DETAILED ACTION
Applicant’s arguments, filed on 03/11/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 03/11/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-9 and 21-31 are the current claims hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Rebec (US 20210228114) in view of Brister (US 20190261907) and Mazlish (US 20190274624).
Regarding independent claim 1, Rebec teaches an apparatus (Abstract: “Systems and methods for operating continuous analyte monitoring (CAM) device are provided”), comprising:
an analyte sensor ([0027]: “the analyte sensor is a continuous analyte sensor implanted interstitially in skin of the user”);
a memory comprising executable instructions; and a processor communicatively coupled to the memory, the processor configured to execute the instructions to cause the apparatus to ([0084]: “the one or more processors 140 is operatively coupled to system memory through one or more links (e.g., interconnects, buses, etc.). In embodiments, system memory is capable of storing information that the one or more processors 140 utilizes to operate and execute programs and operating systems, including computer readable instructions for the method disclosed herein”):
monitor, using the analyte sensor, an analyte of a patient during a time period to obtain measured analyte data for the analyte ([0047]: “retrieving a first data stream corresponding to current that is reflective of a concentration of an analyte sensed by a continuous analyte sensor; converting the first data stream into analyte values reflective of the concentration of the analyte sensed by the continuous analyte sensor”; Fig. 6);
monitor other measured sensor data indicative of a physiological state of the patient during the time period ([0047]: “retrieving one or more additional data streams from one or more additional temperature sensors positioned within a predetermined distance of the continuous analyte sensor”. The temperature of the user is the physiological state.);
determine, based on the physiological state of the patient during the time period, expected analyte data for the analyte ([0047]: “a method for a continuous analyte sensor system, comprises retrieving a first data stream corresponding to current that is reflective of a concentration of an analyte sensed by a continuous analyte sensor; converting the first data stream into analyte values reflective of the concentration of the analyte sensed by the continuous analyte sensor; retrieving one or more additional data streams from one or more additional temperature sensors positioned within a predetermined distance of the continuous analyte sensor; determining, based on the one or more additional data streams, that conversion of the first data stream is predicted to result in analyte values that do not accurately reflect the concentration of the analyte sensed by the continuous analyte sensor; and providing compensated analyte values based on the one or more additional data streams that more accurately reflect the concentration of the analyte within a predetermined threshold range of the concentration of the analyte sensed by the continuous analyte sensor”);
determine a correction factor based on the expected analyte data and the measured analyte data, the correction factor indicative of an error in calibration of the analyte sensor ([0079]: “the process of providing corrected analyte values involves a process of learning situations/conditions where inaccurate values are expected or predicted to be reported, and instead of reporting the inaccurate values, providing corrected values that are based on some level of analysis of historical and/or current data trends (e.g., trends based on data retrieved from the analyte sensor and one or more adjunct sensors)”; [0140]: “the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”. The correction factor is determined from the analyte sensor (the measured analyte data) and data from the adjunct sensors, which is the temperature sensor which is used to determine the expected analyte data.).
However, Rebec does not teach determining whether recalibration of the analyte sensor is possible based on detecting a period of stability.
Brister discloses a duel electrode system for a continuous analyte sensor. Specifically, Brister teaches determining whether recalibration of the analyte sensor is possible based on detecting a period of stability ([0010]: “a stability module configured to determine a stability of glucose transport through the membrane system, wherein the stability of glucose transport is correlated with the sensitivity change. In one embodiment, the processor module is configured to prohibit calibration of the glucose-related sensor data point when the stability of glucose transport falls below a threshold”; [0459]: “the stability module is configured to prohibit calibration of the sensor responsive to the stability (or instability) of the sensor”; [0007]: “the stability of glucose transport is determined by measuring the sensitivity change over a time period”. The stability is determined over a time period, which is the detection of the period of stability. It is determined whether calibration is possible based on the period of stability, and only calibrates the sensor if the sensor is stable enough.). Rebec and Brister are analogous art as they are both related to 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 determination of whether recalibration is possible from Brister into the device from Rebec as it allows the device to analyze the stability, and only correct the values if it is determined that it will be successful and stable enough.
