Detailed ActionNotice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This office action is responsive to the amendment filed on July 28, 2025. No claims have been amended or canceled. Thus, claims 1-20 remain pending. 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morales (US20160038673A1; hereinafter known as “Morales”; previously cited) in view of Brown et al. (US20080097170A1; hereinafter known as “Brown”) in view of Walsh et al. (“Guidelines for optimal bolus calculator settings in adults”; hereinafter known as Walsh; previously cited) and in view of Mensinger et al. (WO2020231866A1; hereinafter known as “Mensinger”; previously cited).
Regarding claim 1, Morales teaches a non-transitory computer readable medium embodied with programming code as part of an artificial pancreas application executable by a processor (See Morales [0029][0142], the system has a non-transitory computer readable medium which stores information to execute processes), and the processor when executing the programming code optimizes a user's duration of insulin action setting by causing the processor to (See Morales Figure 8, determine insulin amount and delivering determined amount, data is communicated using processor and programs (See Morales [0140-0141])):
monitor a number of blood glucose measurements of a user (See Morales [0057] sensor data received includes blood glucose levels or level of another physiological fluid of subject);
determine, at predetermined intervals, a value of a user's insulin onboard (See Morales [0058], sensor data is taken at every 5-minute interval, also see [0059], the controller updates the parameters of the Bayesian network which produces an insulin time-action curve determining amount of insulin and the amounted needed to deliver, also see Figure 4 [0025] depicts the amount of Insulin remaining);
in response to a determination that the user's insulin onboard is less than or equal to zero (See Morales Figure 4, depicts how much insulin left on board, the graph going towards zero, Figure 8 teaches the adaptive insulin delivery [0057] [0112], sensor takes blood glucose level every 5 minutes and provides measurement to controller, determines glucose level change over time),
determine timing of an insulin dose based on the duration of insulin action setting (See Morales Figure 8, determine insulin amount and delivering determined amount, also see [0059]); and
output a command signal to deliver an insulin dose based on the determined timing (See Morales, Claim 1, commanding the infusion pump to deliver the calculated insulin delivery amount also see Figure 1).
Morales is silent to determine a rate of change of the number of blood glucose measurements; as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change.
Brown teaches a system for monitoring blood glucose (See abstract), and further teaches determining a rate of change of the number of the blood glucose measurements; as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change (See Brown [0010], display information or other data that may be useful in administering treatment plan, [0101] trend information either in a graphic or alphanumeric format, changes in blood glucose between time, [0009] changed or fluctuations that occur in blood glucose levels, [0102] calculates and displays average and the standard deviation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application provide Morales with the ability to determine a rate of change of the number of blood glucose measurements and as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change as taught by Brown to determine the appropriate treatment plan (See Brown [0004]).
Morales in view of Brown is silent as to modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modify based on the modified confidence value, a duration of insulin action setting that is optimized for the user. Walsh teaches modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modify based on the modified confidence value, a duration of insulin action setting that is optimized for the user (See Walsh Page 131 Section “Select an Accurate Duration of Insulin Action” A short DIA hides residual bolus insulin activity, causes insulin stacking, and leads to errors in other setting to compensate, therefore when insulin on board decreases and negative rate of change occurs implying the currently set DIA is accurate and requiring modification, determining how trustworthy (confident) the current DIA is, given outcome data, and then modify the DIA setting). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales in view Brown with modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modifying, based on the modified confidence value, a duration of insulin action setting that is optimized for the user as taught by Walsh to provide Morales’ device with a process which minimizes insulin stacking and provides proper insulin dosage (See Walsh abstract). Morales in view of Brown and Walsh is silent as to comparing the modified confidence value to a confidence threshold. Mensinger teaches comparing the modified confidence value to a confidence threshold (See Mensinger [00112-0116, defining a confidence value and increasing if the calculated and actual responses are beyond threshold]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales, as modified with Brown and Walsh with the ability to compare the modified confidence value to a confidence value threshold as taught by Mensinger to give Morales’ device the ability to determine dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See [00111-00112]).
Regarding claim 2, Morales teaches the processor, when executing the programming code, is further caused to determine timing of the insulin dose (See Morales Claim 1, use of a time action model, also see [0059], the time action model used to determine insulin dose), Morales in view of Brown and Walsh fail to teach the confidence value threshold is a positive value threshold.
