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
The amendment filed December 03, 2025 has been entered. Claims 1-26 remain pending in the application. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed September 03, 2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/28/25, 09/26/25, and 01/13/26 have been considered by the examiner.
The information disclosure statement filed 09/26/25 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The IDS cites Non-Patent Literature Documents 2 as “U.S. Patent Application, 11/362,616”. However, the provided document (56 pages) does not appear to be a copy of US patent application 11362616. It appears that the provided document is US patent application 11/954,755.
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 1-3 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro et al. (US 2012/0136336) in view of Yodfat et al. (US 20090018406).
Regarding claim 1, Mastrototaro discloses a method (Figures 12-14), comprising: responsive to a user selection (“In a semi-closed system, the insulin delivery system will prompt the patient to accept the adjusted basal rate prior to the delivery of insulin (S540).” [0093], see also step S660 of Figure 13) to operate a medication delivery system (insulin delivery system 14 having infusion pump 34) according to a first delivery mode allowing at least some control of delivery of medication to the user without user supervision (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12-14), initiating a regimen, comprising:
determining one or more user-specific dosage parameters (“Upon obtaining the measured blood glucose level, the controller 12 determines whether the Target is successfully achieved and maintained (S510). If so, the controller commands the insulin delivery system to continue delivering insulin to the patient according to the patient's preset personal basal pattern (S520). However, if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530).” [0091], wherein the “user-specific dosage parameter” is the adjusted basal rate);
upon determining the one or more user-specific dosage parameters, operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12 and 13; “if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530). Depending on whether the blood glucose is higher or lower than the targeted blood glucose level, more or less insulin will be delivered compared to the existing patient's preset basal rate set in his/her basal pattern…the controller 12 will command the insulin delivery system 14 to deliver insulin at the adjusted basal rate (S550). In a semi-closed system, the insulin delivery system will prompt the patient to accept the adjusted basal rate prior to the delivery of insulin (S540).” [0091-0093]); and
changing a mode of the medication delivery system according to a second delivery mode (“open-loop control” [0116]) responsive to detecting an absence or presence of a signal for communicating the analyte sensor data about the user (“At S720, an event is triggered that requires the system to drop out of closed-loop control. This may be triggered by any of the previously mentioned safety features built into the closed-loop control.” [0116]; “an assessment mechanism that can evaluate the sensor signal fidelity and initiate the appropriate action following detection of a sensor failure. In the event a fault is detected, a request for sensor replacements should be initiated and a temporary suspension of insulin delivery or control should switch to a fixed mode of operation with set basal patterns.” [0074]), the second delivery mode disallowing control of delivery of medication to the user without user supervision (“FIG. 14 describes an embodiment of the invention where the closed-loop algorithm will turn into an open-loop system where patient intervention is required.” [0115]).
Mastrototaro fails to explicitly teach the method comprising initiating a test regimen, comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period to a user of the medication delivery system; obtaining analyte sensor data indicative of one or more of analyte data of the user during the predetermined time period or subsequent to the time period; and based at least partially on the series of predetermined test dosages of medication and the obtained analyte sensor data, determining one or more user-specific dosage parameters; upon determining the one or more user-specific dosage parameters from the test regimen, operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined from the test regimen.
Yodfat teaches a method (Figure 4; “The CIR assessment feature (10) can be also incorporated in this embodiment and used for calculation of the bolus inputs when the system functions in a semi-closed loop mode.” [0077]) comprising: initiating a test regimen (CIR assessment feature 10; Figure 4), comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period to a user of a medication delivery system (“In step (53), a normal insulin bolus can be administered to the patient. The normal insulin bolus can be calculated based on the previously known CIR, i.e., Bolus=Carbs/CIR.sub.old” [0079]); obtaining analyte sensor data indicative of one or more of analyte data of the user during the predetermined time period or subsequent to the time period (“The method then can proceed to step (55), where current BG levels ("CBG") are sensed and measured periodically (e.g., every 15 minutes) until at least two measurements are approximately the same, "BG.sub.1" (e.g. .+-.10 mg/dL).” [0079]); and based at least partially on the series of predetermined test dosages of medication and the obtained analyte sensor data, determining one or more user-specific dosage parameters (CIRNEW; “If glucose level doesn't return to it's initial value (i.e. BG.sub.0), then the current CIR value ("CIR.sub.old") can be inadequate and a new CIR value ("CIR.sub.new") can be calculated according to a formula discussed below and applied.” [0057]; see all of [0080] and Figure 4); upon determining the one or more user-specific dosage parameters from the test regimen, operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined from the test regimen (“The CIR assessment feature (10) can be also incorporated in this embodiment and used for calculation of the bolus inputs when the system functions in a semi-closed loop mode.” [0077]).
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 Mastrototaro to include initiating a test regimen, comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period; and based at least partially on the series of predetermined test dosages of medication and obtained analyte sensor data indicative of one or more of analyte data of the user, determining one or more user-specific dosage parameters and operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined from the test regimen based on the teachings of Yodfat to provide an updated carbohydrate to insulin ratio in order to provide accurate and specific bolus dosing for the individual patient that is periodically updated in order to improve glycemic control (Yodfat [0018-0019], [0062]).
Regarding claim 2, modified Mastrototaro discloses the method of claim 1, further comprising obtaining, while the medication delivery system is operating according to the first delivery mode (Figures 12 and 13), (i) analyte sensor data (“a patient's measured blood glucose level is obtained (S500) using the glucose sensor system 10 of FIG. 1” [0090]) and (ii) one or more of medicine delivery data and food intake data (“Upon obtaining the measured blood glucose level, the controller 12 determines whether the Target is successfully achieved and maintained (S510)…if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530)…in administering the insulin at the adjusted basal rate, the controller 12 preferably limits the adjusted basal rate to a maximum and/or minimum boundary on the adjusted basal rate (S530). The maximum and/or minimum boundary on the adjusted basal rate is set based on the preset basal rate.” [0091-0092]).
Regarding claim 3, modified Mastrototaro discloses the method of claim 2, further comprising responsive to the obtained (i) analyte sensor data and (ii) the one or more of the medicine delivery data and the food intake data, determining user-specific dosage parameters that influence amounts of the medications to deliver to the user according to the first delivery mode (“Over time, if the basal rate is regularly adjusted and consistently reaches the maximum and/or minimum boundary for any given time interval, this may indicate that the patient's insulin requirements have changed, and therefore the patient's personal basal pattern may need to be altered. Accordingly, based on the maximum and/or minimum boundary value consistently reached during any given time interval, the controller 12 may recommend to the patient a new basal rate the patient can integrate into his/her personal basal pattern.” [0095], see Figure 12 and all of [0091-0095]).
Regarding claim 26, modified Mastrototaro discloses the method of claim 1.
Modified Mastrototaro fails to explicitly disclose the series of predetermined test dosages of medication according to the test regimen comprises a series of test boluses of medication.
