DETAILED ACTION
This action is in response to the amendment filed 9/10/2025.
Claims 1-22 and 24 are currently 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 .
Response to Arguments
Applicant’s arguments, see pages 7-9 of amendment, filed 3/19/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Horelik et al. (US 2019/0320310), Horelik.
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.
Claim(s) 1-13, 17, 18, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (US 2012/0238851), hereinafter Kamen, in view of Mensinger et al. (US 20140012117), hereinafter Mensinger, in view of El-Khatib et al. (US 2022/0189604), hereinafter Khatib, in view of Shaanan et al. (US 2015/0205930), hereinafter Shaanan, in view of Horelik et al. (US 2019/0320310), hereinafter Horelik.
As per claim 1, Kamen teaches the following:
a medication delivery system comprising:
a drug delivery device. See paragraph [0066], “infusion pump”;
a user device in wireless communication with the drug delivery device. See Fig. 8, 802, and corresponding paragraph [0090]; and
a user application having a graphical user interface, executing on the user device, the user application controlling delivery of a medication by the drug delivery device. See paragraph [0091], “the remote interface 802 may include the ability to command the device”;
wherein the graphical user interface of the user application includes a default screen displayed on startup of the user application, (see paragraph [0495], “home screen”), the default screen comprising:
an informational area displaying a most-recent blood glucose level of a user. (see Fig. 28A, 2806),
an indicator of the estimated insulin on board. (see Fig. 28A, 2804);
a bolus display area comprising an indicator of a most recent bolus delivered by the drug delivery device. As Kamen teaches in paragraph [0498], and corresponding Fig. 28D, a “bolus display area” 2822 shows the “last bolus” 2838;
a CGM area that, when selected, displays a graph of blood glucose readings within . Kamen teaches in paragraph [0476] of a “graph” tab which may show CGM; and
a mode indicator, indicating whether the user application is operating in automatic or manual modes. Kamen shows in Fig. 28A, 2800, of a mode indicator which displays the current mode of the device. Kamen shows in Fig. 28A that the indicator may show “Delivering”, a form of automatic mode, and Fig. 28C shows “Pump Idle”, which is interpreted as a manual mode as the user may turn off the manual pump and inject a dosage manually.
However, Kamen does note explicitly teach of a trend indicator or the graph having a user selectable time period. In a similar field of endeavor, Mensinger teaches of a smartphone app for controlling a cgm device (see abstract). Mensinger further teaches of a trend indicator 1506 in Fig. 15, and corresponding [0190], and a user selectable time period of glucose readings in Fig. 3A, 308.
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have modified the interfaces of Kamen with the trend indicator and graph time period selection of Mensinger. One of ordinary skill would have been motivated to have made such modification because both tools benefit a user in allowing the visualization of past readings to better appreciate the change of values over time, a benefit which is recognized by Kamen in the viewing of historical readings as shown in Fig. 28B.
While Kamen teaches of a form of “mode indicator” in Fig. 28A, 2800, which may be interpreted as indicting a bolus automatically functioning, Kamen does not explicitly teach of the indication being of an automatic mode or manual mode. In a similar field of endeavor, Khatib teaches of a method for customizing a glucose level control system, (see abstract). Kahatib further teaches the following:
a mode indicator, indicating whether the user application is operating in a manual mode in which the drug delivery device delivers the medication using preprogrammed dosing parameters or an automated mode in which the drug delivery device adapts the dosing parameters over time. As Khatib shows in Fig. 28C, and corresponding paragraph [0455], a user may enter a “manual mode” which is indicated at a top of the display, similar to that of the indicator of Kamen. Khatib further teaches in paragraph [0627] that when the system is operating in an automatic mode, the system may access any manual bolus and timing automatic bolus accordingly, thus “adapt dosing parameters over time”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have modified the indicator of Kamen with the “manual mode” indication of Khatib. One of ordinary skill would have been motivated to have made such modification because as Khatib teaches in paragraphs [0619]–[0621], sometimes it may be necessary for a user to receive a manual bolus and the indicator would benefit a user in allowing recognition of this and allow the system to better adapt its automatic calculations so that too much insulin is not delivered.
The examiner would like to further note that while Khatib does not explicitly show an indication of “automatic”, Khatib does teach of the system working automatically throughout the reference, (see paragraph [0617]). It would have been obvious to one of ordinary skill in the art at the time that application was filed to have presented some form of “automatic” indication. One of ordinary skill would have been motivated to have made such modification because as Khatib teaches of manual indication, an automatic indication would benefit a user in relaying that the current mode is one of “not manual”.