The Rebec/Brister combination teaches if recalibration is possible, recalibrate the analyte sensor based on the correction factor by updating at least one stored calibration parameter of the analyte sensor in the memory (Rebec, [0047]: “providing compensated analyte values based on the one or more additional data streams that more accurately reflect the concentration of the analyte within a predetermined threshold range of the concentration of the analyte sensed by the continuous analyte sensor.”; [0140]: “the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”; [0168]: “In the case where a CGM system of the present disclosure includes a plurality of temperature sensors, this may enable a plurality of temperature-based corrections to improve the quality and/or accuracy of the CGM sensor.”; [0138]: “learning module 410 may feed data into the correction factor module 425 so that appropriate correction factors can be determined for various situations where the reported glucose values are predicted to be inaccurate. In some examples, the correction factor module 425 is thus a part or subset of learning module 410. There may be different correction factors that apply to different circumstances … The correction factor may be used to compensate the error in the otherwise reported glucose values, so that instead, more accurate glucose values are communicated to the user”; [0142]: “The transfer function module 430 comprises a function (e.g., mathematical function) that translates inputs fed into the module into an output via the output module 435. The output in this example refers to glucose values, which may be understood to, at least in some circumstances, comprise glucose values that have been corrected/compensated to at least some degree as compared to glucose values otherwise reported in absence of the process flow 400 of FIG. 4. As depicted, the transfer function module 430 may receive input from the correction factor module 425, meaning that the transfer function module 430 is capable of being modified via one or more correction factors as determined via the correction factor module 425”; [0128]: “Responsive to the providing of corrected values, method 300 continues to block 340, and includes updating CGM system parameters based on the event that led to the providing of corrected values. Updating CGM system parameters may include but is not limited to storing additional data retrieved from any of the glucose and/or adjunct sensor(s), storing an indication that corrected values were provided for a particular duration of time, storing any actual blood glucose values inputted into the system during and/or following the event where corrected values were displayed, updating any relevant filtering parameters (e.g., filtering parameters may be changed during a particular adverse event, and then may be changed back or otherwise updated once the event has passed), and the like. It may be understood that any and all of the above-mentioned updates to CGM system parameters may comprise data that can be fed back into the learning algorithm to enable the algorithm to continue to improve its ability to accurately assess situations where reported glucose values may be inaccurate, and, where possible, provide corrected glucose values of higher and higher confidence”. The steps of adjusting the measured value using the correction factor is the recalibration step, and the CGM system parameters are the calibration parameters that are updated in this process. Fig. 3 shows the steps of updating the parameters based on the sensed data.).
However, the Rebec/Brister combination does not teach if recalibration is not possible, recommending, to the patient, to replace the analyte sensor.
Mazlish discloses alarms and alerts for medication delivery devices and systems. Specifically, Mazlish teaches if recalibration is not possible, recommend, to the patient, to replace the analyte sensor (Claim 16: “the medication delivery device comprises one or more icons, and one or more lights associated with the one or more icons, the one or more icons configured to at least one of: indicate whether the dosage of the medication is being delivered based on the analyte sensor or not or whether there is an error with the analyte sensor; … indicate that a more detailed message for the user is awaiting the user on the remote user-interface device”; [0149]: “wherein the alarm or alert condition is a notice about … a possible need to replace the CGM”. Determining that the sensor cannot be recalibrated is an error in the analyte sensor, therefore triggering the detailed message which can include an alert about the need to replace the CGM (sensor).). Rebec, Brister, and Mazlish are analogous art as they are all related to 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 recommending replacing the sensor from Mazlish into the Rebec/Brister combination as it allows the device to alert the user if there is an issue with the sensor and it is not recording accurate measurements, therefore allowing them to replace the sensor to ensure the system is measuring correct levels of the analyte.
Regarding claim 2, the Rebec/Brister/Mazlish combination teaches the apparatus of Claim 1, wherein the analyte is glucose (Rebec, [0027]: “the analyte sensor is a continuous analyte sensor implanted interstitially in skin of the user. In one example, the analyte may be glucose”).
Regarding claim 3, the Rebec/Brister/Mazlish combination teaches the apparatus of Claim 1, wherein the physiological state comprises an oxygen level of the patient or a temperature of the patient (Rebec, [0080]: “Examples of such variables that impinge upon analyte sensor performance may include but are not limited to temperature effects”; [0082]: “The system can include glucose sensor 150 as well as one or more adjunct sensor(s), such as … temperature sensor”; [0168]: “In the case where a CGM system of the present disclosure includes a plurality of temperature sensors, this may enable a plurality of temperature-based corrections to improve the quality and/or accuracy of the CGM sensor.”).
