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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 18th, 2026 has been entered.
Status of the Claims
Claims 1, 24, and 30 have been amended. Claims 9-20 have been previously canceled. Claims 1-8 and 21-30 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome all claim objections previously set forth in the previous Office Action.
All 35 U.S.C. § 103 rejections from the previous office action are essentially maintained and only modified in response to Applicant’s amendments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1-8 and 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US 20190265186 A1), Chen (US 20190090796 A1), and Duhamel (US 2017/0238851 A1).
Regarding Claim 1, Shah teaches a sensor assembly (sensor assembly 10 in Figure 1A [para. 0021]), comprising:
a substrate (working conductor 104 in Figs. 1B and 1C [para. 0023]) being electrically conductive (working conductor 104 is an electrically conductive material [para. 0024]);
an electrode surface (reactive surface 116 in Fig. 1B [para. 0024]) disposed on the substrate (as illustrated in Fig. 1B, reactive surface 116 is disposed on working conductor 104);
a first transport material (first transport material 108 in Figs. 1B and 1C [para. 0025]) disposed over the electrode surface (as illustrated in Figs. 1B and 1C, first transport material 108 is disposed over the electrode surface) and extending from a peripheral edge region toward a region above the electrode surface (as illustrated in Fig. 1B and Fig. 1C, first transport material 108 extends from edge 14a to edge 14b toward a region above reactive surface 116 [para. 0025]); and
a first reactive chemistry (first reactive chemistry 110 in Figs. 1B and 1C [para. 0027]; the first reactive chemistry can be selected from a family of dehydrogenase chemistries [Claim 17]) disposed above the electrode surface (as illustrated in Figs. 1B and 1C, first reactive chemistry 110 is disposed substantially over reactive surface 116); the limitation “the first reactive chemistry configured to react with the analyte to produce a target species, wherein the target species is electrochemically reduced on the electrode surface to generate an electrical signal representative of a presence on the electrode surface to generate an electrical signal representative of a presence of the target species” is a functional limitation. is a functional limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, as evidenced by Duhamel, glucose oxidase can be selected as the first reactive chemistry and is used in sensors along with hydrogels in the detection of glucose (Duhamel, [paras. 0013, 0050]). Glucose oxidase generates an intermediary hydrogen peroxide, and the hydrogen peroxide concentration can be measured to give a representative signal of glucose (Duhamel, [para. 0025]). Thus, the sensor assembly 10 of Shah is capable of performing the claimed function above.
Shah is silent on a masking disposed on the substrate, the masking forming a window in which the electrode surface is positioned;
a first transport material disposed over the masking, the first transport material having a decreasing thickness profile that decreases from the peripheral edge region toward the region above the electrode surface to a minimum thickness at a boundary of the window such that an effective diffusional cross-section for transport of an analyte through the first transport material decreases along a lateral path toward the window;
wherein the first transport material defines a throat region at the boundary of the window having a cross-sectional area smaller than at the peripheral edge region, the throat region being configured to restrict lateral flux of the analyte into the window; and
wherein the decreasing thickness profile imposes a mass-transfer limitation on the analyte proximate the electrode surface to control and restrict flux of the analyte toward the electrode surface to enhance sensor performance.
However, Shah teaches that in some embodiments, the sensor can be an aperture transducer (Figs. 4A, 4B-1, and 4B2 [paras. 0042-0043]), and that masking can be used to enable placement of various layers/chemistries in particular locations, forming windows [paras. 0044, 0049].
Chen teaches a sensor including an enzyme sensing layer (abstract), and teaches masking disposed on the substrate (mask may be patterned so that enzyme mixture is placed only on desired areas of substrate [para. 0014]), the masking disposed on the substrate (mask placed over platinum electrode substrate [para. 0019]), the masking forming a window in which the electrode surface is positioned (mask placed over platinum electrode substrate in select positions [para. 0019]).
Shah and Chen are considered analogous art to the claimed inventions because they are in the same field of enzymatic biosensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor of Shah to provide a masking disposed on the substrate, the masking forming a window in which the electrode surface is positioned, and a first transport material disposed over the masking as taught by combined Shah and Chen, as masking allows for the enzyme to be depositing on selected areas of the substrate (Chen, [para. 0014]).
