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 § 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 1-2, 5-11, 12, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Vinas et al. (US 2019/0192774A1; hereinafter “Vinas”) in view of Ginsberg (US 20050192494A1), Hellwig et al. (US 2006/0047192A1; hereinafter “Hellwig”) and Palerm (US 2015/0306312A1).
In relation to independent claims 1 and 12, claim 1 recites a device comprising a processor and memory storing programming code, where the processor controls insulin delivery; determines insulin onboard in a postprandial period after a meal; determines a correction term based on differences between measured glucose values and target blood glucose settings during the postprandial period; estimates an updated insulin-to-carbohydrate ratio based on the correction term and approximate meal carbohydrates; and modifies insulin delivery based on the updated ratio. Claim 12 recites materially corresponding programming instructions embodied on a non-transient computer-readable medium.
Processor, memory, and programming instructions for controlling insulin delivery.
Vinas discloses an algorithmic closed-loop insulin-delivery environment, stating that a “closed-loop system for automatic glucose control in type 1 diabetes mellitus (T1DM), also referred to as artificial pancreas.” (Vinas ¶ [0011].) Vinas also discloses a bolus-calculator algorithm, stating that “A standard insulin bolus calculator [Schmidt 2014] is defined by the equation” followed by the bolus equation. (Vinas ¶ [0017].) Vinas does not expressly disclose the specific processor-and-memory hardware formulation of claims 1 and 12. Ginsberg fills that implementation gap by disclosing that glucose results may be stored “in a computerized memory device” and that the patient may use “a medication delivery device (e.g., a syringe, medication delivery pen or infusion pump) to deliver the appropriate amount of insulin.” (Ginsberg ¶ [0008].) Ginsberg further discloses that “[t]he processing device 52 can be connected to a memory device 54 for storing the algorithms for implementing the present invention and data such as, but not limited to, blood glucose levels, carbohydrate intake data and insulin administration data.” (Ginsberg ¶ [0033].) Palerm also discloses software-controlled delivery, stating that “the infusion device 102, the CCD 106 and/or the computer 108 may include electronics and Software that are configured to analyze sensor data and operate the infusion device 102 to deliver fluid to the body of the user based on the sensor data and/or preprogrammed delivery routines.” (Palerm ¶ [0044].)
Determine an amount of insulin onboard in a postprandial time period after a meal.
Vinas discloses insulin-on-board in the bolus calculation, stating that “IOB (U) is the insulin-on-board, which represents an estimation of the remaining active insulin in the body.” (Vinas ¶ [0018].) Vinas further discloses postprandial insulin accounting, stating that “the insulin delivered by the CL controller during the postprandial period over the basal insulin, is insulin that should have been delivered by the meal-priming bolus.” (Vinas ¶ [0037].) Palerm fills any device-implementation gap by disclosing that “an infusion device operable to deliver insulin to a body of a user” performs a method involving “identifying a minimum insulin on board for the user,” “identifying a current insulin on board for the user,” and “operating the infusion device in accordance with the delivery command.” (Palerm ¶ [0008].)
Determine a correction term based on differences between measured glucose values and target blood glucose settings during the postprandial period.
Vinas discloses an error term as a measured-value/set-point difference, stating that “error is the tracking error defined as the difference between a measurement from the process and a set-point.” (Vinas ¶ [0030].) Vinas then applies this to postprandial glucose, stating that “the meal insulin bolus can be adjusted based on the residual between the minimal post-prandial glucose concentration (Gmin), obtained with a continuous glucose monitor, and a predefined glucose set-point (Gsp) over a predefined time window.” (Vinas ¶ [0031].) Vinas further discloses that “Bextra=K (Gmin-Gsp) is the extra insulin that needs to be added (or subtracted) to the original bolus ... in order to bring blood glucose levels back to the set-point.” (Vinas ¶ [0032].) To the extent Vinas does not use the exact phrase “target blood glucose settings,” Hellwig fills that gap by disclosing that “[a] user blood glucose target may be established by storing the user blood glucose target in the memory unit” and that the method includes “computing a difference value as the current blood glucose value less the blood glucose target.” (Hellwig ¶ [0003].)
