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
Claim 3 is objected to because of the following informalities:
Claim 3 recites “wherein the doser is configured to intravenously administer the number of units of insulin corresponding to the value of the total insulin infusion rate intravenously.” The word “intravenously” is repeated twice in the limitation, which is grammatically incorrect and renders the claim unclear. The claim should read “wherein the doser is configured to intravenously administer the number of units of insulin corresponding to the value of the total insulin infusion rate.” As written, the redundant adverb creates ambiguity regarding the intended mode of administration.
Appropriate correction is required.
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 8 and 18 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 8 recites “determining a meal bolus for the patient by dividing the number of carbohydrates…”. The term “a meal bolus” lacks proper antecedent basis in the claim or the base claim (Claim 1), which recites “a meal bolus rate”. While “a meal bolus rate” is introduced in claim 1, “a meal bolus” is introduced for the first time here without antecedent basis. Furthermore, the claim later recites “the estimated meal bolus”, which lacks antecedent basis because the preceding text introduces “a meal bolus”, not an “estimated meal bolus”. The claim should be amended to properly introduce these terms or provide proper antecedent basis. As written, the claim fails to particularly point out and distinctly claim the subject matter because it is unclear what “the estimated meal bolus” refers to.
Claim 18 recites “determining a meal bolus for the patient by dividing the number of carbohydrates…”. The term “a meal bolus” lacks proper antecedent basis in the claim or the base claim (Claim 11), which recites “a meal bolus rate”. Furthermore, the claim later recites “the estimated meal bolus”, which lacks antecedent basis because the preceding text introduces “a meal bolus”, not an “estimated meal bolus”. The claim should be amended to properly introduce these terms or provide proper antecedent basis. As written, the claim fails to particularly point out and distinctly claim the subject matter because it is unclear what “the estimated meal bolus” refers to.
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 1-5, 8-10, 11-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over the publication Davidson et al. (Glucommander: A Computer-Directed Intravenous Insulin System; hereinafter “Davidson 2005”) in view of Davidson et al. (US 2005/0049179A; hereinafter “Hebblewhite”) and Mann et al. (US 6,551,276; hereinafter “Mann”).
In relation to independent claim 1, this claim recites: a computer-implemented method executed on data processing hardware that causes the data processing hardware to perform operations comprising: obtaining an insulin infusion rate multiplier for a patient and a Carbohydrate-to- Insulin Ratio for the patient; receiving a glucose measurement of the patient; determining a regular insulin infusion rate for the patient based on the received glucose measurement of the patient and the insulin infusion rate multiplier for the patient; receiving a number of carbohydrates the patient is about to consume or has begun consuming; determining a meal bolus rate for the patient based on the received number of carbohydrates the patient is about to consume or has begun consuming and the Carbohydrate-to-Insulin Ratio; determining a total insulin infusion rate to administer to the patient by summing the meal bolus rate and the regular insulin infusion rate; and transmitting the total insulin infusion rate to a dose administering system comprising a patient display, the patient display configured to display a number of units of insulin corresponding to a value of the total insulin infusion rate.
A computer-implemented method executed on data processing hardware that causes the data processing hardware to perform operations.
Davidson 2005 discloses a computer-directed algorithm. Specifically, Davidson 2005 discloses: “[a] computer-directed algorithm for advice on the delivery of intravenous insulin that is flexible in blood glucose timing and advises insulin dosing in a graduated manner has been developed.” (Davidson 2005, Abstract, Research Design and Methods, page 2418.)
obtaining an insulin infusion rate multiplier for a patient and a Carbohydrate-to-Insulin Ratio for the patient.
Davidson 2005 discloses obtaining an insulin infusion rate multiplier for a patient. Specifically, Davidson 2005 discloses: “[t]he intravenous insulin protocol developed by the authors in 1982 used the formula: insulin dose/h = (blood glucose − 60) × multiplier (8).” (Davidson 2005, p. 2419, first column, line 3.) To the extent Davidson 2005 does not expressly disclose obtaining a Carbohydrate-to-Insulin Ratio for the patient, Hebblewhite fills this gap by disclosing obtaining a Carbohydrate-to-Insulin Ratio. Specifically, Hebblewhite discloses: “[m]eal Boluses are infused just before a meal in an amount, proportional to the glycemic effect of the meal. This is generally proportional to the number of grams of carbohydrate in the meal. The proportionality constant is a personalized number called the Carbohydrate-to-Insulin Ratio, CIR.” (Hebblewhite ¶ [0005].)
receiving a glucose measurement of the patient.