Modified Shah is silent on the first transport material having a decreasing thickness profile that decreases from the peripheral edge region toward the region above the electrode surface to a minimum thickness at a boundary of the window such that an effective diffusional cross-section for transport of an analyte through the first transport material decreases along a lateral path toward the window;
wherein the first transport material defines a throat region at the boundary of the window having a cross-sectional area smaller than at the peripheral edge region, the throat region being configured to restrict lateral flux of the analyte into the window
wherein the decreasing thickness profile imposes a mass-transfer limitation on the analyte proximate the electrode surface to control and restrict flux of the analyte toward the electrode surface to enhance sensor performance.
Duhamel teaches sensors systems and methods of improving analyte detection (abstract), and teaches a first transport material (hydrophilic substrate, such as a hydrogel [paras. 0040-0041]) having a varying thickness profile and shape (hydrogel can have any suitable shape and thickness for a given sensor system [para. 0041]). Duhamel notes that the flux/concentration of the analyte can be measured by the working electrode depending on the shape/size to cover the analyte transmission site [para. 0072].
Modified Shah and Duhamel are considered analogous art to the claimed inventions because they are in the same field of enzymatic biosensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor of modified Shah to modify the shape and thickness profile of the first transport material, as taught by Duhamel, as varying the hydrogel shape and thickness allows for control of the flux of the analyte (Duhamel, [paras. 0041-0072]).
In addition, as the analyte flux/analyte concentration are variables that can be modified, among others, by adjusting the thickness profile of the first transport layer (Duhamel, [paras. 0041-0072]), the precise thickness profile of the first transport layer would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed thickness profile of the first transport layer cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the thickness of the first transport layer in modified Shah to obtain a decreasing thickness profile that decreases from the peripheral edge region toward the region above the electrode surface in order to obtain the desired flux/concentration of the analyte to be measured. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). In addition, as the thickness of the first transport material has been modified such that the thickness decreases from the peripheral edge towards the window, the first transport material defines a throat region at the boundary of the window that has a cross-sectional area smaller than at the peripheral edge region;
the limitations “the throat region being configured to restrict lateral flux of the analyte into the window”, “such that an effective diffusional cross-section for transport of an analyte through the first transport material decreases along a lateral path toward the electrode surface”, and “wherein the decreasing thickness profile imposes a mass-transfer limitation on the analyte proximate the electrode surface to control and restrict flux of the analyte toward the electrode surface to enhance sensor performance” are inherent properties of the first transport material having the decreasing thickness profile. Regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) and MPEP § 2112.01, I.
Regarding Claim 2, modified Shah teaches the sensor assembly of claim 1.
Shah teaches wherein the window formed by the masking is one of a plurality of apertures in the masking aligned in a row (as illustrated in Fig. 6C, aperture transducer location can be varied to be aligned, for example in the center of the sensor assembly [para. 0050]), wherein the electrode surface is disposed within the plurality of apertures in the masking (transducers are disposed in the aperture openings, as illustrated in Figs. 6A to 6C).
Regarding Claim 3, modified Shah teaches the sensor assembly of claim 1.
Shah teaches wherein the first reactive chemistry is disposed directly over the electrode surface (first reactive chemistry 110 is disposed at least over the working conductor 104 [para. 0027]).
Regarding Claim 4, modified Shah teaches the sensor assembly of claim 1.
Shah teaches wherein the first reactive chemistry is disposed over the electrode surface (first reactive chemistry 110 is disposed at least over the working conductor 104 [para. 0027]).
Shah is silent on wherein the first reactive chemistry is disposed over a portion of the masking.
However, Shah teaches in some embodiments that masking can be used to enable placement of various layers/chemistries in particular locations [paras. 0044, 0049].
Chen teaches wherein the first reactive chemistry is disposed over a portion of the masking (the enzyme can be placed over the substrate and mask on the substrate; the mask may be left in place if required for the deposition of further compounds for the sensor [para. 0014]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the first reactive chemistry of modified Shah to be disposed over a portion of the masking, as taught by combined Shah and Chen, as the mask may be left in place if required for the deposition of further compounds for the sensor (Chen, [para. 0014]).
Regarding Claim 5, modified Shah teaches the sensor assembly of claim 1.
