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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1 and dependents is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 1, Applicant recites “cause the processor to: repeatedly determine a value for a control parameter of a fluid infusion pump based on patient data stored in a database and on a standard scheme” [emphasis added]. It is unclear if these “a value”, “a control parameter”, “a fluid infusion pump”, “patient data”, “a database” and “a standard scheme” are same or different from the items originally introduced in Clause 1 of Claim1.
Regarding Claim 1, Applicant recites “cause the processor to:… display the user interface comprising the welcome screen and the at least a further screen displayable following an interaction with the patient”. However, no “user interface” and “welcome screen” have been previously introduced in the claims. It is unclear if these are the same or different from the elements later introduced in Clause 6 of Claim 1. Similarly Clause 6 makes reference to “a further screen” and “an interaction with the patient”, where it is unclear if these elements are the same or different from those introduced in Clause 4 of Claim 1.
Regarding Claim 13, Applicant likewise creates confusion by referencing (in Clause 3) “a value for a control parameter of a fluid infusion pump based on patient data stored in a database and on a standard scheme” whereas these elements are separately recited also using indefinite articles in Claims 1 of Claim 13.
Regarding Claim 13, Applicant (in Clause 5) makes reference to “a user interface” when Clause 4 makes reference to “a user interface” such that it is unclear if these “a user interface(s)” are necessarily the same user interface.
Regarding Claim 1, Applicant recites “wherein actuation of the actuable button within the temporary period causes…” [emphasis added]. However, such a recitation is indefinite as no “temporary period” has been previously introduced in the claims. It is unclear if this “temporary period” is the same or different from the “a predefined temporary lapse in time into a temporary scheme” or some new and different “temporary period” which may not necessarily be coextensive with the claimed “predefined temporary lapse in time”. As such, the metes and bounds of the “temporary period” cannot possibly be determined. Without being able to determine the metes and bounds of the “temporary period” it becomes impossible to determine the scope of the events caused by actuation of the actuable button during this period including “automatically stopping the temporary scheme”, “prolonging the temporary period” (again reference to “the temporary period” is problematic particularly as it pertains to “prolonging” an indefinite period), and “nothing”.
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.
Claim(s) 1-6 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0203038 (“Desborough”) in view of U.S. Publication No. 2019/0125969 (“Montgomery”) and U.S. Publication No. 2007/0060871 (“Istoc”).
Regarding Claim 1, Desborough discloses a computerized device (60, 200) for repeatedly determining a command to control the infusion of fluid in a diabetic patient (Abstract), wherein then computerized device comprises:
A processor (Par. 63, 179) adapted to repeatedly determine a value for a control parameter of a fluid infusion pump based on patient data stored in a database and on a standard scheme (Abstract; Par. 4, 40, 118),
a non-transitory computer-readable medium storing instructions that, when executed by the processor, perform functions of the computerized device including, but not limited to, repeatedly determine a value for a control parameter of a fluid infusion pump based on patient data stored in a database as part of a standard scheme (Abstract; Par. 4, 40, 118, 217); and
display a user interface (see Fig. 1 – at 60; Par. 56, 103) comprising a first screen and at least a further screen displayable following an interaction of the patient with the first screen (see e.g. Fig. 4, Fig. 8, Fig. 9; Par. 168, 199, 207),
wherein the first screen comprises an actuatable button adapted to, when actuated, amend the standard scheme for a predefined temporary lapse of time into a temporary scheme (Par. 47, 52, 55, 64, 207), the target being selectable by any of “radio buttons, check boxes, hyperlinked images/text, drop-down list, etc.” to permit user selection of the temporary schemes (Par. 119), wherein the temporary scheme is designed to account for changes in behavior that necessitate a different blood glucose level target such as exercise, sleep, driving a car for extended periods of time…etc. (Par. 118, 161, 207).
Desborough does not explicitly illustrate this UI to completely resolve the actuation of buttons (virtual buttons being understood to be permissive) to amend the programming – although such a UI does intimate such user input buttons for the user to interact with the selection interface. Such UI selection buttons are well-known. For example, Montgomery discloses a screen (3600) which presents a pressable button (see i.e. the virtual toggle slides as well as button 1218 – see Fig. 25) which is actuated to activate temporary target schemes (Par. 109, 115-119). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to provide the interface of Desborough with a user actuatable button which when pressed will activate the temporary scheme, as disclosed by Montgomery, in order to provide a suitable interface for permitting user interaction with the UI to perform the desired adjustments.
