DETAILED ACTION
Applicant has elected species A.1 and species B.4 with traverse in the reply filed 08/04/2026, see below. Claims 1-8, 10-12, 15-16, and 19-20 are pending and hereby under examination.
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 .
Election/Restrictions
Applicant's election with traverse of species A.1 and B.4 in the reply filed on 08/04/2026 is acknowledged. The traversal is on the ground(s) that the identified species are directed to a common inventive concept and have not been shown to be patentably distinct. Applicant further asserts that claims 8, 9, 13, 15, and 17 incorporate all of the limitations of a corresponding generic claim. Examiner respectfully disagrees.
The restriction requirement is not based on whether the claims are directed towards an inventive concept, such as that required under the determination of Unity of Invention. The restriction requirement is based on whether the identified limitations are directed to patentably distinct species.
For the species of forming a microneedle array (Species A), claim 8 recites that formation of the microneedle array is based on providing a mold with a microneedle sequence, pouring a polymeric material into the mold, solidifying the polymeric material, and peeling away the polymeric material off the mold to obtain the array. Claim 9 recites that the microneedle array is formed by a 3D printing process or a micro/nanofabrication process. Claim 9 does not require a mold, pouring a polymer into a mold, solidifying the polymer, and peeling the polymer off the mold to obtain the array. Likewise, claim 8 does not require a 3D printer or a micro/nanofabrication process. These formation techniques are mutually exclusive of each other and are not obvious variants of each other. Thus, these species are patentably distinct and would require a different field of search.
For the species of the pump (Species B), claim 13 requires an ultrasonic pump with an upper casing, a lower casing, and a thin film arranged between the two casings. The claim further requires a drug storage chamber, a plurality of conical holes, and a piezoelectric circular ring. Claim 15 requires an electroosmotic pump comprising two electrode layers, an intermediate film layer, and a plurality of perforations distributed on the intermediate film layer. Lastly, claim 17 requires an electrochemical pump comprising an accommodation zone, an electrolyte solution, an electrode layer, and an expanded film. The limitations identified above in each claim are not found in the other claims. As such, the types of pumps are mutually exclusive and are not obvious variants of each other. Thus, these species are patentably distinct and would require a different field of search.
Examiner inadvertently identified claims 14 and 18 as “generic” in the election/restriction requirement filed 05/07/2026. However, as these claims are dependent on claims 13 and 17, respectively, they are directed to the non-elected species of an ultrasonic pump and an electrochemical pump of claims 13 and 17.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9, 13-14, and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/04/2026.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3, line 2 “comprise” should read “comprises”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“reverse iontophoresis device” first recited in claim 1.
The corresponding structure for the identified claim limitations above are as follows:
“reverse iontophoresis device” is identified as “the reverse iontophoresis device includes a positive electrode and a negative electrode”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-5, 7-8, 10-12, 15-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Li et. al. (“A Fully Integrated Closed-Loop System Based on Mesoporous Microneedles-Iontophoresis for Diabetes Treatment”), hereinafter Li, and Luo et. al. (“Closed-Loop Diabetes Minipatch Based on a Biosensor and an Electroosmotic Pump on Hollow Biodegradable Microneedles”), hereinafter Luo.
