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 Objections
Claims 1, 8, 11, 17 and 20 [and related dependent claims] are objected to because of the following informalities:
Claim 1 recites "responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device." The phrase "authorized user" is grammatically incorrect. The claim should read "an authorized user."
Claim 1 also recites "whether the state of the patient satisfies a predetermined criteria." The word "criteria" is plural, but is preceded by the singular article "a". The claim should read "a predetermined criterion."
Claim 8 recites "a electrocardiographic signal." This is grammatically incorrect. The claim should read "an electrocardiographic signal."
Claim 11 recites "responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device." The phrase "authorized user" is grammatically incorrect. The claim should read "an authorized user."
Claim 17 recites "a electrocardiographic signal." This is grammatically incorrect. The claim should read "an electrocardiographic signal."
Claim 20 recites "responsive to receiving the request and biometric information and confirmation that the patient is authorized user to operate the drug delivery device." The phrase "authorized user" is grammatically incorrect. The claim should read "an authorized user."
Appropriate correction is required.
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, 3, 4, 5, 6, 11, 12, 13, 14, 15, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Patek et al. (US2020/0016336A1; hereinafter “Patek”) in view of Atkin (US2012/0072236A1).
In relation to independent claim 1 recites: a device for delivery of insulin based on multiple daily injection (MDI) data, the device comprising: a processor configured to calculate an amount of insulin to be administered using continuous subcutaneous insulin infusion (CSII) via an insulin pump based on at least in part a retrospective virtual basal rate determined from a historical record of MDI insulin amounts injected and a glucose measurement, and wherein the retrospective virtual basal rate is determined based on the historical record of MDI insulin amounts injected via an insulin pen.
A device for delivery of insulin based on multiple daily injection (MDI) data, the device comprising: a processor configured to calculate an amount of insulin to be administered using continuous subcutaneous insulin infusion (CSII) via an insulin pump based on at least in part a retrospective virtual basal rate determined from a historical record of MDI insulin amounts injected and a glucose measurement.
Patek discloses a system and processor that calculates an amount of insulin to be administered based on a retrospective virtual basal rate determined from a historical record of MDI insulin amounts and a glucose measurement. Specifically, Patek discloses: “[a] system for delivery of insulin to a patient, comprising: a glucometer including at least one input for receiving blood glucose measurements from said patient, a processor configured to calculate an amount of insulin to be administered to said patient, based on an insulin dosage in accordance with a retrospective virtual basal rate determined from a historical record of insulin amounts delivered to said patient and at least one received blood glucose measurement”. (Patek; claim 1). Patek further discloses that this provides a framework for CSII: “providing a unified framework for analysis, design, optimization, and adaptation of MDI (multiple daily injections) and CSII (continuous subcutaneous insulin infusion (i.e. insulin pump)) treatment parameters for patients with diabetes.” (Patek; Abstract).
and wherein the retrospective virtual basal rate is determined based on the historical record of MDI insulin amounts injected via an insulin pen.
Patek discloses that the retrospective virtual basal rate is determined based on a historical record of MDI insulin amounts injected. Specifically, Patek discloses: “based on a historical record of insulin injections 104 (including the timing and amounts of doses and allowing for the possibility of missing injections over multiple days), the subsystem 105 constructs a retrospective virtual basal rate 106”. (Patek ¶ [0041]). To the extent Patek does not expressly disclose that the historical record of MDI insulin amounts is injected via an insulin pen, Atkin fills this gap by disclosing an insulin pen that records historical injection data. Specifically, Atkin discloses: “[t]he present invention relates to an existing insulin delivery device, such as an insulin pen. The present invention is an electromechanical device, which is affixed to the pen. When the user rotates the top of the pen to select the prescribed dosage of insulin to be injected into the body, the device mechanically measures the distance traveled by the plunger inside the pen from its original position… the amount of insulin injected is recorded.” (Atkin ¶ [0003]). Atkin further discloses: “a data recorder and transmitter FIG. 2, which collects data regarding injection of insulin including (but not limited to), the dosage for the injection, the time of injection and the date of injection.” (Atkin ¶ [0009]).