Regarding claim 4, the Rebec/Brister/Mazlish combination teaches the apparatus of Claim 1, wherein the expected analyte data is determined based on a mapping between historical analyte data for the analyte and the physiological state (Rebec, [0080]: “the process of providing corrected analyte values involves a process of learning situations/conditions where inaccurate values are expected or predicted to be reported, and instead of reporting the inaccurate values, providing corrected values that are based on some level of analysis of historical and/or current data trends (e.g., trends based on data retrieved from the analyte sensor and one or more adjunct sensors)”; [0054]: “comparing the first data stream and the one or more additional data streams to a set of historical data that has been computationally processed to reveal patterns of data corresponding to the first and the one or more additional data streams indicative of a future event related to blood analyte levels”).
Regarding claim 5, the Rebec/Brister/Mazlish combination teaches the apparatus of Claim 1, wherein the processor is further configured to determine that the measured analyte data deviates from the expected analyte data by an amount exceeding a threshold (Rebec, [0078]: “the term “inaccurate” with reference to reported analyte values is to be given its ordinary and customary meaning to a person of ordinary skill in the art, and refers without limitation to reported analyte values differing from actual analyte concentrations sensed by the continuous analyte sensor by some predetermined threshold amount”).
Regarding claim 6, the Rebec/Brister/Mazlish combination teaches the apparatus of Claim 5, wherein determining the correction factor is in response to determining that the measured analyte data deviates from the expected analyte data by the amount exceeding the threshold (Rebec, [0047]: “providing compensated analyte values based on the one or more additional data streams that more accurately reflect the concentration of the analyte within a predetermined threshold range of the concentration of the analyte sensed by the continuous analyte sensor.”; [0140]: “the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”; [0078]: “the term “inaccurate” with reference to reported analyte values is to be given its ordinary and customary meaning to a person of ordinary skill in the art, and refers without limitation to reported analyte values differing from actual analyte concentrations sensed by the continuous analyte sensor by some predetermined threshold amount”).
Regarding claim 7, the Rebec/Brister/Mazlish combination teaches the apparatus of Claim 5, wherein determining that the measured analyte data deviates from the expected analyte data by the amount exceeding the threshold comprises matching a datapoint from the measured analyte data with a datapoint from the expected analyte data based on a time when the datapoint from the measured analyte data was measured (Rebec, [0079]: “the process of providing corrected analyte values involves a process of learning situations/conditions where inaccurate values are expected or predicted to be reported, and instead of reporting the inaccurate values, providing corrected values that are based on some level of analysis of historical and/or current data trends (e.g., trends based on data retrieved from the analyte sensor and one or more adjunct sensors)”. The measured data can be matched with the current data trends, which includes the expected analyte data, therefore matching datapoints based on the time when the data was measured.).
Regarding claim 8, the Rebec/Brister/Mazlish combination teaches the apparatus of Claim 1, wherein the correction factor is based on an amount by which the measured analyte data deviates from the expected analyte data (Rebec, [0140]: “The pattern recognition module 420 relies on the information learned by way of the learning module 410, in conjunction with the data acquisition module 415 comprising newly acquired data, to predict/infer whether a current situation is one where it is expected that reported glucose values have become inaccurate, or not. There may be varying levels of what is meant by “inaccurate.” For example, some situations may result in reported glucose values being inaccurate by a first amount, other situations may result in reported glucose values being inaccurate by a second amount, other situations may result in reported glucose values being inaccurate by a third amount, and so on. For example, the first amount may be lesser than the second amount, which in turn may be lesser than the third amount. Hence, the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”).
Regarding claim 9, the Rebec/Brister/Mazlish combination teaches the apparatus of Claim 1, wherein the correction factor comprises an adjustment to a sensitivity of the analyte sensor or a rate of change of the sensitivity of the analyte sensor (Rebec, [0048]: “providing the compensated analyte values may comprise utilizing a characterized temperature sensitivity of one or more temperature-sensitive electronic components that can adversely impact the first data stream, and temperature values corresponding to the second data stream, in a model that in turn outputs the compensated analyte values”; [0076]: “calibration may be updated or recalibrated over time to account for changes associated with the sensor, such as changes in sensor sensitivity and sensor background”).
