DETAILED ACTION
This action is pursuant to claims filed on 6/17/2024. Claims 1-20 are pending, with claims 9-14 withdrawn. A first action on the merits of claims 1-8 and 15-20 is as follows.
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 Invention I in the reply filed on 06/17/2026 is acknowledged. The traversal is on the ground(s) that the embodiments can be utilized in combination. This is not found persuasive because the structures of the sensors of the inventions are different and measure different parameters, and therefore cannot be used in combination. Invention I uses two different sensors adapted for different analytes using current, wherein Invention II uses only one sensor to measure an analyte using current and an aptamer to measure a second analyte using impedance, meaning they have a materially different design, mode of operation, and function.
Additionally, the inventions have physical attributes that are different from each other. The search for each invention will involve different strategies and search terms because different terms are necessarily used to described physical attributes. Searching for one set of physical attributes using one set of search terms would not necessarily involve or encompass a different set of physical attributes that is described with different terms.
Further, Applicant asserts that the embodiments can be used in combination in a multi-analyte sensor, and therefore these inventions are not mutually exclusive. This argument is not persuasive. Just because the inventions have some features in common such as analyte sensing does not negate the fact that there are different steps that will need to be searched and examined. These different steps and the overall structure of the different systems and methods makes the searching and examination more burdensome. As previously stated, the searching for each invention will involve different strategies and search terms because different terms are necessarily used to describe different physical attributes. Searching for one set of physical attributes using one set of search terms would not necessarily involve or encompass a different set of physical attributes that is described with different terms. Additionally, paragraph 0108 does not teach the method of using the electrodes with enough specificity so that one of ordinary skill in the art would conclude both inventions are encompassed by such a teaching.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/17/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference character “132” in Figure 1 does not appear in the specification
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 8, 15, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (US 20090178459).
Regarding independent claim 1, Li teaches a system (Abstract: “Systems and methods of use for continuous analyte measurement of a host's vascular system are provided”) comprising:
a first sensor (First working electrode E1) with a first enzyme for a first analyte ([0586]: “The first working electrode E1 is disposed beneath an enzymatic portion of the membrane (not shown) containing an analyte-detecting enzyme”. The analyte-detecting enzyme is the first enzyme for detecting the first analyte.);
a second sensor (Second working electrode E2) with a second enzyme for a second analyte different from the first analyte ([0586]: “The second working electrode E2 is disposed beneath a portion of the membrane comprising either inactivated enzyme”; [0398]: “the sensor can also include one or more additional working electrodes (e.g., for measuring baseline, for measuring a second analyte, or for measuring a substantially non-analyte related signal”. The inactivated enzyme is the second enzyme, used to measure the second analyte.);
a potentiostat arranged to: apply a first voltage to the first sensor to cause a first current to flow through the first sensor; and apply a second voltage to the second sensor to cause a second current to flow through the second sensor ([0313]: “the electronics include at least a potentiostat that provides a bias to the electrodes and measures a current to provide the raw data signal”; [0334]: “The term "potentiostat" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an electronic instrument that controls the electrical potential between the working and reference electrodes at one or more preset values. Typically, a potentiostat works to keep the potential constant by noticing changes in the resistance of the system and compensating inversely with a change in the current. As a result, a change to a higher resistance would cause the current to decrease to keep the voltage constant in the system. In some embodiments, a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.”; [0583]: “sensor electronics are configured to measure the current (or voltage) to provide the first and second signals”);
a memory; and a processor communicatively coupled to the memory ([0698]: “the processor includes hardware and software that performs the processing described herein, for example flash memory provides permanent or semi-permanent storage of data, storing data such as sensor ID, receiver ID, and programming to process data streams (for example, programming for performing estimation and other algorithms described elsewhere herein) and random access memory (RAM) stores the system's cache memory and is helpful in data processing”), the processor configured to:
determine, based on the first current, a level of the first analyte; and determine, based on the second current, a level of the second analyte ([0583]: “the electronics include at least a potentiostat that provides a bias to the electrodes. In some embodiments, sensor electronics are configured to measure the current (or voltage) to provide the first and second signals”; [0112]: “the first working electrode is configured to provide a first signal comprising an analyte component”; [0624]: “a first analyte sensor can detect a first analyte using a first technique, a second analyte sensor can detect a second analyte using a second technique”; [0006]: “an analyte sensor configured and arranged for measuring an analyte concentration”. The potentiostat measures the first and second signals, which correspond to analyte concentrations for each analyte sensor, which measure two different analytes.).