Desborough fails to explicitly disclose that the temporary target button is provided on a “welcome” screen, e.g. the default display screen or dashboard. Montgomery does disclose that such control interfaces may include a welcome screen (1200; see Fig. 12) wherein the screen may include an add event button (1218) for accessing a submenu (2502, 3600; Par. 109, 115-119) to select a temporary target mode such as exercise, sleep, or other temporary targets. In the instant case Examiner submits that the claim is written sufficiently broad so as to encompass the function of main “add event” button (1218) even though additional button presses are necessary to finalize the temporary target. Specifically, while other button presses are necessary, ultimately the function of button (1218) is first necessary to be actuated in order to amend the standard scheme to the temporary scheme. It would have been obvious for one having ordinary skill before the effective filing date of the claimed invention to place a button (1218) on the welcome/dashboard screen of Desborough which is actuated in order to affect the implementation of the temporary target scheme, as disclosed by Montgomery, in order to allow the user to navigate the UI in a predictable manner to access necessary subroutines.
However, should Examiner’s arguments not be found persuasive concerning multiple button presses being permitted by the claims the following is presented. As discussed above, Montgomery provides support for adding events (1904a-1904d) to the dashboard/welcome screen (Fig. 19C, 19F; Par. 109) to permit the user to interact with the events to adjust them (see e.g. Fig. 37A, 39A) – although these events are not added until already active and therefore the use of the added particular event buttons is only used to edit or deactivate the event, not begin the event.
However, Istoc discloses a related insulin pump interface welcome/dashboard screen (Fig. 1) wherein the icons present on the user interface can be customized by the user (Par. 37) to allow display of modes such as exercise and sleep (which alter the blood glucose target), favorites, most recent…etc. higher in the UI as part of user preference. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to permit a user to locate a toggle button for activating frequently used events for activating a temporary target scheme (e.g. sleep, exercise, or other FHI targets) on the dashboard/welcome screen of Desborough itself, in order to allow quick access to frequently used routines to increase the speed of navigation as a product of menu/interface customization as disclosed by Istoc. Examiner submits that the exact arrangement/location of the necessary buttons of the UI is a product of obvious design choice based upon user preference and locating any buttons higher or lower in the interface would have been obvious for the ordinary artisan to achieve only a predictable and expected outcome, i.e. allowing a menu option to be more visible by placing it higher in the menu when it is regularly used.
Desborough discloses the invention substantially as claimed except that actuation of the actuatable button within a temporary period causes one of:
automatically stopping the temporary scheme;
nothing; or
prolonging the temporary period.
However, Montgomery, as discussed above, provides a welcome screen (3600) with pressable buttons to select a temporary scheme, wherein a second pressing of the button can stop the temporary scheme (i.e. toggle it from on back to off – see Par. 119). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the UI of Desborough to permit cancelation of the temporary scheme upon a second press of the button, as disclosed by Montgomery, in order to allow a user to resume standard function should the temporary scheme no longer be desired.
Regarding Claim 2, Desborough discloses the temporary scheme is adapted, upon application, to determine a value for the control parameter which reduces the risk of hypoglycemia compared to the value of the control parameter determined by the standard scheme (Par. 64, 67).
Regarding Claim 3, Desborough discloses the standard scheme is adapted to determine a value for the control parameter which maximizes the likelihood of a predicted blood glucose value predicted by the standard scheme to be close to a pre-defined target (Par. 4, 8, 25; 600).
Regarding Claim 4, Desborough discloses wherein the temporary scheme defines a temporary target higher than the pre-defined target (Par. 64).
Regarding Claim 5, Desborough discloses the standard scheme comprises an auto-learned model (see Fig. 2 – see at 264, 261, 271, 183, 263; Par. 92, 110).
Regarding Claim 6, Desborough discloses actuation of the actuatable button triggers a clock measuring the time spent from the time of actuation (Abstract; Par. 162, i.e. the override to the new target is described as “temporary” and providing an override for a “temporary time period”, which necessarily requires the device to monitor time, i.e. a clock measuring the time spent from the time of actuation).
