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 .
Election/Restrictions
Claim(s) 11 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02 December 2025 electing the invention of Group I, Claims 1-10.
The traversal is on the ground(s) that Claim 11 now effectively claims the specific software component require to drive the specific hardware recited in Claim 1. This is not found persuasive. Firstly, Examiner asserts that as detailed in the prior art rejection below, since the shared subject matter fails to avoid the prior art the inventions of Group I and II lack unity. This requirement is made under the Unity of Invention requirement and unity has been demonstrated to be lacking since the shared subject matter between the two inventions fails to avoid the prior art.
Furthermore, while Claim 11 makes reference to Claim 1, but is not dependent thereupon inasmuch as it does not require all the particulars of Claim 1 ( e.g. the processor), Claim 11 being directed toward ONLY the computer readable media and the instructions contained thereupon. Furthermore, as detailed below with respect to the rejection of Claim 1 over 35 USC 112(b) there is concern over what “functions” the computer-readable medium instructions are actually configured to perform creating additional differences between the subject matter of the two claims. The broadest reasonable interpretation of the software of Claim 1 would be non-transitory computer readable media which performs some non-description functions and not necessarily the functions recited in association with Claim 11. As such, the shared technical feature would logically present ONLY as software with functional instructions, a notoriously well-known feature that cannot be considered a special technical feature.
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 Claim 1, Applicant recites the limitation “a non-transitory computer-readable medium storing instructions that, when executed by the processor, perform the functions of the computerized device”. However, this limitation renders the claim indefinite because no specific function or group of functions has been particularly enumerated. It is unclear if “the functions” includes ANY and ALL functions which would be performed by the “computerized device” including those which would ordinarily be performed by a clinician/user/programmer, functions which might be performed by a co-processor, high level functions (e.g. a BIOS or bootloader) which are responsible for initiating an initial booting of the computer system prior to loading of operative instructions…etc. OR if the function(s) are limited to those functions explicitly introduced in the earlier body of the claim (RE: the “standard scheme” and “repeatedly determine a value for a control parameter…etc.) OR if the functions(s) are limited to those functions specifically enumerated in the claim including BOTH preceding and following functions(s) (e.g. further including the “welcome screen”, “further screen displayable following an interaction of the patient with the welcome screen”, the “actuatable button…”…etc.
As such, the ordinary artisan would not be able to clearly and particularly determine what specific “functions” must be present on the claimed non-transitory computer-readable medium.
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) 1-10 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 the functions of the computerized device (Par. 217);
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.
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 7, Desborough 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 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).
Conclusion
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 01/20/2026