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 .
This Office Action is in response to the Applicants’ communication filed on February 25, 2025. Claims 1-16 have been amended; claims 17-47 have been canceled. In virtue of this communication, claims 1-16 are currently presented in the instant application.
Drawings
The drawings submitted on February 25, 2025. These drawings are reviewed and accepted by the examiner.
Information Disclosure Statement
The information Disclosure Statement (IDS) Forms PTO-1449, filed on February 25, 2025 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosed therein was considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Koehler et al. (US 20230260647 A1) in view of Xu (US 20200092411 A1), and further in view NABUTOVSKY et al. (US 20210366609 A1).
Regarding claim 1. Koehler discloses a management device for displaying glucose information (Koehler, see FIG. 1 and par. [0114]), comprising:
a screen capable of user interaction, wherein the screen is divided into a plurality of display areas (Koehler, see at least par. [0142] FIG. 3B illustrates an exemplary interface for entering meal-related event information. This interface may be displayed on the user interface of the patient's device 18 upon selection of the event entry icon 340 or may be automatically triggered when application 255 receives input indicating that the patent has eaten or is about to eat. The input may be one or more or time of day (e.g. lunchtime), a change in glucose levels indicative of eating a meal (e.g., a rising glucose level), location (e.g., a GPS location corresponding to a restaurant), and the like. A patient may use food input menu 1610 to provide information regarding recent meals, such as breakfast 1622A, lunch 1624, dinner 1626, and snacks 1628. Menu 1610 may include an area 1614 for logging the consumption of favorite foods. For example, if a user consumes coffee, eggs, bread, and fruit for breakfast, he or she may quickly log these items by selecting icons 1632, 1634, 1636, and 1638, respectively. The food input menu 1610 may also display the patient's current or most recent glucose level reading 1616 and a trend graph 1620. Trend graph 1620 may provide a graphical view of fluctuations in the patient's glucose level over a particular period of time.), wherein the plurality of display areas at least comprises a first display area for displaying a status of the management device (Koehler, see at least par. [0144] Returning to FIG. 3A, icon 342 may dynamically change to indicate whether remote monitoring is enabled. To illustrate, a patient may wish to share his or her glucose levels with one or more remote monitors, such as a parent, guardian, or physician, particularly when the patient is a child or elderly person. A patient may enable or disable remote monitoring using primary device 18. In some circumstances, remote monitoring may not be enabled if, for example, the patient has not yet subscribed to the remote monitoring feature. Remote monitoring module 290 may display the status of the remote monitoring function by adjusting the appearance of icon 342 according to a plurality of states. In one implementation, the icon may be displayed in one of three states: an active sharing state, a remote monitoring disabled state, and a remote monitoring error state. The various states may be visually distinguishable by, for example, changing the color of icon 342 and/or displaying one or more badges with icon 342.),
wherein at least one display area further comprises calibration information (Koehler, see at least par. [0148] Returning to FIG. 3A, icon 344 may be a reference calibration icon. When a calibration measurement is needed, calibration module 280 may display a badge on icon 344. In the implementation of FIG. 3A, the badge may include a circle with a number positioned over the calibration icon 344. This number may represent how many calibration readings are needed. For instance, during initialization or warm up of a new sensor system 8, two calibrations may be needed. In some implementations, a calibration measurement may be required at predetermined frequencies (e.g., every 12 hours) or when erratic glucose level readings are detected by sensor system 8. Erratic data may be caused by a faulty sensor, illness, interfering components in the patient's bodily fluid, or electrostatic interference with device electronics, for example.)
