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 .
Response to Amendment
The amendment filed 24 September 2025 has been entered. Claims 1, 11, 20, 28, 38, and 42 are currently amended. Claims 1-9, 11, 13-20, 24-25, 28-29, 32-34, 38, and 42-44 are pending in the application. Applicant’s amendments to the claims have overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 27 March 2025.
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.
Claims 1-9, 11, 13-15, 28-29, 38, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller et al. (US PGPub No. 2020/0178868), hereinafter Mueller, in view of Kahn et al. (US PGPub No. 2013/0248364), hereinafter Kahn.
Regarding claim 1, Mueller teaches a method of operating a biosensor device (par. 0002: “a method for detecting in-vivo properties of a biosensor”), the method comprising:
applying an excitation signal to a biosensor (Fig. 3A: potential step 150; par. 0143: “an application of a potential step 150 to the biosensor 110”),
wherein the biosensor includes a plurality of electrodes (Fig. 7: electrodes 120, 122, 124 on biosensor 110) par. 0032: “the electrochemical sensor as used herein is arranged in a fashion of an electrochemical cell and, thus, employs at least one pair of electrodes”) positionable within a user's skin to access interstitial fluid therein, wherein an electrode of the plurality of electrodes is configured to detect a presence of an analyte of interest in the interstitial fluid (Fig. 7: working electrode 120; par. 0022: “the biosensor may be a fully or a partially implantable biosensor which may, particularly, be adapted for performing the detection of the analyte in the body fluid in a subcutaneous tissue, in particular, in an interstitial fluid”),
wherein applying the excitation signal includes applying the excitation signal to the electrode, and wherein the excitation signal includes a time-varying characteristic configured to perturb a diffusion limited steady state of the biosensor (Fig. 3A: potential step 150; par. 0143: “configured for determining the in-vivo current response indicative of the in-vivo admittance Y(t) of the biosensor”);
measuring a response of the biosensor to the time-varying characteristic (Figs. 3B-3C: current and charge response to potential step 150), wherein the response of the biosensor includes a first contribution that depends at least in part on capacitive charging of a surface of the electrode (Fig. 3C: charge response 160) and a second contribution that depends at least in part on a diffusion limited process for a faradaic response at the electrode (Fig. 3B: current response 152);
separating the first contribution from the second contribution (par. 0120: “the potential step response measuring unit comprises at least one charge counter and at least one peak detector, wherein the peak detector is configured for measuring a first characteristic value being related to an electrical resistance of the membrane and wherein the charge counter is configured for measuring a second characteristic value being related to an electrical capacitance of the working electrode;” examiner interprets the first and second characteristic values as separated first and second contributions, as broadly as claimed);
and determining, based at least in part on the separated first contribution or the separated second contribution, at least one operational parameter that includes: (a) one or more system-dependent parameters of the biosensor device, (b) one or more properties of the interstitial fluid surrounding the electrode, (c) one or more properties of tissue surrounding the electrode, or (d) any combination thereof (par. 0057: “the first operating point reflects the first characteristic value which is related to the electrical resistance of the membrane, thus, providing information about the geometric area of the working electrode carrying the membrane, the thickness of the membrane, and the permeability of the membrane with respect to at least one kind of ions while the second operating point reflects the second characteristic value which is related to the electrical capacitance of the working electrode, thus, providing information about the actual surface area of the working electrode carrying the membrane and the amount of catalyst and/or mediator available in the membrane” and par. 0044: “the term “actual surface area of an electrode” refers to a partition of the surface of the electrode which actually carries the membrane”).
Mueller does not explicitly teach wherein the biosensor includes a multi-analyte detecting needle that includes the plurality of electrodes. However, in an analogous art, Kahn teaches an electrochemical sensor that can take the form of a needle (par. 0160: “The semiconductor substrate can be in any form that is amenable to the production of a semiconductor electrode. […] The semiconductor substrate can be a monolithic form such as a chip, wafer, rod, needle, block, ingot, or the like”) and can detect multiple analytes (par. 0032: “the substrate has a plurality of zones wherein each zone comprises a redox-active moiety immobilized thereon, the redox-active moiety exhibiting an oxidation potential and/or a reduction potential that is sensitive to the presence of an analyte. In some embodiments a first zone comprises a redox moiety sensitive to a first analyte, and a second zone comprises a redox moiety sensitive to a second analyte”), which allows several analytes to be measured simultaneously (par. 0211: “more than one analyte-sensitive redox-active moiety can be used. For example, there can be one redox-active moiety that is sensitive to hydrogen ion, and another that is sensitive to a second analyte such as CO, oxygen, ammonia, or an alkali metal. This approach allows for the simultaneous measurement of several analytes”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Mueller by providing the biosensor with a multi-analyte detecting needle, as taught by Kahn, in order to allow several analytes to be measured simultaneously, as taught by Kahn.