Motivation to combine.
It would have been obvious to combine Patek with Atkin because both references relate to managing insulin therapy for diabetic patients using historical injection data. A person of ordinary skill in the art would have been motivated to incorporate Atkin’s teaching of an insulin pen that automatically records the time, date, and dosage of insulin injections into Patek’s system to provide an accurate, automated historical record of MDI insulin amounts injected, thereby improving the accuracy of the retrospective virtual basal rate calculation without relying on manual patient logging.
In relation to claim 2, this claim depends from claim 1 and further recites: the device of claim 1, wherein the processor is part of or in communication with a hand held or portable electronic device, a cell phone, a computer, glucose monitor device, or an insulin device.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the processor is part of or in communication with a hand held or portable electronic device, a cell phone, a computer, glucose monitor device, or an insulin device.
Patek discloses that the processor is part of a glucose monitor device. Specifically, Patek discloses: “[a] system for delivery of insulin to a patient, comprising: a glucometer including at least one input for receiving blood glucose measurements from said patient, a processor configured to calculate an amount of insulin to be administered.” (Patek; claim 1).
Motivation to combine.
It would have been obvious to combine the base combination of Patek and Atkin because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to incorporate the processor within a glucometer as taught by Patek to provide a convenient, integrated device for the patient to manage their insulin therapy.
In relation to claim 3, this claim depends from claim 1 and further recites: the device of claim 1, wherein the processor is configured to receive the glucose measurement.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the processor is configured to receive the glucose measurement.
Patek discloses that the processor is configured to receive the glucose measurement. Specifically, Patek discloses: “a glucometer including at least one input for receiving blood glucose measurements from said patient, a processor configured to calculate an amount of insulin to be administered to said patient, based on… at least one received blood glucose measurement”. (Patek; claim 1).
Motivation to combine.
It would have been obvious to combine the base combination of Patek and Atkin because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to configure the processor to receive glucose measurements as taught by Patek to enable accurate, data-driven insulin dosage calculations.
In relation to claim 4, this claim depends from claim 1 and further recites: the device of claim 1, wherein the glucose measurement is a self-monitoring glucose (SMBG) measurement.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the glucose measurement is a self-monitoring glucose (SMBG) measurement.
Patek discloses that the glucose measurement is an SMBG measurement. Specifically, Patek discloses: “wherein said at least one input receives a self-monitoring blood glucose (SMBG) measurement from said patient.” (Patek; claim 2).
Motivation to combine.
It would have been obvious to combine the base combination of Patek and Atkin because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to utilize SMBG measurements as taught by Patek because SMBG is a primary and widely available mechanism for assessing blood glucose for treatment.
In relation to claim 5, this claim depends from claim 1 and further recites: the device of claim 1, wherein the glucose measurement is a continuous glucose monitor (CGM) measurement.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the glucose measurement is a continuous glucose monitor (CGM) measurement.
Patek discloses that the glucose measurement is a CGM measurement. Specifically, Patek discloses: “wherein said at least one input receives a continuous glucose monitor (CGM) measurement from said patient.” (Patek; claim 3).
Motivation to combine.
It would have been obvious to combine the base combination of Patek and Atkin because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to utilize CGM measurements as taught by Patek to provide a more complete understanding of glycemic variability throughout the day.
In relation to claim 16, this claim depends from claim 1 and further recites: the device of claim 1, wherein the retrospective virtual basal rate is determined by matching a plasma insulin concentration pattern inferred from a mathematical model of a pharmacokinetic property of insulin with the historical record of insulin amounts delivered, to a pharmacokinetic property of rapid acting insulin delivered.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the retrospective virtual basal rate is determined by matching a plasma insulin concentration pattern inferred from a mathematical model of a pharmacokinetic property of insulin with the historical record of insulin amounts delivered, to a pharmacokinetic property of rapid acting insulin delivered.
