DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Applicant's arguments, filed 02/02/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/02/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1-2, 4-7, 10, 15-18, and 20.
Applicants have left claims 3, 8-9, 11-14, and 19 as previously presented/originally filed.
Claims 1-20 are the current claims hereby under examination.
Claim Objections - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
Claim 18 is objected to because of the following informalities:
Regarding claim 18, line 5 recites “second body”, however it appears it should read --second insulative substrate-- (emphasis added) to maintain consistent claim language.
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 02/02/2026, with respect to claims 15 and 17 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 15 and 17 have been withdrawn. However, applicant’s amendments necessitated new objections.
Claim Rejections - 35 USC § 112 - Withdrawn
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed 02/02/2026, with respect to claim 15 have been fully considered and are persuasive. Applicants have amended the claim, rendering the rejection moot. The 112(b) rejection of claim 15 has been withdrawn.
Claim Rejections - 35 USC § 102 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 12, 14, 15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gottlieb et al. (US 20100025238 A1) (previously cited), hereinafter referred to as Gottlieb.
The claims are generally directed towards a device comprising: an electrochemical cell configured to generate a first electrical signal indicative of an amount of glucose in a fluid of a person, the electrochemical cell comprising a working electrode, a counter electrode, and a reference electrode; a background electrode configured to not catalyze a reaction with glucose and is configured to generate a second electrical signal indicative of an amount of electrochemical interference proximate the electrochemical cell; and a second body separate from the electrochemical cell and comprising a drug eluting layer that is configured to elute a drug.
Regarding claim 1, Gottlieb discloses a device (Abstract, Fig. 3, para. [0008]) comprising:
an electrochemical cell configured to generate a first electrical signal indicative of an amount of glucose in a fluid of a person, the electrochemical cell comprising a working electrode, a counter electrode, and a reference electrode (Fig. 2, Fig. 6A, para. [0049], “sensor includes an electrochemical cell that has a working electrode, a reference electrode, and optionally a counter electrode …”, para. [0060], para. [0062], “produce a signal that can be sensed by the conductive layer … concentration of glucose can be determined …”, para. [0070]);
a background electrode configured to not catalyze a reaction with glucose and is configured to generate a second electrical signal indicative of an amount of electrochemical interference proximate the electrochemical cell (Fig. 2, Fig. 6A, para. [0019], para. [0125], “include a plurality of working electrodes … comparing signals at GOx coated working electrode with signal at working electrode not coated with GOx …”, para. [0145], “compares two or more signals produced by the plurality of sensors … identify background or interfering signals unrelated to blood glucose …”); and
a second body separate from the electrochemical cell and comprising a drug eluting layer that is configured to elute a drug (Fig. 3, element 32, para. [0094], “the adhesive layer includes an anti-inflammatory to reduce an inflammatory response …”).
Regarding claim 12, Gottlieb discloses the device of claim 1, wherein the background electrode is positioned between the counter electrode and the working electrode (Fig. 6A, - at least one additional working electrode is positioned between a counter electrode and a second working electrode; para. [0143], “a plurality of working, counter and reference electrodes … distributed configuration …”).
Regarding claim 14, Gottlieb discloses the device of claim 1, wherein the electrochemical interference is caused by acetaminophen (para. [0020], “interfering compound is acetaminophen …”, para. [0159]).
Regarding claim 15, Gottlieb discloses the device of claim 1, wherein a surface of the background electrode comprises an electrocatalytic material, wherein the electrocatalytic material is at least one of gold or platinum (para. [0218], “electrode may be made of … gold, platinum …”).