Regarding claims 2 and 15, the combination teaches the method of claim 1 as described previously. Mueller further teaches wherein: the at least one operational parameter and one or more system-dependent parameters includes an effective surface area of the electrode, and the determining includes determining the effective surface area from the separated first contribution (par. 0057: “the second operating point reflects the second characteristic value which is related to the electrical capacitance of the working electrode, thus, providing information about the actual surface area of the working electrode carrying the membrane and the amount of catalyst and/or mediator available in the membrane” and par. 0044: “the term “actual surface area of an electrode” refers to a partition of the surface of the electrode which actually carries the membrane. As a result, the actual surface area of the electrode may be identical with the geometric area of the electrode as long as the geometric area of the electrode is completely covered by the membrane. However, the actual surface area of the electrode may be subject to alterations during the operation of the biosensor, in particular, in an event in which the electrode chemistry may at least partially be detached from the electrode pad, which can be considered as active electrode surface after detachment of the electrode chemistry”),
and the method further comprises detecting application of the biosensor device to the user's body based at least in part on the effective surface area of the electrode (par. 0140: “the double-layer capacitance may be used as a quantity representing the surface area A of the electrode 118. A measurement of the double-layer capacitance may reveal changes related to electrode surface, in particular, loss of contact, draining, or detaching of the electrode 118”).
Regarding claim 3, the combination teaches the method of claim 1 as described previously. Mueller further teaches further comprising controlling operation of the biosensor based at least in part on the determined at least one operational parameter to increase detection accuracy of the biosensor for the analyte of interest (par. 0049: “the in-vivo sensitivity drift in the biosensor may, thus, be compensated by correcting the measured value for the raw current by determining an actual value of the sensitivity by using the first characteristic value and, preferably, the second characteristic value, whereby the value of the sensitivity-to-admittance relation as provided during step a) is taken into account”).
Regarding claim 4, the combination teaches the method of claim 1 as described previously. Mueller further teaches further comprising: periodically applying the time-varying characteristic to the electrode and monitoring the response of the biosensor; and adjusting operation of the biosensor based at least in part on changes detected in the response of the biosensor over time (par. 0020: “any or all of the indicated steps may also be repeated several times in order to allow for detecting in-vivo properties of the biosensor, such as after a prespecified time or as a consequence of an occurrence of a prespecified event;” par. 0049: “the in-vivo sensitivity drift in the biosensor may, thus, be compensated by correcting the measured value for the raw current by determining an actual value of the sensitivity by using the first characteristic value and, preferably, the second characteristic value, whereby the value of the sensitivity-to-admittance relation as provided during step a) is taken into account”).
Regarding claim 5, the combination teaches the method of claim 4 as described previously. Mueller further teaches wherein the changes correspond to changes at a detection site of the electrode within the user's skin (Table: “Cause” column listing possible changes at a detection site of the electrode within the user’s skin).
Regarding claim 6, the combination teaches the method of claim 4 as described previously. Mueller further teaches wherein adjusting the operation of the biosensor includes: performing drift correction or calibration based at least in part on the detected changes;
adjusting the operation of the biosensor according to the drift correction or the calibration to generate a detection output for the analyte of interest;
and determining a concentration of the analyte of interest based on the detection output (par. 0072: “determining an analyte value in a sample of a body fluid by using the raw current and compensating an in-vivo sensitivity drift in the biosensor by correcting the measured value for the raw current by determining an actual value of the sensitivity by using the first characteristic value”).
Regarding claim 7, the combination teaches the method of claim 1 as described previously. Mueller further teaches wherein the response of the biosensor is a current response of the biosensor (par. 0049: “For the purpose of determining both the first characteristic value and the second characteristic value, the in-vivo current response indicative of the in-vivo admittance of the biosensor is measured at two different operating points as described elsewhere in this document”).
