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 .
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.
Claims 2-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bohm et al. (US20120265037), hereinafter referred to as ‘Bohm’.
Regarding Claim 2, Bohm discloses a method, comprising: applying a bias voltage change to a bias voltage of an analyte sensor ( applying a bias voltage to an analyte sensor [0099]); measuring a current response based at least on application of the bias voltage change (At step 1202, a stimulus signal in the form of a voltage step can be applied to a bias voltage of the sensor. The voltage step can be in the range of 10-50 mV, for example 10 mV, and the bias voltage can be 600 mV. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206 [0331]); using at least the measured current response, to derive a current value at a time of the application of the bias voltage change (At step 1202, a stimulus signal in the form of a voltage step can be applied to a bias voltage of the sensor. The voltage step can be in the range of 10-50 mV, for example 10 mV, and the bias voltage can be 600 mV. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206. At step 1208, a Fourier transform of the derivative of the response can then be calculated to yield ac currents in the frequency domain [0331] see also [0335] and [0336]); estimating an impedance value using the derived current value (FIG. 13 is a flowchart of process 1300 for determining an impedance of a sensor being studied, such as the impedance of the sensor's membrane, in accordance with one embodiment. At step 1302, a stimulus signal in the form of a voltage step above a bias voltage is applied to the sensor. The signal response is measured at step 1304, and, at step 1306, a peak current (i.e., derived current) of the response is determined. Next, at step 1308, one or more impedance characteristics (e.g., resistance) of the sensor membrane (e.g., Rmembrane) is calculated based on the peak current. The one or more impedance characteristics can then be correlated to a property of the sensor [0332]); and determining a characteristic of the analyte sensor using the estimated impedance value (The signal response is measured at step 1304, and, at step 1306, a peak current of the response is determined. Next, at step 1308, one or more impedance characteristics (e.g., resistance) of the sensor membrane (e.g., Rmembrane) is calculated based on the peak current [0332]; As discussed further below, a relationship between sensitivity (i.e., characteristic of the analyte sensor) and impedance has been observed in embodiments of analyte sensors. Although not wishing to be bound by theory, embodiments of analyte sensors are believed to have a relationship between an impedance of a sensor's membrane and the diffusivity of the membrane. For example, a change in impedance of an analyte sensor can indicate a proportional change in diffusivity of the analyte sensor's membrane[0344]).
Although Bohm does not explicitly disclose extrapolating, using at least the measured current response, to derive a current value at a time of the application of the bias voltage change, Bohm teaches using measured current responses ([0330] response signal) and a derived current value at the time of the voltage change , (see Fig. 14A, 14B, and [0332]). Therefore it would have been obvious to a person having ordinary skill in the art at the time of filing to extrapolate between measured data points to determine the current at the time of the bias voltage change as shown in Fig. 14B in Bohm. This would result in the accurate characterization of the analyte sensor with correctly compensated drift.
Regarding Claim 3, Bohm discloses the claimed invention discussed in claim 2.
Bohm discloses measuring the current response includes integrating a charge over a plurality of time periods after application of the bias voltage change (FIG. 14B is a graph of a current response 1402 of the analyte sensor to the input voltage 1400 of FIG. 14A. As illustrated in FIG. 14B, the current response 1402 can include a sharp spike in current starting at time t2, which corresponds to the time in which the voltage step begins to impact the response. The current response 1402 includes a peak current at point 1404 and then the current response 1402 gradually decreases and levels off to a slightly higher level due to the increase in input voltage 1400 as compared to before the voltage step [0336]).
Regarding Claim 4, Bohm discloses the claimed invention discussed in claim 2.
Bohm discloses extrapolating includes fitting a curve based at least on the current response (In addition, the curve may be fitted using any of a variety of functions, including, but not limited to, a linear function (including a constant function), logarithmic function, quadratic function, cubic function, square root function, power function, polynomial function, rational function, exponential function, sinusoidal function, and variations and combinations thereof [0282]).
Regarding Claim 5, Bohm discloses the claimed invention discussed in claim 4.