Koehler does not disclose a second display area for displaying real-time glucose information, a third display area for displaying historical glucose concentration information, a third display area for displaying historical glucose concentration information, a power button, wherein the power button is at least used to activate or deactivate the screen; and a home key, wherein the home key is at least used to return an[[the]] interface displayed on the screen to a home screen. However,
NABUTOVSKY discloses:
a second display area for displaying real-time glucose information, a third display area for displaying historical glucose concentration information
(NABUTOVSKY, see at least par. [0081] Referring first to FIG. 2D, sensor results GUI 235 depicts an interface comprising a first portion 236 that can include a numeric representation of a current analyte concentration value (e.g., a current glucose value), a directional arrow to indicate an analyte trend direction, and a text description to provide contextual information such as, for example, whether the user's analyte level is in range (e.g., “Glucose in Range”). First portion 236 can also comprise a color or shade that is indicative of an analyte concentration or trend. For example, as shown in FIG. 2D, first portion 236 is a green shade, indicating that the user's analyte level is within a target range. According to some embodiments, for example, a red shade can indicate an analyte level below a low analyte level threshold, an orange shade can indicate an analyte level above a high analyte level threshold, and an yellow shade can indicate an analyte level outside a target range. [0082] In addition, according to some embodiments, sensor results GUI 235 also includes a second portion 237 comprising a graphical representation of analyte data. In particular, second portion 237 includes an analyte trend graph reflecting an analyte concentration, as shown by the y-axis, over a predetermined time period, as shown by the x-axis. As embodied herein, the predetermined time period can be shown in five-minute increments, with a total of twelve hours of data. Those of skill in the art will appreciate, however, that other time increments and durations of analyte data can be utilized and are fully within the scope of this disclosure. Second portion 237 can also include a point 239 on the analyte trend graph to indicate the current analyte concentration value, a shaded green area 240 to indicate a target analyte range, and two dotted lines 238a and 238b to indicate, respectively, a high analyte threshold and a low analyte threshold. According to some embodiments, GUI 235 can also include a third portion 241 comprising a graphical indicator and textual information representative of a remaining amount of sensor life. [0083] Referring next to FIG. 2E, another example embodiment of a sensor results GUI 245 is depicted. In accordance with the disclosed subject matter, first portion 236 is shown in a yellow shade to indicate that the user's current analyte concentration is not within a target range. In addition, second portion 237 includes: an analyte trend line 241 which can reflect historical analyte levels over time and a current analyte data point 239 to indicate the current analyte concentration value (shown in yellow to indicate that the current value is outside the target range)… [0304] One consequence of immediate access for users of the FreeStyle Libre system to a range of glycemic information that can improve their decision making during daily diabetes self-care. These can include their glucose status in real time, the trend arrows that indicate the direction and speed of change in their glucose status and the summary reports that are available to them via the readers or smartphone apps that they use to scan and collect glucose data), and
a third display area for displaying historical glucose concentration information (NABUTOVSKY, see at least par. [0088] FIG. 2I is another example embodiment of a sensor results GUI 265. According to the depicted embodiments, sensor results GUI 265 depicts first portion 236 when there is a sensor error. In accordance with the disclosed subject matter, first portion 236 includes three dashed lines 266 in place of the current analyte concentration value to indicate that a current analyte value is not available. As embodied herein, three dashed lines 266 can indicate one or more error conditions such as, for example, (1) a no signal condition; (2) a signal loss condition; (3) sensor too hot/cold condition; or (4) a glucose level unavailable condition. Furthermore, as can be seen in FIG. 2I, first portion 236 comprises a gray shading (instead of green, yellow, orange, or red) to indicate that no current analyte data is available. In addition, according to another aspect of the embodiments, second portion 237 can be configured to display the historical analyte data in the analyte trend graph, even though there is an error condition preventing the display of a numeric value for a current analyte concentration in first portion 236. However, as shown in FIG. 2I, no current analyte concentration value data point is shown on the analyte trend graph of second portion 237.),
Therefore, 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 and apparatus of Koehler, with a second display area for displaying real-time glucose information, a third display area for displaying historical glucose concentration information, a third display area for displaying historical glucose concentration information, as provided by NABUTOVSKY. The modification provide an improved system and method for displaying glucose information; thereby use analyte monitoring systems for various reasons, including the complexity and volume of data presented, a learning curve associated with the software and user interfaces for analyte monitoring systems, and an overall paucity of actionable information presented. [0007] Thus, needs exist for analyte monitoring systems, as well as methods and devices relating thereto, for improving clinical outcomes. (NABUTOVSKY, see pars. [0006-0007]).