Yodfat teaches a method (Figure 4; “The CIR assessment feature (10) can be also incorporated in this embodiment and used for calculation of the bolus inputs when the system functions in a semi-closed loop mode.” [0077]) comprising: initiating a test regimen (CIR assessment feature 10; Figure 4), comprising: initiating delivery of a series of predetermined test dosages of medication comprising a series of test boluses of medication (“In step (53), a normal insulin bolus can be administered to the patient. The normal insulin bolus can be calculated based on the previously known CIR, i.e., Bolus=Carbs/CIR.sub.old” [0079]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Mastrototaro to include the series of predetermined test dosages of medication according to the test regimen comprises a series of test boluses of medication based on the teachings of Yodfat to provide an updated carbohydrate to insulin ratio in order to provide accurate and specific bolus dosing for the individual patient that is periodically updated in order to improve glycemic control (Yodfat [0018-0019], [0062]).
Claims 4-6, 9-13, and 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro et al. (US 2012/0136336) in view of Yodfat et al. (US 20090018406) as applied in claim 3 above, further in view of Estes (US 2014/0249500).
Regarding claim 4, modified Mastrototaro discloses the method of claim 3.
Mastrototaro fails to explicitly teach the method further comprising, while the medication delivery system is operating according to and without exiting the second delivery mode, performing the following: obtaining (i) additional analyte sensor data and (ii) additional medicine delivery data; determining one or more updates to the updated user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional medicine delivery data; and delivering the medication to the user according to the second delivery mode and responsive to the updates to the updated user-specific dosage parameters.
Estes teaches a method (method 400, method 600, and method 800; Figures 10, 13, and 15) comprising operating in a delivery mode that disallows control of delivery of medication to the user without user supervision (see operations 420, 460-490 of method 400; operations 615, 640 of method 600; and operations 810, 840, 880 of method 800), wherein while the medication delivery system is operating according to and without exiting the delivery mode (“an operation 410 of dispensing medicine to a user from an infusion pump system over a period of time. For example, the infusion pump system 10 can dispense insulin to a user in a combination of basal and bolus dosages over a period of days.” [0096]), performing the following: obtaining (i) additional analyte sensor data (“an operation 410 of dispensing medicine to a user from an infusion pump system over a period of time. For example, the infusion pump system 10 can dispense insulin to a user in a combination of basal and bolus dosages over a period of days” [0096], wherein dispensing insulin includes obtaining analyte sensor data: “The method 600 can include an operation 605 of receiving data indicative of a blood glucose level at time t.sub.1. As previously described, the blood glucose data (which may be indicative of a recent blood glucose level of the user) can be wirelessly received by the controller device 200 of the infusion pump system 10 from the glucose monitoring device 50” [0136]; “the controller device 200 can be configured to suggestion a recommended bolus amount to the user” [0138]) and (ii) additional medicine delivery data (Operation 420 of Figure 10; see all of [0096]); determining one or more updates to the updated user-specific dosage parameters (operations 430, 440, and 480 described in paragraphs [0097-0114], [0122], [0124]; “the method 400 may continue to operation 480 in which the infusion pump system prompts the user to take one or more corrective actions…if the pump usage parameters stored in the memory device reveal that the average total daily bolus dosage is significantly greater than the average total daily basal dosage, the infusion pump device can prompt the user to increase that basal dosage throughout the day, to increase the value for the user's carb ratio setting, to increase the value for the user's insulin sensitivity setting (refer to FIG. 7A), or a combination thereon.” [0124]) based at least partially on (i) the additional analyte sensor data (“an operation 410 of dispensing medicine to a user from an infusion pump system over a period of time. For example, the infusion pump system 10 can dispense insulin to a user in a combination of basal and bolus dosages over a period of days” [0096], wherein dispensing insulin includes obtaining analyte sensor data: “The method 600 can include an operation 605 of receiving data indicative of a blood glucose level at time t.sub.1. As previously described, the blood glucose data (which may be indicative of a recent blood glucose level of the user) can be wirelessly received by the controller device 200 of the infusion pump system 10 from the glucose monitoring device 50” [0136]; “the controller device 200 can be configured to suggestion a recommended bolus amount to the user” [0138]) and (ii) the additional medicine delivery data (Operation 420 of Figure 10; see all of [0096]); and delivering the medication to the user according to the delivery mode and responsive to the updates to the updated user-specific dosage parameters (“The method 400 may also include operation 490 in which the infusion pump system receives user input in response to the prompting at operation 480. For example, the infusion pump system can receive user input at operation 490 when the user provides a new value to replace one or the aforementioned settings…From there, the method 400 can return to operation 410 in which the infusion pump system dispenses the medicine in accordance with normal usage.” [0125-0126]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Mastrototaro to include while the medication delivery system is operating according to and without exiting a delivery mode, performing the following: obtaining (i) additional analyte sensor data and (ii) additional medicine delivery data; determining one or more updates to the updated user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional medicine delivery data; and delivering the medication to the user according to the second delivery mode and responsive to the updates to the updated user-specific dosage parameters based on the teachings of Estes to provide a retrospective safety check of the user-specific dosage parameters and allow them to be corrected to safely deliver insulin to the user (Estes [0006]).
Regarding claim 5, modified Mastrototaro teaches the method of claim 4, further comprising determining the amount of the medication to deliver to the user according to the first delivery mode via a primary feedback loop (Figure 12) that utilizes the analyte sensor data (“FIG. 12 illustrates a method for providing therapy modification in a closed loop/semi-closed loop infusion system…a patient's measured blood glucose level is obtained (S500) using the glucose sensor system 10 of FIG. 1” [0090]) and the user-specific dosage parameters (“the controller may simply be the controller in an infusion pump that calculates the amount of insulin to be infused based upon the insulin sensitivity/carbohydrate ratio of the individual, the target blood glucose level, amount of carbohydrates to be ingested and the current blood glucose level supplied by the sensor.” [0071]).
Regarding claim 6, modified Mastrototaro teaches the method of claim 4, wherein the analyte sensor data indicates a blood analyte level for the user at one or more specific times (“Referring to FIG. 12, at the end of a particular basal pattern time interval, a patient's measured blood glucose level is obtained (S500) using the glucose sensor system 10 of FIG. 1, for example.” [0090]).
Regarding claim 9, modified Mastrototaro teaches the method of claim 4.
Modified Mastrototaro fails to explicitly teach further comprising determining the one or more updates to the user-specific dosage parameters via a secondary feedback loop.
