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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/29/2025 has been entered.
Status of Claims
Applicant's arguments, filed 08/29/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 08/29/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 77 and 88.
Applicants have left claims 78, 80-87, 89, and 91-98 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 1-76, 79, 90, and 99-100.
Claims 77, 78, 80-89, and 91-98 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/17/2025 and 08/29/2025 are being considered by the examiner.
Claim Rejections - 35 USC § 103 - 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 77, 85-88, and 96-98 are rejected under 35 U.S.C. 103 as being unpatentable over Cuijun Yang (US 20160136357 A1), hereinafter referred to as Yang, in view of Ward et al. (US 20140296823 A1) (previously cited), hereinafter referred to as Ward ‘823.
The claims are generally directed towards a system for managing blood glucose in a subject, comprising: an insulin delivery cannula comprising a hollow tube comprising a proximal end and a distal end, wherein the proximal end is in fluid communication with a source of a concentrated insulin or insulin analog formulation, wherein the concentrated insulin or insulin analog formulation has a concentration of at least about 150 units per milliliter (units/mL), wherein the distal end is configured to deliver the concentrated insulin or insulin analog formulation into a subcutaneous space of the subject; a glucose sensor located no more than a pre-determined distance away from the distal end, wherein the pre-determined distance is about 2.5 millimeters (mm), wherein the glucose sensor is a continuous amperometric or coulometric glucose sensor comprising at least one indicating electrode; and an insulin pump fluidically coupled to the proximal end of the insulin delivery cannula, wherein the insulin pump is attached to the insulin delivery cannula either directly or via an intervening tube, wherein the glucose sensor and the insulin delivery cannula are configured to be inserted into the subcutaneous space of the subject simultaneously by a single insertion device.
Regarding claim 77, Yang discloses a system for managing blood glucose in a subject (Abstract, “single needle integrated artificial pancreas …”), comprising:
an insulin delivery cannula comprising a hollow tube comprising a proximal end and a distal end (Fig. 1, Fig. 4, Fig. 9, element 32, para. [0066], “indwelling unit includes … indwelling cannula …”, para. [0076], “indwelling cannula is configured to deliver the insulin in the fluid reservoir unit …”), wherein the proximal end is in fluid communication with a source of a concentrated insulin or insulin analog formulation (Fig. 1, element 1, para. [0069], “indwelling unit is connected to the fluid reservoir … the indwelling unit includes … the indwelling cannula”, para. [0076], “indwelling cannula is configured to deliver the insulin in the fluid reservoir unit …”), wherein the distal end is configured to deliver the concentrated insulin or insulin analog formulation into a subcutaneous space of the subject (Fig. 4, Fig. 9, para. [0068], “configured to deliver insulin stored in the fluid reservoir unit to the subcutaneous tissue of a patient …”);
a glucose sensor (Fig. 1, element 31, para. [0066], “indwelling unit includes a glucose sensor …”) located no more than a pre-determined distance away from the distal end, wherein the pre-determined distance is about 2.5 millimeters (mm) (Fig. 9, Fig. 10, para. [0081-0082], “the distance between the end of the indwelling cannula and the end of the glucose sensor ranges from 1 mm to 8 mm …”), wherein the glucose sensor is a continuous amperometric or coulometric glucose sensor comprising at least one indicating electrode (para. [0002], “real-timely and dynamically monitor the change of glucose …”, para. [0071], “glucose sensor may be an electrode sensor which monitors the glucose by current signal …”); and
an insulin pump fluidically coupled to the proximal end of the insulin delivery cannula, wherein the insulin pump is attached to the insulin delivery cannula either directly or via an intervening tube (Fig. 1, element 1, element 2, para. [0066], “single needle integrated artificial pancreas includes: a fluid reservoir unit, a fluid driving unit … the pump base includes the fluid reservoir unit, the fluid driving unit, and the indwelling unit …”, para. [0068], “fluid driving unit is connected to the fluid reservoir and configured to deliver the insulin stored in the fluid reservoir unit to the subcutaneous tissue of a patient”),
wherein the glucose sensor and the insulin delivery cannula are configured to be inserted into the subcutaneous space of the subject simultaneously by a single insertion device (Fig. 1, Fig. 4, Fig. 9, Fig. 10, para. [0066], “indwelling unit includes a glucose sensor, an indwelling cannula, a puncture needle, and an inserter”, para. [0078], “inserter is configured to simultaneously implant the glucose sensor and the indwelling cannula in the same subcutaneous tissue in the patient with the aid of the puncture needle …”).
