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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 24, 2025 has been entered.
The amendment filed September 25, 2025 has been entered. Claims 1-20 remain pending in the application.
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 1-15 and 17-20 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 1, Estes discloses a method for determining a dose of insulin to administer to a user (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]), the method comprising:
collecting glucose data (“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]) by an in vivo glucose sensor (sensor shaft 56) of a glucose monitoring assembly (glucose monitoring device 50), wherein the glucose sensor comprises a portion (sensor shaft 56) configured to be positioned in fluid contact with an interstitial fluid of a user (“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]), and wherein the glucose sensor is coupled to sensor electronics (wireless communication device 54; “the monitoring device 50 may include a circuit that permits sensor signals (e.g., data from the sensor shaft 56) to be communicated to the communication device 54.” [0034]);
communicating the collected glucose data to a processor (control circuitry 240 of controller device 200 having processor 243) in communication with the glucose monitoring assembly (“The communication device 54 can transfer the collected data to the infusion pump assembly 60 (e.g., by wireless communication to a communication device 247 arranged in the pump assembly 60).” [0034]);
calculating, by the processor, a correction bolus based on the glucose data collected by the in vivo glucose sensor (“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]);
calculating, by the processor, a meal bolus (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage.” [0078]) based at least on meal information 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]); and
administering, by an insulin delivery device (infusion pump assembly 60 having controller device 200 and pump device 100), a first dose at a first time (“In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage…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]), wherein the first dose comprises an entirety of the correction bolus and an entirety of the calculated meal bolus (“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]).
Estes fails to explicitly disclose determining to administer insulin as more than one dose; and wherein the first dose comprises a percentage of the calculated meal bolus.
Yodfat teaches a method for determining a dose of insulin to administer to a user (Figure 4; “FIG. 4 illustrates a flow chart of an exemplary algorithm for implementing a PPH alleviating method” [0066]), the method comprising: determining to administer insulin as more than one dose (“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]); calculating a meal 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. In some embodiments, the total bolus size (TB) can be selected” [0066]) based at least on meal information (“The device can further include a bolus selector adopted for selecting a total bolus dose of a drug corresponding to at least one of the food intake time and the food intake type and a glucose concentration level of a user.” [0042]); and administering a first dose at a first time, wherein the first dose comprises a percentage of the calculated meal bolus (“the first phase bolus can comprise a range of about 10% to about 90% of the total bolus (TB). For example, 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]; Figure 4).
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, which discloses administering an entirety of both the correction bolus and the correction meal bolus in the first dose, to include determining to administer insulin as more than one dose; and wherein the first dose comprises a percentage of the calculated meal bolus rather than an entirety of the calculated meal bolus 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 claims 2 and 3, modified Estes teaches the method of claim 1.
Modified Estes fails to explicitly teach the method further comprising administering a second dose of insulin at a second time after the first time, as required by claim 2; and wherein the second dose is calculated based at least in part on the first dose, as required by claim 3.
Yodfat teaches a method for determining a dose of insulin to administer to a user (Figure 4), the method comprising: determining to administer insulin as more than one dose (“each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases.” [0066-0067]); administering a first dose at a first time (Figure 4 at step 401; [0067]); and administering a second dose of insulin at a second time after the first time (“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]; Figure 4); and wherein the second dose is calculated based at least in part on the first dose (“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]; Figure 4).
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 administering a second dose of insulin at a second time after the first time, as required by claim 2, wherein the second dose is calculated based at least in part on the first dose, as required by claim 3 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 4, modified Estes teaches the method of claim 1, wherein the correction bolus is further calculated based on 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]).
Regarding claim 5, modified Estes teaches the method of claim 1, and a receiver (display 222 of controller device 200) in communication with the glucose monitoring assembly (Figure 1, communication via wireless communication device 54: “The communication device 54 can transfer the collected data to the infusion pump assembly 60 (e.g., by wireless communication to a communication device 247 arranged in the pump assembly 60).” [0034]).