Patek discloses matching a plasma insulin concentration pattern inferred from a mathematical model of PK properties with the historical record to a PK property of rapid acting insulin. Specifically, Patek discloses: “wherein said retrospective virtual basal rate is obtained by matching a plasma insulin concentration pattern inferred from a mathematical model of the pharmacokinetic properties of insulin in conjunction with said historical record of insulin amounts delivered to said patient, to a virtual record of basal rate insulin delivery inferred from a mathematical model of the pharmacokinetic properties of rapid-acting insulin delivered by a continuous infusion pump.” (Patek; claim 4).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to use mathematical modeling of PK properties as taught by Patek to accurately translate discrete historical injections into an equivalent continuous basal rate profile.
In relation to independent claim 11, this claim recites: a device for delivery of insulin based on multiple daily injection (MDI) data, the device comprising: a processor configured to calculate an amount of insulin to be administered using continuous subcutaneous insulin infusion (CSII) via an insulin pump based on at least in part a retrospective virtual basal rate determined from a historical record of MDI insulin amounts injected and a glucose measurement, wherein the processor: infers a history of insulin concentration based on pharmacokinetic (PK) properties of insulin; constructs a virtual basal rate profile, based on PK properties of insulin actually injected, that provides a pattern of insulin concentration that matches with the inferred history of insulin concentration; infers concentration of plasma insulin, based on PK properties of insulin actually injected, and constructs a retrospective virtual basal rate based on the historical record of MDI insulin amounts injected; and uses the retrospective virtual basal rate to calculate the amount of insulin to be administered using CSII via the insulin pump.
A device for delivery of insulin based on multiple daily injection (MDI) data, the device comprising: a processor configured to calculate an amount of insulin to be administered using continuous subcutaneous insulin infusion (CSII) via an insulin pump based on at least in part a retrospective virtual basal rate determined from a historical record of MDI insulin amounts injected and a glucose measurement.
Patek discloses a system and processor that calculates an amount of insulin to be administered based on a retrospective virtual basal rate determined from a historical record of MDI insulin amounts and a glucose measurement. Specifically, Patek discloses: “[a] system for delivery of insulin to a patient, comprising: a glucometer including at least one input for receiving blood glucose measurements from said patient, a processor configured to calculate an amount of insulin to be administered to said patient, based on an insulin dosage in accordance with a retrospective virtual basal rate determined from a historical record of insulin amounts delivered to said patient and at least one received blood glucose measurement”. (Patek; claim 1). To the extent Patek does not expressly disclose the historical record is injected via an insulin pen, Atkin fills this gap as discussed above in claim 1. (Atkin ¶ [0003]).
wherein the processor: infers a history of insulin concentration based on pharmacokinetic (PK) properties of insulin; constructs a virtual basal rate profile, based on PK properties of insulin actually injected, that provides a pattern of insulin concentration that matches with the inferred history of insulin concentration; infers concentration of plasma insulin, based on PK properties of insulin actually injected, and constructs a retrospective virtual basal rate based on the historical record of MDI insulin amounts injected; and uses the retrospective virtual basal rate to calculate the amount of insulin to be administered using CSII via the insulin pump.
Patek discloses that the processor infers a history of insulin concentration based on PK properties, constructs a virtual basal rate profile that matches the pattern, and constructs a retrospective virtual basal rate to calculate the amount of insulin. Specifically, Patek discloses: “wherein said retrospective virtual basal rate is obtained by matching a plasma insulin concentration pattern inferred from a mathematical model of the pharmacokinetic properties of insulin in conjunction with said historical record of insulin amounts delivered to said patient, to a virtual record of basal rate insulin delivery inferred from a mathematical model of the pharmacokinetic properties of rapid-acting insulin delivered by a continuous infusion pump.” (Patek; claim 4). Patek further discloses: “using the PK properties of insulin to infer the concentration of plasma insulin concentration resulting from the injections over time, and then using the PK properties of rapid-acting insulin delivered via CSII to determine the continuous CSII basal rate profile that would lead to the same historical concentrations of plasma insulin concentration over a 24-hour cycle.” (Patek ¶ [0041]).