Regarding claim 20, Gottlieb discloses a method (Abstract, para. [0008]) comprising:
receiving, from an electrochemical cell disposed on a first body separate from a drug eluting body, a first signal indicative of an amount of glucose in a fluid of a person (Fig. 2, Fig. 3, element 32, Fig. 6A, para. [0049], “sensor includes an electrochemical cell that has a working electrode, a reference electrode, and optionally a counter electrode …”, para. [0060], para. [0062], “produce a signal that can be sensed by the conductive layer … concentration of glucose can be determined …”, para. [0070], para. [0094], “the adhesive layer includes an anti-inflammatory to reduce an inflammatory response …”);
receiving, from a background electrode configured to not catalyze a reaction with glucose and positioned proximate the electrochemical cell, a second signal indicative of an amount of electrochemical interference (Fig. 2, Fig. 6A, para. [0019], para. [0125], “include a plurality of working electrodes … comparing signals at GOx coated working electrode with signal at working electrode not coated with GOx …”, para. [0145], “compares two or more signals produced by the plurality of sensors … identify background or interfering signals unrelated to blood glucose …”); and
determining a glucose level of the fluid of the person based on the first and second signals (para. [0125], “subtraction/cancellation process … factor out background signals … arrive at a true signal …”, para. [0128]).
Response to Arguments
Applicant's arguments filed 02/02/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 6-7 of Remarks, filed 02/02/2026, that Gottlieb does not disclose “a second body separate from the electrochemical cell and comprising a drug eluting layer that is configured to elute a drug” and “an electrochemical cell disposed on a first body separate from a drug eluting body”.
The Examiner respectfully disagrees. As recited in the newly applied rejection above, Gottlieb teaches an electrochemical cell as claimed (Fig. 2, Fig. 6A, para. [0049], para. [0060], para. [0062], para. [0070]), and a second body that is separate from the electrochemical cell, which is configured to elute a drug (Fig. 3, element 32, para. [0094]).
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gottlieb et al. (US 20100025238 A1) (previously cited), hereinafter referred to as Gottlieb, in view of Rao et al. (US 20170290535 A1) (previously cited), hereinafter referred to as Rao, in view of Brauker et al. (US 20070027370 A1) (previously cited), hereinafter referred to as Brauker.
Regarding claim 1, Gottlieb discloses a device (Abstract, Fig. 3, para. [0008]) comprising:
an electrochemical cell configured to generate a first electrical signal indicative of an amount of glucose in a fluid of a person, the electrochemical cell comprising a working electrode, a counter electrode, and a reference electrode (Fig. 2, Fig. 6A, para. [0049], “sensor includes an electrochemical cell that has a working electrode, a reference electrode, and optionally a counter electrode …”, para. [0060], para. [0062], “produce a signal that can be sensed by the conductive layer … concentration of glucose can be determined …”, para. [0070]);
a background electrode configured to not catalyze a reaction with glucose and is configured to generate a second electrical signal indicative of an amount of electrochemical interference proximate the electrochemical cell (Fig. 2, Fig. 6A, para. [0019], para. [0125], “include a plurality of working electrodes … comparing signals at GOx coated working electrode with signal at working electrode not coated with GOx …”, para. [0145], “compares two or more signals produced by the plurality of sensors … identify background or interfering signals unrelated to blood glucose …”).
Gottlieb suggests a second body separate from the electrochemical cell. Gottlieb suggests this by disclosing a dual piercing sensor system with first and second piercing members (Fig. 12A, para. [0129]). However, Gottlieb does not explicitly disclose a second body separate from the electrochemical cell.
Rao teaches an analogous device for measuring a glucose concentration (Abstract, para. [0008]). Rao teaches the device comprises an electrochemical cell and a background electrode (Fig. 3, para. [0083], para. [0085], para. [0126]). Rao further teaches a second body separate from the electrochemical cell (Fig. 5, element 12A, element 12B, para. [0085], para. [0091]). 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 device disclosed by Gottlieb to additionally include a second body separate from the electrochemical cell, as taught by Rao. This is because Rao teaches a second body allows for two sensors to be used in conjunction with each other, allowing for multiple characteristics to be sensed within a small area (para. [0085]).
However, modified Gottlieb does not explicitly disclose the second body comprises a drug eluting layer that is configured to elute a drug.
Brauker teaches of an analogous device including a dug eluting layer disposed on a body (Abstract, Fig. 2C, para. [0200], para. [0250], para. [0252]). Brauker further teaches the body comprises a drug eluting layer that is configured to elute a drug (para. [0250], para. [0252], para. [0257]). 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 device and the second body taught by modified Gottlieb to additionally comprise a drug eluting layer that is configured to elute a drug, as taught by Brauker. This is because Brauker teaches a drug eluting layer disposed on at least a portion of the sensor allows for dexamethasone to be released from the sensor directly, reducing local inflammation (para. [0252], para. [0257]).
