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 .
Notice of Amendment
In response to the amendment filed on 7/13/2026, amended claims 9-11, cancelled claim 12, and new claim 21 are acknowledged. Claims 1-11 and 13-21 are currently pending. The following new and reiterated grounds of rejection are set forth:
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.
Claim(s) 1, 4-9, 11, 13, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Narayanaswami (US Publication No. 2023/0338656 A1) (previously cited), further in view of Rebec et al. (US Publication No. 2021/0228114 A1) (previously cited).
Regarding claim 1, Narayanaswami discloses a glucose monitoring system, comprising:
a glucose monitoring device, comprising:
a housing (see Figure 9 and 12A-13),
sensor electronics arranged within the housing (see [0047] – “FIG. 13 depicts components of an illustrative medicament delivery device in more detail than FIG. 2A. The medicament delivery device 1300 may contain a processor 1302, such as a CPU, a GPU, an ASIC, a FPGA or the like. The processor 1302 may run a control application 1303 formed of computer programming instructions for controlling operation of the medicament delivery device 1300. The control application 1303 may be stored in a storage 1304. The storage 1304 may contain non-transitory computer-readable storage media for storing computer programming instructions and data. The storage may include memory and storage devices, such as RAM devices, ROM devices, solid state memory devices, optical disk storage device, magnetic storage devices and the like”),
a glucose sensor (202) coupled to the housing (see [0030] – “A biological sensor 202 may be secured to a user to detect a biological characteristic of the user, such as glucose level, ketone level, heartbeat, temperature, blood oxygen level or the like. In some embodiments, the biological sensor may be secured to the user, such as by having an adhesive layer that holds the sensor in place secured to the user. In some exemplary embodiments, the biological sensor is a continuous glucose monitor (CGM)”), and
a strain gauge (204) configured to detect strain applied to the first portion of the glucose sensor (see [0030] – “A compression sensor 204 is provided to sense compression of the biological sensor 202. The compression sensor 204 may be a pressure sensor that senses pressure, a force sensor that senses magnitude of force and possible direction of force, a strain gauge that senses strain, a rigid compliant capacitive sensor that senses an external mechanical force, or the like. The compression sensor 204 may be an electrical sensor or a mechanical sensor”); and
one or more processors in communication with the glucose monitoring device, and configured to:
determine a glucose level based on the signals detected by the glucose sensor (see [0039] – “The biological sensor data 710 may include timestamps 714. For example, where the biological sensor 202 is a glucose sensor, the biological sensor data may include glucose values from the glucose sensor 202 where each glucose value has an associated timestamp 714 indicative of when the glucose value was logged or sensed”),
detect strain applied to the first portion by the strain gauge (see [0034] – “Compression sensor 204 senses compression of the biological sensor 202, such as when a user lies on top of the biological sensor. At 216, compression sensor data is processed to determine if the biological sensor 202 is too greatly compressed (i.e., excessively compressed). The compression sensor data may specify an amount of pressure or force that is applied to the biological sensor 202. At 216, a pressure or force threshold may be established, and if the force or pressure threshold is exceeded, it can be concluded that the biological sensor 202 is excessively compressed. In still other instances, the compression sensor may act like a switch that only switches to a compressed state when enough force is applied to fully actuate a lever or other actuatable element. There also may be a time component in determining whether the biological sensor 202 is excessively compressed. Specifically, the compression or other measured force or pressure must last at least a minimum amount of time before the biological sensor 202 is deemed to be compressed too greatly (e.g., 5 minutes; 10 minutes; 15 minutes; 30 minutes; or another period of time)” and [0039] – “Similarly, the compression sensor data 712 includes associated timestamps 716”), and
output a glucose level alarm when an alarm condition is satisfied, wherein the alarm condition is based on the glucose level and the strain detected by the strain gauge (see [0035] – “If it determined at 216 that the biological sensor 202 is compressed too greatly, corrective action may be taken at 218. Otherwise, no corrective action may be taken. FIG. 3 depicts examples of possible corrective actions 300. A first variety of corrective action 300 is to trigger alerts 300 to alert the user to the compression and possibly to suggest user actions that may remedy the compression. FIG. 4 depicts illustrative types of alerts 400. The alerts 400 may be visual alerts 402, such as textual and/or graphical content displayed on a display or via a light or LED of medicament delivery device 206, or on a display or user interface of the management device 210 for the medicament delivery device 206 or for the biological sensor 202. The alerts may warn the user of the compression and possibly suggest corrective action. The alerts 400 may include auditory alerts 404, such as beeps, sirens or spoken messages. The alerts may also include vibratory alerts 406, that may be generated using, for example, a vibrating alert motor or a linear resonant actuator. In some instances, combinations of two or more of the visual alerts 402, auditory alerts 404 and vibratory alerts 406 may be used” and [0036] – “At 502, the biological sensor data is received. For example, glucose level data may be received from a glucose monitor, like a CGM. At 504, compression sensor data is received. At 506, a model is used to predict what the sensed data value would have been but for the excessive compression. The model may simply identify when an excessive compression occurs and predict what the expected sensed data values should have been while the biological sensor is excessively compressed but for the excessive compression. The model may use interpolation on the plot of biological sensor data and other techniques to predict the expected biological sensor values”).