Regarding claim 1, Li discloses a diabetes sensor, comprising
a substrate (Fig. 1(d), mesoporous microneedles (MMN) patch)
a microneedle array arranged on one side of the substrate (Fig. 1(d), MMN patch comprising an array of microneedles on one side), and
wherein the microneedle array comprises a plurality of microneedles (Fig. 2(a)(6) depicting microneedles on one side of the MMN patch); and
wherein a plurality of electrodes comprises an electrochemical sensor and a reverse iontophoresis device (Pages 2-3, section 2.1, “The RIMN sensor consists of four components: 1) the MMN for accessing interstitial fluid; 2) a planar glucose electrode (three-electrode system) for detection of extracted glucose; and 3) a reverse-iontophoresis extraction system (Ag/AgCl working electrode and MN C.E.) to enhance glucose extraction, and a 3D printed chamber for sensor integration”; Examiner interprets the planar glucose electrode for detection of extracted glucose to be the electrochemical sensor and the reverse iontophoresis extraction system to be the reverse iontophoresis device);
the electrochemical sensor being configured to detect glucose molecules in interstitial fluid and generate an electric signal (Page 2, section 2.1, “In the RIMN sensor, the glucose in interstitial fluids was extracted into the sensor chamber via reverse iontophoresis after the MN pierced the stratum corneum, followed by electrochemical detection via a three electrodes system”; Pages 2-3, section 2.1, “a planar glucose electrode (three-electrode system) for detection of extracted glucose”), and
the reverse iontophoresis device being configured to generate a reverse iontophoresis effect to attract the glucose molecules from a deep skin layer to an upper part of dermis where needle tips of the microneedles are located (Page 2, section 2.1, “In the RIMN sensor, the glucose in interstitial fluids was extracted into the sensor chamber via reverse iontophoresis after the MN pierced the stratum corneum, followed by electrochemical detection via a three electrodes system”; Examiner interprets the interstitial fluid as coming from a “deep skin layer” to the stratum corneum as the stratum corneum does not contain interstitial fluid. The glucose is extracted from a deeper layer of the skin and brought to the stratum corneum for the microneedles to collect the interstitial fluid).
Li discloses a system wherein the electrodes are placed on the back side of the substrate, but fails to disclose that the electrodes are placed to cover the microneedles.
Li and Luo are analogous art as they are in the same field of closed-loop microneedle arrays. Luo teaches a microneedle array and substrate combination for measuring glucose in the interstitial fluid. The electrodes are arranged such that they are covering the microneedles and substrate (Figs. 2(a)(7-10). Luo discusses the arrangement allows the electrodes to be in close contact with the subcutaneous interstitial fluid continuously (Page 1350). While Li and Luo disclose similar mechanisms of measuring glucose from the interstitial fluid through microneedle arrays, they disclose different arrangements of electrodes. One of ordinary skill in the art could have substituted the electrode arrangement of Li with the electrode arrangement of Luo, and the results of the substitution of measuring glucose in the interstitial fluid would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the electrodes of Li with the electrode arrangement on the microneedles and substrate as taught by Luo, and the results of measuring glucose would have been predictable to one of ordinary skill in the art.
Regarding claim 2, the combination of Li and Luo disclose the sensor of claim 1. Li further discloses wherein the microneedles each have a height of not less than 100 μm and not more than 1000 μm (Page 3, section 2.1, wherein the MN on the patch are about 600 µm in length).
Regarding claim 4, the combination of Li and Luo disclose the sensor of claim 1. Li further discloses wherein the microneedle array comprises a solid microneedle array or a hollow microneedle array (Page 5, section 2.2, wherein the needles are porous and allow the glucose in interstitial fluid to diffuse through the tip channels of the microneedles to the sensing chamber at the back of the patch).
Regarding claim 5, the combination of Li and Luo disclose the sensor of claim 1. Li further discloses wherein the substrate and the microneedle array are each independently made of a material comprising one selected from the group consisting of a polymeric material, a biodegradable material, and a biocompatible material (Page 2, section 2.1, “Mixture of poly (glycidyl methacrylate) (PGMA) and polyethylene glycol (PEG) as porogen in 2-methoxyethanolwas centrifugated into the PDMS mold, where the PGMA was crosslinked (Irgacure 184 as photo initiator) under ultraviolet light to produce the MN structure”; Examiner interprets the PGMA and PEG to be polymeric materials).