Estimate an updated insulin-to-carbohydrate ratio based on the correction term and approximate carbohydrates ingested in the meal.
Vinas discloses the relevant bolus-calculator variables, stating that “B (U) is the total calculated bolus, CHO (g) is the estimated amount of ingested carbohydrates, ICR (g/U) is the insulin-to-carbohydrate-ratio, G (mg/dl) is the measured glucose at meal time, Gsp (mg/dl) is the glucose set-point, ISF (mg/dl/U) is the insulin sensitivity factor, and IOB (U) is the insulin-on-board.” (Vinas ¶ [0018].) Vinas further discloses postprandial updating, stating that “D(t) are the individual insulin doses delivered by the CL controller” and that “the updated ICR ... can be easily obtained by replacing Bextra by Bextra new in Equation (5).” (Vinas ¶ [0039].) To the extent a user-entered or approximate carbohydrate value is required, Hellwig discloses “receiving a carbohydrate value indicative of a quantity of carbohydrates that will be subsequently ingested by the user.” (Hellwig ¶ [0007].)
Modify delivery of insulin based on the updated insulin-to-carbohydrate ratio.
Vinas discloses that its postprandial bolus adaptation changes the ICR used for later bolus calculations, stating that “the updated ICR ... can be easily obtained by replacing Bextra by Bextra new in Equation (5).” (Vinas ¶ [0039].) Ginsberg discloses using CIR and ISF to determine a recommended insulin dose, stating that “the processing device 52 can be programmed to use the calculated CIR and ISF to determine a recommended insulin dose.” (Ginsberg ¶ [0052].) Ginsberg provides the corresponding dose equation: “Insulin=Carb/CIR+(Glucose-Target)/ISF-(remaining insulin).” (Ginsberg ¶ [0052].) Palerm discloses operating the infusion device based on sensor data and routines, stating that electronics and software may “analyze sensor data and operate the infusion device 102 to deliver fluid to the body of the user based on the sensor data and/or preprogrammed delivery routines.” (Palerm ¶ [0044].)
Primary-reference gaps and secondary-reference gap filling [in summary].
Vinas discloses the core postprandial adaptive ICR concept, including IOB, CHO, glucose set point, error/residual, Bextra, and updated ICR. Vinas does not expressly claim the exact processor/memory/CRM packaging of claims 1 and 12, and it does not use the exact phrase “target blood glucose settings.” Ginsberg supplies the processor/memory/programmed-dose-calculation implementation and the CIR/ISF dose equation. Hellwig supplies the blood-glucose-target/difference-value and carbohydrate-value language. Palerm supplies the infusion-device software, IOB control, sensor-data, and pump-operation implementation.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Vinas with Ginsberg, Hellwig, and Palerm because each reference addresses insulin dosing using glucose measurements, carbohydrate intake, target glucose, correction factors, remaining/active insulin, and pump or programmed delivery. A person of ordinary skill would have implemented Vinas’s adaptive ICR calculation using the computerized memory/processing and infusion-pump control structures of Ginsberg and Palerm, and would have used Hellwig’s blood-glucose-target difference logic, to improve postprandial glucose control while accounting for active insulin and carbohydrate intake.
In relation to claim 2, this claim depends from claim 1 and recites a blood glucose sensor communicatively coupled to the processor that measures glucose values and provides them to the processor.
Base rejection incorporated.
The rejection of claim 1 is incorporated into this rejection.
Blood glucose sensor communicatively coupled to the processor.