However, Yang does not explicitly disclose wherein the concentrated insulin or insulin analog formulation has a concentration of at least about 150 units per milliliter (units/mL).
Ward ‘823 teaches of an analogous system for managing blood glucose in a subject, comprising a sensor and catheter in a single unified device, and method for sensing an analyte concentration and delivering a drug (Abstract, para. [0011], para. [0013-0015]). Ward ‘823 further teaches the concentrated insulin or insulin analog formulation has a concentration of at least about 150 units per milliliter (units/mL) (para. [0080], “more concentrated insulins are also available, such as U500 R insulin …”). 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 concentration insulin or insulin analog formulation to have a concentration of at least about 150 units per milliliter (units/mL), as taught by Ward ‘823. This is because Ward ‘823 teaches that highly concentrated insulin is desirable to minimize dilution (para. [0080]). Further, the concentration of insulin would depend upon patient specific parameters. For example, a patient with insulin resistance requires a higher concentration of insulin.
Regarding claim 85, modified Yang discloses the system of claim 77, wherein the glucose sensor is disposed on an outer wall of the hollow tube (Fig. 4, Fig. 9, Fig. 10, para. [0078], “glucose sensor which is integrated in the outer surface of the indwelling cannula”, para. [0080-0081]).
Regarding claim 86, modified Yang discloses the system of claim 77, wherein the insulin pump is a tube pump (para. [0066], “pump base and a controller connected to the pump base, wherein the pump base includes the fluid reservoir unit, the fluid driving unit, and the indwelling unit …” - pump base is capable of being a tube pump because tubing is needed to deliver the fluid from the fluid reservoir).
Regarding claim 87, modified Yang discloses the system of claim 77, wherein the insulin pump is a patch pump (para. [0066], “pump base and a controller connected to the pump base, wherein the pump base includes the fluid reservoir unit, the fluid driving unit, and the indwelling unit …” - pump base is capable of being a patch pump because all elements are included in the pump base).
Regarding claim 88, Yang discloses a method for managing blood glucose in a subject (Abstract, “single needle integrated artificial pancreas …”), comprising:
(a) obtaining a device for delivery of concentrated insulin or insulin analog formulation and measurement of subcutaneous glucose concentration (Fig. 1, para. [0066], “single needle integrated artificial pancreas … fluid reservoir unit, a fluid driving unit, an indwelling unit … glucose sensor, an indwelling cannula …”), wherein the device comprises:
(i) a hollow tube comprising a proximal end and a distal end (Fig. 1, Fig. 4, Fig. 9, element 32, para. [0066], “indwelling unit includes … indwelling cannula …”, para. [0076], “indwelling cannula is configured to deliver the insulin in the fluid reservoir unit …”), wherein the proximal end is in fluid communication with a source of the concentrated insulin or insulin analog formulation (Fig. 1, element 1, para. [0069], “indwelling unit is connected to the fluid reservoir … the indwelling unit includes … the indwelling cannula”, para. [0076], “indwelling cannula is configured to deliver the insulin in the fluid reservoir unit …”), wherein the distal end is configured to deliver the concentrated insulin or insulin analog formulation into a subcutaneous space of the subject (Fig. 4, Fig. 9, para. [0068], “configured to deliver insulin stored in the fluid reservoir unit to the subcutaneous tissue of a patient …”); and
(ii) a glucose sensor (Fig. 1, element 31, para. [0066], “indwelling unit includes a glucose sensor …”) located no more than a pre-determined distance away from the distal end, wherein the pre-determined distance is about 2.5 mm (Fig. 9, Fig. 10, para. [0081-0082], “the distance between the end of the indwelling cannula and the end of the glucose sensor ranges from 1 mm to 8 mm …”), wherein the glucose sensor is a continuous amperometric or coulometric glucose sensor comprising at least one indicating electrode (para. [0002], “real-timely and dynamically monitor the change of glucose …”, para. [0071], “glucose sensor may be an electrode sensor which monitors the glucose by current signal …”);
(b) connecting the proximal end of the hollow tube to the source of the concentrated insulin or insulin analog formulation (Fig. 1, element 1, element 2, para. [0066], “single needle integrated artificial pancreas includes: a fluid reservoir unit, a fluid driving unit … the pump base includes the fluid reservoir unit, the fluid driving unit, and the indwelling unit …”, para. [0068], “fluid driving unit is connected to the fluid reservoir and configured to deliver the insulin stored in the fluid reservoir unit to the subcutaneous tissue of a patient”);