Regarding claim 7, the combination of Li and Luo disclose a method for manufacturing a diabetes sensor, being applicable to the diabetes sensor as claimed in claim 1 (See the rejection of claim 1, above), and comprising the steps of
providing a substrate (Fig. 1(d), mesoporous microneedles (MMN) patch)
forming a microneedle array arranged on one side of the substrate (Fig. 1(d), MMN patch comprising an array of microneedles on one side), wherein the microneedle array comprises a plurality of microneedles (Fig. 2(a)(6) depicting microneedles on one side of the MMN patch); and
wherein a plurality of electrodes comprises an electrochemical sensor and a reverse iontophoresis device (Pages 2-3, section 2.1, “The RIMN sensor consists of four components: 1) the MMN for accessing interstitial fluid; 2) a planar glucose electrode (three-electrode system) for detection of extracted glucose; and 3) a reverse-iontophoresis extraction system (Ag/AgCl working electrode and MN C.E.) to enhance glucose extraction, and a 3D printed chamber for sensor integration”; Examiner interprets the planar glucose electrode for detection of extracted glucose to be the electrochemical sensor and the reverse iontophoresis extraction system to be the reverse iontophoresis device);
the electrochemical sensor being configured to detect glucose molecules in interstitial fluid and generate an electric signal (Page 2, section 2.1, “In the RIMN sensor, the glucose in interstitial fluids was extracted into the sensor chamber via reverse iontophoresis after the MN pierced the stratum corneum, followed by electrochemical detection via a three electrodes system”; Pages 2-3, section 2.1, “a planar glucose electrode (three-electrode system) for detection of extracted glucose”), and
the reverse iontophoresis device being configured to generate a reverse iontophoresis effect to attract the glucose molecules from a deep skin layer to an upper part of dermis where needle tips of the microneedles are located (Page 2, section 2.1, “In the RIMN sensor, the glucose in interstitial fluids was extracted into the sensor chamber via reverse iontophoresis after the MN pierced the stratum corneum, followed by electrochemical detection via a three electrodes system”; Examiner interprets the interstitial fluid as coming from a “deep skin layer” to the upper part of the dermis as the stratum corneum does not contain interstitial fluid. The microneedles pierce the stratum corneum, i.e., the upper part of the dermis. The glucose is extracted from a deeper layer of the skin and brought to the top of the dermis for the microneedles to collect the interstitial fluid).
Li discloses a system wherein the electrodes are placed on the back side of the substrate but fails to disclose that the electrodes are placed to cover the microneedles.
Li and Luo are analogous art as they are in the same field of closed-loop microneedle arrays. Luo teaches a microneedle array and substrate combination for measuring glucose in the interstitial fluid. The electrodes are arranged such that they are covering the microneedles and substrate (Figs. 2(a)(7-10). Luo discusses that the arrangement allows the electrodes to be in close contact with the subcutaneous interstitial fluid continuously (Page 1350). While Li and Luo disclose similar mechanisms of measuring glucose from the interstitial fluid through microneedle arrays, they disclose different arrangements of electrodes. One of ordinary skill in the art could have substituted the electrode arrangement of Li with the electrode arrangement of Luo, and the results of the substitution of measuring glucose in the interstitial fluid would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the electrodes of Li with the electrode arrangement on the microneedles and substrate as taught by Luo, and the results of measuring glucose would have been predictable to one of ordinary skill in the art.
Regarding claim 8, Li and Luo disclose the method of claim 7 as described above. Li further discloses wherein forming the microneedle array on one side of the substrate comprises
providing a mold with a microneedle sequence that matches the microneedle array (Fig. 1(d), the MMN patch being fabricated via PDMS mold); and
pouring a polymeric material into the mold, solidifying the polymeric material, and then peeling a resulting solidified polymeric material off the mold, to obtain the microneedle array (Page 2, section 2.1, “Mixture of poly (glycidyl methacrylate) (PGMA)and polyethylene glycol (PEG) as porogen in 2-methoxyethanolwas centrifugated into the PDMS mold, where the PGMA was crosslinked (Irgacure 184 as photo initiator) under ultraviolet light to produce the MN structure. The as-fabricated MN patch were separated from the PDMS mold”).
Regarding claim 10, Li and Luo disclose the method of claim 7 as described above. Li further discloses wherein forming the plurality of electrodes on the substrate and the microneedle array comprises
forming the plurality of electrodes by a micro/nanofabrication process (Page 5, section 2.1, “Meanwhile, laser micromachining was employed to fabricate a 2D-metal MN patch from a stainless steel-plate. The metal MN was designed to possess ≈225 µm-diameter at the base, ≈800 µm-length, and ≈250 µm interval between ad-jacent MNs (Figure 2l). The steel MN was then sputtered with≈100 nm Au layer to enhance biocompatibility, which was employed as C.E. for both iontophoresis and reverse iontophoresis in the IWCS”; Examiner interprets this fabrication as a “microfabrication” process).