Modified Estes fails to explicitly teach wherein determining to administer insulin as more than one dose comprises prompting the user, via the receiver, for a selection to administer insulin as a single dose or as more than one dose, and receiving a response at an input of the receiver to administer the insulin as more than one dose.
Yodfat teaches a method for determining a dose of insulin to administer to a user (Figure 4), the method comprising: determining to administer insulin as more than one dose (“each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases.” [0066-0067]); wherein determining to administer insulin as more than one dose comprises prompting the user, via a receiver (remote control unit 1008), for selection to administer insulin as a single dose or as more than one dose, and receiving a response at an input of the receiver to administer the insulin as more than one 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], wherein the first phase bolus confirmation windows in Figures 7c, 7c’, and 7c’’ allow the user to select to administer the insulin as at least a single dose and the second phase bolus confirmation windows in Figures 7f, 7f’, and 7f’’ allow the user to select to administer the insulin as only the first, single dose or to confirm the second dose).
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 wherein determining to administer insulin as more than one dose comprises prompting the user, via the receiver, for a selection to administer insulin as a single dose or as more than one dose, and receiving a response at an input of the receiver to administer the insulin as more than one 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]).
Regarding claim 6, modified Estes teaches the method of claim 1.
Modified Estes fails to explicitly teach wherein the percentage of the calculated meal bolus is 70% of the calculated meal bolus.
Yodfat teaches a method for determining a dose of insulin to administer to a user (Figure 4), the method comprising: determining to administer insulin as more than one dose (“each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases.” [0066-0067]); calculating a meal 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. In some embodiments, the total bolus size (TB) can be selected” [0066]); and administering a first dose at a first time (Figure 4, Step 401; [0067]), wherein the first dose comprises a percentage of the calculated meal bolus, wherein the percentage of the calculated meal bolus is 70% of the calculated meal bolus (“the first phase bolus can comprise a range of about 10% to about 90% of the total bolus (TB)” [0067]; Figure 4).
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 percentage of the calculated meal bolus is 70% of the calculated meal bolus 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 7, modified Estes teaches the method of claim 1, wherein the first dose is reduced by an amount of insulin on board (“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). In these circumstances, the suggested bolus dosage may accurately reflect food intake data entered into the controller device 200, the user's blood glucose data (including the recent rate of change in the blood glucose levels), the previously dispensed insulin that has not yet acted (to reduce or otherwise effect the blood glucose level)” [0082]; “As described herein, "insulin load" includes an estimated value of previously dispensed insulin that has not yet acted in the user's body, such as total insulin load (TIL) information (e.g., an insulin load calculation that includes previous basal and bolus dosages, previously consumed food, or the like), traditional insulin-on-board estimates (which typically account for only bolus dosages), or other such estimated insulin load values.” [0028]).
Regarding claim 8, modified Estes teaches the method of claim 1, further comprising prompting the user, via a receiver (display 222 of controller device 200) in communication with the glucose monitoring assembly (Figure 1, communication via wireless communication device 54: “The communication device 54 can transfer the collected data to the infusion pump assembly 60 (e.g., by wireless communication to a communication device 247 arranged in the pump assembly 60).” [0034]), to administer the first dose at the first time (“In operation 430, the suggested bolus dosage can be displayed, for example, on the display 222 of the controller device 200…the user can initiate the proper insulin bolus within a selected time frame soon before or after the meal consumption. In some embodiments, the user interface can 220 prompt the user to accept or decline the suggested bolus dosage that is displayed on the screen 222.” [0085]), and administering the first dose upon receipt of a user input of the receiver (“In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage…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 9, modified Estes teaches the method of claim 1, wherein the meal information comprises a carbohydrate estimate (“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]).