Koehler in view of NABUTOVSKY does not disclose a power button, wherein the power button is at least used to activate or deactivate the screen; and a home key, wherein the home key is at least used to return an[[the]] interface displayed on the screen to a[[the]] home screen. However,
Xu discloses:
a power button, wherein the power button is at least used to activate or deactivate the screen (Xu, see n FIG. 4G, all specific information 405 of the notification 401 is displayed, and a power icon 406 indicates that after the finger 403 of the user taps the icon 406, the touchscreen is turned off or returns to the lock screen (as shown in FIG. 3A).);
and a home key, wherein the home key is at least used to return an interface displayed on the screen to a home screen (Xu, see at least par. FIG. 1, the electronic device 300 may further include the home button 306, a front-facing camera 307, and the like. The home button 306 may be configured to perform an operation of quickly returning to a main screen, performing screen capture, or the like.).
Therefore, 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 and apparatus of Koehler, with a power button, wherein the power button is at least used to activate or deactivate the screen and a home key, wherein the home key is at least used to return an interface displayed on the screen to a home screen, as provided by Xu. The modification provide an improved system and method for displaying glucose information; thereby to improves processing efficiency of an electronic device, simplifies user operation steps, and further improves user experience. (Xu, see par. [0009]).
Regarding claim 2. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 1 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein the first display area comprises at least a power icon, a time icon and a prompt mode icon (NABUTOVSKY, see [0149] FIG. 3H illustrates a user interface 390 for entering a calibration measurement. Calibration module 280 may display user interface 390 when a user selects calibration icon 344 of FIG. 3A, for example. A user may be prompted to measure his or her glucose level using an external blood glucose meter when a badge appears on icon 344. The user may enter measurement 392 into interface 390 using numerical keypad 394. Once the glucose measurement 392 is entered, interface 390 may prompt the user to confirm the value and time 396 of the reading using OK button 398. Once these values are confirmed, the application may initiate calibration of the system using the entered value.).
Therefore, 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 and apparatus of Koehler, with wherein the first display area comprises at least a power icon, a time icon and a prompt mode icon, as provided by NABUTOVSKY. The modification provide an improved system and method for displaying glucose information; thereby use analyte monitoring systems for various reasons, including the complexity and volume of data presented, a learning curve associated with the software and user interfaces for analyte monitoring systems, and an overall paucity of actionable information presented. [0007] Thus, needs exist for analyte monitoring systems, as well as methods and devices relating thereto, for improving clinical outcomes. (NABUTOVSKY, see pars. [0006-0007]).
Regarding claim 3. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 2 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein the power icon, the time icon and the prompt mode icon have different display forms under different operation or setting states (Xu, see par. [0103], The lock screen may include a plurality of interface elements, for example, lock screen wallpaper 301, a fingerprint unlock icon 302, a prompt box 303, a quick-start camera icon 304, and a time and date 305. The lock screen wallpaper 301 may be automatically updated regularly for displaying. The fingerprint unlock icon 302 is configured to prompt a user with the following information: Fingerprint verification may be performed in a display area of the icon 302, to unlock a screen, and the fingerprint unlock icon 302 may use some interface elements to visually prompt the user how to unlock the screen. As shown in FIG. 3A, the fingerprint unlock icon 302 may be displayed as a fingerprint-shaped icon, another control element, or the like. The fingerprint unlock icon 302 may guide and instruct the user to unlock the screen with reference to prompt information in the prompt box 303. The display area of the fingerprint unlock icon 302 on the touchscreen may alternatively be a position in which the fingerprint recognizer is disposed. That is, the area of the fingerprint unlock icon 302 may be considered as a fingerprint unlock area. Therefore, the fingerprint unlock icon 302 is actually also a fingerprint gathering area. A finger (which is alternatively a stylus or the like) of the user can touch the fingerprint unlock icon 302, so that the electronic device 300 gathers and verities a fingerprint and quickly unlocks the screen. In other embodiments of this application, the fingerprint unlock icon 302 and/or the prompt box 303 may alternatively not be displayed on the touchscreen first. However, after receiving input of the user, the electronic device 300 displays, in response to the input, the fingerprint unlock icon 302 and/or the prompt box 303 on the lock screen. The input of the user may be an operation of pressing a home button 306 by using a finger of the user, may be a touch event performed by using the finger of the user on the touchscreen 104, or the like. In addition, the user may also gradually learn, through continuous trial and error learning, that a specific position on the touchscreen is a fingerprint unlock area.).
