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 .
Election/Restrictions
Claims 5-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/02/2025.
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.
Claim 4 is 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.
In relation to Claim 4, this claim recites the phrase "obtain a default amount of carbohydrates from a memory." Claim 1 introduces "a memory storing instructions." By using the indefinite
article "a" again in Claim 4, the claim suggests that the "default amount of carbohydrates" could be obtained from a different memory than the one introduced in Claim 1. To properly refer back to the memory introduced in the parent claim, the definite article "the" should be used to avoid the ambiguity of whether the system requires one memory or potentially two separate memories.
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, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman et al. (US 2011/0098548A1; hereinafter “Budiman”) in view of Mastrototaro et al. (US 2012/0136336A1; hereinafter “Mastrototaro”).
In relation to Claim 1, the claim recites:
"[a] drug delivery system, comprising: a processor; and a memory storing instructions that, when executed by the processor, enable the processor to:
determine that a blood glucose measurement value of a user is diverging from a target blood glucose range;
determine an after-insulin-on-board blood glucose measurement value for the user;
determine, by using the user's after-insulin-on-board blood glucose measurement value, an amount of rescue carbohydrates to be consumed by the user to maintain the user's blood glucose measurement value within the target blood glucose range; and
output the determined amount of the rescue carbohydrates."
Budiman discloses a drug delivery system with the following elements:
"[a] drug delivery system, comprising: a processor; and a memory".
Budiman discloses:
"In still another aspect, the present invention includes a system for controlling insulin delivery to a patient, comprising: a glucose monitor for providing glucose level data representative of an amount of glucose in a patient's blood stream; an input device for inputting carbohydrate intake data; a processor configured to receive the glucose level data and carbohydrate intake data, the processor programmed to analyze the received glucose level and carbohydrate intake data using a model to predict a future glucose level of the patient, and to provide insulin and carbohydrate intake recommendations based on the predicted future glucose level." (¶ [0019])
"Data received from the CGM, as well as intermediate results from calculations performed
by a microprocessor in the computer may be stored either in permanent or semipermanent
or transitory memory, such as RAM or a hard drive or other storage media." (¶ [0151])
"determine an after-insulin-on-board blood glucose measurement value for the user".
Budiman discloses predicting future glucose levels and using insulin-on-board in calculations:
"the processor programmed to analyze the received glucose level and carbohydrate intake data using a model to predict a future glucose level of the patient" (¶ [0019])
"Bolus calculators traditionally have an input called 'insulin onboard' (IOB) that is taken into account in the calculation" (¶ [0130])
"IOB may be calculated based upon previous insulin delivered and consumption of the insulin. The parameters describing the consumption of the insulin may be calculated using the software embodied in the present invention." (¶ [0131])
The "after-insulin-on-board blood glucose measurement value" is equivalent to a predicted future glucose level that accounts for insulin-on-board. Budiman teaches predicting future glucose levels (¶ [0019]) and using IOB in calculations (¶ [0130-0131]).
3. "determine, by using the user's after-insulin-on-board blood glucose measurement value, an amount of rescue carbohydrates to be consumed by the user".
Budiman explicitly discloses determining and recommending specific amounts of carbohydrates:
"the processor programmed to analyze the received glucose level and carbohydrate intake data using a model to predict a future glucose level of the patient, and to provide insulin and carbohydrate intake recommendations based on the predicted future glucose level" (¶ [0019])
"In a still further aspect, the recommendations may include various parameters that relate to the administration of insulin, or alternatively, to other actions, such as a prompt to consume a mass of carbohydrates to prevent or counter the onset of hypoglycemia." (¶ [0010])
"Finally, the results of the process are output in box 375 for use in providing insulin therapy recommendations to the patient. Such recommendations may be used to automatically control insulin delivery to the patient. Additionally, the recommendations may be used to control a display that prompts the patient to take action to modify delivery of insulin, or may prompt the patient to ingest an amount of carbohydrate to minimize the risk that insulin already delivered may cause hypoglycemia." (¶ [0187])
"The results of the process are outputted in box 425 for use in making insulin therapy recommendations to the patient. These recommendations may be used to either automatically or manually control an insulin delivery device, or they may cause a display to provide a prompt to a patient to either administer more insulin, or a different type of insulin, or modify an insulin delivery regime, or to consume carbohydrates to prevent hypoglycemia." (¶ [0219])
Claim 17 of Budiman also claims "to provide insulin and carbohydrate intake recommendations based on the predicted future glucose level."