Regarding Claim 8, Desborough discloses, in some instances, the temporary scheme is not parametrizable by the patient (re: in some instances the user may parameterize a select the target average blood glucose level, particularly, but in other instances the selection is made as an abstract, non-parameterized variable by the user – e.g. an “aggressiveness index” – see Par. 119, 200, in contrast to particularly adjusting the parameter directly).
Regarding Claim 9, Desborough discloses a system (Fig. 1) for repeatedly determining a command to control the infusion of fluid in a diabetic patient, where in the system comprises a data acquisition system (e.g. 50) and a computerized device (60, 200), wherein data of the database was acquired by the data acquisition system.
Regarding Claim 10, Desborough discloses a system (Fig. 1) for controlling the infusion of fluid in a diabetic patient comprising a computerized device (60, 200), and wherein the system further comprises an active system receiving the value for the control parameter from the computerized device, and infusing fluid into the patient based on this value (100, 146 – Par. 105).
Claim(s) 13-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0203038 (“Desborough”) in view of U.S. Publication No. 2019/0125969 (“Montgomery”), U.S. Publication No. 2007/0060871 (“Istoc”), and U.S. Publication No. 2011/0296354 (“Zambetti”).
Regarding Claim 13, Desborough discloses a computerized device (60, 200) for controlling infusion of a fluid in a diabetic patient (Abstract), the computerized device comprising:
A processor (Par. 63, 179) configured to repeatedly determine a value for a control parameter of a fluid infusion pump based on patient data stored in a database and on a standard scheme (Abstract; Par. 4, 40, 118);
A non-transitory computer-readable medium storing instructions that, when executed by the processor, cause the processor to (Par. 217):
repeatedly determine a value for a control parameter of a fluid infusion pump based on patient data stored in a database and on a standard scheme(Abstract; Par. 4, 40, 118); and
display a user interface (Fig. 1 – at 60; Par. 56, 103) comprising first screen and at least a further screen displayable following an interaction of the patient with the first screen (see e.g. Fig. 4, 8, 9; Par. 168, 199, 207);
a user interface (see Fig. 1 – at 60; Par. 56, 103) comprising the first screen and at least the further screen displayable following an interaction of the patient with the first screen (see e.g. Fig. 4, Fig. 8, Fig. 9; Par. 168, 199, 207),
wherein the first screen comprises an actuatable button adapted to, when actuated, amend the standard scheme for a predefined temporary lapse of time into a temporary scheme (Par. 47, 52, 55, 64, 207), the target being selectable by any of “radio buttons, check boxes, hyperlinked images/text, drop-down list, etc.” to permit user selection of the temporary schemes (Par. 119), wherein the temporary scheme is designed to account for changes in behavior that necessitate a different blood glucose level target such as exercise, sleep, driving a car for extended periods of time…etc. (Par. 118, 161, 207).
Desborough does not explicitly illustrate this UI to completely resolve the actuation of buttons (virtual buttons being understood to be permissive) to amend the programming – although such a UI does intimate such user input buttons for the user to interact with the selection interface. Such UI selection buttons are well-known. For example, Montgomery discloses a screen (3600) which presents a pressable button (see i.e. the virtual toggle slides as well as button 1218 – see Fig. 25) which is actuated to activate temporary target schemes (Par. 109, 115-119). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to provide the interface of Desborough with a user actuatable button which when pressed will activate the temporary scheme, as disclosed by Montgomery, in order to provide a suitable interface for permitting user interaction with the UI to perform the desired adjustments.
Desborough fails to explicitly disclose that the temporary target button is provided on a “welcome” screen, e.g. the default display screen or dashboard. Montgomery does disclose that such control interfaces may include a welcome screen (1200; see Fig. 12) wherein the screen may include an add event button (1218) for accessing a submenu (2502, 3600; Par. 109, 115-119) to select a temporary target mode such as exercise, sleep, or other temporary targets. In the instant case Examiner submits that the claim is written sufficiently broad so as to encompass the function of main “add event” button (1218) even though additional button presses are necessary to finalize the temporary target. Specifically, while other button presses are necessary, ultimately the function of button (1218) is first necessary to be actuated in order to amend the standard scheme to the temporary scheme. It would have been obvious for one having ordinary skill before the effective filing date of the claimed invention to place a button (1218) on the welcome/dashboard screen of Desborough which is actuated in order to affect the implementation of the temporary target scheme, as disclosed by Montgomery, in order to allow the user to navigate the UI in a predictable manner to access necessary subroutines.
