CTNF 18/676,061 CTNF 99513 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 20-27 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman (US 20180192963 A1 – Cited by Applicant) in view of Johnson et al. (US 20110201911 A1), hereinafter Johnson, further in view of Zhang (US 20160171871 A1) . Regarding claim 20 , Budiman discloses an analyte monitoring system [ analyte monitoring system 100, see in Fig. 1 and ¶ 0027 ] , comprising: a sensor control device [ see in Fig. 1 ] comprising an analyte sensor [ on body electronics 110, see in ¶ 0027 and Fig. 1 ], wherein a portion of the analyte sensor is configured to be positioned through a skin surface of a subject and in fluid contact with a bodily fluid of a subject [ an analyte sensor for transcutaneous positioning through a skin layer and maintained in fluid contact with an interstitial fluid under the skin layer during a predetermined time period, see in ¶ 0006 ], and wherein the portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid [ configured to receive information from the continuous analyte monitor related to the user's analyte concentration, see in ¶ 0006 ]; and a reader device [ receiver/reader unit, which includes a display 122 to output information to the user, see in ¶ 0028 ], comprising: wireless communication circuitry configured to receive data indicative of the analyte level of the subject from the sensor control device [ Such analyte monitoring routines may be reported or transmitted in real time to a receiver unit/reader device at the time of data sampling and processing, see in ¶ 0025; configured to wirelessly communicate analyte related data when on body electronics 110 receives a command or request signal from display device 120, see in ¶ 0036 ]; and one or more processors [ control logic or microprocessors of display device 120 and data processing module 160, see in ¶ 0047 and Fig. 1 ] coupled to a memory [ Data processing module 160 stores in its memory the received analyte level information, and/or relays or retransmits the received information to another device such as display device 120, see in ¶ 0041; see also ¶ 0048 ], the memory storing an analyte monitoring software program that, when executed by the one or more processors [ software algorithm(s) for execution by data processing module 160 may be stored in an external memory device such as an SD card, microSD card, compact flash card, XD card, Memory Stick card, Memory Stick Duo card, or USB memory stick/device including executable programs stored in such devices for execution upon connection to the respective one or more of the on body electronics 110, remote terminal 170 or display device 120, see in ¶ 0048 ]. Budiman fails to disclose that the software program further causes the one or more processors to: monitor a device alarms settings for a silent mode feature, determine whether the silent mode feature is enabled in the device alarms settings, in response to a determination that the silent mode feature is enabled, disable alarms from outputting an audible noise on the analyte monitoring software program, determine an expiration time for the silent mode feature, wherein the expiration time is a predetermined time at which the silent mode feature is disabled, and output a notification related to the silent mode feature when at least half a duration of the expiration time has elapsed. However, Johnson discloses an analyte sensor system with user selectable modes that can be set to silent [ different user-selectable modes based on the status of a user may include one or more of resting, exercise, do not disturb, silent, loud, soft, illness, menstruation, mealtime, snooze …, see in ¶ 0084 ], when in silent mode, alarms are disabled from outputting an audible noise on the analyte monitoring software program [ while in a silent mode, a vibration alert is used in place of an audible alert, see in ¶ 0087 ], an expiration time for the silent mode feature, wherein the expiration time is a predetermined time at which the silent mode feature is disabled [ a selected mode may be associated with a timer such that after an indicated time period, the mode is automatically changed back to a default mode, see in ¶ 0084 ]. Budiman and Johnson are both analogous to the claimed invention because they are in the same field of continuous analyte monitors with silent mode capabilities. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Johnson and include that the software program further causes the one or more processors to: monitor a device alarms settings for a silent mode feature, determine whether the silent mode feature is enabled in the device alarms settings, in response to a determination that the silent mode feature is enabled, disable alarms from outputting an audible noise on the analyte monitoring software program, determine an expiration time for the silent mode feature, wherein the expiration time is a predetermined time at which the silent mode feature is disabled in order to prevent disturbances caused by the device during user determined times. Budiman as modified still does not disclose that the software program causes the one or more processors to output a notification related to the silent mode feature when at least half a duration of the expiration time has elapsed. However, Zhang discloses outputting a notification related to the silent mode feature when at least half a duration of the expiration time has elapsed [ In this example embodiment, the apparatus, such as the processor, may be configured to again cause a prompt to be presented regarding the length of time that the silent mode of operation is to remain in effect at the end of the predefined period of time. This additional prompt may be presented upon or in advance of expiration of the predefined period of time, see in ¶ 0049 ]. Budiman and Zhang