Estes teaches a method (method 400, method 600, and method 800; Figures 10, 13, and 15) comprising determining one or more updates to the user-specific dosage parameters (operations 430, 440, and 480 described in paragraphs [0097-0114], [0122], [0124]; “the method 400 may continue to operation 480 in which the infusion pump system prompts the user to take one or more corrective actions…if the pump usage parameters stored in the memory device reveal that the average total daily bolus dosage is significantly greater than the average total daily basal dosage, the infusion pump device can prompt the user to increase that basal dosage throughout the day, to increase the value for the user's carb ratio setting, to increase the value for the user's insulin sensitivity setting (refer to FIG. 7A), or a combination thereon.” [0124]) via a secondary feedback loop (Figure 10; “a method 400 for controlling an infusion pump system can be implemented so as to retrospectively evaluate a previously stored value of user-specific settings and pump usage information to thereby alert the user if any of the values is out of balance with a different user-specific setting or pump usage value” [0095], described [0095-0126]).
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 Mastrototaro to include determining the one or more updates to the user-specific dosage parameters via a secondary feedback loop based on the teachings of Estes to provide a retrospective safety check of the user-specific dosage parameters and allow them to be corrected to safely deliver insulin to the user (Estes [0006]).
Regarding claim 10, modified Mastrototaro teaches the method of claim 4, wherein the medication delivery system comprises a portable insulin infusion pump system (infusion device 34; “the infusion device 34 responds to the commands 22 and actuates a plunger 48 that forces insulin 24 out of a reservoir 50 located inside the infusion device 34” [0058]; See Figure 2 showing device 34 on body and therefore portable), the analyte sensor data comprises data describing blood glucose readings (“Referring to FIG. 12, at the end of a particular basal pattern time interval, a patient's measured blood glucose level is obtained (S500) using the glucose sensor system 10 of FIG. 1, for example.” [0090]), and the medicine delivery data identifies insulin dosages delivered to the user from the portable insulin infusion pump system (“Upon obtaining the measured blood glucose level, the controller 12 determines whether the Target is successfully achieved and maintained (S510)…if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530)…in administering the insulin at the adjusted basal rate, the controller 12 preferably limits the adjusted basal rate to a maximum and/or minimum boundary on the adjusted basal rate (S530). The maximum and/or minimum boundary on the adjusted basal rate is set based on the preset basal rate.” [0091-0092]).
Regarding claim 11, modified Mastrototaro teaches the method of claim 4.
Modified Mastrototaro fails to explicitly teach wherein the updates to the updated user-specific dosage parameters are determined based at least partially on both (i) analyte sensor data and medicine delivery data generated during the first delivery mode and (ii) additional analyte sensor data and additional medicine delivery data generated during the second delivery mode.
Estes teaches a method (method 400, method 600, and method 800; Figures 10, 13, and 15) wherein the updates to the updated user-specific dosage parameters (operations 430, 440, and 480 described in paragraphs [0097-0114], [0122], [0124]; “the method 400 may continue to operation 480 in which the infusion pump system prompts the user to take one or more corrective actions…if the pump usage parameters stored in the memory device reveal that the average total daily bolus dosage is significantly greater than the average total daily basal dosage, the infusion pump device can prompt the user to increase that basal dosage throughout the day, to increase the value for the user's carb ratio setting, to increase the value for the user's insulin sensitivity setting (refer to FIG. 7A), or a combination thereon.” [0124]) are determined based at least partially on both (i) analyte sensor data and medicine delivery data generated during the first delivery mode (“retrospectively evaluate previously stored values of user-specific settings and dosage history to determine if any of the values is out of balance with a different user-specific setting or dosage history value” [0015], see all of [0015]) and (ii) additional analyte sensor data and additional medicine delivery data generated during the delivery mode (“The method 400 can include an operation 410 of dispensing medicine to a user from an infusion pump system over a period of time. For example, the infusion pump system 10 can dispense insulin to a user in a combination of basal and bolus dosages over a period of days. In operation 420, the infusion pump system can store values of a number of user-specific settings and pump usage parameters.” [0096], see all of [0096]; wherein the stored values include historical delivery data, such as from a previous delivery, and the data from the current operation 410).
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 Mastrototaro to include wherein the updates to the updated user-specific dosage parameters are determined based at least partially on both (i) analyte sensor data and medicine delivery data generated during the first delivery mode and (ii) additional analyte sensor data and additional medicine delivery data generated during the second delivery mode based on the teachings of Estes to provide a retrospective safety check of the user-specific dosage parameters and allow them to be corrected to safely deliver insulin to the user (Estes [0006]).
Regarding claim 12, modified Mastrototaro teaches the method of claim 4, further comprising: detecting a transition trigger event comprising the detection of the absence or the presence of the signal for communicating the analyte sensor data about the user (“At S720, an event is triggered that requires the system to drop out of closed-loop control. This may be triggered by any of the previously mentioned safety features built into the closed-loop control.” [0116]; “an assessment mechanism that can evaluate the sensor signal fidelity and initiate the appropriate action following detection of a sensor failure. In the event a fault is detected, a request for sensor replacements should be initiated and a temporary suspension of insulin delivery or control should switch to a fixed mode of operation with set basal patterns.” [0074]); and responsive to the transition trigger event, switching from the first delivery mode to the second delivery mode (Figure 14; “At S720, an event is triggered that requires the system to drop out of closed-loop control…At S730, when the closed-loop control reverts into open-loop control” [0016]).
Regarding claim 13, modified Mastrototaro teaches the method of claim 12, wherein detecting the transition trigger event comprises detecting the transition trigger event automatically without user input (“Updates can be done automatically” [0115]; “At S720, an event is triggered that requires the system to drop out of closed-loop control. This may be triggered by any of the previously mentioned safety features built into the closed-loop control.” [0116]).
Regarding claim 15, modified Mastrototaro teaches the method of claim 12, wherein detecting the transition trigger event comprises detecting an expiration of a period of time for operating the medication delivery system according to the first delivery mode (“a controller of an infusion pump can be programmed to go into open loop conditions during meal times (i.e. injections of meal boluses) or correction boluses, where the user will control the amount of insulin given in a bolus.” [0072], wherein the period of time is the time between meal times).
Regarding claim 16, modified Mastrototaro teaches the method of claim 12, wherein detecting the transition trigger event comprises detecting that one or more calibrations for one or more components of the medication delivery system has failed to be completed after a threshold period of time (Figure 13: “if the Target is not achieved and maintained, the controller 12 will prompt the user to perform calibration of the glucose sensor (S630). If the user does not wish to perform calibration, or wishes to perform the calibration at a later time, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S640)” [0102]; “it is contemplated that systematic errors may occur, and therefore the predefined threshold may be exceeded when adjusting the basal rate (i.e. the amount of insulin to be delivered exceeds the maximum/minimum boundary on the preset basal rate). In such a case, the controller does not automatically allow the insulin delivery system 14 to deliver insulin to the patient at the adjusted basal rate. Consequently, at least one of a number of actions will be performed (S680).” [0108]; “At S720, an event is triggered that requires the system to drop out of closed-loop control. This may be triggered by any of the previously mentioned safety features built into the closed-loop control” [0116], wherein the calibration is not completed within a threshold period of time at S630 and therefore a safety action is performed at S680. The safety action can include transitioning to open-loop control).
