DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 16, 2026 has been entered.
Claims 2-5, 7-12, 14-15, 17 remain pending in the application. Claims 1, 6, 13, and 16 were previously cancelled.
Claim Objections
Claim 1 is objected to because of the following informalities: there appears to be a typo regarding “a prediction horizon bounded prediction horizon” in line 13, as opposed to “a bounded prediction horizon”. Appropriate correction is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-5 and 7-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Estes (US 2010/0094251), herein after Estes 2010, in view of Hayes et al. (USPN 7547281), in further view of Estes (US 2003/0114836), hereinafter Estes 2003, in further view of Mandro et al. (US 2011/0040247), and further in view of Budiman et al. (US 2010/0298765).
Regarding claim 2, Estes 2010 discloses a medical infusion pump system (infusion pump system 10), comprising: a controller (controller device 200) that communicates insulin delivery instructions (“the system may also include a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing” [0004]; "The control circuitry 240 can be programmable in that the user may provide one or more instructions to adjust a number of settings for the operation of the infusion pump system 10. Such settings may be stored in the one or more memory devices, such as the memory chip 248 on the processor board 242" [0077]) including basal insulin instructions and bolus insulin instructions (“the pump assembly 60 can operate to deliver insulin to the user by basal dosages, selected bolus dosages, or a combination thereof” [0086], see all of [0086]), the controller adapted to receive user commands to deliver a bolus (“infusion pump system 10 can be configured to supply scheduled basal dosages of insulin (or other medication) along with user-selected bolus dosages.” [0039]), the controller comprising a user interface (user interface 220); a monitoring device (monitoring device 50) that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user (“glucose monitoring device 50 can be in communication with the infusion pump assembly 60 for the purpose of supplying data indicative of a user's blood glucose level to a controller device 200” [0038]); and a pump (pump device 100 of pump assembly 60) adapted to receive insulin for dispensation to a user, the pump at least partially comprising a pump drive system (drive system 300) configured to dispense the insulin through a flow path (tubing 72) to the user responsive to the insulin delivery instructions (“The system may also include a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing,” [0004]); wherein the controller is configured to: predict a future blood glucose level of the user (“calculated TIL value can be used to, for example, predict future blood glucose levels” [0107]) based at least in part upon a food-on-board value, a carbohydrate ratio, and an insulin load of the user (“the process 400 for the determining of the TIL of a user can include a number of operations performed by the controller device 200…the TIL value can be calculated based on two or (optionally) three components: a bolus insulin load component, a basal insulin load component, and (optionally) a previous food component.” [0089]; “the process 400 may include operation 420 in which the previous food component is employed in the TIL calculation…The previous food component can be determined, for example, by estimating the amount of carbohydrates that have been consumed but not yet metabolized…When this yet-to-be-metabolized carbohydrate value is estimated, it can be treated as a "negative" insulin component in the TIL calculation by multiplying the yet-to-be-metabolized carbohydrate value by a carbohydrate ratio” [0092]), wherein the insulin load of the user is an estimated value of previously dispensed insulin that has not yet acted in the user indicative of both bolus insulin dosages and basal insulin dosages that have been dispensed but not yet acted in the user, the food-on-board value being indicative of previous food intake by the user that has not yet metabolized in the user (“the TIL values may accurately reflect both the previously dispensed insulin that has not yet acted and the previously consumed food that has not yet been metabolized.” [0109]).
Estes 2010 fails to explicitly disclose the controller is configured to predict a future blood glucose level of the user based at least in part upon a recent blood glucose level, a trend of blood glucose levels over time, a prediction horizon bounded prediction horizon selectable from a range between 5 and 60 minutes, and an insulin sensitivity value; use the predicted future blood glucose level to make changes to the insulin delivery instructions including increases to or decreases to a basal insulin dosage; in response to the predicted future blood glucose level of the user being below a lower level threshold, automatically cancel any remaining bolus and indicating an amount of bolus that was missed, and operate in a low blood glucose recovery mode in response to the predicted future blood glucose level of the user being below the lower level threshold, wherein while in the low blood glucose recovery mode, basal delivery is reduced without completely stopping basal flow and a bolus programming function of the controller is disabled, preventing the user from programming a bolus delivery; output a message to a user interface of the controller indicating that the controller is operating in a low blood glucose recovery mode.
Hayes teaches a medical infusion pump system (infusion device 10) comprising a controller (processor 18) that communicates basal insulin instructions (“the processor (controller) may recommend resumption of fluid delivery, i.e. basal delivery.” [Col 12, line 10-12]) and bolus insulin instructions (“To deliver a bolus with the keypad the user uses the keypad 24 and keys 108, 110, 112 and/or 114 to can program and/or deliver one or more bolus types through a single touch key or by the use of one or more menus.” [Col 4, line 45-48]); the controller configured to predict the future blood glucose level of the user (“future BG values are obtained (and/or predicted) by using the derivative of the current BG value as described by the derivative predicted algorithm” [Col 6, line 6]) based at least in part upon a recent blood glucose level of a user (“the algorithm may utilize parameters inputted by the patient and/or default parameters stored in the processor (controller). Patient defined parameters may include…current blood glucose concentrations (BG)” [Col 6, line 24]), a trend of blood glucose levels over time (“utilize the traditional algorithm plus a modification of insulin intake using a glucose trend” [Col 9, line 61]), a food-on-board value ("the derivative predicted algorithm may also compute food corrections” [Col 5, line 60]), a prediction horizon bounded prediction horizon selectable from a range between 5 and 60 minutes (“Further embodiments may use predicted sensor readings to determine if low blood glucose levels (i.e. hypoglycemia) will be present a specified amount of time in the future. In these embodiments, sensor-derived trends are utilized to determine low blood glucose levels occurring in the future. The sensor-derived trends may be obtained by utilizing the derivative predicted algorithm described above. The processor (controller) of the infusion device may use current sensor readings to predict sensor readings that will occur a certain amount of time in the future, i.e., fifteen minutes--thus yielding a derivative corrected blood glucose reading…In alternative embodiments, longer times, such as thirty minutes, one hour, several hours, or days, and/or shorter times, such as one minute, five minutes, 10 minutes, or the