It is noted Narayanaswami does not specifically teach the glucose sensor comprises a first portion configured to be placed under a skin surface of a user to detect signals indicative of glucose levels in a bodily fluid and a second portion coupled to the sensor electronics or the strain gauge is disposed on the first portion of the glucose sensor. However, Rebec et al. teaches the glucose sensor (150) comprises a first portion configured to be placed under a skin surface of a user to detect signals indicative of glucose levels in a bodily fluid and a second portion coupled to the sensor electronics (110) or the strain gauge is disposed on the first portion of the glucose sensor (see Figure 5 and [0143] – “Turning now to FIG. 5, depicted is an illustration of a torso 500 of a user of a CAM system of the present disclosure. It is herein recognized that it may be advantageous for one or more adjunct sensors to be in a certain proximity to the analyte sensor. Accordingly, inset 502 shows a close-up view of a location on the torso 500 of the user where the analyte sensor 150 is embedded in the skin of the user. A region 505 of radius r defines an area where at least one other adjunct sensor is positioned. Illustrated is accelerometer 160, temperature sensor 170, and pressure sensor 507. In examples, radius r is 8 cm or less, for example 7 cm or less, 6 cm or less, 5 cm or less, 4 cm or less, 3 cm or less, 2 cm or less, or even 1 cm or less (e.g., within 1-10 mm, 10-50 mm, 50-100 mm, 100-500 mm, 500-1000 mm). Not shown at FIG. 5 is a housing that houses sensor electronics, for example a housing that includes computing device 110. Also not shown at FIG. 5 is an adhesive patch that may comprise a backing of such a housing, and which may be used to adhere the housing to a skin of the user. As elaborated below, in some examples it is within the scope of this disclosure that one or more pressure sensors 507 may be incorporated into such an adhesive patch, and these one or more pressure sensors may comprise adjunct sensors capable of reporting on pressure changes in the close proximity of the analyte 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 system of Narayanaswami to include the glucose sensor comprises a first portion configured to be placed under a skin surface of a user to detect signals indicative of glucose levels in a bodily fluid and a second portion coupled to the sensor electronics and the strain gauge is disposed on the first portion of the glucose sensor, as disclosed in Rebec et al., so as to allow the strain gauge to report on pressure changes in close proximity to where the analyte sensor is embedded in the skin of the user (see Rebec et al.: [0143]).
Regarding claim 4, Narayanaswami teaches a receiver device in wireless communication with the glucose monitoring device, wherein the receiver device is configured to output the glucose level alarm (see [0027] – “The data logger may wirelessly transmit the compression sensor data and/or the biological sensor data to the medicament delivery device or to the management device for processing, including detecting the excessive compression and triggering corrective action”).
Regarding claim 5, Rebec et al. teaches the alarm condition is a first alarm condition, and wherein the alarm condition is adjusted from the first alarm condition to a second alarm condition when strain is detected by the strain gauge (see [0115] – “The issue of pressure in the vicinity of a glucose sensor leading to erroneous readings being displayed may be particularly relevant to sleep events. For example, a user of a CGM device may turn or roll during sleep in such a way that pressure is applied to the area where the sensor is located on the skin. This pressure may cause a change in the raw data signal that in turn is reported as a drop in glucose concentration. Such a drop may trigger an alarm, which could unnecessarily awaken a user thus contributing to disrupted sleep patterns, which in turn may adversely exacerbate efforts to control blood sugar”, [0125] – “In an example where the user is sleeping, a medium and/or high confidence in reported corrected values may prevent an alarm from being triggered that wakes the user, whereas a low confidence in reported corrected values may cause the alarm to be triggered so that a user is apprised of the potential adverse health situation”, and [0180] – “Furthermore, the reported values may be associated with a particular confidence level (e.g., high, medium, or low, etc.), such that the user may be apprised of how accurate the corrected/compensated values are likely to be. In some examples, one or more thresholds for controlling an actuator (e.g., insulin pump, alarm, etc.) may comprise adjustable thresholds, which may be adjusted to more conservative levels during time periods where the reported values comprise compensated values, and adjusted to less conservative levels during time periods when the values are not being adaptively compensated/corrected. In some examples, the degree to which the one or more thresholds are adjusted may be a function of the confidence level of the corrected/compensated reported glucose values. For example, the higher the confidence, the lesser a threshold may be adjusted”).
