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 .
Response to Amendment
The Amendments filed 10/30/2025 have been entered.
Claims 1, 6, 7, 11 and 16 have thereby been amended.
Claims 21 and 22 have been added.
Claims 4 and 14 have been cancelled.
Claims 1-3, 5-13 and 15-22 are being examined in this office action.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-13, 15-20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro (US 9861748) in view of Mazlish (US 11096624).
Regarding claim 1, Mastrototaro discloses an ambulatory infusion pump system, comprising: a user-wearable infusion pump configured to deliver insulin to a user (102, 702); a remote control device configured to remotely control the user-wearable infusion pump (command control device 106, 500, 720; col. 6, lines 26-27 & col. 13, lines 23-26, 106/500 being a remote controlling device); and at least one processor (col. 13, lines 4-11) configured to: present an option to the user on a user interface to have at least one notification delivered by only one of the user-wearable infusion pump or the remote control device (col. 26, lines 48-56, graphical user interface (GUI) presents menu for user to input alert settings; col. 33, lines 16-21, notifications can displayed on the infusion device 702 or remote control device 106); and receive a user entry selecting for delivery of the at least one notification (Fig. 9: 902, receive user-specific alert configuration information); provide a notification to the selected device (Fig. 9: 910, generate user notification in accordance with user-specific alert configuration). Mastrototaro discloses that notifications can be displayed on the infusion device and/or on the remote control device, and that the user can select the ways and destination devices that they prefer to be notified by. Although it is implied that various notification elements exist on both the infusion device and the remote control device, Mastrototaro fails to explicitly disclose this. Mastrototaro also teaches an escalation of notification delivery if the user does not acknowledge the notification in a predetermined period of time (col. 27, lines 39-44), but fails to explicitly disclose that when this occurs, the notification is then provided to the other, non-selected, device.
Mazlish teaches an analogous wearable infusion device with a notification escalation system, wherein both the infusion device and the remote device have notification/alert elements, and if, after a predetermined period of time, the user has not acknowledged the notification on the selected one of the user-wearable infusion pump (infusion device 15) or the remote control device (remote device 10), provide the notification on the other of the user-wearable infusion pump or the remote control device (Figs. 9B, 10B, 11B, 12B: col. 22, lines 27-42, wherein the stated controller is the infusion device; alarm notification presents on the remote device, and if not acknowledged by user within predetermined time period, the notification will be presented on the wearable infusion device). Mazlish teaches a default notification progression in which the device the notification is presented on is selected based on whether or not the initial notification signal fails to reach the remote device or if it is not present (Fig. 9B: col. 18, line 63 – col. 19, line 7). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ambulatory infusion system with alert escalation of Mastrototaro by incorporating the presentation of notifications on both the remote device and the infusion device, as well as incorporating the notification progression, as taught by Mazlish. To a person of ordinary skill in the art, this combination of teachings would be obvious in order to ensure that the user receives and acknowledges the notifications from the infusion system, especially in instances when the remote control device may be misplaced, out of battery, or out of range (Mazlish: col. 18, line 63 – col. 19, line 7). It directly follows that upon incorporating the presentation of notifications on both the remote device and the infusion device taught by Mazlish, the Mastrototaro selection of options for the alert configuration would include selecting a preference for the device the notification is initially sent to. Therefore, it would also be obvious to incorporate the notification progression taught by Mazlish to trigger the progression to the other of either the infusion device of the remote control device, depending on which one was initially selected.
Regarding claim 2, Mastrototaro in view of Mazlish teaches the system of claim 1, as described above, wherein the user interface is part of the remote control device (Mastrototaro: col. 26, lines 49-54; user interface integrated into remote control 106).
Regarding claim 3, Mastrototaro in view of Mazlish teaches the system of claim 1, as described above, wherein the user interface is part of the user-wearable infusion pump (Mastrototaro: col. 26, lines 49-54; user interface integrated into infusion device 702).
