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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 20, 2025 has been entered.
Response to Amendment
The amendment filed June 20, 2025 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome the objections previously set forth in the Final Office Action mailed March 20, 2025.
Claim Objections
Claim 19 is objected to because “a first dose” in line 2 should be “the first dose” because “a first dose” is introduced in independent claim 18, line 13. Appropriate correction is required.
Claim 20 is objected to because “a second dose” in line 2 should be “the second dose” because “a second dose” is introduced in independent claim 18, line 14. 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 1-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Estes (US 20100174266) in view of Yodfat et al. (US 20110071765) in further view of Campbell et al. (US 20030060765).
Regarding claim 1, Estes discloses a method for administering a dose of insulin by an insulin delivery system (infusion pump system 10) comprising an insulin pump (pump device 100) and a receiver unit (controller device 200; Figure 11; “FIG. 11 is a flow diagram depicting an exemplary process used to determine a bolus dosage of insulin in response to, in part, the rate of change in a user's blood glucose level“ [0019]), comprising:
calculating, by the receiver unit, a recommended bolus of medication (Figure 11; “Referring in more detail to the illustrative process 400 shown in FIG. 11, the process 400 for the determining a bolus dosage to suggest to a user can include a number of operations performed by the controller device 200…the suggested bolus dosage value can be calculated based on at least two of the three components as previously described: the food offsetting component, the blood glucose correction component, and the insulin load correction component. It should be understood from the description herein that the components can be contemporaneously calculated to provide the suggested bolus dosage value or, alternatively, calculated in discrete steps and then combined to provide the suggested bolus dosage value.” [0077]);
receiving, by the receiver unit, a carbohydrate estimate for a meal (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage…In some embodiments, the user can enter in the amount and types of food to be consumed and the controller device 200 can estimate the number of grams of carbohydrates from the input food information.” [0078]) and a glucose reading (“In operation 405, the controller device 200 can wait for one or more triggers to initiate a bolus dosage calculation. Exemplary triggers that can cause the controller device 200 to initiate a bolus dosage calculation can include…wireless receipt of current blood glucose information…the user's blood glucose level exceeding a predetermined threshold level, the user's blood glucose level increasing at a high rate greater than a predetermined threshold rate, or the like.” [0077]);
determining a meal portion of the recommended bolus (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage.” [0078]) based on the carbohydrate estimate and an insulin to carbohydrate ratio (“In this operation, the controller device 200 can convert food intake data, such as carbohydrate information, entered into the controller device 200 and determine a quantity of insulin to offset the food intake. For example, in some embodiments, the food offsetting component can be calculated as follows: Food Offsetting Component=(Carbohydrate Intake)*(Insulin to Carb. Ratio), where Carbohydrate Intake represents the number of grams of carbohydrates consumed and Insulin to Carb. Ratio represents a user specific ratio of the amount of insulin required to offset the consumption of a gram of carbohydrates (e.g., 15 U/g or the like).” [0078]);
calculating a correction portion of the recommended bolus based on a difference between a current glucose level and a target glucose level, and an insulin sensitivity factor (“in operation 415, the controller device 200 can determine the blood glucose correction component of the suggested bolus dosage…the controller device 200 can calculate the blood glucose correction component as follows: Blood Glucose Correction Component=(Current Blood Glucose Level-Target Glucose Level)*Insulin Sensitivity*[1+(Rate of Change*Scaling Factor)], where Current Blood Glucose Level represents the most recent blood glucose level, Target Glucose Level represents the user's desired blood glucose level, Insulin Sensitivity represents a user specific value that correlates the number of units of insulin required to alter the user's blood glucose level by 1 mg/dL, and Rate of Change in represents the recent rate of change in the user's blood glucose level.” [0079]), wherein the recommended bolus comprises the meal portion of the recommended bolus and the correction portion of the recommended bolus less an amount of remaining insulin (“in operation 425, the suggested bolus dosage can be calculated by summing the food offsetting component and the blood glucose correction component and subtracting the insulin load correction bolus. For example, in some embodiments, the suggested bolus dosage may be determined as follows: Suggested Bolus Dosage=(Food Offsetting Component)+(Blood Glucose Correction Component)-(Insulin Load Correction Component).” [0082]; “In operation 420, the controller device 200 can determine the insulin load correction component of the suggested bolus dosage. In this operation, the controller device 200 can determine the amount of previously delivered insulin that has not yet acted on the user.” [0080]);
displaying the recommended bolus on a user interface (display 222; “In operation 430, the suggested bolus dosage can be displayed, for example, on the display 222 of the controller device 200.” [0085]);
receiving, by the processor (processor 243 of controller device 200), confirmation to administer the recommended bolus (“the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage (e.g., if the user pressed button 224a to "accept" or button 224d to "decline" as shown in the embodiment in FIG. 1).” [0087]); and
transmitting, via a connection to the insulin pump, the recommended bolus (“the controller device 200 can be electrically connected with the pump device 100 via mating connectors 118 and 218 so that the control circuitry 240 can communicate control signals to the pump device 100 and receive feedback signals from components housed in the pump device 100.” [0066]), wherein the recommended bolus is configured to cause the insulin pump to administer the recommended bolus (“In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage (e.g., if the user pressed button 224a to "accept" or button 224d to "decline" as shown in the embodiment in FIG. 1). If the user accepts the suggested bolus dosage, the controller device 200 can execute operation 440, causing the pump device 100 to dispense an amount of insulin to the user that is equivalent to the suggested bolus dosage.” [0087]).