Regarding claim 6, Rebec et al. teaches the first alarm condition comprises a first glucose level threshold, and wherein the second alarm condition comprises a second glucose level threshold that is different than the first glucose level threshold. (see [0180] – “Furthermore, the reported values may be associated with a particular confidence level (e.g., high, medium, or low, etc.), such that the user may be apprised of how accurate the corrected/compensated values are likely to be. In some examples, one or more thresholds for controlling an actuator (e.g., insulin pump, alarm, etc.) may comprise adjustable thresholds, which may be adjusted to more conservative levels during time periods where the reported values comprise compensated values, and adjusted to less conservative levels during time periods when the values are not being adaptively compensated/corrected. In some examples, the degree to which the one or more thresholds are adjusted may be a function of the confidence level of the corrected/compensated reported glucose values. For example, the higher the confidence, the lesser a threshold may be adjusted”)
Regarding claim 7, Rebec et al. teaches the first alarm condition is satisfied when a first number of glucose levels crosses a glucose level threshold, wherein the second alarm condition is satisfied when a second number of glucose levels crosses the glucose level threshold, and wherein the second number is greater than the first number (see [0125] – “In an example where the user is sleeping, a medium and/or high confidence in reported corrected values may prevent an alarm from being triggered that wakes the user, whereas a low confidence in reported corrected values may cause the alarm to be triggered so that a user is apprised of the potential adverse health situation” and [0180] – “Furthermore, the reported values may be associated with a particular confidence level (e.g., high, medium, or low, etc.), such that the user may be apprised of how accurate the corrected/compensated values are likely to be. In some examples, one or more thresholds for controlling an actuator (e.g., insulin pump, alarm, etc.) may comprise adjustable thresholds, which may be adjusted to more conservative levels during time periods where the reported values comprise compensated values, and adjusted to less conservative levels during time periods when the values are not being adaptively compensated/corrected. In some examples, the degree to which the one or more thresholds are adjusted may be a function of the confidence level of the corrected/compensated reported glucose values. For example, the higher the confidence, the lesser a threshold may be adjusted”).
Regarding claim 8, Rebec et al. teaches the first alarm condition is satisfied when a first number of glucose levels crosses a glucose level threshold (see [0125] – “In an example where the user is sleeping, a medium and/or high confidence in reported corrected values may prevent an alarm from being triggered that wakes the user, whereas a low confidence in reported corrected values may cause the alarm to be triggered so that a user is apprised of the potential adverse health situation” and [0180] – “Furthermore, the reported values may be associated with a particular confidence level (e.g., high, medium, or low, etc.), such that the user may be apprised of how accurate the corrected/compensated values are likely to be. In some examples, one or more thresholds for controlling an actuator (e.g., insulin pump, alarm, etc.) may comprise adjustable thresholds, which may be adjusted to more conservative levels during time periods where the reported values comprise compensated values, and adjusted to less conservative levels during time periods when the values are not being adaptively compensated/corrected. In some examples, the degree to which the one or more thresholds are adjusted may be a function of the confidence level of the corrected/compensated reported glucose values. For example, the higher the confidence, the lesser a threshold may be adjusted”). Narayanaswami teaches the second alarm condition is satisfied when the glucose level exceeds the glucose level threshold for at least a predetermined period of time (see [0034] – “There also may be a time component in determining whether the biological sensor 202 is excessively compressed. Specifically, the compression or other measured force or pressure must last at least a minimum amount of time before the biological sensor 202 is deemed to be compressed too greatly (e.g., 5 minutes; 10 minutes; 15 minutes; 30 minutes; or another period of time)”).