Mensinger teaches a confidence value threshold is a positive value threshold (See [0112][00116], defining a confidence value and increasing if the calculated and actual responses are beyond a minimum threshold.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales as modified with Brown and Walsh with a confidence value threshold being a positive value threshold as taught by Mensinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Mensinger [00111][00112]).
Regarding claim 3, Morales teaches the processor executing the programming code to modify the duration of insulin action setting (See Morales Figure 8, determine insulin amount and delivering determined amount, data is communicated using processor and programs (See Morales [0140-0141])). Morales in view of Brown and Walsh is silent as to the duration of insulin action setting is further caused to increase the duration of insulin action setting.
Mensinger teaches the duration of insulin action setting is further caused to increase the duration of insulin action setting (See [0112] [00116] confidence takes into account duration of insulin action).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales as modified with Brown and Walsh with the duration of insulin action setting cause to increase the duration of insulin action setting as taught by Mensinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Mensinger [00111][00112]).
Regarding claim 4, Morales teaches non-transitory computer readable medium (See Morales Claim 1, use of a time action model, also see [0059], the time action model used to determine insulin dose), Morales in view of Brown and Walsh fails to teach the confidence value threshold is a negative confidence value threshold.
Mensinger teaches comparing the confidence value to a negative threshold (See [00112] [00116], defining a confidence value and decreasing if the calculated and actual responses are beyond a maximum threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales as modified with Brown and Walsh with the confidence value threshold which is negative as taught by Mensinger to allow Morales’ system to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Morales [00111][00112]).
Regarding claim 5, Morales teaches the processor executing the programming code to modify the duration of insulin action setting (See Morales Figure 8, determine insulin amount and delivering determined amount, data is communicated using processor and programs (See Morales [0140-0141])). Morales in view of Brown and Walsh is silent to the duration of insulin action setting is further caused to decrease the duration of insulin action setting.
Mensinger teaches the duration of insulin action setting is further caused to decrease the duration of insulin action setting (See [0112] [00116] confidence takes into account duration of insulin action).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales as modified with Brown and Walsh with the duration of insulin action setting further cause to decrease the duration of insulin action setting as taught by Mensinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Mensinger [00111][00112]).
Regarding claim 6, Morales teaches, when executing the programming code (See Morales [0140], and see figure 8) to modify the duration of insulin action setting (See Morales [0056-0059], parameters effect the time-action curve and the time-action curve is used to determine an amount of insulin to be delivered to the subject, and see [0104] ability to limit pump actuation/activity), and
increasing the duration of insulin action setting by a percentage of an estimated peak time of insulin action (See Morales [0042-0050], describes formula for estimating peak time and time delay for peak infusion, also see [0104] ability to limit the pump activity).
Morales in view Brown and Walsh fail to teach the duration of insulin action setting.
Mensinger teaches the duration of insulin action setting (See Mensinger [0005][0112], modifies duration with confidence value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales as modified with Brown and Walsh with the duration of insulin action setting as taught by Mensinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Morales [00111][00112]).
Regarding claim 7, Morales teaches decreasing the duration of insulin action setting (See Morales [0056-0059], parameters effect the time-action curve and the time-action curve is used to determine an amount of insulin to be delivered to the subject, and see [0104] ability to limit pump actuation/activity) by a percentage of an estimated peak time of insulin action (See Morales [0042-0050], describes formula for estimating peak time and time delay for peak infusion, also see [0104] ability to limit the pump activity).
Regarding claim 8, Morales teaches a device (See Morales Figure 1), comprising:
a processor (See Morales [0140], and see figure 8);
a memory storing programming code (See Morales [0097-0098]), and operable to store data related a personal diabetes treatment plan, wherein the programming code and the artificial pancreas application are executable by the processor (See Morales Abstract); and
a transceiver operable to receive and transmit signals containing information related to the personal diabetes treatment plan (See Morales [0097], uses wireless communication, abstract,[0029][0097]assist in their treatment),
wherein the processor when executing the programming code is operable to control delivery of insulin, and to perform functions to:
monitor a number of glucose measurements of a user (See Morales [0057] [0097] and figure 8; gather and process sensor data);
determine, at predetermined intervals, a value of a user's insulin onboard (See Morales [0058], the value of insulin (sensor information) taken at predetermined interval);
in response to a determination that the user's insulin onboard is less than or equal to zero (See Morales [0058], the value of insulin (sensor information) taken at predetermined interval, see Figure 4),
determine timing of an insulin dose based on the modified duration of insulin action setting (See Morales Figure 8, determine insulin amount and delivering determined amount, also see [0059]); and
output a command signal to deliver an insulin dose based on the determined timing (See Morales Claim 1, commanding the infusion pump to deliver the calculated insulin delivery amount also see Figure 1). Morales is silent to determine a rate of change of the number of blood glucose measurements; as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change. Brown teaches a system for monitoring blood glucose (See abstract) and further teaches a rate of change of the number of the blood glucose measurements; as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change (See Brown [0010], display information or other data that may be useful in administering treatment plan, [0101] trend information either in a graphic or alphanumeric format, changes in blood glucose between time, [0009] changed or fluctuations that occur in blood glucose levels, [0102] calculates and displays average and the standard deviation). Morales in view of Brown is silent to modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modify, based on the modified confidence value, a duration of insulin action setting that is optimized for the user.