Estes fails to explicitly disclose wherein the recommended bolus is configured to be administered as at least two discrete doses comprising a first dose and a subsequent dose; determining that the subsequent dose comprises a second dose and a third dose to be administered after the first dose; receiving, by the receiver unit, confirmation to administer the recommended bolus as the at least two discrete doses; transmitting, via a radio frequency (RF) connection to the insulin pump, the recommended bolus, wherein the recommended bolus is configured to cause the insulin pump to administer the recommended bolus as the at least two discrete doses; detecting an updated analyte level subsequent to administering the first dose of the recommended bolus; updating the subsequent dose based on the updated analyte level; and displaying, by the receiver unit, a prompt to proceed or cancel administration of the second dose or the third dose based on the updated subsequent dose.
Yodfat teaches a method for administering a dose of insulin (Figure 4; “FIG. 4 illustrates a flow chart of an exemplary algorithm for implementing a PPH alleviating method” [0066]), the method comprising: calculating, by a receiver unit, a recommended bolus of medication (“at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured. In some embodiments, the total bolus size (TB) can be selected” [0066]); wherein the recommended bolus is configured to be administered as at least two discrete doses (“the total bolus dose may be divided into a single phase, two phases, three phases or more (for example).” [0042]; “at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured…each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases, for example.” [0066-0067]) comprising a first dose (“The first phase can be administered between about 15 and about 60 minutes, and narrower ranges thereof (in some embodiments) before the approximate meal time (i.e. time of first phase bolus (t) is T-60), as illustrated at 401.” [0067]) and a subsequent dose (“the total bolus dose may be divided into…three phases” [0042]; wherein the subsequent dose is the second and third of the three phases; “At this time before the planned meal (e.g. 5 minutes before the meal) and/or after the user has been reminded to eat, the second phase bolus can be delivered, as illustrated at 403. In some embodiments, the amount of the second phase bolus can be equal to the total bolus (TB) configured at 400 minus the size of the first phase bolus delivered at 401.” [0068]); determining that the subsequent dose comprises a second dose and a third dose to be administered after the first dose (“the total bolus dose may be divided into…three phases” [0042]; wherein the subsequent dose is the second and third of the three phases of the total bolus); displaying the recommended bolus on a user interface (Figure 8); receiving, by a receiver unit (processor 2010), confirmation to administer the recommended bolus as the at least two discrete doses (Figures 7a-7h; “FIGS. 7a-h provides an example of a user interface for a PPH alleviating feature using navigation windows for data inputs…FIGS. 7c, 7c' and 7c'' illustrate examples of windows for confirming delivery of the first phase bolus (e.g. 60 minutes before the contemplated meal time) according to some embodiments…FIGS. 7f, 7f and 7f' illustrate examples of windows for confirming delivery of the second phase bolus” See all of [0093-0099]); transmitting the recommended bolus, wherein the recommended bolus is configured to cause the insulin pump to administer the recommended bolus as the at least two discrete doses (Figures 4-6; “FIG. 2 provides an example of the insulin infusion device/system (1000) which includes a dispensing patch unit (1010) adherable to the user's skin (5), and may further include a remote control unit (1008), which can communicate with the dispensing patch unit (1010), allowing programming, user inputs and data acquisition.” [0058]; “the first phase can be administered between about 15 and about 60 minutes, and narrower ranges thereof (in some embodiments) before the approximate meal time (i.e. time of first phase bolus (t) is T-60), as illustrated at 401.” [0067]; “At this time before the planned meal (e.g. 5 minutes before the meal) and/or after the user has been reminded to eat, the second phase bolus can be delivered, as illustrated at 403.” [0068]); detecting an updated analyte level (“Current Blood Glucose” at Step 304 in Figure 5) subsequent to administering the first dose of the recommended bolus; updating the subsequent dose based on the updated analyte level (“At that time, the user may change the total bolus amount (304) in accordance with the contemplated meal, and the size of the second phase bolus can be further selected accordingly, i.e. the size of the second phase bolus, to be delivered immediately before or after the meal (305), can be equal to the new total bolus size minus the size of the first phase bolus. The manner of selection of the total bolus size as given at (301) can also be applied for the final selection of the second phase bolus…the total bolus size at (304) can be selected from a bolus selector, based on the carbohydrate load of the meal and the current blood glucose level” [0071-0072]; see Figure 5 showing the updated glucose “Current Blood Glucose” is detected at step 304 after administration of the first phase bolus at step 302); and displaying, by the receiver unit, a prompt to proceed or cancel administration of the second dose or the third dose based on the updated subsequent dose (“FIGS. 7f, 7f and 7f' illustrate examples of windows for confirming delivery of the second phase bolus” [0098]; “If the first phase bolus (also referred to as "Phase1 Bolus" and "Phase1") has already been administered and the user chooses to skip the planned meal, as depicted in step (306), then the user can cancel the second phase bolus.” [0075]; Figure 5).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Estes to include the recommended bolus is configured to be administered as at least two discrete doses comprising a first dose and a subsequent dose; determining that the subsequent dose comprises a second dose and a third dose to be administered after the first dose; receiving, by the receiver unit, confirmation to administer the recommended bolus as the at least two discrete doses; transmitting the recommended bolus, wherein the recommended bolus is configured to cause the insulin pump to administer the recommended bolus as the at least two discrete doses; detecting an updated analyte level subsequent to administering the first dose of the recommended bolus; updating the subsequent dose based on the updated analyte level; and displaying, by the receiver unit, a prompt to proceed or cancel administration of the second dose or the third dose based on the updated subsequent dose based on the teachings of Yodfat to alleviate postprandial hyperglycemia by accounting for the lag period between glucose and insulin blood level peaks (Yodfat [0015-0016]).