Regarding claim 5, Li teaches the system of Claim 1, wherein the potentiostat applies the first voltage to the first sensor for a predetermined time period before switching to applying the second voltage to the second sensor ([0608]: “in one embodiment the dual-electrode analyte sensor is a glucose sensor configured for fluid communication with a host's circulatory system, wherein the sensor is configured to generate a first signal associated with glucose (at the first working electrode E1) at an applied potential of 0.6 mV, and then to generate a second signal associated with O.sub.2 (also at the first working electrode E1) at an applied potential of -0.6 mV. Thus, in some embodiments, the potential applied to the first working electrode can be switched from +0.6 mV to -0.6 mV, such that the first working electrode switches from measuring the analyte-related signal (e.g., glucose) to measuring the second signal (e.g., associated with O.sub.2).”; [0609]: “In some alternative embodiments, the second working electrode E2 (e.g., instead of the first working electrode E1) is configured to generate the second signal”; [0397]: “the sensor can measure the analyte concentration continuously or at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes or longer”. The system measures the first analyte (glucose) at the first working electrode, then switches to the second analyte (oxygen) at the second working electrode. Additionally, the signal is obtained to determine analyte concentration, which states can be measures at time intervals, which are the predetermined time periods before the next analyte concentration is measured.).
Regarding claim 8, Li teaches the system of Claim 1, further comprising a reference sensor ([0599]: “the dual-electrode analyte sensor includes a reference sensor”), wherein the potentiostat is further arranged to apply a third voltage to the reference sensor ([0605]: “The reference sensor is configured to generate a reference signal that is also associated with the reference analyte. In general, a "reference analyte" can be any analyte that can be measured by both the analyte sensor and the reference sensor, such those analytes listed under the definition of "analyte" in the section entitled "Definitions."”; [0334]: “The term "potentiostat" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an electronic instrument that controls the electrical potential between the working and reference electrodes at one or more preset values. Typically, a potentiostat works to keep the potential constant by noticing changes in the resistance of the system and compensating inversely with a change in the current. As a result, a change to a higher resistance would cause the current to decrease to keep the voltage constant in the system. In some embodiments, a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.”. If the reference sensor is measuring a different, reference analyte, it will be provided with a different, third voltage specific to the reference analyte.).