While Kamen teaches of sharing data over a network in paragraph [0415], Kamen does not explicitly teach of a list of people authorized to view data. In a similar field of endeavor, Shaanan teaches of user interfaces for an analyte monitoring system (see abstract). Shaanan further teaches the following:
and a viewers screen allowing the viewing of a list of people authorized to view data generated by the user application controlling the delivery of the medication and allowing the adding of new authorized people. As Shaanan teaches in paragraph [0062], and corresponding Fig. 7H, during account set-up, a user may create a list through invitations (adding new people) of users that can view the user’s profile (data generated by the application). Shaanan teaches in paragraph [0050] that the web portal may be viewed on any device, such as a mobile device. While Shaanan does not explicitly teach of viewing the list after creation, Shaanan further suggests that the access list may be found in an “account setting” as taught in paragraph [0059], and corresponding Fig. 6. Further see Fig. 8A which depicts a list of patients for a caregiver account, which further suggests the ability to view an access list for a patient account.
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have modified the data management of Kamen with the access list of Shaanan. One of ordinary skill would have been motivated to have made such modification because it would benefit users in allowing friends and loved ones to view data on the user to assist with the user’s health.
While Kamen in view of Shaanan teaches of a list of authorized users, neither Kamen nor Shaanan explicitly teaches of a status of each user being that of active or pending. In a similar field of endeavor, Horelik teaches of a method for managing access to emergency data and medical information (see paragraph [0049]. Horelik further teaches the following:
wherein each person on the list of the viewer’s screen is associated with a status indicator indicating whether the person is an active viewer or pending approval. As Horelik shows in Fig. 5C, a list of possible users with access to a system’s data may be listed as “approved” and “pending” indicators.
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have further modified the list of viewer of Kamen in view of Shaanan with the pending/approved indicators of Horelik. One of ordinary skill would have been motivated to have made such modifications because the indicators of Horelik would benefit a user in allowing the user to visualize exactly which users may view the medical data and which have not yet been granted access as opposed to simply a list of viewer regardless of status.
Regarding claim 2, modified Kamen teaches the system of claim 1 as described above. Kamen further teaches the following:
the startup screen further comprises:
a tab bar comprising a dashboard tab, an insulin tab and a pod info tab. As Karmen shows in Fig. 28A, various tabs are presented along the bottom of the screen;
wherein, when insulin tab is selected, the informational area displays a graphical representation of a basal program currently being run by the user application and the CGM area displays the most-recent blood glucose level of the user. Karmen shows in Fig. 28D of a display of an insulin tab selected with “basal profile” 2840 (basal program currently running). Last Glucose Result is presented in Fig. 28C; and
wherein, when the pod info tab is selected, the informational area displays status information about the drug delivery device including a number of units of medication remaining in the drug delivery device and the CGM area displays the most-recent blood glucose level of the user. As Karmen shows in Fig. 28C, information about pump activity 2828, Last Glucose Result, and Insulin Left are presented
Regarding claim 3, modified Kamen teaches the system of claim 1 as described above. Kamen further teaches the following:
the bolus display area of the default screen is selected by the user, the graphical user interface displays an indication of an estimate of the insulin on board in the bolus display area. As Kamen shows in Fig. 28C, “Insulin Left” in the pump display is displayed on the bottom of the interface.
Regarding claim 4, modified Kamen teaches the system of claim 1 as described above. Kamen further teaches the following:
the startup screen further comprises a bolus button that, when selected by the user, initiates the delivery of a bolus dose of the medication. As Kamen teaches in paragraph [0469], a button may be presented to “start basal”.
Regarding claim 5, modified Kamen teaches the system of claim 4 as described above. Kamen further teaches the following:
selection of the bolus button causes the graphical user interface to display a bolus calculator screen for calculating a total bolus dose of the medication to be delivered based on a quantity of carbohydrates ingested by the user, the most-recent blood glucose reading of the user and the estimate of the insulin on board. As Karmen shows in Fig. 23A -24B, a graphical user interface is displayed to calculate bolus dosage. Karmen shows part of calculating a bolus may be that of entering carbohydrates in Fig. 26A, most recent glucose readings in Fig. 24A, and “insulin on board” in bolus review Fig. 26C.
Regarding claim 6, modified Kamen teaches the system of claim 4 as described above. Kamen further teaches the following:
the user may initiate delivery of the bolus dose as an immediate bolus dose or as an extended bolus dose. As Kamen shows in Fig. 26C, bolus dosage may be set as “Normal” (immediate) or “Extended”.
Regarding claim 7, modified Kamen teaches the system of claim 6 as described above. Kamen further teaches the following:
the graphical user interface includes a screen allowing the user to specify parameters of the extended bolus delivery of the medication. See Figs. 26E and 26F.