Modified Estes in view of Yodfat fails to explicitly teach transmitting, via a radio frequency (RF) connection to the insulin pump, the recommended bolus.
Campbell teaches a method for administering a dose of insulin by an insulin delivery system (“deliver insulin at a basal rate (continuous base rate of insulin measured in units/hour) and deliver a bolus (a measured number of units of insulin) to compensate for relatively sudden large increases in blood glucose” [0046]) comprising an insulin pump (drive mechanism 24 and reservoir 26) and a receiving unit (processor 14 and RF transmitter/receiver 40), comprising receiving, by a processor (processor 14), confirmation to administer a recommended bolus (“The processor 14 uses the control parameters to calculate and issue commands that affect the rate and/or frequency that the drive mechanism 24 forces fluid out of the reservoir 26, and into tubing 30 connected to an infusion set 32 that provides a fluid path into the user's body.” [0049]); and transmitting, via a radio frequency (RF) connection (via RF programmer 42 in communication with RF (Radio Frequency) transmitter/receiver 40; Figures 1-2) to the insulin pump, the recommended bolus (“the RF programmer is used to access data and/or modify one or more control parameters, such as a bolus amount, a bolus profile, a bolus time, basal rates, priming functions (perhaps including rewinding the plunger slider), self tests, setting date and time, reviewing stats, and the like…the infusion device 10 confirms receipt of instructions from the RF programmer 42 by issuing one or more audible beeps or tactile vibrations. In alternative embodiments, the RF programmer 42 includes a receiver. Additionally, it may provide a feedback signal such as a sound or vibration to indicate that the commands have been received and acknowledged by the infusion device 10.” [0060-0061]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Estes to include transmitting the recommended bolus via a radio frequency (RF) connection to the insulin pump based on the teachings of Campbell to allow control for remote control of the insulin pump in order to limit the need to physically access the insulin pump and therefore allow the user to discreetly carry the insulin pump (Campbell [0061]).
Regarding claim 2, modified Estes teaches the method of claim 1, wherein the glucose reading is received from an in vivo glucose sensor (glucose monitoring device 50; “the sensor shaft 56 can penetrate the skin 20 of a user to make measurements indicative of characteristics of the user's blood (e.g., the user's blood glucose level or the like). In response to the measurements made by the sensor shaft 56, the glucose monitoring device 50 can employ the wireless communication device 54 to transmit data to the controller device 200 of the pump assembly 60.” [0033]).
Regarding claim 3, modifies Estes teaches the method of claim 2, wherein the in vivo glucose sensor (glucose monitoring device 50) comprises an on-body patch device (Figure 1; “the sensor shaft 56 can penetrate the skin 20 of a user to make measurements indicative of characteristics of the user's blood (e.g., the user's blood glucose level or the like).” [0033]).
Regarding claim 4, modified Estes teaches the method of claim 1, wherein the amount of remaining insulin is determined by the receiver unit (controller 200; “In operation 420, the controller device 200 can determine the insulin load correction component of the suggested bolus dosage. In this operation, the controller device 200 can determine the amount of previously delivered insulin that has not yet acted on the user.” [0080]).
Regarding claim 5, modified Estes teaches the method of claim 1.
Modified Estes fails to explicitly teach where the confirmation is received via a wireless connection from a mobile device associated with a user.
Campbell teaches a method for administering a dose of insulin by an insulin delivery system (“deliver insulin at a basal rate (continuous base rate of insulin measured in units/hour) and deliver a bolus (a measured number of units of insulin) to compensate for relatively sudden large increases in blood glucose” [0046]) comprising an insulin pump (drive mechanism 24 and reservoir 26) and a receiving unit (processor 14 and RF transmitter/receiver 40), comprising receiving, by a processor (processor 14), confirmation to administer a recommended bolus (“The processor 14 uses the control parameters to calculate and issue commands that affect the rate and/or frequency that the drive mechanism 24 forces fluid out of the reservoir 26, and into tubing 30 connected to an infusion set 32 that provides a fluid path into the user's body.” [0049]); where the confirmation is received via a wireless connection (via RF programmer 42 in communication with RF (Radio Frequency) transmitter/receiver 40; Figures 1-2) from a mobile device (RF programmer 42) associated with a user (“the RF programmer is used to access data and/or modify one or more control parameters, such as a bolus amount, a bolus profile, a bolus time, basal rates, priming functions (perhaps including rewinding the plunger slider), self tests, setting date and time, reviewing stats, and the like…the infusion device 10 confirms receipt of instructions from the RF programmer 42 by issuing one or more audible beeps or tactile vibrations. In alternative embodiments, the RF programmer 42 includes a receiver. Additionally, it may provide a feedback signal such as a sound or vibration to indicate that the commands have been received and acknowledged by the infusion device 10.” [0060-0061]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Estes to include the confirmation is received via a wireless connection from a mobile device associated with a user based on the teachings of Campbell to allow control for remote control of the insulin pump in order to limit the need to physically access the insulin pump and therefore allow the user to discreetly carry the insulin pump (Campbell [0061]).
Regarding claim 6, modified Estes teaches the method of claim 1, further comprising: administering, by the receiver unit (controller 200), the recommended bolus responsive to receiving the confirmation (“In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage (e.g., if the user pressed button 224a to "accept" or button 224d to "decline" as shown in the embodiment in FIG. 1). If the user accepts the suggested bolus dosage, the controller device 200 can execute operation 440, causing the pump device 100 to dispense an amount of insulin to the user that is equivalent to the suggested bolus dosage.” [0087]).
