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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/06/2026 has been entered.
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 2-9, 280-291, and 294-295 are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (US 20190000360 A1 – previously cited), hereinafter Cole, in view of Raisoni et al. (US 20180228408- Previously cited), hereinfter Raisoni, Harper et al. (US 20110193704 A1 – previously cited), hereinafter Harper, and Chakravarthy et al. (US 20200029911), hereinafter Chakravarthy.
Regarding claim 5, Cole teaches an analyte monitoring system (see ABSTRACT), comprising: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in fluid contact with a bodily fluid of a subject (¶ [0022,0025], an in vivo analyte sensor for contacting bodily fluid of the subject is part of an on-body device (OBD) referred to as the sensor control device hereinafter); and a reader device (¶ [0026], reader device used to analyze information from the sensor data), comprising: wireless communication circuitry configured to receive a current sensor reading from the sensor control device (¶ [0030], sensor control device communicates with the reader device wirelessly); and one or more processors coupled to a memory, the memory storing instructions that, when executed by the one or more processors (¶ [0050] and fig. 2), cause the one or more processors to: determine a time elapsed since the current sensor reading was received (¶ [0103], the reader device executes data synchronization between sensor control device by determining if there has been a time elapsed since the current sensor reading was received during one or more successive receiving windows), determine whether the time elapsed exceeds a signal loss indicator threshold (¶ [0101-0103], the reader device determines when the time elapsed exceeds a communication interval (CI) and/or receiving window referred to hereinafter as the signal loss threshold), in response to a determination that the time elapsed exceeds the signal loss indicator threshold, generate a signal loss indicator (¶ [0103], once the reader device confirms loss of synchronization, a signal loss indicator is generated in the form of an audible, visual, and/or tactile notification).
Cole fails to teach display an analyte trend graph and a numeric analyte level and trend arrow indicator, wherein the numeric analyte level and trend arrow indicator is displayed above the analyte trend graph.
Raisoni teaches an analyte monitoring system with a patient application and display (abstract). The system is configured to display an analyte level and trend arrow above the analyte trend graph (¶[0093] and fig. 14A).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Col, such that an numeric analyte level and trend arrow indicator is displayed above the analyte trend graph, as taught by Raisoni, to aid in providing an inclusive platform of the user’s physiological information for further monitoring.
Cole fails to teach determining whether the current sensor reading is invalid, and in response to a determination that the current sensor reading is invalid, generating an invalid sensor reading indicator, and preventing display of numeric analyte level and trend arrow indicator by displaying non-alphanumeric characters in place of the numeric analyte level above the analyte trend graph.
Harper teaches an analyte monitoring device (see abstract and para. [0053]) comprising a processor (¶ [0058]) configured to determine whether current blood glucose result is settling and glucose results may not be accurate (invalid) and/or other alert determination criteria and generating an invalid sensor reading indicator on a display based on the determination of an alert criteria (¶ [0251-252]). The generated alert indicator displayed prevents display of numeric analyte level and trend arrow indicator and upon user interaction/intervention the user can be returned to a home screen (¶ [0261-262] figs. 2A,3A and 20-21). The display of analyte levels (fig. 17B, analyte levels are shown in the display screen) can be replaced (due to error) with nonalphanumeric characters such as, icon, video clip, sound byte, etc. (¶ [0261], “Although text is specifically shown in FIG. 20, it is contemplated that the text may be replaced by an icon, a series of icons, video clip, sound byte etc.”). Additionally, Harper discloses “information mode home screen 300 may also include system information icons on a portion or panel of the information mode home screen 300. In certain embodiments, the system information icons indicate the status of various system components. Such icons may include a wireless connection icon 330, an audio/vibratory settings icon 332, a calibration status icon 334, and battery icon 336. Although not shown, other icons may be displayed including a sensor life icon that shows the remaining life of a sensor, such as, for example, sensor 101 or an alarm notification icon indicating that an alarm or alert condition is detected.” indicating that the display screen can comprise a plurality of panels that can depict a variety of information, e.g., trend graph, alert message, etc., and arrange them per user preference, e.g., alert above graph, etc. (¶ [0107,0233-235] and figs 3A-3C). In support, Raisoni’s trend graph screen that comprises the trend arrow and glucose level above the trend line can be other “items and features” including alert icons (¶[0093] and Table 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cole-Raisoni, such that an invalid sensor reading indicator is generated based on an invalid sensor reading by displaying non-alphanumeric characters in place of the numeric analyte level above the analyte trend graph, as taught by Harper and Raisoni, to aid in notifying a user when current signal readings are invalid and to recommend actions that will generate valid glucose readings (¶ [0252-253] of Harper). Additionally, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have rearranged the non-alphanumeric characters above the analyte trend graph as it would not have modified the operation of the device and is an obvious matter of design choice (see MPEP 2144.04 IV. C).