like may be used with the time set to meet the patient's particular needs and provide safety.” [Col 11, lines 41-63]), insulin sensitivity value and an insulin load of the user (“the algorithm may utilize parameters inputted by the patient and/or default parameters stored in the processor (controller). Patient defined parameters may include… insulin-on-board…additional parameters may be inputted to the infusion device by the patient including insulin sensitivity)” [Col 6, line 21-34]); use the predicted future blood glucose level to make changes to the insulin delivery instructions including increases to or decreases to a basal insulin dosage (“if a predicted sensor-derived blood glucose level falls below a low-shutoff threshold, the infusion device will go into a suspend mode.” [Col 11, line 52]; “in an insulin based infusion system for a diabetic patient, if the sensor detects a low blood glucose level (i.e. hypoglycemia) over a designated period of sensor readings, the infusion device may stop insulin delivery entirely and alert the patient by going into a normal suspend mode” [Col 11, line 23]); in response to the predicted future blood glucose level of the user being below a lower level threshold, automatically cancel any remaining bolus (“the infusion device suspends fluid delivery when a future blood glucose level falls below the predefined low shutoff threshold.” [Col 1, line 62-64], wherein in suspend mode, all insulin deliver including current bolus infusion is stopped), and operate in a low blood glucose recovery mode (“suspend mode” [Col 11, line 54]) in response to the predicted future blood glucose level of the user being below a lower level threshold, wherein while in the low blood glucose recovery mode, basal delivery is reduced (“if a predicted sensor-derived blood glucose level falls below a low-shutoff threshold, the infusion device will go into a suspend mode.” [Col 11, line 52]; “the infusion device suspends fluid delivery when a future blood glucose level falls below the predefined low shutoff threshold.” [Col 1, line 62-64]; “the infusion device is capable of automatically suspending and resuming fluid delivery based on future blood glucose levels and the patient's predefined low shutoff threshold” [Claim 1]; Noted that as disclosed, when in a suspend mode, all insulin delivery including basal delivery is stopped. If the basal delivery is stopped, it has been reduced); output a message to a user interface (keypad 24 and LCD 28) of the controller indicating that the controller is operating in a low glucose recovery mode (“if a predicted sensor-derived blood glucose level falls below a low-shutoff threshold, the infusion device will go into a suspend mode. Similar to the previous embodiment, this suspend mode may provide alerts to the patient.” [Col 11, line 52]; “the infusion system includes alarm based capabilities to provide alerts to the patient. In some embodiments, the patient selects at least one alarm to activate, and the at least one alarm includes an audible alarm for providing audible alerts, a vibration alarm for providing tactile alert, and a visual alarm for providing visual alerts.” [Col 2, lines 4-11]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the system of Estes 2010 to include that the controller is configured to predict the future blood glucose level based upon a recent blood glucose level, a trend of blood glucose levels, a food-on-board value, a prediction horizon bounded prediction horizon selectable from a range between 5 and 60 minutes, insulin sensitive value, and an insulin load, use the predicted future blood glucose level to make changes to the insulin delivery instructions including increases to or decreases to a basal insulin dosage; in response to the predicted future blood glucose level being below a lower level threshold, automatically cancel any remaining bolus, and operate in a low blood glucose recovery mode in response to the predicted future blood glucose level being below a lower level threshold, wherein while in the low blood glucose recovery mode, basal delivery is reduced; and output a message to the user interface indicating that the controller is operating in a low glucose recovery mode based on the teachings of Hayes to allow for more accurate predictions of future blood glucose levels (Hayes [Col 9, line 63]) and prevent hypoglycemia (Hayes [Col 11, line 42]).
Modified Estes 2010 fails to explicitly disclose the controller is configured to indicate an amount of bolus that was missed; and wherein while in the low blood glucose recovery mode, basal delivery is reduced without completely stopping basal flow and a bolus programming function of the controller is disabled, preventing the user from programming a bolus delivery.
Estes 2003 teaches a medical infusion pump system (Figure 1), comprising: a controller (processor 102) that communicates insulin delivery instructions (“a bolus estimator 128 which may operate as an independent unit within the device or as a program run by the processor 102. The bolus estimator 128 can function as a specialized calculator, providing values for estimating the insulin needs of the patient and simplifying the management of the administration of insulin to the patient.” [0031]); wherein the controller is configured to operate in a low blood glucose recovery mode (“blood glucose lockout (a block, requiring a minimum time delay before the bolus may be adjusted to allow the previous estimate to act).” [0031]), wherein while in the low blood glucose recovery mode, a bolus programming function of the controller is disabled, preventing the user from programming a bolus delivery (“As a safety precaution, the user or healthcare professional may also set a Lockout Period, which takes into account the pharmacokinetic effect of insulin when suggesting a bolus. The purpose is to prevent a successive use of a correction bolus when the pharmacokinetic effects of the previous bolus have not yet been accounted for…the lock out period may be automatically calculated based on boluses recently delivered and/or canceled based on new blood glucose (BG) readings.” [0046]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the medical infusion pump system of Estes 2010 having the low blood glucose recovery mode of Hayes to include wherein while in the low blood glucose recovery mode, a bolus programming function of the controller is disabled, preventing the user from programming a bolus delivery based on the teachings of Estes 2003 to prevent overdosing of insulin that could lead to hypoglycemia (Estes 2003 [0046]).
Modified Estes 2010 fails to explicitly disclose the controller is configured to indicate an amount of bolus that was missed, and wherein while in the low blood glucose recovery mode, basal delivery is reduced without completely stopping basal flow.
Mandro teaches a medical infusion pump system (infusion pump assembly 100) comprising a controller (controller assembly 300) configured to cancel any remaining bolus (“a bolus in progress is stopped/cancelled” [0293]) and indicate an amount of bolus that was missed (“In this case, as shown in FIG. 46, where a bolus was stopped/ cancelled, the home screen may indicate the amount delivered as well as the original amount requested” [0294]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the controller of Estes 2010 in view of Hayes to be configured to indicate an amount of bolus that was missed based on the teachings of Mandro ensure that the user is fully informed that the bolus was not completed and how much insulin was delivered prior to entering the low glucose recovery mode (Mandro [0294]).
Modified Estes 2010 fails to explicitly disclose wherein while in the low blood glucose recovery mode, basal delivery is reduced without completely stopping basal flow.
