DETAILED ACTION
Applicant’s arguments, filed on 12/18/2025, 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 12/18/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 12-28 are the current claims hereby under examination.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 12-26 and 28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gough (US 4671288) in further view of Simpson (US 20080083617).
Regarding independent claim 12, Gough teaches an electrochemical sensor for measuring a concentration of an analyte in a host (Abstract: “An electrochemical cell sensor”), comprising:
a membrane, wherein an electroactive species is configured to be generated at the membrane (Column 3, lines 7-8: “the sensor 18 can be covered by a porous membrane containing oxidase enzyme”; Column 2, line 55 – Column 3, line 27);
a working electrode configured to measure the concentration of the analyte (Column 3, lines 19-24: “the electrode that is in contact with the enzyme gel is polarized as an anode … glucose is determined directly from the signal of the anode”);
a reference electrode comprising a material that depletes during use of the electrochemical sensor, wherein at the reference electrode, a first portion of the electroactive species is configured to regenerate the material during use of the electrochemical sensor (Column 3, lines 60-62: “a reference electrode 28 made of material well known to those in the art, a common example being chlorided silver”. The limitations “a material that depletes during use of the electrochemical sensor” and “a first portion of the electroactive species is configured to regenerate the material during use of the electrochemical sensor” are functional recitations. Apparatus claims cover what a device is, not what a device does. See MPEPE 2114(II). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The sensor use limitations relate to how the sensor is used rather than a structural limitation of the actual sensor itself. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the device of Gough is substantially the same as the claimed electrochemical sensor whereby the reference electrode is formed of Ag/AgCl and is covered with a glucose oxidase enzyme that forms hydrogen peroxide upon reaction with glucose and thus possess the same structural elements of the instant claims and therefore is capable of and configured to specifically perform the functional limitations of the instant claim.); and
a diffusion barrier (Claim 12: “wherein said means for differentially regulating the accessibility of said enzyme substrates or products comprises material with enzyme substrate selective diffusion properties”).
However, Gough does not teach the diffusion barrier configured to attenuate diffusion of a second portion of the electroactive species between the reference electrode and the working electrode.
Simpson discloses a dual electrode system for a continuous analyte sensor. Specifically, Simpson teaches the diffusion barrier positioned between the working electrode and the reference electrode, wherein the diffusion barrier is configured to attenuate diffusion of a second portion of the electroactive species between the reference electrode and the working electrode ([0343]: “the sensor (e.g., a glucose sensor) includes a diffusion barrier configured to substantially block diffusion of the analyte (e.g., glucose) or a co-analyte (e.g., H.sub.2O.sub.2) between the first and second working electrodes. For example, as described with reference to FIG. 10, a diffusion barrier D (e.g., spatial, physical and/or temporal) blocks (e.g., attenuates) diffusion of a species (e.g., glucose and/or H.sub.2O.sub.2) from the first working electrode E1 to the second working electrode E2”; [0218]: “the reference electrode is integrally formed with the one or more working electrodes”). Gough and Simpson are analogous arts as they are both related to continuous analyte sensors.
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 diffusion barrier configured to attenuate the electroactive species between the reference electrode and the working electrode, as it allows the sensor to keep the electrodes separate and having the intended reactions at the working electrode and reference electrode.
Regarding claim 13, the Gough/Simpson combination teaches the electrochemical sensor of claim 12, wherein the diffusion barrier is further configured to prevent diffusion of the analyte between the reference electrode and the working electrode (Gough, Column 4, lines 50-57: “it is desirable to fabricate the gel matrix or its outer layer of a material that permits the electrochemical cell sensor to remain sensitive to glucose over a useful range of concentrations in the presence of such low oxygen levels. This is accomplished by selecting a material that restricts the diffusion or partitioning of glucose while remaining relatively permeable to oxygen”).
Regarding claim 14, the Gough/Simpson combination teaches the electrochemical sensor of claim 12.
However, the Gough/Simpson combination is silent on the type of diffusion barrier.
Simpson teaches wherein the diffusion barrier is a physical diffusion barrier formed of one or more membrane materials ([0301]: “the diffusion barrier D can be spatial, physical or temporal”).
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 structure from Simpson as the Gough/Simpson combination is silent on the type of diffusion barrier, and Simpson teaches a suitable diffusion barrier in an analogous device.
Regarding claim 15, the Gough/Simpson combination teaches the electrochemical sensor of claim 12.
However, the Gough/Simpson combination is silent on the type of diffusion barrier.
Simpson teaches wherein the diffusion barrier is a spatial diffusion barrier ([0301]: “the diffusion barrier D can be spatial, physical or temporal”).
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 structure from Simpson as the Gough/Simpson combination is silent on the type of diffusion barrier, and Simpson teaches a suitable diffusion barrier in an analogous device.
