DETAILED ACTION
This action is in response to the applicant’s response filed on December 22, 2025. As set forth therein, claims 1 and 11 is amended, claims 23 and 24 are newly presented and claims 10 and 20-22 are now canceled. Claims 1-9, 11-19 and 23-24 are pending.
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 .
Reissue Applications
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 11,305,057 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Response to Arguments
Broadening Rejection
The Examiner notes that in view of the amendment to claim 11, the rejection based on broadening has been overcome. Therefore, the rejection will be withdrawn.
Indefiniteness Rejection
In view of the cancellation of claims 21 and 22, the rejection to the claims as being indefinite has been withdrawn.
Novelty and Obviousness Rejections
The Applicant states that the cited portions of Mazlish describe a “medication delivery device” with a “button…,[which] can be used…to check the status of the medication delivery device.” The Applicant also further states that Mazlish also notes that the icons on the medication delivery device can “match icons used in [a] remote[,] user-interface device for communicating alarm or alert conditions.”
The Applicant states that although the cited portions of Mazlish mention illuminating an indication light in response to a button press, they say nothing about the user-interface device also responding to the button press.
The Examiner notes that as acknowledged by the Applicant, Mazlish discloses of a button on the medication delivery device which can be used to check the status of the medication delivery device. See paragraph [0013]. This includes the illumination of icons to indicate certain conditions or modes.
With reference to paragraph [0098], Mazlish discloses in one example that when there is an alarm condition related to a lack of insulin flowing, the visual indictors shown can also be displayed on the remote user-interface device. In addition, Mazlish discloses that pressing button 250 on the medication delivery device can result in the medication delivery device sending a wireless communication to remote user-interface device 10 to stop an audible alarm tone.
Thus, Mazlish discloses that the button is also used to communicate with the remote user device with respect to certain conditions and that these conditions also result in the illumination of lights. In addition, as set forth in paragraph [0106] an icon illuminated on the medication delivery device is also illuminated on the remote user-interface device. Therefore, it would be understood that if a press of a button causes the status of the medication delivery device to illuminate a light based on its status and if the remote-user interface device is designed to match the illuminated light on its display then Mazlish discloses of presenting information related to the current status on the display screen of the remote control device in response to activation of an input button on the infusion pump.
Nonetheless, the Examiner finds that to the extent that it is considered that the action of the input button must directly cause for information related to the current status of the infusion pump to be presented on the remote control device, the Examiner has addressed this below in the prior art rejection in view of the amendment.
With respect to the teachings of Lanigan, the Examiner acknowledges that Lanigan does not specifically disclose the correlation between the activation of an input button on the infusion pump and the illumination of a light pattern. However, as set forth below in the prior art rejections, these features are disclosed by Mazlish.
Response to Amendment
The amendment filed December 22, 2025 proposes amendments to the claims that do not comply with 37 CFR 1.173(b), which sets forth the manner of making amendments in reissue applications.
As set forth 37 CFR 1.173(g), all amendments must be made relative to the patent specification, including the claims. In this case, the Examiner notes that claim 11 includes ‘double brackets’ for indicating the removal of subject matter. Although double brackets are not permitted in accordance with 37 CFR 1.173(d), the amendment is not relative to the original patent claims since the original patent claim never included the claim language which is now being omitted. In addition, “the remote control device” should not be underlined since it is part of the original claim language.
In addition, new claims 23-24 should be underlined.
Reissue Declaration
The reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The Examiner notes that the reissue declaration filed on May 13, 2022 states:
Claim 20 was erroneously issued as being dependent upon method claim 1 and the scope of the claim is changed to be dependent upon apparatus claim 11. New dependent clams are also added due to the Applicant erring in omitting these narrower claims that recite only a single input button to more fully protect the disclosed invention.
In view of the amendment filed on December 22, 2025, Claims 20-22 were canceled. Thus, the stated errors are no longer present in the claims. Therefore, a new error would have to be set forth.
Claims 1-9, 11-19, 23 and 24 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action.
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.
Claim(s) 11-14, 16-19 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mazlish et al. US Patent Pub. 2019/0274624 in view of Sokolovskyy et al. US Patent Pub. 2018/0150614.
Regarding claim 11:
A system for operating an infusion pump with a remote control device, comprising:
Mazlish relates to alarms and alerts for medication delivery devices and systems, particularly for medication delivery systems that have a medication delivery device that communicates with a primary user-interface for the medication delivery device and related systems and methods. See paragraph [0002].
Mazlish discloses the medication delivery systems, methods, and devices include at least a medication delivery device (e.g., an insulin delivery device) (infusion pump) and a remote user-interface device (e.g., a smartphone having an installed app) (remote control device) in communication with each other. See paragraph [0004]. See also Figure 1A and 1B.
a user-wearable infusion pump including an input button, one or more indicator lights and no display screen,
The Examiner notes that the medication delivery device is a user-wearable infusion pump which includes one or more indicator lights (236, 237) and no display screen. See paragraph [0006] which discloses “the medication delivery device may be a medication infusion device, intended to be worn on the user's body to provide regular, near continuous, or continuous delivery of medication to the user based on the user's needs”.