Regarding independent claim 28, Rebec teaches a method for calibration of a glucose sensor (Abstract: “Systems and methods for operating continuous analyte monitoring (CAM) device are provided”), the method comprising:
monitoring, using the glucose sensor, a level of glucose of a patient during a time period to obtain measured glucose data ([0047]: “retrieving a first data stream corresponding to current that is reflective of a concentration of an analyte sensed by a continuous analyte sensor; converting the first data stream into analyte values reflective of the concentration of the analyte sensed by the continuous analyte sensor”; Fig. 6; [0027]: “the analyte sensor is a continuous analyte sensor implanted interstitially in skin of the user. In one example, the analyte may be glucose”);
monitoring other measured sensor data indicative of a physiological state of the patient during the time period ([0047]: “retrieving one or more additional data streams from one or more additional temperature sensors positioned within a predetermined distance of the continuous analyte sensor”. The temperature of the user is the physiological state.);
determining, based on the physiological state of the patient during the time period, expected glucose data ([0047]: “a method for a continuous analyte sensor system, comprises retrieving a first data stream corresponding to current that is reflective of a concentration of an analyte sensed by a continuous analyte sensor; converting the first data stream into analyte values reflective of the concentration of the analyte sensed by the continuous analyte sensor; retrieving one or more additional data streams from one or more additional temperature sensors positioned within a predetermined distance of the continuous analyte sensor; determining, based on the one or more additional data streams, that conversion of the first data stream is predicted to result in analyte values that do not accurately reflect the concentration of the analyte sensed by the continuous analyte sensor; and providing compensated analyte values based on the one or more additional data streams that more accurately reflect the concentration of the analyte within a predetermined threshold range of the concentration of the analyte sensed by the continuous analyte sensor”);
determining a correction factor based on the expected glucose data and the measured glucose data, the correction factor indicative of an error in calibration of the glucose sensor ([0079]: “the process of providing corrected analyte values involves a process of learning situations/conditions where inaccurate values are expected or predicted to be reported, and instead of reporting the inaccurate values, providing corrected values that are based on some level of analysis of historical and/or current data trends (e.g., trends based on data retrieved from the analyte sensor and one or more adjunct sensors)”; [0140]: “the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”. The correction factor is determined from the analyte sensor (the measured analyte data) and data from the adjunct sensors, which is the temperature sensor which is used to determine the expected analyte data.).
However, Rebec does not teach determining whether recalibration of the analyte sensor is possible based on detecting a period of stability.
Brister discloses a duel electrode system for a continuous analyte sensor. Specifically, Brister teaches determining whether recalibration of the analyte sensor is possible based on detecting a period of stability ([0010]: “a stability module configured to determine a stability of glucose transport through the membrane system, wherein the stability of glucose transport is correlated with the sensitivity change. In one embodiment, the processor module is configured to prohibit calibration of the glucose-related sensor data point when the stability of glucose transport falls below a threshold”; [0459]: “the stability module is configured to prohibit calibration of the sensor responsive to the stability (or instability) of the sensor”; [0007]: “the stability of glucose transport is determined by measuring the sensitivity change over a time period”. The stability is determined over a time period, which is the detection of the period of stability. It is determined whether calibration is possible based on the period of stability, and only calibrates the sensor if the sensor is stable enough.). Rebec and Brister are analogous art as they are both related to 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 determination of whether recalibration is possible from Brister into the method from Rebec as it allows the method to analyze the stability, and only correct the values if it is determined that it will be successful and stable enough.