Regarding claim 17, modified Mastrototaro teaches the method of claim 12, wherein detecting the transition trigger event comprises detecting a scheduled transition in a time-based schedule for a patient using the medication delivery system (“a controller of an infusion pump can be programmed to go into open loop conditions during meal times (i.e. injections of meal boluses) or correction boluses, where the user will control the amount of insulin given in a bolus.” [0072]).
Regarding claim 18, modified Mastrototaro teaches the method of claim 12, wherein detecting the transition trigger event comprises detecting one or more components of the medication delivery system failing one or more safety checks (“At S720, an event is triggered that requires the system to drop out of closed-loop control. This may be triggered by any of the previously mentioned safety features built into the closed-loop control.” [0116]; “it is contemplated that systematic errors may occur, and therefore the predefined threshold may be exceeded when adjusting the basal rate (i.e. the amount of insulin to be delivered exceeds the maximum/minimum boundary on the preset basal rate). In such a case, the controller does not automatically allow the insulin delivery system 14 to deliver insulin to the patient at the adjusted basal rate. Consequently, at least one of a number of actions will be performed (S560).” [0096], see also [0108] and [0074]).
Regarding claim 19, modified Mastrototaro teaches the method of claim 12, wherein detecting the transition trigger event comprises detecting a user input at the medication delivery system (Figure 13: “if the Target is not achieved and maintained, the controller 12 will prompt the user to perform calibration of the glucose sensor (S630). If the user does not wish to perform calibration, or wishes to perform the calibration at a later time, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S640)” [0102]; “it is contemplated that systematic errors may occur, and therefore the predefined threshold may be exceeded when adjusting the basal rate (i.e. the amount of insulin to be delivered exceeds the maximum/minimum boundary on the preset basal rate). In such a case, the controller does not automatically allow the insulin delivery system 14 to deliver insulin to the patient at the adjusted basal rate. Consequently, at least one of a number of actions will be performed (S680).” [0108]; “At S720, an event is triggered that requires the system to drop out of closed-loop control. This may be triggered by any of the previously mentioned safety features built into the closed-loop control” [0116], wherein the user input is the decision to not calibrate and therefore a safety action is performed at S680. The safety action can include transitioning to open-loop control).
Regarding claim 20, modified Mastrototaro teaches the method of claim 19, wherein the signal for communicating the analyst sensor data about the user comprises a control signal (“The glucose sensor system 10 generates a sensor signal 16 representative of blood glucose levels 18 in the body 20, and provides the sensor signal 16 to the controller 12. The controller 12 receives the sensor signal 16 and generates commands 22 that are communicated to the insulin delivery system 14.” [0050]).
Regarding claim 21, modified Mastrototaro teaches the method of claim 20, wherein the control signal comprises one or more of a wireless signal or a power signal (“These glucose sensors connected (wired or wirelessly) to a blood glucose monitor can provide continuous glucose readings over a period of time” [0007]; Figure 3b).
Regarding claim 22, Mastrototaro discloses a multi-modal insulin delivery system (Figure 1), comprising:
an insulin delivery device (insulin delivery system 14) configured to deliver insulin to a user of the multi-modal insulin delivery system (“The insulin delivery system 14 receives the commands 22 and infuses insulin 24 into the body 20 in response to the commands 22.” [0050]);
a controller (controller 12) associated with the insulin delivery device and comprising: at least one processor (“the controller 12 processes the digital sensor values Dsig and generates commands 22 for the infusion pump 34” [0058]); and at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the controller to (“the algorithm is incorporated in the controller 12 that is able to receive signals from the glucose sensor system 10. In the preferred embodiments, the algorithm is stored in the controller's firmware, but can be stored in a separate software routine in the controller's memory.” [0085]):
responsive to a user selection (“In a semi-closed system, the insulin delivery system will prompt the patient to accept the adjusted basal rate prior to the delivery of insulin (S540).” [0093], see also step S660 of Figure 13) to operate the insulin delivery system according to a first delivery mode allowing at least some control of delivery of medication to the user without user supervision (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12-14), initiating a regimen, comprising: determining one or more user-specific dosage parameters (“Upon obtaining the measured blood glucose level, the controller 12 determines whether the Target is successfully achieved and maintained (S510). If so, the controller commands the insulin delivery system to continue delivering insulin to the patient according to the patient's preset personal basal pattern (S520). However, if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530).” [0091], wherein the “user-specific dosage parameter” is the adjusted basal rate);
upon determining the one or more user-specific dosage parameters, operating the insulin delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12 and 13; “if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530). Depending on whether the blood glucose is higher or lower than the targeted blood glucose level, more or less insulin will be delivered compared to the existing patient's preset basal rate set in his/her basal pattern…the controller 12 will command the insulin delivery system 14 to deliver insulin at the adjusted basal rate (S550). In a semi-closed system, the insulin delivery system will prompt the patient to accept the adjusted basal rate prior to the delivery of insulin (S540).” [0091-0093]);
while operating according to and without exiting the first delivery mode (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12-14), performing the following:
obtaining (i) analyte sensor data and (ii) one or more of insulin delivery data and food intake data (“FIG. 12 illustrates a method for providing therapy modification in a closed loop/semi-closed loop infusion system…at the end of a particular basal pattern time interval, a patient's measured blood glucose level is obtained (S500) using the glucose sensor system 10 of FIG. 1, for example.” [0090]; “As assumed in S700, the system is running in closed-loop mode. Thus, the delivery system is controlled automatically based on sensor readings. S710 describes that a default basal pattern can be updated periodically as the closed-loop system is run.” [0115]);
responsive to the obtained the (i) analyte sensor data and (ii) the one or more of the insulin delivery data and the food intake data, determining updated user-specific dosage parameters that influence insulin delivery within the first delivery mode; and determining a schedule of basal dosages of insulin based at least partially on the determined updated user-specific dosage parameters (“Over time, if the basal rate is regularly adjusted and consistently reaches the maximum and/or minimum boundary for any given time interval, this may indicate that the patient's insulin requirements have changed, and therefore the patient's personal basal pattern may need to be altered. Accordingly, based on the maximum and/or minimum boundary value consistently reached during any given time interval, the controller 12 may recommend to the patient a new basal rate the patient can integrate into his/her personal basal pattern.” [0095], see Figure 12 and all of [0091-0095]);
switching to a second delivery mode (“open-loop control” [0116]) and delivering insulin to the user according to the second delivery mode and according to the determined schedule of basal dosages of the insulin (“At S720, an event is triggered that requires the system to drop out of closed-loop control…At S730, when the closed-loop control reverts into open-loop control, in preferred embodiments, the basal delivery will use the latest updated default basal patterns as described with respect to S720 to continue to deliver the necessary basal dose of insulin.” [0116]), and
while the multi-modal insulin delivery system is operating according to and without exiting the second delivery mode, performing the following: delivering insulin to the user according to the second delivery mode (“At S730, when the closed-loop control reverts into open-loop control, in preferred embodiments, the basal delivery will use the latest updated default basal patterns as described with respect to S720 to continue to deliver the necessary basal dose of insulin.” [0116]).