Regarding claim 8, modified Kamen teaches the system of claim 6 as described above. Kamen further teaches the following:
when a bolus dose or extended bolus dose is being delivered, the graphical user interface displays status of the bolus or extended bolus dose in the informational area of the default screen. As Kamen shows in Fig. 27F, “Delivering” (status) is displayed at the top of the interface.
Regarding claim 9, modified Kamen teaches the system of claim 2 as described above. Kamen further teaches the following:
when insulin tab is selected, the graphical user interface displays a list of basal programs. Kamen teaches in paragraph [0470] that a user may have a plurality of profiles.
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have modified the multiple profiles of Kamen to be presented in a “list” format. One of ordinary skill would have been motivated to have made such modification because while Kamen does not explicitly teach how the profiles are presented, a list of options was a common display method at the time and is utilized by Kamen for a variety of menus as may be seen in Figs. 26L, 26N, 28B, 28D, 28G, 28H, etc.
Regarding claim 10, modified Kamen teaches the system of claim 9 as described above. Kamen further teaches the following:
the basal programs define timing and quantity of delivery of basal doses of the medication for the current day. As Kamen shows in Fig. 23C, timing and quantity of Basal are defined corresponding to time periods.
Regarding claim 11, modified Kamen teaches the system of claim 9 as described above. Kamen further teaches the following:
the graphical user interface provides a screen allowing the user to create a new basal program. As Kamen teaches in paragraph [0470], “at least one screen for programming basal profiles”.
Regarding claim 12, modified Kamen teaches the system of claim 11 as described above. Kamen further teaches the following:
the screen allowing the user to create a new basal program comprises a graphical representation indicating one or more ranges of hours and a basal rate for delivery of the medication during each range of hours. See Figs. 23C and 23D.
Regarding claim 13, modified Kamen teaches the system of claim 9 as described above. Kamen further teaches the following:
the list of basal programs includes one or more temporary basal programs specifying timing and quantity of delivery of basal doses for a portion of the current day, the temporary basal programs increasing or decreasing the quantity of the medication specified by a currently executing basal program. As Karmen teaches in paragraphs [0407] and [0408], a temporary basal rate may be set in response to an event, where the temporary rate is a modification to an existing profile, thus increasing or decreasing the rate of said profile.
Regarding claim 17, modified Kamen teaches the system of claim 1 as described above. Kamen further teaches the following:
the graphical user interface includes screens providing instructions for replacing the drug delivery device. See Figs. 20A – 20T.
Regarding claim 18, modified Kamen teaches the system of claim 1 as described above. Kamen further teaches the following:
the graphical user interface includes screens providing an interface to a food library containing at least a quantity of carbohydrates contained in individual foods in the food library. Kamen shows a food library view in Figs. 26K and 26L. Kamen teaches in paragraph [0477] that these screens may include indications of nutritional values of food, for example, carbohydrates.
Regarding claim 22, modified Kamen teaches the system of claim 1 as described above. Kamen further teaches the following:
a continuous glucose monitor in wireless communication with the user device, the continuous glucose monitor providing periodic blood glucose readings from the user. See paragraph [0275].
Claim(s) 14-16, 20, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Mensinger in view of Khatib in view of Horelik as applied to claims 1, 2, and 9 above, and further in view of Hayter et al. (US 2017/0128007), hereinafter Hayter
Regarding claim 14, modified Kamen teaches the system of claim 9 as described above. Kamen further teaches the following:
the graphical user interface further comprises a menu button that, when selected, displays a menu comprising a plurality of menu items . As Kamen shows in Fig. 26K, the user may build a “food library” (menu) of different foods and corresponding attributes which may be consumed. Further see Fig. 28H where a “last food” consumed value is given, along with a “view food library” control.
However, Kamen does not explicitly teach of overlaying the menu on the screen. In a similar field of endeavor, Hayter teaches of monitoring and displaying analyte levels of a user (see abstract). Hayter further shows in Fig. 5A that a list of meals may be presented in a front most display position (overlayed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have modified the food library of Kamen with the overlaying menu list of Hayter. One of ordinary skill would have been motivated to have made such modification because Kamen shows a clear desire to display a “food library” and the overlaying window of Hayter would achieve such goal in a manner visible to the user.
Regarding claim 15, modified Kamen teaches the system of claim 14 as described above. Kamen further teaches the following:
one of the menu items, when selected, initiates a HypoProtect mode that suspends delivery of the medication for a user-specified duration. Karmen teaches in paragraph [0417], a user may design a therapy to be used when eating a specific food. Karmen further teaches in paragraph [0408] that a temporary basal rate may be related to certain events (such as consumption of selected food), set for a pre-defined time-frame, and may set a temporary basal rate of 0 units per hour (suspend delivery).