As to “display” Mazlish as shown in Figure 1B disclose that the medication delivery device is a patch pump 15’ which is used to deliver insulin in an insulin delivery system. This pump does not disclose a display and instead includes indicator lights. See paragraphs [0006], [0059] and [0092].
In addition, with respect to an alternative medication delivery device (paragraph [0093]) (shown in Figure 2), although Mazlish uses the term ‘display’ Mazlish discloses that this user interface includes a plurality of indicator lights and/or illuminable icons. Mazlish explains that, as shown, indicator lights 236 and 237 can be positioned adjacent to icons 235. Thus, Mazlish discloses that the user interface can be designed with only indicator lights. The Examiner finds that Mazlish discloses a display screen which is used on a smart phone (paragraph [0095]) and Mazlish never refers to the ‘display’ of the Figure 2 device as having a screen. Only “indicator lights” and/or “icons” are shown. The Examiner finds that the icons are only shown to “illuminate”.
Thus, both the patch pump 15’ (see figure 1B) which only has indicator lights and the infusion pump 15 which includes indicator lights and/or icons (the device can have only indicator lights without icons) do not include a “display” such as a display screen type that is used by the remote device.
See paragraph [0114] which discloses by pushing a button on or double tapping on the housing of medication delivery device 15 or 15′ will illuminate medication delivery indicator light 232 if insulin is being delivered. See paragraph [0093] which discloses that the button is also for checking system status. See also paragraph [0098]
wherein the one or more indicator lights are configured to, responsive to activation of the input button, provide an indication of a current status of the infusion pump by displaying a light pattern corresponding to the current status selected from a plurality of different light patterns each indicating a different type of pump status; and
Mazlish explains in paragraph [0114] that by pushing a button on or double tapping on the housing of medication delivery device 15 or 15′ will illuminate medication delivery indicator light 232 if insulin is being delivered (see Figure 15A-15C which shows a pair of indicator lights). Mazlish also explains that the medication delivery indicator light 232 can display different colors to indicate a mode of insulin delivery. In some cases, medication delivery indicator light 232 can remain continuously illuminated or blink to indicate a mode of insulin delivery. In some cases, medication delivery indicator light 232 can display different colors or blink using a different frequency to indicate whether real-time analyte sensor data is being received by medication delivery device 15 or 15′.
As explained above, the indicator lights can display different colors, can remain continuously illuminated or blink using a different frequency to indicate a mode or to indicate other information. See paragraph [0114]. Mazlish discloses the medication delivery device “will illuminate medication delivery indicator light 232 if insulin is being delivered”, “display different colors to indicate a mode of insulin delivery”, “remain continuously illuminated or blink to indicate a mode of insulin delivery”, “display different colors or blink using a different frequency to indicate whether real-time analyte sensor data is being received by medication delivery device 15 or 15”, “provide lights indicative of whether there is a message for the user available on remote user-interface device 60”, “urgency of the message can be conveyed by the color of message indicator light 234 and/or whether message indicator light 234 is blinking”, “message indicator light 234 can be yellow to indicate that a medication delivery device or analyte sensor maintenance activity is due within the next 3 hours”, and “message indicator light 234 can illuminate red to indicate that the system requires immediate maintenance and/or that the user has a high or low blood glucose reading.”
a remote control device including a display screen configured to present a plurality of menus including menu items enabling programming of operating parameters for the infusion pump to remotely control the user-wearable infusion pump,
As shown in paragraph [0095], Mazlish discloses the remote user interface 62 includes a navigation menu 302, a mode indicator icon 335, a message, blood glucose data 310 illustrated with a blood glucose value, a blood glucose trend line, and a blood glucose prediction, and a bolus button/user-selectable icon 390. See also paragraph [0096] which discloses of a bolus button/user-selectable icon which controls the operation of the medication delivery device.
See also paragraph [0055] which discloses the medication delivery device can be adapted to automatically administer medication according to a programmed rate, a programmed schedule, or based on analyte sensor data without user input. The remote user-interface device can be adapted to receive user commands for the medication delivery device to administer additional doses of medication, adjust the programmed delivery rate or schedule, or adjust an algorithm that determines a dosage based on the analyte sensor data.
wherein the remote control device is configured to, responsive to the activation of the input button, display on the display screen information relating to the current status of the infusion pump indicated by the light pattern displayed by the one or more indicator lights of the infusion pump.
Mazlish explains in paragraph [0006] that a remote user-interface devices can permit users to check the status of a medication delivery system provided herein without needing to directly access their medication delivery devices. See also paragraphs [0055], [0098] and [0104]. As set forth above, the indicator lights are used to show the current status of the medication delivery device and thus the remote user device sees the current status on the display screen which is indicated by the light pattern. See also paragraphs [0009], [0013], [0110], [0015] and [0106] (“the icon displayed for the alert message on the remote user-interface device matches the icon illuminated on the medication delivery device”). Mazlish explains that matching the icons on the medication delivery device on the remote user-interface device can reinforce the meaning behind these icons as the user uses the system. In paragraph [0106], Mazlish explains that the automation mode indicator light 236 still illuminated if the alarm is snoozed on the medication delivery device or the status is checked and this is displayed for the alert message on the remote user-interface device.