Cole-Raisoni-Harper teach determine a time elapsed since a last valid current sensor reading was received (¶[0026] of Harper, “glucose data has not been received from the sensor 101 for a predetermined amount of time”), but fails to teach determining whether the time elapsed since the last valid current sensor reading exceeds a recent valid sensor reading alarm threshold, and in response to a determination that the time elapsed since the last valid current sensor reading exceeds the recent valid sensor reading alarm threshold, generate a no recent valid reading alarm.
Chakravarthy teaches a method of determining signal quality in patient monitoring devices (abstract). The device can use sensors capable of measuring analyte (¶[0021]). During data collection, a noise determination alarm can be generated when the duration of noisy data exceeds a time threshold (¶[0061-63], alerting to the patient that the patient monitoring device needs to be re-positioned).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cole-Raisoni-Harper, such that a no recent valid signal is generated based on invalid data generated for more than a time interval, as taught by Chakravarthy, to aid in changing the noise condition status towards noise free or downgrade the noisy signal (¶[0082] of Chakravarthy).
Regarding claims 287 and 295, Cole teaches an analyte monitoring system and (see ABSTRACT), comprising: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in fluid contact with a bodily fluid of a subject (¶ [0022,0025], an in vivo analyte sensor for contacting bodily fluid of the subject is part of an on-body device (OBD) referred to as the sensor control device hereinafter); and a reader device (¶[0026], reader device used to analyze information from the sensor data), comprising: wireless communication circuitry configured to receive a current sensor reading from the sensor control device (¶[0030], sensor control device communicates with the reader device wirelessly); and one or more processors coupled to a memory, the memory storing instructions that, when executed by the one or more processors (¶ [0050] and fig. 2), cause the one or more processors to: determine a time elapsed since the current sensor reading was received (¶[0103], the reader device executes data synchronization between sensor control device by determining if there has been a time elapsed since the current sensor reading was received during one or more successive receiving windows), determine whether the time elapsed exceeds a signal loss indicator threshold (¶ [0101-0103], the reader device determines when the time elapsed exceeds a communication interval (CI) and/or receiving window referred to hereinafter as the signal loss threshold), in response to a determination that the time elapsed exceeds the signal loss indicator threshold, generate a signal loss indicator (¶ [0103], once the reader device confirms loss of synchronization, a signal loss indicator is generated in the form of an audible, visual, and/or tactile notification), in response to a determination that the time elapsed does not exceed a signal loss indicator threshold, measurements will continue to be received (¶ [0074-76,80-82]).
Cole fails to teach display an analyte trend graph and a numeric analyte level and trend arrow indicator, wherein the numeric analyte level and trend arrow indicator is displayed above the analyte trend graph.
Raisoni teaches an analyte monitoring system with a patient application amd display (abstract). The system is configured to display an analyte level and trend arrow above the analyte trend graph (¶[0093] and fig. 14A).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Cole, such that an numeric analyte level and trend arrow indicator is displayed above the analyte trend graph, as taught by Raisoni, to aid in providing an inclusive platform of the user’s physiological information for further monitoring.
Cole-Raisoni fails to teach determining whether the current sensor reading is invalid, and in response to a determination that the current sensor reading is invalid, generating an invalid sensor reading indicator, and preventing display of numeric analyte level and trend arrow indicator, and preventing display of numeric analyte level and trend arrow indicator by displaying non-alphanumeric characters in place of the numeric analyte level above the analyte trend graph.