(c) inserting the glucose sensor and the distal end of the hollow tube of the insulin delivery cannula into the subcutaneous space of the subject simultaneously by a single insertion device (Fig. 1, Fig. 4, Fig. 9, Fig. 10, para. [0066], “indwelling unit includes a glucose sensor, an indwelling cannula, a puncture needle, and an inserter”, para. [0078], “inserter is configured to simultaneously implant the glucose sensor and the indwelling cannula in the same subcutaneous tissue in the patient with the aid of the puncture needle …”); and
(d) simultaneously (1) delivering the concentrated insulin or insulin analog formulation into the subcutaneous space of the subject using an insulin pump fluidically coupled to the proximal end of the insulin delivery cannula, wherein the insulin pump is attached to the insulin delivery cannula either directly or via an intervening tube, and (2) measuring the subcutaneous glucose concentration of the subject (para. [0002], “real-timely and dynamically monitor the change of glucose … continuously and accurately deliver insulin to the subcutaneous tissue of the patient …”, para. [0066], “single needle integrated artificial pancreas includes: a fluid reservoir unit, a fluid driving unit … the pump base includes the fluid reservoir unit, the fluid driving unit, and the indwelling unit …”, para. [0068], “fluid driving unit is connected to the fluid reservoir and configured to deliver the insulin stored in the fluid reservoir unit to the subcutaneous tissue of a patient”, para. [0086], “process a useful blood sugar signal output by the glucose sensor, and to control the fluid reservoir unit …”).
However, Yang does not explicitly disclose wherein the concentrated insulin or insulin analog formulation has a concentration of at least about 150 units per milliliter (units/mL).
Ward ‘823 teaches of an analogous system and method for managing blood glucose in a subject, comprising a sensor and catheter in a single unified device, and method for sensing an analyte concentration and delivering a drug (Abstract, para. [0011], para. [0013-0015]). Ward ‘823 further teaches the concentrated insulin or insulin analog formulation has a concentration of at least about 150 units per milliliter (units/mL) (para. [0080], “more concentrated insulins are also available, such as U500 R insulin …”). 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 concentration insulin or insulin analog formulation to have a concentration of at least about 150 units per milliliter (units/mL), as taught by Ward ‘823. This is because Ward ‘823 teaches that highly concentrated insulin is desirable to minimize dilution (para. [0080]). Further, the concentration of insulin would depend upon patient specific parameters. For example, a patient with insulin resistance requires a higher concentration of insulin.
Regarding claim 96, modified Yang discloses the method of claim 88, wherein the glucose sensor is disposed on an outer wall of the hollow tube (Fig. 4, Fig. 9, Fig. 10, para. [0078], “glucose sensor which is integrated in the outer surface of the indwelling cannula”, para. [0080-0081]).
Regarding claim 97, modified Yang discloses the method of claim 88, wherein the insulin pump is a tube pump (para. [0066], “pump base and a controller connected to the pump base, wherein the pump base includes the fluid reservoir unit, the fluid driving unit, and the indwelling unit …” - pump base is capable of being a tube pump because tubing is needed to deliver the fluid from the fluid reservoir).
Regarding claim 98, modified Yang discloses the method of claim 88, wherein the insulin pump is a patch pump (para. [0066], “pump base and a controller connected to the pump base, wherein the pump base includes the fluid reservoir unit, the fluid driving unit, and the indwelling unit …” - pump base is capable of being a patch pump because all elements are included in the pump base).
Claims 78 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Cuijun Yang (US 20160136357 A1), hereinafter referred to as Yang, in view of Ward et al. (US 20140296823 A1) (previously cited), hereinafter referred to as Ward ‘823 as applied to claims 77 and 88 above, and further in view of the NPL “Patient Information Humulin R U-500”.
Regarding claim 78, modified Yang discloses the system of claim 77.
However, modified Yang does not explicitly disclose wherein the concentrated insulin or insulin analog formulation comprises an excipient comprising a phenolic compound or cresol.
Ward ‘823 teaches the concentrated insulin or insulin analog formulation is U500 R insulin available from Lilly (See the rejection of claim 77 - para. [0080]). U500 R insulin from Lilly includes metacresol (NPL, pg. 3).