Regarding claims 8-9, the combination teaches the method of claim 1 as described previously. Mueller further teaches wherein the time-varying characteristic includes a positive voltage step in the excitation signal, and wherein the excitation signal includes a square wave, a triangular wave, a sawtooth wave, or any combination thereof; and the time-varying characteristic includes all or a portion of the square wave, the triangular wave, the sawtooth wave, or any combination thereof (Fig. 3A: positive voltage step and square wave 150).
Regarding claims 11 and 14, the combination teaches the method of claim 1 as described previously. Mueller further teaches wherein separating the first contribution from the second contribution includes: modeling the expected response of the biosensor to the time-varying characteristic, fitting the response of the biosensor to a model of an expected response of the bio sensor to the time-varying characteristic; and simultaneously solving for the first contribution and the second contribution (Equations 6-12 modeling the expected response of the biosensor; Equation 9: solving for electrical resistance of the membrane; Equations 11-12: solving for electrical capacitance of the working electrode). Examiner notes that as the limitation “simultaneously solving for (a) the first contribution and the second contribution or (b) the first contribution, the second contribution, and a third contribution” is stated in the alternative, the limitation is considered to be met when the prior art reads on only one of the alternatives.
Regarding claim 13, the combination teaches the method of claim 11 as described previously. Mueller further teaches wherein the model of the expected response is a model of an expected current response of the biosensor to the time-varying characteristic as measured downstream from an integrated analog filter (Fig. 9B: peak determination circuit 238 including integrated passive low-pass filter R14 and C2).
Regarding claim 28, Mueller teaches a method, comprising: determining an effective surface area of an electrode of a biosensor (par. 0140: “the surface area A of the electrode 118 may be described by having a double layer being represented by a double-layer capacitance as schematically depicted in FIG. 8 below, wherein the double-layer capacitance may be determined by measuring the in-vivo current response of the biosensor 110. As used herein, the double-layer capacitance may be used as a quantity representing the surface area A of the electrode 118” and par. 0044: “the term “actual surface area of an electrode” refers to a partition of the surface of the electrode which actually carries the membrane. As a result, the actual surface area of the electrode may be identical with the geometric area of the electrode as long as the geometric area of the electrode is completely covered by the membrane. However, the actual surface area of the electrode may be subject to alterations during the operation of the biosensor, in particular, in an event in which the electrode chemistry may at least partially be detached from the electrode pad, which can be considered as active electrode surface after detachment of the electrode chemistry”),
wherein the biosensor is configured to determine a concentration of an analyte of interest in interstitial fluid of a user, wherein the electrode of the biosensor is positionable within tissue of the user to access the interstitial fluid when the biosensor is applied to the user's body, (par. 0022: “the biosensor may be a fully or a partially implantable biosensor which may, particularly, be adapted for performing the detection of the analyte in the body fluid in a subcutaneous tissue, in particular, in an interstitial fluid”),
and wherein determining the effective surface area of the electrode includes determining the effective surface area from capacitive charging of a surface of the electrode that is measured when a perturbation in an excitation signal is applied to the electrode (Figs. 3A-3B: potential step 150 and current response 152; par. 0140: “the double-layer capacitance may be determined by measuring the in-vivo current response of the biosensor 110. As used herein, the double-layer capacitance may be used as a quantity representing the surface area A of the electrode 118”);
and detecting application of the biosensor to the user's body based at least in part on the determined effective surface area of the electrode (par. 0140: “A measurement of the double-layer capacitance may reveal changes related to electrode surface, in particular, loss of contact, draining, or detaching of the electrode 118. As a result, the measurement of the double-layer capacitance may be employed as additional parameter, particularly, adapted to provide additional failsafe information with regard to the operation of the biosensor”).
Mueller does not teach wherein the biosensor includes a multi-analyte detecting needle. However, Kahn teaches including a multi-analyte detecting needle, and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Mueller in view of Kahn and arrive at the method of claim 28, for the same reasons set forth in the rejection of claim 1.
Regarding claim 29, the combination teaches the method of claim 28 as described previously. Mueller further teaches further comprising determining whether a minimum application threshold is met based at least in part on the determined effective surface area of the electrode (par. 0140: “the double-layer capacitance may be used as a quantity representing the surface area A of the electrode 118. A measurement of the double-layer capacitance may reveal changes related to electrode surface, in particular, loss of contact, draining, or detaching of the electrode 118”).