Shah teaches wherein the first transport material is disposed over an entirety of the substrate (first transport material 108 extends from edge 14a across the sensor assembly to edge 14b which includes transducers 12 including working conductor 104 in Figs. 1a-1b [para. 0025] and an entirety of the electrode surface (surface of working conductor 104 in Fig. 1b).
Shah does not explicitly teach wherein the first transport material is disposed over an entirety of the first reactive chemistry.
However, in another embodiment, Figure 3B-5 of Shah teaches wherein the first transport material is disposed over an entirety of the first reactive chemistry (first reactive chemistry 110 is moved closer to working electrode 104, and as illustrated in Figure 3B-5, first transport material 108 covers entirety of first reactive chemistry 110 [para. 0039]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the first reactive chemistry of Shah to be closer to the working electrode so that the first transport material is disposed over an entirety of the first reactive chemistry, as taught by Shah, as moving the first reactive chemistry closer to the working electrode is more suitable for a crosslinked first transport material (Shah, [para. 0047]).
Regarding Claim 6, modified Shah teaches the sensor assembly of claim 1.
Shah teaches wherein the first transport material is disposed over at least a portion of the substrate (first transport material 108 extends from edge 14a across the sensor assembly to edge 14b which includes transducers 12 including working conductor 104 in Figs. 1a-1b [para. 0025], at least a portion of the electrode surface (surface of working conductor 104 in Fig. 1b).
Shah does not explicitly teach wherein the first transport material is disposed over the first reactive chemistry.
However, in another embodiment, Figure 3B-5 of Shah teaches wherein the first transport material is disposed over the first reactive chemistry (first reactive chemistry 110 is moved closer to working electrode 104, and as illustrated in Figure 3B-5, first transport material 108 covers entirety of first reactive chemistry 110 [para. 0039]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the first reactive chemistry of Shah to be closer to the working electrode so that the first transport material is disposed over the first reactive chemistry, as taught by Shah, as moving the first reactive chemistry closer to the working electrode is more suitable for a crosslinked first transport material (Shah, [para. 0047]).
Regarding Claim 7, modified Shah teaches the sensor assembly of claim 1.
Shah teaches wherein a second transport material is disposed over at least a portion of the first transport material (as illustrated in Fig. 1b, second transport material 114 extend over a portion of the first transport material 108 [para. 0026]).
Regarding Claim 8, modified Shah teaches the sensor assembly of claim 7.
Shah teaches wherein a second transport material is disposed over an entirety of the first transport material (as illustrated in Fig 1b, second transport material 114 is disposed over the entirety of first transport material 108 [Claim 14]; illustrated in Fig. 1b) and the first reactive chemistry (as illustrated in Fig 1b, second transport material 114 is disposed over the entirety of the first reactive chemistry 110 [Claim 14]; illustrated in Fig. 1b).
Regarding Claim 21, modified Shah teaches the sensor assembly of claim 1.
Shah is silent on wherein the thickness profile of the first transport material decreases at a constant slope moving from the peripheral edge region to the region above the electrode surface.
However, as outlined in the claim 1 rejection above, as the thickness profile of the first transport material is considered a results effective variable, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the thickness profile of the first transport material of modified Shah to decreases at a constant slope moving from the peripheral edge region to the region above the electrode surface, as the amount of current produced by a sensor is directly related to the rate of analyte indicator in the hydrogel, which is related to the amount of analyte flux through the skin (Duhamel, [para. 0132]).
Regarding Claim 22, modified Shah teaches the sensor assembly of claim 1.
Shah teaches wherein the thickness profile of the first transport material is constant over a first lateral segment moving from the peripheral edge region toward the region above the electrode surface (as illustrated in Fig. 1C, first transport material 108 has a constant thickness that extends moving from edges 14b and 14c towards the working electrode 104).
Shah is silent on “decreases over a second lateral segment inside of the first lateral segment”.
However, as outlined in the claim 1 rejection above, as the thickness profile of the first transport material is considered a results effective variable, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the thickness profile of the first transport material of modified Shah to decreases over a second lateral segment inside of the first lateral segment, as the amount of current produced by a sensor is directly related to the rate of analyte indicator in the hydrogel, which is related to the amount of analyte flux through the skin (Duhamel, [para. 0132]).
Regarding Claim 23, modified Shah teaches the sensor assembly of claim 1.