Newton 2010 discloses receiving a glucose measurement of the patient. Specifically, Newton 2010 discloses: “[d]uring the infusion, the nurse entered BG levels into the system and the computer recommended the insulin infusion rate and a variable time to check the next glucose testing.” (Newton 2010, p. 3, third paragraph.)
determining a regular insulin infusion rate for the patient based on the received glucose measurement of the patient and the insulin infusion rate multiplier for the patient.
Newton 2010 discloses determining a regular insulin infusion rate based on the received glucose measurement and the multiplier. Specifically, Newton 2010 discloses: “[t]he insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG − 60).” (Newton 2010, p. 3, third paragraph.) Davidson 2005 further confirms this formula, disclosing: “The intravenous insulin protocol developed by the authors in 1982 used the formula: insulin dose/h = (blood glucose − 60) × multiplier.” (Davidson 2005, p. 2419, column 1, starting in line 3.)
receiving a number of carbohydrates the patient is about to consume or has begun consuming.
Hebblewhite discloses receiving a number of carbohydrates the patient is about to consume. Specifically, Hebblewhite discloses: “[t]his calculation is generally performed by the patient, but there are pump models that can store the patient’s CIR in memory and require only the grams of carbohydrate in the meal as the input.” (Hebblewhite ¶ [0006].)
determining a meal bolus rate for the patient based on the received number of carbohydrates the patient is about to consume or has begun consuming and the Carbohydrate-to-Insulin Ratio.
Hebblewhite discloses determining a meal bolus based on carbohydrates and CIR. Specifically, Hebblewhite discloses: “[m]eal Insulin Bolus=(grams of carbohydrates in the meal)/CIR” (Hebblewhite ¶ [0005].)
determining a total insulin infusion rate to administer to the patient by summing the meal bolus rate and the regular insulin infusion rate.
Hebblewhite discloses determining a total insulin infusion rate by summing the meal bolus and regular (basal) rate. Specifically, Hebblewhite discloses: “[p]rescription Insulin=Basal Insulin+Meal Insulin” (Hebblewhite ¶ [0017].)
transmitting the total insulin infusion rate to a dose administering system comprising a patient display, the patient display configured to display a number of units of insulin corresponding to a value of the total insulin infusion rate.
Newton 2010 discloses transmitting the insulin infusion rate to a dose administering system. Specifically, Newton 2010 discloses: “the computer recommended the insulin infusion rate” and the Glucommander was “programmed to adjust the multiplier to achieve and maintain target glucose.” (Newton 2010, p. 3, third paragraph.) To the extent Davidson 2005 does not expressly disclose a patient display configured to display a number of units of insulin corresponding to a value of the total insulin infusion rate, Mann fills this gap by disclosing a patient display displaying units of insulin. Specifically, Mann discloses: “[t]he LCD 28 of the external infusion device 10 introduces the capability to use icons for easier identification and use” (Mann, col. 28, lines 8-9) and “An alert will sound when the plunger reaches the point where approximately 20 units of insulin (U-100) remain.” (Mann, col. 28, lines 21-23.)
Motivation to combine.
It would have been obvious to combine the computer-directed intravenous insulin infusion system of Davidson 2005 with the carbohydrate-to-insulin ratio and meal bolus teachings of Hebblewhite and the patient display features of Mann. A person of ordinary skill in the art would have been motivated to incorporate Hebblewhite’s meal bolus calculation using a Carbohydrate-to-Insulin Ratio into Davidson 2005’s intravenous insulin system to better control blood glucose spikes associated with meals, and to incorporate Mann’s display features to provide the patient or nurse with clear visual feedback regarding the insulin units being administered, thereby improving patient safety and glycemic control.
In relation to claim 2, this claim depends from claim 1 and further recites: the method of claim 1, wherein the dose administering system further comprises: a doser; and an administration computing device in communication with the doser, the administration computing device configured to cause the doser to administer, to the patient, the number of units of insulin corresponding to the value of the total insulin infusion rate.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the dose administering system further comprises: a doser; and an administration computing device in communication with the doser, the administration computing device configured to cause the doser to administer, to the patient, the number of units of insulin corresponding to the value of the total insulin infusion rate.
Mann discloses an administration computing device causing a doser to administer insulin. Specifically, Mann discloses: “a drive mechanism to operatively couple with a reservoir to infuse a liquid into a body” and “a processor… controls the external infusion device in accordance with the remotely generated commands”. (Mann, claim 1.)