Regarding claim 2, modified Gottlieb discloses the device of claim 1.
However, modified Gottlieb does not explicitly disclose wherein the electrochemical cell is disposed on a first side of a first body, wherein the background electrode is disposed on a first side of the second body.
Rao further teaches the sensors are configured such that the electrochemical cell is disposed on a first side of a first body, and wherein the background electrode is disposed on a first side of the second body (Fig. 5, element 12A, 12B, para. [0085], para. [0091]). 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 device taught by modified Gottlieb to explicitly have the electrochemical cell disposed on a first side of a first body, and the background electrode disposed on a first side of the second body, as taught by Rao. This is because Rao teaches sensor substrates disposed back to back allows for the sensors to be used in conjunction with each other while also being able to be inserted with a single needle (para. [0091]).
Regarding claim 3, modified Gottlieb discloses the device of claim 2.
However, modified Gottlieb does not explicitly disclose wherein the first side of the first body faces a first direction, wherein the first side of the second body faces a second direction opposite the first direction, wherein a second side of the first body opposite the first side of the first body is adjacent a second side of the second body, the second side of the second body opposite the first side of the second body.
Rao further teaches wherein the first side of the first body faces a first direction, wherein the first side of the second body faces a second direction opposite the first direction, wherein a second side of the first body opposite the first side of the first body is adjacent a second side of the second body, the second side of the second body opposite the first side of the second body (Fig. 6, element 12A, 123A, 12B, 123B, para. [0085], para. [0087], para. [0091]). 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 first body and the second body taught by modified Gottlieb to explicitly be positioned such that the first side of the first body faces a first direction, wherein the first side of the second body faces a second direction opposite the first direction, wherein a second side of the first body opposite the first side of the first body is adjacent a second side of the second body, the second side of the second body opposite the first side of the second body, as taught by Rao. This is because Rao teaches this configuration allows for the two sensors to be used in conjunction with each other, share electrical contacts, and be inserted with a single needle (para. [0087], para. [0091]).
Regarding claim 4, modified Gottlieb discloses the device of claim 3.
However, modified Gottlieb does not explicitly disclose wherein the drug eluting layer is disposed on the first side of the second body.
Brauker further teaches the drug eluting layer is disposed on the first side of the second body (para. [0250], para. [0252], para. [0257]). 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 drug eluting layer taught by modified Gottlieb to explicitly be disposed on the first side of the second body, as taught by Brauker. This is because Brauker teaches a drug eluting layer disposed on at least a portion of the sensor allows for dexamethasone to be released from the sensor directly, reducing local inflammation (para. [0252], para. [0257]).
Alternatively and/or additionally, as to location of the drug eluting layer, Brauker teaches at least a portion of the sensor is coated with protective coatings, including anti-inflammatory agents (para. [0250], para. [0252], para. [0257]). The location of drug eluting layer will depend upon available space of the bodies and characteristics of the drug eluting layer, such as if the layer allows for transport of target molecules to the electrochemical cell. As such, the location of drug eluting layer are results-effective variables that would have been optimized through routine experimentation based on available space of the bodies and characteristics of the drug eluting layer. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location of the drug eluting layer so as to be disposed on the first side of the second body.
Regarding claim 5, modified Gottlieb discloses the device of claim 4.
However, modified Gottlieb does not explicitly disclose wherein the drug eluting layer is disposed on the first side of the second body only proximal to the background electrode.
Brauker further teaches the drug eluting layer is disposed on the first side of the second body only proximal to the background electrode (para. [0250], para. [0252], para. [0257]). 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 drug eluting layer taught by modified Gottlieb to explicitly be disposed on the first side of the second body only proximal to the background electrode, as taught by Brauker. This is because Brauker teaches a drug eluting layer disposed on at least a portion of the sensor allows for dexamethasone to be released from the sensor directly, reducing local inflammation (para. [0252], para. [0257]).
