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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites "generating a plurality insulin delivery profiles". The phrase "a plurality insulin delivery profiles" is grammatically incorrect because it omits the preposition "of." The claim should read "a plurality of insulin delivery profiles." As written, the claim fails to particularly point out and distinctly claim the subject matter because the missing preposition creates an ambiguous noun phrase.
Claim 17 recites "generating a plurality insulin delivery profiles". As with claim 4, the phrase "a plurality insulin delivery profiles" is grammatically incorrect for the same reason. The claim should read "a plurality of insulin delivery profiles."
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, 7, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2014/0066892A1; hereinafter “Keenan”) in view of Parikh et al. (US 2014/0066888A1; hereinafter “Parikh”).
In relation to independent claim 1, this claim recites a method of insulin delivery, the method comprising: monitoring insulin delivery actions to determine an amount of insulin delivered above or below a predefined baseline basal rate; and responsive to the amount of insulin exceeding a threshold amount, adjusting one or more subsequent insulin delivery actions.
A method of insulin delivery, the method comprising: monitoring insulin delivery actions to determine an amount of insulin delivered above or below a predefined baseline basal rate.
Keenan discloses a method of insulin delivery comprising monitoring insulin delivery relative to a basal glucose level. Specifically, Keenan discloses: "the controller 12 may or may not issue commands to infuse insulin depending on the derivative component (whether the glucose level is raising or falling) and the integral component (how long and by how much glucose level has been above or below the basal blood glucose level GB)." (Keenan ¶ [0151].) Keenan further discloses that the controller monitors total insulin delivered: "In practice, task 1186 considers the total insulin (basal, bolus, and any other insulin delivered) for all sampling periods." (Keenan ¶ [0554].) To the extent Keenan does not expressly disclose monitoring insulin delivery actions to determine an amount of insulin delivered above or below a predefined baseline basal rate as a distinct method step, Parikh fills this gap by disclosing explicitly tracking the amount of insulin delivered against a baseline. Parikh discloses: "calculating a maximum insulin infusion rate for the user based on a fasting blood glucose value associated with the user, a total daily insulin value associated with the user, and fasting insulin delivery data that is indicative of insulin delivered to the user during a fasting period." (Parikh ¶ [0026].)
Responsive to the amount of insulin exceeding a threshold amount, adjusting one or more subsequent insulin delivery actions.
Keenan discloses adjusting insulin delivery responsive to exceeding a threshold. Specifically, Keenan discloses: "If the resulting sum is greater than a pre-selected hypoglycemic integral threshold, then the controller gains are increased by a factor (1+α). Conversely, if the integral of the glucose level measurements that were measured above the basal glucose level G, within the predefined time window is greater than a pre-selected hyperglycemic integral threshold, then the controller gains are decreased by a factor (1-α)." (Keenan ¶ [0186].) Keenan does not expressly disclose the threshold being expressed as an amount of insulin delivered above or below the basal rate. Parikh fills this gap by disclosing providing a second closed-loop insulin infusion rate when the first rate exceeds the calculated maximum: "providing a second closed-loop insulin infusion rate for the user when the obtained first closed-loop insulin infusion rate is greater than the calculated maximum insulin infusion rate, wherein the second closed-loop insulin infusion rate is less than the first closed-loop insulin infusion rate." (Parikh ¶ [0026].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Keenan with Parikh because both references are directed to closed-loop insulin infusion systems that monitor blood glucose and adjust insulin delivery to maintain a target glucose level. A person of ordinary skill in the art would have been motivated to incorporate Parikh's specific threshold-based maximum insulin infusion rate calculation [based on total daily insulin value and fasting delivery data] into Keenan's controller to prevent over-delivery of insulin and improve patient safety during closed-loop operation.
In relation to claim 7, this claim depends from claim 1 and further recites wherein monitoring insulin delivery actions comprises monitoring bolus doses and basal doses.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein monitoring insulin delivery actions comprises monitoring bolus doses and basal doses.
Keenan discloses monitoring total insulin including basal and bolus doses. Specifically, Keenan discloses: "In practice, task 1186 considers the total insulin (basal, bolus, and any other insulin delivered) for all sampling periods." (Keenan ¶ [0554].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Keenan with Parikh because both references are directed to closed-loop insulin infusion systems that monitor blood glucose and adjust insulin delivery to maintain a target glucose level. A person of ordinary skill in the art would have been motivated to incorporate Parikh's specific threshold-based maximum insulin infusion rate calculation [based on total daily insulin value and fasting delivery data] into Keenan's controller to prevent over-delivery of insulin and improve patient safety during closed-loop operation.