See also paragraphs [0114-0115], which discloses “message indicator light 234 can be included on medication delivery device 15 or 15′ to provide lights indicative of whether there is a message for the user available on remote user-interface device 60. The message could be a message that the system has entered a non-automated mode because of a loss of analyte sensor data reaching the medication delivery device.
The Examiner finds that because Mazlish matches the illuminated icons on the remote user-interface device and that Mazlish discloses that pressing the button is used to indicate the status. Thus, Mazlish discloses a correspondence between pressing a button on the medication delivery device, the illumination of a light on the medication delivery device and the display of information on the remote user interface device.
Nonetheless, to the extent it is considered that Mazlish does not disclose that the remote user-interface device is not displaying information related to the medication delivery device in response to the activation of the button, the Examiner finds that Sokolovskyy is directed to an infusion pump device for delivering insulin to a patient. As disclosed in paragraph [0046], Sokolovskyy discloses that in response to a user manipulating a user input element (button) of the infusion device 302, updated user interface status information is automatically pushed from the infusion device to the client device. See also paragraph [0005]
Thus, Sokolovskyy discloses that it was known for a client device (remote user device) to be responsive to a button press on an infusion device for the purpose of status information. As set forth above with respect to Mazlish, lights are illuminated in response to the activation of a button press in order to indicate the current status. In addition, Mazlish discloses of matching the illuminated light on the medication delivery device to an icon on the remote user-interface button.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have a remote control device be configured, to be responsive to the activation of the input button and to display on the display screen information relating to the current status of the infusion pump as disclosed by Sokolovskyy as well as having the information be related to the light pattern displayed by the one or more indicator lights of the infusion pump as taught by Mazlish.
As disclosed by Mazlish, matching icons on the medication delivery device and on the remote user-interface device can reinforce the meaning behind these icons as the user uses the system. In addition, matching icons may provide a user with a more robust explanation of an icon at the remote user-interface device. See paragraph [0009]. As disclosed in paragraph [0098], Mazlish discloses that pressing button 250 can result in the mediation delivery device sending a wireless communication to remote user-interface device. Thus, Mazlish already disclose of a mechanism for the remote-delivery device to be ‘responsive’ to a button push. This teaching would have yielded a predictable result to a person of ordinary skill in the art since Mazlish already disclosed of both the means to communicate with a remote user device in response to a press of a button as well as matching icons which pertain to a status condition of the medication delivery device in response to a press of a button. Thus, as explained by Sokolovskyy as well as Mazlish by displaying information on the remote user device, the user can have more detailed information that is related to the illuminated icons (of Mazlish) or the status of the infusion device/medicated delivery device.
Regarding claim 12:
The system of claim 11, wherein the light pattern corresponding to the current status of the infusion pump corresponds to an alarm and the information presented on the display screen of the remote control device notifies the user of an actual or potential stopping of medicament delivery with the infusion pump.
See paragraph [0104] which is directed to alarm notification for a lack of insulin flowing. As set forth therein, an icon will illuminate to tell the user that an alarm condition relates to the supply of insulin. A remote user device is also used to resolve this alarm condition. See also Figure 5B and paragraphs [0098] and [0114](which illuminates or blink to indicate insulin delivery).
Regarding claim 13:
The system of claim 11, wherein the light pattern corresponding to the current status of the infusion pump corresponds to an alert and the information presented on the display screen of the remote control device notifies the user of a safety condition relating to use of the infusion pump.
See paragraph [0104] which is directed to alarm notification for a lack of insulin flowing. As set forth therein, an icon will illuminate to tell the user that an alarm condition relates to the supply of insulin. A remote user device is also used to resolve this alarm condition. See also Figure 5B and paragraphs [0098] and [0114].
Regarding claim 14:
The system of claim 11, wherein the light pattern corresponding to the current status of the infusion pump corresponds to a malfunction and the information presented on the display screen of the remote control device notifies the user of an error stopping delivery of medicament.
See paragraph [0104] which is directed to alarm notification for a lack of insulin flowing. As set forth therein, an icon will illuminate to tell the user that an alarm condition relates to the supply of insulin. A remote user device is also used to resolve this alarm condition. See also paragraphs [0098-0099]. In paragraph [0116] and [0149], Mazlish disclose that occlusions can occur and a visual alert on the device can be illuminated.
Regarding claim 16:
The system of claim 11, wherein the light pattern corresponding to the current status of the infusion pump relates to a current delivery of medicament with the infusion pump and the information presented on the display screen includes a status of the current delivery of medicament.