Motivation to combine.
It would have been obvious to combine the base combination with Mann because a person of ordinary skill in the art would have been motivated to utilize a standard doser and a computing device as taught by Mann to physically administer the insulin calculated by the computer-directed algorithm, ensuring accurate and automated delivery.
In relation to claim 3, this claim depends from claim 2 and further recites: the method of claim 2, wherein the doser is configured to intravenously administer the number of units of insulin corresponding to the value of the total insulin infusion rate intravenously.
Base rejection incorporated.
The rejection of claim 2 is incorporated herein.
wherein the doser is configured to intravenously administer the number of units of insulin corresponding to the value of the total insulin infusion rate intravenously.
Davidson 2005 discloses intravenous administration of insulin. Specifically, Davidson 2005 discloses: “Intravenous insulin is now the recommended method of diabetes management in critically ill persons in the hospital.” (Davidson 2005, page 2418, Objective.)
Motivation to combine.
It would have been obvious to combine the base combination with Davidson 2005’s intravenous delivery because a person of ordinary skill in the art would have been motivated to configure the doser for intravenous administration to provide rapid and precise glycemic control in hospitalized or critically ill patients, as taught by Davidson 2005.
In relation to claim 4, this claim depends from claim 1 and further recites: the method of claim 1, wherein determining the regular insulin infusion rate for the patient comprises calculating: IIR= (BG - K) * M; wherein IIR is the regular insulin infusion rate, BG is the received glucose measurement for the patient, M is the insulin infusion rate multiplier for the patient, and K is an offset target.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein determining the regular insulin infusion rate for the patient comprises calculating: IIR= (BG - K) * M; wherein IIR is the regular insulin infusion rate, BG is the received glucose measurement for the patient, M is the insulin infusion rate multiplier for the patient, and K is an offset target.
Newton 2010 discloses calculating the infusion rate using this exact formula. Specifically, Newton 2010 discloses: “[t]he insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG − 60).” (Newton 2010, p. 3, third paragraph.) Davidson 2005 further confirms this formula, disclosing: “The intravenous insulin protocol developed by the authors in 1982 used the formula: insulin dose/h = (blood glucose − 60) × multiplier.” (Davidson 2005, p. 2419, first column, starting in line 3.)
Motivation to combine.
It would have been obvious to combine the base combination with Davidson 2005’s formula because a person of ordinary skill in the art would have been motivated to use the established and proven Glucommander formula to calculate the regular insulin infusion rate for safe and effective glycemic control.
In relation to claim 5, this claim depends from claim 4 and further recites: the method of claim 4, wherein K is equal to 60.
Base rejection incorporated.
The rejection of claim 4 is incorporated herein.
wherein K is equal to 60.
Newton 2010 discloses an offset target of 60. Specifically, Newton 2010 discloses: “[t]he insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG − 60).” (Newton 2010, p. 3, third paragraph.) Davidson 2005 further confirms this value, disclosing: “[t]he intravenous insulin protocol developed by the authors in 1982 used the formula: insulin dose/h = (blood glucose − 60) × multiplier.” (Davidson 2005, p. 2419, column 1, starting in line 3.)
Motivation to combine.
It would have been obvious to combine the base combination with Davidson 2005’s offset of 60 because a person of ordinary skill in the art would have been motivated to use the specific offset value of 60, which has been clinically validated in the Glucommander system to prevent hypoglycemia.
In relation to claim 8, this claim depends from claim 1 and further recites: the method of claim 1, wherein the operations further comprise: determining a meal bolus for the patient by dividing the number of carbohydrates the patient is about to consume or has begun consuming by the Carbohydrate-to-Insulin Ratio, wherein determining the meal bolus rate for the patient comprises calculating: Estimated Meal Bolus Rate= Estimated Meal Bolus* C /TMealBolus1 wherein TMealBolus1 is a time duration of a first time interval and C is a constant adjusted to infuse an optimum portion of the estimated meal bolus.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the operations further comprise: determining a meal bolus for the patient by dividing the number of carbohydrates the patient is about to consume or has begun consuming by the Carbohydrate-to-Insulin Ratio.
Hebblewhite discloses determining a meal bolus by dividing carbohydrates by the CIR. Specifically, Hebblewhite discloses: “[m]eal Insulin Bolus=(grams of carbohydrates in the meal)/CIR” (Hebblewhite ¶ [0005].)
wherein determining the meal bolus rate for the patient comprises calculating: Estimated Meal Bolus Rate= Estimated Meal Bolus* C /TMealBolus1 wherein TMealBolus1 is a time duration of a first time interval and C is a constant adjusted to infuse an optimum portion of the estimated meal bolus.
