DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 02/25/2025. As directed by the amendment: Claims 21-23 have been amended, claims 2-4 and 6-7 have been cancelled, and no claims have been added. Thus, claims 1, 5, and 8-23 are presently pending in the application wherein claims 10-20 are withdrawn.
Applicant’s amendments to claims 21-23 have overcome the previous 112 rejection previously set forth in the Non-Final Office Action mailed 11/29/2024.
Response to Arguments
Applicant’s arguments, see pages 9-10, filed 02/25/2025, with respect to the rejection of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nguyen (US 11607491). Nguyen discloses a disposable pump such that it is configured to be disposed after three days and wherein the disposable pump includes a reservoir 125 capable of storing a volume of medication giver per day over three days (column 3, lines 4-7). Nguyen further teaches determining that an amount of insulin to be filled in the reservoir 125 is equal to the highest dose of medication giver per day (daily estimate of insulin needs for the user) multiplied by three days (number of days in the period of days) (column 3, lines 4-16). Nguyen teaches a FILL diode 113 on display 105 to prompt the user to fill reservoir 125 (column 2, lines 62-65).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5, 8-9, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Booth (US 2015/0217053); in view of Parikh (US 11147919), and Nguyen (US 11607491).
Regarding Claim 1, Booth discloses a method performed by a processor of an insulin delivery system (system (100); Fig.1B) that includes an insulin delivery device (insulin pump (123a)), comprising: with the processor of the insulin delivery system (the system (100) has a processor/computing device (112) capable of executing instructions) (parag. [0084], first sentence), estimating total daily basal insulin needs of a user, wherein the estimating of the total daily basal insulin needs (Based on those measurements (that may be stored in non-transitory memory 24, 114, 144), the system 100 recommends an intravenous dosage of insulin, glucose, or saline or a subcutaneous basal and bolus insulin dosing recommendation or prescribed dose to adjust and maintain the blood glucose level towards a configurable (based on the patient's information) physician's determined blood glucose target range BGTR; parag. [0057], lines 20-26) comprises: analyzing historic data regarding basal insulin deliveries to a user by the insulin delivery device to determine an average basal insulin delivery dose (the system analyzes/evaluates patient’s information (insulin doses being administered to the patient e.g. log-acting insulin doses for basal insulin and rapid-acting insulin doses for meal and correction boluses) (parag. [0057]); with the processor (112) of the insulin delivery system, estimating total daily bolus insulin needs of the user (parag. [0057], lines 20-26) based on past insulin bolus deliveries to the user (parag. [0057], lines 16-26); with the processor of the insulin delivery system, adding the estimate of the total daily basal insulin needs of the user with the estimate of the total daily bolus insulin needs of the user to obtain a daily estimate of insulin needs for the user (The method further includes determining, using the computing device, recommended insulin dose comprising a daily basal insulin and a daily meal insulin for subcutaneous therapy as an apportioning of the total daily dose of insulin; parag. [0011], lines 12-16).
Booth does not appear to disclose determining the estimate of total daily basal insulin needs from the average basal insulin delivery dose per the interval. Booth does not disclose the insulin delivery device is disposable such that it is configured to be disposed of at an end of a period of days and wherein the insulin delivery device includes a reservoir having sufficient capacity for storing insulin to be delivered by the insulin delivery device for the period of days; with the processor of the insulin delivery system, determining that an amount of insulin to be filled in the reservoir is equal to the daily estimate of insulin needs for the user multiplied by a number of days in the period of days; and causing display of a prompt via a user interface to have the user add the determined amount of insulin to the reservoir.
Parikh teaches it was known in the art to determine an average percentage of basal insulin delivery per segment (3 hours segment) and determine total daily basal of insulin (column 9 and table 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Booth to incorporate the teachings of Parikh to determine an average basal insulin delivery dose per interval that is less than a day in duration to calculate the basal rate of delivery (Table 3).