Therefore, 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 and apparatus of Koehler, with wherein the power icon, the time icon and the prompt mode icon have different display forms under different operation or setting states, as provided by Xu. The modification provide an improved system and method for displaying glucose information; thereby to improves processing efficiency of an electronic device, simplifies user operation steps, and further improves user experience. (Xu, see par. [0009]).
Regarding claim 4. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 1 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein the second display area at least comprises a glucose tendency icon, a glucose concentration value, a glucose concentration detection time and a closed circle, and the glucose tendency icon, the glucose concentration value and the glucose concentration detection time are located in the closed circle (Koehler, see FIG. 3A, and [0148] Returning to FIG. 3A, icon 344 may be a reference calibration icon. When a calibration measurement is needed, calibration module 280 may display a badge on icon 344. In the implementation of FIG. 3A, the badge may include a circle with a number positioned over the calibration icon 344. This number may represent how many calibration readings are needed. For instance, during initialization or warm up of a new sensor system 8, two calibrations may be needed. In some implementations, a calibration measurement may be required at predetermined frequencies (e.g., every 12 hours) or when erratic glucose level readings are detected by sensor system 8. Erratic data may be caused by a faulty sensor, illness, interfering components in the patient's bodily fluid, or electrostatic interference with device electronics, for example.).
Regarding claim 5. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 4 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein a tendency of glucose is represented by a trend icon (NABUTOVSKY, see at least par. [0081], [0081] Referring first to FIG. 2D, sensor results GUI 235 depicts an interface comprising a first portion 236 that can include a numeric representation of a current analyte concentration value (e.g., a current glucose value), a directional arrow to indicate an analyte trend direction, and a text description to provide contextual information such as, for example, whether the user's analyte level is in range (e.g., “Glucose in Range”). First portion 236 can also comprise a color or shade that is indicative of an analyte concentration or trend. For example, as shown in FIG. 2D, first portion 236 is a green shade, indicating that the user's analyte level is within a target range. According to some embodiments, for example, a red shade can indicate an analyte level below a low analyte level threshold, an orange shade can indicate an analyte level above a high analyte level threshold, and an yellow shade can indicate an analyte level outside a target range.).
Therefore, 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 and apparatus of Koehler, with wherein a tendency of glucose is represented by a trend icon, as provided by NABUTOVSKY. The modification provide an improved system and method for displaying glucose information; thereby use analyte monitoring systems for various reasons, including the complexity and volume of data presented, a learning curve associated with the software and user interfaces for analyte monitoring systems, and an overall paucity of actionable information presented. [0007] Thus, needs exist for analyte monitoring systems, as well as methods and devices relating thereto, for improving clinical outcomes. (NABUTOVSKY, see pars. [0006-0007]).