Vinas discloses obtaining postprandial glucose with a continuous monitor, stating that the residual is based on “the minimal post-prandial glucose concentration (Gmin), obtained with a continuous glucose monitor.” (Vinas ¶ [0031].) Palerm discloses sensor-to-controller data communication, stating that the sensing arrangement may “provide data indicative of the blood glucose level to the infusion device 102, the CCD 106 and/or the computer 108.” (Palerm ¶ [0044].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use Palerm’s sensor-data communication architecture in Vinas’s adaptive bolus system because Vinas’s postprandial residual requires measured glucose values.
In relation to claims 5 and 6, claim 5 depends from claim 1 and recites receiving an approximate amount of carbohydrates ingested in the meal via a user interface. Claim 6 depends from claim 1 and recites determining that the meal has been ingested or is to be ingested, monitoring insulin delivery over time, and using delivered insulin over that period in determining insulin onboard in the postprandial time period.
Base rejection incorporated.
The rejection of claim 1 is incorporated into this rejection.
Approximate carbohydrates via a user interface.
Hellwig discloses receiving meal carbohydrate information, stating that the method includes “receiving a carbohydrate value indicative of a quantity of carbohydrates that will be subsequently ingested by the user.” (Hellwig ¶ [0007].) Ginsberg discloses user input of carbohydrate values, stating that “[t]he carbohydrate values are generally provided manually by the user via a keyboard or other type of user input device 58 but could be input automatically, remotely or both.” (Ginsberg ¶ [0042].)
Meal/postprandial determination and monitoring delivered insulin over time.
Vinas discloses estimated meal carbohydrates and postprandial delivered-insulin accounting, stating that “CHO (g) is the estimated amount of ingested carbohydrates” and that “the insulin delivered by the CL controller during the postprandial period over the basal insulin, is insulin that should have been delivered by the meal-priming bolus.” (Vinas ¶¶ [0018], [0037].) Vinas further discloses that “D(t) are the individual insulin doses delivered by the CL controller.” (Vinas ¶ [0039].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Hellwig’s and Ginsberg’s carbohydrate input teachings with Vinas’s postprandial ICR adaptation because Vinas’s bolus calculation expressly uses CHO and postprandial insulin-delivery information.
In relation to claim 7, this claim depends from claim 1 and recites determining a difference between received blood glucose measurements and a target blood glucose setting, summing differences during the postprandial period, and dividing the summed differences by a correction factor that accounts for the user’s ability to process delivered insulin.
Base rejection incorporated.
The rejection of claim 1 is incorporated into this rejection.
Glucose-target difference and correction factor.
Vinas discloses a measured-value/set-point error: “error is the tracking error defined as the difference between a measurement from the process and a set-point.” (Vinas ¶ [0030].) Vinas further discloses a postprandial residual between “minimal post-prandial glucose concentration (Gmin)” and “a predefined glucose set-point (Gsp).” (Vinas ¶ [0031].) Ginsberg discloses the correction-factor division, stating that “[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” and that “The dose is the difference of the current blood glucose value from the target glucose value, divided by the ISF.” (Ginsberg ¶ [0006].) Hellwig discloses “computing a difference value as the current blood glucose value less the blood glucose target.” (Hellwig ¶ [0003].)
Primary-reference gaps and secondary-reference gap filling [in summary].
Vinas discloses a postprandial glucose residual but does not expressly recite summing multiple differences and dividing that sum by a correction factor. Ginsberg fills the correction-factor division using ISF, and Hellwig supplies the target-difference calculation. Applying those teachings to accumulated postprandial CGM deviations would have been a predictable use of known correction-factor logic.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine the teachings because the references use the same correction principle: glucose deviation from a target or set point is converted into insulin correction using insulin sensitivity.
In relation to claims 8 and 17, claim 8 depends from claim 1 and recites that modified insulin delivery is either a newly calculated next dose or a modification of dose amount and timing. Claim 17 depends from claim 12 and recites corresponding programming instructions.
Base rejection incorporated.
The rejections of claims 1 and 12 are incorporated into this rejection.
New or modified next dose.