Shah is silent on wherein the thickness profile of the first transport material in a manner as to define an upwardly concave, curved upper surface over the window in the masking.
However, as outlined in the claim 1 rejection above, as the thickness profile of the first transport material is considered a results effective variable, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the thickness profile of the first transport material of modified Shah to the thickness profile of the first transport material in a manner as to define an upwardly concave, curved upper surface over the window in the masking, as the amount of current produced by a sensor is directly related to the rate of analyte indicator in the hydrogel, which is related to the amount of analyte flux through the skin (Duhamel, [para. 0132]).
Regarding Claim 24, Shah teaches a sensor assembly (sensor assembly 10 in Figure 1A [para. 0021]), comprising:
an elongated sensor probe (as illustrate in Figs. 6A-6C, sensor assembly 10 can be elongated) comprising:
an elongated substrate (working conductor 104 in Figs. 1B and 1C [para. 0023]; as illustrate in Figs. 6A-6C, sensor assembly 10 can be elongated)
an aperture (Fig. 4A and 4B-1 teach an aperture electrode configuration [para. 0042-0043]) formed therein exposing a working electrode surface (reactive surface 116 in Fig. 1B [para. 0024]);
a first transport material layer (first transport material 108 in Figs. 1B and 1C [para. 0025]) comprising hydrophilic material (first transport material can be, for example, a hydrogel [para. 0025]), the first transport material layer being disposed over the working electrode surface (as illustrated in Figs. 1B and 1C, first transport material 108 is disposed over the electrode surface) and extending from a central region over the aperture to peripheral edge regions on lateral sides of the elongated sensor probe (as illustrated in Fig. 4A, first transport material 108 extends from a central region over the aperture to edges of biosensor; Fig. 1B and Fig. 1C also illustrate non-aperture embodiments where the first transport material 108 extends from edge 14a to edge 14b toward a region above reactive surface 116 [para. 0025]); the limitation “configured to conduct interstitial fluid” is a functional limitation. is a functional limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, the apparatus of Shah generally provides information regarding the amount of analyte within interstitial fluid of a subject [para. 0002]. Thus, the first transport material of Shah is capable of performing the claimed function above; and
a reactive chemistry (first reactive chemistry 110 in Figs. 1B and 1C [para. 0027]; the first reactive chemistry can be selected from a family of dehydrogenase chemistries [Claim 17]) disposed above the working electrode surface (as illustrated in Figs. 1B and 1C, first reactive chemistry 110 is disposed substantially over reactive surface 116); the limitation “the reactive chemistry configured to react with the analyte to produce a target species, wherein the target species is electrochemically reduced on the electrode surface to generate an electrical signal representative of a presence on the electrode surface to generate an electrical signal representative of a presence of the target species” is a functional limitation. is a functional limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, as evidenced by Duhamel, glucose oxidase can be selected as the first reactive chemistry and is used in sensors along with hydrogels in the detection of glucose [paras. 0013, 0050]. Glucose oxidase generates intermediary hydrogen peroxide, and the hydrogen peroxide concentration can be measured to give a representative signal of glucose [para. 0025]. Thus, the sensor assembly 10 of Shah is capable of performing the claimed function above.
Shah is silent on a masking layer formed on the substrate, the masking having an aperture formed therein;
a first transport material disposed over the masking layer, the first transport material having a greater thickness at the peripheral edge regions than at a region at a boundary of the aperture; and
wherein a thickness of the first transport material layer at the region at the boundary of the aperture controls an amount of flux of the analyte that reaches central region over the working electrode surface.
However, Shah teaches that in some embodiments, the sensor can be an aperture transducer (Figs. 4A, 4B-1, and 4B2 [paras. 0042-0043]), and that masking can be used to enable placement of various layers/chemistries in particular locations [paras. 0044, 0049].
Chen teaches a sensor including an enzyme sensing layer (abstract), and teaches masking having apertures (mask may be patterned so that enzyme mixture is placed only on desired areas of substrate [para. 0014]), the masking being placed over the substrate (mask placed over platinum electrode substrate [para. 0019]), wherein the electrode surface is disposed within the apertures (mask placed over platinum electrode substrate [para. 0019]).
