DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement (IDS)
US Patent Application Publication citation 4 on the IDS submitted 04 March 2026 has not been considered, as indicated in the annotated copy of said IDS mailed herewith, because the information provided for this citation is inconsistent. US 2018/0251958 A1 was not published on 07 September 2017, and does not name "Pushpala" as an Applicant or inventor. Accordingly, it is unclear if US 2018/0251958 A1 was meant to be cited, or another US application publication having the publication date and/or name information listed on the IDS.
Response to Amendment
The amendment to the claims filed 04 March 2026 has been entered. Claim(s) 21 and 44 is/are currently amended. Claim(s) 1-20, 29, 32, 34-35, 38 and 48-51 has/have been canceled. Claim(s) 21-28, 30-31, 33, 36-37 and 39-47 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 103
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 negatived 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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 21-22, 24-25, 27-28, 30-31, 36-37, 39, 44-45 and 47 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2008/0033269 A1 (previously cited, Zhang) in view of US 2004/0111017 A1 (previously cited, Say); or alternatively, over Zhang in view of Say and US 2011/0042241 A1 (previously cited, Kotsis).
Regarding claim 21, Zhang teaches/suggests an analyte sensor for measuring an analyte in a biological fluid of a user, the analyte sensor comprising:
a supporting substrate (base 1) comprising a top skin-facing surface (surface 11'), a bottom surface opposite the top skin-facing surface (surface 12'), and a thickness there between (e.g., Fig. 1);
an array of electrically-conductive probes (Abstract, needle-shaped electrodes made of conducting materials; e.g., Fig. 1, 401-402 and/or 401'-403'), each electrically-conductive probe extending perpendicularly from the bottom surface of the supporting substrate through the thickness of the supporting substrate and past the top skin-facing surface of the supporting substrate (see, e.g., Fig. 1); and
an array of conductors, wherein each conductor is coupled to a corresponding electrically-conductive probe at the bottom surface of the supporting substrate (connection plates/contact means 21-22 and/or 21'-23'),
wherein at least one electrically-conductive probe includes a working electrode comprising a coating configured to interact with the analyte and produce an electrical sensing signal that transfers through the at least one electrically-conductive probe to a corresponding conductor (Fig. 1, anode 401, 401'; ¶¶ [0013]-[0015] at least one electrode is an anode having a biosensing layer including an inner layer containing an enzyme; ¶ [0034] indicating electrode; ¶ [0045]; ¶ [0047]; etc.);
wherein at least one electrically-conductive probe includes a counter electrode (Fig. 1, cathode 402, 402'; ¶ [0013] wherein at least one electrode is a cathode; ¶ [0034] counter electrode; clm. 20; assisting cathode; etc.),
wherein at least one electrically-conductive probe includes a reference electrode (Fig. 1, cathode 403'; ¶ [0035] three-electrode system including a reference electrode; col. 20, referencing cathode; etc.).
Zhang further discloses at least a portion of each of the working, counter and reference electrodes extending past the top skin-facing surface of the supporting substrate is covered by a material (¶ [0015] biocompatible polymers possessing molecular diffusion limiting characteristics; ¶¶ [0047]-[0048] each of the anode(s) and cathode(s) comprises a polymer diffusion membrane; etc.). Zhang does not expressly disclose said material is a nonconductive material. Further, Zhang does not disclose the analyte interacts with the working electrode at a portion thereof uncovered by the nonconductive material.
Say discloses a sensor (e.g., Fig. 3) comprising at least one electrically-conductive probe including a working electrode (conductive central rod or wire that serves as the working electrode 304) comprising a coating configured to interact with an analyte and produce an electrical sensing signal (sensing layer 334 coated on the rod or wire 304; ¶ [0035]); and a nonconductive material covering at least a portion of the electrically-conductive probe (outer, insulating layer 352 coated on top of the sensing layer 33). Say discloses the outer/insulating material possesses molecular diffusion limiting characteristics, i.e., is impervious to the analyte (¶ [0009]; claim 20), such that the analyte interacts with the working electrode at a portion of working electrode via an opening in the non-conductive material (¶ [0051] sensing layer and working electrode are exposed at the distal edge 324 (i.e., uncovered by layer 352), such that they come into contact with fluid to be measured when the sensor is inserted; ¶ [0041] sensing positions may include recesses in the external perimeter of the sensor; etc.). Further, Say discloses said nonconductive material may additionally be provided around a counter and/or reference electrode of the sensor (e.g., Fig. 4; ¶ [0052] counter and/or reference electrode 408 are formed in insulating outer layer 452).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with at least a portion of each of the electrically-conductive probes extending past the top skin-facing surface of the substrate being covered by a non-conductive material, such that the analyte interacts with the working electrode via an opening in the nonconductive material, as taught and/or suggested by Say in order to address a fundamental constraint on subcutaneous analyte glucose sensors based on peroxide detection, namely the dependence of the signal on a stoichiometrically adequate supply of oxygen to the coating (sensing layer) by allowing limited analyte flux to the coating via an edge(s) of the sensor and enhanced oxygen flux to the coating via the nonconductive material (top layer) and through the sensor edge (Say, ¶ [0046]).