Motivation to combine.
It would have been obvious to combine Patek with Atkin because both references relate to managing insulin therapy using historical injection data. A person of ordinary skill in the art would have been motivated to incorporate Atkin’s insulin pen recording device into Patek’s system to provide an accurate historical record of MDI insulin amounts, enabling the processor to accurately construct the retrospective virtual basal rate profile based on actual PK properties as taught by Patek.
In relation to claim 12, this claim depends from claim 11 and further recites: the device of claim 11, wherein the processor is part of or in communication with a hand held or portable electronic device, a cell phone, a computer, glucose monitor device, or an insulin device.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the processor is part of or in communication with a hand held or portable electronic device, a cell phone, a computer, glucose monitor device, or an insulin device.
Patek discloses that the processor is part of a glucose monitor device. Specifically, Patek discloses: “[a] system for delivery of insulin to a patient, comprising: a glucometer including at least one input for receiving blood glucose measurements from said patient, a processor configured to calculate an amount of insulin to be administered”. (Patek; claim 1).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to incorporate the processor within a glucometer as taught by Patek to provide a convenient, integrated device.
In relation to claim 13, this claim depends from claim 11 and further recites: The device of claim 11, wherein the processor is configured to receive the glucose measurement.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the processor is configured to receive the glucose measurement.
Patek discloses that the processor is configured to receive the glucose measurement. Specifically, Patek discloses: “a glucometer including at least one input for receiving blood glucose measurements from said patient, a processor configured to calculate an amount of insulin to be administered to said patient, based on… at least one received blood glucose measurement”. (Patek; claim 1).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to configure the processor to receive glucose measurements to enable accurate, data-driven insulin dosage calculations.
In relation to claim 14, this claim depends from claim 11 and further recites: the device of claim 11, wherein the glucose measurement is a self-monitoring glucose (SMBG) measurement.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the glucose measurement is a self-monitoring glucose (SMBG) measurement.
Patek discloses that the glucose measurement is an SMBG measurement. Specifically, Patek discloses: “wherein said at least one input receives a self-monitoring blood glucose (SMBG) measurement from said patient.” (Patek; claim 2).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to utilize SMBG measurements because SMBG is a primary and widely available mechanism for assessing blood glucose.
In relation to claim 15, this claim depends from claim 11 and further recites: The device of claim 11, wherein the glucose measurement is a continuous glucose monitor (CGM) measurement.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the glucose measurement is a continuous glucose monitor (CGM) measurement.
Patek discloses that the glucose measurement is a CGM measurement. Specifically, Patek discloses: “wherein said at least one input receives a continuous glucose monitor (CGM) measurement from said patient.” (Patek; claim 3).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to utilize CGM measurements to provide a more complete understanding of glycemic variability.
In relation to claim 18, this claim depends from claim 11 and further recites: The device of claim 11, wherein the processor constructs the retrospective virtual basal rate that provides a concentration of plasma insulin that matches with the inferred concentration of plasma insulin.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the processor constructs the retrospective virtual basal rate that provides a concentration of plasma insulin that matches with the inferred concentration of plasma insulin.
Patek discloses constructing a retrospective virtual basal rate that provides a concentration of plasma insulin that matches the inferred concentration. Specifically, Patek discloses: “Using the PK properties of rapid-acting insulin delivered via CSII insulin pump, the system infers a virtual historical record of basal rate insulin delivery {b(σ)}o=0T… whose corresponding instantaneous plasma insulin concentrations Gtransient(τ; {b(σ)}… match the plasma insulin concentration pattern from the historical injections, i.e. G transient (τ; {b(σ)} o=0T … = I transient (τ)” (Patek ¶ [0047]-[0048]).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to construct the virtual basal rate to match the inferred plasma insulin concentration to ensure the calculated CSII delivery accurately replaces the historical MDI delivery.