Regarding claim 89, modified Yang discloses the method of claim 88.
However, modified Yang does not explicitly disclose wherein the concentrated insulin or insulin analog formulation comprises an excipient comprising a phenolic compound or cresol.
Ward ‘823 teaches the concentrated insulin or insulin analog formulation is U500 R insulin available from Lilly (See the rejection of claim 77 - para. [0080]). U500 R insulin from Lilly includes metacresol (NPL, pg. 3).
Claims 80-84 and 91-95 are rejected under 35 U.S.C. 103 as being unpatentable over Cuijun Yang (US 20160136357 A1), hereinafter referred to as Yang, in view of Ward et al. (US 20140296823 A1) (previously cited), hereinafter referred to as Ward ‘823 as applied to claim 77 and claim 88 above, and further in view of Ward et al. (US 20160354542 A1) (previously cited), hereinafter referred to as Ward ‘542.
Regarding claim 80, modified Yang discloses the system of claim 77, wherein the glucose sensor comprises an electrode layer comprising the at least one indicating electrode (Fig. 4, Fig. 9, Fig. 10, para. [0071], “glucose sensor may be a three electrode system …”, para. [0074], “three electrode system … working electrode …”), wherein the electrode layer underlies (2) an enzyme comprising glucose oxidase or glucose dehydrogenase (para. [0071], “glucose electrode sensor mainly includes an enzyme layer … glucose may occur an oxidation reaction under the catalysis of glucose oxidase … glucose oxidase is fixed on the surface of the platinum electrode …”).
Yang suggests the use of other layers by disclosing using an enzyme layer and a hydrogen peroxide electrode to detect the production of hydrogen peroxide to measure glucose (para. [0075]). However, modified Yang does not explicitly disclose the electrode layer underlies a redox-catalytic layer comprising (1) a redox mediator comprising a metal compound covalently bound to a ligand.
Ward ‘542 teaches of an analogous insulin delivery cannula with electrodes to allow for continuous glucose sensing (Abstract). Ward ‘542 further teaches the sensor comprises a redox mediator comprising a metal compound covalently bound to ligand (para. [0017], para. [0035], para. [0088], para. [0096]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor taught by modified Yang to additionally include a redox-catalytic layer comprising (1) a redox mediator comprising a metal compound covalently bound to a ligand, as taught by Ward ‘542. This is because Ward ‘542 teaches osmium-based redox mediators that operate at a low bias potential allow for the sensor to operate correctly without interference from the insulin preservatives, thereby measuring an accurate glucose concentration (para. [0017]).
Regarding claim 81, modified Yang discloses the system of claim 80.
However, modified Yang does not explicitly disclose wherein the glucose sensor further comprises an insulating layer and a metal layer, wherein the insulating layer is coupled to the metal layer, and wherein the metal layer is coupled to the electrode layer.
Ward ’542 further teaches the glucose sensor further comprises an insulating layer and a metal layer, wherein the insulating layer is coupled to the metal layer, and wherein the metal layer is coupled to the electrode layer (Fig. 10, para. [0030], para. [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the glucose sensor taught by modified Yang to additionally include an insulating layer and a metal layer, wherein the insulating layer is coupled to the metal layer, and wherein the metal layer is coupled to the electrode layer, as taught by Ward ‘542. This is because Ward ‘542 teaches a titanium foil laminated to a polyimide layer underlying the electrode layer produces a sensor that can be easily incorporated into the walls of a hollow needle or catheter (para. [0015]).
Regarding claim 82, modified Yang discloses the system of claim 80.
However, modified Yang does not explicitly disclose wherein the redox mediator and the enzyme allow electron transfer from subcutaneous glucose to the at least one indicating electrode sufficient to cause a response of the glucose sensor to a subcutaneous glucose concentration of the subject at an applied bias potential of no more than about +300 millivolts (mV), +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to a reference electrode.