Zhang as modified does not expressly describe each of the electrically-conductive probes and corresponding conductors of the array as individually addressable. However, the above-noted limitation does not require that each electrically-conductive probe is individually addressed, or any element of the sensor is configured to individually address each probe. Rather, the limitation only requires that each probe is capable of being individually addressed. Since Zhang discloses each probe comprises an individual contact (connection plates/contact means 21-22 and/or 21'-23') provided on an electrically insulating substrate (¶ [0051]; claim 7; etc.), the structure disclosed by Zhang allows electrical connection to be made to each probe individually. This understanding or interpretation is supported by, e.g., Kotsis, which discloses electrodes are individually addressable if said electrodes have individual contacts to allow electrical connection to be made to them individually (e.g., ¶ [0033]). Accordingly, one of ordinary skill in the art would readily appreciate the structure taught/suggested by Zhang as modified meets the above-noted limitation.
Alternatively/Additionally, Zhang discloses the sensor may comprise additional (i.e., more than three) probes/electrodes (¶ [0013] more than one anode(s) and/or cathode(s)). Kotsis teaches and/or suggests a sensor (Fig. 4b) comprising an array of electrically-conductive probes (electrodes 118a-c) and corresponding conductors (¶ [0056] individual conductive tracks leading to respective terminals 120), wherein each of the electrically-conductive probes and corresponding conductors of the array is individually addressable (¶ [0057]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with the array of probes comprising multiple electrodes (e.g., a plurality of anodes/working electrodes configured to measure glucose concentration, as described in ¶¶ [0047]-[0050] of Zhang), wherein each of the electrically-conductive probes and corresponding conductors are individually addressable as taught/suggested by Kotsis in order to allow multiple simultaneous glucose measurements to be made, providing a very high measurement accuracy (Kotsis, ¶ [0057]).
Regarding claim 22, Zhang as modified teaches/suggests the analyte sensor is integrated into an adhesive patch for placement on skin (Fig. 1c, ¶ [0064] medical adhesive tape 3 fixed to the planar bottom of the base 1 for affixing the sensor base to the skin).
Regarding claim 24, Zhang as modified teaches and/or suggests the biological fluid is extracellular or interstitial fluid, (¶ [0047] tissue fluid).
Regarding claim 25, Zhang as modified teaches/suggests an electrochemical interaction between the analyte and working electrode is detectable using amperometry, voltammetry, or potentiometry (¶ [0047]; ¶ [0020]; etc.).
Regarding claims 27-28, Zhang as modified teaches and/or suggests the coating includes an entrapped biocatalyst, such as glucose oxidase (e.g., ¶ [0056]).
Regarding claim 30, Zhang as modified teaches/suggests each conductor is configured to transmit the sensing signal produced by the respective electrically-conductive probe to a sensor circuit for processing (e.g., ¶ [0045]).
Regarding claim 31, Zhang as modified teaches and/or suggests each of the electrically-conductive probes of the array is solid (e.g., ¶ [0033]).
Regarding claim 36, Zhang as modified teaches/suggests teaches the analyte includes a biochemical and/or a metabolite (e.g., glucose, throughout document).
Regarding claim 37, Zhang as modified teaches/suggests the working electrode comprises platinum (e.g., ¶ [0014]).
Regarding claim 39, Zhang as modified teaches and/or suggests the at least one electrically-conductive probe is insulated within the supporting substrate (e.g., ¶ [0051] the base is insulating).