Budiman teaches a medical infusion pump system (Figure 1; “any of the one or more of the medical devices 30, 32 may be implanted within the user's body, coupled externally to the user's body (such as, for example, an infusion pump)” [0041]) comprising a controller operate in a low glucose recovery mode (“if the current IOB and the current CGM measurements indicate the user may be carbohydrate deficient already or trending towards being carbohydrate deficient…the pump may automatically terminate or suspend further delivery of the programmed extended bolus delivery of insulin…The decision to terminate may be arrived at by the processor by programming the processor to consider one or more of the following parameters:…Projected BG Threshold” [0119-0124]) such that basal delivery is reduced without completely stopping basal flow (“In addition to terminating an extended bolus or a temporary basal rate insulin delivery that is higher than programmed basal before the scheduled termination time,…the processor may issue a command to reduce the future basal delivery rate by setting a temporary basal rate to be less than the current programmed basal delivery rate for a selected duration that is either pre-defined, calculated, or defined by the user to allow the user to recover from the carbohydrate deficient state.” [0126]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the controller of the infusion pump system of Estes 2010 to include that while in the low blood glucose recovery mode, basal delivery is reduced without completely stopping basal flow based on the teachings of Budiman to prevent hypoglycemia by gradually allowing the user to recover from a carbohydrate deficient state (Budiman [0119, 0126]).
Regarding claim 3, modified Estes 2010 teaches the system of claim 2, further comprising one or more computer-readable memory devices (memory chip 248) of the controller that store the glucose information received from the monitoring device and time values associated with the glucose information ("The one or more memory devices (e.g., the memory chip 248) can also store information related to a user's blood glucose level and total insulin load (described in more detail in association with FIGS. 11-16B) over a period of time." [0077]).
Regarding claim 4, modified Estes 2010 teaches the system of claim 2, wherein one or more computer-readable memory devices (memory chip 248) of the controller (controller device 200) store computer-readable instructions for a blood glucose prediction process ("The control circuitry 240 can be programmable in that the user may provide one or more instructions to adjust a number of settings for the operation of the infusion pump system 10. Such settings may be stored in the one or more memory devices, such as the memory chip 248 on the processor board 242" [0077]) that, when executed by a processor (processor board 242) of the controller, cause the controller to: calculate the predicted future blood glucose level of the user ("calculated TIL value can be used to predict future blood glucose levels" [0107]; “controller device 200 may implement a process 400 to determine the user's total insulin load)” [0089]) based at least in part upon the insulin load of the user ("the TIL value can be calculated based on two or three components: a bolus insulin load component, a basal insulin load component, and a previous food component." [0089]).
Modified Estes 2010 fails to explicitly teach the computer-readable instructions cause the controller to calculate the predicated future blood glucose level of the user based at least in part upon the recent blood glucose level, the trend of blood glucose levels over time, and the insulin load of the user; determining whether the predicted future blood glucose level is less than a lower threshold value; output an alarm in response to determining that the predicted future blood glucose level is less than the lower threshold value; and operate in the low blood glucose recovery mode in response to user input that confirms an operational change for the controller.
Hayes teaches a medical infusion pump system (infusion device 10) comprising a computer-readable memory device (memory device 22) of a controller (Figure 16) that stores computer-readable instructions that, when executed by the processor (processor 18), cause the controller calculate a predicted future blood glucose level of the user (“future BG values are obtained (and/or predicted) by using the derivative of the current BG value as described by the derivative predicted algorithm” [Col 6, line 6]) based on a recent blood glucose level of a user (“the algorithm may utilize parameters inputted by the patient and/or default parameters stored in the processor (controller). Patient defined parameters may include…current blood glucose concentrations (BG)” [Col 6, line 24]), a trend of blood glucose levels over time (“utilize the traditional algorithm plus a modification of insulin intake using a glucose trend” [Col 9, line 61]), and an insulin load of the user (“the algorithm may utilize parameters inputted by the patient and/or default parameters stored in the processor (controller). Patient defined parameters may include…insulin-on-board)” [Col 6, line 24]), determining whether the predicted future blood glucose level is less than a lower threshold value; output an alarm in response to determining the predicted future blood glucose level is less than a lower threshold value (“if a predicted sensor-derived blood glucose level falls below a low-shutoff threshold, the infusion device will go into a suspend mode. Similar to the previous embodiment, this suspend mode may provide alerts to the patient.” [Col 11, line 52]), and operate in a low blood glucose recovery mode (“if a predicted sensor-derived blood glucose level falls below a low-shutoff threshold, the infusion device will go into a suspend mode.” [Col 11, line 52]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the computer-readable instructions of the infusion pump system of Estes 2010 to include that they cause the controller to calculate the predicted future blood glucose level based upon the recent blood glucose level, the trend of blood glucose levels over time, and the insulin load, determine whether the predicted future blood glucose level is less than a lower threshold value, and output an alarm and operate in the low glucose recovery mode based on the teaching of Hayes to allow for more accurate predictions of future blood glucose levels (Hayes [Col 9, line 63]) while alerting the patient to potential hypoglycemia (Hayes [Col 11, line 42]).
Modified Estes 2010 in view of Hayes in the embodiment described above, fails to explicitly teach the controller operates in the low glucose recovery mode in response to user input that confirms an operational change for the controller.
Hayes, in the embodiment described in Col 10, line 20, teaches a controller that operates in a mode in response to user input confirms an operational change for the controller ("if the recommended delivery amounts exceed or fall below the patient-defined thresholds, the infusion device will provide alarms for too much or too little fluid delivery, followed by displaying the recommendation on the screen for patient input on whether to accept, alter or reject the recommendation” [Col 10, line 33]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the controller of Estes 2010 to include operating in the low glucose recover mode in response to user input based on the teachings of Hayes to allow the user to verify that the recommended change in delivery is proper even when such a modification falls below a defined threshold of the amount of fluid to be delivered, such as when the device enters a suspend mode (Hayes [Col 10, line 30]).
Regarding claim 5, modified Estes 2010 in view of Hayes teaches the system of claim 4, further comprising a user interface (user interface 220) coupled to the controller (Figure 2), the user interface including (i) a display device (display 222) that is configured to provide a visual indication of the alarm (“the display 222 may be used to communicate a number of status indicators, alarms” [0058]) and (ii) a user input device (buttons 224a-d) that is configured to receive user input to activate the controller to operate in a mode (“the user can adjust the settings or otherwise program the controller device 200 by pressing one or more buttons 224a, 224b, 224c, and 224d of the user interface 220." [0059]), wherein the controller is configured to operate in a low blood glucose recovery mode (as provided by Hayes).
Modified Estes 2010 fails to explicitly teach the user input device is configured to receive user input to activate the controller to operate in the low blood glucose recovery mode.