In relation to claim 9, this claim depends from claim 1 and further recites wherein the threshold amount comprises a percentage of the predefined baseline basal rate.
Base rejection incorporated herein.
The rejection of claim 1 is incorporated herein.
wherein the threshold amount comprises a percentage of the predefined baseline basal rate.
Keenan discloses threshold amounts expressed as factors (percentages) of the baseline. Specifically, Keenan discloses: "[i]f the resulting sum is greater than a pre-selected hypoglycemic integral threshold, then the controller gains are increased by a factor (1+α). Conversely, if the integral of the glucose level measurements that were measured above the basal glucose level G, within the predefined time window is greater than a pre-selected hyperglycemic integral threshold, then the controller gains are decreased by a factor (1-α)." (Keenan ¶ [0186].) To the extent Keenan does not expressly disclose the threshold as a percentage of the predefined baseline basal rate, Parikh fills this gap by disclosing calculating maximum insulin infusion limits based on baseline delivery data. (Parikh ¶ [0026].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Keenan with Parikh because both references are directed to closed-loop insulin infusion systems that monitor blood glucose and adjust insulin delivery to maintain a target glucose level. A person of ordinary skill in the art would have been motivated to incorporate Parikh's specific threshold-based maximum insulin infusion rate calculation [based on total daily insulin value and fasting delivery data] into Keenan's controller to prevent over-delivery of insulin and improve patient safety during closed-loop operation.
In relation to claim 10, this claim depends from claim 1 and further recites wherein the threshold amount comprises a percentage of a previous total daily basal dose.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the threshold amount comprises a percentage of a previous total daily basal dose.
Keenan discloses utilizing the total daily dose for calculating parameters. Specifically, Keenan discloses: "The nominal (i.e., for the case with no insulin feedback) controller gain Kpo is calculated based on the subjects insulin total daily dose I (in Units/day)." (Keenan ¶ [0477].) Parikh further discloses calculating limits based on "a total daily insulin value associated with the user." (Parikh ¶ [0026].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Keenan with Parikh because both references are directed to closed-loop insulin infusion systems that monitor blood glucose and adjust insulin delivery to maintain a target glucose level. A person of ordinary skill in the art would have been motivated to incorporate Parikh's specific threshold-based maximum insulin infusion rate calculation [based on total daily insulin value and fasting delivery data] into Keenan's controller to prevent over-delivery of insulin and improve patient safety during closed-loop operation.
Claims 2, 5, 6, 12, 13, 14, 17, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2014/0066892A1; hereinafter “Keenan”) in view of Parikh et al. (US 2014/0066888A1; hereinafter “Parikh”) as discussed above, and in further view of Finan et al. (US 2014/0180240A1; hereinafter “Finan”).
In relation to claim 2, this claim depends from claim 1 and further recites wherein adjusting one or more subsequent insulin delivery actions comprises adjusting at least one subsequent insulin delivery action of the one or more subsequent insulin delivery actions to deliver insulin according to the predefined baseline basal rate.
Base rejection incorporated herein.
The rejection of claim 1 is incorporated herein.
wherein adjusting one or more subsequent insulin delivery actions comprises adjusting at least one subsequent insulin delivery action of the one or more subsequent insulin delivery actions to deliver insulin according to the predefined baseline basal rate.
Keenan discloses adjusting insulin delivery back to the basal rate. Specifically, Keenan discloses: "If the glucose level error GE is negative (meaning that the present estimate of the blood glucose level is lower than the desired basal blood glucose level GB) then the controller 12 reduces or stops the insulin delivery depending on whether the integral component response of the glucose error GE is still positive." (Keenan ¶ [0150].) To the extent the base combination does not expressly disclose that the adjusted subsequent insulin delivery action delivers insulin according to the predefined baseline basal rate, Finan fills this gap by disclosing that when all predicted glucose values are within the target zone, the algorithm defaults to the patient's current basal rate. Finan discloses: "if all the predicted glucose values are within the Zone, then every element of Gzone is equal to 0, and consequently J is minimized with I, basal for that time of day, i.e., the algorithm 'defaults' to the patient's current basal insulin infusion rate." (Finan ¶ [0070].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Finan because all three references address the same technical problem of optimizing automated insulin delivery for individual patients.
In relation to claim 5, this claim depends from claim 1 and further recites wherein adjusting one or more subsequent insulin delivery actions comprises adjusting a single subsequent insulin delivery action.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein adjusting one or more subsequent insulin delivery actions comprises adjusting a single subsequent insulin delivery action.