Mastrototaro fails to explicitly disclose initiating a test regimen, comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period to a user of the insulin delivery system; obtaining analyte sensor data indicative of one or more of analyte data of the user during the predetermined time period or subsequent to the time period; and based at least partially on the series of predetermined test dosages of medication and the obtained analyte sensor data, determining one or more user-specific dosage parameters; upon determining the one or more user-specific dosage parameters from the test regimen, operating the insulin delivery system according to the first delivery mode based at least partially on the determined one or more user-specific dosage parameters determined from the test regimen; and while the multi-modal insulin delivery system is operating according to and without exiting the second delivery mode, performing the following: obtaining additional analyte sensor data and additional insulin delivery data; determining one or more updates to the updated user-specific dosage parameters based on (i) the additional analyte sensor data and (ii) the additional insulin delivery data; and delivering insulin to the user according to the second delivery mode and responsive to the updates to the updated user-specific dosage parameters.
Yodfat teaches a method (Figure 4; “The CIR assessment feature (10) can be also incorporated in this embodiment and used for calculation of the bolus inputs when the system functions in a semi-closed loop mode.” [0077]) comprising: initiating a test regimen (CIR assessment feature 10; Figure 4), comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period to a user of a medication delivery system (“In step (53), a normal insulin bolus can be administered to the patient. The normal insulin bolus can be calculated based on the previously known CIR, i.e., Bolus=Carbs/CIR.sub.old” [0079]); obtaining analyte sensor data indicative of one or more of analyte data of the user during the predetermined time period or subsequent to the time period (“The method then can proceed to step (55), where current BG levels ("CBG") are sensed and measured periodically (e.g., every 15 minutes) until at least two measurements are approximately the same, "BG.sub.1" (e.g. .+-.10 mg/dL).” [0079]); and based at least partially on the series of predetermined test dosages of medication and the obtained analyte sensor data, determining one or more user-specific dosage parameters (CIRNEW; “If glucose level doesn't return to it's initial value (i.e. BG.sub.0), then the current CIR value ("CIR.sub.old") can be inadequate and a new CIR value ("CIR.sub.new") can be calculated according to a formula discussed below and applied.” [0057]; see all of [0080] and Figure 4); upon determining the one or more user-specific dosage parameters from the test regimen, operating the insulin delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined from the test regimen (“The CIR assessment feature (10) can be also incorporated in this embodiment and used for calculation of the bolus inputs when the system functions in a semi-closed loop mode.” [0077]).
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 Mastrototaro to include initiating a test regimen, comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period; and based at least partially on the series of predetermined test dosages of medication and obtained analyte sensor data indicative of one or more of analyte data of the user, determining one or more user-specific dosage parameters and operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined from the test regimen based on the teachings of Yodfat to provide an updated carbohydrate to insulin ratio in order to provide accurate and specific bolus dosing for the individual patient that is periodically updated in order to improve glycemic control (Yodfat [0018-0019], [0062]).
Modified Mastrototaro fails to explicitly disclose while the multi-modal insulin delivery system is operating according to and without exiting the second delivery mode, performing the following: obtaining additional analyte sensor data and additional insulin delivery data; determining one or more updates to the updated user-specific dosage parameters based on (i) the additional analyte sensor data and (ii) the additional insulin delivery data; and delivering insulin to the user according to the second delivery mode and responsive to the updates to the updated user-specific dosage parameters.
Estes teaches an insulin delivery system (method 400, method 600, and method 800; Figures 10, 13, and 15; “The insulin infusion pump system may further include control circuitry that electrically communicates with the pump drive system to control dispensation of the insulin from the portable housing” [0009]) comprising: an insulin delivery device (pump device 100) and a controller (controller device 200); the controller programmed to operate in a delivery mode that disallows control of delivery of medication to the user without user supervision (see operations 420, 460-490 of method 400; operations 615, 640 of method 600; and operations 810, 840, 880 of method 800), wherein while the multi-modal insulin delivery system is operating according to and without exiting a delivery mode (“an operation 410 of dispensing medicine to a user from an infusion pump system over a period of time. For example, the infusion pump system 10 can dispense insulin to a user in a combination of basal and bolus dosages over a period of days.” [0096]), performing the following: obtaining (i) additional analyte sensor data (“an operation 410 of dispensing medicine to a user from an infusion pump system over a period of time. For example, the infusion pump system 10 can dispense insulin to a user in a combination of basal and bolus dosages over a period of days” [0096], wherein dispensing insulin includes obtaining analyte sensor data: “The method 600 can include an operation 605 of receiving data indicative of a blood glucose level at time t.sub.1. As previously described, the blood glucose data (which may be indicative of a recent blood glucose level of the user) can be wirelessly received by the controller device 200 of the infusion pump system 10 from the glucose monitoring device 50” [0136]; “the controller device 200 can be configured to suggestion a recommended bolus amount to the user” [0138]) and (ii) additional insulin delivery data (Operation 420 of Figure 10; see all of [0096]); determining one or more updates to the user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional insulin delivery data, (operations 430, 440, and 480 described in paragraphs [0097-0114], [0122], [0124]; “the method 400 may continue to operation 480 in which the infusion pump system prompts the user to take one or more corrective actions…if the pump usage parameters stored in the memory device reveal that the average total daily bolus dosage is significantly greater than the average total daily basal dosage, the infusion pump device can prompt the user to increase that basal dosage throughout the day, to increase the value for the user's carb ratio setting, to increase the value for the user's insulin sensitivity setting (refer to FIG. 7A), or a combination thereon.” [0124]); and delivering insulin to the user according to the second delivery mode and responsive to the updates to the user-specific dosage parameters (“The method 400 may also include operation 490 in which the infusion pump system receives user input in response to the prompting at operation 480. For example, the infusion pump system can receive user input at operation 490 when the user provides a new value to replace one or the aforementioned settings…From there, the method 400 can return to operation 410 in which the infusion pump system dispenses the medicine in accordance with normal usage.” [0125-0126]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Mastrototaro to include while the multi-modal insulin delivery system is operating according to and without exiting the second delivery mode, performing the following: obtaining additional analyte sensor data and additional insulin delivery data; determining one or more updates to the updated user-specific dosage parameters based on (i) the additional analyte sensor data and (ii) the additional insulin delivery data; and delivering insulin to the user according to the second delivery mode and responsive to the updates to the updated user-specific dosage parameters based on the teachings of Estes to provide a retrospective safety check of the user-specific dosage parameters and allow them to be corrected to safely deliver insulin to the user (Estes [0006]).