Regarding claim 16, the Gough/Simpson combination teaches the electrochemical sensor of claim 15, wherein the spatial diffusion barrier comprises a gap between the working electrode and the reference electrode (Simpson, [0189]: “diffusion barrier is spatial, such as separating working electrodes by a distance sufficiently large enough to substantially prevent a species at a first electrode from affecting a second electrode”; [0344]: “if the diffusion barrier is spatial, a distance D separates the working electrodes, such that the analyte or co-analyte substantially cannot diffuse from a first electrode E1 to a second electrode E2”; [0218]: “the reference electrode is integrally formed with the one or more working electrodes”), and wherein the gap is configured such that the second portion of the electroactive species is attenuated between the reference electrode and the working electrode (Simpson, [0343]: “the sensor (e.g., a glucose sensor) includes a diffusion barrier configured to substantially block diffusion of the analyte (e.g., glucose) or a co-analyte (e.g., H.sub.2O.sub.2) between the first and second working electrodes. For example, as described with reference to FIG. 10, a diffusion barrier D (e.g., spatial, physical and/or temporal) blocks (e.g., attenuates) diffusion of a species (e.g., glucose and/or H.sub.2O.sub.2) from the first working electrode E1 to the second working electrode E2”; [0218]: “the reference electrode is integrally formed with the one or more working electrodes”).
Regarding claim 17, the Gough/Simpson combination teaches the electrochemical sensor of claim 12.
However, the Gough/Simpson combination is silent on the type of diffusion barrier.
Simpson teaches wherein the diffusion barrier is a temporal diffusion batter ([0301]: “the diffusion barrier D can be spatial, physical or temporal”).
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 structure from Simpson as the Gough/Simpson combination is silent on the type of diffusion barrier, and Simpson teaches a suitable diffusion barrier in an analogous device.
Regarding claim 18, the Gough/Simpson combination teaches the electrochemical sensor of claim 12.
However, the Gough/Simpson combination is silent on the structure of the diffusion barrier.
Simpson teaches wherein the diffusion barrier comprises an electrical insulation material ([0287]: “the working electrodes are coated with a layer of insulating material I (e.g., non-conductive material or dielectric) to prevent direct contact between the working electrodes E1, E2 and the reference electrode R”).
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 structure from Simpson as the Gough/Simpson combination is silent on the structure of diffusion barrier, and Simpson teaches a suitable diffusion barrier in an analogous device.
Regarding claim 19, the Gough/Simpson combination teaches the electrochemical sensor of claim 12.
However, the Gough/Simpson combination is silent on the structure of the diffusion barrier.
Simpson teaches wherein at least a portion of the membrane forms the diffusion barrier ([0017]: “the sensor further comprises a physical diffusion barrier comprising a discontinuous portion of a membrane disposed between the first electroactive surface and the second electroactive surface”).
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 structure from Simpson as the Gough/Simpson combination is silent on the structure of diffusion barrier, and Simpson teaches a suitable diffusion barrier in an analogous device.
Regarding claim 20, the Gough/Simpson combination teaches the electrochemical sensor of claim 19, wherein the portion of the membrane is a discontinuity in the membrane (Simpson, [0017]: “the sensor further comprises a physical diffusion barrier comprising a discontinuous portion of a membrane disposed between the first electroactive surface and the second electroactive surface”).
Regarding claim 21, the Gough/Simpson combination teaches the electrochemical sensor of claim 12, wherein the electrochemical sensor is configured to increase a rate of material regeneration responsive to an increase in a rate of material depletion (The limitation “wherein the electrochemical sensor is configured to increase a rate of regeneration responsive to an increase in a rate of material depletion” are functional claims. Apparatus claims cover what a device is, not what a device does. See MPEPE 2114(II). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The sensor use limitations relate to how the sensor is used rather than a structural limitation of the actual sensor itself. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the device of Gough is substantially the same as the claimed electrochemical sensor whereby the reference electrode is formed of Ag/AgCl and is covered with a glucose oxidase enzyme that forms hydrogen peroxide upon reaction with glucose and thus possess the same structural elements of the instant claims and therefore is capable of and configured to specifically perform the functional limitations of the instant claim.).
Regarding claim 22, the Gough/Simpson combination teaches the electrochemical sensor of claim 12, wherein the electrochemical sensor is configured to decrease a rate of material regeneration responsive to a decrease in a rate of material depletion (The limitation “wherein the electrochemical sensor is configured to decrease a rate of material regeneration responsive to a decrease in a rate of material depletion” are functional claims. Apparatus claims cover what a device is, not what a device does. See MPEPE 2114(II). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The sensor use limitations relate to how the sensor is used rather than a structural limitation of the actual sensor itself. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the device of Gough is substantially the same as the claimed electrochemical sensor whereby the reference electrode is formed of Ag/AgCl and is covered with a glucose oxidase enzyme that forms hydrogen peroxide upon reaction with glucose and thus possess the same structural elements of the instant claims and therefore is capable of and configured to specifically perform the functional limitations of the instant claim.).