Alternatively and/or additionally, as to location of the drug eluting layer, Brauker teaches at least a portion of the sensor is coated with protective coatings, including anti-inflammatory agents (para. [0250], para. [0252], para. [0257]). The location of drug eluting layer will depend upon available space of the bodies and characteristics of the drug eluting layer, such as if the layer allows for transport of target molecules to the electrochemical cell. As such, the location of drug eluting layer are results-effective variables that would have been optimized through routine experimentation based on available space of the bodies and characteristics of the drug eluting layer. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location of the drug eluting layer so as to be disposed on the first side of the second body only proximal to the background electrode.
Regarding claim 6, modified Gottlieb discloses the device of claim 4.
However, modified Gottlieb does not explicitly disclose wherein the drug eluting layer is disposed on the first side of the second body only distal to the background electrode.
Brauker further teaches the drug eluting layer is disposed on the first side of the second body only distal to the background electrode (para. [0250], para. [0252], para. [0257]). 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 drug eluting layer taught by modified Gottlieb to explicitly be disposed on the first side of the second body only distal to the background electrode, as taught by Brauker. This is because Brauker teaches a drug eluting layer disposed on at least a portion of the sensor allows for dexamethasone to be released from the sensor directly, reducing local inflammation (para. [0252], para. [0257]).
Alternatively and/or additionally, as to location of the drug eluting layer, Brauker teaches at least a portion of the sensor is coated with protective coatings, including anti-inflammatory agents (para. [0250], para. [0252], para. [0257]). The location of drug eluting layer will depend upon available space of the bodies and characteristics of the drug eluting layer, such as if the layer allows for transport of target molecules to the electrochemical cell. As such, the location of drug eluting layer are results-effective variables that would have been optimized through routine experimentation based on available space of the bodies and characteristics of the drug eluting layer. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location of the drug eluting layer so as to be disposed on the first side of the second body only distal to the background electrode.
Regarding claim 7, modified Gottlieb discloses the device of claim 4.
However, modified Gottlieb does not explicitly disclose wherein the drug eluting layer is disposed on the first side of the second body only proximal and distal to the background electrode.
Brauker further teaches the drug eluting layer is disposed on the first side of the second body only proximal and distal to the background electrode (para. [0250], para. [0252], para. [0257]). 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 drug eluting layer taught by modified Gottlieb to explicitly be disposed on the first side of the second body only proximal and distal to the background electrode, as taught by Brauker. This is because Brauker teaches a drug eluting layer disposed on at least a portion of the sensor allows for dexamethasone to be released from the sensor directly, reducing local inflammation (para. [0252], para. [0257]).
Alternatively and/or additionally, as to location of the drug eluting layer, Brauker teaches at least a portion of the sensor is coated with protective coatings, including anti-inflammatory agents (para. [0250], para. [0252], para. [0257]). The location of drug eluting layer will depend upon available space of the bodies and characteristics of the drug eluting layer, such as if the layer allows for transport of target molecules to the electrochemical cell. As such, the location of drug eluting layer are results-effective variables that would have been optimized through routine experimentation based on available space of the bodies and characteristics of the drug eluting layer. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location of the drug eluting layer so as to be disposed on the first side of the second body only proximal and distal to the background electrode.
Regarding claim 8, modified Gottlieb discloses the device of claim 3.
However, modified Gottlieb does not explicitly disclose wherein a surface area of the background electrode is greater than a surface area of the electrochemical cell.
However, Gottlieb clearly teaches in para. [0104-0105] and para. [0207] variability of the dimensions and dimensional relationships of the components, such as the surface area of the electrodes, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the surface area of the electrodes 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 electrodes, using the teachings of Gottlieb, para. [0104-0105] and para. [0207], as a starting point, so as to obtain the desired manufacturing, design, and use applications. Gottlieb additionally teaches an increase in surface area provides for greater sensor sensitivity (para. [0207]).
Regarding claim 9, modified Gottlieb discloses the device of claim 3.
However, modified Gottlieb does not explicitly disclose wherein the background electrode is disposed at a first position along a length direction of the second body, the length direction perpendicular to the first and second directions, wherein the electrochemical cell is disposed at the first position along the first body.