Harper teaches an analyte monitoring device (see abstract and para. [0053]) comprising a processor (¶ [0058]) configured to determine whether current blood glucose result is settling and glucose results may not be accurate (invalid) and/or other alert determination criteria and generating an invalid sensor reading indicator on a display based on the determination of an alert criteria (¶ [0251-252]). The generated alert indicator displayed prevents display of numeric analyte level and trend arrow indicator and upon user interaction/intervention the user can be returned to a home screen (¶ [0261-262] figs. 2A,3A and 20-21). The display of analyte levels can be replaced with nonalphanumeric characters such as, icon, video clip, sound byte, etc. (¶ [0261], “Although text is specifically shown in FIG. 20, it is contemplated that the text may be replaced by an icon, a series of icons, video clip, sound byte etc.”). In support, Raisoni’s trend graph screen that comprises the trend arrow and glucose level above the trend line can be other “items and features” including alert icons (¶[0093] and Table 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cole-Raisoni, such that an invalid sensor reading indicator is generated based on an invalid sensor reading by displaying non-alphanumeric characters in place of the numeric analyte level above the analyte trend graph, as taught by Harper, to aid in notifying a user when current signal readings are invalid and to recommend actions that will generate valid glucose readings (¶ [0252-253] of Harper). Additionally, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have rearranged the non-alphanumeric characters above the analyte trend graph as it would not have modified the operation of the device and is an obvious matter of design choice (see MPEP 2144.04 IV. C).
Cole-Raisoni-Harper fail to teach determine a time elapsed since a last valid current sensor reading was received, determine whether the time elapsed since the last valid current sensor reading exceeds a recent valid sensor reading alarm threshold, and in response to a determination that the time elapsed since the last valid current sensor reading exceeds the recent valid sensor reading alarm threshold, generate a no recent valid reading alarm.
Chakravarthy teaches a method of determining signal quality in patient monitoring devices (abstract). The device can use sensors capable of measuring analyte (¶[0021]). During data collection, a noise determination alarm can be generated when the duration of noisy data exceeds a time threshold (¶[0061-63], alerting to the patient that the patient monitoring device needs to be re-positioned).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Cole-Raisoni-Harper, such that a no recent valid signal is generated based on invalid data generated for more than a time interval, as taught by Chakravarthy, to aid in changing the noise condition status towards noise free or downgrade the noisy signal (¶[0082] of Chakravarthy).
Regarding claim 2, Cole teaches wherein the signal loss indicator threshold is five minutes (¶ [0075-76,0080,0103], the analyte monitoring system is configured to collect analyte measurements in successive intervals and/or communication intervals, wherein the processor is configured to determine when no transmission has been detected during a successive interval and/or communication interval which can be every five minutes(threshold), and output a notification to the user when the synchronous link has been lost or enter a procedure to reestablish synchronization).
Regarding claim 3, Cole teaches wherein the reader device is a smart phone (¶ [0049], the reader device is a smart phone).
Regarding claim 4, Cole teaches wherein the processor is configured to output the signal loss indicator as a signal loss message to a display of the reader device (¶ [0071,0080], " the transmitted alarm indication can specify whether the alarm is related to an analyte measurement or some other factor" and "If no transmission is received at the Xth transmission time then reader 120 can determine that the synchronous link has been lost and generate a notification" indicating that when synchronization is lost, the device will output an alarm/notification on the display of the reader device to inform the user).
Regarding claims 6 and 288, Harper teaches wherein the invalid sensor reading indicator is a sensor error indicator or a temperature error indicator (¶ [0251-252], the display outputs a sensor indicator when there is a problem with the test strip or analyte monitoring device e.g., sensor and a temperature error indicator based on skin or sensor temperature).
Regarding claims 7 and 289, Harper teaches wherein the temperature error indicator is based on a temperature measurement obtained by the sensor control device (¶ [0235,0251], the error is based on a temperature measurement of the skin or sensor obtained by the analyte monitoring device/sensor control device).
Regarding claims 8 and 290, Harper teaches wherein the sensor error indicator is based on an early signal attenuation detected by the sensor control device (¶ [0108,0251], signal strength/attenuation can be determined and based on the determination, a notification can be generated to indicate that the sensor signal is settling, glucose measurement is inaccurate, and/or the system requires another measurement).
Regarding claims 9 and 291, Cole-Raisoni fail to teach wherein the processor is configured to display a valid current sensor reading in response to a determination that the current sensor reading is not invalid. Harper teaches wherein the processor is configured to display a valid current sensor reading in response to a determination that the current sensor reading is not invalid (¶ [0048], the analyte monitoring device displays valid current sensor readings when alert conditions are not detected). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Cole-Raisoni-Harper-Chakravarthy, such that a valid sensor reading is displayed, as taught by Harper to accurately output a severity of a condition that the system state information and the user state information represents (¶ [0084]).