Regarding claim 38, Mueller teaches a method, comprising: measuring a signal output from a sensing element of a biosensor (Fig. 7: potential step response measuring unit 206; par. 0120: “the potential step response measuring unit is configured for measuring the current response”),
wherein the signal is output in response to an interrogation signal in a drive signal that is applied to the sensing element (Fig. 3; par. 0143: “FIG. 3 illustrates an application of a potential step 150 to the biosensor 110 and a response of the biosensor 110 to the application of the potential step 150”),
wherein the sensing element is positionable at a detection site within tissue of a user to access a body fluid of the user and is configured to detect presence of an analyte of interest in the body fluid (par. 0022: “the biosensor may be a fully or a partially implantable biosensor which may, particularly, be adapted for performing the detection of the analyte in the body fluid in a subcutaneous tissue, in particular, in an interstitial fluid”);
fitting the signal to a model of an expected signal to isolate a transient response of the signal output (Equations 6-12 describing transient response in Figs. 3B and 3C),
wherein the transient response is associated with one or more characteristics of a detection site (par. 0057: “the first operating point reflects the first characteristic value which is related to the electrical resistance of the membrane, thus, providing information about the geometric area of the working electrode carrying the membrane, the thickness of the membrane, and the permeability of the membrane with respect to at least one kind of ions while the second operating point reflects the second characteristic value which is related to the electrical capacitance of the working electrode, thus, providing information about the actual surface area of the working electrode carrying the membrane and the amount of catalyst and/or mediator available in the membrane”);
and determining the presence of the analyte of interest based at least in part on the transient response (par. 0072: “determining an analyte value in a sample of a body fluid by using the raw current and compensating an in-vivo sensitivity drift in the biosensor by correcting the measured value for the raw current by determining an actual value of the sensitivity by using the first characteristic value”).
Mueller does not teach wherein the biosensor includes a multi-analyte detecting needle. However, Kahn teaches including a multi-analyte detecting needle, and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Mueller in view of Kahn and arrive at the method of claim 38, for the same reasons set forth in the rejection of claim 1.
Regarding claim 42, the combination teaches the method of claim 38 as described previously. Mueller further teaches further comprising determining an effective surface area of the sensing element based at least in part on the transient response (par. 0057: “the second operating point reflects the second characteristic value which is related to the electrical capacitance of the working electrode, thus, providing information about the actual surface area of the working electrode carrying the membrane and the amount of catalyst and/or mediator available in the membrane” and par. 0140: “the surface area A of the electrode 118 may be described by having a double layer being represented by a double-layer capacitance as schematically depicted in FIG. 8 below, wherein the double-layer capacitance may be determined by measuring the in-vivo current response of the biosensor 110. As used herein, the double-layer capacitance may be used as a quantity representing the surface area A of the electrode 118”).
Regarding claim 43, the combination teaches the method of claim 42 as described previously. Mueller further teaches further comprising detecting application of the biosensor to the user's body based at least in part on the determined effective surface area (par. 0140: “A measurement of the double-layer capacitance may reveal changes related to electrode surface, in particular, loss of contact, draining, or detaching of the electrode 118. As a result, the measurement of the double-layer capacitance may be employed as additional parameter, particularly, adapted to provide additional failsafe information with regard to the operation of the biosensor”).
Claims 16-18, 32-34, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Kahn and further in view of Nogueria et al. (US PGPub No. 2019/0076070), hereinafter Nogueria.
