Office Action 3: Non-Final Rejection (2023-11-15)
Rejection types: 103 - Obviousness

CLAIMS:
Amendments to the Claims:

The following Listing of Claims will replace all prior versions, and listings, of claims in the application:

Claim 1: (Currently Amended) A system comprising:one or more processors; and
one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of:
obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal;
converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor;
determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value;
determining, based on the equivalent carbohydrate value for the meal, an amount of insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal; and
causing delivery of insulin to the patient, with an insulin delivery device, based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal.
Claim 2: (Original) The system of claim 1, wherein determining the amount of insulin to deliver to the patient comprises:

to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal; and

determining, based on the predicted amounts of glucose to be absorbed into the bloodstream, a bolus dosage of insulin to deliver to the patient.
Claim 3: (Original) The system of claim 2, wherein determining the amount of insulin to deliver to the patient comprises:
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient, and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin.
Claim 4: (Original) The system of claim 2, wherein determining the bolus dosage comprises:
identifying a plurality of candidate dosages;
for each candidate dosage of the plurality of candidate dosages, predicting a respective amount of time within a target range for the patient's glucose levels; and
selecting a candidate dosage that results in a maximum amount of time within the target range.
Claim 5: (Currently Amended) The system of claim 1, wherein determining the equivalent carbohydrate value comprises:
determining \[\[a\]\] the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor.
Claim 6: (Original) The system of claim 5, wherein the conversion factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient.
Claim 7: (Original) The system of claim 5, wherein the conversion factor is determined based on a time of day that the patient consumes the meal.

Claim 8: (Original) The system of claim 5, wherein the instructions, when executed by the one or more processors, cause performance of:
obtaining an estimated fat value for the meal;
determining, based on the estimated fat value, a glucose absorption rate resulting from consumption of the meal,
wherein determining the amount of insulin to deliver to the patient is based on the equivalent carbohydrate value for the meal and is further based on the glucose absorption rate resulting from consumption of the meal.
Claim 9: (Original) The system of claim 8, wherein determining the glucose absorption rate comprises:
determining an absorption rate tuning factor for approximating an effect of fat on the glucose absorption rate; and
determining the glucose absorption rate based on the estimated fat value for the meal and the absorption rate tuning factor,
wherein the absorption rate tuning factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient.

Claim 10: (Currently Amended) A processor-implemented method comprising:obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal;
converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor;
determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value;

insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal; and

causing delivery of insulin to the patient, with an insulin delivery device, based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal.

Claim 11: (Original) The method of claim 10, wherein determining the amount of insulin to deliver to the patient comprises:predicting, based on the equivalent carbohydrate value for the meal, amounts of glucose to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal; and
determining, based on the predicted amounts of glucose to be absorbed into the bloodstream, a bolus dosage of insulin to deliver to the patient.

Claim 12: (Original) The method of claim 11, wherein determining the amount of insulin to deliver to the patient comprises:
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient, and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin.

Claim 13: (Original) The method of claim 11, wherein determining the bolus dosage comprises:identifying a plurality of candidate dosages;
for each candidate dosage of the plurality of candidate dosages, predicting a respective amount of time within a target range for the patient's glucose levels; and
selecting a candidate dosage that results in a maximum amount of time within the target range.

Claim 14: (Currently Amended) The method of claim 10, wherein determining the equivalent carbohydrate value comprises:determining \[\[a\]\] the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor.

Claim 15: (Original) The method of claim 14, wherein the conversion factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient.

Claim 16: (Original) The method of claim 14, wherein the conversion factor is determined based on a time of day that the patient consumes the meal.

Claim 17: (Original) The method of claim 10, further comprising:obtaining an estimated fat value for the meal;
determining, based on the estimated fat value, a glucose absorption rate resulting from consumption of the meal,
wherein determining the amount of insulin to deliver to the patient is based on the equivalent carbohydrate value for the meal and is further based on the glucose absorption rate resulting from consumption of the meal.

Claim 18: (Currently Amended) One or more non-transitory processor-readable storage media storing instructions which, when executed by one or more processors, cause performance of:obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal;
converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor;
determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value;

insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal; and

causing delivery of insulin to the patient, with an insulin delivery device, based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal.

Claim 19: (Original) The one or more non-transitory processor-readable storage media of claim 18, wherein determining the amount of insulin to deliver to the patient comprises:predicting, based on the equivalent carbohydrate value for the meal, amounts of glucose to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal;
determining, based on the predicted amounts of glucose to be absorbed into the bloodstream, a bolus dosage of insulin to deliver to the patient; and
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient, and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin.

Claim 20: (Currently Amended) The one or more non-transitory processor-readable storage media of claim 18, wherein determining the equivalent carbohydrate value comprises:determining \[\[a\]\] the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor,
wherein the conversion factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient.