Regarding claim 16, modified Kamen teaches the system of claim 15 as described above. Kamen further teaches the following:
when HypoProtect mode is enabled, the graphical user interface displays a HypoProtect mode indicia in the informational area of the default screen. As Kamen shows in Fig. 28C, 2828, a pump activity indicator is shown, and would thus relay to the user that the pump is idle while a basal rate of 0 is set.
Regarding claim 20, modified Kamen teaches the system of claim 14. However, Kamen does not explicitly teach of displaying a history of delivery of medication and a timeline of events. Hayter teaches the following:
one of the menu items, when selected, causes the graphical user interface to display a history of the delivery of the medication and a timeline of events. As Hayter teaches in paragraph [0155], and corresponding Fig. 5A, a group of logged meals are presented. Hayter teaches in paragraph [0160], and corresponding Fig. 5B, that selection of a meal causes display of a graph of glucose readings surrounding the meal event, i.e., a history of delivery (glucose readings) and timeline of events (graph of said readings).
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have further modified the food logs of Kamen with the historical presentation data of Hayter. One of ordinary skill would have been motivated to have made such modification because as Hayter teaches in paragraph [0009], such presentation would benefit a user in improved correlation between meals and analyte levels.
Regarding claim 21, modified Kamen teaches the system of claim 14 as described above. Kamen further teaches the following:
one of the menu items, when selected, causes the graphical user interface to display screens allowing the user to switch between the automated mode and the manual mode. Kamen in view of Hayter teaches of selectable food items as described with respect to claim 14. Kamen shows in Fig. 28D, 2836, that a control may be displayed which allows a user to turn off a Basal, thus switching between automated and manual.
Claim(s) 19, 23, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Mensinger in view of Khatib in view of Horelik as applied to claim 1 above, and further in view of Goodnow et al. (US 2006/0010098), hereinafter Goodnow.
Regarding claim 19, modified Kamen teaches the system of claim 1 as described above. However, Kamen does not explicitly teach of allowing the user to set and enter the PIN. In a similar field of endeavor, Goodnow teaches of user interfaces for diabetes management (see abstract). Goodnow further teaches the following:
access to the user application requires entry of a user PIN and further wherein the graphical user interface includes screens allowing the user to set and enter the PIN. As Goodnow shows in Figs. 12 and 13, and corresponding paragraph [0229], a user may set security to require a password, and set said password.
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have modified the user data of Kamen with the password setting of Goodnow. One of ordinary skill would have been motivated to have made such modification because Kamen teaches in paragraph [0439], interface access may be password protected, and allowing users to set their password benefits users in selecting a password which is memorable to them.
Regarding claim 23, modified Kamen teaches the system of claim 1 as described above. However, Kamen does not explicitly teach of a list of people authorized to view data and adding new people to said list. In a similar field of endeavor, Goodnow teaches of user interfaces for diabetes management (see abstract). Goodnow further teaches the following:
the graphical user interface includes a screen allowing the viewing of a list of people authorized to view data generated by the user application and a screen allowing the adding of new authorized people. As Goodnow teaches in paragraph [0409], and corresponding Figs. 167-169, a user may manage a list of authorized home care providers that may access the user’s data, as well as invite new providers to accept said access.
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have modified the user data of Kamen with the access list of Goodnow. One of ordinary skill would have been motivated to have made such modification because Kamen shows a clear desire to protect user privacy in paragraph [0415], where password protection is implemented, and the access lists of Goodnow would improve the protection of said privacy.
Regarding claim 24, modified Kamen teaches the system of claim 1 as described above. However, Kamen does not explicitly teach of a screen allowing sending of log files to a care facility. In a similar field of endeavor, Goodnow teaches of user interfaces for diabetes management (see abstract). Goodnow further teaches the following:
the user application generating one or more log files, wherein the graphical user interface includes a screen allowing the sending of the one or more log files to a customer care facility. As Goodnow teaches in paragraphs [0217] and [0218], a user may share data with care professionals through synchronization on a host server. Goodnow further shows in Fig. 168 of a user option to “synchronize” which suggests a manual command to transmit files for synchronization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of applicant’s claimed invention to have modified the user data of Kamen with the synchronization of Goodnow. One of ordinary skill would have been motivated to have made such modification because as Goodnow teaches in paragraph [0008], such synchronization benefits users in management of a diabetic condition.
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 GREGORY A DISTEFANO whose telephone number is (571)270-1644. The examiner can normally be reached Monday - Friday: 9 am - 5 pm.
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/GREGORY A. DISTEFANO/
Examiner
Art Unit 2174
/WILLIAM L BASHORE/ Supervisory Patent Examiner, Art Unit 2174