Nguyen teaches it was known in the art to have a disposable pump such that it is configured to be disposed after three days and wherein the disposable pump includes a reservoir (125; Fig.3) capable of storing a volume of medication giver per day over three days (column 3, lines 4-7). Nguyen further teaches determining that an amount of insulin to be filled in the reservoir (125) is equal to the highest dose of medication giver per day (daily estimate of insulin needs for the user) multiplied by three days (number of days in the period of days) (column 3, lines 4-16). Nguyen teaches a FILL diode (113; Fig.1B) on display (105) to prompt the user to fill reservoir (125) (column 2, lines 62-65).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Booth to incorporate the teachings of Nguyen to have a disposable insulin delivery device configured to be disposed of at an end of a period of days and wherein the insulin delivery device includes a reservoir having sufficient capacity for storing insulin to be delivered by the insulin delivery device for the period of days; with the processor of the insulin delivery system, determining that an amount of insulin to be filled in the reservoir is equal to the daily estimate of insulin needs for the user multiplied by a number of days in the period of days in order to have a selectable continuous rate dosage setting (column 1, lines 42-44) and causing display of a prompt via a user interface to have the user add the determined amount of insulin to the reservoir in order to indicate pump status and user prompts to enhance control of the delivery device (column 2, lines 47-49).
Regarding Claim 5, Booth as modified discloses the method of claim 1, and further discloses further comprising adjusting the estimate of the total daily bolus insulin needs of the user by a safety factor (multiplier) before adding with the estimate of the total daily basal insulin needs of the user (The method may further include determining, using the computing device, a total daily dose of insulin based on the multiplier when the current blood glucose measurement is within a stability target range for a threshold period of time. The method further includes determining, using the computing device, recommended insulin dose comprising a daily basal insulin and a daily meal insulin for subcutaneous therapy as an apportioning of the total daily dose of insulin; parag. [0011], lines 9-16).
Regarding Claim 8, Booth discloses a non-transitory computer-readable storage medium storing instruction for execution by a processor (112) of a drug delivery system (100 and 123a) that includes an insulin delivery device (123a) to perform the following: estimate total daily basal insulin needs of a user (Based on those measurements (that may be stored in non-transitory memory 24, 114, 144), the system 100 recommends an intravenous dosage of insulin, glucose, or saline or a subcutaneous basal and bolus insulin dosing recommendation or prescribed dose to adjust and maintain the blood glucose level towards a configurable (based on the patient's information) physician's determined blood glucose target range BGTR; parag. [0057], lines 20-26) based on a historical amount of insulin delivered by the insulin delivery device to the user per day (parag. [0057], lines 16-26), wherein the estimating of the total daily basal insulin needs comprises: analyzing historic data regarding basal insulin deliveries to a user by the insulin delivery device to determine an average basal insulin delivery dose (the system analyzes/evaluates patient’s information (insulin doses being administered to the patient e.g. log-acting insulin doses for basal insulin and rapid-acting insulin doses for meal and correction boluses) (parag. [0057]); estimate total daily bolus insulin needs of the user (parag. [0057], lines 20-26) based on past insulin bolus deliveries to the user (parag. [0057], lines 16-26); add the estimate of the total daily basal insulin needs of the user with the estimate of the total daily bolus insulin needs of the user to obtain a daily estimate of insulin needs for the user (The method further includes determining, using the computing device, recommended insulin dose comprising a daily basal insulin and a daily meal insulin for subcutaneous therapy as an apportioning of the total daily dose of insulin; parag. [0011], lines 12-16).
Booth does not appear to disclose determining the estimate of total daily basal insulin needs from the average basal insulin delivery dose per the interval. Booth does not disclose the insulin delivery device is disposable such that it is configured to be disposed of at an end of a period of days and wherein the insulin delivery device includes a reservoir having sufficient capacity for storing insulin to be delivered by the insulin delivery device for the period of days; determine that an amount of insulin to be filled in the reservoir is equal to the daily estimate of insulin needs for the user multiplied by a number of days in the period of days; and cause display of a prompt via a user interface to have the user add the determined amount of insulin to the reservoir.
Parikh teaches it was known in the art to determine an average percentage of basal insulin delivery per segment (3 hours segment) and determine total daily basal of insulin (column 9 and table 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Booth to incorporate the teachings of Parikh to determine an average basal insulin delivery dose per interval that is less than a day in duration to calculate the basal rate of delivery (Table 3).