Vinas discloses dose modification through Bextra, stating that “Bextra=K (Gmin-Gsp) is the extra insulin that needs to be added (or subtracted) to the original bolus ... in order to bring blood glucose levels back to the set-point.” (Vinas ¶ [0032].) Ginsberg discloses that the programmed device determines a recommended insulin dose: “the processing device 52 can be programmed to use the calculated CIR and ISF to determine a recommended insulin dose.” (Ginsberg ¶ [0052].) Palerm discloses delivery-command control, stating that an insulin-on-board method includes “generating a delivery command configured to regulate the current insulin on board to the minimum insulin onboard” and “operating the infusion device in accordance with the delivery command.” (Palerm ¶ [0008].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use Vinas’s updated bolus/ICR with Ginsberg’s dose-calculation software and Palerm’s delivery-command execution because the combination implements the calculated therapy adjustment in an insulin pump.
In relation to claims 9 and 18, claim 9 depends from claim 1 and recites actuating a pump mechanism to deliver a next insulin dose calculated using the updated ICR. Claim 18 depends from claim 12 and recites corresponding programming instructions.
Base rejection incorporated.
The rejections of claims 1 and 12 are incorporated into this rejection.
Pump actuation to deliver next insulin dose.
Vinas discloses insulin dosing in a closed-loop artificial-pancreas context and an updated ICR, stating that “the updated ICR ... can be easily obtained by replacing Bextra by Bextra new in Equation (5).” (Vinas ¶ [0039].) Palerm discloses pump delivery, stating that “the infusion device 102 is designed as a portable medical device suitable for infusing a fluid ... into the body of a user” and that “the infused fluid is insulin.” (Palerm ¶ [0043].) Palerm also discloses software operating the pump to deliver fluid, stating that software may “operate the infusion device 102 to deliver fluid to the body of the user.” (Palerm ¶ [0044].)
Based on the above comments, for an artisan skilled in the art, it would have been obvious to actuate Palerm’s insulin infusion pump according to Vinas’s updated bolus calculation because Vinas’s adaptive ICR is used to improve insulin delivery.
In relation to claim 10, this claim depends from claim 1 and recites a transceiver operable to receive and transmit signals containing information usable by or generated by the processor.
Base rejection incorporated.
The rejection of claim 1 is incorporated into this rejection.
Transceiver.
Palerm discloses that system components may include “a transmitter, a receiver, and/or other transceiver electronics that allow for communication with other components of the infusion system 100.” (Palerm ¶ [0044].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use Palerm’s transceiver electronics in Vinas’s closed-loop insulin delivery environment because glucose sensor data and delivery commands must be communicated among system components.
In relation to claims 11 and 19, claim 11 depends from claim 1 and claim 19 depends from claim 12. Each recites that the difference between the determined amount of insulin on board and an error factor provides an estimated amount of insulin to compensate for meal ingestion.
Base rejection incorporated.
The rejections of claims 1 and 12 are incorporated into this rejection.
Insulin-on-board and error/correction factor used for meal compensation.
Vinas discloses IOB, stating that “IOB (U) is the insulin-on-board, which represents an estimation of the remaining active insulin in the body.” (Vinas ¶ [0018].) Vinas also discloses the error-derived extra insulin, stating that “Bextra=K (Gmin-Gsp) is the extra insulin that needs to be added (or subtracted) to the original bolus ... in order to bring blood glucose levels back to the set-point.” (Vinas ¶ [0032].) Ginsberg discloses a dose equation using carbohydrate, CIR, glucose-target correction, and remaining insulin: “Insulin=Carb/CIR+(Glucose-Target)/ISF-(remaining insulin).” (Ginsberg ¶ [0052].) Palerm discloses active insulin control, stating that the system identifies “a current insulin on board for the user” and generates a delivery command to regulate it. (Palerm ¶ [0008].)
Primary-reference gaps and secondary-reference gap filling [in summary].