Regarding claim 6. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 2 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein a tendency of glucose is represented by a trend icon (NABUTOVSKY, see at least par. [0098] According to one aspect of the embodiment shown in FIG. 3F, each bar portion of Time-in-Ranges GUI 340 can comprise a different color. As embodied herein, bar portions can be separated by dashed or dotted lines 342 and/or interlineated with numeric markers 344 to indicate the ranges reflected by the adjacent bar portions. As embodied herein, the time in ranges reflected by the bar portions can be further expressed as a percentage, an actual amount of time (e.g., 4 hours and 19 minutes), or, as shown in FIG. 3F, both. Furthermore, those of skill in the art will recognize that the percentages of time associated with each bar portion can vary depending on the analyte data of the user. In some embodiments of Time-in-Ranges GUI 340, the Target Range can be configured by the user. In other embodiments, the Target Range of Time-in-Ranges GUI 340 is not modifiable by the user.).
Regarding claim 7. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 4 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein a tendency of glucoses is represented by coded color (Koehler, see at least par. [0187] The current data point 437 may also be illustrated differently than older data points using different data point types. Doing so allows a user to quickly distinguish the current reading from historical readings. Data point 437 may be a circle having a black border and color background fill. The color of the background fill may be white because data point 437 lies below threshold value 332. Previous or historical glucose level readings may be illustrated using solid circles. The color of the circles may be white or black depending on whether the data point lies above or below threshold value 332 as described above.).
Regarding claim 8. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 7 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein the coded color is filled in a background area of the closed circle or the second display area (Kochler, see at least par. [0187] The current data point 437 may also be illustrated differently than older data points using different data point types. Doing so allows a user to quickly distinguish the current reading from historical readings. Data point 437 may be a circle having a black border and color background fill. The color of the background fill may be white because data point 437 lies below threshold value 332. Previous or historical glucose level readings may be illustrated using solid circles. The color of the circles may be white or black depending on whether the data point lies above or below threshold value 332 as described above.).
Regarding claim 9. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 4 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein when an event is triggered, at least one of the glucose tendency icon, the glucose concentration value, and the glucose concentration detection time is replaced by an event icon (Koehler, see at least par. 3B and at least par. [0142] FIG. 3B illustrates an exemplary interface for entering meal-related event information. This interface may be displayed on the user interface of the patient's device 18 upon selection of the event entry icon 340 or may be automatically triggered when application 255 receives input indicating that the patent has eaten or is about to eat. The input may be one or more or time of day (e.g. lunchtime), a change in glucose levels indicative of eating a meal (e.g., a rising glucose level), location (e.g., a GPS location corresponding to a restaurant), and the like. A patient may use food input menu 1610 to provide information regarding recent meals, such as breakfast 1622A, lunch 1624, dinner 1626, and snacks 1628…).
Regarding claim 10. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 10 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein the event at least comprises a warm-up of glucose probe, a glucose probe calibration, a loss of signal, an abnormal glucose probe detection or an abnormal glucose concentration value (Koehler, see at least par. [0148] Returning to FIG. 3A, icon 344 may be a reference calibration icon. When a calibration measurement is needed, calibration module 280 may display a badge on icon 344. In the implementation of FIG. 3A, the badge may include a circle with a number positioned over the calibration icon 344. This number may represent how many calibration readings are needed. For instance, during initialization or warm up of a new sensor system 8, two calibrations may be needed. In some implementations, a calibration measurement may be required at predetermined frequencies (e.g., every 12 hours) or when erratic glucose level readings are detected by sensor system 8. Erratic data may be caused by a faulty sensor, illness, interfering components in the patient's bodily fluid, or electrostatic interference with device electronics, for example.).
Regarding claim 11. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 2 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein the third display area comprises a dynamic graph with time as a horizontal axis and glucose concentration value as a vertical axis, wherein the dynamic graph is for displaying historical glucose information (Koehler, see at least [0190] FIGS. 5A, 5B, 5C, and 5D display various views of a trend graph as a user interacts with the user interface. Time may be shown on the horizontal axis, and the glucose level may be illustrated on the vertical axis. These trend graphs may be similar to the trend graphs described above with respect to FIG. 4A but may be extended over a different period of time (e.g., a longer or a shorter period of time). The implementation of FIGS. 5A, 5B, 5C, and 5D shows glucose levels over a default, twelve-hour period. Like the trend graphs of FIGS. 4A and 4B, the current or most recent glucose level reading may be shown on the right. Data points to the left of the current data point may represent earlier readings. These trend graphs may include horizontal lines that represent the lower and higher threshold values described above.).