Regarding claim 44, Zhang teaches/suggests a method for measuring an analyte within a biological fluid comprising:
providing an analyte sensor integrated with an adhesive patch (e.g., Fig. 1c; assembly 10'', or medical adhesive tape 3'' thereof), the analyte sensor comprising:
a supporting substrate (base 1) comprising a top skin-facing surface (surface 11'), a bottom surface opposite the top skin-facing surface (surface 12'), and a thickness there-between (e.g., Fig. 1);
an array of electrically-conductive probes (Abstract, needle-shaped electrodes made of conducting materials; e.g., Fig. 1, 401-402 and/or 401'-403'), each electrically-conductive probe extending perpendicularly from the bottom surface of the supporting substrate through the thickness of the supporting substrate and past the top skin-facing surface of the supporting substrate (see, e.g., Fig. 1); and
an array of conductors, wherein each conductor is coupled to a corresponding electrically-conductive probe at the bottom surface of the supporting substrate (connection plates and/or contact means 21-22 and/or 21'-23'),
wherein at least one electrically-conductive probe includes a working electrode comprising a coating configured to interact with the analyte and produce an electrical sensing signal that transfers through the at least one electrically-conductive probe to a corresponding conductor (Fig. 1, anode 401, 401'; ¶¶ [0013]-[0015] at least one electrode is an anode having a biosensing layer including an inner layer containing an enzyme; ¶ [0034] indicating electrode; ¶ [0045]; ¶ [0047]; etc.),
wherein at least one electrically-conductive probe includes a counter electrode (Fig. 1, cathode 402, 402'; ¶ [0013] wherein at least one electrode is a cathode; ¶ [0034] counter electrode; clm. 20; assisting cathode; etc.),
wherein at least one electrically-conductive probe includes a reference electrode (Fig. 1, cathode 403'; ¶ [0035] three-electrode system including a reference electrode; col. 20, referencing cathode; etc.);
placing the adhesive patch on skin to transdermally contact the array of electrically-conductive probes of the analyte sensor with the biological fluid (¶ [0064] where the needles are directly inserted into the skin and the adhesive tape affixes the sensor base to the skin);
applying an electrical stimulus signal to the at least one electrically-conductive probe (¶ [0047], ¶ [0064] applying a voltage/polarizing at 0.5-0.6V);
measuring a resultant sensing signal arising by an interaction between the coating on the working electrode and the analyte in the biological fluid (¶ [0047], ¶ [0064] measuring the current formed in the electrode circuit); and
determining a concentration of the analyte based on the sensing signal (¶ [0064] the current is converted into concentration information), wherein the sensing signal is transferred through the at least one electrically-conductive probe to the corresponding conductor (¶ [0045]).
Zhang further discloses at least a portion of each of the working, counter and reference electrodes extending past the top skin-facing surface of the supporting substrate is covered by a material (¶ [0015] biocompatible polymers possessing molecular diffusion limiting characteristics; ¶¶ [0047]-[0048] each of the anode(s) and cathode(s) comprises a polymer diffusion membrane; etc.). Zhang does not expressly disclose said material is a nonconductive material. Further, Zhang does not disclose the analyte interacts with the working electrode via an opening in the non-conductive material.
Say discloses a sensor (e.g., Fig. 3) comprising at least one electrically-conductive probe including a working electrode (conductive central rod or wire that serves as the working electrode 304) comprising a coating configured to interact with an analyte and produce an electrical sensing signal (sensing layer 334 coated on the rod or wire 304; ¶ [0035]); and a nonconductive material covering at least a portion of the electrically-conductive probe (outer, insulating layer 352 coated on top of the sensing layer 33). Say discloses the outer/insulating material possesses molecular diffusion limiting characteristics, i.e., is impervious to the analyte (¶ [0009]; claim 20), such that the analyte interacts with the working electrode at a portion thereof uncovered by the non-conductive material (¶ [0051] sensing layer and working electrode are exposed at the distal edge 324 (i.e., uncovered by layer 352), such that they come into contact with fluid to be measured when the sensor is inserted; ¶ [0041] sensing positions may include recesses in the external perimeter of the sensor; etc.). Further, Say discloses said nonconductive material may additionally be provided around a counter and/or reference electrode of the sensor (e.g., Fig. 4; ¶ [0052] counter and/or reference electrode 408 are formed in insulating outer layer 452).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with at least a portion of each of the electrically-conductive probes extending past the top skin-facing surface of the substrate being covered by a non-conductive material, such that the analyte interacts with the working electrode via an opening in nonconductive material, as taught/suggested by Say in order to address a fundamental constraint on subcutaneous glucose sensors based on peroxide detection, namely the dependence of the signal on a stoichiometrically adequate supply of oxygen to the coating (sensing layer) by allowing limited analyte flux to the coating via an edge of the sensor and enhanced oxygen flux to the coating via the nonconductive material (top layer) and through the sensor edge (Say, ¶ [0046]).
Zhang as modified does not expressly describe each of the electrically-conductive probes and corresponding conductors of the array as individually addressable. However, the above-noted limitation does not require that each electrically-conductive probe is individually addressed, or any element of the sensor is configured to individually address each probe. Rather, the limitation only requires that each probe is capable of being individually addressed. Since Zhang discloses each probe comprises an individual contact (connection plates/contact means 21-22 and/or 21'-23') provided on an electrically insulating substrate (¶ [0051]; claim 7; etc.), the structure disclosed by Zhang allows electrical connection to be made to each probe individually. This understanding or interpretation is supported by, e.g., Kotsis, which discloses electrodes are individually addressable if said electrodes have individual contacts to allow electrical connection to be made to them individually (e.g., ¶ [0033]). Accordingly, one of ordinary skill in the art would readily appreciate the structure taught/suggested by Zhang as modified meets the above-noted limitation.