"output the determined amount of the rescue carbohydrates".
Budiman explicitly teaches outputting carbohydrate recommendations:
"the processor programmed to analyze the received glucose level and carbohydrate intake data using a model to predict a future glucose level of the patient, and to provide insulin and carbohydrate intake recommendations based on the predicted future glucose level" (¶ [0019])
"may prompt the patient to ingest an amount of carbohydrate to minimize the risk that insulin already delivered may cause hypoglycemia" (¶ [0187])
"The results of the process are outputted in box 425 for use in making insulin therapy recommendations to the patient...or to consume carbohydrates to prevent hypoglycemia" (¶ [0219])
Budiman does NOT explicitly disclose:
1. "a target blood glucose range" - While Budiman discusses achieving "good patient specific glucose control" (¶ [0082]) and maintaining glucose levels, it does not explicitly teach a specific "target blood glucose range" parameter.
2. "determine that a blood glucose measurement value of a user is diverging from a target blood glucose range" - Budiman predicts future glucose levels but does not explicitly teach comparing the blood glucose value to a specific target blood glucose range to determine divergence.
3. "to maintain the user's blood glucose measurement value within the target blood glucose range" - While Budiman teaches preventing hypoglycemia, it does not explicitly frame this in terms of maintaining glucose within a specific target range.
Mastrototaro discloses the missing elements:
1. "a target blood glucose range".
Mastrototaro explicitly teaches target blood glucose values and ranges:
"A patient's target blood glucose level (Target) is the amount of blood glucose (BG) that the patient wishes to achieve and maintain. Typically, a target blood glucose value is between 70-120 mg/dL for pre-prandial BG and 100-150 mg/dL for postprandial BG. Thus, the patient's basal pattern is set to achieve and maintain the Target during insulin therapy." (¶ [0083])
"The algorithm automatically adjusts insulin delivery parameters based on the difference between a glycemic target and a measured glucose value." (¶ [0084])
Claim 39 of Mastrototaro recites: "triggering an alarm when the current measured blood glucose value is higher or lower than a target blood glucose value". The teaching of a target blood glucose value between 70-120 mg/dL or 100-150 mg/dL constitutes a target blood glucose range.
2. "determine that a blood glucose measurement value of a user is diverging from a target blood glucose range".
Mastrototaro teaches determining when measured glucose values diverge from target:
"In one embodiment, the alarm is triggered when the measured blood glucose value is not consistent with a target blood glucose value." (¶ [0012])
"Preferably, the controller obtains a measured blood glucose value after performing the
calibration, and compares the measured blood glucose value to a target blood glucose value." (¶ [0023])
"The algorithm automatically adjusts insulin delivery parameters based on the difference between a glycemic target and a measured glucose value." (¶ [0084])
Claim 39 of Mastrototaro recites: "triggering an alarm when the current measured blood glucose value is higher or lower than a target blood glucose value".
"to maintain the user's blood glucose measurement value within the target blood glucose range".
Mastrototaro teaches maintaining glucose within target:
"A patient's target blood glucose level (Target) is the amount of blood glucose (BG) that the patient wishes to achieve and maintain. Typically, a target blood glucose value is between 70-120 mg/dL for pre-prandial BG and 100-150 mg/dL for postprandial BG. Thus, the patient's basal pattern is set to achieve and maintain the Target during insulin therapy." (¶ [0083])
"determining a basal rate adjustment from the current basal rate to an adjusted basal rate if the user decides not to perform the calibration in order to bring the current measured blood glucose value to be consistent with the target blood glucose value". (Claim 39 of Mastrototaro)
Based on the above comments, a person of ordinary skill in the art would have been motivated to combine the teachings of Budiman and Mastrototaro because both references operate in the identical technical field of automated diabetes management systems that use glucose monitoring to provide therapy recommendations. Budiman teaches a system for "controlling insulin delivery to a patient" using glucose monitoring and predictive models (¶ [0019]), while Mastrototaro teaches a "closed loop/semi-closed loop infusion system" that provides "therapy modification" based on
measured glucose values (Abstract). A person of ordinary skill would have naturally look to both references when designing an automated diabetes management system to create a more robust hypoglycemia prevention system.