are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Zhang and include outputting a notification related to the silent mode feature when at least half a duration of the expiration time has elapsed in order to ensure that the user is aware of the system’s notification mode and can adjust the mode to align with the user’s schedule. Regarding claim 21 , Budiman, as modified, discloses the analyte monitoring system of claim 20, wherein the notification is outputted silently to the subject [ audio and vibratory output of notifications are available, see in ¶ 0034 and ¶ 0047 ]. Regarding claim 22 , Budiman, as modified, discloses the analyte monitoring system of claim 20, wherein the notification is configured to indicate to the subject the duration of time remaining until the expiration time is reached [ In this example embodiment, the apparatus, such as the processor, may be configured to again cause a prompt to be presented regarding the length of time that the silent mode of operation is to remain in effect at the end of the predefined period of time. This additional prompt may be presented upon or in advance of expiration of the predefined period of time, see in Zhang ¶ 0049, as rejected above for claim 20 ]. Regarding claim 23 , Budiman, as modified, discloses the analyte monitoring system of claim 20. Budiman fails to disclose wherein the notification is configured to indicate to the subject that the silent mode feature is enabled. However, Zhang discloses wherein the notification is configured to indicate to the subject that the silent mode feature is enabled [ an apparatus is provided that includes means for receiving an indication of at least a start time for a silent mode of operation of a device and means, see in ¶ 0017 ]. Budiman and Zhang are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Zhang and include that an indication of the silent mode being enabled is provided with the notification so that the user is aware of the notification mode and can adjust the system accordingly whether or not silent mode was enabled intentionally. Regarding claim 24 , Budiman, as modified, discloses the analyte monitoring system of claim 20, wherein the reader device further comprises a touchscreen [ touch screen user interface, see in ¶ 0031 ]. Budiman fails to disclose wherein the analyte monitoring software application, when executed by the one or more processors, further causes the one or more processors to: in response to a predetermined input by the subject on the notification, output a modal, wherein the modal provides the subject with information related to the device alarm settings for the silent mode feature. However, Zhang discloses wherein the analyte monitoring software application, when executed by the one or more processors, further causes the one or more processors to: in response to a predetermined input by the subject on the notification, output a modal, wherein the modal provides the subject with information related to the device alarm settings for the silent mode feature [ blocks 22 , 24, 26, 28, and 30, see in Fig. 2 ]. Budiman and Zhang are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Zhang and include that in response to a predetermined input by the subject on the notification, a modal is outputted, wherein the modal provides the subject with information related to the device alarm settings for the silent mode feature in order to ensure user awareness of silent mode being enabled and user control of silent mode settings. Regarding claim 25 , Budiman, as modified, discloses the analyte monitoring system of claim 24. Budiman fails to disclose wherein the modal comprises a list indicating which alarms are disabled from outputting the audible noise. However, Zhang discloses wherein the modal comprises a list indicating which alarms are disabled from outputting the audible noise [ block 26, 28, and 30, see in Fig. 2 ]. Budiman and Zhang are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Zhang and include that the modal comprises a list indicating which alarms are disabled from outputting the audible noise so that the user is aware of and can control which alarms are on silent mode. Regarding claim 26 , Budiman, as modified, discloses the analyte monitoring system of claim 24. Budiman fails to disclose wherein the modal comprises a countdown time indicating the duration of time remaining until the expiration time. However, Zhang discloses wherein the modal comprises a countdown time indicating the duration of time remaining until the expiration time [ prompting the user upon receiving the indication of operation in the silent mode as to the length of time to remain in the silent mode, see in ¶ 0048 ]. Budiman and Zhang are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Zhang and include that the modal comprises a countdown time indicating the duration of time remaining until the expiration time to keep the user alert of the active silent mode duration. Regarding claim 27 , Budiman, as modified, discloses the analyte monitoring system of claim 24. Budiman fails to disclose wherein the modal comprises a textual indicator to indicate the expiration time of the silent mode feature. However, Zhang discloses wherein the modal comprises a textual indicator to indicate the expiration time of the silent mode feature [ prompting the user upon receiving the indication of operation in the silent mode as to the length of time to remain in the silent mode, see in ¶ 0048; Examiner notes that indication is interpreted to be textual, as indications in Zhang Figs. 3-5 are textual ]. Budiman and Zhang are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Zhang and include that the modal comprises a textual indicator to indicate the expiration time of the silent mode feature to clearly indicate expiration time information of the silent mode