Regarding claim 9, Narayanaswami teaches the strain gauge comprises a strain-sensitive resistor (see [0040] – “Force sensitive resistors 808A, 808B, 808C and 808D may be provided to act as the compression sensor 204. Multiple force sensitive resistors 808A, 808B, 808C and 808D are provided to provide coverage across the biological sensor”).
Regarding claim 11, Narayanaswami teaches a detection circuit comprising a voltage input, a voltage output, and the strain-sensitive resistor (see [0046] – “In some exemplary embodiments, as shown in FIG. 12B, the co-located insulin delivery and CGM system may provide a voltage supply 1316 to force sensitive resistor”).
Regarding claim 13, Narayanaswami discloses a method of providing a glucose level alarm, the method comprising:
detecting, by a glucose monitoring device, signals indicative of glucose levels in a bodily fluid, wherein the glucose monitoring device comprises a housing (see Figure 9 and 12A-13), sensor electronics arranged within the housing (see [0047] – “FIG. 13 depicts components of an illustrative medicament delivery device in more detail than FIG. 2A. The medicament delivery device 1300 may contain a processor 1302, such as a CPU, a GPU, an ASIC, a FPGA or the like. The processor 1302 may run a control application 1303 formed of computer programming instructions for controlling operation of the medicament delivery device 1300. The control application 1303 may be stored in a storage 1304. The storage 1304 may contain non-transitory computer-readable storage media for storing computer programming instructions and data. The storage may include memory and storage devices, such as RAM devices, ROM devices, solid state memory devices, optical disk storage device, magnetic storage devices and the like”), a glucose sensor (202) coupled to the housing (see [0030] – “A biological sensor 202 may be secured to a user to detect a biological characteristic of the user, such as glucose level, ketone level, heartbeat, temperature, blood oxygen level or the like. In some embodiments, the biological sensor may be secured to the user, such as by having an adhesive layer that holds the sensor in place secured to the user. In some exemplary embodiments, the biological sensor is a continuous glucose monitor (CGM)”), and a strain gauge (204) (see [0030] – “A compression sensor 204 is provided to sense compression of the biological sensor 202. The compression sensor 204 may be a pressure sensor that senses pressure, a force sensor that senses magnitude of force and possible direction of force, a strain gauge that senses strain, a rigid compliant capacitive sensor that senses an external mechanical force, or the like. The compression sensor 204 may be an electrical sensor or a mechanical sensor”);
detecting, by the strain gauge of the glucose monitoring device, a strain applied to the first portion of the glucose sensor (see [0034] – “Compression sensor 204 senses compression of the biological sensor 202, such as when a user lies on top of the biological sensor. At 216, compression sensor data is processed to determine if the biological sensor 202 is too greatly compressed (i.e., excessively compressed). The compression sensor data may specify an amount of pressure or force that is applied to the biological sensor 202. At 216, a pressure or force threshold may be established, and if the force or pressure threshold is exceeded, it can be concluded that the biological sensor 202 is excessively compressed. In still other instances, the compression sensor may act like a switch that only switches to a compressed state when enough force is applied to fully actuate a lever or other actuatable element. There also may be a time component in determining whether the biological sensor 202 is excessively compressed. Specifically, the compression or other measured force or pressure must last at least a minimum amount of time before the biological sensor 202 is deemed to be compressed too greatly (e.g., 5 minutes; 10 minutes; 15 minutes; 30 minutes; or another period of time)” and [0039] – “Similarly, the compression sensor data 712 includes associated timestamps 716”); and
outputting, by one or more processors in communication with the glucose monitoring device, a glucose level alarm when an alarm condition is satisfied, wherein the alarm condition is based on the glucose level and the strain detected by the strain gauge (see [0035] – “If it determined at 216 that the biological sensor 202 is compressed too greatly, corrective action may be taken at 218. Otherwise, no corrective action may be taken. FIG. 3 depicts examples of possible corrective actions 300. A first variety of corrective action 300 is to trigger alerts 300 to alert the user to the compression and possibly to suggest user actions that may remedy the compression. FIG. 4 depicts illustrative types of alerts 400. The alerts 400 may be visual alerts 402, such as textual and/or graphical content displayed on a display or via a light or LED of medicament delivery device 206, or on a display or user interface of the management device 210 for the medicament delivery device 206 or for the biological sensor 202. The alerts may warn the user of the compression and possibly suggest corrective action. The alerts 400 may include auditory alerts 404, such as beeps, sirens or spoken messages. The alerts may also include vibratory alerts 406, that may be generated using, for example, a vibrating alert motor or a linear resonant actuator. In some instances, combinations of two or more of the visual alerts 402, auditory alerts 404 and vibratory alerts 406 may be used” and [0036] – “At 502, the biological sensor data is received. For example, glucose level data may be received from a glucose monitor, like a CGM. At 504, compression sensor data is received. At 506, a model is used to predict what the sensed data value would have been but for the excessive compression. The model may simply identify when an excessive compression occurs and predict what the expected sensed data values should have been while the biological sensor is excessively compressed but for the excessive compression. The model may use interpolation on the plot of biological sensor data and other techniques to predict the expected biological sensor values”).