See paragraphs [0012-0013] which discloses that the medication delivery device includes one or more indicator lights which is used to indicate whether the medication delivery device is delivering medication. See also paragraphs [0013], [0015] and [0106] (“the icon displayed for the alert message on the remote user-interface device matches the icon illuminated on the medication delivery device.”). See also paragraphs [0104] and [0149].
Regarding claim 17:
The system of claim 11, wherein the information presented on the display screen includes textual information.
See Figures 5B, 5C, 6,7A, 7B, 8A and 8B. See also paragraph [0130] which discloses wherein the remote user-interface device is adapted to present the user with troubleshooting instructions using text, audio, or video to remove the alarm or alert condition. See also paragraph [0028].
Regarding claim 18:
The system of claim 11, wherein the information presented on the display screen includes graphical information.
See Figures 5B, 5C, 6,7A, 7B, 8A and 8B.
Regarding claim 19:
The system of claim 11, wherein the light pattern varies one or more of a color of the one or more lights, a frequency of illumination of the one or more lights, a duration of illumination of the one or more lights and an intensity of illumination of the one or more lights.
As explained above, the indicator lights can display different colors, can remain continuously illuminated or blink using a different frequency to indicate a mode or to indicate other information. See paragraph [0114].
Regarding claim 24:
The system of claim 11, wherein: the user-wearable infusion pump is further configured to detect occurrence of a system- driven event comprising (i) administration of a bolus via the user-wearable infusion pump, (ii) malfunction of the user-wearable infusion pump, or (iii) activation of an alarm or alert associated with the user-wearable infusion pump; and the one or more indicator lights are further configured to, responsive to the occurrence of the system-driven event, provide an indication of the system-driven event with a light pattern selected from a plurality of different light patterns stored in memory each indicating a different type of system-driven event.
Mazlish discloses in paragraph [0091], that the medication delivery device 15 can include indicator lights 232 and 234, which can be used to indicate a mode of operation, and optionally certain error conditions. As set forth in paragraph [0094], Mazlish discloses that illuminable icon 243 indicates a depletion of insulin in the medication delivery device 15 and illuminable icon 244 indicates an error with CGM data. See also paragraph [0134] where Mazlish discloses the medication delivery device comprises one or more icons, and one or more lights associated with those one or more icons, indicating whether the medication is being delivered based on the analyte sensor or not or whether there is an error with the analyte sensor. See also Mazlish at paragraphs [0012-0013]
As explained above, the indicator lights can display different colors, can remain continuously illuminated or blink using a different frequency to indicate a mode or to indicate other information. See paragraph [0114]. Mazlish discloses the medication delivery device “will illuminate medication delivery indicator light 232 if insulin is being delivered”, “display different colors to indicate a mode of insulin delivery”, “remain continuously illuminated or blink to indicate a mode of insulin delivery”, “display different colors or blink using a different frequency to indicate whether real-time analyte sensor data is being received by medication delivery device 15 or 15”, “provide lights indicative of whether there is a message for the user available on remote user-interface device 60”, “urgency of the message can be conveyed by the color of message indicator light 234 and/or whether message indicator light 234 is blinking”, “message indicator light 234 can be yellow to indicate that a medication delivery device or analyte sensor maintenance activity is due within the next 3 hours”, and “message indicator light 234 can illuminate red to indicate that the system requires immediate maintenance and/or that the user has a high or low blood glucose reading.”
Claim(s) 1-9, 15 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mazlish et al. US Patent Pub. 2019/0274624 in view of Lanigan US Patent Pub. 2014/0054883 and further in view of Sokolovskyy et al. US Patent Pub. 2018/0150614.
Regarding claim 1:
A method of operating a user-wearable infusion pump having no display screen with a remote control device, comprising:
Mazlish relates to alarms and alerts for medication delivery devices and systems, particularly for medication delivery systems that have a medication delivery device that communicates with a primary user-interface for the medication delivery device and related systems and methods. See paragraph [0002].
Mazlish discloses medication delivery systems, methods, and devices provided herein include at least a medication delivery device (e.g., an insulin delivery device) and a remote user-interface device (e.g., a smartphone having an installed app) in communication (e.g., wireless communication) with each other. See paragraph [0004]. See also Figure 1A and 1B.
The Examiner notes that the medication delivery device is a user-wearable infusion pump and the remote user-interface device (smart phone) is the remote control device. See paragraph [0006] which discloses “the medication delivery device may be a medication infusion device, intended to be worn on the user's body to provide regular, near continuous, or continuous delivery of medication to the user based on the user's needs”. See also paragraphs [0057] which discloses “the medication delivery device can include an insulin infusion pump, the medication can be insulin, and the remote user-interface device can be a smartphone.”
As to “display” Mazlish as shown in Figure 1B disclose that the medication delivery device is a patch pump which also can be used to deliver insulin in an insulin delivery system. This pump does not disclose a display and instead includes indicator lights. See paragraph [0092].