Parikh discloses adjusting insulin delivery at each discrete sampling point. Specifically, Parikh discloses: "obtaining a first closed-loop insulin infusion rate for the user, wherein the first closed-loop insulin infusion rate is obtained for a current sampling point during the period of closed-loop operation." (Parikh ¶ [0026].) To the extent the base combination does not expressly disclose that the adjustment is limited to a single subsequent insulin delivery action, Finan fills this gap by disclosing that the MPC controller implements only the first insulin infusion of the calculated sequence at each step. Finan discloses: "[t]he first insulin infusion (out of N steps) is then implemented. At the next time step, k+1 based on the new measured glucose value and the last insulin rate, the process is repeated." (Finan ¶ [0053].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Finan because all three references address the same technical problem of optimizing automated insulin delivery.
In relation to claim 6, this claim depends from claim 1 and further recites wherein adjusting one or more subsequent insulin delivery actions comprises adjusting a plurality of subsequent insulin delivery actions.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein adjusting one or more subsequent insulin delivery actions comprises adjusting a plurality of subsequent insulin delivery actions.
To the extent the base combination does not expressly disclose adjusting a plurality of subsequent insulin delivery actions at once, Finan fills this gap by disclosing MPC that determines multiple future insulin infusion amounts. Finan discloses: "the MPC controller will determine, in the CTT mode of FIG. 5B, the appropriate insulin infusion in the near future (e.g., the next five insulin infusion amounts) at 510... such that the predicted future glucose values 512 would trend sharply downward". (Finan ¶ [0094].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Finan because all three references address the same technical problem of optimizing automated insulin delivery. A person of ordinary skill in the art would have been motivated to incorporate Finan's MPC approach of determining and adjusting a plurality of future insulin delivery actions (e.g., the next five amounts) into the base system to provide a smoother, more predictive response to glucose excursions, rather than reacting only point-by-point.
In relation to independent claim 12, this claim recites a method of insulin delivery, the method comprising: based on glucose values of a user, generating a set of planned insulin delivery actions that include delivery of a predefined baseline basal rate; monitoring executed insulin delivery actions to identify an amount of insulin delivered above or below the predefined baseline basal rate; and responsive to the amount of insulin delivered above or below the predefined baseline basal rate, determining whether to: adjust one or more subsequent insulin delivery actions to deliver insulin according to the predefined baseline basal rate; or personalize one or more subsequent insulin delivery actions.
A method of insulin delivery, the method comprising: based on glucose values of a user, generating a set of planned insulin delivery actions that include delivery of a predefined baseline basal rate.
Keenan discloses generating planned insulin delivery actions based on glucose values. Specifically, Keenan discloses: "Preferred embodiments include a glucose sensor system 10, a controller 12 and an insulin delivery system 14... 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." (Keenan ¶ [0112].) To the extent Keenan does not expressly disclose generating a set of planned insulin delivery actions that include delivery of a predefined baseline basal rate, Finan fills this gap by disclosing that the MPC controller generates planned insulin delivery actions anchored to the patient's predefined basal rate. Finan discloses: "the controller 10 in example B, has been commanding the pump to deliver a basal rate of 1 Units per hour (U/h)... However, a prediction into the future by the MPC controller shows that (assuming the same basal insulin rate as before at 505), there would likely be a clear excursion of the blood glucose values 506 in the subject above the target Zone 508." (Finan ¶ [0094].) Finan further discloses: "if all the predicted glucose values are within the zone, then every element of Gzone is equal to 0, and consequently J is minimized with I, basal for that time of day, i.e., the algorithm 'defaults' to the patient's current basal insulin infusion rate." (Finan ¶ [0070].)
monitoring executed insulin delivery actions to identify an amount of insulin delivered above or below the predefined baseline basal rate.
Keenan discloses monitoring insulin delivery relative to a desired basal glucose level. Specifically, Keenan discloses: "the controller 12 may or may not issue commands to infuse insulin depending on the derivative component (whether the glucose level is raising or falling) and the integral component (how long and by how much glucose level has been above or below the basal blood glucose level GB)." (Keenan ¶ [0151].) Keenan also discloses that the controller monitors total insulin delivered: "[i]n practice, task 1186 considers the total insulin (basal, bolus, and any other insulin delivered) for all sampling periods." (Keenan ¶ [0554].) To the extent Keenan does not expressly disclose monitoring insulin delivery actions to determine an amount of insulin delivered above or below a predefined baseline basal rate as a distinct method step, Parikh fills this gap by disclosing explicitly tracking the amount of insulin delivered against a baseline. Parikh discloses: "calculating a maximum insulin infusion rate for the user based on a fasting blood glucose value associated with the user, a total daily insulin value associated with the user, and fasting insulin delivery data that is indicative of insulin delivered to the user during a fasting period." (Parikh ¶ [0026].)
and responsive to the amount of insulin delivered above or below the predefined baseline basal rate, determining whether to: adjust one or more subsequent insulin delivery actions to deliver insulin according to the predefined baseline basal rate; or personalize one or more subsequent insulin delivery actions.