To the extent Hebblewhite does not expressly disclose this specific rate equation, Mann fills this gap by disclosing administering a meal bolus over a specified time duration (a square wave or extended bolus). Specifically, Mann discloses: “The duration will be set by activating the SEL key 114 and incrementing the time.” (Mann, col. 20, lines 21-23.) A person of ordinary skill in the art would have recognized that distributing a bolus over a time interval inherently requires calculating a rate by dividing the bolus amount by the time duration.
Motivation to combine.
It would have been obvious to combine the base combination with Mann’s extended bolus duration because a person of ordinary skill in the art would have been motivated to calculate an estimated meal bolus rate over a specific time interval to match the absorption profile of the consumed carbohydrates, preventing postprandial hypoglycemia or hyperglycemia.
In relation to claim 9, this claim depends from claim 1 and further recites: the method of claim 1, wherein the patient display is configured to display a first number of units of insulin corresponding to the regular insulin infusion rate and a second number of units of insulin corresponding to the meal bolus rate.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the patient display is configured to display a first number of units of insulin corresponding to the regular insulin infusion rate and a second number of units of insulin corresponding to the meal bolus rate.
Mann discloses a patient display configured to display different components of an insulin dose. Specifically, Mann discloses displaying the correction bolus and the carbohydrate bolus: “Suggests a ‘4.0’ unit bolus (−1 unit correction and 5 units to account for the carbohydrates to be consumed).” (Mann, col. 20, lines 51-53.)
Motivation to combine.
It would have been obvious to combine the base combination with Mann’s display features because a person of ordinary skill in the art would have been motivated to display the separate components of the total insulin rate (regular infusion rate and meal bolus rate) to allow the patient or healthcare provider to verify the accuracy of each component before administration.
In relation to claim 10, this claim depends from claim 1 and further recites: the method of claim 1, wherein receiving the glucose measurement of the patient comprises receiving the glucose measurement from a continuous glucose monitoring system.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein receiving the glucose measurement of the patient comprises receiving the glucose measurement from a continuous glucose monitoring system.
Mann discloses receiving glucose measurements from a glucose monitoring device. Specifically, Mann discloses: “wherein the commander receiver receives information from a glucose monitoring device.” (Mann, claim 12.)
Motivation to combine.
It would have been obvious to combine the base combination with Mann’s glucose monitoring device because a person of ordinary skill in the art would have been motivated to receive glucose measurements from a continuous glucose monitoring system to automate the data entry process, reduce human error, and provide real-time data for more responsive insulin infusion rate adjustments.
In relation to independent claim 11, this claim recites: a system comprising: data processing hardware; and memory hardware in communication with the data processing hardware and storing instructions that when executed on the data processing hardware causes the data processing hardware to perform operations comprising: obtaining an insulin infusion rate multiplier for a patient and a Carbohydrate-to-Insulin Ratio for the patient; receiving a glucose measurement of the patient; determining a regular insulin infusion rate for the patient based on the received glucose measurement of the patient and the insulin infusion rate multiplier for the patient; receiving a number of carbohydrates the patient is about to consume or has begun consuming; determining a meal bolus rate for the patient based on the received number of carbohydrates the patient is about to consume or has begun consuming and the Carbohydrate-to-Insulin Ratio; determining a total insulin infusion rate to administer to the patient by summing the meal bolus rate and the regular insulin infusion rate; and transmitting the total insulin infusion rate to a dose administering system comprising a patient display, the patient display configured to display a number of units of insulin corresponding to a value of the total insulin infusion rate.
A system comprising: data processing hardware; and memory hardware in communication with the data processing hardware and storing instructions that when executed on the data processing hardware causes the data processing hardware to perform operations.
Davidson 2005 discloses a computer system. Specifically, Davidson 2005 discloses: “A computer-directed algorithm for advice on the delivery of intravenous insulin… This software program, known as the Glucommander” (Davidson 2005, page 2418, Research Design and Methods.)
obtaining an insulin infusion rate multiplier for a patient and a Carbohydrate-to-Insulin Ratio for the patient.