Walsh teaches modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modifying based on the modified confidence value, a duration of insulin action setting that is optimized for the user (See Walsh Page 131 Section “Select an Accurate Duration of Insulin Action” A short DIA hides residual bolus insulin activity, causes insulin stacking, and leads to errors in other setting to compensate, therefore when insulin on board decreases and negative rate of change occurs implying the currently set DIA is accurate and requires modification). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales in view of Brown with modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modifying, based on the modified confidence value, a duration of insulin action setting that is optimized for the user as taught by Walsh to provide modified Morales’ device with a process which minimizes insulin stacking and provide proper insulin dosage (See Walsh abstract). Morales in view of Brown and Walsh is silent as to comparing the modified confidence value to a confidence threshold. Mensinger teaches comparing the modified confidence value to a confidence threshold (See Mensinger [00112-0116, defining a confidence value and increasing if the calculated and actual responses are beyond threshold]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales, as modified with Brown and Walsh, with the ability to compare the modified confidence value to a confidence value threshold as taught by Mensinger to provide Morales’ device with the ability to determine dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See [00111-00112]).
Regarding claim 9, Morales teaches a blood glucose sensor communicatively coupled to the processor, wherein the glucose sensor is operable to (See Morales Figure 1, and see [0097] and [0140]):
measure a glucose value at a predetermined time interval (See Morales [0058] and [0093]); and
provide measured glucose values to the processor and memory (See Morales abstract)
Regarding claim 10, Morales teaches a medical device communicatively coupled to the processor (See Morales Figure 1 and [0097] and [0140]), a pump mechanism (See Morales abstract and see [0057] and Figure 8 method for controlling the pump), wherein the processor is operable to: actuate the pump mechanism in response to the received command signal (See Morales Figure 8, shutdown pump).
Regarding claim 11, Morales teaches the processor, when executing the programming code, is further caused to determine timing of the insulin dose (See Morales Claim 1, use of a time action model, also see [0059], the time action model used to determine insulin dose), Morales in Brown and Walsh fail to teach the confidence value threshold is a positive value threshold.
Mensinger teaches a confidence value threshold is a positive value threshold (See [00112][00116], defining a confidence value and increasing if the calculated and actual responses are beyond a minimum threshold.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales, as modified with Brown and Walsh, with a confidence value threshold is a positive value threshold as taught by Mensinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Mensinger [00111][00112]).
Regarding claim 12, Morales teaches the processor executing the programming code to modify the duration of insulin action setting (See Morales Figure 8, determine insulin amount and delivering determined amount, data is communicated using processor and programs (See Morales [0140-0141])). Morales in view Brown and Walsh is silent to the duration of insulin action setting is further caused to increase the duration of insulin action setting.
Mensinger teaches the duration of insulin action setting is further caused to increase the duration of insulin action setting (See [0112][00116] confidence takes into account duration of insulin action).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales, as modified with Brown and Walsh, with the duration of insulin action setting further cause to increase the duration of insulin action setting as taught by Mensinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Mensinger [00111][00112]).
Regarding claim 13, Morales teaches computer readable medium (See Morales Claim 1, use of a time action model, also see [0059], the time action model used to determine insulin dose), Morales in view Brown and Walsh fails to teach the confidence value threshold is a negative confidence value threshold.
Mensinger teaches comparing the confidence value to a negative threshold (See [00112][00116], defining a confidence value and decreasing if the calculated and actual responses are beyond a maximum threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales, as modified with Brown and Walsh, with the confidence value threshold which is negative as taught by Mensinger to allow Morales’ system to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Morales [00111][00112]).