Vinas discloses the components of the calculation, but does not use the exact phrase “difference between the determined amount of insulin on board and an error factor.” Ginsberg fills the express subtraction of remaining insulin in a bolus equation, and Palerm fills the device-side determination/regulation of current IOB.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use active-insulin subtraction and glucose-error correction together because the references identify both factors as necessary to avoid over delivery while compensating for meal-related glucose excursions.
In relation to claim 16, this claim depends from claim 12 and recites determining that the meal has been ingested or is to be ingested, monitoring insulin delivery over a period of time in response, and using delivered insulin over that period in determining insulin onboard in the postprandial period.
Base rejection incorporated.
The rejection of claim 12 is incorporated into this rejection.
Meal and postprandial delivered-insulin monitoring.
Hellwig discloses receiving carbohydrates that will be ingested, stating that the method includes “receiving a carbohydrate value indicative of a quantity of carbohydrates that will be subsequently ingested by the user.” (Hellwig ¶ [0007].) Vinas discloses postprandial delivered-insulin accounting, stating that “the insulin delivered by the CL controller during the postprandial period over the basal insulin, is insulin that should have been delivered by the meal-priming bolus.” (Vinas ¶ [0037].) Vinas further states that “D(t) are the individual insulin doses delivered by the CL controller.” (Vinas ¶ [0039].) Palerm discloses determining current IOB, stating that the method involves “identifying a current insulin on board for the user.” (Palerm ¶ [0008].)
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use delivered-insulin monitoring after a meal announcement or carbohydrate entry because the postprandial adaptation in Vinas expressly treats postprandial insulin over basal as insulin relevant to the meal bolus.
Claims 13 are rejected under 35 U.S.C. 103 as being unpatentable over Vinas et al. (US 2019/0192774A1; hereinafter “Vinas”) in view of Ginsberg (US 2005/0192494A1), Hellwig et al. (US 2006/0047192A1; hereinafter “Hellwig”) and Palerm (US 2015/0306312A1), as discussed above, and in further view of Mazlish et al. (US 2018/0200437A1; hereinafter “Mazlish”).
In relation to claim 13, this claim depends from claim 12 and recites receiving, from a blood glucose sensor communicatively coupled to the processor, a glucose measurement value at a predetermined time interval.
Base rejection incorporated.
The rejection of claim 12 is incorporated into this rejection.
Glucose sensor and predetermined interval.
Vinas discloses that postprandial glucose is “obtained with a continuous glucose monitor.” (Vinas ¶ [0031].) Palerm discloses providing blood-glucose sensor data to system components, stating that the sensing arrangement may “provide data indicative of the blood glucose level to the infusion device 102, the CCD 106 and/or the computer 108.” (Palerm ¶ [0044].) Mazlish supplies the predetermined-interval teaching, stating that “continuous glucose monitor 50 can be adapted to provide blood glucose measurements for a PWD when in use for the PWD at regular or irregular time intervals” and that it can detect measurements “at least every thirty minutes, at least every fifteen minutes, at least every ten minutes, at least every five minutes, or about every minute.” (Mazlish ¶ [0040].)
Based on the above teachings, it would have been obvious to use Mazlish’s CGM interval measurements with Vinas’s postprandial bolus adaptation because Vinas’s residual-based method depends on CGM glucose data over a predefined time window.
Allowable Subject Matter
Claims 3-4 and 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 3, 4, 14, and 15 recite TDI updating using a first confidence coefficient or a coefficient indicating a confidence level of the TDI setting. Vinas does mention TDI as an evaluation metric, stating that standard glycemic metrics include “daily average of insulin delivered in units of insulin (TDI).” (Vinas ¶ [0051].) Ginsberg also discloses that ISF may be estimated by “dividing the at least one number by the total daily insulin dose.” (Ginsberg ¶ [0015].) However, these quotations do not disclose or suggest multiplying a retrieved TDI setting by a first confidence coefficient.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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