Alternatively/Additionally, Zhang discloses the sensor may comprise additional (i.e., more than three) probes/electrodes (¶ [0013] more than one anode(s) and/or cathode(s)). Kotsis teaches and/or suggests a sensor (Fig. 4b) comprising an array of electrically-conductive probes (electrodes 118a-c) and corresponding conductors (¶ [0056] individual conductive tracks leading to respective terminals 120), wherein each of the electrically-conductive probes and corresponding conductors of the array is individually addressable (¶ [0057]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with the array of probes comprising multiple electrodes (e.g., a plurality of anodes/working electrodes configured to measure glucose concentration, as described in ¶¶ [0047]-[0050] of Zhang), wherein each of the electrically-conductive probes and corresponding conductors are individually addressable as taught/suggested by Kotsis in order to allow multiple simultaneous glucose measurements to be made, providing a very high measurement accuracy (Kotsis, ¶ [0057]).
Regarding claim 45, Zhang as modified teaches/suggests the biological fluid is interstitial fluid, (¶ [0047] tissue fluid).
Regarding claim 47, Zhang as modified teaches/suggests the electrically-conductive probes are insulated within the supporting substrate (e.g., ¶ [0051] the base is insulating).
Claim(s) 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zhang in view of Say (or Zhang in view of Say and Kotsis) as applied to claim 22 above, and further in view of US 2003/0100040 A1 (previously cited, Bonnecaze).
Regarding claim 23, Zhang as modified teaches/suggests the limitations of claim 22, as discussed above, and further discloses analyte concentration information may be recorded by an external electronic device for display and analysis (e.g., ¶ [0064]), but does not expressly teach the adhesive patch is integrated with electronics configured for communication.
Bonnecaze teaches/suggests an analyte sensor (sensor 42) integrated into an adhesive patch (mounting unit 77; ¶ [0242]) for placement on skin, wherein the adhesive patch is integrated with electronics configured for communication (control unit 44 or housing 45 containing the electronic components; ¶ [0266] where said electronic components may include transmitter 98).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with the adhesive patch being integrated with electronics for communication as taught and/or suggested by Bonnecaze in order to facilitate communication to an external electronic device for recording, displaying, analyzing, etc. analyte information (Zhang, ¶ [0064]; Bonnecaze, ¶ [0344]; etc.).
Claim(s) 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zhang in view of Say (or Zhang in view of Say and Kotsis) as applied to claim(s) 21 above, and further in view of US 2010/0025238 A1 (previously cited, Gottlieb).
Regarding claim 26, Zhang as modified teaches/suggests the limitations of claim 21, as discussed above, but does not expressly teach a first electrically-conductive probe of the array is configured to detect a first analyte and a second electrically-conductive probe of the array is configured to detect a second, different analyte. However, as noted above, Zhang as modified does disclose the analyte sensor may comprise multiple electrodes (e.g., ¶ [0013]) and suggests more than one analyte that may be monitored by the system by functionalizing an electrode/anode with an appropriate biocatalyst (e.g., ¶ [0056], glucose, alcohol, lactate and/or cholesterol oxidase). Similarly, Kotsis discloses a plurality of electrodes for sensing different analytes may be provided in a sensor array (¶¶ [0026]-[0027]).
Gottlieb teaches/suggests an analyte sensor comprising a first electrically-conductive probe of configured to detect a first analyte and a second electrically-conductive probe configured to detect a second, different analyte (¶ [0207] multiple working, counter and reference electrodes for measuring multiple analytes).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with a first electrically-conductive probe of the array being configured to detect a first analyte and a second electrically-conductive probe of the array being configured to detect a second, different analyte as taught/suggested by Gottlieb in order to provide a linear response, ease in calibration and/or recalibration, etc. (Gottlieb, ¶ [0207]).
Claim(s) 33 and 46 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being un-patentable over Zhang in view of Say (or Zhang in view of Say and Kotsis) as applied to claim(s) 21 and 45 above, and further in view of US 2011/0196216 A1 (previously cited, Quarder).
Regarding claims 33 and 46, Zhang as modified teaches and/or suggests the limitations of claims 21 and 45, as discussed above, and further teaches/suggests the coating comprises an entrapped biocatalyst (e.g., ¶ [0056]), but does not expressly teach the coating (i.e., inner/enzyme layer) comprises a conducting polymer with an/the entrapped biocatalyst.
Quarder teaches/suggests an analyte sensor comprising an electrode (¶ [0003]; Fig. 2; etc., working electrode) comprising a coating configured to interact with the analyte and produce an electrical sensing signal (¶ [0003]; Fig. 2; etc., electrically conductive enzyme layer), wherein the coating comprises a conducting polymer with an entrapped biocatalyst (¶ [0043] enzyme layer 5 contains immobilized enzyme molecules for catalytic conversion of the analyte, wherein the enzyme layer 5 can be applied in the form of a curing paste of carbon particles, a polymeric binding agent, and enzyme molecules; ¶ [0005]; etc.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with the coating comprising a conducting polymer with the entrapped biocatalyst as taught/suggested by Quarder in order to allow charge carriers that are released to be detected as measuring signal as completely as possible (Quarder, ¶ [0004]) and/or as a simple substitution of one suitable enzyme layer that catalyzes an electrochemical reaction with an analyte to permit measurement of a concentration of said analyte for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 40-41 and 43 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being un-patentable over Zhang in view of Say and Quarder; or alternatively, over Zhang in view of Say, Quarder and Kotsis.