Regarding claim 7, modified Estes teaches the method of claim 8, wherein the receiver unit (controller 200) comprises the insulin pump (infusion pump assembly 60; “a controller device 200 included in the pump assembly 60” [0026]).
Regarding claim 8, modified Estes teaches the method of claim 1, wherein the amount of remaining insulin is determined based on how much insulin remains in a blood stream of a user from a prior insulin dose (“In operation 420, the controller device 200 can determine the insulin load correction component of the suggested bolus dosage. In this operation, the controller device 200 can determine the amount of previously delivered insulin that has not yet acted on the user.” [0080]).
Regarding claim 9, Estes discloses an insulin delivery system (Figure 1) comprising:
an insulin pump (pump device 100);
a receiver unit (controller device 200) configured to:
calculate a recommended bolus of medication (Figure 11; “Referring in more detail to the illustrative process 400 shown in FIG. 11, the process 400 for the determining a bolus dosage to suggest to a user can include a number of operations performed by the controller device 200…the suggested bolus dosage value can be calculated based on at least two of the three components as previously described: the food offsetting component, the blood glucose correction component, and the insulin load correction component. It should be understood from the description herein that the components can be contemporaneously calculated to provide the suggested bolus dosage value or, alternatively, calculated in discrete steps and then combined to provide the suggested bolus dosage value.” [0077]);
receive a carbohydrate estimate for a meal (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage…In some embodiments, the user can enter in the amount and types of food to be consumed and the controller device 200 can estimate the number of grams of carbohydrates from the input food information.” [0078]) and a blood glucose reading (“In operation 405, the controller device 200 can wait for one or more triggers to initiate a bolus dosage calculation. Exemplary triggers that can cause the controller device 200 to initiate a bolus dosage calculation can include…wireless receipt of current blood glucose information…the user's blood glucose level exceeding a predetermined threshold level, the user's blood glucose level increasing at a high rate greater than a predetermined threshold rate, or the like.” [0077]);
determine a meal portion of the recommended bolus (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage.” [0078]) based on the carbohydrate estimate and an insulin to carbohydrate ratio (“In this operation, the controller device 200 can convert food intake data, such as carbohydrate information, entered into the controller device 200 and determine a quantity of insulin to offset the food intake. For example, in some embodiments, the food offsetting component can be calculated as follows: Food Offsetting Component=(Carbohydrate Intake)*(Insulin to Carb. Ratio), where Carbohydrate Intake represents the number of grams of carbohydrates consumed and Insulin to Carb. Ratio represents a user specific ratio of the amount of insulin required to offset the consumption of a gram of carbohydrates (e.g., 15 U/g or the like).” [0078]);
calculate a correction portion of the recommended bolus based on a difference between a current analyte level and a target analyte level, and an insulin sensitivity factor (“in operation 415, the controller device 200 can determine the blood glucose correction component of the suggested bolus dosage…the controller device 200 can calculate the blood glucose correction component as follows: Blood Glucose Correction Component=(Current Blood Glucose Level-Target Glucose Level)*Insulin Sensitivity*[1+(Rate of Change*Scaling Factor)], where Current Blood Glucose Level represents the most recent blood glucose level, Target Glucose Level represents the user's desired blood glucose level, Insulin Sensitivity represents a user specific value that correlates the number of units of insulin required to alter the user's blood glucose level by 1 mg/dL, and Rate of Change in represents the recent rate of change in the user's blood glucose level.” [0079]), wherein the recommended bolus comprises the meal portion and the correction portion less an amount of remaining insulin (“in operation 425, the suggested bolus dosage can be calculated by summing the food offsetting component and the blood glucose correction component and subtracting the insulin load correction bolus. For example, in some embodiments, the suggested bolus dosage may be determined as follows: Suggested Bolus Dosage=(Food Offsetting Component)+(Blood Glucose Correction Component)-(Insulin Load Correction Component).” [0082]; “In operation 420, the controller device 200 can determine the insulin load correction component of the suggested bolus dosage. In this operation, the controller device 200 can determine the amount of previously delivered insulin that has not yet acted on the user.” [0080]);
display the recommended bolus on a user interface (display 222) of the receiver unit (“In operation 430, the suggested bolus dosage can be displayed, for example, on the display 222 of the controller device 200.” [0085]);
receive confirmation to administer the recommended bolus (“the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage (e.g., if the user pressed button 224a to "accept" or button 224d to "decline" as shown in the embodiment in FIG. 1).” [0087]);
transmit, via a connection to the insulin pump, the recommended bolus (“the controller device 200 can be electrically connected with the pump device 100 via mating connectors 118 and 218 so that the control circuitry 240 can communicate control signals to the pump device 100 and receive feedback signals from components housed in the pump device 100.” [0066]), wherein the recommended bolus is configured to cause the insulin pump to administer the recommended bolus (“In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage (e.g., if the user pressed button 224a to "accept" or button 224d to "decline" as shown in the embodiment in FIG. 1). If the user accepts the suggested bolus dosage, the controller device 200 can execute operation 440, causing the pump device 100 to dispense an amount of insulin to the user that is equivalent to the suggested bolus dosage.” [0087]).
Estes fails to explicitly teach transmit, via a radio frequency (RF) connection to the insulin pump, the recommended bolus, wherein the recommended bolus is configured to cause the insulin pump to administer the recommended bolus in at least two discrete doses comprising a first dose and a subsequent dose; determine that the subsequent dose comprises a second dose and a third dose to be administered after the first dose; and display prompts for administering the first dose and the subsequent dose.