Regarding claim 16, Mueller in view of Kahn teaches the method of claim 15 as described previously. Mueller does not explicitly teach further comprising determining an absolute concentration of the analyte of interest based at least in part on the effective surface area of the electrode. However, in an analogous art, Nogueria teaches determining an absolution concentration of an analyte of interest based at least in part on the effective surface area of an electrode (par. 0015: “periodically measuring, by the physical sensor electronics, electrode current (Isig) signals for the working electrode; performing, by the microcontroller, an Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode; calculating, by the microcontroller, an adjusted calibration factor for the sensor based on the EIS-related data; calculating, by the microcontroller, an adjusted offset value for the sensor based on at least one of a stabilization time adjustment and a non-linear sensor response adjustment; and calculating, by the microcontroller, an optimized measured glucose value (SG) based on the adjusted calibration factor and the adjusted offset value, wherein SG=(adjusted calibration factor)×(Isig+adjusted offset value);” examiner notes that EIS provides information related to effective surface area of the electrode), which allows the sensor to be calibrated without the need for additional finger-stick or meter data (par. 0690: “In block 6395, the Cal Factor may be adjusted based on the monitored parameters, so as to provide a “calibration-free” CGM sensor. It is noted that, within the context of the invention, the term “calibration-free” does not mean that a particular sensor needs no calibration at all. Rather, it means that the sensor can self-calibrate based on the EIS output data, in real time, and without the need for additional finger-stick or meter data”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Mueller and Kahn to calibrate analyte measurements based on the effective surface area, as taught by Nogueria, in order for the sensor to be calibrated without the need for additional finger-stick or meter data, as taught by Nogueria.
Regarding claims 17-18, Mueller in view of Kahn teaches the method of claim 1 as described previously. Mueller further teaches wherein the method steps can be repeated over time (par. 0020: “Additionally, any or all of the indicated steps may also be repeated several times in order to allow for detecting in-vivo properties of the biosensor, such as after a prespecified time or as a consequence of an occurrence of a prespecified event”) and that detachment of the electrode can be detected from effective surface area (par. 0140: “A measurement of the double-layer capacitance may reveal changes related to electrode surface, in particular, loss of contact, draining, or detaching of the electrode 118”) but does not explicitly teach comparing the at least one operational parameter determined from a second response to the at least one operational parameter determined from the first response, wherein the operational parameter includes an effective surface area, and determining that a position of the electrode within the user's skin has changed based at least in part on a difference between the first effective surface area and the second effective surface area.
However, Nogueria teaches periodically collecting data related to effective surface area (par. 0319: “The diagnostic procedure illustrated in the flow diagram of FIG. 31 is based on the collection of EIS data on a periodic basis, such as, e.g., hourly, every half hour, every 10 minutes, or at any other interval—including continuously—as may be appropriate for the specific sensor under analysis”), and determining that a position of the electrode within the user's skin has changed based at least in part on a difference between the first effective surface area and the second effective surface area (Fig. 31: pullout detection step 3100; par. 0321: “each time EIS is run (i.e., each time an EIS procedure is performed), data may be gathered about a multiplicity of impedance-based parameters, or characteristics, which can be used to detect sensor condition or quality, including, e.g., whether the sensor has failed or is failing”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Mueller and Kahn by periodically collecting data related to effective surface area of the electrode and determining that electrode pullout has occurred, as taught by Nogueria, in order to detect whether the sensor has failed or is failing, as taught by Nogueria.
Regarding claim 32, Mueller in view of Kahn teaches the method of claim 29 as described previously but does not explicitly teach further comprising instructing the user to reapply the biosensor to the user's body based at least in part on a determination that the minimum application threshold is not met. However, Nogueria teaches alerting a user that pullout has occurred (i.e., instructing the user that reapplication is required) when it is determined that the sensor is no longer in place (par. 0322: “it is determined that the sensor is no longer in place, and an alert is sent, e.g., to the patient/user, indicating that sensor pullout has occurred”). To provide the method of Mueller and Kahn with the alert of Nogueria would have been obvious to one of ordinary skill in the art for the following reasons:
Mueller in view of Kahn discloses a prior art method upon which the claimed invention (instructing the user to reapply the biosensor) can be seen as an “improvement” (the combination only teaches determining that the biosensor is in a failure mode). Nogueria teaches a prior art method using a known technique that is applicable to the method of the combined reference, namely, the technique of alerting the user that the particular failure of pullout has occurred, so that the user knows to reapply the biosensor. Thus, it would have been recognized by one of ordinary skill in the art the applying the known technique taught by Nogueria to the method of the combined reference would have yielded predictable results and resulted in an improved method, namely, a method that alerts the user to the nature of the failure and the necessity of reapplying the biosensor.
Regarding claim 33, Mueller in view of Kahn teaches the method of claim 28 as described previously but does not explicitly teach further comprising applying a correction factor to signals generated at least in part by the electrode, wherein the correction factor is based at least in part on the determined effective surface area of the electrode.