Nguyen teaches it was known in the art to have a disposable pump such that it is configured to be disposed after three days and wherein the disposable pump includes a reservoir (125; Fig.3) capable of storing a volume of medication giver per day over three days (column 3, lines 4-7). Nguyen further teaches determining that an amount of insulin to be filled in the reservoir (125) is equal to the highest dose of medication giver per day (daily estimate of insulin needs for the user) multiplied by three days (number of days in the period of days) (column 3, lines 4-16). Nguyen teaches a FILL diode (113; Fig.1B) on display (105) to prompt the user to fill reservoir (125) (column 2, lines 62-65).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Booth to incorporate the teachings of Nguyen to have a disposable insulin delivery device configured to be disposed of at an end of a period of days and wherein the insulin delivery device includes a reservoir having sufficient capacity for storing insulin to be delivered by the insulin delivery device for the period of days; with the processor of the insulin delivery system, determining that an amount of insulin to be filled in the reservoir is equal to the daily estimate of insulin needs for the user multiplied by a number of days in the period of days in order to have a selectable continuous rate dosage setting (column 1, lines 42-44) and causing display of a prompt via a user interface to have the user add the determined amount of insulin to the reservoir in order to indicate pump status and user prompts to enhance control of the delivery device (column 2, lines 47-49).
Regarding Claim 9, Booth discloses a drug delivery system (100 and 123a), comprising: an insulin reservoir for storing insulin (The device includes: a pump, a disposable reservoir for insulin, and a disposable infusion set; parag. [0072], lines 4-6); a storage (non-transitory memory (24)) for storing a program (process (200); Fig.2A) for determining an amount of insulin to be filled into the insulin reservoir for a user (Therefore, the clinical decision support system 100 calculates a personalized dose of insulin to bring and maintain the patient's blood glucose level into a target range BGTR, while taking into consideration the condition of the patient 10; parag. [0080], last sentence), a history of insulin deliveries by the drug delivery device to the user and a history of bolus insulin deliveries for the user (Based on those measurements (that may be stored in non-transitory memory 24, 114, 144), the system 100 recommends an intravenous dosage of insulin, glucose, or saline or a subcutaneous basal and bolus insulin dosing recommendation or prescribed dose to adjust and maintain the blood glucose level towards a configurable (based on the patient's information) physician's determined blood glucose target range BGTR; parag. [0057], lines 20-26); a processor (112) for executing the program (200) to perform the following: estimating total daily basal insulin needs of a user based on a historical amount of insulin delivered by the drug delivery device to the user per day (parag. [0057], lines 16-26), wherein the estimating of the total daily basal insulin needs comprises: analyzing historic data regarding basal insulin deliveries to a user by the insulin delivery device (the system analyzes/evaluates patient’s information (insulin doses being administered to the patient e.g. log-acting insulin doses for basal insulin and rapid-acting insulin doses for meal and correction boluses) (parag. [0057]); estimating total daily bolus insulin needs of the user (parag. [0057], lines 20-26) based on past insulin bolus deliveries to the user (parag. [0057], lines 16-26); adding the estimate of the total daily basal insulin needs of the user with the estimate of the total daily bolus insulin needs of the user to obtain a daily estimate of insulin needs for the user (The method further includes determining, using the computing device, recommended insulin dose comprising a daily basal insulin and a daily meal insulin for subcutaneous therapy as an apportioning of the total daily dose of insulin; parag. [0011], lines 12-16).
Booth does not appear to disclose determining the estimate of total daily basal insulin needs from the average basal insulin delivery dose per the interval. Booth does not disclose the insulin delivery device is disposable such that it is configured to be disposed of at an end of a period of days and wherein the insulin delivery device includes a reservoir having sufficient capacity for storing insulin to be delivered by the insulin delivery device for the period of days; with the processor of the insulin delivery system, determining that an amount of insulin to be filled in the reservoir is equal to the daily estimate of insulin needs for the user multiplied by a number of days in the period of days; and causing display of a prompt via a user interface to have the user add the determined amount of insulin to the reservoir.
Parikh teaches it was known in the art to determine an average percentage of basal insulin delivery per segment (3 hours segment) and determine total daily basal of insulin (column 9 and table 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Booth to incorporate the teachings of Parikh to determine an average basal insulin delivery dose per interval that is less than a day in duration to calculate the basal rate of delivery (Table 3).