In addition, with respect to an alternative medication delivery device (paragraph [0093]) (shown in Figure 2), although Mazlish uses the term ‘display’ Mazlish discloses that this user interface includes a plurality of indicator lights and/or illuminable icons. Mazlish explains that, as shown, indicator lights 236 and 237 can be positioned adjacent to icons 235. Thus, Mazlish discloses that the user interface can be designed with only indicator lights. The Examiner finds that Mazlish discloses a display screen which is used on a smart phone (paragraph [0095]) and Mazlish never refers to the ‘display’ of the Figure 2 device as having a screen. Only “indicator lights” and/or “icons” are shown. The Examiner finds that the icons are only shown to “illuminate”.
Thus, both the patch pump 15’ (see figure 1B) which only has indicator lights and the infusion pump 15 which includes indicator lights and/or icons (the device can have only indicator lights without icons) do not include a “display” such as a display screen type that is used by the remote device.
presenting a plurality of menus on a display screen of the remote control device, the plurality of menus including menu items enabling programming of operating parameters for the user-wearable infusion pump;
As shown in paragraph [0095], Mazlish discloses the remote user interface 62 includes a navigation menu 302, a mode indicator icon 335, a message, blood glucose data 310 illustrated with a blood glucose value, a blood glucose trend line, and a blood glucose prediction, and a bolus button/user-selectable icon 390. See also paragraph [0096] which discloses of a bolus button/user-selectable icon which controls the operation of the medication delivery device.
See also paragraph [0055] which discloses the medication delivery device can be adapted to automatically administer medication according to a programmed rate, a programmed schedule, or based on analyte sensor data without user input. The remote user-interface device can be adapted to receive user commands for the medication delivery device to administer additional doses of medication, adjust the programmed delivery rate or schedule, or adjust an algorithm that determines a dosage based on the analyte sensor data.
responsive to activation of an input button on the infusion pump;
See paragraph [0114] which discloses by pushing a button on or double tapping on the housing of medication delivery device 15 or 15′ will illuminate medication delivery indicator light 232 if insulin is being delivered. See paragraph [0093] which discloses that the button is also for checking system status. See also paragraph [0098]
detecting a current status of the infusion pump;
As set forth in paragraph [0085], notification lights can be used to inform a user about the status of the medication delivery system. See also paragraphs [0104] and [0114].
providing an indication of the current status of the infusion pump with a light pattern provided by one or more indicator lights disposed on the infusion pump,
Mazlish explains in paragraph [0114] that by pushing a button on or double tapping on the housing of medication delivery device 15 or 15′ will illuminate medication delivery indicator light 232 if insulin is being delivered. Mazlish also explains that the medication delivery indicator light 232 can display different colors to indicate a mode of insulin delivery. In some cases, medication delivery indicator light 232 can remain continuously illuminated or blink to indicate a mode of insulin delivery. In some cases, medication delivery indicator light 232 can display different colors or blink using a different frequency to indicate whether real-time analyte sensor data is being received by medication delivery device 15 or 15′.
the light pattern of the current status being selected from a plurality of different light patterns stored in memory each indicating a different type of pump status;
As explained above, the indicator lights can display different colors, can remain continuously illuminated or blink using a different frequency to indicate a mode or to indicate other information. See paragraph [0114]. Mazlish discloses the medication delivery device “will illuminate medication delivery indicator light 232 if insulin is being delivered”, “display different colors to indicate a mode of insulin delivery”, “remain continuously illuminated or blink to indicate a mode of insulin delivery”, “display different colors or blink using a different frequency to indicate whether real-time analyte sensor data is being received by medication delivery device 15 or 15”, “provide lights indicative of whether there is a message for the user available on remote user-interface device 60”, “urgency of the message can be conveyed by the color of message indicator light 234 and/or whether message indicator light 234 is blinking”. “message indicator light 234 can be yellow to indicate that a medication delivery device or analyte sensor maintenance activity is due within the next 3 hours”, and “message indicator light 234 can illuminate red to indicate that the system requires immediate maintenance and/or that the user has a high or low blood glucose reading.”
As also explained above, the medication delivery device can be programmed (see paragraphs [0011], [0055] and [0158]) and as set forth in paragraph [0121], Mazlish discloses that the medication delivery device comprises a controller. The Examiner notes that although, Mazlish discloses of using a plurality of different light patterns and different types of pump status for the lights (different modes, types of status or other information), as well showing that the mediation delivery device is programmed (see paragraph [0114]), Mazlish does not specifically disclose a “memory” which is used to store this information.
However, the Examiner finds that a person of ordinary skill in the art would have understood the use of memories is well known in the art for storing programmed information and that the mediation delivery device would have stored any programmed information including light patterns in a memory due to the fact that Mazlish discloses of operating in accordance with programming operations as well as using different light patterns. Indeed, Mazlish in paragraph [0095-0096] discloses that it was known to store a user interface and user experiences in a memory as well as storing parameters. Thus, a person of ordinary skill in the art would have understood that memory was known to be used to store different types of information which is used for operation of the device.