Claims 6, 7, 17, 8, 9, 10, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Patek et al. (US2020/0016336A1; hereinafter “Patek”) in view of Atkin (US 2012/0072236A1), as discussed above, and in further view of Blomquist (US 2014/0171772A1).
In relation to independent claim 6, this claim recites: a method for delivery of insulin based on multiple daily injection (MDI) data, the method comprising: calculating an amount of insulin to be administered using continuous subcutaneous insulin infusion (CSII) via an insulin pump based on at least in part a retrospective virtual basal rate determined from a historical record of MDI insulin amounts injected and a glucose measurement, and wherein the retrospective virtual basal rate is determined based on the historical record of MDI insulin amounts actually injected into a patient via an insulin pen, wherein the amount of insulin is to be administered to the patient using CSII via the insulin pump based on the historical record of MDI insulin amounts actually injected into the patient, thereby reducing training required for the patient to use CSII via the insulin pump.
A method for delivery of insulin based on multiple daily injection (MDI) data, the method comprising: calculating an amount of insulin to be administered using continuous subcutaneous insulin infusion (CSII) via an insulin pump based on at least in part a retrospective virtual basal rate determined from a historical record of MDI insulin amounts injected and a glucose measurement, and wherein the retrospective virtual basal rate is determined based on the historical record of MDI insulin amounts actually injected into a patient.
Patek discloses calculating an amount of insulin to be administered based on a retrospective virtual basal rate determined from a historical record of MDI insulin amounts and a glucose measurement. Specifically, Patek discloses: “[a] method for delivery of insulin to a patient, comprising: receiving, by at least one processor, blood glucose measurements from said patient; calculating, by at least one processor, an amount of insulin to be administered to said patient, based on an insulin dosage in accordance with a retrospective virtual basal rate determined from a historical record of insulin amounts delivered to said patient and at least one received blood glucose measurement”. (Patek; claim 12). Patek further discloses a framework for CSII: “providing a unified framework for analysis, design, optimization, and adaptation of MDI (multiple daily injections) and CSII (continuous subcutaneous insulin infusion (i.e. insulin pump)) treatment parameters for patients with diabetes.” (Patek; Abstract).
via an insulin pen.
To the extent Patek does not expressly disclose that the historical record of MDI insulin amounts is injected via an insulin pen, Atkin fills this gap by disclosing an insulin pen that records historical injection data. Specifically, Atkin discloses: “The present invention relates to an existing insulin delivery device, such as an insulin pen. The present invention is an electromechanical device, which is affixed to the pen. When the user rotates the top of the pen to select the prescribed dosage of insulin to be injected into the body, the device mechanically measures the distance traveled by the plunger inside the pen from its original position… the amount of insulin injected is recorded”. (Atkin ¶ [0003]).
wherein the amount of insulin is to be administered to the patient using CSII via the insulin pump based on the historical record of MDI insulin amounts actually injected into the patient, thereby reducing training required for the patient to use CSII via the insulin pump.
Patek discloses using the historical MDI record to calculate CSII treatment parameters. To the extent Patek does not expressly disclose that this reduces training required for the patient to use CSII via the insulin pump, Blomquist fills this gap by disclosing that transitioning to an insulin pump requires a learning curve and training, and providing automated assistance reduces this burden. Specifically, Blomquist discloses: “[p]roper use of an insulin pump requires a user to go through a learning curve to properly treat their diabetes using the insulin pump.” (Blomquist ¶ [0005]). Blomquist further discloses: “Because proper use of an insulin pump requires a user to go through a learning curve to properly treat their diabetes using the pump, it is desirable for a pump to provide assistance to the user… Providing an expert system in an insulin pump device will provide assistance to the user to effectively treat their diabetes using the insulin pump device.” (Blomquist ¶ [0017]).
Motivation to combine.