Keenan discloses adjusting insulin delivery back to the basal rate. Specifically, Keenan discloses: "[i]f the glucose level error GE is negative (meaning that the present estimate of the blood glucose level is lower than the desired basal blood glucose level GB) then the controller 12 reduces or stops the insulin delivery depending on whether the integral component response of the glucose error GE is still positive." (Keenan ¶ [0150].) Keenan also discloses personalizing insulin delivery actions. Specifically, Keenan discloses: "[f]urther embodiments may include a controller that self-tunes one or more the gains, KP, KI, KD, to accommodate changes in insulin sensitivity." (Keenan ¶ [0186].)
Based on the above teachings, for a person of ordinary skilled in the art, it would have been obvious to combine Keenan with Parikh and Finan because all three references are directed to closed-loop insulin infusion systems that monitor blood glucose and adjust insulin delivery to maintain a target glucose level.
In relation to claim 13, this claim depends from claim 12 and further recites wherein monitoring executed insulin delivery actions to identify an amount of insulin delivered above or below the predefined baseline basal rate comprises determining a total daily insulin dose.
Base rejection incorporated.
The rejection of claim 12 is incorporated herein.
wherein monitoring executed insulin delivery actions to identify an amount of insulin delivered above or below the predefined baseline basal rate comprises determining a total daily insulin dose.
Keenan discloses determining a total daily insulin dose. Specifically, Keenan discloses: "The nominal (i.e., for the case with no insulin feedback) controller gain KPO is calculated based on the subjects insulin total daily dose ITDD (in Units/day)." (Keenan ¶ [0477].) Parikh further discloses obtaining "a total daily insulin value associated with the user." (Parikh ¶ [0026].)
Based on the above teachings, for a person of ordinary skilled in the art, it would have been obvious to combine Keenan with Parikh and Finan because all three references are directed to closed-loop insulin infusion systems that monitor blood glucose and adjust insulin delivery to maintain a target glucose level.
In relation to claim 14, this claim depends from claim 13 and further recites wherein the total daily insulin dose comprises a total daily basal amount and a total daily bolus dose.
Base rejection incorporated.
The rejection of claim 13 is incorporated herein.
wherein the total daily insulin dose comprises a total daily basal amount and a total daily bolus dose.
Keenan discloses that total insulin includes basal and bolus components. Specifically, Keenan discloses: "In practice, task 1186 considers the total insulin (basal, bolus, and any other insulin delivered) for all sampling periods." (Keenan ¶ [0554].)
The motivation to combine Keenan and Parikh is the same as stated for claim 13.
In relation to claim 17, this claim depends from claim 12 and further recites wherein personalizing one or more subsequent insulin delivery actions comprises: generating a plurality insulin delivery profiles and projecting glucose levels for each of the plurality insulin delivery profiles; and selecting an insulin delivery profile of the plurality insulin delivery profiles that most closely tracks towards a target glucose level.
Base rejection incorporated.
The rejection of claim 12 is incorporated herein.
wherein personalizing one or more subsequent insulin delivery actions comprises: generating a plurality insulin delivery profiles and projecting glucose levels for each of the plurality insulin delivery profiles; and selecting an insulin delivery profile of the plurality insulin delivery profiles that most closely tracks towards a target glucose level.
Keenan discloses generating a plurality of candidate solutions (profiles) and selecting the best match. Specifically, Keenan discloses: "[c]onceptually, task 1160 generates a plurality of curves (or discrete values that may be used to visualize curves for purposes of this explanation) and compares the portion of the curves within the model training period to the actual sensor glucose values obtained during the model training period. In an ideal scenario with a perfect match, one of the generated curves will precisely track the actual sensor glucose values within the model training period... task 1160 identifies the calculated curve that best matches the actual sensor values." (Keenan ¶ [0547].) To the extent the base combination does not expressly disclose projecting glucose levels for a plurality of insulin delivery profiles and selecting the one that most closely tracks towards a target glucose level, Finan fills the gap by disclosing MPC that generates predicted glucose profiles and selects the insulin delivery plan that brings glucose to the target zone. Finan discloses: "[t]he MPC of control logic 10 incorporates an explicit model of human T1DM glucose-insulin dynamics. The model is used to predict future glucose values and to calculate future controller moves that will bring the glucose profile to the desired range or 'Zone.'" (Finan ¶ [0053].) Finan further discloses: "the MPC controller will determine, in the CTT mode of FIG. 5B, the appropriate insulin infusion in the near future (e.g., the next five insulin infusion amounts) at 510... such that the predicted future glucose values 512 would trend sharply downward so as to be under the CTT set point of 140 mg/dL." (Finan ¶ [0094].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Finan because all three references address the same technical problem of optimizing automated insulin delivery for individual patients with diabetes. A person of ordinary skill in the art would have been motivated to incorporate Finan's MPC approach of generating multiple projected glucose profiles and selecting the one that best tracks a target glucose zone into the base system because MPC was a well-known and widely adopted technique for predictive insulin delivery.