Regarding claim 11, the combination of Li and Luo disclose a closed-loop control system, comprising the diabetes sensor as claimed in claim 1 (See the rejection of claim 1, above).
While Li discloses insulin delivery (Page 2, section 2.1, paragraph 1), Li fails to disclose a pump, a signal conversion module, a first conversion module, a second conversion module, a control module, and their respective limitations.
Li and Luo are analogous art as they are in the same field of closed-loop microneedle arrays. Luo teaches an electroosmotic pump connected to a cavity stored with insulin and the other side is connected to the microneedle array, wherein the tip of the microneedle array faces away from the pump (Fig. 1(a)). The system is controlled by a microcontroller (i.e., the control module). An analog to digital converter (3) (i.e., the first conversion module) is connected to an output end of the sensor and to an input end of the microcontroller, and the analog to digital converter (3) receives and converts electrical signals output by the diabetes sensor. The microcontroller receives an electrical signal converted by the analog to digital converter (3) and sends that to the digital to analog converter (5), wherein the digital to analog converter is connected to an output end of the microcontroller and an input end of the pump. The digital to analog converter (5) converts the output from the controller and sends it to the pump to control opening/closing of the pump (Fig. 1(d) depicts the entire system of the sensor, analog to digital converter (3), the microcontroller, the digital to analog converter (5), and the pump; Examiner interprets this entire system to read on the “signal conversion module” limitation; Page 1351-1352, “When the blood glucose value exceeded the normal value, the sensing signal was further processed by the microcontroller (4), a digital-to-analog converter (5), and an analog switch to turn on electroosmotic pump”). As Li is concerned with delivering insulin in response to the measured glucose levels, Luo teaches an electroosmotic pump for delivering the insulin. Luo discusses the electroosmotic pump is useful compared to other pumps as it reduces the overall size and weight of the array. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insulin delivery system of the microneedle array disclosed by Li and Luo with the electroosmotic pump as taught by Luo, the benefit being a pump that reduces the overall size and weight of the array system.
Regarding claim 12, the combination of Li and Luo disclose the system of claim 11. Luo further discloses, as discussed above, wherein the first conversion module is a first signal converter, the control module is a microcontroller, and the second conversion module is a second signal converter (Fig. 1(d)).
Regarding claim 15, the combination of Li and Luo disclose the system of claim 11. Luo further discloses, as discussed above, wherein the pump is an electroosmotic pump (Page 1349, section Electroosmotic Pump Preparation and Flow Measurement), the electroosmotic pump comprising a first electrode layer, a second electrode layer, and an intermediate film layer (Page 1349, section Electroosmotic Pump Preparation and Flow Measurement, “Two Au-plated stainless steel meshes were placed on both sides of the polycarbonate film with nanopores as electroosmotic electrodes, which were further connected to an external circuit”),
wherein the intermediate film layer is located between the first electrode layer and the second electrode layer, and a plurality of perforations are distributed on the intermediate film layer (Page 1348, section Electroosmotic Pump Preparation and Flow Measurement, “Two Au-plated stainless steel meshes were placed on both sides of the polycarbonate film with nanopores as electroosmotic electrodes”; Examiner interprets the nanopores to be a plurality of perforations); and
the substrate is connected with the second electrode layer, and the tip end of the microneedle array faces a side away from the second electrode layer (Fig. 1(a), wherein one side of the pump comprising the second electrode layer is connected to the substrate, and wherein the tip end of the microneedle array faces away from the electrode layer/pump).
Regarding claim 16, the combination of Li and Luo disclose the system of claim 11. Luo further discloses wherein the first electrode layer, the second electrode layer, and the intermediate film layer are each independently made of a material comprising a hard film material or a flexible film material (Page 1348, section Electroosmotic Pump Preparation and Flow Measurement, wherein the electrode layers are gold plated stainless steel meshes, and the film is a polycarbonate film).
Regarding claim 19, the combination of Li and Luo disclose the system of claim 11. Li further discloses wherein the microneedles each have a height of not less than 100 μm and not more than 1000 μm (Page 3, section 2.1, wherein the MN on the patch are about 600 µm in length).