The Rebec/Brister combination teaches if recalibration is possible recalibrate the glucose sensor based on the correction factor by modifying at least one stored calibration parameter (Rebec, [0047]: “providing compensated analyte values based on the one or more additional data streams that more accurately reflect the concentration of the analyte within a predetermined threshold range of the concentration of the analyte sensed by the continuous analyte sensor.”; [0140]: “the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”; [0168]: “In the case where a CGM system of the present disclosure includes a plurality of temperature sensors, this may enable a plurality of temperature-based corrections to improve the quality and/or accuracy of the CGM sensor.”; [0138]: “learning module 410 may feed data into the correction factor module 425 so that appropriate correction factors can be determined for various situations where the reported glucose values are predicted to be inaccurate. In some examples, the correction factor module 425 is thus a part or subset of learning module 410. There may be different correction factors that apply to different circumstances … The correction factor may be used to compensate the error in the otherwise reported glucose values, so that instead, more accurate glucose values are communicated to the user”; [0142]: “The transfer function module 430 comprises a function (e.g., mathematical function) that translates inputs fed into the module into an output via the output module 435. The output in this example refers to glucose values, which may be understood to, at least in some circumstances, comprise glucose values that have been corrected/compensated to at least some degree as compared to glucose values otherwise reported in absence of the process flow 400 of FIG. 4. As depicted, the transfer function module 430 may receive input from the correction factor module 425, meaning that the transfer function module 430 is capable of being modified via one or more correction factors as determined via the correction factor module 425”; [0128]: “Responsive to the providing of corrected values, method 300 continues to block 340, and includes updating CGM system parameters based on the event that led to the providing of corrected values. Updating CGM system parameters may include but is not limited to storing additional data retrieved from any of the glucose and/or adjunct sensor(s), storing an indication that corrected values were provided for a particular duration of time, storing any actual blood glucose values inputted into the system during and/or following the event where corrected values were displayed, updating any relevant filtering parameters (e.g., filtering parameters may be changed during a particular adverse event, and then may be changed back or otherwise updated once the event has passed), and the like. It may be understood that any and all of the above-mentioned updates to CGM system parameters may comprise data that can be fed back into the learning algorithm to enable the algorithm to continue to improve its ability to accurately assess situations where reported glucose values may be inaccurate, and, where possible, provide corrected glucose values of higher and higher confidence”. The steps of adjusting the measured value using the correction factor is the recalibration step, and the CGM system parameters are the calibration parameters that are updated in this process. Fig. 3 shows the steps of updating the parameters based on the sensed data.).
However, the Rebec/Brister combination does not teach if recalibration is not possible, recommending, to the patient, to replace the analyte sensor.
Mazlish discloses alarms and alerts for medication delivery devices and systems. Specifically, Mazlish teaches if recalibration is not possible, recommend, to the patient, to replace the analyte sensor (Claim 16: “the medication delivery device comprises one or more icons, and one or more lights associated with the one or more icons, the one or more icons configured to at least one of: indicate whether the dosage of the medication is being delivered based on the analyte sensor or not or whether there is an error with the analyte sensor; … indicate that a more detailed message for the user is awaiting the user on the remote user-interface device”; [0149]: “wherein the alarm or alert condition is a notice about … a possible need to replace the CGM”. Determining that the sensor cannot be recalibrated is an error in the analyte sensor, therefore triggering the detailed message which can include an alert about the need to replace the CGM (sensor).). Rebec, Brister, and Mazlish are analogous art as they are all related to 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 recommending replacing the sensor from Mazlish into the Rebec/Brister combination as it allows the method to alert the user if there is an issue with the sensor and it is not recording accurate measurements, therefore allowing them to replace the sensor to ensure the method is measuring correct levels of the analyte.
Regarding claim 29, the Rebec/Brister/Mazlish combination teaches the method of Claim 28, wherein the physiological state comprises an oxygen level of the patient or a temperature of the patient (Rebec, [0080]: “Examples of such variables that impinge upon analyte sensor performance may include but are not limited to temperature effects”; [0082]: “The system can include glucose sensor 150 as well as one or more adjunct sensor(s), such as … temperature sensor”; [0168]: “In the case where a CGM system of the present disclosure includes a plurality of temperature sensors, this may enable a plurality of temperature-based corrections to improve the quality and/or accuracy of the CGM sensor.”).
Regarding claim 30, the Rebec/Brister/Mazlish combination teaches the method of Claim 28, further comprising the steps of determining that the measured glucose data deviates from the expected glucose data by an amount exceeding a threshold (Rebec, [0078]: “the term “inaccurate” with reference to reported analyte values is to be given its ordinary and customary meaning to a person of ordinary skill in the art, and refers without limitation to reported analyte values differing from actual analyte concentrations sensed by the continuous analyte sensor by some predetermined threshold amount”).
Regarding claim 31, the Rebec/Brister/Mazlish combination teaches the method of claim 30, wherein determining the correction factor is in response to determining that the measured glucose data deviates from the expected glucose data by the amount exceeding the threshold (Rebec, [0078]: “the term “inaccurate” with reference to reported analyte values is to be given its ordinary and customary meaning to a person of ordinary skill in the art, and refers without limitation to reported analyte values differing from actual analyte concentrations sensed by the continuous analyte sensor by some predetermined threshold amount”).
Claims 21-22 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Rebec in view of Brister.