Davidson 2005 discloses obtaining an insulin infusion rate multiplier for a patient. Specifically, Davidson 2005 discloses: “[t]he intravenous insulin protocol developed by the authors in 1982 used the formula: insulin dose/h = (blood glucose − 60) × multiplier (8).” (Davidson 2005, first column, starting in line 3.) To the extent Davidson 2005 does not expressly disclose obtaining a Carbohydrate-to-Insulin Ratio for the patient, Hebblewhite fills this gap by disclosing obtaining a Carbohydrate-to-Insulin Ratio. Specifically, Hebblewhite discloses: “[m]eal Boluses are infused just before a meal in an amount, proportional to the glycemic effect of the meal. This is generally proportional to the number of grams of carbohydrate in the meal. The proportionality constant is a personalized number called the Carbohydrate-to-Insulin Ratio, CIR.” (Hebblewhite ¶ [0005].)
receiving a glucose measurement of the patient.
Newton 2010 discloses receiving a glucose measurement of the patient. Specifically, Newton 2010 discloses: “[d]uring the infusion, the nurse entered BG levels into the system and the computer recommended the insulin infusion rate and a variable time to check the next glucose testing.” (Newton 2010, p. 3, paragraph 3.)
determining a regular insulin infusion rate for the patient based on the received glucose measurement of the patient and the insulin infusion rate multiplier for the patient.
Newton 2010 discloses determining a regular insulin infusion rate based on the received glucose measurement and the multiplier. Specifically, Newton 2010 discloses: “[t]he insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG − 60).” (Newton 2010, p. 3, third paragraph.) Davidson 2005 further confirms this formula, disclosing: “[t]he intravenous insulin protocol developed by the authors in 1982 used the formula: insulin dose/h = (blood glucose − 60) × multiplier.” (Davidson 2005, p. 2419, column 1, starting in line 3.)
receiving a number of carbohydrates the patient is about to consume or has begun consuming.
Hebblewhite discloses receiving a number of carbohydrates the patient is about to consume. Specifically, Hebblewhite discloses: “[t]his calculation is generally performed by the patient, but there are pump models that can store the patient’s CIR in memory and require only the grams of carbohydrate in the meal as the input.” (Hebblewhite ¶ [0006].)
determining a meal bolus rate for the patient based on the received number of carbohydrates the patient is about to consume or has begun consuming and the Carbohydrate-to-Insulin Ratio.
Hebblewhite discloses determining a meal bolus based on carbohydrates and CIR. Specifically, Hebblewhite discloses: “[m]eal Insulin Bolus=(grams of carbohydrates in the meal)/CIR” (Hebblewhite ¶ [0005].)
determining a total insulin infusion rate to administer to the patient by summing the meal bolus rate and the regular insulin infusion rate.
Hebblewhite discloses determining a total insulin infusion rate by summing the meal bolus and regular (basal) rate. Specifically, Hebblewhite discloses: “[p]rescription Insulin=Basal Insulin+Meal Insulin” (Hebblewhite ¶ [0017].)
transmitting the total insulin infusion rate to a dose administering system comprising a patient display, the patient display configured to display a number of units of insulin corresponding to a value of the total insulin infusion rate.
Newton 2010 discloses transmitting the insulin infusion rate to a dose administering system. Specifically, Newton 2010 discloses: “the computer recommended the insulin infusion rate” and the Glucommander was “programmed to adjust the multiplier to achieve and maintain target glucose.” (Newton 2010, p. 3, third paragraph.) To the extent Davidson 2005 does not expressly disclose a patient display configured to display a number of units of insulin corresponding to a value of the total insulin infusion rate, Mann fills this gap by disclosing a patient display displaying units of insulin. Specifically, Mann discloses: “[t]he LCD 28 of the external infusion device 10 introduces the capability to use icons for easier identification and use” (Mann, col. 28, lines 8-10.) and “An alert will sound when the plunger reaches the point where approximately 20 units of insulin (U-100) remain.” (Mann, col. 28, lines 21-23.)
Motivation to combine.
It would have been obvious to combine the computer-directed intravenous insulin infusion system of Davidson 2005 with the carbohydrate-to-insulin ratio and meal bolus teachings of Hebblewhite and the patient display features of Mann. A person of ordinary skill in the art would have been motivated to incorporate Hebblewhite’s meal bolus calculation using a Carbohydrate-to-Insulin Ratio into Davidson 2005’s intravenous insulin system to better control blood glucose spikes associated with meals, and to incorporate Mann’s display features to provide the patient or nurse with clear visual feedback regarding the insulin units being administered, thereby improving patient safety and glycemic control.