Regarding claim 10, Estes discloses a system for determining a dose of insulin to administer to a user (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]), the system comprising:
a glucose monitoring assembly (glucose monitoring device 50) configured to collect glucose data (“a glucose monitoring device 50 that communicates 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 included in the pump assembly 60.” [0026]; “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]), the glucose monitoring assembly comprising:
an in vivo glucose sensor (sensor shaft 56) comprising a portion (sensor shaft 56) configured to be positioned in fluid contact with an interstitial fluid of a user (“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]), and
sensor electronics (wireless communication device 54) coupled to the in vivo glucose sensor (“the monitoring device 50 may include a circuit that permits sensor signals (e.g., data from the sensor shaft 56) to be communicated to the communication device 54.” [0034]); and
a processor (controller device 200 having processor 243) coupled to a memory (memory chip 248), wherein the memory stores instructions for determining the dose of insulin to administer to the user (“the control circuitry 240 may include one or more dedicated memory devices that store executable software instructions for the processor 243. 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 delivered bolus dosages over a period of time.” [0065]), and wherein when the instructions are executed by the processor, the processor is caused to:
receive glucose data from the glucose monitoring assembly (“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]; “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]);
calculate a correction bolus based on the glucose data collected by the glucose monitoring assembly (“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]);
calculate a meal bolus (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage.” [0078]) based at least on meal information 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]); and
cause administration of a first dose at a first time by an insulin delivery device in communication with the processor (infusion pump assembly 60 having controller device 200 and pump device 100; “In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage…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]), wherein the first dose comprises an entirety of the correction bolus and an entirety of the calculated meal bolus (“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]).
Estes fails to explicitly disclose the processor is caused to determine to administer insulin as more than one dose; and wherein the first dose comprises a percentage of the calculated meal bolus.
Yodfat teaches a system for determining a dose of insulin to administer to a user (Figure 4; “FIG. 4 illustrates a flow chart of an exemplary algorithm for implementing a PPH alleviating method” [0066]), the system comprising causing a processor (“Some embodiments of the present disclosure preferably implement the PPH alleviation feature via software operated on a processor contained in a remote control device of an insulin dispensing system and/or a processor contained in a insulin dispensing device being party of an insulin dispensing system.” [0111]): determine to administer insulin as more than one dose (“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]); calculate a meal 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. In some embodiments, the total bolus size (TB) can be selected” [0066]) based at least on meal information (“The device can further include a bolus selector adopted for selecting a total bolus dose of a drug corresponding to at least one of the food intake time and the food intake type and a glucose concentration level of a user.” [0042]); and administer a first dose at a first time, wherein the first dose comprises a percentage of the calculated meal bolus (“the first phase bolus can comprise a range of about 10% to about 90% of the total bolus (TB). For example, 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]; Figure 4).
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 system of Estes, which discloses administering an entirety of both the correction bolus and the correction meal bolus in the first dose, to include determine to administer insulin as more than one dose; and wherein the first dose comprises a percentage of the calculated meal bolus rather than an entirety of the calculated meal bolus 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 11, modified Estes teaches the system of claim 10.
Modified Estes fails to explicitly teach wherein the processor is further configured to cause administration of a second dose of insulin at a second time after the first time.
Yodfat teaches a system for determining a dose of insulin to administer to a user (Figure 4), the system comprising: determine to administer insulin as more than one dose (“each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases.” [0066-0067]); administer a first dose at a first time (Figure 4 at step 401; [0067]); and cause administration of a second dose of insulin at a second time after the first time (“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]; Figure 4); and wherein the second dose is calculated based at least in part on the first dose (“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]; Figure 4).
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 system of Estes to include wherein the processor is further configured to cause administration of a second dose of insulin at a second time after the first time 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 12, modified Estes teaches the system of claim 10.
Modified Estes fails to explicitly teach wherein the processor is further caused to prompt the user to administer insulin as a single dose or as more than one dose, and wherein the determination to administer insulin as more than one dose comprises receiving a response by the receiver to administer the insulin as more than one dose.