Regarding independent claim 21, Rebec teaches an analyte monitoring system (Abstract: “Systems and methods for operating continuous analyte monitoring (CAM) device are provided”), comprising:
an analyte sensor configured to generate an analyte signal corresponding to a concentration of an analyte within a body of a patient ([0047]: “retrieving a first data stream corresponding to current that is reflective of a concentration of an analyte sensed by a continuous analyte sensor; converting the first data stream into analyte values reflective of the concentration of the analyte sensed by the continuous analyte sensor”; Fig. 6); and
a processor operably coupled with the analyte sensor ([0084]: “the one or more processors 140 is operatively coupled to system memory through one or more links (e.g., interconnects, buses, etc.). In embodiments, system memory is capable of storing information that the one or more processors 140 utilizes to operate and execute programs and operating systems, including computer readable instructions for the method disclosed herein”), the processor configured to:
determine a physiological state of the patient during a time period ([0047]: “retrieving one or more additional data streams from one or more additional temperature sensors positioned within a predetermined distance of the continuous analyte sensor”. The temperature of the user is the physiological state.);
determine expected analyte data based on the analyte signal and the physiological state of the patient ([0047]: “a method for a continuous analyte sensor system, comprises retrieving a first data stream corresponding to current that is reflective of a concentration of an analyte sensed by a continuous analyte sensor; converting the first data stream into analyte values reflective of the concentration of the analyte sensed by the continuous analyte sensor; retrieving one or more additional data streams from one or more additional temperature sensors positioned within a predetermined distance of the continuous analyte sensor; determining, based on the one or more additional data streams, that conversion of the first data stream is predicted to result in analyte values that do not accurately reflect the concentration of the analyte sensed by the continuous analyte sensor; and providing compensated analyte values based on the one or more additional data streams that more accurately reflect the concentration of the analyte within a predetermined threshold range of the concentration of the analyte sensed by the continuous analyte sensor”);
determine a correction factor based on the expected analyte data and the analyte signal, wherein the correction factor is indicative of an error in calibration of the analyte sensor ([0079]: “the process of providing corrected analyte values involves a process of learning situations/conditions where inaccurate values are expected or predicted to be reported, and instead of reporting the inaccurate values, providing corrected values that are based on some level of analysis of historical and/or current data trends (e.g., trends based on data retrieved from the analyte sensor and one or more adjunct sensors)”; [0140]: “the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”. The correction factor is determined from the analyte sensor (the measured analyte data) and data from the adjunct sensors, which is the temperature sensor which is used to determine the expected analyte data.).
However, Rebec does not teach detecting whether recalibration of the analyte sensor is possible based on detecting a period of stability.
Brister discloses a duel electrode system for a continuous analyte sensor. Specifically, Brister teaches detecting whether recalibration of the analyte sensor is possible based on detecting a period of stability ([0010]: “a stability module configured to determine a stability of glucose transport through the membrane system, wherein the stability of glucose transport is correlated with the sensitivity change. In one embodiment, the processor module is configured to prohibit calibration of the glucose-related sensor data point when the stability of glucose transport falls below a threshold”; [0459]: “the stability module is configured to prohibit calibration of the sensor responsive to the stability (or instability) of the sensor”; [0007]: “the stability of glucose transport is determined by measuring the sensitivity change over a time period”. The stability is determined over a time period, which is the detection of the period of stability. It is determined whether calibration is possible based on the period of stability, and only calibrates the sensor if the sensor is stable enough.). Rebec and Brister are analogous art as they are both related to 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 detection of whether recalibration is possible from Brister into the device from Rebec as it allows the device to analyze the stability, and only correct the values if it is determined that it will be successful and stable enough.
