodiments they are separate but connectable post manufacture (e.g., before, during or after sensor insertion into a body).”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with a method for biofluid analysis, by attaching the disposable sensor onto an electrode contact of a wearable device exposing the disposable sensor to a biofluid during a sensing operation and detaching the disposable sensor from the electrode contact subsequent to the sensing operation, as taught by Bernstein to create a system with easy-to-use biosensors.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Publication No 20170325724; Previously Cited) in view of Bernstein et al. (US Publication No 20160015267; Previously Cited), and Wogoman (US Publication No. 4938860; Previously Cited).
Regarding claim 3, Claims 1 & 2 are obvious over Wang in view of Bernstein. Neither Wang nor Bernstein disclose wherein the conductive film has a higher electrical conductivity along a direction extending between the first major surface and the second major surface, relative to an electrical conductivity along a direction parallel to the first major surface or the second major surface. Wogoman in an analogous field of endeavor of analyte detection teaches wherein the conductive film has a higher electrical conductivity along a direction extending between the first major surface and the second major surface, relative to an electrical conductivity along a direction parallel to the first major surface or the second major surface (Wogoman Figures 5-7). Neither Wogoman, Bernstein, nor Wang explicitly detail the direction of conductivity of the claimed electrode, though it would have been obvious before the effective filing date of the claimed invention to particularly configure the electrode explicitly such that the conductive film has a higher electrical conductivity along a direction extending between the first major surface and the second major surface, relative to an electrical conductivity along a direction parallel to the first major surface or the second major surface, since this would be a typical design choice for a functional electrode. Additionally, Wang combined with Bernstein and Wogoman discloses the claimed invention except for path of conductivity. It would have been an obvious matter of design choice to configure the electrode explicitly such that the conductive film has a higher electrical conductivity along a direction extending between the first major surface and the second major surface, relative to an electrical conductivity along a direction parallel to the first major surface or the second major surface, since this is an obvious design choice for the typical functionality of an electrode and such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claims 6-8, & 15 are rejected under 35 U.S.C. 103 as being unpatentable Wang et al. (US Publication No 20170325724; Previously Cited) in view of Yamashita et al. (Us Publication No 5185208; Previously Cited).
Regarding claim 6, Claim 1 is anticipated by Wang. Wang does not additionally disclose a set of charge transfer layers disposed between the sensing layer and the conductive film. Yamashita in the similar field of endeavor of electrode design teaches a set of charge transfer layers (Yamashita Abstract “Functional devices using charge transfer complexes formed as a layer on a substrate. In one embodiment of the invention, the device comprises a substrate, an electrode layer formed on one side of the substrate, at least one layer of a charge transfer complex capable of undergoing a variation in charge transferability by application of external energy, and another electrode layer formed on the complex layer.” Column 12 Lines 3-6) disposed between the sensing layer and the conductive film (Yamashita Column 4 Lines 26-31 “The substrate 1 has a transparent electrode 2 such as an indium tin oxide film, a layer 3 of a charge transfer complex of the type which will be described hereinafter, and a counter electrode 4 such as an indium tin oxide film.”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify the electrode system of Wang by integrating a set of charge transfer layers as taught in Yamashita. The motivation to integrate this into the system of Wang would be to create provide a stabilizing force for the molecular complexes of the electrode sensing system.
Regarding claim 7, Claims 1 & 6 are obvious over Wang in view of Yamashita. Wang does not additionally disclose wherein the set of charge transfer layers includes a metallic layer. Yamashita in a similar field of endeavor of electrode design teaches wherein the set of charge transfer layers includes a metallic layer (Yamashita Column 4 Lines 26-31). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with a set of charge transfer layers which includes a metallic layer, as taught by Yamashita to create a system with the charge transfer abilities facilitated with the metal layers that can serve as a biosensor.
Regarding claim 8, claims 1 & 6-7 are obvious over Wang in view of Yamashita. Wang does not additionally disclose wherein the set of charge transfer layers includes an electrochemically active layer. Yamashita in a similar field of endeavor of electrode design teaches wherein the set of charge transfer layers includes an electrochemically active layer (Yamashita Column 3 Lines 7-15 “In the device, the charge transfer complex used is made of an electron donor and an electron acceptor, one of which is an organic compound having has a long-chain alkyl substituent. The alkyl substituent has preferably from 10 to 22 carbon atoms. When external energy such as electric, optical or electromagnetic energy is applied to the device, a neutral-ionic or ionic-neutral phase transition takes place in the charge transfer complex layer”). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with the set of charge transfer layers including an electrochemically active layer, as taught by Yamashita to create a system with the charge transfer abilities that can serve as a biosensor.
Regarding claim 15, claim 11 is anticipated by Wang. Wang does not additionally disclose wherein the first sensor includes a first sensing layer and a first set of charge transfer layers disposed between the first sensing layer and the conductive film; and the second sensor includes a second sensing layer and a second set of charge transfer layers disposed between the second sensing layer and the conductive film. Yamashita in a similar field of endeavor of electrode design teaches wherein the first sensor includes a first sensing layer and a first set of charge transfer layers disposed between the first sensing layer and the conductive film; and the second sensor includes a second sensing layer and a second set of charge transfer layers disposed between the second sensing layer and the conductive film (Yamashita Abstract, Column 4 Lines 26-31). Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Wang with the first sensor including a first sensing layer and a first set of charge transfer layers disposed between the first sensing layer and the conductive film and the second sensor including a second sensing layer and a second set of charge transfer layers disposed between the second sensing layer and the conductive film, as taught in Yamashita to create a system with signals that are optimized for noise cancelation between signals. This helps the data be more accurate and aids in later data processing steps. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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, Jennifer McDonald can be reached on M-F 9:30-4:30. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN T FEDORKY/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796