Shah and Chen are considered analogous art to the claimed inventions because they are in the same field of enzymatic biosensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor of Shah to include a masking layer formed on the substrate, the masking having an aperture formed therein; a first transport material disposed over the masking layer, as taught by combined Shah and Chen, as masking allows for the enzyme to be depositing on selected areas of the substrate (Chen, [para. 0014]).
Modified Shah is silent on the first transport material having a greater thickness at the peripheral edge regions than at a region at a boundary of the aperture; and
wherein a thickness of the first transport material layer at the region at the boundary of the aperture controls an amount of flux of the analyte that reaches central region over the working electrode surface.
Duhamel teaches sensors systems and methods of improving analyte detection (abstract), and teaches a first transport material (hydrophilic substrate, such as a hydrogel [paras. 0040-0041]) having a varying thickness profile and shape (hydrogel can have any suitable shape and thickness for a given sensor system [para. 0041]). Duhamel notes that the flux/concentration of the analyte can be measured by the working electrode depending on the shape/size to cover the analyte transmission site [para. 0072].
Modified Shah and Duhamel are considered analogous art to the claimed inventions because they are in the same field of enzymatic biosensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor of modified Shah to modify the shape and thickness profile of the first transport material layer, as taught by Duhamel, as varying the hydrogel shape and thickness profile allows for control of the flux of the analyte (Duhamel, [paras. 0041-0072]).
In addition, as the analyte flux/analyte concentration are variables that can be modified, among others, by adjusting the thickness profile of the first transport material layer (Duhamel, [paras. 0041-0072]), the precise thickness profile of the first transport material layer would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed thickness profile of the first transport material layer cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the thickness profile of the first transport material layer in modified Shah to obtain a greater thickness at the peripheral edge regions than at a region at a boundary of the aperture in order to obtain the desired flux/concentration of the analyte to be measured. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.);
the limitation “a thickness of the first transport material layer at the region at the boundary of the aperture controls an amount of flux of the analyte that reaches central region over the working electrode surface” are inherent properties of the first transport material layer. Regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) and MPEP § 2112.01, I.
Regarding Claim 25, modified Shah teaches the working electrode of claim 24.
Shah teaches wherein the first transport material layer is applied directly to the working electrode surface (first transport material 108 extends from edge 14a across the sensor assembly to edge 14b which includes transducers 12 including working conductor 104 in Figs. 1a-1b [para. 0025]).
Shah does not explicitly teach wherein the first transport material layer is applied directly to a top surface of the masking layer.
However, as the making layer has been applied to the working electrode layer of modified Shah, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to rearrange the first transport material layer of modified Shah directly to a top surface of the masking layer.
Regarding Claim 26, modified Shah teaches the sensor assembly of claim 25, wherein the reactive chemistry is applied to a top surface of the first transport material layer (first reactive chemistry 110 is applied between first transport material 108 and second transport material 114 Shah [para. 0027]; illustrated in Fig. 1B).
Regarding Claim 27, modified Shah teaches the sensor assembly of claim 26.
Shah teaches further comprising a second transport material layer applied over the first transport material layer and the reactive chemistry (as illustrated in Fig. 1b, second transport material 114 extend over first transport material 108 and first reactive chemistry 110 [para. 0026]), the second transport material layer being impermeable to the analyte and permeable to oxygen (second transport material 114 can be selected from hydrophobic materials such as silicone to create a no flux boundary for the analyte [para. 0038]).
Regarding Claim 28, modified Shah teaches the sensor assembly of claim 24.
Shah is silent on wherein the thickness profile of the first transport material layer decreases at a constant slope moving from the peripheral edge region to the region above the electrode surface.
However, as outlined in the claim 24 rejection above, as the thickness profile of the first transport material is considered a results effective variable, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the thickness profile of the first transport material of modified Shah to the thickness profile of the first transport material decreases at a constant slope moving from the peripheral edge region to the region above the electrode surface, as the amount of current produced by a sensor is directly related to the rate of analyte indicator in the hydrogel (Duhamel, [para. 0132]).
Regarding Claim 29, modified Shah teaches the sensor assembly of claim 24.
Shah is silent on wherein a top surface of the first transport material layer is upwardly concave, forming a saucer-shaped recess over the aperture in the masking layer.