Yodfat teaches an insulin delivery system (Figure 2) comprising: an insulin pump (dispensing patch unit 1010); and a receiver unit (remote control unit 1008) configured to
calculate a recommended bolus of medication (“at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured. In some embodiments, the total bolus size (TB) can be selected” [0066]); display the recommended bolus on a user interface of the receiver unit (Figure 8); receive confirmation to administer the recommended bolus (“at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured…each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases.” [0066-0067]; Figures 7a-7h; “FIGS. 7a-h provides an example of a user interface for a PPH alleviating feature using navigation windows for data inputs…FIGS. 7c, 7c' and 7c'' illustrate examples of windows for confirming delivery of the first phase bolus (e.g. 60 minutes before the contemplated meal time) according to some embodiments…. FIGS. 7f, 7f and 7f' illustrate examples of windows for confirming delivery of the second phase bolus” See all of [0093-0099]); transmitting the recommended bolus, wherein the recommended bolus is configured to cause the insulin pump to administer the recommended bolus in at least two discrete doses (Figures 4-6; “FIG. 2 provides an example of the insulin infusion device/system (1000) which includes a dispensing patch unit (1010) adherable to the user's skin (5), and may further include a remote control unit (1008), which can communicate with the dispensing patch unit (1010), allowing programming, user inputs and data acquisition.” [0058]; “the total bolus dose may be divided into a single phase, two phases, three phases or more (for example).” [0042]; “at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured…each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases, for example.” [0066-0067]) comprising a first dose (“The first phase can be administered between about 15 and about 60 minutes, and narrower ranges thereof (in some embodiments) before the approximate meal time (i.e. time of first phase bolus (t) is T-60), as illustrated at 401.” [0067]) and a subsequent dose (“the total bolus dose may be divided into…three phases” [0042]; wherein the subsequent dose is the second and third of the three phases; “At this time before the planned meal (e.g. 5 minutes before the meal) and/or after the user has been reminded to eat, the second phase bolus can be delivered, as illustrated at 403. In some embodiments, the amount of the second phase bolus can be equal to the total bolus (TB) configured at 400 minus the size of the first phase bolus delivered at 401.” [0068]); determining that the subsequent dose comprises a second dose and a third dose to be administered after the first dose (“the total bolus dose may be divided into…three phases” [0042]; wherein the subsequent dose is the second and third of the three phases of the total bolus); and display prompts for administering the first dose and the subsequent dose (Figures 7a-7h; “FIGS. 7a-h provides an example of a user interface for a PPH alleviating feature using navigation windows for data inputs…FIGS. 7c, 7c' and 7c'' illustrate examples of windows for confirming delivery of the first phase bolus (e.g. 60 minutes before the contemplated meal time) according to some embodiments…FIGS. 7f, 7f and 7f' illustrate examples of windows for confirming delivery of the second phase bolus” See all of [0093-0099]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the insulin delivery system of Estes to include the recommended bolus is configured to cause the insulin pump to administer the recommended bolus in at least two discrete doses comprising a first dose and a subsequent dose; determine that the subsequent dose comprises a second dose and a third dose to be administered after the first dose; and display prompts for administering the first dose and the subsequent dose based on the teachings of Yodfat to alleviate postprandial hyperglycemia by accounting for the lag period between glucose and insulin blood level peaks (Yodfat [0015-0016]).
Modified Estes in view of Yodfat fails to explicitly teach the receiver unit is configured to transmit, via a radio frequency (RF) connection to the insulin pump, the recommended bolus.
Campbell teaches an insulin delivery system (Figures 1 and 2) comprising: an insulin pump (drive mechanism 24 and reservoir 26); and a receiving unit (processor 14 and RF transmitter/receiver 40) configured to receive confirmation to administer a recommended bolus (“The processor 14 uses the control parameters to calculate and issue commands that affect the rate and/or frequency that the drive mechanism 24 forces fluid out of the reservoir 26, and into tubing 30 connected to an infusion set 32 that provides a fluid path into the user's body.” [0049]); and transmit, via a radio frequency (RF) connection (via RF programmer 42 in communication with RF (Radio Frequency) transmitter/receiver 40; Figures 1-2) to the insulin pump, the recommended bolus (“the RF programmer is used to access data and/or modify one or more control parameters, such as a bolus amount, a bolus profile, a bolus time, basal rates, priming functions (perhaps including rewinding the plunger slider), self tests, setting date and time, reviewing stats, and the like…the infusion device 10 confirms receipt of instructions from the RF programmer 42 by issuing one or more audible beeps or tactile vibrations. In alternative embodiments, the RF programmer 42 includes a receiver. Additionally, it may provide a feedback signal such as a sound or vibration to indicate that the commands have been received and acknowledged by the infusion device 10.” [0060-0061]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the insulin delivery system of Estes to include the receiver unit is configured to transmit, via a radio frequency (RF) connection to the insulin pump, the recommended bolus based on the teachings of Campbell to allow control for remote control of the insulin pump in order to limit the need to physically access the insulin pump and therefore allow the user to discreetly carry the insulin pump (Campbell [0061]).
Regarding claim 10, modified Estes teaches the insulin delivery system of claim 9, wherein the blood glucose reading is received from an in vivo glucose sensor (glucose monitoring device 50; “the sensor shaft 56 can penetrate the skin 20 of a user to make measurements indicative of characteristics of the user's blood (e.g., the user's blood glucose level or the like). In response to the measurements made by the sensor shaft 56, the glucose monitoring device 50 can employ the wireless communication device 54 to transmit data to the controller device 200 of the pump assembly 60.” [0033]).