In relation to claim 12, this claim depends from claim 11 and further recites: the system of claim 11, wherein the dose administering system further comprises: a doser; and an administration computing device in communication with the doser, the administration computing device configured to cause the doser to administer, to the patient, the number of units of insulin corresponding to the value of the total insulin infusion rate.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the dose administering system further comprises: a doser; and an administration computing device in communication with the doser, the administration computing device configured to cause the doser to administer, to the patient, the number of units of insulin corresponding to the value of the total insulin infusion rate.
Mann discloses an administration computing device causing a doser to administer insulin. Specifically, Mann discloses: “a drive mechanism to operatively couple with a reservoir to infuse a liquid into a body” and “a processor… controls the external infusion device in accordance with the remotely generated commands”. (Mann, col. 24, lines 5-18.)
Motivation to combine.
It would have been obvious to combine the base combination with Mann because a person of ordinary skill in the art would have been motivated to utilize a standard doser and computing device as taught by Mann to physically administer the insulin calculated by the computer-directed algorithm, ensuring accurate and automated delivery.
In relation to claim 13, this claim depends from claim 12 and further recites: The system of claim 12, wherein the doser is configured to intravenously administer the number of units of insulin corresponding to the value of the total insulin infusion rate.
Base rejection incorporated.
The rejection of claim 12 is incorporated herein.
wherein the doser is configured to intravenously administer the number of units of insulin corresponding to the value of the total insulin infusion rate.
Davidson 2005 discloses intravenous administration of insulin. Specifically, Davidson 2005 discloses: “Intravenous insulin is now the recommended method of diabetes management in critically ill persons in the hospital.” (Davidson 2005, Abstract.)
Motivation to combine.
It would have been obvious to combine the base combination with Davidson 2005’s intravenous delivery because a person of ordinary skill in the art would have been motivated to configure the doser for intravenous administration to provide rapid and precise glycemic control in hospitalized or critically ill patients, as taught by Davidson 2005.
In relation to claim 14, this claim depends from claim 11 and further recites: The system of claim 11, wherein determining the regular insulin infusion rate for the patient comprises calculating: IIR= (BG - K) * M; wherein IIR is the regular insulin infusion rate, BG is the received glucose measurement for the patient, Mis the insulin infusion rate multiplier for the patient, and K is an offset target.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein determining the regular insulin infusion rate for the patient comprises calculating: IIR= (BG - K) * M; wherein IIR is the regular insulin infusion rate, BG is the received glucose measurement for the patient, Mis the insulin infusion rate multiplier for the patient, and K is an offset target.
Newton 2010 discloses calculating the infusion rate using this exact formula. Specifically, Newton 2010 discloses: “[t]he insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG − 60).” (Newton 2010, p. 3, third paragraph.) Davidson 2005 further confirms this formula, disclosing: “The intravenous insulin protocol developed by the authors in 1982 used the formula: insulin dose/h = (blood glucose − 60) × multiplier.” (Davidson 2005, p. 2419, first column, starting in line 3.)
Motivation to combine.
It would have been obvious to combine the base combination with Davidson 2005’s formula because a person of ordinary skill in the art would have been motivated to use the established and proven Glucommander formula to calculate the regular insulin infusion rate for safe and effective glycemic control.
In relation to claim 15, this claim depends from claim 14 and further recites: The system of claim 14, wherein K is equal to 60.
Base rejection incorporated.
The rejection of claim 14 is incorporated herein.
wherein K is equal to 60.
Newton 2010 discloses an offset target of 60. Specifically, Newton 2010 discloses: “The insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG − 60).” (Newton 2010, p. 3, third paragraph.) Davidson 2005 further confirms this value, disclosing: “The intravenous insulin protocol developed by the authors in 1982 used the formula: insulin dose/h = (blood glucose − 60) × multiplier.” (Davidson 2005, p. 2419, first column, starting in line 3.)
Motivation to combine.
It would have been obvious to combine the base combination with Davidson 2005’s offset of 60 because a person of ordinary skill in the art would have been motivated to use the specific offset value of 60, which has been clinically validated in the Glucommander system to prevent hypoglycemia.
In relation to claim 18, this claim depends from claim 11 and further recites: the system of claim 11, wherein the operations further comprise: determining a meal bolus for the patient by dividing the number of carbohydrates the patient is about to consume or has begun consuming by the Carbohydrate-to-Insulin Ratio, wherein determining the meal bolus rate for the patient comprises calculating: Estimated Meal Bolus Rate= Estimated Meal Bolus* C/TMealBolus1 wherein TMealBolus1 is a time duration of a first time interval and C is a constant adjusted to infuse an optimum portion of the estimated meal bolus.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the operations further comprise: determining a meal bolus for the patient by dividing the number of carbohydrates the patient is about to consume or has begun consuming by the Carbohydrate-to-Insulin Ratio.