Regarding claim 23, modified Mastrototaro teaches the system of claim 22.
Modified Mastrototaro fails to explicitly teach wherein the one or more user-specific dosage parameters are selected from a group comprising: a carbohydrate to insulin ratio, an insulin sensitivity factor, and a daily basal rate.
Estes teaches a method comprising determining one or more usage-specific dosage parameters selected from a group comprising: a carbohydrate to insulin ratio, an insulin sensitivity factor, and a daily basal rate (“the method 400 may continue to operation 480 in which the infusion pump system prompts the user to take one or more corrective actions…if the pump usage parameters stored in the memory device reveal that the average total daily bolus dosage is significantly greater than the average total daily basal dosage, the infusion pump device can prompt the user to increase that basal dosage throughout the day, to increase the value for the user's carb ratio setting, to increase the value for the user's insulin sensitivity setting (refer to FIG. 7A), or a combination thereon.” [0124]).
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 Mastrototaro to include the one or more user-specific dosage parameters are selected from a group comprising: a carbohydrate to insulin ratio, an insulin sensitivity factor, and a daily basal rate based on the teachings of Estes to provide a retrospective safety check of the user-specific dosage parameters and allow them to be corrected to safely deliver insulin to the user (Estes [0006]).
Regarding claim 24, Mastrototaro teaches a method of delivering insulin (“a control system for regulating the rate of insulin infusion into the body of a user based on a glucose concentration measurement taken from the body.” [0046]; see also Figures 12-14), comprising:
responsive to a user selection (“In a semi-closed system, the insulin delivery system will prompt the patient to accept the adjusted basal rate prior to the delivery of insulin (S540).” [0093], see also step S660 of Figure 13) to operate a medication delivery system (insulin delivery system 14 having infusion pump 34) according to a first delivery mode allowing at least some control of delivery of medication to the user without user supervision (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12-14), initiating a regimen, comprising: determining one or more user-specific dosage parameters (“Upon obtaining the measured blood glucose level, the controller 12 determines whether the Target is successfully achieved and maintained (S510). If so, the controller commands the insulin delivery system to continue delivering insulin to the patient according to the patient's preset personal basal pattern (S520). However, if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530).” [0091], wherein the “user-specific dosage parameter” is the adjusted basal rate);
upon determining the one or more user-specific dosage parameters, operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12 and 13; “if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530). Depending on whether the blood glucose is higher or lower than the targeted blood glucose level, more or less insulin will be delivered compared to the existing patient's preset basal rate set in his/her basal pattern…the controller 12 will command the insulin delivery system 14 to deliver insulin at the adjusted basal rate (S550). In a semi-closed system, the insulin delivery system will prompt the patient to accept the adjusted basal rate prior to the delivery of insulin (S540).” [0091-0093]);
obtaining, while delivering insulin to a user, according to the first delivery mode (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12-14;), (i) analyte sensor data and (ii) one or more insulin delivery data and food intake data associated with the user (“FIG. 12 illustrates a method for providing therapy modification in a closed loop/semi-closed loop infusion system…at the end of a particular basal pattern time interval, a patient's measured blood glucose level is obtained (S500) using the glucose sensor system 10 of FIG. 1, for example.” [0090]; “As assumed in S700, the system is running in closed-loop mode. Thus, the delivery system is controlled automatically based on sensor readings. S710 describes that a default basal pattern can be updated periodically as the closed-loop system is run.” [0115]);
determining updated usage-specific dosage parameters based at least partially on the (i) analyte sensor data and (ii) the one or more of the insulin delivery data and the food intake data (“Over time, if the basal rate is regularly adjusted and consistently reaches the maximum and/or minimum boundary for any given time interval, this may indicate that the patient's insulin requirements have changed, and therefore the patient's personal basal pattern may need to be altered. Accordingly, based on the maximum and/or minimum boundary value consistently reached during any given time interval, the controller 12 may recommend to the patient a new basal rate the patient can integrate into his/her personal basal pattern.” [0095], see Figure 12 and all of [0091-0095]);
operating the medication delivery system according to the first delivery mode based at least partially on the determined updated user-specific dosage parameters (“a closed loop/semi-closed loop infusion system” [0090]; Figures 12 and 13; “if the Target is not achieved or maintained, then the controller 12 will attempt to adjust the basal rate to a temporary adjusted basal rate (S530). Depending on whether the blood glucose is higher or lower than the targeted blood glucose level, more or less insulin will be delivered compared to the existing patient's preset basal rate set in his/her basal pattern…the controller 12 will command the insulin delivery system 14 to deliver insulin at the adjusted basal rate (S550). In a semi-closed system, the insulin delivery system will prompt the patient to accept the adjusted basal rate prior to the delivery of insulin (S540).” [0091-0093]; “As assumed in S700, the system is running in closed-loop mode. Thus, the delivery system is controlled automatically based on sensor readings. S710 describes that a default basal pattern can be updated periodically as the closed-loop system is run.” [0115]);
switching to a second delivery mode (“open-loop control” [0116]) and delivering insulin to the user based at least partially on the updated determined usage-specific dosage parameters (“At S720, an event is triggered that requires the system to drop out of closed-loop control…At S730, when the closed-loop control reverts into open-loop control, in preferred embodiments, the basal delivery will use the latest updated default basal patterns as described with respect to S720 to continue to deliver the necessary basal dose of insulin.” [0116]); and
delivering insulin to the user according to the second delivery mode (“At S730, when the closed-loop control reverts into open-loop control, in preferred embodiments, the basal delivery will use the latest updated default basal patterns as described with respect to S720 to continue to deliver the necessary basal dose of insulin.” [0116]).
Mastrototaro fails to explicitly disclose the method comprising initiating a test regimen, comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period to a user of the medication delivery system; obtaining analyte sensor data indicative of one or more of analyte data of the user during the predetermined time period or subsequent to the time period; and based at least partially on the series of predetermined test dosages of medication and the obtained analyte sensor data, determining one or more user-specific dosage parameters; upon determining the one or more user-specific dosage parameters from the test regimen, operating the medication delivery system according to the first delivery mode based at least partially on the determined one or more user-specific dosage parameters determined from the test regimen; and obtaining, while delivering insulin to the user according to the second delivery mode, (i) additional analyte sensor data and (ii) additional insulin delivery data; determining one or more updates to the updated user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional insulin delivery data, the updates to the usage-specific dosage parameters at least partially determining amounts by which insulin is delivered to the user according to the second delivery mode; and delivering insulin to the user according to the second delivery mode and responsive to the updates to the updated user-specific dosage parameters.