feature. Regarding claim 33 , Budiman, as modified, discloses the analyte monitoring system of claim 20. Budiman fails to disclose wherein the expiration time is a minimum time limit of five minutes. However, Zhang discloses wherein the expiration time is a minimum time limit of five minutes [ expiration time is at least five minutes, see Fig. 5 ]. Budiman and Zhang are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Zhang and include that the expiration time is a minimum time limit of five minutes so that the silent mode feature is on for a long enough period of time to be useful for the user. Regarding claim 34 , Budiman, as modified, discloses the analyte monitoring system of claim 20. Budiman fails to disclose wherein the expiration time is a maximum time limit of six hours. However, Zhang discloses wherein the expiration time is a maximum time limit of six hours [ see in Fig. 5; Examiner notes that expiration time can be adjusted so that no more than 6 hours is set for silent mode, either by using 2 hours and then 4 hours as the length of time or setting the timer to indefinite for 6 hours; see; see also ¶ 0054 ]. Budiman and Zhang are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Zhang and include that the expiration time is a maximum time limit of six hours to prevent the silent mode feature from being enabled unintentionally for an extended amount of time . 07-21-aia AIA Claim s 28-32 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman (US 20180192963 A1 – Cited by Applicant) in view of Johnson (US 20110201911 A1) and Zhang (US 20160171871 A1), further in view of Dempski (US 20140282174 A1) . Regarding claim 28 , Budiman, as modified, discloses the analyte monitoring system of claim 24. Examiner notes that Budiman modified by Johnson and Zhang discloses causing a prompt to be presented regarding a potential change to at least one of the activation mode or activation time for at least one of the alarms that was identified [ see Zhang Fig. 2, block 28 and 30 ]. However, Budiman fails to explicitly disclose wherein the modal comprises a first button, wherein a first predetermined increment of time is added to the expiration time upon the subject selecting the first button. Dempski discloses wherein the modal comprises a first button, wherein a first predetermined increment of time is added to the expiration time upon the subject selecting the first button [ The notification selection control may further provide an indication of an amount of time being applied to the countdown timer as it is being applied, such that a user may continue to hold the swipe and add time until the timeout reaches a desired value, see in ¶ 0012 ]. Budiman and Dempski are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Dempski and include that the modal comprises a first button, wherein a first predetermined increment of time is added to the expiration time upon the subject selecting the first button in order for the user to easily and quickly adjust the silent mode duration. Regarding claim 29 , Budiman, as modified, discloses the analyte monitoring system of claim 28. Budiman fails to disclose wherein the first predetermined increment of time is five minutes. However, Dempski discloses wherein the first predetermined increment of time is five minutes [ the timer mode may initialize the countdown timer with a default amount of time (e.g., five minutes). The amount of time applied to the countdown timer may increment according to how long the user holds the swipe, see in ¶ 0012; continuing to hold the swipe gesture may increment the amount of time by one increment interval, see in ¶ 0033; Examiner notes that one increment interval can be interpreted as 5 minute increments ]. Budiman and Dempski are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Dempski and include that the first predetermined increment of time is five minutes so that the user can alter the silent mode feature duration by increments of the minimum time allowed for the feature to function. Regarding claim 30 , Budiman, as modified, discloses the analyte monitoring system of claim 24. Budiman fails to disclose wherein the modal comprises a second button, wherein a second predetermined increment of time is reduced from the expiration time upon the subject selecting the second button. However, Dempski discloses that the modal comprises a second button, wherein a second predetermined increment of time is reduced from the expiration time upon the subject selecting the second button [ The notification selection control may further provide an indication of an amount of time being applied to the countdown timer as it is being applied, such that a user may continue to hold the swipe and add time until the timeout reaches a desired value (or swipe in the opposite direction to remove time if too much is applied), see in ¶ 0012 ]. Budiman and Dempski are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Dempski and include that the modal comprises a second button, wherein a second predetermined increment of time is reduced from the expiration time upon the subject selecting the second button in order for the user to easily and quickly adjust the silent mode duration. Regarding claim 31 , Budiman, as modified, discloses the analyte monitoring system of claim 30. Budiman fails to disclose wherein the second predetermined increment of time is five minutes. However, Dempski discloses wherein the second predetermined increment of time is five minutes [ the timer mode may initialize the countdown timer with a default amount of time (e.g., five minutes). The amount of time applied to the countdown timer may increment according to how long the user holds the swipe, see in ¶ 0012; continuing to hold the swipe gesture may increment the amount of time by one increment interval, see in ¶ 0033; Examiner notes that