Regarding claim 12. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 11 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein a real-time glucose concentration value is located at a right most side of the dynamic graph (NABUTOVSKY, see at least par. [0082] In addition, according to some embodiments, sensor results GUI 235 also includes a second portion 237 comprising a graphical representation of analyte data. In particular, second portion 237 includes an analyte trend graph reflecting an analyte concentration, as shown by the y-axis, over a predetermined time period, as shown by the x-axis. As embodied herein, the predetermined time period can be shown in five-minute increments, with a total of twelve hours of data. Those of skill in the art will appreciate, however, that other time increments and durations of analyte data can be utilized and are fully within the scope of this disclosure. Second portion 237 can also include a point 239 on the analyte trend graph to indicate the current analyte concentration value, a shaded green area 240 to indicate a target analyte range, and two dotted lines 238a and 238b to indicate, respectively, a high analyte threshold and a low analyte threshold. According to some embodiments, GUI 235 can also include a third portion 241 comprising a graphical indicator and textual information representative of a remaining amount of sensor life.).
Therefore, 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 and apparatus of Koehler, with wherein a real-time glucose concentration value is located at a right most side of the dynamic graph, as provided by NABUTOVSKY. The modification provide an improved system and method for displaying glucose information; thereby use analyte monitoring systems for various reasons, including the complexity and volume of data presented, a learning curve associated with the software and user interfaces for analyte monitoring systems, and an overall paucity of actionable information presented. [0007] Thus, needs exist for analyte monitoring systems, as well as methods and devices relating thereto, for improving clinical outcomes. (NABUTOVSKY, see pars. [0006-0007]).
Regarding claim 13. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 11 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein when the user taps the dynamic graph, an information display associated with the historical glucose information is expanded in the dynamic graph (Koehler, see at least par. [0193] FIGS. 7A, 7B, 7C, 7D, and 7E illustrate additional views 352 of a user interface in a reflection mode. Data review module 264 may generate views 352 when computing device 18 and/or 19 is rotated from a portrait orientation into a landscape orientation or held in the landscape orientation. Views 352 may include trend graphs that span different lengths of time. For example, in views 350 and 351 of FIGS. 5A-5D and 6A-6C, respectively, the trend graphs display glucose level data over a 12-hour period of time. If a user wishes to see more data (e.g., over a 24 hour period of time) or less data (e.g., over a 3 hour period of time) on the trend graph, the user may change the amount of data that is displayed using view 352. In view 352, one or more selectable timeframe icons (1 HR, 3 HR, 6 HR, 12 HR, and 24 HR) may be displayed at the top of the view. A user may select the desired timeframe icon to indicate the amount of data that he/she wishes to see. These timeframe icons may appear when a user is not interacting with the screen (e.g., computing device 18 and/or 19 does not detect any user input including the presence of a touch or selection). Other actions, such as hand gestures, may also be used to increase or decrease the timeframe (e.g., swiping, pinching, and stretching the display on devices 18 and/or 19). These hour designations are merely exemplary and other increments may be used. The current time may be displayed on the right side of each trend graph. ).
Regarding claim 14. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 1 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein the second display area and the third display area update display at fixed time intervals (Koehler, see at least par. [0241] At 2020, communication failure alert module 277 may use functions locally available on the patient's computing device 18, such as a local calendar application or alarm function, to warn a user that application 255 has stopped running. In these implementations, communication failure alert module 277 may schedule an alarm to trigger at a predetermined time, such as a half hour from the current time. Communication failure alert module 277 may continuously push this alarm out at fixed time intervals (e.g., every 15 minutes) to reschedule the alarm. Communication failure alert module 277 may be unable to reschedule the alarm, however, if application 255 is terminated. When this occurs, the local alarm may eventually trigger and sound off. The computing device 18 may display a notification indicating that application 255 is no longer working to accompany the local alarm.).