Regarding claim 40, Zhang teaches/suggests an analyte sensor for transdermally measuring an analyte in an interstitial fluid of a user, the analyte sensor comprising:
a supporting substrate (base 1) comprising a top skin-facing surface (surface 11'), a bottom surface opposite the top skin-facing surface (surface 12'), and a thickness there between (e.g., Fig. 1);
an array of solid electrically-conductive probes (Abstract, needle-shaped electrodes made of conducting materials; e.g., Fig. 1, 401-402 and/or 401'-403'; ¶ [0033] where the electrodes may have rigid metal cores), each solid electrically-conductive probe extending perpendicularly from the bottom surface of the supporting substrate through the thickness of the supporting substrate and past the top skin-facing surface of the supporting substrate (see, e.g., Fig. 1); and
an array of conductors, wherein each conductor is coupled to a corresponding solid electrically-conductive probe at the bottom surface of the supporting substrate (connection plates or contact means 21-22 and/or 21'-23'),
wherein at least one solid electrically-conductive probe includes a platinum working electrode disposed on a surface of the at least one electrically-conductive probe (¶ [0014] where the anode/indicating electrode comprises a platinum layer), wherein the platinum working electrode comprises a coating including an entrapped biocatalyst (¶¶ [0014]-[0015] wherein at least one electrode is an anode having a biosensing layer including an inner layer containing an enzyme; ¶ [0056]) and is configured to interact with the analyte and produce an electrical sensing signal that transfers through the at least one solid electrically-conductive probe to a corresponding conductor (¶ [0045]; ¶ [0047]; etc.).
Zhang further discloses at least a portion of each electrically-conductive probe extending past the top skin-facing surface of the substrate is covered by a material (¶ [0015] biocompatible polymers possessing molecular diffusion limiting characteristics; ¶¶ [0047]-[0048] each of the anode and cathode comprises the polymer diffusion membrane; etc.). Zhang does not expressly disclose said material is a nonconductive material. Further, Zhang does not disclose the analyte interacts with interacts with the platinum working electrode via an opening in the nonconductive material.
Say discloses a sensor (e.g., Fig. 3) comprising at least one electrically-conductive probe including a platinum working electrode (conductive central rod or wire that serves as the working electrode 304; ¶ [0032]) comprising a coating configured to interact with an analyte and produce an electrical sensing signal (sensing layer 334 coated on the rod/wire 304; ¶ [0035]); and a non-conductive material covering a portion of the electrically-conductive probe (outer, insulating layer 352 coated on top of the sensing layer 33). Say discloses the outer/insulating material possesses molecular diffusion limiting characteristics, i.e., is impervious to the analyte (¶ [0009]; claim 20), such that the analyte interacts with the working electrode at an opening in the non-conductive material (¶ [0051] sensing layer and working electrode are exposed at the distal edge 324 (i.e., having no layer 352), such that they come into contact with fluid to be measured when the sensor is inserted; ¶ [0041] sensing positions may include recesses in the external perimeter of the sensor; etc.). Further, Say discloses said nonconductive material may additionally be provided around a counter/reference electrode of the sensor (e.g., Fig. 4; ¶ [0052] counter and/or reference electrode 408 are formed in insulating outer layer 452).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with at least a portion of each of the electrically-conductive probes extending past the top skin-facing surface of the substrate being covered by a non-conductive material, such that the analyte interacts with interacts with the working electrode via an opening in the nonconductive material, as taught and/or suggested by Say in order to address a fundamental constraint on subcutaneous glucose sensors based on peroxide detection, namely the dependence of the signal on a stoichiometrically adequate supply of oxygen to the coating (sensing layer) by allowing limited analyte flux to the coating via an edge of the sensor and enhanced oxygen flux to the coating via the nonconductive material (top layer) and through the sensor edge (Say, ¶ [0046]).
Zhang as modified does not expressly teach the coating (inner/enzyme layer) comprises a conducting polymer with an/the entrapped biocatalyst.
Quarder teaches/suggests an analyte sensor comprising an electrode (¶ [0003]; Fig. 2; etc., working electrode) comprising a coating configured to interact with the analyte and produce an electrical sensing signal (¶ [0003]; Fig. 2; etc., electrically conductive enzyme layer), wherein the coating comprises a conducting polymer with an entrapped biocatalyst (¶ [0043] enzyme layer 5 contains immobilized enzyme molecules for catalytic conversion of the analyte, wherein the enzyme layer 5 can be applied in the form of a curing paste of carbon particles, a polymeric binding agent, and enzyme molecules; ¶ [0005]; etc.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with the coating comprising a conducting polymer with the entrapped biocatalyst as taught/suggested by Quarder in order to allow charge carriers that are released to be detected as measuring signal as completely as possible (Quarder, ¶ [0004]) and/or as a simple substitution of one suitable enzyme layer that catalyzes an electrochemical reaction with an analyte to permit measurement of a concentration of said analyte for another to yield no more than predictable results. See MPEP 2143(I)(B).