one increment interval can be interpreted as 5 minute increments ]. Budiman and Dempski are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Dempski and include that the second predetermined increment of time is five minutes so that the user can alter the silent mode feature duration by increments of the minimum time allowed for the feature to function. Regarding claim 32 , Budiman, as modified, discloses the analyte monitoring system of claim 24. Budiman fails to disclose wherein the modal comprises a third button, wherein the silent mode feature is configured to be disabled upon the subject selecting the third button. However, Dempski discloses wherein the modal comprises a third button, wherein the silent mode feature is configured to be disabled upon the subject selecting the third button [ notification selection mode, swipe towards speaker button disables silence mode to go into notification mode, see in ¶ 0028; see also in Fig. 5 ]. Budiman and Dempski are both analogous to the claimed invention because they are in the same field of user notification systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Dempski and include that the modal comprises a third button, wherein the silent mode feature is configured to be disabled upon the subject selecting the third button in order to for the user to easily turn off the silent mode feature . 07-21-aia AIA Claim s 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman (US 20180192963 A1 – Cited by Applicant) in view of Johnson (US 20110201911 A1), Zhang (US 20160171871 A1), and Dempski (US 20140282174 A1), further in view of Kamath et al. (US 20190125224 A1), hereinafter Kamath . Regarding claim 35, and substantially similar limitations in claim 36 , Budiman, as modified, discloses the analyte monitoring system of claim 20. Budiman fails to disclose wherein the analyte monitoring software application, when executed by the one or more processors, further causes the one or more processors to: prior to enabling the silent mode feature in the device alarms settings, authenticate the subject through a biometric routine. However, Kamath discloses authentication of the subject through a biometric routine [ to authenticate the user (e.g., by fingerprint, facial, voice, or security code etc.), and/or to enter user preferences or plans for operation of partner device 315 (e.g., planned use or non-use, mode control, etc.), and/or analyte sensor system 308 (e.g., sensor replacement, expected operation time, etc.), and/or display device 310 (e.g., permissions for accessing data from partner device 315), see in ¶ 0272 ]. Budiman and Kamath are both analogous to the claimed invention because they are in the same field of analyte management and monitoring systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Tran and include that user authentication using biometrics is carried out prior to changing system settings, particularly enabling silent mode features, in order to ensure that only authorized users are making changes to the user’s analyte monitoring system . 07-21-aia AIA Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Budiman (US 20180192963 A1 – Cited by Applicant) in view of Johnson (US 20110201911 A1), Zhang (US 20160171871 A1), and Dempski (US 20140282174 A1), further in view of Tran (US 20210212606 A1) . Regarding claim 37 , Budiman, as modified, discloses the analyte monitoring system of claim 20. Budiman fails to disclose wherein the analyte monitoring software application, when executed by the one or more processors, further causes the one or more processors to: prior to enabling the silent mode feature in the device alarms settings, prompting the subject to enter a password or PIN number for authentication. However, Tran discloses prompting the subject to enter a password or PIN number for authentication [ a connection with the server 200 is established and user identity authenticated using suitable password or other security mechanisms, see in ¶ 0214 ]. Budiman and Tran are both analogous to the claimed invention because they are in the same field of analyte management and monitoring systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Budiman to incorporate the teachings of Tran and include that authentication of a subject using a password or PIN number is carried out prior to enabling the silent mode feature in order to ensure that only authorized users are making changes to the user’s analyte monitoring system . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20110105854 A1 – Facial recognition used in medical monitoring system. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m.. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /HY KHANH DOAN/ Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791 Application/Control Number: 18/676,061 Page 2 Art Unit: 3791 Application/Control Number: 18/676,061 Page 3 Art Unit: 3791 Application/Control Number: 18/676,061 Page 4 Art Unit: 3791 Application/Control Number: 18/676,061 Page 5 Art Unit: 3791 Application/Control Number: 18/676,061 Page 6 Art Unit: 3791 Application/Control Number: 18/676,061 Page 7 Art Unit: 3791 Application/Control Number: 18/676,061 Page 8 Art Unit: 3791 Application/Control Number: 18/676,061 Page 9 Art Unit: 3791 Application/Control Number: 18/676,061 Page 10 Art Unit: 3791 Application/Control Number: 18/676,061 Page 11 Art Unit: 3791 Application/Control Number: 18/676,061 Page 12 Art Unit: 3791 Application/Control Number: 18/676,061 Page 13 Art Unit: 3791 Application/Control Number: 18/676,061 Page 14 Art Unit: 3791 Application/Control Number: 18/676,061 Page 15 Art Unit: 3791 Application/Control Number: 18/676,061 Page 16 Art Unit: 3791 Application/Control Number: 18/676,061 Page 17 Art Unit: 3791 Application/Control Number: 18/676,061 Page 18 Art Unit: 3791
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