Rao further teaches the background electrode is disposed at a first position along a length direction of the second body, the length direction perpendicular to the first and second directions, wherein the electrochemical cell is disposed at the first position along the first body (Fig. 6, element 12A, 123A, 12B, 123B, para. [0085], para. [0087], para. [0091]). 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 first body and the second body taught by modified Gottlieb to explicitly be positioned such that the background electrode is disposed at a first position along a length direction of the second body, the length direction perpendicular to the first and second directions, wherein the electrochemical cell is disposed at the first position along the first body, as taught by Rao. This is because Rao teaches this configuration allows for the two sensors to be used in conjunction with each other, share electrical contacts, and be inserted with a single needle (para. [0087], para. [0091]).
Regarding claim 10, modified Gottlieb discloses the device of claim 4.
However, modified Gottlieb does not explicitly disclose wherein the drug eluting layer is disposed on only a portion of the surface of the background electrode.
Brauker further teaches the drug eluting layer is disposed on only a portion of the surface of the background electrode (para. [0250], para. [0252], para. [0257]). 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 drug eluting layer taught by modified Gottlieb to explicitly be disposed on only a portion of the surface of the background electrode, as taught by Brauker. This is because Brauker teaches a drug eluting layer disposed on at least a portion of the sensor allows for dexamethasone to be released from the sensor directly, reducing local inflammation (para. [0252], para. [0257]).
Alternatively and/or additionally, as to location of the drug eluting layer, Brauker teaches at least a portion of the sensor is coated with protective coatings, including anti-inflammatory agents (para. [0250], para. [0252], para. [0257]). The location of drug eluting layer will depend upon available space of the bodies and characteristics of the drug eluting layer, such as if the layer allows for transport of target molecules to the electrochemical cell. As such, the location of drug eluting layer are results-effective variables that would have been optimized through routine experimentation based on available space of the bodies and characteristics of the drug eluting layer. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location of the drug eluting layer so as to be disposed on only a portion of the surface of the background electrode.
Regarding claim 11, modified Gottlieb discloses the device of claim 4, wherein the background electrode comprises a glucose limiting membrane disposed over the background electrode surface (para. [0064], para. [0125], para. [0128], para. [0198], “analyte modulating layers operate to prevent or restrict the diffusion of one or more analytes, such as glucose, through the layers …”).
Regarding claim 12, modified Gottlieb discloses the device of claim 1, wherein the background electrode is positioned between the counter electrode and the working electrode (Fig. 6A, - at least one additional working electrode is positioned between a counter electrode and a second working electrode; para. [0143], “a plurality of working, counter and reference electrodes … distributed configuration …”).
Regarding claim 13, modified Gottlieb discloses the device of claim 1.
However, modified Gottlieb does not explicitly disclose wherein the electrochemical cell is disposed on a first side of a first body, wherein the background electrode is disposed on a second side of the first body opposite the first side.
Rao further teaches the sensors are configured such that the electrochemical cell is disposed on a first side of a first body, wherein the background electrode is disposed on a second side of the first body opposite the first side (para. [0085], “one double-sided sensor, with up to five electrodes per side”). 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 device taught by modified Gottlieb to explicitly have the electrochemical cell disposed on a first side of a first body, and the background electrode disposed on a second side of the first body opposite the first side, as taught by Rao. This is because Rao teaches sensor substrates that are double sided allows for the multiple readings while also being able to be inserted with a single needle (para. [0091]).
Regarding claim 14, modified Gottlieb discloses the device of claim 1, wherein the electrochemical interference is caused by acetaminophen (para. [0020], “interfering compound is acetaminophen …”, para. [0159]).
Regarding claim 15, modified Gottlieb discloses the device of claim 1, wherein a surface of the background electrode comprises an electrocatalytic material, wherein the electrocatalytic material is at least one of gold or platinum (para. [0218], “electrode may be made of … gold, platinum …”).