However, Nogueria teaches applying a calibration factor to signals generated by the electrode, wherein the correction factor is based at least in part on the determined effective surface area of the electrode (par. 0015: “calculating, by the microcontroller, an adjusted calibration factor for the sensor based on the EIS-related data; calculating, by the microcontroller, an adjusted offset value for the sensor based on at least one of a stabilization time adjustment and a non-linear sensor response adjustment; and calculating, by the microcontroller, an optimized measured glucose value (SG) based on the adjusted calibration factor and the adjusted offset value, wherein SG=(adjusted calibration factor)×(Isig+adjusted offset value);” examiner notes that EIS-related data provides information about effective surface area). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference by applying a calibration factor based on effective surface area, as taught by Nogueria, in order to calculate an optimized measured glucose value, as taught by Nogueria.
Regarding claim 34, Mueller in view of Kahn teaches the method of claim 28 as described previously but does not explicitly teach further comprising adjusting the excitation signal based at least in part on the determined effective surface area of the electrode. However, Nogueria teaches adjusting the excitation signal after determining, based on the effective surface area of the electrode, that remedial action is to be taken to remove polluting species (par. 0289: “Polluting species can reduce the surface area of the electrode or the diffusion pathways of analytes and reaction byproducts, thereby causing the sensor current to drop;” par. 0293: “The block 2030 remedial action is performed to remove any of the polluting species, which may have caused the abnormal impedance value. In preferred embodiments, the remedial action is performed by applying a reverse current, or a reverse voltage between the working electrode and the reference electrode;” examiner interprets applying a reverse current or reverse voltage as adjusting the excitation signal). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference by incorporating the remedial action logic taught by Nogueria in order to remove polluting species when detected based on effective surface area, as taught by Nogueria.
Regarding claim 44, Mueller in view of Kahn teaches the method of claim 42 as described previously. Mueller and Kahn further in view of Nogueria teaches the limitations of claim 44 for the same reasons described in the rejections of claims 33-34.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Kahn and Nogueria and further in view of Gottlieb et al. (US PGPub No. 2014/0135605), hereinafter Gottlieb.
The combination of Mueller in view of Kahn and Nogueria teaches the method of claim 17 as described previously. The combined reference does not explicitly teach wherein: the at least one operational parameter determined from the first response include first diffusion properties at a membrane proximate the electrode; the at least one operational parameter determined from the second response include second diffusion properties at the membrane; and the monitoring further includes determining a hydration state of the membrane based at least in part on a difference between the first diffusion properties and the second diffusion properties. However, in an analogous art, Gottlieb teaches determining a hydration state of a membrane based at least in part on a difference between first and second diffusion properties (Fig. 13 and par. 0139: “detecting hydration includes applying a series of hydration pulses (voltages selected to detect or facilitate sensor hydration) to the sensor for a first hydration time; recording the current response of the sensor during application of the series of hydration pulses; and comparing the current response to a predetermined hydration threshold. Application of the series of hydration pulses may be terminated if the current response reaches or exceeds the predetermined hydration threshold. Detecting hydration may further include applying a second series of hydration pulses to the sensor for a second hydration time if the current response does not reach the predetermined hydration threshold during the first predetermined hydration time”). Gottlieb teaches that detecting hydration can help prevent compromising accuracy or lifetime of the sensor (par. 0141: “This can solve problems that occur when a user attempts to initialize a sensor that is not fully hydrated (e.g. compromising the accuracy and/or lifetime of the sensor)”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference by incorporating the hydration detection method taught by Gottlieb in order to help prevent comprising accuracy or lifetime of the sensor, as taught by Gottlieb.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Kahn and Nogueria and further in view of Ordonez Orellana et al. (US PGPub No. 2014/0135605), hereinafter Ordonez.
The combination of Mueller in view of Kahn and Nogueria teaches the method of claim 17 as described previously. The combined reference does not explicitly teach wherein the at least one operational parameter determined from the first response includes first diffusion properties of the interstitial fluid and/or the tissue; the at least one operational parameter determined from the second response includes second diffusion properties of the interstitial fluid and/or the tissue; and the monitoring further includes determining, based at least in part on a difference between the first diffusion properties and the second diffusion properties, (a) an extent of healing of the tissue surrounding the electrode, (b) a physiology of the user has changed, (c) a hydration level of the user has changed, or (d) any combination thereof.