Regarding independent claim 15, Li teaches a method (Abstract: “Systems and methods of use for continuous analyte measurement of a host's vascular system are provided”) comprising:
applying, by a potentiostat ([0313]: “the electronics include at least a potentiostat that provides a bias to the electrodes and measures a current to provide the raw data signal”), a first voltage ([0313]: “the electronics include at least a potentiostat that provides a bias to the electrodes and measures a current to provide the raw data signal”; [0334]: “The term "potentiostat" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an electronic instrument that controls the electrical potential between the working and reference electrodes at one or more preset values. Typically, a potentiostat works to keep the potential constant by noticing changes in the resistance of the system and compensating inversely with a change in the current. As a result, a change to a higher resistance would cause the current to decrease to keep the voltage constant in the system. In some embodiments, a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.”; [0583]: “sensor electronics are configured to measure the current (or voltage) to provide the first and second signals”) to a first sensor (First working electrode E1) with a first enzyme for a first analyte ([0586]: “The first working electrode E1 is disposed beneath an enzymatic portion of the membrane (not shown) containing an analyte-detecting enzyme”. The analyte-detecting enzyme is the first enzyme for detecting the first analyte.) to cause a first current to flow through the first sensor ([0313]: “the electronics include at least a potentiostat that provides a bias to the electrodes and measures a current to provide the raw data signal”; [0334]: “The term "potentiostat" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an electronic instrument that controls the electrical potential between the working and reference electrodes at one or more preset values. Typically, a potentiostat works to keep the potential constant by noticing changes in the resistance of the system and compensating inversely with a change in the current. As a result, a change to a higher resistance would cause the current to decrease to keep the voltage constant in the system. In some embodiments, a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.”; [0583]: “sensor electronics are configured to measure the current (or voltage) to provide the first and second signals”); and
applying, by the potentiostat, a second voltage ([0313]: “the electronics include at least a potentiostat that provides a bias to the electrodes and measures a current to provide the raw data signal”; [0334]: “The term "potentiostat" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an electronic instrument that controls the electrical potential between the working and reference electrodes at one or more preset values. Typically, a potentiostat works to keep the potential constant by noticing changes in the resistance of the system and compensating inversely with a change in the current. As a result, a change to a higher resistance would cause the current to decrease to keep the voltage constant in the system. In some embodiments, a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.”; [0583]: “sensor electronics are configured to measure the current (or voltage) to provide the first and second signals”) to a second sensor (Second working electrode E2) with a second enzyme for a second analyte different from the first analyte ([0586]: “The second working electrode E2 is disposed beneath a portion of the membrane comprising either inactivated enzyme”; [0398]: “the sensor can also include one or more additional working electrodes (e.g., for measuring baseline, for measuring a second analyte, or for measuring a substantially non-analyte related signal”. The inactivated enzyme is the second enzyme, used to measure the second analyte.) to cause a second current to flow through the second sensor ([0313]: “the electronics include at least a potentiostat that provides a bias to the electrodes and measures a current to provide the raw data signal”; [0334]: “The term "potentiostat" as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an electronic instrument that controls the electrical potential between the working and reference electrodes at one or more preset values. Typically, a potentiostat works to keep the potential constant by noticing changes in the resistance of the system and compensating inversely with a change in the current. As a result, a change to a higher resistance would cause the current to decrease to keep the voltage constant in the system. In some embodiments, a potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.”; [0583]: “sensor electronics are configured to measure the current (or voltage) to provide the first and second signals”);
determining, based on the first current, a level of the first analyte; and determining, based on the second current, a level of the second analyte ([0583]: “the electronics include at least a potentiostat that provides a bias to the electrodes. In some embodiments, sensor electronics are configured to measure the current (or voltage) to provide the first and second signals”; [0112]: “the first working electrode is configured to provide a first signal comprising an analyte component”; [0624]: “a first analyte sensor can detect a first analyte using a first technique, a second analyte sensor can detect a second analyte using a second technique”; [0006]: “an analyte sensor configured and arranged for measuring an analyte concentration”. The potentiostat measures the first and second signals, which correspond to analyte concentrations for each analyte sensor, which measure two different analytes.).
Regarding claim 19, Li teaches the method of Claim 15, wherein the potentiostat applies the first voltage to the first sensor for a predetermined time period before switching to applying the second voltage to the second sensor ([0608]: “in one embodiment the dual-electrode analyte sensor is a glucose sensor configured for fluid communication with a host's circulatory system, wherein the sensor is configured to generate a first signal associated with glucose (at the first working electrode E1) at an applied potential of 0.6 mV, and then to generate a second signal associated with O.sub.2 (also at the first working electrode E1) at an applied potential of -0.6 mV. Thus, in some embodiments, the potential applied to the first working electrode can be switched from +0.6 mV to -0.6 mV, such that the first working electrode switches from measuring the analyte-related signal (e.g., glucose) to measuring the second signal (e.g., associated with O.sub.2).”; [0609]: “In some alternative embodiments, the second working electrode E2 (e.g., instead of the first working electrode E1) is configured to generate the second signal”; [0397]: “the sensor can measure the analyte concentration continuously or at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes or longer”. The system measures the first analyte (glucose) at the first working electrode, then switches to the second analyte (oxygen) at the second working electrode. Additionally, the signal is obtained to determine analyte concentration, which states can be measures at time intervals, which are the predetermined time periods before the next analyte concentration is measured.).