Regarding claim 16, Gottlieb discloses a glucose monitor system (Abstract, Fig. 3, para. [0008]) comprising:
an electrochemical cell configured to generate a first electrical signal indicative of an amount of glucose in a fluid of a person (Fig. 2, Fig. 6A, para. [0049], “sensor includes an electrochemical cell that has a working electrode, a reference electrode, and optionally a counter electrode …”, para. [0060], para. [0062], “produce a signal that can be sensed by the conductive layer … concentration of glucose can be determined …”, para. [0070]);
a background electrode configured to not catalyze a reaction with glucose and is configured to generate a second electrical signal indicative of an amount of electrochemical interference (Fig. 2, Fig. 6A, para. [0019], para. [0125], “include a plurality of working electrodes … comparing signals at GOx coated working electrode with signal at working electrode not coated with GOx …”, para. [0145], “compares two or more signals produced by the plurality of sensors … identify background or interfering signals unrelated to blood glucose …”);
an electrical circuit configured to receive the first electrical signal indicative of the amount of glucose and the second electrical signal indicative of the amount of electrochemical interference, wherein the electrical circuit is configured to determine an amount of glucose based on the first signal and the second signal (para. [0098], “sensor electronics device … processing electronics …”, para. [0125], “processor … designed factor out background signals … subtraction/cancellation process … factor out background signals … arrive at a true signal …”, para. [0128]).
Gottlieb suggests multiple insulative substrates. Gottlieb suggests this by disclosing a dual piercing sensor system with first and second piercing members (Fig. 12A, para. [0129]). However, Gottlieb does not explicitly disclose the electrochemical cell is disposed on a first side of a first insulative substrate; and the background electrode is disposed on a first side of a second insulative substrate, wherein a second side opposite the first side of the first insulative substrate is adjacent to a second side opposite the first side of the second insulative substrate.
Rao teaches an analogous glucose monitor system (Abstract, para. [0008]). Rao teaches the device comprises an electrochemical cell and a background electrode (Fig. 3, para. [0083], para. [0085], para. [0126]). Rao further teaches the sensors are configured such that the electrochemical cell is disposed on a first side of a first insulative substrate; and the background electrode is disposed on a first side of a second insulative substrate, wherein a second side opposite the first side of the first insulative substrate is adjacent to a second side opposite the first side of the second insulative substrate (Fig. 5, element 12A, 12B, para. [0083], para. [0085], para. [0091]). 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 device disclosed by Gottlieb to explicitly have the electrochemical cell disposed on a first side of a first insulative substrate; and the background electrode disposed on a first side of a second insulative substrate, wherein a second side opposite the first side of the first insulative substrate is adjacent to a second side opposite the first side of the second insulative substrate, as taught by Rao. This is because Rao teaches sensor substrates disposed back to back allows for the sensors to be used in conjunction with each other while also being able to be inserted with a single needle (para. [0091]).
However, modified Gottlieb does not explicitly disclose a drug eluting layer disposed only on the second insulative substrate.
Brauker teaches of an analogous device including a dug eluting layer disposed on a body (Abstract, Fig. 2C, para. [0200], para. [0250], para. [0252]). Brauker further teaches a drug eluting layer disposed on an insulative substrate (para. [0250], para. [0252], para. [0257]). 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 device taught by modified Gottlieb to additionally comprise a drug eluting layer disposed on the insulative substrate, as taught by Brauker. This is because Brauker teaches a drug eluting layer disposed on at least a portion of the sensor allows for dexamethasone to be released from the sensor directly, reducing local inflammation (para. [0252], para. [0257]).
Alternatively and/or additionally, as to location of the drug eluting layer, Brauker teaches at least a portion of the sensor is coated with protective coatings, including anti-inflammatory agents (para. [0250], para. [0252], para. [0257]). The location of drug eluting layer will depend upon available space of the insulative substrates and characteristics of the drug eluting layer, such as if the layer allows for transport of target molecules to the electrochemical cell. As such, the location of drug eluting layer are results-effective variables that would have been optimized through routine experimentation based on available space of the insulative substrates and characteristics of the drug eluting layer. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location of the drug eluting layer so as to be disposed only on the second insulative substrate.
Regarding claim 17, modified Gottlieb discloses the glucose monitor system of claim 16.