The Rebec/Brister combination teaches performing a responsive action based on the determination whether recalibration of the analyte sensor is possible (Rebec, [0047]: “providing compensated analyte values based on the one or more additional data streams that more accurately reflect the concentration of the analyte within a predetermined threshold range of the concentration of the analyte sensed by the continuous analyte sensor.”; [0140]: “the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”; [0168]: “In the case where a CGM system of the present disclosure includes a plurality of temperature sensors, this may enable a plurality of temperature-based corrections to improve the quality and/or accuracy of the CGM sensor.”; [0138]: “learning module 410 may feed data into the correction factor module 425 so that appropriate correction factors can be determined for various situations where the reported glucose values are predicted to be inaccurate. In some examples, the correction factor module 425 is thus a part or subset of learning module 410. There may be different correction factors that apply to different circumstances … The correction factor may be used to compensate the error in the otherwise reported glucose values, so that instead, more accurate glucose values are communicated to the user”; [0142]: “The transfer function module 430 comprises a function (e.g., mathematical function) that translates inputs fed into the module into an output via the output module 435. The output in this example refers to glucose values, which may be understood to, at least in some circumstances, comprise glucose values that have been corrected/compensated to at least some degree as compared to glucose values otherwise reported in absence of the process flow 400 of FIG. 4. As depicted, the transfer function module 430 may receive input from the correction factor module 425, meaning that the transfer function module 430 is capable of being modified via one or more correction factors as determined via the correction factor module 425”; [0128]: “Responsive to the providing of corrected values, method 300 continues to block 340, and includes updating CGM system parameters based on the event that led to the providing of corrected values. Updating CGM system parameters may include but is not limited to storing additional data retrieved from any of the glucose and/or adjunct sensor(s), storing an indication that corrected values were provided for a particular duration of time, storing any actual blood glucose values inputted into the system during and/or following the event where corrected values were displayed, updating any relevant filtering parameters (e.g., filtering parameters may be changed during a particular adverse event, and then may be changed back or otherwise updated once the event has passed), and the like. It may be understood that any and all of the above-mentioned updates to CGM system parameters may comprise data that can be fed back into the learning algorithm to enable the algorithm to continue to improve its ability to accurately assess situations where reported glucose values may be inaccurate, and, where possible, provide corrected glucose values of higher and higher confidence”. The steps of adjusting the measured value using the correction factor is the recalibration step, and the CGM system parameters are the calibration parameters that are updated in this process. Fig. 3 shows the steps of updating the parameters based on the sensed data.).
Regarding claim 22, the Rebec/Brister combination teaches the analyte monitoring system of Claim 21, wherein the responsive action is recalibrating the analyte sensor using the correction factor when it is determined that recalibration of the analyte sensor is possible (Rebec, [0047]: “providing compensated analyte values based on the one or more additional data streams that more accurately reflect the concentration of the analyte within a predetermined threshold range of the concentration of the analyte sensed by the continuous analyte sensor.”; [0140]: “the correction factor module 425 may necessarily generate different correction factors for a variety of learned circumstances”; [0168]: “In the case where a CGM system of the present disclosure includes a plurality of temperature sensors, this may enable a plurality of temperature-based corrections to improve the quality and/or accuracy of the CGM sensor.”; [0138]: “learning module 410 may feed data into the correction factor module 425 so that appropriate correction factors can be determined for various situations where the reported glucose values are predicted to be inaccurate. In some examples, the correction factor module 425 is thus a part or subset of learning module 410. There may be different correction factors that apply to different circumstances … The correction factor may be used to compensate the error in the otherwise reported glucose values, so that instead, more accurate glucose values are communicated to the user”; [0142]: “The transfer function module 430 comprises a function (e.g., mathematical function) that translates inputs fed into the module into an output via the output module 435. The output in this example refers to glucose values, which may be understood to, at least in some circumstances, comprise glucose values that have been corrected/compensated to at least some degree as compared to glucose values otherwise reported in absence of the process flow 400 of FIG. 4. As depicted, the transfer function module 430 may receive input from the correction factor module 425, meaning that the transfer function module 430 is capable of being modified via one or more correction factors as determined via the correction factor module 425”; [0128]: “Responsive to the providing of corrected values, method 300 continues to block 340, and includes updating CGM system parameters based on the event that led to the providing of corrected values. Updating CGM system parameters may include but is not limited to storing additional data retrieved from any of the glucose and/or adjunct sensor(s), storing an indication that corrected values were provided for a particular duration of time, storing any actual blood glucose values inputted into the system during and/or following the event where corrected values were displayed, updating any relevant filtering parameters (e.g., filtering parameters may be changed during a particular adverse event, and then may be changed back or otherwise updated once the event has passed), and the like. It may be understood that any and all of the above-mentioned updates to CGM system parameters may comprise data that can be fed back into the learning algorithm to enable the algorithm to continue to improve its ability to accurately assess situations where reported glucose values may be inaccurate, and, where possible, provide corrected glucose values of higher and higher confidence”. The steps of adjusting the measured value using the correction factor is the recalibration step, and the CGM system parameters are the calibration parameters that are updated in this process. Fig. 3 shows the steps of updating the parameters based on the sensed data.).