Regarding claim 11, modifies Estes teaches the insulin delivery system of claim 10, wherein the in vivo glucose sensor (glucose monitoring device 50) comprises an on-body patch device (Figure 1; “the sensor shaft 56 can penetrate the skin 20 of a user to make measurements indicative of characteristics of the user's blood (e.g., the user's blood glucose level or the like).” [0033]).
Regarding claim 12, modified Estes teaches the insulin delivery system of claim 9, wherein the amount of remaining insulin is determined by the receiver unit (controller 200; “In operation 420, the controller device 200 can determine the insulin load correction component of the suggested bolus dosage. In this operation, the controller device 200 can determine the amount of previously delivered insulin that has not yet acted on the user.” [0080]).
Regarding claim 13, modified Estes teaches the insulin delivery system of claim 9.
Modified Estes fails to explicitly teach where the confirmation is received via a wireless connection from a mobile device associated with a user.
Campbell teaches an insulin delivery system (Figures 1 and 2) comprising: an insulin pump (drive mechanism 24 and reservoir 26); and a receiving unit (processor 14 and RF transmitter/receiver 40) configured to receive confirmation to administer a recommended bolus (“The processor 14 uses the control parameters to calculate and issue commands that affect the rate and/or frequency that the drive mechanism 24 forces fluid out of the reservoir 26, and into tubing 30 connected to an infusion set 32 that provides a fluid path into the user's body.” [0049]); where the confirmation is received via a wireless connection (via RF programmer 42 in communication with RF (Radio Frequency) transmitter/receiver 40; Figures 1-2) from a mobile device (RF programmer 42) associated with a user (“the RF programmer is used to access data and/or modify one or more control parameters, such as a bolus amount, a bolus profile, a bolus time, basal rates, priming functions (perhaps including rewinding the plunger slider), self tests, setting date and time, reviewing stats, and the like…the infusion device 10 confirms receipt of instructions from the RF programmer 42 by issuing one or more audible beeps or tactile vibrations. In alternative embodiments, the RF programmer 42 includes a receiver. Additionally, it may provide a feedback signal such as a sound or vibration to indicate that the commands have been received and acknowledged by the infusion device 10.” [0060-0061]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the insulin delivery system of Estes to include the confirmation is received via a wireless connection from a mobile device associated with a user based on the teachings of Campbell to allow control for remote control of the insulin pump in order to limit the need to physically access the insulin pump and therefore allow the user to discreetly carry the insulin pump (Campbell [0061]).
Regarding claim 14, modified Estes teaches the insulin delivery system of claim 9, wherein the receiver unit (controller device 200) is further configured to: transmit, to a data processing terminal, a command to administer the recommended bolus responsive to receiving the confirmation (“the controller device 200 includes control circuitry 240 arranged in the controller housing 210 that is configured to communicate control signals to the drive system of the pump device 100. In this embodiment, the control circuitry 240 includes a main processor board 242 that is in communication with a power supply board 244. The control circuitry 240 includes at least one processor 243 that coordinates the electrical communication to and from the controller device 200 (e.g., communication between the controller device 200 and the pump device 100)” [0064]; “In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage (e.g., if the user pressed button 224a to "accept" or button 224d to "decline" as shown in the embodiment in FIG. 1). If the user accepts the suggested bolus dosage, the controller device 200 can execute operation 440, causing the pump device 100 to dispense an amount of insulin to the user that is equivalent to the suggested bolus dosage.” [0087]).
Regarding claim 15, modified Estes teaches the insulin delivery system of claim 14, wherein the data processing terminal comprises the insulin pump (pump device 100 of infusion pump assembly 60; “a controller device 200 included in the pump assembly 60” [0026]) and wherein the insulin pump administers the recommended bolus (“If the user accepts the suggested bolus dosage, the controller device 200 can execute operation 440, causing the pump device 100 to dispense an amount of insulin to the user that is equivalent to the suggested bolus dosage.” [0087]).
Regarding claim 16, modified Estes teaches the insulin delivery system of claim 9, wherein the insulin pump is further configured to: administer the recommended bolus responsive to receiving the confirmation (“In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage (e.g., if the user pressed button 224a to "accept" or button 224d to "decline" as shown in the embodiment in FIG. 1). If the user accepts the suggested bolus dosage, the controller device 200 can execute operation 440, causing the pump device 100 to dispense an amount of insulin to the user that is equivalent to the suggested bolus dosage.” [0087]).
Regarding claim 17, modified Estes teaches the insulin delivery system of claim 16, comprising a data processing terminal (“the controller device 200 includes control circuitry 240 arranged in the controller housing 210 that is configured to communicate control signals to the drive system of the pump device 100. In this embodiment, the control circuitry 240 includes a main processor board 242 that is in communication with a power supply board 244. The control circuitry 240 includes at least one processor 243 that coordinates the electrical communication to and from the controller device 200 (e.g., communication between the controller device 200 and the pump device 100)” [0064]), and wherein the data processing terminal comprises the insulin pump (pump device 100 of infusion pump assembly 60; “a controller device 200 included in the pump assembly 60” [0026]).
Claims 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Estes (US 20100174266) in view of Yodfat et al. (US 20110071765).