Regarding claim 5, Mastrototaro in view of Mazlish teaches the system of claim 1, as described above, wherein the at least one processor is further configured to provide notifications on both the remote control device and the user-wearable infusion pump simultaneously (Mazlish: col. 21, lines 14-20, illumination of the delivery device indicator 234 conveys the simultaneous light notification on delivery device 15 and message notification to the remote device 60). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated into the Mastrototaro system the simultaneous presentation of notifications on both the remote and infusion devices taught by Mazlish, in order to ensure that important or time sensitive notifications are received by the user without having to wait for the predetermined amount of time for the standard notification progression.
Regarding claim 6, Mastrototaro in view of Mazlish teaches the system of claim 5, as described above, wherein the notifications provided on both the remote control device and the user-wearable infusion pump simultaneously are critical notifications (Mazlish: col. 21, lines 24-27, red illumination of indicator 234 on the delivery device 15 conveys urgent and critical message notification on the remote device 60).
Regarding claim 7, Mastrototaro in view of Mazlish teaches the system of claim 1, as described above, wherein the at least one processor is configured to provide some notifications on only the selected one of the user-wearable infusion pump or the remote control device and to not provide those notifications on the other of the user-wearable infusion pump or the remote control device even if the user has not acknowledged the notification within the predetermined period of time (Mastrototaro: col. 27, lines 39-44, the user may optionally set the alert configuration such that the notification sent to a device repeats on the same device if not acknowledged, rather than the notification being presented on another device).
Regarding claim 8, Mastrototaro in view of Mazlish teaches the system of claim 1, as described above, wherein the at least one processor is further configured to store a default selection for the one of the user-wearable infusion pump or the remote control device to first deliver the at least one notification (Mastrototaro: col. 25, lines 59-64, processor of control device 720 causes selected user preferences for notifications to be stored in memory 808; these stored preferences used as the default further visualized in Fig. 9 where 902 and 904 are maintained during all closed-loop operations of the infusion device).
Regarding claim 9, Mastrototaro in view of Mazlish teaches the system of claim 8, as described above, wherein the option enables the user to select the other of the user-wearable infusion pump or the remote control device from the default selection (Mastrototaro: col. 26, lines 37-57, the user is able to update alert configuration to select device for notification delivery and other specific notification preferences).
Regarding claim 10, Mastrototaro in view of Mazlish teaches the system of claim 8, as described above, wherein the default selection is the remote control device (Mastrototaro: col. 33, lines 27-35, user can set and save alert configuration to only notify control device 106 such as for when they are sleeping).
Regarding claim 11, Mastrototaro discloses an ambulatory infusion pump system, comprising: a user-wearable infusion pump configured to deliver insulin to a user (102, 702); a remote control device configured to remotely control the user-wearable infusion pump (command control device 106, 500, 720; col. 6, lines 26-27 & col. 13, lines 23-26, 106/500 being a remote controlling device); and at least one processor (col. 13, lines 4-11) configured to: store a preference to have at least one notification delivered by only one device for first delivery of the at least one notification (col. 25, lines 59-64, processor of control device 720 causes selected user preferences for notifications to be stored in memory 808; Fig. 9: 902 and 904); provide the at least one notification to the device (Fig. 9: 910, generate user notification in accordance with user-specific alert configuration). Mastrototaro discloses that notifications can be displayed on the infusion device and/or on the remote control device, and that the user can select the ways and destination devices that they prefer to be notified by. Although it is implied that various notification elements exist on both the infusion device and the remote control device, Mastrototaro fails to explicitly disclose this. Mastrototaro also teaches an escalation of notification delivery if the user does not acknowledge the notification in a predetermined period of time (col. 27, lines 39-44), but fails to explicitly disclose that when this occurs, the notification is then provided to the other, non-selected, device.