Hayes teaches operating in a mode in response to user input that confirms an operational change for the controller, wherein the mode is the pump delivering an amount of fluid that falls below a threshold ("if the recommended delivery amounts exceed or fall below the patient-defined thresholds, the infusion device will provide alarms for too much or too little fluid delivery, followed by displaying the recommendation on the screen for patient input on whether to accept, alter or reject the recommendation” [Col 10, line 33]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the user input device of the infusion pump system of Estes 2010 to be configured to receive user input to activate the controller to operate in the low blood glucose recovery mode based on the teachings of Hayes to allow the user to verify that the recommended change in delivery is proper even when such a modification falls below a defined threshold of the amount of fluid to be delivered, such as when the device enters a suspend mode (Hayes [Col 10, line 30]).
Regarding claim 7, modified Estes 2010 teaches the system of claim 5.
Modified Estes 2010 fails to explicitly teach wherein, in response to the activation of the controller to operate in the low glucose recovery mode, the controller is configured to exit from the low glucose recovery mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to the lower threshold value.
Hayes teaches an medical infusion pump system (infusion device 10), wherein in response to the activation of the controller to operate in the low glucose recovery mode, the controller is configured to exit from the low glucose recovery mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to the lower threshold value (“When the sensor-derived trends yield a derivative corrected blood glucose level above the low target of the infusion system's target range, the processor (controller) may recommend resumption of fluid delivery, i.e. basal delivery. In further embodiments, the resumption may occur automatically upon the sensor-detected readings and/or sensor-derived trends reaching certain values determined to meet patient needs and safety” [Col 12, line 9]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the infusion pump system of Estes 2010 to include that the controller is configured to exit the low glucose recovery mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to the lower threshold value based on the teachings of Hayes to allow the system to operate as a semi-closed loop infusion system in order to automatically prevent hypoglycemia and hyperglycemia (Hayes [Col 11, line 42]).
Regarding claim 8, modified Estes 2010 teaches the system of claim 4.
Modified Estes 2010 fails to explicitly teach wherein in response to the controller determining that the predicted future blood glucose level is less than the lower threshold value, the controller automatically cancels any previously scheduled bolus amount of insulin to be dispensed from the pump.
Budiman teaches a medical infusion pump system (Figure 1) comprising a controller, wherein in response to the predicted future blood glucose level being less than a lower threshold value, the controller automatically cancels any previously scheduled bolus dosage of insulin to be dispensed from the pump (“the pump may automatically terminate or suspend further delivery of the programmed extended bolus delivery of insulin…The decision to terminate may be arrived at by the processor by programming the processor to consider one or more of the following parameters:…Projected BG Threshold--how soon will the user cross the low BG threshold, that is, what is the estimated time until the user's glucose level crosses the threshold and places the user at risk of hypoglycemia?” [0119-0123]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the infusion pump system of Estes 2010 having the low blood glucose recovery mode of Hayes to include that the controller automatically cancels any previously scheduled bolus dosage of insulin based on the teachings of Budiman to prevent hypoglycemia and allow the user to recover form a carbohydrate deficient state (Budiman [0119, 0126]).
Regarding claim 9, modified Estes 2010 teaches the system of claim 2, wherein the controller comprises a controller housing (controller housing structure 210) that removably attaches to a pump housing (pump housing structure 110) of the pump ("controller housing structure 210 having a number of features that are configured to mate with complementary features of the pump housing structure 110 so as to form a releasable mechanical connection" [0056]), the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing ("mechanical mounting can form an electrical connection between the removable controller device 200 and the pump device 100" [0055]), wherein the controller is a reusable device (“controller device 200 is a reusable component” [0069]) while the pump housing and the pump drive system include a structure (retainer wings 119 on pump device 100) to prevent reuse of the pump housing and the pump drive system ("Because the retainer wings 119 can interfere with attempts to remove the medicine cartridge 120 from the pump device 100, the pump device 100 will be discarded along with the medicine cartridge 120 after the medicine cartridge 120 is emptied, expired, or otherwise exhausted." [0053]).
Regarding claim 10, modified Estes 2010 teaches the system of claim 2, wherein the pump defines an opening (cavity 116) that slidably receives a prefilled cartridge of the insulin ("pump device 100 includes a housing structure 110 that defines a cavity 116 in which a fluid cartridge 120 can be received" [0046]; “that is preloaded with insulin" [0051]), the pump further comprising a cap device (cap device 130) configured to cover the opening ("cap device 130 to retain the fluid cartridge 120 in the cavity 116." [0046]) and pierce the prefilled cartridge of insulin when the pump receives the prefilled cartridge of insulin ("the fluid cartridge 120 can be pierced to permit fluid outflow when the cap device 130 is connected to the pump housing structure 110." [0055]).
Regarding claim 11, modified Estes 2010 teaches the system of claim 2, wherein the monitoring device comprises a portable housing (housing 52) wearable on the user's skin (Figure 1), a sensor shaft (sensor shaft 56) that penetrates into the user's skin (“the sensor shaft 56 can penetrate the skin 20 of a user to make measurements indicative of characteristics of the user's blood” [0043]), and a wireless communication device (wireless communication device 54) to transmit the glucose information to a wireless communication device (communication device 247) of the controller (“the glucose monitoring device 50 can employ the wireless communication device 54 to transmit data to the controller device 200” [0043]).
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Estes 2010 (2010/0094251), in view of Hayes et al. (USPN 7547281), in further view of Estes 2003 (2003/0114836), in further view of Mandro et al. (US 2011/0040247) further in view of Budiman et al. (US 2010/0298765) as applied in claim 2 above, and in further view of Campbell et al. (US 2005/0022274).
Regarding claim 17, modified Estes 2010 in view of Hayes teaches the system of claim 2, wherein the controller is configured to operate in a low blood glucose recovery mode (as provided by Hayes).
Modified Estes 2010 fails to explicitly teach wherein the controller is further configured to: provide the user with an option to manually override and exit the low glucose recovery mode; and exit the low glucose recovery mode in response to a manual override received from the user.