In relation to independent claim 18, this claim recites an insulin delivery monitoring system comprising: an insulin delivery device configured to deliver insulin to a user; and a controller comprising: at least one processor; 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: based on glucose values of a user, generate a set of planned insulin delivery actions that include delivery of a predefined baseline basal rate; monitoring executed insulin delivery actions to identify an amount of insulin delivered above or below the predefined baseline basal rate; and responsive to the amount of insulin delivered above or below the predefined baseline basal rate, personalizing one or more subsequent insulin delivery actions.
An insulin delivery monitoring system comprising: an insulin delivery device configured to deliver insulin to a user; and a controller comprising: at least one processor; 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.
Keenan discloses a system with an insulin delivery device and a controller with processor and memory. Specifically, Keenan discloses: "[p]referred embodiments include a glucose sensor system 10, a controller 12 and an insulin delivery system 14... The controller 12 receives the sensor signal 16 and generates commands 22 that are communicated to the insulin delivery system 14. The insulin delivery system 14 receives the commands 22 and infuses insulin 24 into the body 20 in response to the commands 22." (Keenan ¶ [0112].) Keenan further discloses that the controller includes electrical components and software: "[t]ypically, the controller 12 includes controller electrical components and software to generate commands for the insulin delivery system 14 based on the sensor signal 16." (Keenan ¶ [0114].)
based on glucose values of a user, generate a set of planned insulin delivery actions that include delivery of a predefined baseline basal rate.
Keenan discloses generating planned insulin delivery actions based on glucose values. Specifically, Keenan discloses: "[p]referred embodiments include a glucose sensor system 10, a controller 12 and an insulin delivery system 14... 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." (Keenan ¶ [0112].) To the extent Keenan does not expressly disclose generating a set of planned insulin delivery actions that include delivery of a predefined baseline basal rate, Finan fills this gap by disclosing that the MPC controller generates planned insulin delivery actions anchored to the patient's predefined basal rate. Finan discloses: "the controller 10 in example B, has been commanding the pump to deliver a basal rate of 1 Units per hour (U/h) ... However, a prediction into the future by the MPC controller shows that (assuming the same basal insulin rate as before at 505), there would likely be a clear excursion of the blood glucose values 506 in the subject above the target zone 508." (Finan ¶ [0094].) Finan further discloses: "if all the predicted glucose values are within the zone, then every element of Gzone is equal to 0, and consequently J is minimized with I, basal for that time of day, i.e., the algorithm 'defaults' to the patient's current basal insulin infusion rate." (Finan ¶ [0070].)
monitoring executed insulin delivery actions to identify an amount of insulin delivered above or below the predefined baseline basal rate.
Keenan discloses monitoring insulin delivery relative to a desired basal glucose level. Specifically, Keenan discloses: "the controller 12 may or may not issue commands to infuse insulin depending on the derivative component (whether the glucose level is raising or falling) and the integral component (how long and by how much glucose level has been above or below the basal blood glucose level GB)." (Keenan ¶ [0151].) Keenan also discloses that the controller monitors total insulin delivered: "[i]n practice, task 1186 considers the total insulin (basal, bolus, and any other insulin delivered) for all sampling periods." (Keenan ¶ [0554].) To the extent Keenan does not expressly disclose monitoring insulin delivery actions to determine an amount of insulin delivered above or below a predefined baseline basal rate as a distinct method step, Parikh fills this gap by disclosing explicitly tracking the amount of insulin delivered against a baseline. Parikh discloses: "calculating a maximum insulin infusion rate for the user based on a fasting blood glucose value associated with the user, a total daily insulin value associated with the user, and fasting insulin delivery data that is indicative of insulin delivered to the user during a fasting period." (Parikh ¶ [0026].)
and responsive to the amount of insulin delivered above or below the predefined baseline basal rate, personalizing one or more subsequent insulin delivery actions.
Keenan discloses personalizing insulin delivery actions responsive to monitored levels. Specifically, Keenan discloses: "Further embodiments may include a controller that self-tunes one or more the gains, KP, KI, KD, to accommodate changes in insulin sensitivity." (Keenan ¶ [0186].)