It would have been obvious to combine Patek, Atkin, and Blomquist because all relate to managing insulin therapy and transitioning patients from MDI to insulin pumps. A person of ordinary skill in the art would have been motivated to incorporate Atkin’s insulin pen recording device into Patek’s system to automate data collection, and would have recognized that utilizing Patek’s retrospective virtual basal rate calculation based on historical MDI data to automate the CSII pump setup would have reduced the training and learning curve required for the patient to use the CSII pump, as taught by Blomquist.
In relation to claim 7, this claim depends from claim 6 and further recites: the device of claim 6, wherein the processor is part of or in communication with a hand held or portable electronic device, a cell phone, a computer, glucose monitor device, or an insulin device.
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
wherein the processor is part of or in communication with a hand held or portable electronic device, a cell phone, a computer, glucose monitor device, or an insulin device.
Patek discloses that the processor is part of a glucose monitor device. Specifically, Patek discloses: “[a] system for delivery of insulin to a patient, comprising: a glucometer including at least one input for receiving blood glucose measurements from said patient, a processor configured to calculate an amount of insulin to be administered”. (Patek; claim 1).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to incorporate the processor within a glucometer as taught by Patek to provide a convenient, integrated device for the patient.
In relation to claim 17, this claim depends from claim 7 and further recites: the method of claim 7, wherein the retrospective virtual basal rate is determined by matching a plasma insulin concentration pattern inferred from a mathematical model of a pharmacokinetic property of insulin with the historical record of insulin amounts delivered, to a pharmacokinetic property of rapid acting insulin delivered.
Base rejection incorporated.
The rejection of claim 7 is incorporated herein.
wherein the retrospective virtual basal rate is determined by matching a plasma insulin concentration pattern inferred from a mathematical model of a pharmacokinetic property of insulin with the historical record of insulin amounts delivered, to a pharmacokinetic property of rapid acting insulin delivered.
Patek discloses matching a plasma insulin concentration pattern inferred from a mathematical model of PK properties with the historical record to a PK property of rapid acting insulin. Specifically, Patek discloses: “wherein said retrospective virtual basal rate is obtained by matching a plasma insulin concentration pattern inferred from a mathematical model of the pharmacokinetic properties of insulin in conjunction with said historical record of insulin amounts delivered to said patient, to a virtual record of basal rate insulin delivery inferred from a mathematical model of the pharmacokinetic properties of rapid-acting insulin delivered by a continuous infusion pump.” (Patek; claim 15).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to use mathematical modeling of PK properties as taught by Patek to accurately translate discrete historical injections into an equivalent continuous basal rate profile.
In relation to claim 8, this claim depends from claim 6 and further recites: the device of claim 6, wherein the processor is configured to receive the glucose measurement.
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
wherein the processor is configured to receive the glucose measurement.
Patek discloses that the processor is configured to receive the glucose measurement. Specifically, Patek discloses: “a glucometer including at least one input for receiving blood glucose measurements from said patient, a processor configured to calculate an amount of insulin to be administered to said patient, based on… at least one received blood glucose measurement”. (Patek; claim 1).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to configure the processor to receive glucose measurements to enable accurate, data-driven insulin dosage calculations.
In relation to claim 9, this depends from claim 6 and further recites: the device of claim 6, wherein the glucose measurement is a self-monitoring glucose (SMBG) measurement.
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
wherein the glucose measurement is a self-monitoring glucose (SMBG) measurement.
Patek discloses that the glucose measurement is an SMBG measurement. Specifically, Patek discloses: “wherein said blood glucose measurements comprise a self-monitoring blood glucose (SMBG) measurement from said patient.” (Patek; claim 13).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to utilize SMBG measurements because SMBG is a primary and widely available mechanism for assessing blood glucose.
In relation to claim 10, this claim depends from claim 6 and further recites: the device of claim 6, wherein the glucose measurement is a continuous glucose monitor (CGM) measurement.
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
wherein the glucose measurement is a continuous glucose monitor (CGM) measurement.