However, should Examiner’s arguments not be found persuasive concerning multiple button presses being permitted by the claims the following is presented. As discussed above, Montgomery provides support for adding events (1904a-1904d) to the dashboard/welcome screen (Fig. 19C, 19F; Par. 109) to permit the user to interact with the events to adjust them (see e.g. Fig. 37A, 39A) – although these events are not added until already active and therefore the use of the added particular event buttons is only used to edit or deactivate the event, not begin the event.
However, Istoc discloses a related insulin pump interface welcome/dashboard screen (Fig. 1) wherein the icons present on the user interface can be customized by the user (Par. 37) to allow display of modes such as exercise and sleep (which alter the blood glucose target), favorites, most recent…etc. higher in the UI as part of user preference. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to permit a user to locate a toggle button for activating frequently used events for activating a temporary target scheme (e.g. sleep, exercise, or other FHI targets) on the dashboard/welcome screen of Desborough itself, in order to allow quick access to frequently used routines to increase the speed of navigation as a product of menu/interface customization as disclosed by Istoc. Examiner submits that the exact arrangement/location of the necessary buttons of the UI is a product of obvious design choice based upon user preference and locating any buttons higher or lower in the interface would have been obvious for the ordinary artisan to achieve only a predictable and expected outcome, i.e. allowing a menu option to be more visible by placing it higher in the menu when it is regularly used.
Desborough, as modified, discloses the invention substantially as claimed except that that the welcome screen is a default screen of the user interface that is displayed when the computerized device has been in an idle state for a predefined duration. Rather, Montgomery only specifically envisages the screen as a default “dashboard” without any indication as to whether or not the display reverts to this default dashboard after an idle state has been achieved during a predefined duration. However, Zambetti discloses a menu construction and user interface display which is programmed to automatically revert to the default landing screen/dashboard after some predetermined period of activity (Par. 144). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the user interface of modified Desborough to display the default dashboard welcome screen upon an idle state being achieved during a predefined duration, as disclosed by Zambetti, thereby allowing the user interface to revert back into the higher menu hierarchy after a period of inactivity to allow the user to be presented with the most relevant menu options for changing the currently programmed parameters of the system as opposed to being limited to a submenu display requiring additional navigation to get back to the main dashboard level.
Regarding Claim 14, Desborough discloses the temporary scheme is adapted, upon application, to determine a value for the control parameter which reduces the risk of hypoglycemia compared to the value of the control parameter determined by the standard scheme (Par. 64, 67).
Regarding Claim 15, Desborough discloses the standard scheme is adapted to determine a value for the control parameter which maximizes the likelihood of a predicted blood glucose value predicted by the standard scheme to be close to a pre-defined target (Par. 4, 8, 25; 600).
Regarding Claim 16, Desborough discloses wherein the temporary scheme defines a temporary target higher than the pre-defined target (Par. 64).
Regarding Claim 17, Desborough discloses the standard scheme comprises an auto-learned model (see Fig. 2 – see at 264, 261, 271, 183, 263; Par. 92, 110).
Regarding Claim 18, Desborough discloses actuation of the actuatable button triggers a clock measuring the time spent from the time of actuation (Abstract; Par. 162, i.e. the override to the new target is described as “temporary” and providing an override for a “temporary time period”, which necessarily requires the device to monitor time, i.e. a clock measuring the time spent from the time of actuation).
Regarding Claim 19, Desborough, as modified, discloses the invention substantially as claimed except that actuation of the actuatable button within the temporary period causes one of:
automatically stopping the temporary scheme;
nothing; or
prolonging the temporary period.
However, Montgomery, as discussed above, provides a welcome screen (3600) with pressable buttons to select a temporary scheme, wherein a second pressing of the button can stop the temporary scheme (i.e. toggle it from on back to off – see Par. 119). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the UI of Desborough to permit cancelation of the temporary scheme upon a second press of the button, as disclosed by Montgomery, in order to allow a user to resume standard function should the temporary scheme no longer be desired.