Yodfat teaches a system for determining a dose of insulin to administer to a user (Figure 4), the system comprising: determine to administer insulin as more than one dose (“each total bolus can be automatically divided/segmented, by the PPH alleviating feature, into two phases.” [0066-0067]); wherein a processor (processor 2010) is caused to prompt the user to administer insulin as a single dose or as more than one dose, and wherein the determination to administer insulin as more than one dose comprises receiving a response by the receiver to administer the insulin as more than one 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], wherein the first phase bolus confirmation windows in Figures 7c, 7c’, and 7c’’ prompts the user to administer the insulin as at least a single dose and the second phase bolus confirmation windows in Figures 7f, 7f’, and 7f’’ further prompts the user to administer the insulin as only the first, single dose or to confirm the second dose).
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 system of Estes to include wherein the processor is further caused to prompt the user to administer insulin as a single dose or as more than one dose, and wherein the determination to administer insulin as more than one dose comprises receiving a response by the receiver to administer the insulin as more than one 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]).
Regarding claim 13, modified Estes teaches the system of claim 10, wherein the first dose is reduced by an amount of insulin on board (“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). In these circumstances, the suggested bolus dosage may accurately reflect food intake data entered into the controller device 200, the user's blood glucose data (including the recent rate of change in the blood glucose levels), the previously dispensed insulin that has not yet acted (to reduce or otherwise effect the blood glucose level)” [0082]; “As described herein, "insulin load" includes an estimated value of previously dispensed insulin that has not yet acted in the user's body, such as total insulin load (TIL) information (e.g., an insulin load calculation that includes previous basal and bolus dosages, previously consumed food, or the like), traditional insulin-on-board estimates (which typically account for only bolus dosages), or other such estimated insulin load values.” [0028]).
Regarding claim 14, modified Estes teaches the system of claim 10, wherein the processor is further caused to prompt the user to administer the first dose at the first time, and wherein the first dose is administered based on receipt of a user input (“In operation 430, the suggested bolus dosage can be displayed, for example, on the display 222 of the controller device 200…the user can initiate the proper insulin bolus within a selected time frame soon before or after the meal consumption. In some embodiments, the user interface can 220 prompt the user to accept or decline the suggested bolus dosage that is displayed on the screen 222.” [0085]; “In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage…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 system of claim 10, wherein the meal information comprises a carbohydrate estimate (“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]).
Regarding claim 17, modified Estes teaches the system of claim 10, wherein the insulin delivery device comprises an infusion pump (infusion pump assembly 60; Figure 1).
Regarding claim 18, modified Estes teaches the system of claim 10, wherein a receiver (controller device 200 having communication device 247) in communication with the glucose monitoring assembly (via communication device 54: “The communication device 54 can transfer the collected data to the infusion pump assembly 60 (e.g., by wireless communication to a communication device 247 arranged in the pump assembly 60).” [0034]) comprises the processor (controller device 200 having processor 243).
Regarding claim 19, modified Estes teaches the system of claim 10, wherein the insulin delivery device (infusion pump assembly 60) comprises the processor (controller device 200 having processor 243; “a controller device 200 included in the pump assembly 60” [0026]).
Regarding claim 20, Estes discloses a non-transitory computer-readable medium (memory chip 248) having instructions stored thereon that, when executed by at least one computing device (controller device 200 having processor 243), cause the at least one computing device to perform operations (“the control circuitry 240 may include one or more dedicated memory devices that store executable software instructions for the processor 243. 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 delivered bolus dosages over a period of time.” [0065]) comprising
receive glucose data (Figure 11; “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]) from an in vivo glucose sensor (sensor shaft 56) of a glucose monitoring assembly (glucose monitoring device 50), wherein the in vivo glucose sensor comprises a portion (sensor shaft 56) configured to be positioned in fluid contact with an interstitial fluid of a user (“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]), and wherein the in vivo glucose sensor (sensor shaft 56) is coupled to sensor electronics (wireless communication device 54; “the monitoring device 50 may include a circuit that permits sensor signals (e.g., data from the sensor shaft 56) to be communicated to the communication device 54.” [0034]);
calculating a correction bolus based on the glucose data collected by the in vivo glucose monitoring assembly (“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]);
calculating a meal bolus (“In operation 410, the controller device 200 can determine the food offsetting component of the suggested bolus dosage.” [0078]) based at least on meal information 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]); and
administering a first dose at a first time (“In operation 435, the controller device 200 can determine, from user input, whether the user accepted or declined the suggested bolus dosage…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]), wherein the first dose comprises an entirety of the correction bolus and an entirety of the calculated meal bolus (“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]).