Zhang as modified does not expressly describe each of the electrically-conductive probes and corresponding conductors of the array as individually addressable. However, the above-noted limitation does not require that each electrically-conductive probe is individually addressed, or any element of the sensor is configured to individually address each probe. Rather, the limitation only requires that each probe is capable of being individually addressed. Since Zhang discloses each probe comprises an individual contact (connection plates/contact means 21-22 and/or 21'-23') provided on an electrically insulating substrate (¶ [0051]; claim 7; etc.), the structure disclosed by Zhang allows electrical connection to be made to each probe individually. This understanding or interpretation is supported by, e.g., Kotsis, which discloses electrodes are individually addressable if said electrodes have individual contacts to allow electrical connection to be made to them individually (e.g., ¶ [0033]). Accordingly, one of ordinary skill in the art would readily appreciate the structure taught/suggested by Zhang as modified meets the above-noted limitation.
Alternatively/Additionally, Zhang discloses the sensor may comprise additional (i.e., more than three) probes/electrodes (¶ [0013] more than one anode(s) and/or cathode(s)). Kotsis teaches and/or suggests a sensor (Fig. 4b) comprising an array of electrically-conductive probes (electrodes 118a-c) and corresponding conductors (¶ [0056] individual conductive tracks leading to respective terminals 120), wherein each of the electrically-conductive probes and corresponding conductors of the array is individually addressable (¶ [0057]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with the array of probes comprising multiple electrodes (e.g., a plurality of anodes/working electrodes configured to measure glucose concentration, as described in ¶¶ [0047]-[0050] of Zhang), wherein each of the electrically-conductive probes and corresponding conductors are individually addressable as taught/suggested by Kotsis in order to allow multiple simultaneous measurements to be made, providing a very high measurement accuracy (Kotsis, ¶ [0057]).
Regarding claim 41, Zhang as modified teaches/suggests the analyte sensor is integrated into an adhesive patch for placement on skin (Fig. 1c, ¶ [0064] medical adhesive tape 3 fixed to the planar bottom of the base 1 for affixing the sensor base to the skin).
Regarding claim 43, Zhang as modified teaches/suggests the solid electrically-conductive probes are insulated within the supporting substrate (e.g., ¶ [0051] the base is insulating).
Claim(s) 42 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zhang in view of Say and Quarder (or Zhang in view of Say, Quarder and Kotsis) as applied to claim(s) 41 above, and further in view of Bonnecaze.
Regarding claim 42, Zhang as modified teaches/suggests the limitations of claim 41, as discussed above, and further discloses analyte concentration information may be recorded by an external electronic device for display and analysis (e.g., ¶ [0064]), but does not expressly teach the adhesive patch is integrated with electronics configured for communication.
Bonnecaze teaches/suggests an analyte sensor (sensor 42) integrated into an adhesive patch (mounting unit 77; ¶ [0242]) for placement on skin, wherein the adhesive patch is integrated with electronics configured for communication (control unit 44 or housing 45 containing the electronic components; ¶ [0266] where said electronic components may include transmitter 98).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the analyte sensor of Zhang with the adhesive patch being integrated with electronics for communication as taught and/or suggested by Bonnecaze in order to facilitate communication to an external electronic device for recording, displaying and/or analyzing analyte information (Zhang, ¶ [0064]; Bonnecaze, ¶ [0344]; etc.).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 21 and 44 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 2 of US 9,737,247 in view of Zhang and Kotsis.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of US 9,737,247 recites each limitation of claims 21 and 44 of the present application with the exception of the claimed substrate, the claimed arrangement of the array of electrically-conductive probes, and array of conductors on the substrate, the electrically-conductive probes including at least one counter and reference electrode, and an explicit recitation that the probes and conductors individually addressable. However, as discussed above with respect to the prior art rejections, Zhang teaches/suggests the claimed arrangement of the array of probes and respective conductors on the substrate, such that it would have been obvious to modify the device of claim 2 of US 9,737,247 with these features as a simple substitution of one suitable means/arrangement for connecting protruding electrically-conductive probes with a respective plurality of conductors for another to yield no more than predictable results. See MPEP 2143(I)(B). Additionally, Zhang further discloses a three-electrode system including a counter and reference electrode is suitable for a long-term application (¶ [0035]), such that it would have been obvious to modify the device of claim 2 of US 9,737,247 with the probes including at least one counter and reference electrode in order to enable long-term use of the device. Furthermore, Kotsis teaches and/or suggests at least one benefit to having individually addressable probes and conductors, such that it would have been obvious to modify the device of claim 2 of US 9,737,247 with the probes and/or conductors being individually addressable in order to allow a plurality of simultaneous measurements of an analyte concentration, thereby providing a more accurate measurement.