Hebblewhite discloses determining a meal bolus by dividing carbohydrates by the CIR. Specifically, Hebblewhite discloses: “Meal Insulin Bolus=(grams of carbohydrates in the meal)/CIR” (Hebblewhite ¶ [0005].)
wherein determining the meal bolus rate for the patient comprises calculating: Estimated Meal Bolus Rate= Estimated Meal Bolus* C/TMealBolus1 wherein TMealBolus1 is a time duration of a first time interval and C is a constant adjusted to infuse an optimum portion of the estimated meal bolus.
To the extent Hebblewhite does not expressly disclose this specific rate equation, Mann fills this gap by disclosing administering a meal bolus over a specified time duration (a square wave or extended bolus). Specifically, Mann discloses: “The duration will be set by activating the SEL key 114 and incrementing the time.” (Mann, col. 20, lines 21-22.) A person of ordinary skill in the art would have recognized that distributing a bolus over a time interval inherently requires calculating a rate by dividing the bolus amount by the time duration.
Motivation to combine.
It would have been obvious to combine the base combination with Mann’s extended bolus duration because a person of ordinary skill in the art would have been motivated to calculate an estimated meal bolus rate over a specific time interval to match the absorption profile of the consumed carbohydrates, preventing postprandial hypoglycemia or hyperglycemia.
In relation to claim 19, this claim depends from claim 11 and further recites: the system of claim 11, wherein the patient display is configured to display a first number of units of insulin corresponding to the regular insulin infusion rate and a second number of units of insulin corresponding to the meal bolus rate.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the patient display is configured to display a first number of units of insulin corresponding to the regular insulin infusion rate and a second number of units of insulin corresponding to the meal bolus rate.
Mann discloses a patient display configured to display different components of an insulin dose. Specifically, Mann discloses displaying the correction bolus and the carbohydrate bolus: “Suggests a ‘4.0’ unit bolus (−1 unit correction and 5 units to account for the carbohydrates to be consumed).” (Mann, col. 20, lines 51-53.)
Motivation to combine.
It would have been obvious to combine the base combination with Mann’s display features because a person of ordinary skill in the art would have been motivated to display the separate components of the total insulin rate (regular infusion rate and meal bolus rate) to allow the patient or healthcare provider to verify the accuracy of each component before administration.
In relation to claim 20, this claim depends from claim 11 and further recites: the system of claim 11, wherein receiving the glucose measurement of the patient comprises receiving the glucose measurement from a continuous glucose monitoring system.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein receiving the glucose measurement of the patient comprises receiving the glucose measurement from a continuous glucose monitoring system.
Mann discloses receiving glucose measurements from a glucose monitoring device. Specifically, Mann discloses: “wherein the commander receiver receives information from a glucose monitoring device.” (Mann, col. 24, lines 52-53.)
Motivation to combine.
It would have been obvious to combine the base combination with Mann’s glucose monitoring device because a person of ordinary skill in the art would have been motivated to receive glucose measurements from a continuous glucose monitoring system to automate the data entry process, reduce human error, and provide real-time data for more responsive insulin infusion rate adjustments.
Claims 6, 7, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the publication Davidson et al. (Glucommander: A Computer-Directed Intravenous Insulin System; hereinafter “Davidson 2005”) in view of Davidson et al. (US 2005/0049179A; hereinafter “Hebblewhite”) and Mann et al. (US 6,551,276; hereinafter “Mann”), as discussed above, and in further view of the publication Newton et al. (A Comparison Study of Continuous Insulin Infusion Protocols in the Medical Intensive Care Unit: Computer-Guided vs. Standard Column-Based Algorithms; hereinafter “Newton”).
In relation to claim 6, this claim depends from claim 1 and further recites: the method of claim 1, wherein the operations further comprise: obtaining a body mass index (BMI) of the patient; and determining the insulin infusion rate multiplier for the patient based on the BMI of the patient.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the operations further comprise: obtaining a body mass index (BMI) of the patient; and determining the insulin infusion rate multiplier for the patient based on the BMI of the patient.