Estes fails to explicitly disclose determining to administer insulin as more than one dose; and wherein the first dose comprises a percentage of the calculated meal bolus.
Yodfat teaches a method for determining a dose of insulin to administer to a user (Figure 4; “FIG. 4 illustrates a flow chart of an exemplary algorithm for implementing a PPH alleviating method” [0066]), the method comprising: determining to administer insulin as more than one dose (“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]); calculating a meal 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. In some embodiments, the total bolus size (TB) can be selected” [0066]) based at least on meal information (“The device can further include a bolus selector adopted for selecting a total bolus dose of a drug corresponding to at least one of the food intake time and the food intake type and a glucose concentration level of a user.” [0042]); and administering a first dose at a first time, wherein the first dose comprises a percentage of the calculated meal bolus (“the first phase bolus can comprise a range of about 10% to about 90% of the total bolus (TB). For example, 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]; Figure 4).
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 operations of Estes, which discloses administering an entirety of both the correction bolus and the correction meal bolus in the first dose, to include determining to administer insulin as more than one dose; and wherein the first dose comprises a percentage of the calculated meal bolus rather than an entirety of the calculated meal bolus 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]).
Claim 16 is 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) as applied to claim 10 above, and further in view of Hayter et al. (US 20090164239).
Regarding claim 16, modified Estes teaches the system of claim 10. Modified Estes fails to explicitly teach wherein the insulin delivery device comprises a pen.
Hayter teaches a system for determining a dose of insulin to administer to a user (Figure 8), the system comprising: a processor (processor 210) caused to receive glucose data (“the analyte monitoring system 110 (FIG. 1) may be configured to receive and store available and/or valid analyte sensor data including continuous glucose level measurement data (8100) which are indicative of the user or patient's current and past glucose levels” [0108]); calculate a correction bolus and a meal bolus (“the bolus determination may include glucose level information from the analyte monitoring system 110 (FIG. 1) and the meal information received from the patient or the user, in conjunction with one or more of other relevant parameters described below, to propose an insulin dosage or level information to attain an anticipated blood glucose level or the future or target glucose profile (8190)” [0111]); and cause administering a first dose at a first time by an insulin infusion device (“The patient or the user may be also provided with a function or a user input command to execute the delivery of the determined bolus amount (8150), which, upon activation is configured to control the fluid delivery device 120 (FIG, 1) to deliver the determined amount of insulin to the patient.” [0117]); wherein the insulin delivery device (fluid delivery device 120) comprises a pen (“the fluid delivery device 120 may include…a pen-type insulin injector device” [0044]).
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 device of Estes to comprise a pen based on the teachings of Hayter to allow the user to manually administer the insulin (Hayter [0077]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-10, 12 and 20 of U.S. Patent No. 11737687 in view of Estes (US 20100174266), Yodfat et al. (US 20110071765) and Hayter et al. (US 20090164239).
Claims 1, 9-10, 12 and 20 of USPN 11737687 discloses all of the features of claims 1-20 (see Table below) except for:
The in vivo sensor being an glucose sensor comprising a portion configured to be positioned in fluid contact with an interstitial fluid of a user, the glucose sensor coupled to sensor electronics, as required by claims 1, 10 and 20
Calculating a meal bolus based at least on meal information and an insulin to carbohydrate ratio, as required by claims 1, 10 and 20
Administering a first dose at a first time, wherein the first dose comprises an entirety of the correction bolus and a percentage of the calculated meal bolus as required by claims 1, 10 and 20
The second dose is calculated based at least in part on the first dose, as required by claim 3
The correction bolus is further calculated based on an insulin sensitivity factor,