Bohm discloses fitting the curve includes fitting an exponential curve ( In addition, the curve may be fitted using any of a variety of functions, including, but not limited to, a linear function (including a constant function), logarithmic function, quadratic function, cubic function, square root function, power function, polynomial function, rational function, exponential function, sinusoidal function, and variations and combinations thereof [0282]).
Regarding Claim 6, Bohm discloses the claimed invention discussed in claim 5.
Bohm discloses the characteristic of the analyte sensor includes a sensitivity of the analyte sensor (iteratively determining, with an electronic device, a sensitivity value of the continuous analyte sensor as a function of time by applying a priori information comprising sensor sensitivity information; and calibrating the sensor data based at least in part on the determined sensitivity value [0006]).
Regarding Claim 7, Bohm discloses the claimed invention discussed in claim 1.
Bohm discloses compensating for sensor drift using at least one of the estimated impedance value or the sensitivity ( In certain embodiments, the continuous analyte sensor may measure an additional signal associated with the baseline and/or sensitivity of the sensor, thereby enabling monitoring of baseline and/or additional monitoring of sensitivity changes or drift that may occur in a continuous analyte sensor over time[0264]).
Regarding Claim 8, Bohm discloses the claimed invention discussed in claim 7.
Bohm discloses the characteristic of the analyte sensor includes a level of damage or a defect of the analyte sensor (The alarm can notify a user that the current sensor system is defective, for example. If, on the other hand, one or both of the impedance and phase values fall within the respective predefined levels, then process 1900 ends [0365]).
Regarding Claim 9, Bohm discloses the claimed invention discussed in claim 1.
Bohm discloses the characteristic of the analyte sensor includes a compensation for the analyte sensor (In accordance with some embodiments, the membrane impedance of each electrode of a dual-electrode system can be used to determine or update a scaling factor[0393]).
Regarding Claim 10, Bohm discloses the claimed invention discussed in claim 9.
Bohm discloses applying the bias voltage change to the bias voltage includes applying a step in the bias voltage (FIG. 14B is a graph of a current response 1402 of the analyte sensor to the input voltage 1400 of FIG. 14A. As illustrated in FIG. 14B, the current response 1402 can include a sharp spike in current starting at time t2, which corresponds to the time in which the voltage step begins to impact the response. The current response 1402 includes a peak current at point 1404 and then the current response 1402 gradually decreases and levels off to a slightly higher level due to the increase in input voltage 1400 as compared to before the voltage step [0336]).
Regarding Claim 11, Bohm discloses an analyte sensor system, comprising: an analyte sensor configured to provide a sensor signal indicative of an analyte concentration level (The estimated analyte concentration values can then be used for further processing and/or outputting, such as triggering alerts, displaying information representative of the estimated values on a user device and/or outputting the information to an external device [0347]); and sensor electronics configured to: apply a bias voltage change to a bias voltage of an analyte sensor ( applying a bias voltage to an analyte sensor [0099]); measure a current response based at least on application of the bias voltage change (At step 1202, a stimulus signal in the form of a voltage step can be applied to a bias voltage of the sensor. The voltage step can be in the range of 10-50 mV, for example 10 mV, and the bias voltage can be 600 mV. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206 [0331]); using at least the measured current response to derive a current value at a time of the application of the bias voltage change (At step 1202, a stimulus signal in the form of a voltage step can be applied to a bias voltage of the sensor. The voltage step can be in the range of 10-50 mV, for example 10 mV, and the bias voltage can be 600 mV. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206. At step 1208, a Fourier transform of the derivative of the response can then be calculated to yield ac currents in the frequency domain [0331] see also [0335] and [0336]); and determine a characteristic of the analyte sensor using the estimated impedance value (The signal response is measured at step 1304, and, at step 1306, a peak current of the response is determined. Next, at step 1308, one or more impedance characteristics (e.g., resistance) of the sensor membrane (e.g., Rmembrane) is calculated based on the peak current [0332]; As discussed further below, a relationship between sensitivity (i.e., characteristic of the analyte sensor) and impedance has been observed in embodiments of analyte sensors. Although not wishing to be bound by theory, embodiments of analyte sensors are believed to have a relationship between an impedance of a sensor's membrane and the diffusivity of the membrane. For example, a change in impedance of an analyte sensor can indicate a proportional change in diffusivity of the analyte sensor's membrane[0344]).