Based on the above comments, for an artisan skilled in the art, it would have been obvious to combine Keenan with Parikh and Finan because all three references are directed to closed-loop insulin infusion systems that monitor blood glucose and adjust insulin delivery to maintain a target glucose level.
In relation to claim 19, this claim depends from claim 18 and further recites wherein monitoring executed insulin delivery actions to identify an amount of insulin delivered above or below the predefined baseline basal rate comprises determining a total daily insulin dose.
Base rejection incorporated.
The rejection of claim 18 is incorporated herein.
wherein monitoring executed insulin delivery actions to identify an amount of insulin delivered above or below the predefined baseline basal rate comprises determining a total daily insulin dose.
Keenan discloses determining a total daily insulin dose. Specifically, Keenan discloses: "The nominal (i.e., for the case with no insulin feedback) controller gain KPO is calculated based on the subjects insulin total daily dose ITDD (in Units/day)." (Keenan ¶ [0477].) Parikh further discloses obtaining "a total daily insulin value associated with the user." (Parikh ¶ [0026].)
The motivation to combine Keenan and Parikh is the same as stated for claim 18.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2014/0066892A1; hereinafter “Keenan”) in view of Parikh et al. (US 2014/0066888A1; hereinafter “Parikh”) as discussed above, and in further view of Blomquist (US 2014/0171772A1).
In relation to claim 11, this claim depends from claim 1 and further recites further comprising: receiving an acknowledgement of the adjustment to the one or more subsequent insulin delivery actions; and in response to receiving the acknowledgment, enabling insulin to be delivered according to the adjusted one or more subsequent insulin delivery actions.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
further comprising: receiving an acknowledgement of the adjustment to the one or more subsequent insulin delivery actions; and in response to receiving the acknowledgment, enabling insulin to be delivered according to the adjusted one or more subsequent insulin delivery actions.
Keenan discloses a semi-closed-loop system requiring user confirmation before delivery. Specifically, Keenan discloses: "[i]n further embodiments, a 'semi-closed-loop' system may be used, in which the user is prompted to confirm insulin delivery before any insulin is actually delivered." (Keenan ¶ [0125].) Keenan further discloses: "[i]n 'semi-closed loop' embodiments, the user is prompted before the controller 12 issues the commands to infuse insulin. The prompts may be displayed to the user on a display, sounded to the user, or otherwise provide an indication to the user that the system is ready to deliver insulin... In response, the user may indicate that the insulin should or should not be delivered, for example by selecting a button, key, or other input." (Keenan ¶ [0151].) To the extent the base combination does not expressly disclose receiving an acknowledgement specifically of the adjustment to subsequent insulin delivery actions and enabling delivery in response, Blomquist fills the gap by disclosing receiving an indication that a recommended action was taken and using that indication to determine further actions. Blomquist discloses: "the insulin pump device 200 may receive an indication that a recommended action was taken. The rule module 225 may apply the rule to the blood glucose data, the response to the question, and the indication that the action was taken to determine at least one of a further question and a further recommended action to be presented." (Blomquist ¶ [0032].) Blomquist further discloses: "[t]he user responds to the question through the user interface 210. Based at least in part on one or more responses, the controller 220 displays at least one recommended action for the user to take." (Blomquist ¶ [0025].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Blomquist because all three references relate to insulin pump systems with user interfaces and safety mechanisms. A person of ordinary skill in the art would have been motivated to incorporate Blomquist's interactive user acknowledgment and feedback loop into the semi-closed-loop confirmation step of Keenan to ensure that the user is actively aware of and approves any automated adjustments to their insulin delivery regimen before delivery is enabled. This combination would have improved patient safety by preventing accidental or unintended insulin delivery.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2014/0066892A1; hereinafter “Keenan”) in view of Parikh et al. (US 2014/0066888A1; hereinafter “Parikh”) and Sloan et al. (US 2007/0106135A1; hereinafter “Sloan”).
In relation to claim 3, this claim depends from claim 1 and further recites wherein adjusting one or more subsequent insulin delivery actions comprises personalizing at least one subsequent insulin delivery action of the one or more subsequent insulin delivery actions to deliver insulin according to a personalized insulin delivery profile.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein adjusting one or more subsequent insulin delivery actions comprises personalizing at least one subsequent insulin delivery action of the one or more subsequent insulin delivery actions to deliver insulin according to a personalized insulin delivery profile.