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 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claims 1 and 15 above, and further in view of Rihani (“Liquid crystal elastomer-based microelectrode array for in vitro neuronal recordings”) and Ware (“Voxelated liquid crystal elastomers”).
Regarding claim 2, Li teaches the system of Claim 1.
However, Li does not teach wherein the first sensor comprises a voxelated surface, and wherein the first enzyme is deposited on the voxelated surface.
Rihani discloses liquid crystal elastomer-based microelectrode arrays. Specifically, Rihani teaches wherein the first sensor comprises a liquid crystal elastomer-based surface, and wherein the first enzyme is deposited on the surface (Abstract: “Liquid crystal elastomers (LCEs) are a class of smart materials that reversibly change shape when exposed to a variety of stimuli. Our interest in LCEs is based on leveraging this shape change to deploy electrode sites beyond the tissue regions exhibiting inflammation associated with chronic implantation”. Rihani discloses constructing an electrode, which includes a voxelated surface. Since the enzyme is deposited on the electrode, it includes depositing an enzyme on a voxelated surface.). Li and Rihani are analogous art as they are both related to the same field of endeavor of the structure of sensing electrodes.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure from Rihani into the system from Li as Li is silent on the structure of the electrodes used, and Rihani discloses a suitable structure in an analogous device.
However, the Li-Rihani combination does not teach the liquid crystal elastomer-based surface being voxelated.
Ware discloses voxelated liquid crystal elastomers. Specifically, Ware teaches wherein the liquid crystal elastomer-based surface is voxelated (Pages 1-18 discloses methods to create voxelated liquid crystal elastomers.). Rihani and Ware are analogous art as they are both related to liquid crystal elastomer structures.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure of the liquid crystal elastomer from Ware into the device from the Li/Rihani combination as the combination is silent on the specific structure of the liquid crystal elastomers, and Ware discloses the structure of the liquid crystal elastomers being voxelated.
Regarding claim 16, Li teaches the method of Claim 15.
However, Li does not teach wherein the first sensor comprises a voxelated surface, and wherein the first enzyme is deposited on the voxelated surface.
Rihani discloses liquid crystal elastomer-based microelectrode arrays. Specifically, Rihani teaches wherein the first sensor comprises a liquid-crystal elastomer-based surface, and wherein the first enzyme is deposited on the surface (Abstract: “Liquid crystal elastomers (LCEs) are a class of smart materials that reversibly change shape when exposed to a variety of stimuli. Our interest in LCEs is based on leveraging this shape change to deploy electrode sites beyond the tissue regions exhibiting inflammation associated with chronic implantation” Rihani discloses constructing an electrode, which includes a voxelated surface. Since the enzyme is deposited on the electrode, it includes depositing an enzyme on a voxelated surface.). Li and Rihani are analogous art as they are both related to the same field of endeavor of the structure of sensing electrodes.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure from Rihani into the method from Li as Li is silent on the structure of the electrodes used, and Rihani discloses a suitable structure in an analogous device.
However, the Li-Rihani combination does not teach the liquid crystal elastomer-based surface being voxelated.
Ware discloses voxelated liquid crystal elastomers. Specifically, Ware teaches wherein the liquid crystal elastomer-based surface is voxelated (Pages 1-18 discloses methods to create voxelated liquid crystal elastomers.). Rihani and Ware are analogous art as they are both related to liquid crystal elastomer structures.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure of the liquid crystal elastomer from Ware into the device from the Li/Rihani combination as the combination is silent on the specific structure of the liquid crystal elastomers, and Ware discloses the structure of the liquid crystal elastomers being voxelated.