Although Bohm does not explicitly disclose extrapolating, using at least the measured current response, to derive a current value at a time of the application of the bias voltage change, Bohm teaches using measured current responses ([0330] response signal) and a derived current value at the time of the voltage change , (see Fig. 14A, 14B, and [0332]). Therefore it would have been obvious to a person having ordinary skill in the art at the time of filing to extrapolate between measured data points to determine the current at the time of the bias voltage change as shown in Fig. 14B in Bohm. This would result in the accurate characterization of the analyte sensor with correctly compensated drift.
Regarding Claim 12, Bohm discloses the claimed invention discussed in claim 11.
Bohm discloses measuring the current response includes integrating a charge over a plurality of time periods after application of the bias voltage change (FIG. 14B is a graph of a current response 1402 of the analyte sensor to the input voltage 1400 of FIG. 14A. As illustrated in FIG. 14B, the current response 1402 can include a sharp spike in current starting at time t2, which corresponds to the time in which the voltage step begins to impact the response. The current response 1402 includes a peak current at point 1404 and then the current response 1402 gradually decreases and levels off to a slightly higher level due to the increase in input voltage 1400 as compared to before the voltage step [0336]).
Regarding Claim 13, Bohm discloses the claimed invention discussed in claim 11.
Bohm discloses extrapolating includes fitting a curve based at least on the current response (In addition, the curve may be fitted using any of a variety of functions, including, but not limited to, a linear function (including a constant function), logarithmic function, quadratic function, cubic function, square root function, power function, polynomial function, rational function, exponential function, sinusoidal function, and variations and combinations thereof [0282]).
Regarding Claim 14, Bohm discloses the claimed invention discussed in claim 13.
Bohm discloses fitting the curve includes fitting an exponential curve ( In addition, the curve may be fitted using any of a variety of functions, including, but not limited to, a linear function (including a constant function), logarithmic function, quadratic function, cubic function, square root function, power function, polynomial function, rational function, exponential function, sinusoidal function, and variations and combinations thereof [0282]).
Regarding Claim 15, Bohm discloses the claimed invention discussed in claim 11.
Bohm discloses the characteristic of the analyte sensor includes a sensitivity of the analyte sensor (iteratively determining, with an electronic device, a sensitivity value of the continuous analyte sensor as a function of time by applying a priori information comprising sensor sensitivity information; and calibrating the sensor data based at least in part on the determined sensitivity value [0006]).
Regarding Claim 16, Bohm discloses the claimed invention discussed in claim 15.
Bohm discloses compensating for sensor drift using at least one of the estimated impedance value or the sensitivity ( In certain embodiments, the continuous analyte sensor may measure an additional signal associated with the baseline and/or sensitivity of the sensor, thereby enabling monitoring of baseline and/or additional monitoring of sensitivity changes or drift that may occur in a continuous analyte sensor over time[0264]).
Regarding Claim 17, Bohm discloses the claimed invention discussed in claim 11.
Bohm discloses the characteristic of the analyte sensor includes a level of damage or a defect of the analyte sensor (The alarm can notify a user that the current sensor system is defective, for example. If, on the other hand, one or both of the impedance and phase values fall within the respective predefined levels, then process 1900 ends [0365]).
Regarding Claim 18, Bohm discloses the claimed invention discussed in claim 11.
Bohm discloses the characteristic of the analyte sensor includes a compensation for the analyte sensor (In accordance with some embodiments, the membrane impedance of each electrode of a dual-electrode system can be used to determine or update a scaling factor[0393]).
Regarding Claim 19, Bohm discloses the claimed invention discussed in claim 11.
Bohm discloses applying the bias voltage change to the bias voltage includes applying a step in the bias voltage (The impedance data was generated by applying a step voltage to the CGM sensor and calculating an impedance based on the peak current of the response, as discussed herein with reference to FIG. 13 [0465]).