Campbell teaches a medical infusion pump system (infusion pump 10 and remote controller 100), comprising a controller (remote controller 100) that communicates insulin delivery instructions (“A wireless receiver 24 is connected to the local processor 22 for receiving flow instructions from the remote controller 100 and delivering the flow instructions to the local processor 22.” [0061]); wherein the controller is configured to operate in a low blood glucose recovery mode (“The suggested bolus dosage is equal to a reverse correction bolus plus the carbohydrate bolus if the current blood glucose value is less than the target blood glucose value, and the user has enabled reverse correction boluses through the user interface components.” [0125]); wherein the controller is further configured to: provide the user with an option to manually override and exit the low glucose recovery mode; and exit the low glucose recovery mode in response to a manual override received from the user (“If the suggested bolus calculated by the remote exceeds the maximum bolus volume configured by the user, the remote informs the user that this bolus would exceed that limit, and offer the user the option to cancel or temporarily override this limit. If the user decides to temporarily override the maximum bolus limit to deliver a suggested bolus, the remote indicates this override within the bolus history.” [0126]).
At the time of the invention, it would have been obvious to further modify the medical infusion pump system having a low glucose recovery mode of Estes 2010 in view of Hayes to include that the controller is further configured to: provide the user with an option to manually override and exit the low glucose recovery mode; and exit the low glucose recovery mode in response to a manual override received from the user based on the teachings of Campbell to allow the user to manually control the delivery of insulin (Campbell [0125-0126]).
Claims 12 and 14-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Estes 2010 (2010/0094251), in view of Hayes et al. (USPN 7547281) in further view of Estes 2003 (2003/0114836), in further view of Atlas et al. (US 2012/0123234), Budiman et al. (US 2010/0298765), in further view of Campbell et al. (US 2005/0022274).
Regarding claim 12, Estes 2010 discloses a controller (controller device 200) for an insulin infusion pump system (infusion pump system 10), comprising: a processor (processor 243); one or more computer-readable memory devices (memory chip 248) that store glucose information received from a monitoring device (monitoring device 50) and time values associated with the glucose information ("The one or more memory devices (e.g., the memory chip 248) can also store information related to a user's blood glucose level and total insulin load (described in more detail in association with FIGS. 11-16B) over a period of time." [0077]; “glucose monitoring device 50 can be in communication with the infusion pump assembly 60 for the purpose of supplying data indicative of a user's blood glucose level to a controller device 200” [0038]), wherein the one or more computer-readable memory devices store computer-readable instructions ("The control circuitry 240 can be programmable in that the user may provide one or more instructions to adjust a number of settings for the operation of the infusion pump system 10. Such settings may be stored in the one or more memory devices, such as the memory chip 248 on the processor board 242" [0077]) for a blood glucose prediction process ("calculated TIL value can be used to predict future blood glucose levels" [0107]; “controller device 200 may implement a process 400 to determine the user's total insulin load)” [0089]) that, when executed by the processor, cause the controller to: activate basal insulin deliveries; receive instructions to deliver bolus insulin and activate bolus insulin deliveries (“the pump assembly 60 can operate to deliver insulin to the user by basal dosages, selected bolus dosages, or a combination thereof” [0086], see all of [0086]; “infusion pump system 10 can be configured to supply scheduled basal dosages of insulin (or other medication) along with user-selected bolus dosages.” [0039]); calculate a predicted future blood glucose level of the user (“calculated TIL value can be used to, for example, predict future blood glucose levels” [0107]) based at least in part upon a food-on-board value, a carbohydrate ratio, and an insulin load of the user (“the process 400 for the determining of the TIL of a user can include a number of operations performed by the controller device 200…the TIL value can be calculated based on two or (optionally) three components: a bolus insulin load component, a basal insulin load component, and (optionally) a previous food component.” [0089]; “the process 400 may include operation 420 in which the previous food component is employed in the TIL calculation…The previous food component can be determined, for example, by estimating the amount of carbohydrates that have been consumed but not yet metabolized…When this yet-to-be-metabolized carbohydrate value is estimated, it can be treated as a "negative" insulin component in the TIL calculation by multiplying the yet-to-be-metabolized carbohydrate value by a carbohydrate ratio” [0092]), wherein the insulin load of the user is an estimated value of previously dispensed bolus insulin dosages and basal insulin dosages that have been dispensed but have not yet acted in the user, and the food-on-board value being indicative of previous food intake by the user that has not yet metabolized in the user ("the TIL values may accurately reflect both the previously dispensed insulin that has not yet acted and the previously consumed food that has not yet been metabolized." [0109]).
Estes 2010 fails to explicitly teach the computer-readable instructions for a blood glucose prediction process cause the controller to calculate a predicted future blood glucose level of the user based at least in part upon a recent blood glucose level of a user, a trend of blood glucose levels over time, a food-on-board value, a bounded prediction horizon selectable to range between 5 and 60 minutes, insulin sensitivity, and an insulin load of the user; operate in a high glucose recovery mode in response to user input that accepts activation of the high glucose recovery mode, the high glucose recovery mode temporarily increasing the delivery of basal insulin; operate, when the predicted future blood glucose level of the user is below a lower level threshold, in a low glucose recovery mode in response to user input that accepts activation of the low glucose recovery mode, wherein the processor, while in the low glucose recover mode, automatically stops the delivery of bolus insulin in progress, reduces basal delivery without completely stopping basal flow, and disables a bolus programming function of the controller, thereby automatically not permitting infusion of any bolus amount even if input by a user; and output a message to a user interface of the controller indicating the controller is operating in the low blood glucose recovery mode and a message that no bolus is allowed in response to a user attempting to program a bolus.