Regarding claim 18, Estes discloses an insulin delivery system (infusion pump system 10; Figure 1), comprising:
an insulin pump (pump device 100) in communication with a receiver unit (controller device 200; “the infusion pump assembly 60 can include a pump device 100 and the controller device 200 that communicates with the pump device 100.” [0030]), the insulin pump configured to (See Figures 11 and 17):
implement a basal profile that is configured to administer an insulin dose as a single dose (“the drive system 300 can accurately and incrementally dispense fluid from the pump device 100 in a controlled manner (e.g., during the substantially continuous basal delivery,” [0072]; “Referring now to FIG. 17, in one exemplary process 950, a user can prompt a suggested bolus calculation by testing his or her blood glucose level using an external blood glucose meter. In operation 955, the user can receive infusion treatment as the pump assembly 60 operates to deliver insulin by basal dosages, selected bolus dosages, or a combination thereof.” [0143]);
receive, from the receiver unit, an adjustment instruction (“the infusion pump system 10 can be used to calculate and suggest a bolus dosage to be delivered to the user. For example, a process 400 for calculating and displaying a suggested bolus dosage can be implemented by the controller device 200.” [0074]; “After the user's current blood glucose information is input into the controller device 200, the controller device 200 may be prompted to calculate a suggested bolus dosage as previously described herein. In operation 980, the user can choose to accept or decline a bolus dosage that is suggested (e.g., via the display 222 of the controller device 200) by the controller device 200.” [0146]), wherein the adjustment instruction is based on a meal portion of a recommended bolus (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage.” [0078]) and a correction of the recommended bolus (“in operation 415, the controller device 200 can determine the blood glucose correction component of the suggested bolus dosage” [0079]) less an amount of remaining insulin (“in operation 425, the suggested bolus dosage can be calculated by summing the food offsetting component and the blood glucose correction component and subtracting the insulin load correction bolus. For example, in some embodiments, the suggested bolus dosage may be determined as follows: Suggested Bolus Dosage=(Food Offsetting Component)+(Blood Glucose Correction Component)-(Insulin Load Correction Component).” [0082]; “In operation 420, the controller device 200 can determine the insulin load correction component of the suggested bolus dosage. In this operation, the controller device 200 can determine the amount of previously delivered insulin that has not yet acted on the user.” [0080]), wherein the meal portion is based on a carbohydrate estimate and an insulin to carbohydrate ratio (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage…the controller device 200 can convert food intake data, such as carbohydrate information, entered into the controller device 200 and determine a quantity of insulin to offset the food intake. For example, in some embodiments, the food offsetting component can be calculated as follows: Food Offsetting Component=(Carbohydrate Intake)*(Insulin to Carb. Ratio), where Carbohydrate Intake represents the number of grams of carbohydrates consumed and Insulin to Carb. Ratio represents a user specific ratio of the amount of insulin required to offset the consumption of a gram of carbohydrates (e.g., 15 U/g or the like).” [0078]), and wherein the correction portion is based on a difference between a current glucose level and a target glucose level, and an insulin sensitivity factor (“in operation 415, the controller device 200 can determine the blood glucose correction component of the suggested bolus dosage…the controller device 200 can calculate the blood glucose correction component as follows: Blood Glucose Correction Component=(Current Blood Glucose Level-Target Glucose Level)*Insulin Sensitivity*[1+(Rate of Change*Scaling Factor)], where Current Blood Glucose Level represents the most recent blood glucose level, Target Glucose Level represents the user's desired blood glucose level, Insulin Sensitivity represents a user specific value that correlates the number of units of insulin required to alter the user's blood glucose level by 1 mg/dL, and Rate of Change in represents the recent rate of change in the user's blood glucose level.” [0079]);
update the basal profile based on the adjustment instruction (“In operation 405, the controller device 200 can wait for one or more triggers to initiate a bolus dosage calculation.” [0077]; “If the user accepts the suggested bolus dosage, the controller device 200 can execute operation 440, causing the pump device 100 to dispense an amount of insulin to the user that is equivalent to the suggested bolus dosage. The bolus dosage can be dispensed over a period of time according to a predetermined profile, such as a ramp profile, a square wave profile, or a curved profile.” [0087]); and
administer, based on the updated basal profile, the recommended bolus (“If the user accepts the suggested bolus dosage, the controller device 200 can execute operation 440, causing the pump device 100 to dispense an amount of insulin to the user that is equivalent to the suggested bolus dosage.” [0087]).
Estes fails to explicitly teach wherein the adjustment instruction comprises an instruction to fractionate the single dose into at least two discrete doses comprising a first dose and a subsequent dose; determine that the subsequent dose comprises a second dose and a third dose to be administered after the first dose; and administering, based on the updated basal profile, the recommended bolus in the at least two discrete doses.