However, as outlined in the claim 24 rejection above, as the thickness profile of the first transport material is considered a results effective variable, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the thickness profile of the first transport material of modified Shah to the upwardly concave, forming a saucer-shaped recess over the aperture in the masking layer, as the amount of current produced by a sensor is directly related to the rate of analyte indicator in the hydrogel (Duhamel, [para. 0132]).
Regarding Claim 30, Shah teaches a sensor assembly (sensor assembly 10 in Figure 1A [para. 0021]), comprising:
an elongated sensor probe (as illustrate in Figs. 6A-6C, sensor assembly 10 can be elongated) comprising:
an elongated substrate (working conductor 104 in Figs. 1B and 1C [para. 0023]; and as illustrated in Figs. 6A-6C, biosensor can be elongated)
a window (Fig. 4A and 4B-1 teach an aperture electrode configuration [para. 0042-0043]), a working electrode surface being accessible through the window (reactive surface 116 in Fig. 1B [para. 0024]);
an analyte transport material layer (first transport material 108 in Figs. 1B and 1C [para. 0025]) disposed over the working electrode surface (as illustrated in Figs. 1B and 1C, first transport material 108 is disposed over the electrode surface) and extending from a central region over the window to a peripheral edge region on lateral sides of the elongated sensor probe (as illustrated in Fig. 4A, first transport material 108 extends from a central region over the aperture to edges of biosensor; Fig. 1B and Fig. 1C also illustrate non-aperture embodiments where the first transport material 108 extends from edge 14a to edge 14b toward a region above reactive surface 116 [para. 0025]); and
a reactive chemistry deposit (first reactive chemistry 110 in Figs. 1B and 1C [para. 0027]; the first reactive chemistry can be selected from a family of dehydrogenase chemistries [Claim 17]) disposed above the central region of the analyte transport material layer (as illustrated in Figs. 1B and 1C, first reactive chemistry 110 is disposed first transport material 108); the limitation “the reactive chemistry being configured to react with the analyte to produce an electrochemically detectable species at the working electrode surface” is a functional limitation. is a functional limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, as evidenced by Duhamel, glucose oxidase can be selected as the first reactive chemistry and is used in sensors along with hydrogels in the detection of glucose [paras. 0013, 0050]. Glucose oxidase generates intermediary hydrogen peroxide, and the hydrogen peroxide concentration can be measured to give a representative signal of glucose [para. 0025]. Thus, the sensor assembly 10 of Shah is capable of performing the claimed function above;
an oxygen transport material layer disposed over the analyte transport material layer and the reactive chemistry deposit (as illustrated in Fig. 1b, second transport material 114 extend over first transport material 108 and first reactive chemistry 110 [para. 0026]; second transport material 114 can be selected from hydrophobic materials such as silicone to create a no flux boundary for the analyte [para. 0038]).
Shah is silent on a masking layer formed on the substrate, the masking having a window formed therein;
the analyte transport material layer disposed over the masking layer, the analyte transport material layer having a top surface that slopes downward moving laterally from the peripheral edge region to a lateral center of the sensor probe, thereby producing a throat region in the analyte transport material layer that restricts passage of an analyte through the analyte transport material later to the central region; and
wherein a downward slope of the top surface of the analyte transport material layer decreases a thickness of the analyte transport material layer around the window of the masking layer in a manner that imposes a mass-transfer limitation on the analyte proximate the window to control and restrict flux of the analyte toward the working electrode surface to enhance sensor performance.
However, Shah teaches that in some embodiments, the sensor can be an aperture transducer (Figs. 4A, 4B-1, and 4B2 [paras. 0042-0043]), and that masking can be used to enable placement of various layers/chemistries in particular locations [paras. 0044, 0049].
Chen teaches a sensor including an enzyme sensing layer (abstract), and teaches masking having apertures (mask may be patterned so that enzyme mixture is placed only on desired areas of substrate [para. 0014]), the masking being placed over the substrate (mask placed over platinum electrode substrate [para. 0019]), wherein the electrode surface is disposed within the apertures (mask placed over platinum electrode substrate [para. 0019]).
Shah and Chen are considered analogous art to the claimed inventions because they are in the same field of enzymatic biosensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor of Shah to include a masking layer formed on the substrate, the masking having a window formed therein, as taught by Chen, as masking allows for the enzyme to be depositing on selected areas of the substrate (Chen, [para. 0014]).