Ward ‘542 further teaches the redox mediator and the enzyme allow electron transfer from subcutaneous glucose to the at least one indicating electrode sufficient to cause a response of the glucose sensor to a subcutaneous glucose concentration of the subject at an applied bias potential of no more than about +300 millivolts (mV), +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to a reference electrode (Fig. 4, para. [0024], para. [0027], para. [0039], para. [0041], “polarized at 180 mV … able to measure glucose with little or no interference from the preservatives …”, para. [0096]). 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 system disclosed by modified Yang to explicitly apply a bias potential of no more than about +300 millivolts (mV), +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to a reference electrode, as taught by Ward ‘542. This is because Ward ‘542 teaches a bias potential of 180 mV in combination with certain coatings allows for glucose to be accurately measured without interference from insulin preservatives (para. [0041]).
Regarding claim 83, modified Yang discloses the system of claim 82.
However, modified Yang does not explicitly disclose wherein the applied bias potential of no more than about +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to the reference electrode allows the electrode layer to undergo substantially no electropolymerization of the excipient during continuous operation of at least one hour of the amperometric glucose sensor, thereby maintaining a sensitivity of the amperometric glucose sensor to the subcutaneous glucose concentration in presence of the concentrated insulin or insulin analog formulation.
Ward ‘542 further teaches the applied bias potential of no more than about +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to the reference electrode allows the electrode layer to undergo substantially no electropolymerization of the excipient during continuous operation of at least one hour of the amperometric glucose sensor, thereby maintaining a sensitivity of the amperometric glucose sensor to the subcutaneous glucose concentration in presence of the concentrated insulin or insulin analog formulation (para. [0096], “potential bias of 180 mV … low bias also avoids the problem of electropolymerization …”). 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 applied bias potential to be of no more than +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to the reference electrode, as taught by Ward ‘542. This is because Ward ‘542 teaches a bias potential of 180 mV in combination with certain coatings allows for glucose to be accurately measured without interference from insulin preservatives (para. [0041]).
Regarding claim 84, modified Yang discloses the system of claim 80.
However, modified Yang does not explicitly disclose wherein the metal compound comprises a metal selected from the group consisting of: Osmium, Ruthenium, Palladium, Platinum, Rhodium, Iridium, Cobalt, Iron, and Copper.
Ward ‘542 further teaches the metal compound comprises a metal selected from the group consisting of: Osmium, Ruthenium, Palladium, Platinum, Rhodium, Iridium, Cobalt, Iron, and Copper (para. [0017], para. [0035], para. [0088], para. [0096]). 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 metal compound to explicitly be selected from the group consisting of: Osmium, Ruthenium, Palladium, Platinum, Rhodium, Iridium, Cobalt, Iron, and Copper, as taught by Ward ‘542. This is because Ward ‘542 teaches an osmium-based redox mediator allows for the sensor to operate at a low bis potential without interference from insulin preservatives, thereby producing an accurate glucose reading (para. [0017]).
Regarding claim 91, modified Yang discloses the method of claim 88, wherein the glucose sensor comprises an electrode layer comprising the at least one indicating electrode (Fig. 4, Fig. 9, Fig. 10, para. [0071], “glucose sensor may be a three electrode system …”, para. [0074], “three electrode system … working electrode …”), wherein the electrode layer underlies (2) an enzyme comprising glucose oxidase or glucose dehydrogenase (para. [0071], “glucose electrode sensor mainly includes an enzyme layer … glucose may occur an oxidation reaction under the catalysis of glucose oxidase … glucose oxidase is fixed on the surface of the platinum electrode …”).
Yang suggests the use of other layers by disclosing using an enzyme layer and a hydrogen peroxide electrode to detect the production of hydrogen peroxide to measure glucose (para. [0075]). However, modified Yang does not explicitly disclose the electrode layer underlies a redox-catalytic layer comprising (1) a redox mediator comprising a metal compound covalently bound to a ligand.
Ward ‘542 teaches of method of using an analogous insulin delivery cannula with electrodes to allow for continuous glucose sensing (Abstract). Ward ‘542 further teaches the sensor comprises a redox mediator comprising a metal compound covalently bound to ligand (para. [0017], para. [0035], para. [0088], para. [0096]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor taught by modified Yang to additionally include a redox-catalytic layer comprising (1) a redox mediator comprising a metal compound covalently bound to a ligand, as taught by Ward ‘542. This is because Ward ‘542 teaches osmium-based redox mediators that operate at a low bias potential allow for the sensor to operate correctly without interference from the insulin preservatives, thereby measuring an accurate glucose concentration (para. [0017]).
Regarding claim 92, modified Yang discloses the method of claim 91
However, modified Yang does not explicitly disclose wherein the glucose sensor further comprises an insulating layer and a metal layer, wherein the insulating layer is coupled to the metal layer, and wherein the metal layer is coupled to the electrode layer.