However, modified Gottlieb does not explicitly disclose wherein the electrical circuit is connected to the electrochemical cell via a first electrical contact in contact with the first surface of the first insulative substrate, wherein the electrical circuit is connected to background the electrode via a second electrical contact in contact with a connector configured to contact the first surface of the second insulative substrate and the second electrical contact.
Rao further teaches the electrical circuit is connected to the electrochemical cell via a first electrical contact in contact with the first surface of the first insulative substrate, wherein the electrical circuit is connected to the background electrode via a second electrical contact in contact with a connector configured to contact the first surface of the second insulative substrate and the second electrical contact (Fig. 6, elements 121A, 121B, 322, para. [0087]). 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 electrical circuit taught by modified Gottlieb to explicitly be connected to the electrochemical cell via a first electrical contact in contact with the first surface of the first insulative substrate, wherein the electrical circuit is connected to the background electrode via a second electrical contact in contact with a connector configured to contact the first surface of the second insulative substrate and the second electrical contact, as taught by Rao. This is because Rao teaches electrical contacts on both sensors allows for all sensor components to be housed within a single housing, allowing the sensors to be inserted with a single needle (para. [0087]).
Regarding claim 18, modified Gottlieb discloses the glucose monitor system of claim 16.
However, modified Gottlieb does not explicitly disclose wherein the drug eluting layer is disposed on at least one of a surface of the background electrode, the first side of the second insulative substrate proximal to the background electrode, the first side of the second insulative substrate distal to the background electrode, or the first side of the second body proximal and distal to the background electrode.
Brauker further teaches a drug eluting layer disposed on at least a portion of the sensor (para. [0250], para. [0252], para. [0257]). 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 device taught by modified Gottlieb to explicitly be disposed on at least one of a surface of the background electrode, the first side of the second insulative substrate proximal to the background electrode, the first side of the second insulative substrate distal to the background electrode, or the first side of the second body proximal and distal to the background electrode, as taught by Brauker. This is because Brauker teaches a drug eluting layer disposed on at least a portion of the sensor allows for dexamethasone to be released from the sensor directly, reducing local inflammation (para. [0252], para. [0257]).
Alternatively and/or additionally, as to location of the drug eluting layer, Brauker teaches at least a portion of the sensor is coated with protective coatings, including anti-inflammatory agents (para. [0250], para. [0252], para. [0257]). The location of drug eluting layer will depend upon available space of the insulative substrates and characteristics of the drug eluting layer, such as if the layer allows for transport of target molecules to the electrochemical cell. As such, the location of drug eluting layer are results-effective variables that would have been optimized through routine experimentation based on available space of the insulative substrates and characteristics of the drug eluting layer. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location of the drug eluting layer so as to be disposed on at least one of a surface of the background electrode, the first side of the second insulative substrate proximal to the background electrode, the first side of the second insulative substrate distal to the background electrode, or the first side of the second body proximal and distal to the background electrode.
Regarding claim 19, modified Gottlieb discloses the glucose monitor system of claim 16.
However, modified Gottlieb does not explicitly disclose wherein a surface area of the background electrode is greater than a surface area of the electrochemical cell.
However, Gottlieb clearly teaches in para. [0104-0105] and para. [0207] variability of the dimensions and dimensional relationships of the components, such as the surface area of the electrodes, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. As such, the dimensions and dimensional relationships of the surface area of the electrodes 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 electrodes, using the teachings of Gottlieb, para. [0104-0105] and para. [0207], as a starting point, so as to obtain the desired manufacturing, design, and use applications. Gottlieb additionally teaches an increase in surface area provides for greater sensor sensitivity (para. [0207]).
Response to Arguments
Applicant’s arguments, see pages 7-8 of Remarks, filed 02/02/2026, with respect to the rejection(s) of claim(s) 2-11, 13, 16-19 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of Gottlieb et al. (US 20100025238 A1) (previously cited), hereinafter referred to as Gottlieb, in view of Rao et al. (US 20170290535 A1) (previously cited), hereinafter referred to as Rao, in view of Brauker et al. (US 20070027370 A1) (previously cited), hereinafter referred to as Brauker.
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.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791