Claims 3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claims 1 and 15 above, and further in view of Gofman (US 20210137426).
Regarding claim 3, Li teaches the system of Claim 1.
However, Li does not teach further comprising an ammeter arranged to measure the first current and the second current.
Gofman discloses devices and methods for measuring analytes in interstitial fluid. Specifically, Gofman teaches further comprising an ammeter arranged to measure the first current and the second current ([0041]: “The analog front end 220 may also include a current measurement circuit (e.g., an ammeter) 230 configured to measure the output current 121 of the WE source 224, which may be the current flowing to the working electrode 117.”). Li and Gofman are analogous art as they are related to the same field of endeavor of analyte sensors.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the ammeter from Gofman into the system from Li as the system is silent on the specific device used to measure the current, and Gofman discloses a suitable component in an analogous device.
Regarding claim 17, Li teaches the method of Claim 15.
However, Li does not teach further comprising measuring, by an ammeter, the first current and the second current.
Gofman discloses devices and methods for measuring analytes in interstitial fluid. Specifically, Gofman teaches further comprising measuring, by an ammeter, the first current and the second current ([0041]: “The analog front end 220 may also include a current measurement circuit (e.g., an ammeter) 230 configured to measure the output current 121 of the WE source 224, which may be the current flowing to the working electrode 117.”). Li and Gofman are analogous art as they are related to the same field of endeavor of analyte sensors.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the ammeter from Gofman into the method from Li as the system is silent on the specific device used to measure the current, and Gofman discloses a suitable component in an analogous device.
Claims 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claims 1 and 15 above, and further in view of Pless (US 20020169485).
Regarding claim 4, Li teaches the system of Claim 1, wherein the potentiostat is arranged to switch the potentiostat from applying the first voltage to the first sensor to applying the second voltage to the second sensor ([0608]: “in one embodiment the dual-electrode analyte sensor is a glucose sensor configured for fluid communication with a host's circulatory system, wherein the sensor is configured to generate a first signal associated with glucose (at the first working electrode E1) at an applied potential of 0.6 mV, and then to generate a second signal associated with O.sub.2 (also at the first working electrode E1) at an applied potential of -0.6 mV. Thus, in some embodiments, the potential applied to the first working electrode can be switched from +0.6 mV to -0.6 mV, such that the first working electrode switches from measuring the analyte-related signal (e.g., glucose) to measuring the second signal (e.g., associated with O.sub.2).”; [0609]: “In some alternative embodiments, the second working electrode E2 (e.g., instead of the first working electrode E1) is configured to generate the second signal”. The system measures the first analyte (glucose) at the first working electrode, then switches to the second analyte (oxygen) at the second working electrode.).
However, Li does not teach the component of the potentiostat being a multiplexer.
Pless discloses a neurostimulator system. Specifically, Pless teaches using a multiplexer to switch stimulation between electrodes ([0106]: “The multiplexer 524 may allow only one type of stimulation to be performed at a time, but in a presently preferred embodiment, the multiplexer 524 allows different types of stimulation to be selectively applied to the different electrodes 312-318, either sequentially or substantially simultaneously.”). Li and Pless are analogous art as they are both directed to solving the same problem of changing stimulation applied to electrodes.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiplexer from Pless into the system from Li as Li is silent on the specific component used to change the stimulation, and Pless discloses a suitable component in an analogous device.