In relation to Claim 2, the claim recites:
"The drug delivery system of claim 1, wherein the stored instructions configure the processor to:
receive the user's blood glucose measurement value at a particular time;
obtain a target blood glucose measurement value setting for the user at the particular time;
determine a difference between the user's blood glucose measurement value at the particular time and the target blood glucose measurement value setting for the user at the particular time; and
divide the difference by a correction factor of the user to obtain a modified difference value."
Budiman discloses the following additional elements for Claim 2:
1. "receive the user's blood glucose measurement value at a particular time".
Budiman discloses:
"a processor configured to receive the glucose level data and carbohydrate intake data" (¶ [0019])
"a glucose monitor for providing glucose level data representative of an amount of glucose in a patient's blood stream" (¶ [0019])
The glucose level data is inherently received at a particular time, as glucose monitoring systems provide time-stamped glucose measurements.
2. "divide the difference by a correction factor of the user".
Budiman extensively teaches correction factor (referred to as "insulin sensitivity factor" or
"ISF"):
"In another aspect, the model is simplified using selected assumptions regarding selected data to reduce the time needed to determine the selected parameters, and in yet another aspect, the output of the model is used to determine an insulin sensitivity factor" (¶ [0017])
"Typically, models used to calculate insulin dosage for an insulin therapy regime are specified using three numbers: an insulin sensitivity factor, insulin-to-carbohydrate ratio, and a daily dosage of insulin." (¶ [0081])
"Currently, insulin therapy is specified by an insulin sensitivity factor, an insulin to carbohydrate ratio and a total daily dose of insulin." (¶ [0141])
"Using the definition of the insulin sensitivity factor, that is, the drop in blood glucose following a one unit dose of rapid-acting insulin, the insulin sensitivity factor becomes: ISF = ...". (¶ [0144])
"Finally, if it is desirable to avoid parameter identification of a model, one could parse the log file of a continuous glucose monitoring system for meal and insulin events and note plasma glucose change at some time post-event. The change in plasma glucose could then be used to estimate the insulin sensitivity factor and insulin-to-carbohydrate ratio". (¶ [0150])
Claim 11 of Budiman recites: "determining an insulin sensitivity factor from the model output." Notably, “Insulin sensitivity factor" (ISF) and "correction factor" (CF) are equivalent terms in diabetes management. Both represent the expected drop in blood glucose (in mg/dL) per unit of insulin. Dividing a glucose difference by the correction factor yields the insulin units needed to correct that difference, which is a standard calculation in diabetes management.
Budiman does NOT explicitly disclose:
1. "obtain a target blood glucose measurement value setting for the user at the particular time" - While Budiman discusses achieving glucose control, it does not explicitly teach obtaining a specific target blood glucose measurement value setting.
2. "determine a difference between the user's blood glucose measurement value at the particular time and the target blood glucose measurement value setting for the user at the particular time" - Budiman does not explicitly teach calculating the difference between current glucose and a target value.
3. The specific application of dividing the glucose difference by the correction factor in the context of determining an "after-insulin-on-board blood glucose measurement value" - While Budiman teaches insulin sensitivity factor, it teaches using it for insulin dose calculations, not explicitly for predicting after-IOB glucose values.
Mastrototaro discloses the missing elements:
"obtain a target blood glucose measurement value setting for the user at the particular time".
Mastrototaro teaches obtaining target blood glucose settings that can vary by time:
"A patient's target blood glucose level (Target) is the amount of blood glucose (BG) that the patient wishes to achieve and maintain. Typically, a target blood glucose value is between 70-120 mg/dL for pre-prandial BG and 100-150 mg/dL for postprandial BG. Thus, the patient's basal pattern is set to achieve and maintain the Target during insulin therapy." (¶ [0083])
"FIG. 11 is an example of a basal rate profile broken up into three-hour intervals in accordance with an embodiment of the present invention. Referring to FIG. 11, the basal pattern 800 can have various basal rates (810, 820, 830, 840) throughout the day, and the basal rates do not necessarily change at each interval." (¶ [0082])
Mastrototaro teaches that therapy parameters (including targets) can vary by time of day, supporting the concept of obtaining a "target blood glucose measurement value setting for the user at the particular time."
"determine a difference between the user's blood glucose measurement value at the particular time and the target blood glucose measurement value setting for the user at the particular time".