Patek discloses that the glucose measurement is a CGM measurement. Specifically, Patek discloses: “wherein said blood glucose measurements comprise a continuous glucose monitor (CGM) measurement from said patient.” (Patek; claim 14).
Motivation to combine.
It would have been obvious to combine the base combination with Patek’s teaching because Patek already discloses the additional limitation. A person of ordinary skill in the art would have been motivated to utilize CGM measurements to provide a more complete understanding of glycemic variability.
In relation to claim 19, this claim depends from claim 1 and further recites: The device of claim 1, wherein the amount of insulin is to be administered to a patient using CSII via the insulin pump based on the historical record of MDI insulin amounts actually injected into the patient via the insulin pen, thereby reducing training required for the patient to use CSII via the insulin pump.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the amount of insulin is to be administered to a patient using CSII via the insulin pump based on the historical record of MDI insulin amounts actually injected into the patient via the insulin pen, thereby reducing training required for the patient to use CSII via the insulin pump.
As discussed above, Patek discloses using the historical MDI record to calculate CSII treatment parameters. To the extent Patek does not expressly disclose that this reduces training required for the patient to use CSII via the insulin pump, Blomquist fills this gap by disclosing that transitioning to an insulin pump requires a learning curve and training, and providing automated assistance reduces this burden. Specifically, Blomquist discloses: “[p]roper use of an insulin pump requires a user to go through a learning curve to properly treat their diabetes using the insulin pump.” (Blomquist ¶ [0005]). Blomquist further discloses: “[b]ecause proper use of an insulin pump requires a user to go through a learning curve to properly treat their diabetes using the pump, it is desirable for a pump to provide assistance to the user… Providing an expert system in an insulin pump device will provide assistance to the user to effectively treat their diabetes using the insulin pump device.” (Blomquist ¶ [0017]).
Motivation to combine.
It would have been obvious to combine the base combination with Blomquist because all the cited prior art relates to managing insulin therapy and transitioning patients from MDI to insulin pumps. A person of ordinary skill in the art would have recognized that utilizing Patek’s retrospective virtual basal rate calculation based on historical MDI data to automate the CSII pump setup would reduce the training and learning curve required for the patient to use the CSII pump, as taught by Blomquist.
In relation claim 20, this claim depends from claim 11 and further recites: The device of claim 11, wherein the amount of insulin is to be administered to a patient using CSII via the insulin pump based on the historical record of MDI insulin amounts actually injected into the patient via an insulin pen, thereby reducing training required for the patient to use CSII via the insulin pump.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the amount of insulin is to be administered to a patient using CSII via the insulin pump based on the historical record of MDI insulin amounts actually injected into the patient via an insulin pen, thereby reducing training required for the patient to use CSII via the insulin pump.
Patek discloses using the historical MDI record to calculate CSII treatment parameters (Patek ¶ [0051]). To the extent Patek does not expressly disclose that this reduces training required for the patient to use CSII via the insulin pump, Blomquist fills this gap by disclosing that transitioning to an insulin pump requires a learning curve and training, and providing automated assistance reduces this burden. Specifically, Blomquist discloses: “[p]roper use of an insulin pump requires a user to go through a learning curve to properly treat their diabetes using the insulin pump.” (Blomquist ¶ [0005]). Blomquist further discloses: “[b]ecause proper use of an insulin pump requires a user to go through a learning curve to properly treat their diabetes using the pump, it is desirable for a pump to provide assistance to the user… Providing an expert system in an insulin pump device will provide assistance to the user to effectively treat their diabetes using the insulin pump device.” (Blomquist ¶ [0017]).
Motivation to combine.
It would have been obvious to combine the base combination with Blomquist because all relate to managing insulin therapy and transitioning patients from MDI to insulin pumps. A person of ordinary skill in the art would have recognized that utilizing Patek’s retrospective virtual basal rate calculation based on historical MDI data to automate the CSII pump setup would have reduced the training and learning curve required for the patient to use the CSII pump, as taught by Blomquist.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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