Hayes teaches a controller (Figure 16) for an insulin infusion pump system (infusion device 10), comprising: a processor (processor 18); a computer-readable memory devices (memory device 22) that stores computer-readable instructions for a blood glucose prediction process that, when executed by the processor, cause the controller to: activate basal insulin deliveries (“external insulin pump having the capability to deliver 0 to 35 Units/hour in basal rates” [Col 4, line 40-41]; “the processor (controller) may recommend resumption of fluid delivery, i.e. basal delivery.” [Col 12, line 10-12]); receive instructions to deliver basal and bolus insulin (“To deliver a bolus with the keypad the user uses the keypad 24 and keys 108, 110, 112 and/or 114 to can program and/or deliver one or more bolus types through a single touch key or by the use of one or more menus.” [Col 4, line 45-48]); calculate a predicted future blood glucose level of the user (“future BG values are obtained (and/or predicted) by using the derivative of the current BG value as described by the derivative predicted algorithm” [Col 6, line 6]) based at least in part upon on a recent blood glucose level of a user (“the algorithm may utilize parameters inputted by the patient and/or default parameters stored in the processor (controller). Patient defined parameters may include…current blood glucose concentrations (BG)” [Col 6, line 24]), a trend of blood glucose levels over time (“utilize the traditional algorithm plus a modification of insulin intake using a glucose trend” [Col 9, line 61]), a food-on-board value (“the derivative predicted algorithm may also compute food corrections” [Col 5, line 60]), a bounded prediction horizon selectable from a range between 5 and 60 minutes (“Further embodiments may use predicted sensor readings to determine if low blood glucose levels (i.e. hypoglycemia) will be present a specified amount of time in the future. In these embodiments, sensor-derived trends are utilized to determine low blood glucose levels occurring in the future. The sensor-derived trends may be obtained by utilizing the derivative predicted algorithm described above. The processor (controller) of the infusion device may use current sensor readings to predict sensor readings that will occur a certain amount of time in the future, i.e., fifteen minutes--thus yielding a derivative corrected blood glucose reading…In alternative embodiments, longer times, such as thirty minutes, one hour, several hours, or days, and/or shorter times, such as one minute, five minutes, 10 minutes, or the like may be used with the time set to meet the patient's particular needs and provide safety.” [Col 11, lines 41-63]), an insulin sensitivity value and an insulin load of the user (“the algorithm may utilize parameters inputted by the patient and/or default parameters stored in the processor (controller). Patient defined parameters may include…insulin-on-board…additional parameters may be inputted to the infusion device by the patient including insulin sensitivity)” [Col 6, line 21-34]); and operate, when the predicted future blood glucose level of the user is below a lower level threshold, in a low glucose recovery mode (“if a predicted sensor-derived blood glucose level falls below a low-shutoff threshold, the infusion device will go into a suspend mode.” [Col 11, line 52]), wherein the processor, while in the low glucose recover mode, automatically stops delivery of bolus insulin in progress, thereby automatically not permitting infusion of any bolus amount (“in an insulin based infusion system for a diabetic patient, if the sensor detects a low blood glucose level (i.e. hypoglycemia) over a designated period of sensor readings, the infusion device may stop insulin delivery entirely and alert the patient by going into a normal suspend mode” [Col 11, line 23]; “the infusion device suspends fluid delivery when a future blood glucose level falls below the predefined low shutoff threshold.” [Col 1, line 62-64]; “the infusion device is capable of automatically suspending and resuming fluid delivery based on future blood glucose levels and the patient's predefined low shutoff threshold” [Claim 1]; wherein in suspend mode, all insulin delivery, including bolus infusion, is stopped/not permitted); and output a message to a user interface (keypad 24 and LCD 28) of the controller indicating that the controller is operating in the low glucose recovery mode (“if a predicted sensor-derived blood glucose level falls below a low-shutoff threshold, the infusion device will go into a suspend mode. Similar to the previous embodiment, this suspend mode may provide alerts to the patient.” [Col 11, line 52]; “the infusion system includes alarm based capabilities to provide alerts to the patient. In some embodiments, the patient selects at least one alarm to activate, and the at least one alarm includes an audible alarm for providing audible alerts, a vibration alarm for providing tactile alert, and a visual alarm for providing visual alerts.” [Col 2, lines 4-11]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the computer-readable instructions for the controller of Estes 2010 to include calculating a predicted future blood glucose level based upon a recent blood glucose level, a trend of blood glucose levels, a food-on-board value, a bounded prediction horizon selectable to range between 5 and 60 minutes, insulin sensitivity value, and an insulin load, and operate in a low glucose recovery mode including automatically stopping delivery of bolus insulin in progress thereby automatically not permitting infusion of any bolus amount; and output a message to a user interface of the controller indicating the controller is operating in the low blood glucose recovery mode based on the teachings of Hayes to allow for more accurate predictions of future blood glucose levels (Hayes [Col 9, line 63]) and prevent hypoglycemia (Hayes [Col 11, line 42]).
Modified Estes 2010 in view of Hayes fails to explicitly teach the computer-readable instructions for a blood glucose prediction process cause the controller to operate in a high glucose recovery mode in response to user input that accepts activation of the high glucose recovery mode, the high glucose recover mode temporarily increasing the delivery of basal insulin; operate in a low glucose recovery mode in response to user input that accepts activation of the low glucose recovery mode; the processor, while in the low glucose recovery mode, reduces basal delivery without completely stopping basal flow, and disables a bolus programming function of the controller, thereby automatically not permitting infusion of any bolus amount even if input by a user; and output a message that no bolus is allowed in response to a user attempting to program a bolus.
Estes 2003 teaches a controller (processor 102) for an insulin infusion pump system (Figure 1) comprising: a processor (processor 102); and one or more computer-readable memory devices that store computer-readable instructions that cause the controller to: operate in a low glucose recovery mode (“blood glucose lockout (a block, requiring a minimum time delay before the bolus may be adjusted to allow the previous estimate to act).” [0031]) including disabling a bolus programming function of the controller, thereby automatically not permitting infusion of any bolus amount (“As a safety precaution, the user or healthcare professional may also set a Lockout Period, which takes into account the pharmacokinetic effect of insulin when suggesting a bolus. The purpose is to prevent a successive use of a correction bolus when the pharmacokinetic effects of the previous bolus have not yet been accounted for…the lock out period may be automatically calculated based on boluses recently delivered and/or canceled based on new blood glucose (BG) readings.” [0046]) even in input by a user (see all of [0081] describing the lockout function).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the controller of Estes 2010 to include the processor disables a bolus programming function of the controller while in the low glucose recovery mode thereby automatically not permitting infusion of any bolus amount even if input by a user based on the teachings of Estes 2003 to prevent overdosing of insulin that could lead to hypoglycemia (Estes 2003 [0046]).
Modified Estes 2010 fails to explicitly teach the computer-readable instructions for a blood glucose prediction process cause the controller to operate in a high glucose recovery mode in response to user input that accepts activation of the high glucose recovery mode, the high glucose recover mode temporarily increasing the delivery of basal insulin; and operate in the low glucose recovery mode in response to user input that accepts activation of the low glucose recovery mode, wherein the processor, while in the low glucose recover mode, reduces basal delivery without completely stopping basal flow; and output a message that no bolus is allowed in response to a user attempting to program a bolus.