Regarding claim 280, Cole teaches the analyte monitoring system uses Bluetooth (¶ [0034]) and Harper teaches wherein the invalid sensor reading indicator is a Bluetooth Off indicator (¶ [0108,0251] of Harper, "when a connection has not been established between the transmitter and the analyte monitoring device 200 [sensor], a second form of the wireless connection icon 330 is output on the display to indicate a connection has not been established" and "CGM not available. Connect to Sensor."--indicating that the analyte monitoring device has not been receiving signals sent by the transmitter" indicates that the invalid sensor reading is a Bluetooth Off Indicator).
Regarding claim 281, Harper teaches wherein the Bluetooth Off indicator indicates that a Bluetooth transmitter of the reader device is disabled or switched off (¶ [0108,0061], the bluetooth off indicator indicates when the connection between the bluetooth transmitter of the analyte monitoring device/reading device is not established indicating that it can be disabled or switched off).
Regarding claim 282, Harper teaches wherein the temperature error indicator is a Sensor Too Hot indicator (¶ [0251], the temperature error is a Sensor/Analyte monitoring device too hot indicator output on display of the analyte monitoring device).
Regarding claim 283, Harper teaches wherein the temperature error indicator is a Sensor Too Cold indicator (¶ [0251], the temperature error is a Sensor/Analyte monitoring device too cold indicator output on display of the analyte monitoring device).
Regarding claim 284, Harper teaches wherein the temperature error indicator indicates an error based on the temperature of the sensor (¶ [0251], "calibration failed because the analyte monitoring device was too warm or too cold").
Regarding claim 285, Harper teaches wherein the temperature error indicator indicated an error based on the temperature of skin (¶ [0251], a message indicating " the skin to cold or too warm to display continuous glucose readings and that glucose alarms are not active" is output as the temperature error indicator).
Regarding claim 286, Harper teaches wherein the processor is configured to display an informational window with information related to the invalid sensor reading indicator (¶ [0251], depending on which alert criteria is met, the analyte monitoring system outputs to a display information regarding the alert, e.g., when too hot or too cold, battery level when low, when communication is lost with the transmitter).
Regarding claim 294, Cole- Raisoni fail to teach wherein the instructions, when executed by the one or more processors, further cause the one or more processors to display an information icon in response to the determination that the current sensor reading is invalid, and display an informational window with information related to the invalid sensor reading indicator when the information icon is pressed.
Harper teaches “In certain embodiments, the user may acquire additional information regarding the alarm or event such as analyte levels, insulin bolus administered, meal intake details and activities and the like by selecting one of the notification icons 470” (emphasis added) indicating that information icon representing an alarm condition/alarm can be displayed and selected on to provide additional information(¶ [0125]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Cole-Raisoni-Harper-Chakravarthy, such that display an information icon in response to the determination that the current sensor reading is invalid, and display an informational window with information related to the invalid sensor reading indicator when the information icon is pressed, as taught by Harper, to aid the user in acquiring additional information, e.g., current, retrospective, and/or historical, regarding the alarm or event (¶ [0125]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/06/2026, with respect to the rejection(s) of claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chakravarthy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Al-Ali teaches the freshness calculator 1130 determines that a certain amount of time has elapsed, for example, by comparison with a predetermined threshold time value, the freshness calculator 1130 can cause the respiratory rate calculator 1110 to output a zero or no respiratory rate value. US 20110172551
Broadley teaches when a certain counter threshold value (based on the chosen data sampling rate and the chosen predetermined period of time described above) is reached, that will indicate that the predetermined period of time has elapsed. US 20090099471
Van Slyke teaches when a requisite length of a valid signal segment is received, a new physiological parameter measurement may be taken and outputted (e.g., displayed). If a region of invalid signal segments is encountered, previously known-good physiological measurements may be held until a sufficient valid signal segment is received and used to determine an updated physiological measurement. In an embodiment, an alarm (e.g., audible or visual alarm) may be automatically triggered when a measurement is stale (e.g., derived from signals received beyond some elapsed threshold time window). US 20110077484
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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