Regarding claim 18, Li teaches the method of Claim 15, comprising switching the potentiostat from applying the first voltage to the first sensor to applying the second voltage to the second sensor ([0608]: “in one embodiment the dual-electrode analyte sensor is a glucose sensor configured for fluid communication with a host's circulatory system, wherein the sensor is configured to generate a first signal associated with glucose (at the first working electrode E1) at an applied potential of 0.6 mV, and then to generate a second signal associated with O.sub.2 (also at the first working electrode E1) at an applied potential of -0.6 mV. Thus, in some embodiments, the potential applied to the first working electrode can be switched from +0.6 mV to -0.6 mV, such that the first working electrode switches from measuring the analyte-related signal (e.g., glucose) to measuring the second signal (e.g., associated with O.sub.2).”; [0609]: “In some alternative embodiments, the second working electrode E2 (e.g., instead of the first working electrode E1) is configured to generate the second signal”. The system measures the first analyte (glucose) at the first working electrode, then switches to the second analyte (oxygen) at the second working electrode.).
However, Li does not teach the component of the potentiostat being a multiplexer.
Pless discloses a neurostimulator system. Specifically, Pless teaches using a multiplexer to switch stimulation between electrodes ([0106]: “The multiplexer 524 may allow only one type of stimulation to be performed at a time, but in a presently preferred embodiment, the multiplexer 524 allows different types of stimulation to be selectively applied to the different electrodes 312-318, either sequentially or substantially simultaneously.”). Li and Pless are analogous art as they are both directed to solving the same problem of changing stimulation applied to electrodes.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiplexer from Pless into the method from Li as Li is silent on the specific component used to change the stimulation, and Pless discloses a suitable component in an analogous device.
Claims 6-7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claims 1 and 15 above, and further in view of Heikenfeld (US 20190029654).
Regarding claim 6, Li teaches the system of Claim 1.
However, Li does not teach wherein applying the first voltage comprises directing a first waveform to the first sensor, and wherein applying the second voltage comprises directing a second waveform different from the first waveform to the second sensor.
Heikenfeld discloses devices for monitoring analytes in a biofluid. Specifically, Heikenfeld teaches wherein applying the first voltage comprises directing a first waveform to the first sensor, and wherein applying the second voltage comprises directing a second waveform different from the first waveform to the second sensor ([0060]: “the use of various polarities, frequencies, magnitudes, waveforms, and other methods of altering the electroporation voltage application could enhance electroporation specific to certain types or sizes of analytes”. The waveforms can be changed depending on what analyte is being sensed, and since the first electrode and second electrode measure different analytes, they have different waveforms.). Li and Heikenfeld are analogous art as they are both related to the same field of endeavor of analyte sensing.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the change in waveform from Heikenfeld into the system from Li as Li is silent on the specific characteristics changed to change the voltage, and Heikenfeld discloses suitable characteristics in an analogous device.
Regarding claim 7, the Li/Heikenfeld combination teaches the system of Claim 6, wherein the first waveform comprises at least one of a different shape or a different frequency than the second waveform (Heikenfeld, [0060]: “the use of various polarities, frequencies, magnitudes, waveforms, and other methods of altering the electroporation voltage application could enhance electroporation specific to certain types or sizes of analytes”. Different frequencies can be used for the different waveforms.).
Regarding claim 20, Li teaches the method of Claim 15.
However, Li does not teach wherein applying the first voltage comprises directing a first waveform to the first sensor, and wherein applying the second voltage comprises directing a second waveform different from the first waveform to the second sensor.
Heikenfeld discloses devices for monitoring analytes in a biofluid. Specifically, Heikenfeld teaches wherein applying the first voltage comprises directing a first waveform to the first sensor, and wherein applying the second voltage comprises directing a second waveform different from the first waveform to the second sensor ([0060]: “the use of various polarities, frequencies, magnitudes, waveforms, and other methods of altering the electroporation voltage application could enhance electroporation specific to certain types or sizes of analytes”. The waveforms can be changed depending on what analyte is being sensed, and since the first electrode and second electrode measure different analytes, they have different waveforms.). Li and Heikenfeld are analogous art as they are both related to the same field of endeavor of analyte sensing.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the change in waveform from Heikenfeld into the method from Li as Li is silent on the specific characteristics changed to change the voltage, and Heikenfeld discloses suitable characteristics in an analogous device.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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