Claim(s) 21 and 44 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 12 of US 9,743,870 in view of Zhang, US 2004/0146611 A1 (previously cited, Arias) and Kotsis.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of US 9,743,870 recites each limitation of claims 21 and 44 of the present application with the exception of the claimed arrangement of the array of electrically-conductive probes and array of conductors on the substrate and the electrically-conductive probes including at least one counter and reference electrode. However, as discussed above with respect to the prior art rejections, Zhang teaches/suggests these elements, such that it would have been obvious to modify the device of claim 12 of US 9,743,870 with these features as a simple substitution of one suitable means/arrangement for connecting protruding electrically-conductive probes with a respective plurality of conductors for another to yield no more than predictable results and/or to enable long-term use of the device. Additionally, though claim 12 of US 9,743,870 does not recite the microneedles covering the probes are non-conductive/insulating, claim 12 of US 9,743,870 does recite the microneedles are made of a polymer, which one of ordinary skill in the art would readily appreciate are typically non-conductive/electrically insulating. Alternatively/Additionally, Arias teaches/suggests providing a non-conductive/insulating material around at least a portion of electrode configured to interact with an analyte to produce an electrical sensing signal (¶ [0156]), such that it would have been obvious to modify the device of claim 12 of US 9,743,870 with at least a portion of at least one of the electrically-conductive, functionalized probes being covered by a nonconductive or insulating material as taught and/or suggested by Arias in order to facilitate insulating the conductive components of the device from each other (Arias, ¶ [0156]). Lastly, claim 12 of US 9,743,870 does not explicitly recite that the electrodes and conductive structures are individually addressable. However, Kotsis teaches and/or suggests at least one benefit to having individually addressable electrodes and conductors, such that it would have been obvious to modify the device of claim 12 of US 9,743,870 with the probes/conductors being individually addressable for at least the reasons noted above.
Claim(s) 21 and 44 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of US 10,136,846 in view of Zhang, Arias and Kotsis
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of US 10,136,846 recites each limitation of claims 21 and 44 of the present application with the exception of the claimed arrangement of the array of electrically-conductive probes and array of conductors on the substrate and the device comprising a plurality of probes and/or conductors, wherein the plurality of probes include a counter and reference electrode(s). However, as discussed above with respect to the prior art rejections, Zhang teaches/suggests these elements, such that it would have been obvious to modify the device of claim 1 of US 10,136,846 with these features as a simple substitution of one suitable means or arrangement for connecting protruding electrically-conductive probes with a respective plurality of conductors for another to yield no more than predictable results, to enable long-term use of the device and/or an additional anode/working electrode for sensing analyte(s), etc. Additionally, claim 1 of US 10,136,846 does not expressly recite at least a portion of the probe is covered by a nonconductive/insulating material. However, Arias teaches/suggests providing a non-conductive/insulating material around at least a portion of electrode configured to interact with an analyte to produce an electrical sensing signal (¶ [0156]), such that it would have been obvious to modify the device of claim 12 of US 9,743,870 with at least a portion of at least one of the electrically-conductive, functionalized probes being covered by a nonconductive or insulating material as taught and/or suggested by Arias in order to facilitate insulating the conductive components of the device from each other (Arias, ¶ [0156]). Lastly, claim 1 of US 10,136,846 does not expressly recite the probes and conductors individually addressable. However, Kotsis discloses at least one benefit to having individually addressable probes and conductors, such that it would have been obvious to modify the device of claim 12 of US 9,743,870 with the probes/conductors being individually addressable for at least the reasons noted above.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to independent claims 21, 40 and 44, Applicant contends a person of ordinary skill in the art (POSITA) would have no motivation to combine Zhang and Say in the manner proposed. Specifically, Applicant contends, "Introducing an opening into Zhang's continuous biosensing layer per Say's edge-based sensing design approach would violate Zhang's stated principle for subcutaneous analyte sensing: 'implanted needle shaped sensors, with minimal diameter and large sensing surface area.' Zhang, ¶ [0011]. Moreover, without full coverage by the sensing layer, Zhang's other design principle of biocompatibility could be compromised, thereby inviting undesired tissue reaction, biofouling, and/or molecular interference. Id., ¶ [0007]. A POSITA would have recognized Zhang's needle structure and biocompatible chemical layer formulation are meant to act together as an uninterrupted system" (Remarks, pgs. 8-9).