Nguyen teaches it was known in the art to have a disposable pump such that it is configured to be disposed after three days and wherein the disposable pump includes a reservoir (125; Fig.3) capable of storing a volume of medication giver per day over three days (column 3, lines 4-7). Nguyen further teaches determining that an amount of insulin to be filled in the reservoir (125) is equal to the highest dose of medication giver per day (daily estimate of insulin needs for the user) multiplied by three days (number of days in the period of days) (column 3, lines 4-16). Nguyen teaches a FILL diode (113; Fig.1B) on display (105) to prompt the user to fill reservoir (125) (column 2, lines 62-65).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Booth to incorporate the teachings of Nguyen to have a disposable insulin delivery device configured to be disposed of at an end of a period of days and wherein the insulin delivery device includes a reservoir having sufficient capacity for storing insulin to be delivered by the insulin delivery device for the period of days; with the processor of the insulin delivery system, determining that an amount of insulin to be filled in the reservoir is equal to the daily estimate of insulin needs for the user multiplied by a number of days in the period of days in order to have a selectable continuous rate dosage setting (column 1, lines 42-44) and causing display of a prompt via a user interface to have the user add the determined amount of insulin to the reservoir in order to indicate pump status and user prompts to enhance control of the delivery device (column 2, lines 47-49).
Regarding Claim 21, Booth as modified discloses the method of claim 1, and further discloses wherein the estimating of the total daily bolus insulin needs of the user further comprises multiplying one half of a difference between an average daily sum of all insulin deliveries to the user and twice the estimate of total daily basal needs by a variance coefficient that accounts for variability in daily bolus insulin doses delivered to the user to estimate the total daily bolus insulin needs of the user. Booth discloses determining the total daily insulin needs by adding the total daily insulin and the total daily basal insulin (parag. [0011], lines 12-16) and Parikh discloses obtaining an average total basal insulin delivery to the user per day (based on 3 hours segment) (column 9, Table 1, and Table 3). Booth is fully capable of estimating the total daily bolus insulin needs by multiplying one half (since the total daily basal insulin is half the total daily insulin needs (parag. [0011], lines 12-16)) of the difference between an average daily sum of all insulin deliveries to the user ((parag. [0011], lines 12-16) in Booth) and two times the total basal insulin delivery to the user per day (disclosed by Parikh) by a variance coefficient (since the variance coefficient is variable).
Regarding Claim 22, Booth as modified discloses the non-transitory computer-readable storage medium of claim 8, and further discloses wherein the computer programming instructions include instructions by the processor of the drug delivery system to estimate the total daily bolus insulin needs of the user further comprises multiplying one half of a difference between an average daily sum of all insulin deliveries to the user and twice the estimate of total daily basal needs by a variance coefficient that accounts for variability in daily bolus insulin doses delivered to the user to estimate the total daily bolus insulin needs of the user. Booth discloses determining the total daily insulin needs by adding the total daily insulin and the total daily basal insulin (parag. [0011], lines 12-16) and Parikh discloses obtaining an average total basal insulin delivery to the user per day (based on 3 hours segment) (column 9, Table 1, and Table 3). Booth is fully capable of estimating the total daily bolus insulin needs by multiplying one half (since the total daily basal insulin is half the total daily insulin needs (parag. [0011], lines 12-16)) of the difference between an average daily sum of all insulin deliveries to the user ((parag. [0011], lines 12-16) in Booth) and two times the total basal insulin delivery to the user per day (disclosed by Parikh) by a variance coefficient (since the variance coefficient is variable).
Regarding Claim 23, Booth as modified discloses the drug delivery system of claim 9, and further discloses wherein the processor, in estimating of the total daily bolus insulin needs of the user, multiplies one half of a difference between an average daily sum of all insulin deliveries to the user and twice the estimate of total daily basal needs by a variance coefficient that accounts for variability in daily bolus insulin doses delivered to the user to estimate the total daily bolus insulin needs of the user. Booth discloses determining the total daily insulin needs by adding the total daily insulin and the total daily basal insulin (parag. [0011], lines 12-16) and Parikh discloses obtaining an average total basal insulin delivery to the user per day (based on 3 hours segment) (column 9, Table 1, and Table 3). Booth is fully capable of estimating the total daily bolus insulin needs by multiplying one half (since the total daily basal insulin is half the total daily insulin needs (parag. [0011], lines 12-16)) of the difference between an average daily sum of all insulin deliveries to the user ((parag. [0011], lines 12-16) in Booth) and two times the total basal insulin delivery to the user per day (disclosed by Parikh) by a variance coefficient (since the variance coefficient is variable).
Conclusion
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/T.I./ Examiner, Art Unit 3783
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