To the extent the base combination does not expressly disclose determining the multiplier based on BMI, Newton 2010 fills this gap by disclosing adjusting insulin sensitivity (multiplier) based on patient characteristics such as weight and insulin resistance. Specifically, Newton 2010 discloses: “The algorithm is divided into four columns based on empirically determined insulin sensitivity… Insulin-resistant patients, such as those receiving glucocorticoids or receiving >80 units of insulin per day as outpatients, started in the algorithm 2 column.” (Newton 2010, p. 3, second paragraph.) While Newton 2010 discusses insulin resistance, a person of ordinary skill in the art would have recognized that BMI is a standard clinical indicator of insulin resistance.
Motivation to combine.
It would have been obvious to combine the base combination with Newton 2010 because a person of ordinary skill in the art would have been motivated to determine the initial insulin infusion rate multiplier based on the patient’s BMI to provide a more personalized and accurate initial estimate of insulin sensitivity, thereby achieving target blood glucose levels more safely and rapidly.
In relation to claim 7, this claim depends from claim 1 and further recites: the method of claim 1, wherein the operations further comprise: obtaining an age of the patient; and determining the insulin infusion rate multiplier for the patient based on the age of the patient.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the operations further comprise: obtaining an age of the patient; and determining the insulin infusion rate multiplier for the patient based on the age of the patient.
To the extent the base combination does not expressly disclose determining the multiplier based on age, Newton 2010 fills this gap by disclosing adjusting insulin algorithms based on patient demographics and characteristics. Specifically, Newton 2010 discloses adjusting the starting column based on patient characteristics. (Newton 2010, p. 3, second paragraph.) A person of ordinary skill in the art would have recognized age as a fundamental demographic factor affecting insulin sensitivity (also see Age factor, Newton 2010, page 4, Results).
Motivation to combine.
It would have been obvious to combine the base combination with Newton 2010 because a person of ordinary skill in the art would have been motivated to adjust the insulin infusion rate multiplier based on the patient’s age to account for age-related changes in insulin sensitivity and renal function, ensuring safe dosing for pediatric or elderly patients.
In relation to claim 16, this claim depends from claim 11 and further recites: the system of claim 11, wherein the operations further comprise: obtaining a body mass index (BMI) of the patient; and determining the insulin infusion rate multiplier for the patient based on the BMI of the patient.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the operations further comprise: obtaining a body mass index (BMI) of the patient; and determining the insulin infusion rate multiplier for the patient based on the BMI of the patient.
To the extent the base combination does not expressly disclose determining the multiplier based on BMI, Newton 2010 fills this gap by disclosing adjusting insulin sensitivity (multiplier) based on patient characteristics such as weight and insulin resistance. Specifically, Newton 2010 discloses: “[t]he algorithm is divided into four columns based on empirically determined insulin sensitivity… Insulin-resistant patients, such as those receiving glucocorticoids or receiving >80 units of insulin per day as outpatients, started in the algorithm 2 column.” (Newton 2010, p. 3, second paragraph.) While Newton 2010 discusses insulin resistance, a person of ordinary skill in the art would recognize that BMI is a standard clinical indicator of insulin resistance.
Motivation to combine.
It would have been obvious to combine the base combination with Newton 2010 because a person of ordinary skill in the art would have been motivated to determine the initial insulin infusion rate multiplier based on the patient’s BMI to provide a more personalized and accurate initial estimate of insulin sensitivity, thereby achieving target blood glucose levels more safely and rapidly.
In relation to claim 17, this claim depends from claim 11 and further recites: the system of claim 11, wherein the operations further comprise: obtaining an age of the patient; and determining the insulin infusion rate multiplier for the patient based on the age of the patient.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the operations further comprise: obtaining an age of the patient; and determining the insulin infusion rate multiplier for the patient based on the age of the patient.
To the extent the base combination does not expressly disclose determining the multiplier based on age, Newton 2010 fills this gap by disclosing adjusting insulin algorithms based on patient demographics and characteristics. Specifically, Newton 2010 discloses adjusting the starting column based on patient characteristics. (Newton 2010, p. 3, second paragraph.) A person of ordinary skill in the art would have recognized age as a fundamental demographic factor affecting insulin sensitivity (also see Age factor, Newton 2010, page 4, Results).
Motivation to combine.
It would have been obvious to combine the base combination with Newton 2010 because a person of ordinary skill in the art would have been motivated to adjust the insulin infusion rate multiplier based on the patient’s age to account for age-related changes in insulin sensitivity and renal function, ensuring safe dosing for pediatric or elderly patients.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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