Mastrototaro explicitly teaches determining the difference:
"The algorithm automatically adjusts insulin delivery parameters based on the difference between a glycemic target and a measured glucose value." (¶ [0084])
"The standard deviation is compared against the difference between an average blood glucose value and the target blood glucose value." (¶ [0110])
In addition to the motivation to combine provided for Claim 1, a person of ordinary skill in the art would have been motivated to combine the teachings for Claim 2 for the following reasons:
The calculation described in Claim 2—determining the difference between current glucose and target, then dividing by correction factor—is a standard calculation in diabetes management known as the "correction bolus" or "correction dose" calculation. Budiman teaches the correction factor (insulin sensitivity factor) (¶ [0081], ¶ [0141], ¶ [0144]), and Mastrototaro teaches determining the difference from target (¶ [0084]). Combining these elements to perform the standard correction calculation would have been obvious to a person of ordinary skill.
Moreover, Budiman explicitly teaches that insulin sensitivity factor is used in calculations:
"Typically, models used to calculate insulin dosage for an insulin therapy regime are specified using three numbers: an insulin sensitivity factor, insulin-to-carbohydrate ratio, and a daily dosage of insulin." (¶ [0081])
A person of ordinary skill would have understood that the insulin sensitivity factor (correction factor) is used by dividing the glucose difference by this factor to determine insulin units needed.
In relation to Claim 3, the claim recites:
"The drug delivery system of claim 2, wherein the stored instructions configure the
processor to:
take a negative of the modified difference value;
determine an amount of insulin-on-board;
sum the negative of the modified difference value with the determined amount of insulin-on-board; and
divide the sum by an insulin-to-carbohydrate ratio of the user to obtain the determined amount of the rescue carbohydrates."
Budiman discloses the following elements for Claim 3:
"determine an amount of insulin-on-board".
Budiman explicitly teaches determining insulin-on-board:
"Bolus calculators traditionally have an input called 'insulin onboard' (IOB) that is taken into account in the calculation". (¶ [0130])
"IOB may be calculated based upon previous insulin delivered and consumption of the insulin. The parameters describing the consumption of the insulin may be calculated using the software embodied in the present invention." (¶ [0131])
2. "divide the sum by an insulin-to-carbohydrate ratio of the user".
Budiman extensively teaches insulin-to-carbohydrate ratio:
"In another aspect, the model is simplified using selected assumptions regarding
selected data to reduce the time needed to determine the selected parameters, and in yet
another aspect, the output of the model is used to determine an insulin sensitivity factor,
or in other aspects, the output of the model is used to determine an insulin-to carbohydrate
ratio". (¶ [0017])
"Typically, models used to calculate insulin dosage for an insulin therapy regime are
specified using three numbers: an insulin sensitivity factor, insulin-to-carbohydrate
ratio, and a daily dosage of insulin." (¶ [0081])
"One advantage of using a continuous glucose monitoring system is that frequent
measurements of blood glucose are available for analysis. When such measurements are
combined with information provided by the patient, such as, the amount of
carbohydrates consumed in a meal and the amount of insulin taken daily or at specific
intervals, a dynamic model describing the affect of food and subsequent insulin dosing
on glucose levels can be determined. These parameters can then be used to estimate an
insulin sensitivity, insulin-to-carbohydrate ratio, and total daily dosage of insulin that
will produce good patient-specific glucose control." (¶ [0082])
"Currently, insulin therapy is specified by an insulin sensitivity factor, an insulin to
carbohydrate ratio and a total daily dose of insulin." (¶ [0141])
"The insulin-to-carbohydrate ratio is then defined in terms of the insulin sensitivity
factor and the expected rise in blood glucose resulting from a meal" (¶ [0145])
"Where I:C=insulin to carbohydrate ratio" (¶ [0146])
Claim 12 of Budiman recites: "determining an insulin to carbohydrate ratio from the model
output."
3. "to obtain the determined amount of the rescue carbohydrates".
Budiman explicitly teaches outputting carbohydrate amounts:
"to other actions, such as a prompt to consume a mass of carbohydrates to prevent or counter the onset of hypoglycemia" (¶ [0010])
"may prompt the patient to ingest an amount of carbohydrate to minimize the risk that insulin already delivered may cause hypoglycemia" (¶ [0187])
Budiman does NOT explicitly disclose:
1. "take a negative of the modified difference value" - The specific step of taking the
negative of the glucose difference divided by correction factor.