Regarding claim 20, the combination of Li and Luo disclose the system of claim 11. Li further discloses wherein the microneedle array comprises a solid microneedle array or a hollow microneedle array (Page 5, section 2.2, wherein the needles are porous and allow the glucose in interstitial fluid to diffuse through the tip channels of the microneedles to the sensing chamber at the back of the patch).
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Li (“A Fully Integrated Closed-Loop System Based on Mesoporous Microneedles-Iontophoresis for Diabetes Treatment”) and Luo (“Closed-Loop Diabetes Minipatch Based on a Biosensor and an Electroosmotic Pump on Hollow Biodegradable Microneedles”) as applied to claim 1 above, and further in view of Zhao et. al. (“A Flexible Interdigital Electrode Used in Skin Penetration Promotion and Evaluation with Electroporation and Reverse Iontophoresis Synergistically”), hereinafter Zhao.
Regarding claim 3, the combination of Li and Luo disclose the sensor of claim 1 above. Li further discloses wherein the electrochemical sensor comprises a working electrode and a counter electrode, or comprises a working electrode, a reference electrode, and a counter electrode (Page 2, section 2.1, “a planar glucose electrode (three-electrode system) for detection of extracted glucose”; Page 5, section 2.2, “The glucose detection employed the standard amperometric strategy of an enzymatic three-electrodes electrochemical system, including an enzymatically functionalized carbon electrode as W.E., a Pt-plated carbon electrode as C.E., and an Ag/AgCl electrode as R.E”); and
the reverse iontophoresis device comprises a positive electrode and a negative electrode (Pages 2-3, section 2.1, “a reverse-iontophoresis extraction system (Ag/AgCl working electrode and MN C.E.) to enhance glucose extraction”);
glucose oxidase is immobilized on the working electrode of the electrochemical sensor (Page 5, section 2.2, “Prussian blue(PB) was then electrodeposited in situ on the W.E., followed by immobilization of glucose oxidase on the surface”);
Li discloses the electrodes of the sensors next to each other (Page 5, section 2.2, “A sensor electrode on top of MMN for reverse iontophoresis, coupled with a MN C.E. placed next to it), but the combination fails to disclose that they form interdigital electrodes.
Li, Luo, and Zhao are in the same field of blood glucose monitoring. Zhao teaches a blood glucose monitoring system with interdigital microelectrodes (Fig. 1(a-c)). Zhao discusses this sensor arrangement is useful as it can sensitively detect changes in material properties. Applying the structure of interdigital electrodes to the combination of Li and Luo would necessarily lead the counter electrode of the electrochemical sensor and the positive electrode of the reverse iontophoresis device to be located on one or two sides of the interdigital electrodes as those are the only two possible arrangements. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode arrangement of Li and Luo to incorporate the interdigital electrode arrangement taught by Zhao, as this structure is useful to sensitively detect changes when applying reverse iontophoresis.
Regarding claim 6, the combination of Li, Luo, and Zhao disclose the sensor of claim 3 above. Li further discloses wherein the working electrode of the electrochemical sensor is made of a material comprising one selected from the group consisting of gold, platinum, carbon, a gold composite, a platinum composite, a carbon composite, and silver/silver chloride (Page 5, section 2.2, “The glucose detection employed the standard amperometric strategy of an enzymatic three-electrodes electrochemical system, including an enzymatically functionalized carbon electrode as W.E.”);
the counter electrode of the electrochemical sensor is made of a material comprising one selected from the group consisting of gold, platinum, carbon, a gold composite, a platinum composite, a carbon composite, and silver/silver chloride (Page 5, section 2.2, “The glucose detection employed the standard amperometric strategy of an enzymatic three-electrodes electrochemical system, including a Pt-plated carbon electrode as C.E.); and
the reverse iontophoresis device is made of a material comprising one selected from the group consisting of silver/silver chloride, a silicone material, a conductive polymer, graphene, and gold (Page 5, section 2.2, “The glucose detection employed the standard amperometric strategy of an enzymatic three-electrodes electrochemical system, including an Ag/AgCl electrode as R.E”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liu et. al. (“Continuous monitoring of diabetes with an integrated microneedle biosensing device through 3D printing”) discloses a microneedle array with electrodes for glucose detection (Fig. 1(a-b).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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