It is noted Narayanaswami does not specifically teach the glucose sensor comprises a first portion configured to be placed under a skin surface of a user to detect signals indicative of glucose levels in a bodily fluid and a second portion coupled to the sensor electronics or the strain gauge is disposed on the first portion of the glucose sensor. However, Rebec et al. teaches the glucose sensor (150) comprises a first portion configured to be placed under a skin surface of a user to detect signals indicative of glucose levels in a bodily fluid and a second portion coupled to the sensor electronics (110) or the strain gauge is disposed on the first portion of the glucose sensor (see Figure 5 and [0143] – “Turning now to FIG. 5, depicted is an illustration of a torso 500 of a user of a CAM system of the present disclosure. It is herein recognized that it may be advantageous for one or more adjunct sensors to be in a certain proximity to the analyte sensor. Accordingly, inset 502 shows a close-up view of a location on the torso 500 of the user where the analyte sensor 150 is embedded in the skin of the user. A region 505 of radius r defines an area where at least one other adjunct sensor is positioned. Illustrated is accelerometer 160, temperature sensor 170, and pressure sensor 507. In examples, radius r is 8 cm or less, for example 7 cm or less, 6 cm or less, 5 cm or less, 4 cm or less, 3 cm or less, 2 cm or less, or even 1 cm or less (e.g., within 1-10 mm, 10-50 mm, 50-100 mm, 100-500 mm, 500-1000 mm). Not shown at FIG. 5 is a housing that houses sensor electronics, for example a housing that includes computing device 110. Also not shown at FIG. 5 is an adhesive patch that may comprise a backing of such a housing, and which may be used to adhere the housing to a skin of the user. As elaborated below, in some examples it is within the scope of this disclosure that one or more pressure sensors 507 may be incorporated into such an adhesive patch, and these one or more pressure sensors may comprise adjunct sensors capable of reporting on pressure changes in the close proximity of the analyte 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 Narayanaswami to include the glucose sensor comprises a first portion configured to be placed under a skin surface of a user to detect signals indicative of glucose levels in a bodily fluid and a second portion coupled to the sensor electronics and the strain gauge is disposed on the first portion of the glucose sensor, as disclosed in Rebec et al., so as to allow the strain gauge to report on pressure changes in close proximity to where the analyte sensor is embedded in the skin of the user (see Rebec et al.: [0143]).
Regarding claim 16, Narayanaswami teaches communicating data from the glucose monitoring device to a receiver device, wherein the receiver device outputs the glucose level alarm (see [0027] – “The data logger may wirelessly transmit the compression sensor data and/or the biological sensor data to the medicament delivery device or to the management device for processing, including detecting the excessive compression and triggering corrective action”).
Regarding claim 17, Rebec et al. teaches adjusting the alarm condition from a first alarm condition to a second alarm condition when strain is detected by the strain gauge (see [0115] – “The issue of pressure in the vicinity of a glucose sensor leading to erroneous readings being displayed may be particularly relevant to sleep events. For example, a user of a CGM device may turn or roll during sleep in such a way that pressure is applied to the area where the sensor is located on the skin. This pressure may cause a change in the raw data signal that in turn is reported as a drop in glucose concentration. Such a drop may trigger an alarm, which could unnecessarily awaken a user thus contributing to disrupted sleep patterns, which in turn may adversely exacerbate efforts to control blood sugar”, [0125] – “In an example where the user is sleeping, a medium and/or high confidence in reported corrected values may prevent an alarm from being triggered that wakes the user, whereas a low confidence in reported corrected values may cause the alarm to be triggered so that a user is apprised of the potential adverse health situation”, and [0180] – “Furthermore, the reported values may be associated with a particular confidence level (e.g., high, medium, or low, etc.), such that the user may be apprised of how accurate the corrected/compensated values are likely to be. In some examples, one or more thresholds for controlling an actuator (e.g., insulin pump, alarm, etc.) may comprise adjustable thresholds, which may be adjusted to more conservative levels during time periods where the reported values comprise compensated values, and adjusted to less conservative levels during time periods when the values are not being adaptively compensated/corrected. In some examples, the degree to which the one or more thresholds are adjusted may be a function of the confidence level of the corrected/compensated reported glucose values. For example, the higher the confidence, the lesser a threshold may be adjusted”).