Nonetheless, the Examiner notes that Lanigan, like Mazlish, is also directed to an infusion pump assembly which includes indicator lights (see paragraph [1449]). Lanigan explains that it was known for an infusion pump assembly to include nonvolatile memory which is used for storage of information. See paragraphs [0457] and [0914].
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include a memory in the medication delivery device of Mazlish. As explained by Mazlish, the medication delivery device includes programmed information regarding a plurality of light patterns as well as a controller for controlling the operations of the medication delivery device. Lanigan discloses that including a memory for storage of information was well known in this field of endeavor and therefore, a person of ordinary skill in the art would have found it obvious and thus yielded a predictable result to include a memory for the storage of information such as the programmed information used by Mazlish in using the plurality of light patterns.
presenting information relating to the current status of the infusion pump indicated by the light pattern of the current status on the display screen of the remote control device.
Mazlish explains in paragraph [0006] that a remote user-interface devices can permit users to check the status of a medication delivery system provided herein without needing to directly access their medication delivery devices. See also paragraphs [0098] and [0104]. As set forth above, the indicator lights are used to show the current status of the medication delivery device and thus the remote user device sees the current status on the display screen which is indicated by the light pattern. See also paragraphs [0009], [0013], [0110], [0015] and [0106] (“the icon displayed for the alert message on the remote user-interface device matches the icon illuminated on the medication delivery device”). Mazlish explains that matching the icons on the medication delivery device on the remote user-interface device can reinforce the meaning behind these icons as the user uses the system. In paragraph [0106], Mazlish explains that the automation mode indicator light 236 still illuminated if the alarm is snoozed on the medication delivery device or the status is checked and this is displayed for the alert message on the remote user-interface device.
See also paragraphs [0114-0115], which discloses “message indicator light 234 can be included on medication delivery device 15 or 15′ to provide lights indicative of whether there is a message for the user available on remote user-interface device 60. The message could be a message that the system has entered a non-automated mode because of a loss of analyte sensor data reaching the medication delivery device.
The Examiner finds that because Mazlish matches the illuminated icons on the remote user-interface device and that Mazlish discloses that pressing the button is used to indicate the status. Thus, Mazlish discloses a correspondence between pressing a button on the medication delivery device, the illumination of a light on the medication delivery device and the display of information on the remote user interface device.
Nonetheless, to the extent it is considered that Mazlish does not disclose that the remote user-interface device is not displaying information related to the medication delivery device in response to the activation of the button, the Examiner finds that Sokolovskyy is directed to an infusion pump device for delivering insulin to a patient. As disclosed in paragraph [0046], Sokolovskyy discloses that in response to a user manipulating a user input element (button) of the infusion device 302, updated user interface status information is automatically pushed from the infusion device to the client device. See also paragraph [0005]
Thus, Sokolovskyy discloses that it was known for a client device (remote user device) to be responsive to a button press on an infusion device for the purpose of status information. As set forth above with respect to Mazlish, lights are illuminated in response to the activation of a button press in order to indicate the current status. In addition, Mazlish discloses of matching the illuminated light on the medication delivery device to an icon on the remote user-interface button.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have a remote control device be configured, to be responsive to the activation of the input button and to display on the display screen information relating to the current status of the infusion pump as disclosed by Sokolovskyy as well as having the information be related to the light pattern displayed by the one or more indicator lights of the infusion pump as taught by Mazlish.
As disclosed by Mazlish, matching icons on the medication delivery device and on the remote user-interface device can reinforce the meaning behind these icons as the user uses the system. In addition, matching icons may provide a user with a more robust explanation of an icon at the remote user-interface device. See paragraph [0009]. As disclosed in paragraph [0098], Mazlish discloses that pressing button 250 can result in the mediation delivery device sending a wireless communication to remote user-interface device. Thus, Mazlish already disclose of a mechanism for the remote-delivery device to be ‘responsive’ to a button push. This teaching would have yielded a predictable result to a person of ordinary skill in the art since Mazlish already disclosed of both the means to communicate with a remote user device in response to a press of a button as well as matching icons which pertain to a status condition of the medication delivery device in response to a press of a button. Thus, as explained by Sokolovskyy as well as Mazlish by displaying information on the remote user device, the user can have more detailed information that is related to the illuminated icons (of Mazlish) or the status of the infusion device/medicated delivery device.
Regarding claim 2:
The method of claim 1, wherein the light pattern of the current status of the infusion pump corresponds to an alarm and the information presented on the display screen of the remote control device notifies the user of an actual or potential stopping of medicament delivery with the infusion pump.
See paragraph [0104] which is directed to alarm notification for a lack of insulin flowing. As set forth therein, an icon will illuminate to tell the user that an alarm condition relates to the supply of insulin. A remote user device is also used to resolve this alarm condition. See also Figure 5B and paragraphs [0098] and [0114] (which illuminates or blink to indicate insulin delivery).
Regarding claim 3:
The method of claim 1, wherein the light pattern of the current status of the infusion pump corresponds to an alert and the information presented on the display screen of the remote control device notifies the user of a safety condition relating to use of the infusion pump.