Yodfat teaches a method (Figure 4; “The CIR assessment feature (10) can be also incorporated in this embodiment and used for calculation of the bolus inputs when the system functions in a semi-closed loop mode.” [0077]) comprising: initiating a test regimen (CIR assessment feature 10; Figure 4), comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period to a user of a medication delivery system (“In step (53), a normal insulin bolus can be administered to the patient. The normal insulin bolus can be calculated based on the previously known CIR, i.e., Bolus=Carbs/CIR.sub.old” [0079]); obtaining analyte sensor data indicative of one or more of analyte data of the user during the predetermined time period or subsequent to the time period (“The method then can proceed to step (55), where current BG levels ("CBG") are sensed and measured periodically (e.g., every 15 minutes) until at least two measurements are approximately the same, "BG.sub.1" (e.g. .+-.10 mg/dL).” [0079]); and based at least partially on the series of predetermined test dosages of medication and the obtained analyte sensor data, determining one or more user-specific dosage parameters (CIRNEW; “If glucose level doesn't return to it's initial value (i.e. BG.sub.0), then the current CIR value ("CIR.sub.old") can be inadequate and a new CIR value ("CIR.sub.new") can be calculated according to a formula discussed below and applied.” [0057]; see all of [0080] and Figure 4); upon determining the one or more user-specific dosage parameters from the test regimen, operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined from the test regimen (“The CIR assessment feature (10) can be also incorporated in this embodiment and used for calculation of the bolus inputs when the system functions in a semi-closed loop mode.” [0077]).
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 Mastrototaro to include initiating a test regimen, comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period; and based at least partially on the series of predetermined test dosages of medication and obtained analyte sensor data indicative of one or more of analyte data of the user, determining one or more user-specific dosage parameters and operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined from the test regimen based on the teachings of Yodfat to provide an updated carbohydrate to insulin ratio in order to provide accurate and specific bolus dosing for the individual patient that is periodically updated in order to improve glycemic control (Yodfat [0018-0019], [0062]).
Modified Mastrototaro fails to explicitly disclose the method comprising obtaining, while delivering insulin to the user according to the second delivery mode, (i) additional analyte sensor data and (ii) additional insulin delivery data; determining one or more updates to the updated user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional insulin delivery data, the updates to the usage-specific dosage parameters at least partially determining amounts by which insulin is delivered to the user according to the second delivery mode; and delivering insulin to the user according to the second delivery mode and responsive to the updates to the updated user-specific dosage parameters.
Estes teaches a method (method 400, method 600, and method 800; Figures 10, 13, and 15) of delivering insulin (“The insulin infusion pump system may further include control circuitry that electrically communicates with the pump drive system to control dispensation of the insulin from the portable housing” [0009]) comprising: obtaining, while delivering insulin to the user according to the second delivery mode (“an operation 410 of dispensing medicine to a user from an infusion pump system over a period of time. For example, the infusion pump system 10 can dispense insulin to a user in a combination of basal and bolus dosages over a period of days.” [0096]), (i) additional analyte sensor data (“an operation 410 of dispensing medicine to a user from an infusion pump system over a period of time. For example, the infusion pump system 10 can dispense insulin to a user in a combination of basal and bolus dosages over a period of days” [0096], wherein dispensing insulin includes obtaining analyte sensor data: “The method 600 can include an operation 605 of receiving data indicative of a blood glucose level at time t.sub.1. As previously described, the blood glucose data (which may be indicative of a recent blood glucose level of the user) can be wirelessly received by the controller device 200 of the infusion pump system 10 from the glucose monitoring device 50” [0136]; “the controller device 200 can be configured to suggestion a recommended bolus amount to the user” [0138]) and (ii) additional insulin delivery data (Operation 420 of Figure 10; see all of [0096]); determining one or more updates to the user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional insulin delivery data, the updates to the usage-specific dosage parameters at least partially determining amounts by which insulin is delivered to the user according to the second delivery mode (operations 430, 440, and 480 described in paragraphs [0097-0114], [0122], [0124]; “the method 400 may continue to operation 480 in which the infusion pump system prompts the user to take one or more corrective actions…if the pump usage parameters stored in the memory device reveal that the average total daily bolus dosage is significantly greater than the average total daily basal dosage, the infusion pump device can prompt the user to increase that basal dosage throughout the day, to increase the value for the user's carb ratio setting, to increase the value for the user's insulin sensitivity setting (refer to FIG. 7A), or a combination thereon.” [0124]); and delivering insulin to the user according to the second delivery mode and responsive to the updates to the user-specific dosage parameters (“The method 400 may also include operation 490 in which the infusion pump system receives user input in response to the prompting at operation 480. For example, the infusion pump system can receive user input at operation 490 when the user provides a new value to replace one or the aforementioned settings…From there, the method 400 can return to operation 410 in which the infusion pump system dispenses the medicine in accordance with normal usage.” [0125-0126]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Mastrototaro to include obtaining, while delivering insulin to the user according to the second delivery mode, (i) additional analyte sensor data and (ii) additional insulin delivery data; determining one or more updates to the updated user-specific dosage parameters based at least partially on (i) the additional analyte sensor data and (ii) the additional insulin delivery data, the updates to the usage-specific dosage parameters at least partially determining amounts by which insulin is delivered to the user according to the second delivery mode; and delivering insulin to the user according to the second delivery mode and responsive to the updates to the updated user-specific dosage parameters based on the teachings of Estes to provide a retrospective safety check of the user-specific dosage parameters and allow them to be corrected to safely deliver insulin to the user (Estes [0006]).
Regarding claim 25, modified Mastrototaro teaches the method of claim 24.
Modified Mastrototaro fails to explicitly teach wherein the one or more user-specific dosage parameters are selected from a group comprising: a carbohydrate to insulin ratio, an insulin sensitivity factor, and a daily basal rate.
Estes teaches a method comprising determining one or more usage-specific dosage parameters selected from a group comprising: a carbohydrate to insulin ratio, an insulin sensitivity factor, and a daily basal rate (“the method 400 may continue to operation 480 in which the infusion pump system prompts the user to take one or more corrective actions…if the pump usage parameters stored in the memory device reveal that the average total daily bolus dosage is significantly greater than the average total daily basal dosage, the infusion pump device can prompt the user to increase that basal dosage throughout the day, to increase the value for the user's carb ratio setting, to increase the value for the user's insulin sensitivity setting (refer to FIG. 7A), or a combination thereon.” [0124]).
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 Mastrototaro to include the one or more user-specific dosage parameters are selected from a group comprising: a carbohydrate to insulin ratio, an insulin sensitivity factor, and a daily basal rate based on the teachings of Estes to provide a retrospective safety check of the user-specific dosage parameters and allow them to be corrected to safely deliver insulin to the user (Estes [0006]).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro et al. (US 2012/0136336) in view of Yodfat et al. (US 20090018406) further in view of Estes (US 2014/0249500) as applied to claim 4 above, and further in view of Atlas et al. (US 2012/0246106).
Regarding claim 7, modified Mastrototaro teaches the method of claim 4.