Atlas teaches a controller (control unit 30) for an insulin infusion pump system (treatment system 10), comprising a processor and a computer-readable memory device storing computer-readable instructions for a blood glucose prediction process (“The first processor module 34 preprocess the measured data 106 to calculate trends in the glucose traces (past trend 110 and future trend 114) and predict the future glucose trace 114 in a certain horizon.” [0134]; see also [0078]) that cause the controller to: operate in a high glucose recovery mode, the high glucose recover mode temporarily increasing the delivery of basal insulin (“Rule #53: If the Current Blood Glucose Level is NormalHigh and the Predicted Blood Glucose Level is at NormalHigh than increase the basal rate by 60%” [0178]; “Rule #21: If Time Passed from Meal Start is not greater than 45 minutes, Current Blood Glucose Level is Normal and Predicted Blood Glucose Level is Very High than give 200% of basal and 300% of recommended bolus” [0246]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the controller of Estes 2010 to include that the controller operates in a high glucose recovery mode based on the teachings of Atlas to prevent hyperglycemia and its related side effects (Atlas [0014]).
Modified Estes 2010 fails to explicitly teach the computer-readable instructions for a blood glucose prediction process cause the controller to operate in the high glucose recovery mode in response to user input that accepts activation of the high glucose recovery mode and operate in a low glucose recovery mode in response to user input that accepts activation of the low glucose recovery mode, wherein the processor, while in the low glucose recover mode, reduces basal delivery without completely stopping basal flow, and output a message that no bolus is allowed in response to a user attempting to program a bolus.
Budiman teaches a controller for an insulin infusion pump (Figure 1; “any of the one or more of the medical devices 30, 32 may be implanted within the user's body, coupled externally to the user's body (such as, for example, an infusion pump)” [0041]) comprising: computer-readable instructions that, when executed by a processor (processors 14, 33, 53) operate in a low glucose recovery mode (“if the current IOB and the current CGM measurements indicate the user may be carbohydrate deficient already or trending towards being carbohydrate deficient…the pump may automatically terminate or suspend further delivery of the programmed extended bolus delivery of insulin…The decision to terminate may be arrived at by the processor by programming the processor to consider one or more of the following parameters:…Projected BG Threshold” [0119-0124]) and reduce basal delivery without completely stopping basal flow (“In addition to terminating an extended bolus or a temporary basal rate insulin delivery that is higher than programmed basal before the scheduled termination time,…the processor may issue a command to reduce the future basal delivery rate by setting a temporary basal rate to be less than the current programmed basal delivery rate for a selected duration that is either pre-defined, calculated, or defined by the user to allow the user to recover from the carbohydrate deficient state.” [0126]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the controller of Estes 2010 to include the processor, while in the low blood glucose recovery mode, reduces basal delivery without completely stopping basal flow based on the teachings of Budiman to prevent hypoglycemia by gradually allowing the user to recover from a carbohydrate deficient state (Budiman [0119, 0126]).
Modified Estes 2010 in view of Hayes, in the embodiment detailed above, fails to explicitly teach the computer-readable instructions for a blood glucose prediction process cause the controller to operate in the high glucose recovery mode in response to user input that accepts activation of the high glucose recovery mode and operate in a low glucose recovery mode in response to user input that accepts activation of the low glucose recovery mode and output a message that no bolus is allowed in response to a user attempting to program a bolus.
Hayes, in the embodiment described in Col 10, line 20, teaches a controller that operates in a glucose recovery mode in response to user input that accepts activation of the glucose recovery mode (“if the recommended delivery amounts exceed or fall below the patient-defined thresholds, the infusion device will provide alarms for too much or too little fluid delivery, followed by displaying the recommendation on the screen for patient input on whether to accept, alter or reject the recommendation” [Col 10, line 33]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the computer-readable instructions for the controller of Estes 2010 to include operating in the high and/or low glucose recover modes in response to user input based on the teachings of Hayes to allow the user to verify that the recommended change in delivery is proper even when such a modification falls below or above a defined threshold of the amount of fluid to be delivered, such as when the device enters a suspend mode (Hayes [Col 10, line 30]).
Modified Estes 2010 fails to explicitly teach the computer-readable instructions for a blood glucose prediction process cause the controller to output a message that no bolus is allowed in response to a user attempting to program a bolus.
Campbell teaches a controller (remote controller 100) for an insulin infusion pump system (infusion pump 10), comprising computer-readable instructions that, when executed by a processor (“A wireless receiver 24 is connected to the local processor 22 for receiving flow instructions from the remote controller 100 and delivering the flow instructions to the local processor 22.” [0061]), cause the controller to: operate in a low blood glucose recovery mode (“The suggested bolus dosage is equal to a reverse correction bolus plus the carbohydrate bolus if the current blood glucose value is less than the target blood glucose value, and the user has enabled reverse correction boluses through the user interface components.” [0125], wherein the bolus dosages are calculated to correct a low blood glucose and therefor the operation described is a “low blood glucose recovery mode”); and output a message that no bolus is allowed in response to a user attempt to program a bolus (“If the suggested bolus calculated by the remote exceeds the maximum bolus volume configured by the user, the remote informs the user that this bolus would exceed that limit, and offer the user the option to cancel or temporarily override this limit.” [0126], wherein the “suggested bolus” is an attempt by the user to program a bolus delivery: “During extended bolus delivery, the remote 100 allows the user to initiate an immediate bolus delivery. The remote 100 recalculates the bolus and reprograms the pump 10 to deliver the immediate bolus first, then resume delivery of the extended bolus.” [0118]; “A Max Bolus Volume Exceeded CB.04 screen informs the user that the current bolus volume exceeds the user-specified max bolus limit. The user is given the option to temporarily override this limit or to cancel.” [0137]).
At the time of the invention, it would have been obvious to further modify the controller of Estes 2010 to include that the controller outputs a message that no bolus is allowed in response to a user attempting to program a bolus based on the teachings of Campbell to prevent overdosing of insulin and limit the risk of hypoglycemia (Campbell [0125-0126]).
Regarding claim 14, modified Estes 2010 teaches the controller of claim 12.
Modified Estes 2010 fails to explicitly teach wherein the one or more computer-readable memory devices store computer-readable instructions for the blood glucose prediction process that, when executed by the processor, cause the controller to: in response to the activation of the controller to operate in the low glucose recovery mode, automatically exit from the low glucose recovery mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to a lower threshold value.