Keenan discloses personalizing insulin delivery by self-tuning controller parameters to the individual patient. Specifically, Keenan discloses: "[f]urther embodiments may include a controller that self-tunes one or more the gains, KP, KI, KD, to accommodate changes in insulin sensitivity." (Keenan ¶ [0186].) To the extent the base combination does not expressly disclose personalizing delivery according to a personalized insulin delivery profile, Sloan fills this gap by disclosing a system that determines a personalized modification to the current basal profile based on the patient's monitored analyte levels and patient-specific parameters. Specifically, Sloan discloses: "based on one or more patterns from the analyte levels monitored and factoring in the current basal profile(s), a recommendation or modification to the current basal profile(s) is determined." (Sloan ¶ [0040].) Sloan further discloses that the modification to the current basal profile accounts for patient-specific parameters including "patient's activities during the monitored time period, patient's diet, insulin sensitivity, level of insulin on board, and the insulin type, and the frequency of bolus dosing during the time period of the analyte level monitoring." (Sloan ¶ [0042].)
In view of the above teachings, for a person of ordinary skill in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Sloan because all three references address the same technical problem of optimizing automated insulin delivery for individual patients with diabetes.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2014/0066892A1; hereinafter “Keenan”) in view of Parikh et al. (US 2014/0066888A1; hereinafter “Parikh”) and Sloan et al. (US 2007/0106135A1; hereinafter “Sloan”), as discussed above, and in further view of Finan et al. (US 2014/0180240A1; hereinafter “Finan”).
In relation to claim 4, this claim depends from claim 3 and further recites wherein personalizing at least one subsequent insulin delivery action of the one or more subsequent insulin delivery actions comprises: responsive to the amount of insulin exceeding a threshold amount and measured glucose values , generating a plurality insulin delivery profiles and projecting glucose levels for each of the plurality insulin delivery profiles; and selecting an insulin delivery profile of the plurality insulin delivery profiles that most closely tracks towards a target glucose level.
Base rejection incorporated.
The rejection of claim 3 is incorporated herein.
wherein personalizing at least one subsequent insulin delivery action of the one or more subsequent insulin delivery actions comprises: responsive to the amount of insulin exceeding a threshold amount and measured glucose values , generating a plurality insulin delivery profiles and projecting glucose levels for each of the plurality insulin delivery profiles; and selecting an insulin delivery profile of the plurality insulin delivery profiles that most closely tracks towards a target glucose level.
Keenan discloses generating a plurality of candidate solutions (profiles) and selecting the best match. Specifically, Keenan discloses: "Conceptually, task 1160 generates a plurality of curves (or discrete values that may be used to visualize curves for purposes of this explanation) and compares the portion of the curves within the model training period to the actual sensor glucose values obtained during the model training period. In an ideal scenario with a perfect match, one of the generated curves will precisely track the actual sensor glucose values within the model training period... task 1160 identifies the calculated curve that best matches the actual sensor values." (Keenan ¶ [0547].) To the extent the base combination does not expressly disclose projecting glucose levels for a plurality of insulin delivery profiles and selecting the one that most closely tracks towards a target glucose level, Finan fills the gap by disclosing MPC that generates predicted glucose profiles and selects the insulin delivery plan that brings glucose to the target zone. Finan discloses: "The MPC of control logic 10 incorporates an explicit model of human T1DM glucose-insulin dynamics. The model is used to predict future glucose values and to calculate future controller moves that will bring the glucose profile to the desired range or 'Zone.'" (Finan ¶ [0053].) Finan further discloses: "the MPC controller will determine, in the CTT mode of FIG. 5B, the appropriate insulin infusion in the near future (e.g., the next five insulin infusion amounts) at 510... such that the predicted future glucose values 512 would trend sharply downward so as to be under the CTT set point of 140 mg/dL." (Finan ¶ [0094].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Keenan, Parikh, and Sloan with Finan because all four references address the same technical problem of optimizing automated insulin delivery for individual patients.
Claims 8, 15, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 2014/0066892A1; hereinafter “Keenan”) in view of Parikh et al. (US 2014/0066888A1; hereinafter “Parikh”) and Ginsberg (US 2005/0192494A1).
In relation to claim 8, this claim depends from claim 1 and further recites wherein adjusting one or more subsequent insulin delivery actions comprises adjusting parameters utilized to calculate and recommend subsequent bolus doses.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein adjusting one or more subsequent insulin delivery actions comprises adjusting parameters utilized to calculate and recommend subsequent bolus doses.