See paragraph [0104] which is directed to alarm notification for a lack of insulin flowing. As set forth therein, an icon will illuminate to tell the user that an alarm condition relates to the supply of insulin. A remote user device is also used to resolve this alarm condition. See also Figure 5B and paragraphs [0098] and [0114].
Regarding claim 4:
The method of claim 1, wherein the light pattern of the current status of the infusion pump corresponds to a malfunction and the information presented on the display screen of the remote control device notifies the user of an error stopping delivery of medicament.
See paragraph [0104] which is directed to alarm notification for a lack of insulin flowing. As set forth therein, an icon will illuminate to tell the user that an alarm condition relates to the supply of insulin. A remote user device is also used to resolve this alarm condition. See also paragraphs [0098-0099]. In paragraph [0116] and [0149], Mazlish disclose that occlusions can occur and a visual alert on the device can be illuminated.
Regarding claim 5:
The method of claim 1, wherein the light pattern of the current status of the infusion pump corresponds to a reminder and the information presented on the display screen of the remote control device notifies the user of an optional notification set by the user.
The Examiner notes that although Mazlish discloses of using a light pattern for the current status of the infusion pump as set forth above, as well as providing information on the display screen of the remote control device of information (see figure 6 and paragraph [0013] and [0096]), Mazlish does not specifically disclose of using a “reminder”.
Nonetheless, Lanigan discloses that it may be desirable for the user to have the option to preselect/preprogram/predetermine when a non-critical reminder/alarm/alert is given, regardless of the type of reminder/alarm/alert. For example, in some embodiments, the user may request that no non-critical reminder/alarm/alert be given between 11 pm and 6 am, i.e., while the user is sleeping. In some embodiments, this may be termed a timeout. In some embodiments, the user may request a "temporary" timeout for non-critical reminders/alarms/alerts, for example, between 6 pm-8 pm, while, for example, attending a quiet event. See paragraph [1452-1453] and [1449-1450].
In addition, Mazlish discloses the use of schedules ([0011]), “a missed meal announcement” and need to change an infusion set or to check ketone levels (see paragraph [0047]).
Therefore, it would have been obvious to a person of ordinary skill before the effective filing date of the claimed invention to include reminders. As explained in paragraph [1449] of Lanigan, reminders can be used to remind a user to check blood glucose or to change sensors. Lanigan discloses that this is set forth via alarms. As set forth in paragraph [01451] when the interface ‘lights up’ a message is indicated to the user. Since the light patterns of Mazlish is used to provide alerts to the user, it would have been obvious to a person of ordinary skill in the art to include reminders for various conditions as explained by Lanigan. The Examiner finds that using reminders would have yielded a predictable result to a person of ordinary skill in the art since it was known for infusion pump assemblies to provide alarms, alerts, light patterns to indicate various types of information to the user. In addition, Mazlish discloses the use of schedules ([0011]), “a missed meal announcement” and need to change an infusion set or to check ketone levels (see paragraph [0047]). Thus, reminding the user as to a possible missed meal announcement, a possible need to change an infusion set or a possible need to check ketone as a visual indicator on the insulin delivery device would have been obvious to a person of ordinary skill in the art and further indicating that the user should check the remote user-interface device for information about the alert would have been further obvious so that the user can perform any necessary steps in compliance of the reminder. See paragraph [0047]
Regarding claim 6:
The method of claim 1, wherein the light pattern of the current status of the infusion pump relates to a current delivery of medicament with the infusion pump and the information presented on the display screen includes a status of the current delivery of medicament.
See paragraphs [0012-0013] which discloses that the medication delivery device includes one or more indicator lights which is used to indicate whether the medication delivery device is delivering medication. See also paragraphs [0013], [0015] and [0106] (“the icon displayed for the alert message on the remote user-interface device matches the icon illuminated on the medication delivery device.”). See also paragraphs [0104] and [0149].
Regarding claim 7:
The method of claim 1, wherein the information presented on the display screen includes textual information.
See Figures 5B, 5C, 6,7A, 7B, 8A and 8B. See also paragraph [0130] which discloses wherein the remote user-interface device is adapted to present the user with troubleshooting instructions using text, audio, or video to remove the alarm or alert condition. See also paragraph [0028]
Regarding claim 8:
The method of claim 1, wherein the information presented on the display screen includes graphical information.
See Figures 5B, 5C, 6,7A, 7B, 8A and 8B.
Regarding claim 9:
The method of claim 1, wherein the light pattern varies one or more of a color of the one or more lights, a frequency of illumination of the one or more lights, a duration of illumination of the one or more lights and an intensity of illumination of the one or more lights.
As explained above, the indicator lights can display different colors, can remain continuously illuminated or blink using a different frequency to indicate a mode or to indicate other information. See paragraph [0114].
Regarding claim 15:
The system of claim 11, wherein the light pattern corresponding to the current status of the infusion pump corresponds to a reminder and the information presented on the display screen of the remote control device notifies the user of an optional notification set by the user.