Modified Shah is silent on the analyte transport material layer having a top surface that slopes downward moving laterally from the peripheral edge region to a lateral center of the sensor probe, thereby producing a throat region in the analyte transport material layer that restricts passage of an analyte through the analyte transport material later to the central region; and
wherein a downward slope of the top surface of the analyte transport material layer decreases a thickness of the analyte transport material layer around the window of the masking layer in a manner that imposes a mass-transfer limitation on the analyte proximate the window to control and restrict flux of the analyte toward the working electrode surface to enhance sensor performance.
Duhamel teaches sensors systems and methods of improving analyte detection (abstract), and teaches a first transport material (hydrophilic substrate, such as a hydrogel [paras. 0040-0041]) having a varying thickness profile and shape (hydrogel can have any suitable shape and thickness for a given sensor system [para. 0041]). Duhamel notes that the flux/concentration of the analyte can be measured by the working electrode depending on the shape/size to cover the analyte transmission site [para. 0072].
Modified Shah and Duhamel are considered analogous art to the claimed inventions because they are in the same field of enzymatic biosensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor of modified Shah to modify the shape and thickness profile of the analyte transport material layer, as taught by Duhamel, as varying the hydrogel shape and thickness allows for control of the flux of the analyte (Duhamel, [paras. 0041-0072]).
In addition, as the analyte flux/analyte concentration are variables that can be modified, among others, by adjusting the thickness profile of the analyte transport material layer, the precise thickness profile of the analyte transport material layer would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed thickness profile of analyte transport material layer cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the thickness of the analyte transport material layer in modified Shah to obtain the analyte transport material layer having a top surface that slopes downward moving laterally from the peripheral edge region to a lateral center of the sensor probe, thereby producing a throat region in the analyte transport material layer that restricts passage of an analyte through the analyte transport material later to the central region; and wherein a downward slope of the top surface of the analyte transport material layer decreases a thickness of the analyte transport material layer around the window of the masking layer in a manner. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.);
the limitation “a downward slope of the top surface of the analyte transport material layer decreases a thickness of the analyte transport material layer around the window of the masking layer in a manner that imposes a mass-transfer limitation on the analyte proximate the window to control and restrict flux of the analyte toward the working electrode surface to enhance sensor performance” are inherent properties of the analyte transport material layer decreases a thickness of the analyte transport material layer around the window of the masking layer. Regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) and MPEP § 2112.01, I.
Response to Arguments
Applicant's arguments, see Remarks pgs. 1-7, filed 03/18/2026, with respect to the 35 U.S.C 103 rejections and amended claims have been fully considered.
Applicant’s Argument #1:
Applicant traverses the 35 U.S.C 103 prior art rejections for Claim 1 by amending Claim 1 to recite “wherein the first transport material defines a throat region at the boundary of the window having a cross-sectional area smaller than at the peripheral edge region, the throat region being configured to restrict lateral flux of the analyte into the window”. In addition, Applicant argues that although the Office asserts that the precise thickness profile is a “result-effective variable”, this is flawed as Duhamel also states that the hydrogel “can have any suitable shape and thickness for a given sensor system”, which is generic and fails to recognize or discuss directional tapering of thickness as a meaningful variable. In addition, Duhamel is directed to enabling transdermal analyte flux, and one of ordinary skill would not have applied the generic discussion of surface area to an aperture-based electrode.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. As Duhamel teaches that the hydrogel may have any suitable shape and thickness (Duhamel, [para. 0041]), and that a transport material (such as a hydrogel), allows for easy diffusion of the analyte, analyte indicators, and non-analyte components into the electrode (Duhamel, [para. 0040]), varying the thickness of the first transport material in a linear fashion would be ambit to one of ordinary skill in the art. In addition, as both Shah and Duhamel are enzymatic biosensors, it would be obvious to one of ordinary skill in the art to utilize the teachings on the hydrogel/transport layers from both references. In addition, as the thickness of the first transport material decreases from the peripheral to the window, the cross-sectional area of the first transport material near the window will be smaller than at the peripheral edge. The limitation the throat region “configured to restrict lateral flux of the analyte into the window” is a functional limitation, which is taught by Duhamel as the first transport material, such as a hydrogel, allows for diffusion of the analyte into the electrode (Duhamel, [para. 0040]).
Conclusion
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795