Ginsberg discloses adjusting parameters to calculate subsequent bolus doses. Specifically, Ginsberg discloses that the carbohydrate-to-insulin ratio and insulin sensitivity factor are used to calculate bolus doses: "[t]he correction dose is determined by the insulin sensitivity factor, ISF, which is the amount that 1 unit of insulin will lower the blood glucose value... The dose is the difference of the current blood glucose value from the target glucose value, divided by the ISF." (Ginsberg ¶ [0006].) Ginsberg further discloses determining the CIR: "determining a carbohydrate to insulin ratio for the selected period from an average of the daily carbohydrate to insulin ratios." (Ginsberg ¶ [0015].) To the extent the base combination does not expressly disclose adjusting parameters for subsequent bolus dose calculation, Ginsberg fills this gap by disclosing a system that determines and updates the CIR and ISF parameters used to calculate bolus doses.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Ginsberg because all three references address the same technical problem of optimizing automated insulin delivery for individual patients with diabetes. One skilled in the art would have been motivated to incorporate Ginsberg's methods for calculating and updating the carbohydrate-to-insulin ratio (CIR) and insulin sensitivity factor (ISF) because these parameters are fundamental to accurate bolus dose calculation, and their automated determination from patient data would have been a natural extension of the closed-loop system disclosed in Keenan.
In relation to claim 15, this claim depends from claim 12 and further recites wherein personalizing one or more subsequent insulin delivery actions comprises determining at least one new parameter utilized to determine at least one of subsequent bolus doses or an insulin delivery profile.
Base rejection incorporated.
The rejection of claim 12 is incorporated herein.
wherein personalizing one or more subsequent insulin delivery actions comprises determining at least one new parameter utilized to determine at least one of subsequent bolus doses or an insulin delivery profile.
Ginsberg discloses determining new parameters for bolus doses. Specifically, Ginsberg discloses: "An apparatus and method are provided for determining a patient's carbohydrate to insulin ratio (CIR) and insulin sensitivity factor (ISF), and using these values, along with values for current blood glucose level and deviation from target blood glucose level, for determining insulin dose in view of carbohydrate intake during a particular time period." (Ginsberg, Abstract.) Ginsberg further discloses: "determining a carbohydrate to insulin ratio for the selected period from an average of the daily carbohydrate to insulin ratios." (Ginsberg ¶ [0015].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Ginsberg because all three references address the same technical problem of optimizing automated insulin delivery. One skilled in the art would have been motivated to incorporate Ginsberg's methods for calculating and updating the carbohydrate-to-insulin ratio (CIR) and insulin sensitivity factor (ISF) because these parameters are fundamental to accurate bolus dose calculation and personalization of insulin therapy.
In relation to claim 16, this claim depends from claim 15 and further recites wherein the at least one new parameter comprises at least one of a carbohydrate-to-insulin ratio or insulin sensitivity factor associated with the user.
Base rejection incorporated.
The rejection of claim 15 is incorporated herein.
wherein the at least one new parameter comprises at least one of a carbohydrate-to-insulin ratio or insulin sensitivity factor associated with the user.
Ginsberg expressly discloses determining a carbohydrate-to-insulin ratio and insulin sensitivity factor. Specifically, Ginsberg discloses: "[a]n apparatus and method are provided for determining a patient's carbohydrate to insulin ratio (CIR) and insulin sensitivity factor (ISF)." (Ginsberg, Abstract.) Ginsberg further discloses: "[t]he correction dose is determined by the insulin sensitivity factor, ISF, which is the amount that 1 unit of insulin will lower the blood glucose value." (Ginsberg ¶ [0006].)
The motivation to combine Keenan, Parikh, and Ginsberg is the same as stated for claim 15.
In relation to claim 20, this claim depends from claim 18 and further recites wherein personalizing one or more subsequent insulin delivery actions comprises determining at least one new parameter utilized to determine at least one of subsequent bolus doses or an insulin delivery profile.
Base rejection incorporated.
The rejection of claim 18 is incorporated herein.
wherein personalizing one or more subsequent insulin delivery actions comprises determining at least one new parameter utilized to determine at least one of subsequent bolus doses or an insulin delivery profile.
Ginsberg discloses determining new parameters for bolus doses. Specifically, Ginsberg discloses: "[a]n apparatus and method are provided for determining a patient's carbohydrate to insulin ratio (CIR) and insulin sensitivity factor (ISF), and using these values, along with values for current blood glucose level and deviation from target blood glucose level, for determining insulin dose in view of carbohydrate intake during a particular time period." (Ginsberg, Abstract.) Ginsberg further discloses: "determining a carbohydrate to insulin ratio for the selected period from an average of the daily carbohydrate to insulin ratios." (Ginsberg ¶ [0015].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the base combination of Keenan and Parikh with Ginsberg because all three references address the same technical problem of optimizing automated insulin delivery. One skilled in the art would have been motivated to incorporate Ginsberg's methods for calculating and updating the carbohydrate-to-insulin ratio (CIR) and insulin sensitivity factor (ISF) because these parameters are fundamental to accurate bolus dose calculation and personalization of insulin therapy.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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