Regarding claim 23, the Gough/Simpson combination teaches the electrochemical sensor of claim 12, wherein at least a portion of the reference electrode is covered with an enzyme layer, wherein the enzyme is an oxidase enzyme (Gough, Column 3, lines 7-8: “the sensor 18 can be covered by a porous membrane containing oxidase enzyme”; Column 4, lines 36-39: “the electrode can be covered with an oxidase enzyme containing membrane. Additionally, the electrochemical cell sensor contains a silver/silver chloride reference electrode 28”; Column 3, lines 15-16: “FIG. 4 shows both oxygen-sensing electrodes and the silver/silver chloride reference electrode”).
Regarding claim 24, the Gough/Simpson combination teaches the electrochemical sensor of claim 12, wherein the analyte is glucose (Gough, Column 2, lines 12-14: “An enzyme electrode sensor is described for determining directly in the body the concentration of certain biochemicals, particularly glucose”).
Regarding claim 25, the Gough/Simpson combination teaches the electrochemical sensor of claim 12, wherein the material is silver chloride (Gough, Column 3, lines 60-62: “a reference electrode 28 made of material well known to those in the art, a common example being chlorided silver”).
Regarding claim 26, the Gough/Simpson combination teaches the electrochemical sensor of claim 12, wherein the reference electrode is formed of a chloridized elongated silver body (Gough, Column 3, lines 60-62: “a reference electrode 28 made of material well known to those in the art, a common example being chlorided silver”; Figs. 1-5).
Regarding claim 28, the Gough/Simpson combination teaches the electrochemical sensor of claim 23, wherein a percentage of a surface area of the reference electrode covered with the enzyme layer is from 10% to 100% (Gough, Column 3, lines 7-8: “the sensor 18 can be covered by a porous membrane containing oxidase enzyme”).
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over the Gough/Simpson combination as applied to claim 23 above, and further in view of Holker (US 20040074785).
Regarding claim 27, the Gough/Simpson combination teaches the electrochemical sensor of claim 23.
However, the Gough/Simpson combination is silent on the thickness of the enzyme layer.
Holker discloses an analyte sensor. Specifically, Holker teaches wherein the enzyme layer has a thickness from 0.01 microns to 12 microns thick ([0009]: “an enzyme layer (preferably less than 2 microns in thickness) disposed upon the sensor layer”). Gough, Simpson, and Holker are analogous arts as they are all related to analyte sensors.
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 thickness from Holker as the Gough/Simpson combination is silent on the thickness, and Holker provides a suitable thickness in an analogous device.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive. Applicant argues that Simpson does not teach the diffusion barrier between the working electrode and the reference electrode, however as stated in the 103 rejection above, Simpson teaches the diffusion barrier between two working electrodes and that the reference electrode is incorporated in the working electrode, therefore the diffusion barrier is between the working electrode and the reference electrode ([0343]: “the sensor (e.g., a glucose sensor) includes a diffusion barrier configured to substantially block diffusion of the analyte (e.g., glucose) or a co-analyte (e.g., H.sub.2O.sub.2) between the first and second working electrodes. For example, as described with reference to FIG. 10, a diffusion barrier D (e.g., spatial, physical and/or temporal) blocks (e.g., attenuates) diffusion of a species (e.g., glucose and/or H.sub.2O.sub.2) from the first working electrode E1 to the second working electrode E2”; [0218]: “the reference electrode is integrally formed with the one or more working electrodes”).
Additionally, Applicant argues that incorporating the diffusion barrier into Gough would render it inoperable, however Gough only states that the reference electrode is preferably situated close to an unshielded segment of the two electrode sensors. This situation for the reference electrode is only preferred, not required. Additionally, the unshielded segment does not require the entirety of the two electrode sensors to be unshielded, only a segment of it, therefore the diffusion barrier would not render it inoperable and would allow for the advantage of ensuring only the desired reaction occurs at the working electrode site.
Applicant also argues that the reference electrode is not covered with an enzyme layer, however as shown in the rejection above, the sensor includes the oxygen sensing electrode and the reference electrode, which are both present in the in the enzyme layer (Gough, Column 3, lines 7-8: “the sensor 18 can be covered by a porous membrane containing oxidase enzyme”; Column 4, lines 36-39: “the electrode can be covered with an oxidase enzyme containing membrane. Additionally, the electrochemical cell sensor contains a silver/silver chloride reference electrode 28”; Column 3, lines 15-16: “FIG. 4 shows both oxygen-sensing electrodes and the silver/silver chloride reference electrode”).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 5712727540. 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.
/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791