Regarding claim 24, the Rebec/Brister combination teaches the analyte monitoring system of Claim 21, wherein the physiological state comprises an oxygen level of the patient or a temperature of the patient (Rebec, [0080]: “Examples of such variables that impinge upon analyte sensor performance may include but are not limited to temperature effects”; [0082]: “The system can include glucose sensor 150 as well as one or more adjunct sensor(s), such as … temperature sensor”; [0168]: “In the case where a CGM system of the present disclosure includes a plurality of temperature sensors, this may enable a plurality of temperature-based corrections to improve the quality and/or accuracy of the CGM sensor.”).
Regarding claim 25, the Rebec/Brister combination teaches the analyte monitoring system of Claim 21, wherein the processor is further configured to determine that the analyte signal deviates from the expected analyte data by an amount exceeding a threshold (Rebec, [0078]: “the term “inaccurate” with reference to reported analyte values is to be given its ordinary and customary meaning to a person of ordinary skill in the art, and refers without limitation to reported analyte values differing from actual analyte concentrations sensed by the continuous analyte sensor by some predetermined threshold amount”).
Regarding claim 26, the Rebec/Brister combination teaches the analyte monitoring system of Claim 25, wherein determining the correction factor is in response to determining that the analyte signal deviates from the expected analyte data by the amount exceeding the threshold (Rebec, [0078]: “the term “inaccurate” with reference to reported analyte values is to be given its ordinary and customary meaning to a person of ordinary skill in the art, and refers without limitation to reported analyte values differing from actual analyte concentrations sensed by the continuous analyte sensor by some predetermined threshold amount”).
Regarding claim 27, the Rebec/Brister combination teaches the analyte monitoring system of Claim 21, wherein the correction factor comprises an adjustment to a sensitivity of the analyte sensor (Rebec, [0048]: “providing the compensated analyte values may comprise utilizing a characterized temperature sensitivity of one or more temperature-sensitive electronic components that can adversely impact the first data stream, and temperature values corresponding to the second data stream, in a model that in turn outputs the compensated analyte values”; [0076]: “calibration may be updated or recalibrated over time to account for changes associated with the sensor, such as changes in sensor sensitivity and sensor background”).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over the Rebec/Brister combination as applied to claim 21 above, and further in view of Mazlish.
Regarding claim 23, the Rebec/Brister combination teaches the analyte monitoring system of Claim 21.
However, the Rebec/Brister combination does not teach wherein the responsive action is displaying a message to replace the analyte sensor when it is determined that recalibration of the analyte sensor is not possible.
Mazlish discloses alarms and alerts for medication delivery devices and systems. Specifically, Mazlish teaches wherein the responsive action is displaying a message to replace the analyte sensor when it is determined that recalibration of the analyte sensor is not possible (Claim 16: “the medication delivery device comprises one or more icons, and one or more lights associated with the one or more icons, the one or more icons configured to at least one of: … whether there is an error with the analyte sensor; … indicate that a more detailed message for the user is awaiting the user on the remote user-interface device”; [0149]: “wherein the alarm or alert condition is a notice about … a possible need to replace the CGM”. Determining that the sensor cannot be recalibrated is an error in the analyte sensor, therefore triggering the detailed message which can include an alert about the need to replace the CGM (sensor).). Rebec, Brister, and Mazlish are analogous art as they are all related to 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 recommending replacing the sensor from Mazlish into the Rebec/Brister combination as it allows the device to alert the user if there is an issue with the sensor and it is not recording accurate measurements, therefore allowing them to replace the sensor to ensure the system is measuring correct levels of the analyte.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to the stability detection have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments with regards to the calibration parameter have been fully considered but they are not persuasive. Applicant argues that Rebec does not teach updating a calibration factor, however Rebec discloses updating CGM parameters, which function the same as a calibration parameter, and therefore teaches on this limitation ([0128]: “Responsive to the providing of corrected values, method 300 continues to block 340, and includes updating CGM system parameters based on the event that led to the providing of corrected values. Updating CGM system parameters may include but is not limited to storing additional data retrieved from any of the glucose and/or adjunct sensor(s), storing an indication that corrected values were provided for a particular duration of time, storing any actual blood glucose values inputted into the system during and/or following the event where corrected values were displayed, updating any relevant filtering parameters (e.g., filtering parameters may be changed during a particular adverse event, and then may be changed back or otherwise updated once the event has passed), and the like. It may be understood that any and all of the above-mentioned updates to CGM system parameters may comprise data that can be fed back into the learning algorithm to enable the algorithm to continue to improve its ability to accurately assess situations where reported glucose values may be inaccurate, and, where possible, provide corrected glucose values of higher and higher confidence”).
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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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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