Ward ’542 further teaches the glucose sensor further comprises an insulating layer and a metal layer, wherein the insulating layer is coupled to the metal layer, and wherein the metal layer is coupled to the electrode layer (Fig. 10, para. [0030], para. [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the glucose sensor taught by modified Yang to additionally include an insulating layer and a metal layer, wherein the insulating layer is coupled to the metal layer, and wherein the metal layer is coupled to the electrode layer, as taught by Ward ‘542. This is because Ward ‘542 teaches a titanium foil laminated to a polyimide layer underlying the electrode layer produces a sensor that can be easily incorporated into the walls of a hollow needle or catheter (para. [0015]).
Regarding claim 93, modified Yang discloses the method of claim 91.
However, modified Yang does not explicitly disclose wherein the redox mediator and the enzyme allow electron transfer from subcutaneous glucose to the at least one indicating electrode sufficient to cause a response of the glucose sensor to a subcutaneous glucose concentration of the subject at an applied bias potential of no more than about +300 millivolts (mV), +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to a reference electrode.
Ward ‘542 further teaches the redox mediator and the enzyme allow electron transfer from subcutaneous glucose to the at least one indicating electrode sufficient to cause a response of the glucose sensor to a subcutaneous glucose concentration of the subject at an applied bias potential of no more than about +300 millivolts (mV), +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to a reference electrode (Fig. 4, para. [0024], para. [0027], para. [0039], para. [0041], “polarized at 180 mV … able to measure glucose with little or no interference from the preservatives …”, para. [0096]). 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 system disclosed by modified Yang to explicitly apply a bias potential of no more than about +300 millivolts (mV), +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to a reference electrode, as taught by Ward ‘542. This is because Ward ‘542 teaches a bias potential of 180 mV in combination with certain coatings allows for glucose to be accurately measured without interference from insulin preservatives (para. [0041]).
Regarding claim 94, modified Yang discloses the method of claim 93.
However, modified Yang does not explicitly disclose wherein the applied bias potential of no more than about +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to the reference electrode allows the electrode layer to undergo substantially no electropolymerization of the excipient during continuous operation of at least one hour of the amperometric glucose sensor, thereby maintaining a sensitivity of the amperometric glucose sensor to the subcutaneous glucose concentration in presence of the concentrated insulin or insulin analog formulation.
Ward ‘542 further teaches the applied bias potential of no more than about +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to the reference electrode allows the electrode layer to undergo substantially no electropolymerization of the excipient during continuous operation of at least one hour of the amperometric glucose sensor, thereby maintaining a sensitivity of the amperometric glucose sensor to the subcutaneous glucose concentration in presence of the concentrated insulin or insulin analog formulation (para. [0096], “potential bias of 180 mV … low bias also avoids the problem of electropolymerization …”). 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 applied bias potential to be of no more than +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to the reference electrode, as taught by Ward ‘542. This is because Ward ‘542 teaches a bias potential of 180 mV in combination with certain coatings allows for glucose to be accurately measured without interference from insulin preservatives (para. [0041]).
Regarding claim 95, modified Yang discloses the method of claim 91.
However, modified Yang does not explicitly disclose wherein the metal compound comprises a metal selected from the group consisting of: Osmium, Ruthenium, Palladium, Platinum, Rhodium, Iridium, Cobalt, Iron, and Copper.
Ward ‘542 further teaches the metal compound comprises a metal selected from the group consisting of: Osmium, Ruthenium, Palladium, Platinum, Rhodium, Iridium, Cobalt, Iron, and Copper (para. [0017], para. [0035], para. [0088], para. [0096]). 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 metal compound to explicitly be selected from the group consisting of: Osmium, Ruthenium, Palladium, Platinum, Rhodium, Iridium, Cobalt, Iron, and Copper, as taught by Ward ‘542. This is because Ward ‘542 teaches an osmium-based redox mediator allows for the sensor to operate at a low bis potential without interference from insulin preservatives, thereby producing an accurate glucose reading (para. [0017]).
Response to Arguments
Applicant’s arguments, see pages 6-10 of Remarks, filed 08/29/2025, with respect to the rejection of independent claims 77-78, 8-89, and 91-100 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 Cuijun Yang (US 20160136357 A1), hereinafter referred to as Yang.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791