Regarding claim 18, Rebec et al. teaches the first alarm condition comprises a first glucose level threshold, and wherein the second alarm condition comprises a second glucose level threshold that is different than the first glucose level threshold. (see [0180] – “Furthermore, the reported values may be associated with a particular confidence level (e.g., high, medium, or low, etc.), such that the user may be apprised of how accurate the corrected/compensated values are likely to be. In some examples, one or more thresholds for controlling an actuator (e.g., insulin pump, alarm, etc.) may comprise adjustable thresholds, which may be adjusted to more conservative levels during time periods where the reported values comprise compensated values, and adjusted to less conservative levels during time periods when the values are not being adaptively compensated/corrected. In some examples, the degree to which the one or more thresholds are adjusted may be a function of the confidence level of the corrected/compensated reported glucose values. For example, the higher the confidence, the lesser a threshold may be adjusted”)
Regarding claim 19, Rebec et al. teaches the first alarm condition is satisfied when a first number of glucose levels crosses a glucose level threshold, wherein the second alarm condition is satisfied when a second number of glucose levels crosses the glucose level threshold, and wherein the second number is greater than the first number (see [0125] – “In an example where the user is sleeping, a medium and/or high confidence in reported corrected values may prevent an alarm from being triggered that wakes the user, whereas a low confidence in reported corrected values may cause the alarm to be triggered so that a user is apprised of the potential adverse health situation” and [0180] – “Furthermore, the reported values may be associated with a particular confidence level (e.g., high, medium, or low, etc.), such that the user may be apprised of how accurate the corrected/compensated values are likely to be. In some examples, one or more thresholds for controlling an actuator (e.g., insulin pump, alarm, etc.) may comprise adjustable thresholds, which may be adjusted to more conservative levels during time periods where the reported values comprise compensated values, and adjusted to less conservative levels during time periods when the values are not being adaptively compensated/corrected. In some examples, the degree to which the one or more thresholds are adjusted may be a function of the confidence level of the corrected/compensated reported glucose values. For example, the higher the confidence, the lesser a threshold may be adjusted”).
Regarding claim 20, Rebec et al. teaches the first alarm condition is satisfied when a first number of glucose levels crosses a glucose level threshold (see [0125] – “In an example where the user is sleeping, a medium and/or high confidence in reported corrected values may prevent an alarm from being triggered that wakes the user, whereas a low confidence in reported corrected values may cause the alarm to be triggered so that a user is apprised of the potential adverse health situation” and [0180] – “Furthermore, the reported values may be associated with a particular confidence level (e.g., high, medium, or low, etc.), such that the user may be apprised of how accurate the corrected/compensated values are likely to be. In some examples, one or more thresholds for controlling an actuator (e.g., insulin pump, alarm, etc.) may comprise adjustable thresholds, which may be adjusted to more conservative levels during time periods where the reported values comprise compensated values, and adjusted to less conservative levels during time periods when the values are not being adaptively compensated/corrected. In some examples, the degree to which the one or more thresholds are adjusted may be a function of the confidence level of the corrected/compensated reported glucose values. For example, the higher the confidence, the lesser a threshold may be adjusted”). Narayanaswami teaches the second alarm condition is satisfied when the glucose level exceeds the glucose level threshold for at least a predetermined period of time (see [0034] – “There also may be a time component in determining whether the biological sensor 202 is excessively compressed. Specifically, the compression or other measured force or pressure must last at least a minimum amount of time before the biological sensor 202 is deemed to be compressed too greatly (e.g., 5 minutes; 10 minutes; 15 minutes; 30 minutes; or another period of time)”).
Claim(s) 2-3 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Narayanaswami and Rebec et al., further in view of Bremer (US Publication No. 2017/0055906 A1) (previously cited).