Regarding claim 16. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 2 (as rejected above), Koehler in view of NABUTOVSKY and in view of Xu further discloses wherein when an alarm event is triggered, an alarm interface replaces at least one of the plurality of display areas of the home screen (Koehler, see at least pars. [0139] Alert module 275 may generate various alarms or alerts using glucose level alert module 276, mute mode alert module 278, and communication failure alert module 277. Glucose level alert module 276 may be a sub-module of alert module 275 and may be configured to generate an alarm if a patient's glucose level drops below or rises above a predetermined threshold value. A patient may use alert module 275 to set alerts for different parameters and designate which alerts to propagate to the remote monitors. Alert module 275 is described below with respect to FIGS. 9A-14 and 16A-17. Mute mode alert module 278 may be a sub-module of alert module 275 and may be configured to alert a patient if the patient's computing device 18 is determined to be muted. Because a patient may not hear any alerts when his or her device 18 is muted, mute mode alert module 278 may initiate one or more remedial actions, such as propagating one or more alerts to remote monitors. Mute mode alert module 278 is described below with respect to FIGS. 18 and 19. Communication failure alert module 277 may be a sub-module of alert module 275 and may be configured to alert a patient or remote follower if application 255 is determined to be terminated. This notification may prompt the patient to reboot or relaunch application 255 so that he or she may continue receiving glucose level data from sensor system 8. Communication failure alert module 277 is described below with respect to FIGS. 15 and 20.
[0140] FIG. 3A illustrates a home screen 310 that may be displayed by data review module 264 when application 255 is launched. A user, such as a patient and/or remote monitor, may use home screen 310 to assess the status and clinical risk of a patient and to access various features associated with application 255.).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Koehler et al. (US 20230260647 A1) in view of Xu (US 20200092411 A1), and further in view NABUTOVSKY et al. (US 20210366609 A1), as applied claim 14 above and further in view Kocis et al. (US 20100057490 A1).
Regarding claim 15. Koehler in view of NABUTOVSKY and in view of Xu discloses the management device of claim 2 (as rejected above), but Koehler in view of NABUTOVSKY and in view of Xu does not disclose wherein the fixed time interval is 2 min. However,
Kocis discloses:
wherein the fixed time interval is 2 min (Kocis, see at least par. [0070] Physiological data may be collected at different rates. For example, ECG data may be collected at millisecond intervals and processed into time domain information at sub-second intervals. Frequency domain information may be collected in increments that vary about 128 beats and then interpolated into strict 128 beats that vary along an approximate one minute interval. Laboratory and chart information may be collected repeatedly as requested. Demographic information may be collected once at admittance, A common time frame is required to join this information. The information may be taken and different time intervals and re-aggregated into strict fixed time intervals. In one example, a two minute time frame may be used, although any other suitable time frame may be used.).
Therefore, 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 and apparatus of Koehler, with wherein the fixed time interval is 2 min, as provided by Kocis. The modification provide an improved system and method for displaying glucose information; thereby to provided additional information to the bedside clinician, but most have failed to demonstrate improvement in patient morbidity or mortality. Each of these monitoring devices provides a unidimensional time domain appraisal of a specific organ function that must be assimilated, interpreted, and acted upon by the bedside physician, nurse, or allied health care worker. It is desirable to provide improvements for presenting this information and analysis of this information to medical practitioners. (Kocis, see par. [0006]).
Conclusion
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/KIM THANH T TRAN/Examiner, Art Unit 2615
/JAMES A THOMPSON/Primary Examiner, Art Unit 2615