Mazlish teaches an analogous wearable infusion device with a notification escalation system, wherein both the infusion device and the remote device have notification/alert elements, and if, after a predetermined period of time, the user has not acknowledged the notification on the selected one of the user-wearable infusion pump (infusion device 15) or the remote control device (remote device 10), provide the notification on the other of the user-wearable infusion pump or the remote control device (Figs. 9B, 10B, 11B, 12B: col. 22, lines 27-42, wherein the stated controller is the infusion device; alarm notification presents on the remote device, and if not acknowledged by user within predetermined time period, the notification will be presented on the wearable infusion device). Mazlish teaches a default notification progression in which the device the notification is presented on is selected based on whether or not the initial notification signal fails to reach the remote device or if it is not present (Fig. 9B: col. 18, line 63 – col. 19, line 7). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ambulatory infusion system with alert escalation of Mastrototaro by incorporating the presentation of notifications on both the remote device and the infusion device, as well as incorporating the notification progression, as taught by Mazlish. To a person of ordinary skill in the art, this combination of teachings would be obvious in order to ensure that the user receives and acknowledges the notifications from the infusion system, especially in instances when the remote control device may be misplaced, out of battery, or out of range (Mazlish: col. 18, line 63 – col. 19, line 7). It directly follows that upon incorporating the presentation of notifications on both the remote device and the infusion device taught by Mazlish, the Mastrototaro selection of options for the alert configuration would include selecting a preference for the device the notification is initially sent to. Therefore, it would also be obvious to incorporate the notification progression taught by Mazlish to trigger the progression to the other of either the infusion device of the remote control device, depending on which one was initially selected.
Regarding claim 12, Mastrototaro in view of Mazlish teaches the system of claim 11, as described above, wherein the preference is stored in a memory of the remote control device (Mastrototaro: col. 25, lines 49-53).
Regarding claim 13, Mastrototaro in view of Mazlish teaches the system of claim 11, as described above, wherein the preference is stored in a memory of the user-wearable infusion pump (Mastrototaro: col. 20, lines 65-67).
Regarding claim 15, Mastrototaro in view of Mazlish teaches the system of claim 11, as described above, wherein the at least one processor is further configured to provide notifications on both the remote control device and the user-wearable infusion pump simultaneously (Mazlish: col. 21, lines 14-20, illumination of the delivery device indicator 234 conveys the simultaneous light notification on delivery device 15 and message notification to the remote device 60). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated into the Mastrototaro system the simultaneous presentation of notifications on both the remote and infusion devices taught by Mazlish, in order to ensure that important or time sensitive notifications are received by the user without having to wait for the predetermined amount of time for the standard notification progression.
Regarding claim 16, Mastrototaro in view of Mazlish teaches the system of claim 15, as described above, wherein the notifications provided on both the remote control device and the user-wearable infusion pump simultaneously are critical notifications (Mazlish: col. 21, lines 24-27, red illumination of indicator 234 on the delivery device 15 conveys urgent and critical message notification on the remote device 60).
Regarding claim 17, Mastrototaro in view of Mazlish teaches the system of claim 11, as described above, wherein the at least one processor is configured to provide some notifications on only the one of the user-wearable infusion pump or the remote control device and to not provide those notifications on the other of the user-wearable infusion pump or the remote control device even if the user has not acknowledged the notification within the predetermined period of time (Mastrototaro: col. 27, lines 39-44, the user may optionally set the alert configuration such that the notification sent to a device repeats on the same device if not acknowledged, rather than the notification being presented on another device).
Regarding claim 18, Mastrototaro in view of Mazlish teaches the system of claim 11, as described above, wherein the at least one processor is further configured to store a default preference for the one of the user-wearable infusion pump or the remote control device to first deliver the at least one notification (Mastrototaro: col. 25, lines 59-64, processor of control device 720 causes selected user preferences for notifications to be stored in memory 808; these stored preferences used as the default further visualized in Fig. 9 where 902 and 904 are maintained during all closed-loop operations of the infusion device).
Regarding claim 19, Mastrototaro in view of Mazlish teaches the system of claim 18, as described above, wherein the at least one processor is further configured to display an option that enables the user to select the other of the user-wearable infusion pump or the remote control device from the default preference (Mastrototaro: col. 26, lines 37-57, the user is able to update alert configuration to select device for notification delivery and other specific notification preferences).
Regarding claim 20, Mastrototaro in view of Mazlish teaches the system of claim 18, as described above, wherein the default preference is the remote control device (Mastrototaro: col. 33, lines 27-35, user can set and save alert configuration to only notify control device 106 such as for when they are sleeping).