The examiner respectfully disagrees. Firstly, the proposed modification is not to "introduce an opening into Zhang's continuous biosensing layer." Rather, the proposed modification is to utilize a nonconductive material having an opening(s) through which an analyte of interest interacts with the working electrode via a sensing/enzyme layer as disclosed by Say as an alternative to the outer layer of the bio-sensing layer disclosed by Zhang. Zhang discloses the outer layer possesses molecular diffusion limiting characteristics (e.g., ¶ [0015]), and to create such a layer requires mixing different polymers, preparing a membrane, membrane re-structuring, etc., (e.g., ¶ [0056]-[0063]). Say discloses sensor/layer geometry commensurate in scope with the structure as claimed (i.e., nonconductive material having an opening(s) through which an analyte of interest interacts with the working electrode via a sensing/enzyme layer) eliminates the need for creating a mass transport limiting membrane with reproducible analyte mass transport characteristics (¶¶ [0063]-[0064]), comparable to the bio-sensing layer (or outer layer thereof) disclosed by Zhang. Further, Say discloses the non-conductive material, like the outer layer of the bio-sensing layer of Zhang, is biocompatible (e.g., ¶ [0037]). Accordingly, there is no reasonable basis to conclude the proposed combination would compromise sensor biocompatibility, as Applicant asserts.
Applicant further contends, "Zhang expressed clear reasons against sensor designs, like Say's sensor, that 'feature a very small active sensing area [where the] majority of the implanted arts only serves as the supporting body.' […] Long, continuously-coated needle electrodes that utilize the entire sensing area along the needle-not a 'very small' edge area like Say - was Zhang's solution to this problem. A POSITA would not have ignored Zhang's sensor design motivation and, from it, would be dissuaded to modify the sensor's architecture with Say's design principles that Zhang expressly described as being the very problem Zhang was designing around" (Remarks, pg. 10).
The examiner respectfully disagrees. The active sensing area of a sensor and the edge or recess by which analyte enters the sensor are not equivalent. Indeed, Say expressly discloses active sensing may occur beyond the edge/recess at which analyte is permitted to enter the sensor (e.g., ¶ [0067]). Further, there is no indication in Say that only a single opening (e.g., edge, recess, etc.) must be utilized. For example, Say discloses the opening may comprise recesses (plural) in the external perimeter of a sensor (e.g., ¶ [0041]). Say additionally discloses that the surface area of the opening is factor that can be controlled in the design of the sensor to provide a desired sensitivity (e.g., ¶ [0073]). A POSITA would not need to ignore Zhang's sensor design and/or considerations when modifying the sensor with Say's design principles, as in the modification as proposed. These considerations are not contradictory, as Applicant appears to contend. For example, given Zhang's disclosure of high molecular flux in a very small area causing sensor inaccuracy and instability, in combining the Zhang and Say, a POSITA may recognize that providing multiple openings/recesses having a combined surface area around the perimeter and/or along the length of the sensor may be more beneficial than providing a single opening of said surface area.
Lastly, Applicant submits, "Zhang teaches away from an analyte sensor having an electrically conductive probe where a portion of the probe that extends past a top skin-facing surface of the substrate is covered by a nonconductive material. […] Zhang […] makes clear that the objective of its design is to maximize the working electrode surface area for contact with the tissue and surrounding fluid. Any modification of Zhang's electrodes to provide a nonconducting material covering any portion of the electrodes extending from the bottom surface of Zhang's base, as recited in Claims 21, 40 and 44, would be directly counter to the teachings of Zhang and would disadvantageously make Zhang's electrodes less effective for their intended purpose" (Remarks, pg. 10).
It is unclear to the examiner how the above-noted objective of Zhang teaches away from any portion of the probe being nonconductive. While Zhang does not expressly disclose the bio-sensing layer (or outer layer thereof) is non-conductive, there is no indication in Zhang that every component of the working electrode, including the bio-sensing layer thereof, is conductive. Rather, Zhang expressly discloses the bio-sensing layer is formed of various polymers, with named exemplary polymers (e.g., ¶ [0059] polydimethylsiloxane) including those a person of ordinary skill in the art would readily recognize are inherently non-conductive unless specifically modified to conduct electricity (e.g., by embedding conductive material therein). As Zhang provides no indication the polymers or copolymers of the outer bio-sensing layer are modified to be conductive, Zhang appears to disclose the working electrode, or at least the outer layer thereof, may comprise a non-conductive material(s).
With respsect to the double patenting rejections, Applicant submits, "In light of the amendments to and corresponding remarks about Claims 21 and 44 above, Applicant respectfully requests the rejections based on non-statutory double patenting - which each rely on a combination with Zhang and Kotsi - be reconsidered. Upon reconsideration, if the Examiner believes that the pending claims are still subject to double patenting rejections, and upon an indication that the pending claims are otherwise in allowable condition, Applicant will consider filing a Terminal Disclaimer" (Remarks, pg. 11).
Applicant's remarks with respect to claims 21 and 44 address a combination of Zhang and Say, specifically a modification(s) to Zhang in view of the disclosure of Say, and Applicant's reasoning as to why said combination/modification(s) would not have been made or would not be obvious to make. However, the double patenting rejections do not rely on a combination of Zhang and Say, or modifying Zhang in view of Say, etc., such that it is unclear to the examiner how Applicant's remarks regarding claims 21 and 44 apply to the double patenting rejections.
Conclusion
THIS ACTION IS MADE FINAL. 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 Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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