Yodfat teaches an insulin delivery system (Figure 2) comprising: an insulin pump (dispensing patch unit 1010) in communication with a receiver unit (remote control unit 1008), the insulin pump configured to: update a delivery profile based on an adjustment instruction comprising an instruction to fractionate the single dose into at least two discrete doses (“the total bolus dose may be divided into a single phase, two phases, three phases or more (for example).” [0042]; “at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured…each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases, for example.” [0066-0067]) comprising a first dose (“The first phase can be administered between about 15 and about 60 minutes, and narrower ranges thereof (in some embodiments) before the approximate meal time (i.e. time of first phase bolus (t) is T-60), as illustrated at 401.” [0067]) and a subsequent dose (“the total bolus dose may be divided into…three phases” [0042]; wherein the subsequent dose is the second and third of the three phases; “At this time before the planned meal (e.g. 5 minutes before the meal) and/or after the user has been reminded to eat, the second phase bolus can be delivered, as illustrated at 403. In some embodiments, the amount of the second phase bolus can be equal to the total bolus (TB) configured at 400 minus the size of the first phase bolus delivered at 401.” [0068]); determine that the subsequent dose comprises a second dose and a third dose to be administered after the first dose (“the total bolus dose may be divided into…three phases” [0042]; wherein the subsequent dose is the second and third of the three phases of the total bolus); and administer, based on the updated delivery profile, the recommended bolus in the at least two discrete doses (“the total bolus dose may be divided into a single phase, two phases, three phases or more (for example).” [0042]; “the first phase can be administered between about 15 and about 60 minutes, and narrower ranges thereof (in some embodiments) before the approximate meal time (i.e. time of first phase bolus (t) is T-60), as illustrated at 401.” [0067]; “At this time before the planned meal (e.g. 5 minutes before the meal) and/or after the user has been reminded to eat, the second phase bolus can be delivered, as illustrated at 403.” [0068]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the insulin delivery system of Estes to include the adjustment instruction comprises an instruction to fractionate the single dose into at least two discrete doses comprising a first dose and a subsequent dose; determine that the subsequent dose comprises a second dose and a third dose to be administered after the first dose; and administer, based on the updated basal profile, the recommended bolus in the at least two discrete doses based on the teachings of Yodfat to alleviate postprandial hyperglycemia by accounting for the lag period between glucose and insulin blood level peaks (Yodfat [0015-0016]).
Regarding claim 19, modified Estes teaches the insulin delivery system of claim 18.
Modified Estes fails to explicitly teach the at least two discrete doses comprises a first dose that is administrated based on receipt of a user input.
Yodfat teaches an insulin delivery system (Figure 2) comprising: an insulin pump (dispensing patch unit 1010) in communication with a receiver unit (remote control unit 1008), the insulin pump configured to: update a delivery profile based on an adjustment instruction comprising an instruction to fractionate the single dose into at least two discrete doses (“at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured…each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases.” [0066-0067]); the at least two discrete doses comprises a first dose (“the first phase can be administered between about 15 and about 60 minutes, and narrower ranges thereof (in some embodiments) before the approximate meal time (i.e. time of first phase bolus (t) is T-60), as illustrated at 401.” [0067]) that is administrated based on receipt of a user input (“at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured.” [0066]; “FIGS. 7a-h provides an example of a user interface for a PPH alleviating feature using navigation windows for data inputs according to some embodiments. FIGS. 7a, 7b, 7b' and 7b'' illustrate examples of windows (also referred-to as "screens" and "displays") for inputting a daily bolus plan. The bolus plan can comprise the number of meals and approximate bolus size and meal time ("time") for each meal.” [0093]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the insulin delivery system of Estes to include the at least two discrete doses comprises a first dose that is administrated based on receipt of a user input based on the teachings of Yodfat to alleviate postprandial hyperglycemia by accounting for the lag period between glucose and insulin blood level peaks (Yodfat [0015-0016]).
Regarding claim 20, modified Estes teaches the insulin delivery system of claim 18.
Modified Estes fails to explicitly teach the at least two discrete doses comprises a second dose administered after the first dose, and wherein the second dose is calculated based at least in part on the first dose.
Yodfat teaches an insulin delivery system (Figure 2) comprising: an insulin pump (dispensing patch unit 1010) in communication with a receiver unit (remote control unit 1008), the insulin pump configured to: update a delivery profile based on an adjustment instruction comprising an instruction to fractionate the single dose into at least two discrete doses (“at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured…each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases.” [0066-0067]); the at least two discrete doses comprises a second dose administered after the first dose, and wherein the second dose is calculated based at least in part on the first dose (Figure 4; “the total bolus dose may be divided into a single phase, two phases, three phases or more (for example).” [0042]; “At this time before the planned meal (e.g. 5 minutes before the meal) and/or after the user has been reminded to eat, the second phase bolus can be delivered, as illustrated at 403. In some embodiments, the amount of the second phase bolus can be equal to the total bolus (TB) configured at 400 minus the size of the first phase bolus delivered at 401.” [0068]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the insulin delivery system of Estes to include the at least two discrete doses comprises a second dose administered after the first dose, and wherein the second dose is calculated based at least in part on the first dose based on the teachings of Yodfat to alleviate postprandial hyperglycemia by accounting for the lag period between glucose and insulin blood level peaks (Yodfat [0015-0016]).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 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 the prior art of record, specifically Yodfat et al. (US 20110071765), fails to teach or suggest the recommended bolus is configured to be administer as at least two discrete doses comprising a first dose and a subsequent dose comprising a second dose and a third dose to be administered after the first dose as required by amended claims 1, 9, and 18 (Remarks, page 8), the examiner respectfully disagrees. As detailed above, Yodfat discloses a the recommended bolus is configured to be administered as at least two discrete doses comprising a first dose and a subsequent dose comprising a second dose and a third dose to be administered after the first dose (“the total bolus dose may be divided into a single phase, two phases, three phases or more (for example).” [0042]; “at 400, the meal total bolus at least one of and preferably both of size (TB) and meal time (T) (e.g. start time of a meal) can be configured…each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases, for example.” [0066-0067] wherein the subsequent dose is the second and third of the three phases of the total bolus). Additionally, Yodfat discloses displaying a prompt to proceed or cancel administration of the second dose or the third dose based on the updated subsequent dose (“FIGS. 7f, 7f and 7f' illustrate examples of windows for confirming delivery of the second phase bolus” [0098]; “If the first phase bolus (also referred to as "Phase1 Bolus" and "Phase1") has already been administered and the user chooses to skip the planned meal, as depicted in step (306), then the user can cancel the second phase bolus.” [0075]; Figure 5).
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
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