2. "sum the negative of the modified difference value with the determined amount of
insulin-on-board" - The specific mathematical operation of summing these two values.
3. The specific formula: Carbs = [-(BGdiff/CF) + IOB] / I:C - While Budiman teaches all
the individual parameters (correction factor, IOB, I:C ratio) and teaches recommending
carbohydrates, it does not explicitly disclose this specific mathematical formula for
calculating the carbohydrate amount.
However, firstly, Budiman and Mastrototaro teach all the parameters used in the formula:
• Correction factor (insulin sensitivity factor): Budiman ¶ [0017], ¶ [0081], ¶ [0141], ¶ [0144];
• Insulin-on-board (IOB): Budiman ¶ [0130-0131];
• Insulin-to-carbohydrate ratio (I:C): Budiman ¶ [0017], ¶ [0081], ¶ [0141-0146]; and
• Target blood glucose: Mastrototaro ¶ [0083], [0084], and Claim 39.
Secondly, Budiman explicitly teaches that the insulin-to-carbohydrate ratio relates insulin to
carbohydrates:
"The insulin-to-carbohydrate ratio is then defined in terms of the insulin sensitivity factor and the expected rise in blood glucose resulting from a meal" (¶ [0145])
A person of ordinary skill would understand that if the I:C ratio tells you how much insulin is needed for a given amount of carbs (forward direction), you can use the same ratio to calculate how many carbs are needed for a given amount of insulin (reverse direction).
Thirdly, Budiman explicitly recognizes the problem of excess insulin and the need for carbohydrates:
"if the calculator determines that no insulin is needed or that too much insulin has already been delivered, the calculator may recommend cancelling any further insulin delivery and warning the user that hypoglycemia may occur". (¶ [0131])
"may prompt the patient to ingest an amount of carbohydrate to minimize the risk that insulin already delivered may cause hypoglycemia". (¶ [0187])
Therefore, the formula in Claim 3 is a predictable use of known mathematical relationships in diabetes management. The correction factor, IOB, and I:C ratio are all standard parameters taught in Budiman. Combining them algebraically to solve for carbohydrates (instead of insulin) would have been obvious to a person of ordinary skill.
In relation to claim 4, Claim 4 recites:
"The drug delivery system of claim 1, wherein the stored instructions configure the processor to:
obtain a default amount of carbohydrates from a memory; and
set the default amount of carbohydrates as the amount of the rescue carbohydrates."
Budiman discloses:
System with memory and processor.
"a processor configured to receive the glucose level data and carbohydrate intake data". (¶ [0019])
"Data received from the CGM, as well as intermediate results from calculations performed by a microprocessor in the computer may be stored either in permanent or semipermanent or transitory memory, such as RAM or a hard drive or other storage media." (¶ [0151])
Carbohydrate recommendations
"to other actions, such as a prompt to consume a mass of carbohydrates to prevent or counter the onset of hypoglycemia" (¶ [0010])
"may prompt the patient to ingest an amount of carbohydrate to minimize the risk that insulin already delivered may cause hypoglycemia" (¶ [0187])
Budiman does NOT explicitly disclose:
1. "obtain a default amount of carbohydrates from a memory" - Using a preset/default carbohydrate amount stored in memory.
2. "set the default amount of carbohydrates as the amount of the rescue carbohydrates" - Outputting a fixed default amount rather than calculating a personalized amount.
However, it was well-known in the art before the effective filing date of this application that hypoglycemia treatment follows the "15-15 default rule" of the American Diabetes Association (ADA) which consist of consuming 15 grams of fast acting carbohydrates, waiting 15 minutes, rechecking blood glucose, and repeating the steps if glucose still low. The use of a default amount (typically 15 grams) of carbohydrates for hypoglycemia treatment was well-known and routinely practiced before the priority date. Moreover, Budiman teaches storing data in memory:
"Data received from the CGM, as well as intermediate results from calculations performed by a microprocessor in the computer may be stored either in permanent or semipermanent or transitory memory". (¶ [0151])
Based on the above information, a person of ordinary skill in the art would have been motivated to incorporate a default carbohydrate amount option into the system of Budiman because the carbohydrate default option was well-known in the art and such data could have been stored in permanent or semipermanent or transitory memory as explicitly taught by Budiman.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783