Modified Mastrototaro fails to explicitly teach the medicine delivery data identifies amounts and times at which the medication was previously delivered to the user.
Atlas teaches a method (Figure 10) comprising responsive to the obtained (i) analyte sensor data and (ii) the one or more of the medicine delivery data and the food intake data (obtaining raw log data 210; “Obtaining raw log data of glucose measurements, meals events and insulin delivered” [Figure 10]; “The data is typically generated by at least one of drug delivery devices and glucose measurement devices and comprises the sensor readings,” [0491]), determining user-specific dosage parameters that influence amounts of the medications to deliver to the user according to the first delivery mode (“the informative data piece being identified can thereafter be used for further unsupervised learning (or determining) of the insulin pump settings 240. The insulin pump settings 240 can be any of carbohydrate ratio, basal plan and correction factor.” [0161]), wherein the medicine delivery data identifies amounts and times at which the medication was previously delivered to the user (“the method 200 includes specific sectioning of the raw log data 220…the raw log data is processed by sectioned portions which can be used for the determination of basal plan 222. The procedure to isolate or section the raw log data input to BaS section (i.e. basal related information) were described above…the method 200 includes sectioning the raw log data input to BS section 226 i.e. bolus related data.” [0164-0165] see BaS section detailed in [0050-0053] and [0141] and BS section detailed in [0145]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Mastrototaro to include the medicine delivery data identifies amounts and times at which the medication was previously delivered to the user based on the teachings of Atlas to provided automated adjustment of the user-specific dosage parameters to provide more accurate diabetes treatment for the patient (Atlas [0026]).
Regarding claim 8, modified Mastrototaro teaches the method of claim 4.
Modified Mastrototaro fails to explicitly teach wherein the food intake data identifies amounts and times at which one or more foods were consumed by the user.
Atlas teaches a method (Figure 10) comprising responsive to the obtained (i) analyte sensor data and (ii) the one or more of the medicine delivery data and the food intake data (obtaining raw log data 210; “Obtaining raw log data of glucose measurements, meals events and insulin delivered” [Figure 10]; “The data is typically generated by at least one of drug delivery devices and glucose measurement devices and comprises the sensor readings,” [0491]), determining user-specific dosage parameters that influence amounts of the medications to deliver to the user according to the first delivery mode (“the informative data piece being identified can thereafter be used for further unsupervised learning (or determining) of the insulin pump settings 240. The insulin pump settings 240 can be any of carbohydrate ratio, basal plan and correction factor.” [0161]), wherein the food intake data (“the method 200 includes sectioning the raw log data input to MS section 224 i.e. meal events related data.” [0165]) identifies amounts and times at which one or more foods were consumed by the user (“The meal/activity log(the detailed log of the amount and time of meals or activity)” [0120]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Mastrototaro to include the food intake data identifies amounts and times at which one or more foods were consumed by the user based on the teachings of Atlas to provided automated adjustment of the user-specific dosage parameters to provide more accurate diabetes treatment for the patient (Atlas [0026]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Mastrototaro et al. (US 2012/0136336) in view of Yodfat et al. (US 20090018406) further in view of Estes (US 2014/0249500) as applied to claim 4 above, and further in view of Rosinko et al. (US 2012/0246106).
Regarding claim 14, modified Mastrototaro teaches the method of claim 12.
Modified Mastrototaro fails to explicitly teach wherein detecting the transition trigger event comprises detecting that communication with the analyte sensor has been lost or initiated.
Rosinko teaches a method (Figures 5 and 6) comprising changing a mode of a medication delivery from a first mode to a second mode responsive detecting that communication with an analyte sensor has been lost (“Referring now to FIG. 6, an operational flowchart is depicted upon detection of an error. Such error may include…a loss of signal between sensor 102 and glucose monitoring system 100…Such error may occur at any time during operation of pump 12 in closed-loop mode…At step 316, pump 12 switches from closed-loop to open-loop operation” [0043]).
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 Mastrototaro to include wherein detecting the transition trigger event comprises detecting that communication with the analyte sensor has been lost or initiated based on the teachings of Rosinko to maintain the accuracy and safety of delivery of insulin to the patient (Rosinko [0043]).
Response to Arguments
Applicant's arguments filed December 03, 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (Remarks, page 11), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding the argument that “Mastrototaro in view of Yodfat does not teach or suggest the feature of ‘responsive to a user selection to operate a medication delivery system according to a first delivery mode allowing at least some control of delivery of medication to the user without user supervision, imitating a test regimen” of claim 1 (Remarks, page 11), the examiner respectfully disagrees. As detailed above with respect to the rejection of claim 1, The disclosure of Mastrototaro was relied upon for a teaching of initiating a regimen response to a user selection to operate in a first delivery mode, while the disclose of Yodfat was relied upon for a teaching that the regimen is “a test regimen” as claimed. Mastrototaro discloses a method (Figures 12-14), comprising: responsive to a user selection ([0093], see also step S660 of Figure 13) to operate a medication delivery system (14) according to a first delivery mode allowing at least some control of delivery of medication to the user without user supervision ([0090]; Figures 12-14), initiating a regimen (steps of methods shown in Figures 12-14). However, Mastrototaro does not explicitly disclose that this regimen is “a test regimen” as claimed. Yodfat discloses, at least, a method (Figure 4; [0077]) comprising: initiating a test regimen (CIR assessment feature 10; Figure 4), upon determining one or more user-specific dosage parameters from the test regimen, operating the medication delivery system according to the first delivery mode based at least partially on the one or more user-specific dosage parameters determined from the test regimen ([0077]). Based on this disclosure, it is maintained that it would have been obvious to one having ordinary skill in the art to modify the method of Mastrototaro to include initiating a test regimen based on the teachings of Yodfat to provide an updated carbohydrate to insulin ratio in order to provide accurate and specific bolus dosing for the individual patient that is periodically updated in order to improve glycemic control (Yodfat [0018-0019], [0062]).
Regarding the argument that “Mastrototaro in view of Yodfat does not teach or suggest the feature of “initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period to a user of the medication delivery system’ of Claim 1” (Remarks, page 12), the examiner respectfully disagrees. Yodfat discloses a test regimen (CIR assessment feature 10; Figure 4) comprising: initiating delivery of a series of predetermined test dosages of medication according to the test regimen over a predetermined time period to a user of a medication delivery system (“In step (53), a normal insulin bolus can be administered to the patient. The normal insulin bolus can be calculated based on the previously known CIR, i.e., Bolus=Carbs/CIR.sub.old” [0079]). The limitation “a series of predetermined test dosages of medication” has been given the broadest reasonable interpretation of at least one test dosage because “a series” can be a single number. This is consistent with the present application in paragraph [0160] which states “a suitable test regimen may provide for X number of medicine dosages (where X is any non-negative whole number)”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the CIR test of Yodfat…does not show any loops in the test” (Remarks, page 11)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783