However, in a related health monitoring art, Ordonez teaches a method of evaluating a hydration status of a user by detecting changes in diffusion properties of interstitial fluid (par. 0096: “Based on impedance spectroscopy, changes in the physiological ionic status in interstitial fluids can be determined, allowing evaluation of a hydration status of a user. Impedance spectroscopy analysis thereby may be based on e.g. Nyquist/Warburg plots of the derived information”), which allows health to be monitored automatically without the need for consulting a medical practitioner (par. 0087: “It is an advantage of embodiments of the present invention that there is no need for manual intervention, i.e. measurements can be performed in an automated way and automatically, due to the fact that measurements are based on an implantable sensor. It is an advantage of embodiments of the present invention that monitoring health can be performed without the need for consulting a medical practitioner”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of the combined reference by evaluating hydration status of a user, as taught by Ordonez, in order to monitor health automatically, as taught by Ordonez.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Kahn and further in view of Wang et al. (WO 2021/138473), hereinafter Wang.
Mueller in view of Kahn teaches the method of claim 1 as described previously but does not explicitly teach detecting a second analyte of interest in the interstitial fluid, wherein the method further comprises applying a second excitation signal to the electrode or to a second electrode of the plurality of electrodes that corresponds to the second analyte of interest and includes a different time-varying characteristic configured to perturb the diffusion limited steady state of the biosensor. However, Mueller contemplates multiple analytes (par. 0025: “As an example, the at least one analyte may be selected from the group consisting of glucose, cholesterol, triglycerides, lactate. Additionally, or alternatively, however, other types of analytes may be used and/or any combination of analytes may be determined”) and various kinds of time-varying electrical potential steps (par. 0053: “other kind of measures which may be capable of providing a time-varying electrical potential to the biosensor may also be feasible. As used herein, these kinds of measures may also be comprised by the term “potential step.” In particular, a time-varying waveform, be it a sine or a cosine wave or a linear or a non-linear combination of sine and/or cosine waves, at least one linear or non-linear sweep, at least one cyclically varying signal, such as provided by voltammetry, may also be applicable”), and in an analogous art, Wang teaches an in vivo sensor capable of monitoring at least two analytes using one or more electrodes (par. 0048: “The present disclosure provides for monitoring at least two analytes, e.g., both glucose and another analyte, using one or more in vivo analyte sensors responsive to each analyte, and in particularly advantageous configurations, a single analyte sensor that is responsive to both analytes in vivo may be used;” par. 0056-0057: “both the first analyte-responsive active area and the second analyte-responsive active area may be disposed upon the single working electrode […] Analyte sensors featuring multiple working electrodes may similarly comprise at least one additional electrode”). Wang teaches that it is desirable to monitor analytes that are commonly subject to concurrent dysregulation for glucose in diabetic individuals (par. 0004: “Other analytes commonly subject to concurrent dysregulation with glucose in diabetic individuals include, for example, lactate, oxygen, pH, Ale, ketones, and the like;” see also pars. 0006-0009) and that providing monitoring for multiple analytes in a single sensor helps solve the problems of inconvenience, added cost burden, and increased likelihood of failure (par. 0005: “Analyte monitoring approaches employing multiple in vivo analyte sensors may be highly inconvenient for a user. Moreover, when multiple in vivo analyte sensors are used for analyte monitoring, there is an added cost burden for equipment and an increased statistical likelihood for failure of at least one of the individual in vivo analyte sensors”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Mueller and Kahn by configuring the biosensor to detect a second analyte of interest on either the same electrode or a second electrode for monitoring concurrent dysregulation with glucose, as taught by Wang, in order to help solve the problems of inconvenience, added cost burden, and increased likelihood of failure, as taught by Wang.
It further would have been an obvious matter of design choice to one of ordinary skill in the art to choose a different time-varying characteristic to perturb the diffusion limited steady state of the biosensor, since Mueller teaches that other kinds of time-varying characteristics can be used in this method, and applicant has not disclosed that using different time-varying characteristics for different analytes provides an advantage, is used for a particular purpose, or solves a stated problem, and it appears that the invention would perform equally as well with the same or with different time-varying characteristics for different analytes.
Response to Arguments
Applicant’s arguments, filed 24 September 2025, with respect to the rejection(s) of claim(s) 1, 28, and 38 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 in view of Kahn. As previously described, Kahn teaches a multi-analyte detecting needle.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794