Regarding claim 21, Mastrototaro in view of Mazlish teaches the system of claim 1, as described above, wherein the processor is further configured to: before providing the notification to the selected one of the user-wearable infusion pump or the remote device, determine whether the notification is critical (Mazlish: Fig. 4: alarms of “Must Act”; col. 16, lines 46-54), semi-critical (Mazlish: Fig. 4: alerts of “Should Act”; col. 16, lines 60-67), or non-critical (Mazlish: Fig. 4: notifications of “Should Know,” “Good to Know,” and “System Information”; col. 17, lines 11-15); responsive to determining that the notification is critical, (i) provide the notification to the selected one of the user-wearable infusion pump or the remote control device (Mastrototaro: Fig. 9: 910, generate user notification in accordance with user-specific alert configuration) and (ii) provide the notification to the other of the user-wearable infusion pump or the remote control device regardless of whether the user has acknowledged the notification on the selected one of the user-wearable infusion pump or the remote control device (Mazlish: col. 21, lines 11-20, the infusion device has light notifications for the alarm that can also indicate there is a notification present on the remote device for the alarm notifications; both the infusion device and the remote device simultaneously displaying notifications also happens upon the Mastrototaro and Mazlish combination); responsive to determining that the notification is semi-critical, (i) provide the notification to the selected one of the user-wearable infusion pump or the remote control device (Mastrototaro: Fig. 9: 910, generate user notification in accordance with user-specific alert configuration) and (ii) provide the notification to the other of the user-wearable infusion pump or the remote control device if the user has not acknowledged the notification on the selected one of the user-wearable infusion pump or the remote control device within the predetermined period of time (Mazlish: col. 26, lines 35-55); and responsive to determining that the notification is non-critical, (i) provide the notification to the selected one of the user-wearable infusion pump or the remote control device (Mastrototaro: Fig. 9: 910, generate user notification in accordance with user-specific alert configuration) and (ii) forgo providing the notification to the other of the user-wearable infusion pump or the remote control device even if the user has not acknowledged the notification on the selected one of the user-wearable infusion pump or the remote control device within the predetermined period of time (Mazlish: col. 18, lines 14-21). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated into the Mastrototaro-Mazlish device, the distinction of the non-critical, semi-critical and critical notifications and their corresponding escalating/non-escalating notification patterns, as taught by Mazlish, in order to provide the user with distinctions between routine/non-critical notifications and urgent notifications that require immediate action and help ensure that the urgent alerts are not ignored.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro (US 9861748) in view of Mazlish (US 11096624) in further view of Davis (20170311903).
Regarding claim 22, Mastrototaro in view of Mazlish teaches the system of claim 1, as described above, wherein the processor is further configured to: before providing the notification to the selected one of the user-wearable infusion pump or the remote device, provide the notification to at least one of the user-wearable infusion pump and the remote control device in accordance with the current annunciation protocol (Mastrototaro: Fig. 9: 910, generate user notification in accordance with user-specific alert configuration); wherein the current annunciation protocol indicates whether the notification should be provided via the user-wearable infusion pump or the remote device (Mazlish: col. 26, lines 35-55 and upon the Mastrototaro and Mazlish combination). However, Mastrototaro in view of Mazlish does not explicitly teach that the annunciation protocol is based on the time of day or calendar event.
Davis teaches an analogous wearable infusion device with a notification system, wherein the system will determine a current annunciation protocol based on at least one of (i) a time of day (para. [0135], sentences 3-4), (ii) a calendar event associated with the user (para. [0118]), (iii) a mode of use of the user-wearable infusion pump, and (iv) whether the user-wearable infusion pump is operating in a closed-loop mode or an open-loop mode; and responsive to determining the current annunciation protocol. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Mastrototaro-Mazlish system by incorporating the annunciation protocol being based upon the time and/or calendar events, as taught by Davis, in order to deliver insulin and notifications to the user in a more user-specific manner that takes into account significant events such as sleep and exercise that impact glucose levels (Davis: para. [0135], sentences 1-2).
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive. Applicant argues that Mastrototaro fails to teach the storing a preference to have at least one notification delivered by only one of the user-wearable infusion pump of the remote control device. However, Mastrototaro does teach user set preferences for the delivery of notifications, and also teaches that notifications may be sent to only the remote device. Therefore, Examiner interprets Mastrototaro to teach these limitations as recited in claims 1 and 11.
For these reasons, claims 1-3, 5-13 and 15-22 are rejected as recited above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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