Regarding claims 2 and 14, it is noted neither Narayanaswami nor Rebec et al. specifically teach the alarm condition is satisfied when the glucose level crosses a glucose level threshold and no strain is detected by the strain gauge. However, Bremer teaches the alarm condition is satisfied when the glucose level crosses a glucose level threshold and no strain is detected by the strain gauge (see [0227] – “For example, the analysis engine 130 may trigger an alarm when sensor 110 senses a blood glucose reading that is sustained over 150 mg/dl for 30 minutes when an activity sensor determines that a patient is not sleeping based on a reading from motion sensor 165d or data received from an activity sensor 180, which can be indicative of patient activity other than sleeping. However, the analysis engine 130 may not trigger an alarm when the sensor 110 senses a blood glucose reading that is sustained over 150 mg/dl for 30 minutes when an analysis engine determines that a patient is at rest based on a reading from motion sensor 165d or an activity sensor 180 in conjunction with the time of day and ambient light level; but the analysis engine 130 can be configured to trigger an alarm when sensor 110 senses a blood glucose reading has been sustained over 150 mg/dl for 2 hours if the analysis engine determines a patient is at rest” and [0256] – “In this embodiment, the analysis engine 130 determines that the patient is sleeping. In block 1610, the analysis engine 130 issues protocols for the sleeping patient to the controller 120. In block 1615, the controller 120 interrogates the sensor 110 based on a sleeping patient protocol that is included in the controller 120. In block 1620, the controller 120 determines glucose level estimates based on the sensor measures over a time period. In block 1625, the controller 120 transmits a time series burst of glucose readings to the analysis engine. In block 1630, the analysis engine 130 analyzes burst(s) of glucose readings to determine trends, patterns, and trigger alerts. The alerts are dependent on the protocol. For example, a patient who is sleeping may have the low glucose alert set to a lower threshold value than a patient that is not sleeping, but exercising. For example, in a sleeping patient, the alarm for a high glucose level may not be triggered if the glucose measurement is slowly climbing above a primary threshold but has not yet crossed a secondary threshold”). 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 system and method of Narayanaswami and Rebec et al. to include the alarm condition is satisfied when the glucose level crosses a glucose level threshold and no strain is detected by the strain gauge, as disclosed in Bremer, so as to avoid unnecessarily issuing an alarm to the user while they are sleeping.
Regarding claims 3 and 15, it is noted neither Narayanaswami nor Rebec et al. specifically teach the alarm condition is satisfied when the glucose level crosses a glucose level threshold and the strain detected by the strain gauge is below a predetermined level. However, Bremer teaches the alarm condition is satisfied when the glucose level crosses a glucose level threshold and the strain detected by the strain gauge is below a predetermined level (see [0227] – “For example, the analysis engine 130 may trigger an alarm when sensor 110 senses a blood glucose reading that is sustained over 150 mg/dl for 30 minutes when an activity sensor determines that a patient is not sleeping based on a reading from motion sensor 165d or data received from an activity sensor 180, which can be indicative of patient activity other than sleeping. However, the analysis engine 130 may not trigger an alarm when the sensor 110 senses a blood glucose reading that is sustained over 150 mg/dl for 30 minutes when an analysis engine determines that a patient is at rest based on a reading from motion sensor 165d or an activity sensor 180 in conjunction with the time of day and ambient light level; but the analysis engine 130 can be configured to trigger an alarm when sensor 110 senses a blood glucose reading has been sustained over 150 mg/dl for 2 hours if the analysis engine determines a patient is at rest” and [0256] – “In this embodiment, the analysis engine 130 determines that the patient is sleeping. In block 1610, the analysis engine 130 issues protocols for the sleeping patient to the controller 120. In block 1615, the controller 120 interrogates the sensor 110 based on a sleeping patient protocol that is included in the controller 120. In block 1620, the controller 120 determines glucose level estimates based on the sensor measures over a time period. In block 1625, the controller 120 transmits a time series burst of glucose readings to the analysis engine. In block 1630, the analysis engine 130 analyzes burst(s) of glucose readings to determine trends, patterns, and trigger alerts. The alerts are dependent on the protocol. For example, a patient who is sleeping may have the low glucose alert set to a lower threshold value than a patient that is not sleeping, but exercising. For example, in a sleeping patient, the alarm for a high glucose level may not be triggered if the glucose measurement is slowly climbing above a primary threshold but has not yet crossed a secondary threshold”). 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 system and method of Narayanaswami and Rebec et al. to include the alarm condition is satisfied when the glucose level crosses a glucose level threshold and the strain detected by the strain gauge is below a predetermined level, as disclosed in Bremer, so as to avoid unnecessarily issuing an alarm to the user while they are sleeping.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Narayanaswami and Rebec et al., further in view of Tehrani et al. (US Publication No. 2025/0025077 A1) (previously cited).