Regarding claim 14, Morales teaches the processor executing the programming code to modify the duration of insulin action setting (See Morales Figure 8, determine insulin amount and delivering determined amount, data is communicated using processor and programs (See Morales [0140-0141])). Morales in view of Brown and Walsh is silent to the duration of insulin action setting is further caused to decrease the duration of insulin action setting.
Mensinger teaches the duration of insulin action setting is further caused to decrease the duration of insulin action setting (See [0112][00116] confidence takes into account duration of insulin action).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales, as modified with Brown and Walsh, with the duration of insulin action setting further cause to decrease the duration of insulin action setting as taught by Mesinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Mesinger [00111][00112]).
Regarding claim 15, Morales teaches a method for determining an optimal duration of insulin action (See Morales Figure 8, determine insulin amount and delivering determined amount, data is communicated using processor and programs (See Morales [0140-0141])), comprising:
monitoring a number of blood glucose measurements of a user (See Morales [0057] [0097] and figure 8; gather and process sensor data);
determining, at predetermined intervals by a processor executing artificial pancreas application (See Morales [0029]), a value of a user's insulin onboard (See Morales [0058], sensor data is taken at every 5-minute interval, also see [0059], the controller updates the parameters of the Bayesian network which produces an insulin time-action curve determining amount of insulin and the amounted needed to deliver, also see Figure 4 [0025] depicts the amount of Insulin remaining);
in response to a determination that the user's insulin onboard is less than or equal to zero (See Morales Figure 4, depicts how much insulin left onboard, the graph going towards zero, Figure 8 teaches also the adaptive insulin delivery [0057][0112], sensor takes blood glucose level every 5 minutes and provides measurement to controller, determines glucose level change over time),
determining timing of an insulin dose based on the modified duration of insulin action setting (See Morales [0059], and Figure 8); and
outputting a command signal to deliver an insulin dose based on the determined timing (See Morales Claim 1, commanding the infusion pump to deliver the calculated insulin delivery amount and see Figure 1).
Morales is silent to determining a rate of change of the number of blood glucose measurements; as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change. Brown teaches a system for bolus dosage calculations (See abstract), and further teaches a rate of change of the number of the blood glucose measurements; as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change (See Brown [0010], display information or other data that may be useful in administering treatment plan, [0101] trend information either in a graphic or alphanumeric format, changes in blood glucose between time, [0009] changed or fluctuations that occur in blood glucose levels, [0102] calculates and displays average and the standard deviation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application provide Morales with the ability to determine a rate of change of the number of blood glucose measurements and as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change as taught by Brown to determine the appropriate determine the appropriate treatment plan (See Brown [0004]).
Morales in view of Brown is silent to modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modifying based on the modified confidence value, a duration of insulin action setting that is optimized for the user. Walsh teaches modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modifying based on the modified confidence value, a duration of insulin action setting that is optimized for the user (See Walsh Page 131 Section “Select an Accurate Duration of Insulin Action” A short DIA hides residual bolus insulin activity, causes insulin stacking, and leads to errors in other setting to compensate, therefore when insulin on board decreases and negative rate of change occurs implying the currently set DIA is accurate and requiring modification, determining how trustworthy (confident) the current DIA is, given outcome data, and then modify the DIA setting). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales in view Brown with modifying a confidence value, wherein the confidence value is related to a duration of insulin action setting, and modifying, based on the modified confidence value, a duration of insulin action setting that is optimized for the user as taught by Walsh to modify Morales’ device with a process which minimizes insulin stacking and provide proper insulin dosage (See Walsh abstract). Morales in view Brown and Walsh is silent to comparing the modified confidence value to a confidence threshold.
Mensinger teaches comparing the modified confidence value to a confidence threshold (See Mensinger [00112-0116, defining a confidence value and increasing if the calculated and actual responses are beyond threshold]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales, as modified with Brown and Walsh with the ability to compare the modified confidence value to a confidence value threshold as taught by Mensinger to give Morales’ device the ability to determine dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See [00111-00112]).
Regarding claim 16, Morales teaches to determine timing of the insulin dose (See Morales Claim 1, use of a time action model, also see [0059], the time action model used to determine insulin dose), Morales in view of Brown and Walsh fail to teach the confidence value threshold is a positive confidence value threshold value.
Mensinger teaches a confidence value threshold is a positive confidence value threshold value (See [00112][00116], defining a confidence value and increasing if the calculated and actual responses are beyond a minimum threshold.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales as modified with Brown and Walsh with the ability to compare the modified confidence value to a confidence value threshold as taught by Mensinger to allow Morales’ device the ability to determine dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See [00111-00112]).