Regarding Claim 20, Bohm discloses a method of operating an analyte sensor system using sensor electronics to correct for an error from double-layer capacitance of a sensor membrane, the method comprising: applying a bias voltage change to a bias voltage of an analyte sensor ( applying a bias voltage to an analyte sensor [0099]); measuring a current response based at least on application of the bias voltage change (At step 1202, a stimulus signal in the form of a voltage step can be applied to a bias voltage of the sensor. The voltage step can be in the range of 10-50 mV, for example 10 mV, and the bias voltage can be 600 mV. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206 [0331]); using at least the measured current response, to derive a current value at a time of the application of the bias voltage change (At step 1202, a stimulus signal in the form of a voltage step can be applied to a bias voltage of the sensor. The voltage step can be in the range of 10-50 mV, for example 10 mV, and the bias voltage can be 600 mV. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206. The signal response can then be measured and recorded (e.g., an output current) at step 1204, and a derivative of the response can be taken at step 1206. At step 1208, a Fourier transform of the derivative of the response can then be calculated to yield ac currents in the frequency domain [0331] see also [0335] and [0336]); estimating an impedance value using the derived current value ( FIG. 13 is a flowchart of process 1300 for determining an impedance of a sensor being studied, such as the impedance of the sensor's membrane, in accordance with one embodiment. At step 1302, a stimulus signal in the form of a voltage step above a bias voltage is applied to the sensor. The signal response is measured at step 1304, and, at step 1306, a peak current (i.e., derived current) of the response is determined. Next, at step 1308, one or more impedance characteristics (e.g., resistance) of the sensor membrane (e.g., Rmembrane) is calculated based on the peak current. The one or more impedance characteristics can then be correlated to a property of the sensor [0332]); and determining a characteristic of the analyte sensor using the estimated impedance value (The signal response is measured at step 1304, and, at step 1306, a peak current of the response is determined. Next, at step 1308, one or more impedance characteristics (e.g., resistance) of the sensor membrane (e.g., Rmembrane) is calculated based on the peak current [0332]; As discussed further below, a relationship between sensitivity and impedance has been observed in embodiments of analyte sensors. Although not wishing to be bound by theory, embodiments of analyte sensors are believed to have a relationship between an impedance of a sensor's membrane and the diffusivity of the membrane. For example, a change in impedance of an analyte sensor can indicate a proportional change in diffusivity of the analyte sensor's membrane[0344]) and estimating an analyte concentration value of the analyte sensor based at least on the estimated impedance value (and estimating an analyte concentration value of the analyte sensor based at least on the estimated impedance value. [0110]).
Although Bohm does not explicitly disclose extrapolating, using at least the measured current response, to derive a current value at a time of the application of the bias voltage change, Bohm teaches using measured current responses ([0330] response signal) and a derived current value at the time of the voltage change , (see Fig. 14A, 14B, and [0332]). Therefore it would have been obvious to a person having ordinary skill in the art at the time of filing to extrapolate between measured data points to determine the current at the time of the bias voltage change as shown in Fig. 14B in Bohm. This would result in the accurate characterization of the analyte sensor with correctly compensated drift.
Regarding Claim 21, Bohm discloses the claimed invention discussed in claim 20.
Bohm discloses applying the bias voltage change to the bias voltage includes applying a step in the bias voltage (FIG. 14B is a graph of a current response 1402 of the analyte sensor to the input voltage 1400 of FIG. 14A. As illustrated in FIG. 14B, the current response 1402 can include a sharp spike in current starting at time t2, which corresponds to the time in which the voltage step begins to impact the response. The current response 1402 includes a peak current at point 1404 and then the current response 1402 gradually decreases and levels off to a slightly higher level due to the increase in input voltage 1400 as compared to before the voltage step [0336]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rodney Goodman (US20020098119) discloses an analyte sensor with capacitance measurements.
Mark Samuels (US20030191376) discloses bias voltage with sensor resistance.
Paul Goode (US20050043598) discloses impedance measurement with a glucose sensor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARAH ZAAB whose telephone number is (571)272-4973. The examiner can normally be reached Monday - Friday 7:00 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Catherine Rastovski can be reached on 571-272-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARAH ZAAB/Examiner, Art Unit 2857
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2857
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