Hayes teaches a controller (Figure 16) for an medical infusion pump system (infusion device 10) comprising computer-readable instructions for the blood glucose prediction process (“future BG values are obtained (and/or predicted) by using the derivative of the current BG value as described by the derivative predicted algorithm” [Col 6, line 6]) that when executed by the processor, cause the controller to: in response to the activation of the controller to operate in the low glucose recovery mode, automatically exit from the low glucose recovery mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to a lower threshold value (“When the sensor-derived trends yield a derivative corrected blood glucose level above the low target of the infusion system's target range, the processor (controller) may recommend resumption of fluid delivery, i.e. basal delivery. In further embodiments, the resumption may occur automatically upon the sensor-detected readings and/or sensor-derived trends reaching certain values determined to meet patient needs and safety” [Col 12, line 9]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the computer-readable instructions for the controller of Estes 2010 to include that the controller is configured to automatically exit the low glucose recovery mode based on a subsequent determination that the predicted future blood glucose level is greater than or equal to the lower threshold value based on the teachings of Hayes to allow the system to operate as a semi-closed loop infusion system in order to automatically prevent hypoglycemia and hyperglycemia (Hayes [Col 11, line 42]).
Regarding claim 15, modified Estes 2010 teaches the controller of claim 12.
Modified Estes 2010 fails to explicitly teach wherein the one or more computer-readable memory devices store computer-readable instructions for the blood glucose prediction process that, when executed by the processor, cause the controller to: determine whether the predicted future blood glucose level is less than a lower threshold value, and in response to the predicted future blood glucose level being less than the lower threshold value, automatically cancel any previously scheduled bolus dosage of insulin.
Budiman teaches a medical infusion pump system (Figure 1) comprising a controller, the controller determining whether the predicted future blood glucose level is less than a lower threshold value, and wherein in response to the predicted future blood glucose level being less than the lower threshold value, the controller automatically cancels any previously scheduled bolus dosage of insulin to be dispensed from the pump (“the pump may automatically terminate or suspend further delivery of the programmed extended bolus delivery of insulin…The decision to terminate may be arrived at by the processor by programming the processor to consider one or more of the following parameters:…Projected BG Threshold--how soon will the user cross the low BG threshold, that is, what is the estimated time until the user's glucose level crosses the threshold and places the user at risk of hypoglycemia?” [0119-0123]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the computer-readable instructions for the controller of Estes 2010 in view of Hayes to include that the controller automatically cancels any previously scheduled bolus dosage of insulin in response to the predicted future blood glucose level being less than a lower threshold value based on the teachings of Budiman to prevent hypoglycemia and allow the user to recover from a carbohydrate deficient state (Budiman [0119, 0126]).
Response to Arguments
Applicant’s arguments with respect to claims 2-5, 7-12, 14-15, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the argument that prior art of record fails to disclose or suggest “predict a future blood glucose level of the user based at least in part upon…a bounded prediction horizon selected between 5 and 60 minutes” as required by amended independent claims 2 and 12 (Remarks, page 9-13), the examiner respectfully disagrees. As detailed above, Hayes discloses a medical infusion pump system (10) comprising a controller (18) configured to predict the future blood glucose level of the user ([Col 6, line 6]) based at least in part upon a bounded prediction horizon selectable from a range between 5 and 60 minutes (“Further embodiments may use predicted sensor readings to determine if low blood glucose levels (i.e. hypoglycemia) will be present a specified amount of time in the future. In these embodiments, sensor-derived trends are utilized to determine low blood glucose levels occurring in the future. The sensor-derived trends may be obtained by utilizing the derivative predicted algorithm described above. The processor (controller) of the infusion device may use current sensor readings to predict sensor readings that will occur a certain amount of time in the future, i.e., fifteen minutes--thus yielding a derivative corrected blood glucose reading…In alternative embodiments, longer times, such as thirty minutes, one hour, several hours, or days, and/or shorter times, such as one minute, five minutes, 10 minutes, or the like may be used with the time set to meet the patient's particular needs and provide safety.” [Col 11, lines 41-63]). It is maintained that it would have been obvious to modify the system of Estes 2010 to include that the controller is configured to predict the future blood glucose level based at least in part upon a prediction horizon bounded prediction horizon selectable from a range between 5 and 60 minutes based on the teachings of Hayes to allow for more accurate predictions of future blood glucose levels (Hayes [Col 9, line 63]) and prevent hypoglycemia (Hayes [Col 11, line 42]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the Office’s obviousness combinations do not teach or suggest…the precise mathematical relationships claimed” (Remarks, page 9)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims as currently presented require that that predicting hte future blood glucose level is “based at least in part on a recent blood glucose level of a user, a trend of blood glucose levels over time, a food-on-board value, a bounded prediction horizon selectable to range between 5 and 60 minutes, insulin sensitivity value and carbohydrate ratio, and an insulin load of the user”. A specific mathematical relationship between these factors is not recited or claimed.
Regarding the argument that “Campbell provides no teaching, suggestion, or motivation for applying its bolus-limit override concept to a low-glucose recovery mode exit function” as required by claim 17 (Remarks, page 13-14), the examiner respectfully disagrees. As detailed above in the rejection of claim 17, Campbell discloses a medical infusion pump system (10) comprising a controller (100) configured to operate in a low blood glucose recovery mode (“The suggested bolus dosage is equal to a reverse correction bolus plus the carbohydrate bolus if the current blood glucose value is less than the target blood glucose value, and the user has enabled reverse correction boluses through the user interface components.” [0125]). The bolus dosages are calculated to correct a low blood glucose and therefore the operation described is a “low blood glucose recovery mode”. It is noted that the disclosure of Campbell was not relied upon for a teaching of the low glucose recovery mode operating to reduce basal delivery without completely stopping basal flow. These features of the claimed low glucose recovery mode are disclosed by Hayes and Budiman, as detailed above. Campbell additionally discloses that the user can manually override and exit this “low glucose recovery mode” (“If the suggested bolus calculated by the remote exceeds the maximum bolus volume configured by the user, the remote informs the user that this bolus would exceed that limit, and offer the user the option to cancel or temporarily override this limit. If the user decides to temporarily override the maximum bolus limit to deliver a suggested bolus, the remote indicates this override within the bolus history.” [0126]). Based on this disclosure, it is maintained that it would have been obvious to further modify the medical infusion pump system/controller of Estes 2010 to include that the controller is further configured to: provide the user with an option to manually override and exit the low glucose recovery mode; and exit the low glucose recovery mode in response to a manual override received from the user based on the teachings of Campbell to allow the user to manually control the delivery of insulin (Campbell [0125-0126]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783