Regarding claim 17, Morales teaches the method (See Morales Figure 8, determine insulin amount and delivering determined amount, data is communicated using processor and programs (See Morales [0140-0141])). Morales in view Brown and Walsh is silent to the duration of insulin action setting is further caused to increase the duration of insulin action setting.
Mensinger teaches the duration of insulin action setting is further caused to increase the duration of insulin action setting (See [0112][00116] confidence takes into account duration of insulin action).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Morales as modified with Brown and Walsh with the duration of insulin action setting further cause to increase the duration of insulin action setting as taught by Mesinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Mesinger [00111][00112]).
Regarding claim 18, Morales teaches determining timing of the insulin dose (See Morales Claim 1, use of a time action model, also see [0059], the time action model used to determine insulin dose) and the duration of insulin action setting (See Morales Figure 8, determine insulin amount and delivering determined amount, data is communicated using processor and programs (See Morales [0140-0141])).
Morales in view of Brown and Walsh fail to teach comparing the confidence value to a negative confidence threshold value and in response to the comparison decreasing the duration of insulin action setting.
Mensinger teaches comparing the confidence value to a negative confidence threshold value (See [00112][00116], defining a confidence value and decreasing if the calculated and actual responses are beyond a maximum threshold). Mensinger further teaches, in response to a result of the comparison of the confidence value to the negative confidence threshold value, decreasing the duration of insulin action setting (See [0112][00116], defining a confidence value and increasing if the calculated and actual responses are beyond a minimum threshold, confidence value effects the duration of insulin action).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to compare the confidence value of Morales, as modified with Brown and Walsh with a negative threshold and in response decrease the duration of insulin action setting as taught by Mensinger in order to mitigate the risk of compounding error when determining dose for blood glucose trends and achieve the most accurate blood glucose control for a user (See Morales [00111][00112]).
Regarding claim 19, Morales teaches modifying the duration of insulin action setting (See Morales [0056-0059], parameters effect the time-action curve and the time-action curve is used to determine an amount of insulin to be delivered to the subject, and see [0104] ability to limit pump actuation/activity), comprising:
increasing the duration of insulin action setting by a percentage of an estimated peak time of insulin action (See Morales [0042-0050], describes formula for estimating peak time and time delay for peak infusion, also see [0104] ability to limit the pump activity).
Regarding claim 20, Morales teaches modifying the duration of insulin action setting (See Morales [0056-0059], parameters effect the time-action curve and the time-action curve is used to determine an amount of insulin to be delivered to the subject, and see [0104] ability to limit pump actuation/activity), comprising:
decreasing the duration of insulin action setting (See Morales [0056-0059], parameters effect the time-action curve and the time-action curve is used to determine an amount of insulin to be delivered to the subject, and see [0104] ability to limit pump actuation/activity) by a percentage of an estimated peak time of insulin action (See Morales [0042-0050], describes formula for estimating peak time and time delay for peak infusion, also see [0104] ability to limit the pump activity). Response to Arguments Applicant’s argument filed July 28, 2025 with respect to claims 1-20 rejected under U.S.C. 103 specifically regarding “None of the above quoted language from the Office's statement corresponds to the claim language of "as a result of determining the rate of change of the number of glucose measurements is a negative rate of change, modify a confidence value, wherein the confidence value is related to a duration of insulin action setting; compare the modified confidence value to a confidence value threshold; modify, based on a result of the comparison, a duration of insulin action setting."” has been fully considered and is persuasive. Walsh does not teach determining the rate of change of the number of glucose measurements is a negative rate of change, however Walsh does teach determining an accurate DIA give outcome data, then modifying the DIA; therefore it also is determining incorrect settings and modifying using algorithmic evaluation (See Walsh 131). The rejection has been withdrawn. However, upon further search and consideration the claims are rejected under U.S.C 103 as being unpatentable over Morales (US20160038673A1; hereinafter known as “Morales”; previously cited) in view of Brown et al. (US20080097170A1; hereinafter known as “Brown”) of Walsh et al. (“Guidelines for optimal bolus calculator settings in adults”; hereinafter known as Walsh) of Mensinger et al. (WO2020231866A1; hereinafter known as “Mensinger”; previously cited).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meghan R Kumar whose telephone number is (571)272-7125. The examiner can normally be reached Monday-Friday, 8a.m - 5p.m.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.R.K./Examiner, Art Unit 3791