Regarding Claim 20, Desborough discloses, in some instances, the temporary scheme is not parametrizable by the patient (re: in some instances the user may parameterize a select the target average blood glucose level, particularly, but in other instances the selection is made as an abstract, non-parameterized variable by the user – e.g. an “aggressiveness index” – see Par. 119, 200, in contrast to particularly adjusting the parameter directly).
Regarding Claim 21, Desborough discloses a system (Fig. 1) for repeatedly determining a command to control the infusion of fluid in a diabetic patient, where in the system comprises a data acquisition system (e.g. 50) and a computerized device (60, 200), wherein data of the database was acquired by the data acquisition system.
Regarding Claim 22, Desborough discloses a system (Fig. 1) for controlling the infusion of fluid in a diabetic patient comprising a computerized device (60, 200), and wherein the system further comprises an active system receiving the value for the control parameter from the computerized device, and infusing fluid into the patient based on this value (100, 146 – Par. 105).
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive or are moot in view of the new ground(s) of rejection.
Applicant argues (Pg. 7) that “actuation of button 1218, however, does not amend any delivery scheme”. However, this is not persuasive. Firstly, Examiner notes that providing a user input to allow the system to enter an amended delivery scheme is not provided by Montgomery alone, but must be made in consideration of disclosure by Desborough as to entering of temporary schemes (Par. 47, 52, 55, 64) via user input at a user interface including (radio buttons, check boxes, hyperlinked images/text, drop-down lists…etc. – Par. 119).
Furthermore, in Montgomery actuation of button 1218 is an “event button” which causes the user interface to navigate the operating system to a submenu system (see 2502, 3600; Par. 109, 115-119) which permits selection by the user of a variety of temporary target modes for amended delivery schemes in accordance with exercise, sleep, or other temporary target parameters. While additional button presses would be necessary to fully navigate to the amended profiles (see Fig. 25 where button 1218 is pressed, followed by selection of “Temporary Targets” 2508 in the drop down menu, followed by input to select the specifically targeted event amended profile in Fig. 36A to toggle the events/amended schemes off and on) Examiner submits that the open transitional “comprising” is permissive to additional button presses (other than simply that of button 1218) to ultimately activate them. Specifically, as long as button (1218) is necessary for access to these amended settings at the top level, it arguably satisfies the metes and bounds of the broadest reasonable interpretation of “an actuable button adapted to, when actuated, amend the standard scheme…” since actuation of the actuable button is clearly necessary to access the root menus for enacting the temporary schemes.
Further consideration must be made in adaptation of the system in obvious and predictable manners as typified by Istoc to provide, on a main dashboard, shortcuts to favorite and most recent settings and modes which when combined with disclosure by Montgomery of emplacing mode toggle icons/buttons to toggle event schemes on the main dashboard (see 3602 – Fig. 36B) would obviate the modification of the user interface of Desborough to provide selectable shortcut buttons directly on the home screen that allow a user to toggle commonly used or favorite amended event modes such as exercise, sleep…etc. thereby allowing these modes to be toggled both OFF and ON directly from the welcome dashboard to allow them to be quickly activated without any additional navigation through root menus. In performing such modification the button (see e.g. 3602 of Montgomery) will be located on the main welcome screen and conditioned to toggle the event on with a first press and off with a second press (see generally replicating the operation of the respective sliders in root menu Fig. 36A and the function of the icon 3602 – Par. 109, 119, Montgomery).
It other words, the totality of the prior art obviates the modification of the welcome dashboard of Desborough to have quick access shortcuts provided thereon which allow the direct activation of temporary schemes (e.g. exercise, sleep…etc.) directly on the welcome dashboard via first button press of the icon and then permit a user to turn the scheme off via a second button press. Again such a modification to the user interface will present only the expected and predictable results, as directed by the prior art, of providing an easily accessible mode shortcut to allow the user to quickly activate or deactivate preferred and commonly used protocols without requiring additional button presses and root menu navigation.
Consideration of the new claims is made through further modification in view of Zambetti which relatedly applies to menu and user interface display navigation in interactive menus/displays.
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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/30/2026
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