The Examiner notes that although Mazlish discloses of using a light pattern for the current status of the infusion pump as set forth above, as well as providing information on the display screen of the remote control device of information (see figure 6 and paragraph [0013] and [0096]), Mazlish does not specifically disclose of using a “reminder”.
Nonetheless, Lanigan discloses that it may be desirable for the user to have the option to preselect/preprogram/predetermine when a non-critical reminder/alarm/alert is given, regardless of the type of reminder/alarm/alert. For example, in some embodiments, the user may request that no non-critical reminder/alarm/alert be given between 11 pm and 6 am, i.e., while the user is sleeping. In some embodiments, this may be termed a timeout. In some embodiments, the user may request a "temporary" timeout for non-critical reminders/alarms/alerts, for example, between 6 pm-8 pm, while, for example, attending a quiet event. See paragraph [1452-1453] and [1449-1450].
In addition, Mazlish discloses the use of schedules ([0011]), “a missed meal announcement” and need to change an infusion set or to check ketone levels (see paragraph [0047]).
Therefore, it would have been obvious to a person of ordinary skill before the effective filing date of the claimed invention to include reminders. As explained in paragraph [1449] of Lanigan, reminders can be used to remind a user to check blood glucose or to change sensors. Lanigan discloses that this is set forth via alarms. As set forth in paragraph [01451] when the interface ‘lights up’ a message is indicated to the user. Since the light patterns of Mazlish is used to provide alerts to the user, it would have been obvious to a person of ordinary skill in the art to include reminders for various conditions as explained by Lanigan. The Examiner finds that using reminders would have yielded a predictable result to a person of ordinary skill in the art since it was known for infusion pump assemblies to provide alarms, alerts, light patterns to indicate various types of information to the user. In addition, Mazlish discloses the use of schedules ([0011]), “a missed meal announcement” and need to change an infusion set or to check ketone levels (see paragraph [0047]). Thus, reminding the user as to a possible missed meal announcement, a possible need to change an infusion set or a possible need to check ketone as a visual indicator on the insulin delivery device would have been obvious to a person of ordinary skill in the art and further indicating that the user should check the remote user-interface device for information about the alert would have been further obvious so that the user can perform any necessary steps in compliance of the reminder. See paragraph [0047]
Regarding claim 23:
The method of claim 1, further comprising: detecting occurrence of a system-driven event at the user-wearable infusion pump comprising (i) administration of a bolus via the user-wearable infusion pump, (ii) malfunction of the user-wearable infusion pump, or (iii) activation of an alarm or alert associated with the user- wearable infusion pump; and responsive to detecting the occurrence of the system-driven event, providing an indication of the system-driven event with a light pattern provided by one or more indicator lights disposed on the infusion pump, wherein the light pattern is selected from a plurality of different light patterns stored in memory each indicating a different type of system-driven event.
Mazlish discloses in paragraph [0091], that the medication delivery device 15 can include indicator lights 232 and 234, which can be used to indicate a mode of operation, and optionally certain error conditions. As set forth in paragraph [0094], Mazlish discloses that illuminable icon 243 indicates a depletion of insulin in the medication delivery device 15 and illuminable icon 244 indicates an error with CGM data. See also paragraph [0134] where Mazlish discloses the medication delivery device comprises one or more icons, and one or more lights associated with those one or more icons, indicating whether the medication is being delivered based on the analyte sensor or not or whether there is an error with the analyte sensor. See also Mazlish at paragraphs [0012-0013]
As explained above, the indicator lights can display different colors, can remain continuously illuminated or blink using a different frequency to indicate a mode or to indicate other information. See paragraph [0114]. Mazlish discloses the medication delivery device “will illuminate medication delivery indicator light 232 if insulin is being delivered”, “display different colors to indicate a mode of insulin delivery”, “remain continuously illuminated or blink to indicate a mode of insulin delivery”, “display different colors or blink using a different frequency to indicate whether real-time analyte sensor data is being received by medication delivery device 15 or 15”, “provide lights indicative of whether there is a message for the user available on remote user-interface device 60”, “urgency of the message can be conveyed by the color of message indicator light 234 and/or whether message indicator light 234 is blinking”, “message indicator light 234 can be yellow to indicate that a medication delivery device or analyte sensor maintenance activity is due within the next 3 hours”, and “message indicator light 234 can illuminate red to indicate that the system requires immediate maintenance and/or that the user has a high or low blood glucose reading.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ovidio Escalante whose telephone number is (571)272-7537. The examiner can normally be reached on Monday to Friday - 6:00 AM to 2:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Michael Fuelling can be reached on (571) 270-1367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-9000. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR.Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ovidio Escalante/
Primary Examiner
Central Reexamination Unit - Art Unit 3992
(571) 272-7537
Conferees:
/MATTHEW E HENEGHAN/Primary Examiner, Art Unit 3992 /M.F/Supervisory Patent Examiner, Art Unit 3992