Regarding claim 10, it is noted neither Narayanaswami nor Rebec et al. specifically teach the strain-sensitive resistor comprises a piezoresistive trace. However, Tehrani et al. teaches the strain-sensitive resistor comprises a piezoresistive trace (see [0018] – “The force touch sensor may be selected from the group consisting of pressure, strain gauge, piezoelectric, piezoresistive, resonant, electromagnetic, capacitive, and diaphragm-based MEMS sensors operating individually or in combination with each other, and the force touch sensor is configured to transduce an applied force into an electrical parameter selected from the group consisting of resistance, current, capacitance, inductance, frequency or phase shift, voltage variability, optical or thermal changes and magnetic field variations”). 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 system and method of Narayanaswami and Rebec et al. to include the strain-sensitive resistor comprises a piezoresistive trace, as disclosed in Tehrani et al, because piezoresistive traces are a common type of strain gauge that is well-known to those of ordinary skill in the art.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Narayanaswami and Rebec et al., further in view of Roscher (US Publication No. 2024/0180446 A1).
Regarding claim 21, it is noted neither Narayanaswami et al. nor Rebec et al. specifically teach the glucose sensor further comprises a membrane, and wherein at least a portion of the strain gauge is covered by the membrane. However, Roscher teaches the glucose sensor further comprises a membrane, and wherein at least a portion of the strain gauge is covered by the membrane (see [0034] – “According to this disclosure, such a strain measurement device, e.g., in a pattern as is known to be used on a strain gauge, can, in particular after proper size adjusting, i.e., typically a miniaturization, be mounted in or on a flexible insertion piece, in particular on an insulating layer of the flexible insertion piece and/or below a protective, e.g., biocompatibility, layer, e.g., in the case of the flexible insertion piece comprising an analyte sensor or a flexible cannula for drug delivery”). 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 system of Narayanaswami and Rebec et al. to include the glucose sensor further comprises a membrane, and wherein at least a portion of the strain gauge is covered by the membrane, as disclosed in Roscher, so as to protect the strain gauge from outside influences that may distort the measurement results of the deformation information (see Roscher: [0103]).
Response to Arguments
Applicant's arguments filed 7/13/2026 have been fully considered but they are not persuasive.
Applicant argues that neither Narayanaswami nor Rebec disclose or suggest a glucose sensor having a first portion configured to be arranged under a skin surface and having a strain gauge on the first portion of the glucose sensor. The Examiner respectfully disagrees and points primarily to Figure 5 of Rebec as constituting the claimed “first portion”, which includes pressure sensor 507 in close proximity to analyte sensor 150 to detect pressure changes near the analyte sensor. The analyte sensor, also on the first portion 505, is embedded in the skin of the user (see [0143]). Thus, Rebec describes a “first portion” that is at least partially placed under a skin surface and includes the strain gauge. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the strain gauge is arranged under the skin surface) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues the rejection of claims 2-3 and 14-15, specifically arguing that Bremer does not disclose or suggest outputting a glucose level alarm when a glucose level crosses a threshold. Applicant’s argument ignores what is already taught by the combination of Narayanaswami and Rebec, in particular issuing alarms based on the glucose level and the strain detected by the strain gauge crossing certain threshold. Rebec describes activating the alarm when a hyoglycemic or hyperglycemic event is detected (see [0029]), while Narayanaswami describes activating the alarm when a force or pressure threshold is exceeded (see [0034]-[0035]). Thus, the combination of Narayanaswami and Rebec describes activating an alarm when the glucose level is high or low and the strain is high. What is missing from the combination of Narayanaswami and Rebec is the alarm being activated when no strain or strain below a predetermined level is detected. Bremer teaches an activity sensor (analogous to the strain sensors described by Narayanaswami and Rebec) and further describes activating the alarm when the glucose level is above a threshold (e.g. 150 mg/dl) and the activity sensor determines the patient is at rest (i.e. there is no activity detected by the activity sensor or the activity is below a predetermined level) (see [0227]). Thus, the combination of Narayanaswami and Rebec as modified by Bremer teaches the alarm condition is satisfied when the glucose level crosses a glucose level threshold and no strain is detected by the strain gauge or the strain detected by the strain gauge is below a predetermined level.
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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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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