OFFICE ACTION:
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection.  Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.  Applicant's submission filed on July 19, 2023 has been entered.
Acknowledgement of Amendments
This Office Action is responsive to the amendment filed July 19, 2023. The examiner acknowledges the amendments to claims 1, 5, 10, 14, 18, and 20. Claims 1-20 are subject to examination hereinbelow.
Response to Arguments
Applicant’s arguments, see pg 9, filed October 23, 2023, with respect to the rejection(s) of claim(s) 1, 10, and 18 under USC 103 have been fully considered and are persuasive.  Therefore, the rejection has been withdrawn.  However, upon further consideration, a new ground(s) of rejection is made in view of US 20050187749 A1 to Singley.
Claim Objections
Claims 5, 14, and 20 are objected to because of the following informalities: converting protein to a parameter should be amended to --converting the estimated protein value to a parameter--.  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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5, 7-12, 14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weinert (US 20070179434 A1) (cited in previous Office Action) in view of US 20050187749 A1 to Singley.
Regarding claim 1, Weinert teaches a system [abstract] comprising:
one or more processors (Paragraph 0003:  “a processor”); and
one or more processor-readable storage media storing instructions which, when executed by the one or more processors (Paragraph 0065:  “one or more suitable data and/or program storage devices”), cause performance of:
obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal (Paragraph 0010:  “meal size values for each of the fat amount, protein amount and carbohydrate amount”);
determining, based on the equivalent carbohydrate value for the meal, an amount of insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal (Paragraph 0023:  “The drug may be a blood glucose lowering drug. The drug may be, for example, insulin. The first parameter may correspond to carbohydrate content of a meal and the second parameter may correspond to an expected speed of overall glucose absorption from the meal by the user”); and
causing delivery of insulin to the patient, with an insulin delivery device (Paragraph 0069:  “the insulin pump is configured to wirelessly transmit information relating to insulin delivery to the handheld device 12”), based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal (Paragraph 0020:  “The method may further include displaying at least some of the drug administration information on a display unit”).
However, Weinert does not teach converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor; and
determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value.
Singley teaches converting an estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function (shown in step 208) or by dividing the estimated protein value by a conversion factor (CFP multiplier) [0025] (Fig 2); and determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value (step 210) [0026] (Fig 2).
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the processor-readable storage media storing instructions of Weinert to cause converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor; and determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Regarding claim 2, Weinert in view of Singley teach the system of claim 1, and Weinert further teaches wherein determining the amount of insulin to deliver to the patient (Paragraph 0023:  “The drug may be a blood glucose lowering drug. The drug may be, for example, insulin. The first parameter may correspond to carbohydrate content of a meal and the second parameter may correspond to an expected speed of overall glucose absorption from the meal by the user”) comprises:
predicting, based on the equivalent carbohydrate value for the meal, amounts of glucose to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal (Paragraph 0077:  “the estimate of the expected speed of overall glucose absorption parameter, the shape and duration of the glucose absorption profile may be mapped to the composition of the meal”); and
determining, based on the predicted amounts of glucose to be absorbed into the bloodstream, a bolus dosage of insulin to deliver to the patient (Paragraph 0023:  “The drug may be a blood glucose lowering drug. The drug may be, for example, insulin. The first parameter may correspond to carbohydrate content of a meal and the second parameter may correspond to an expected speed of overall glucose absorption from the meal by the user”).
Regarding claim 3, Weinert in view of Singley teach the system of claim 2, and Weinert further teaches wherein determining the amount of insulin to deliver to the patient comprises:
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient (Paragraph 0121:  “Information is entered into a database … In such cases, the other bolus-related information may include, for example, but should not be limited to, number of meal compensation or correction boluses administered, amount of each bolus administered, time between administered boluses and time of administration of first bolus”), and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin (Paragraph 0157:  “ Any such stored information may be evaluated immediately or in the future, and/or may be re-evaluated when new entries or updates are made to the database and/or to the one or more system control algorithms. Examples of user feedback entered into the system 10 include, but are not limited to, any of the information illustrated in FIG. 13”:  the prior bolus dose is a database entry which is used in the system algorithms used for bolus control).
Regarding claim 5, Weinert in view of Singley teach the system of claim 1, however Weinert does not teach determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor.
Singley teaches determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient [0025]; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor [0025 – 0027].
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the processor-readable storage media storing instructions of Weinert to cause the determining the equivalent carbohydrate value by:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Regarding claim 7, Weinert in view of Singley teach the system of claim 5, however Weinert does not teach the conversion factor is determined based on a time of day that the patient consumes the meal.
Singley teaches the conversion factor is determined based on a time of day that the patient consumes the meal [0025, 0027, 0061] (Fig 3).
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the processor-readable storage media storing instructions of Weinert to determine the conversion factor based on a time of day that the patient consumes the meal, because doing so would help track a patient’s meal times, as recognized by Singley [0061].
Regarding claim 8, Weinert in view of Singley teach the system of claim 5, and Weinert further teaches wherein the instructions, when executed by the one or more processors, cause performance of:
obtaining an estimated fat value for the meal (Paragraph 0010:  “meal size values for each of the fat amount, protein amount and carbohydrate amount”);
determining, based on the estimated fat value, a glucose absorption rate resulting from consumption of the meal, wherein determining the amount of insulin to deliver to the patient is based on the equivalent carbohydrate value for the meal and is further based on the glucose absorption rate resulting from consumption of the meal (Paragraph 0077).
Regarding claim 9, Weinert in view of Singley teach the system of claim 8, and Weinert teaches wherein determining the glucose absorption rate comprises:
determining an absorption rate tuning factor for approximating an effect of fat on the glucose absorption rate (Fig. 4/5 and Paragraph 0081-0083:  amount of fat is tuned based on meal composition and details); and
determining the glucose absorption rate based on the estimated fat value for the meal and the absorption rate tuning factor (Fig. 4/5 and Paragraphs 0081-0083), wherein the absorption rate tuning factor is determined based on historical meal data for the patient (Paragraph 0100:  “a suitable graphical user interface can be defined based on the patient's recorded dietary habits, the outcome of the third process module is a graphical user interface that maps user-selectable feed forward information to insulin delivery information”) and further based on historical glucose level data for the patient (Paragraph 0121 and Fig. 13:  previous glucose levels used).
Regarding claim 10, Weinert teaches a processor-implemented method [abstract, 0015] comprising:
obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal (Paragraph 0010:  “meal size values for each of the fat amount, protein amount and carbohydrate amount”);
determining, based on the equivalent carbohydrate value for the meal, an amount of insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal (Paragraph 0023:  “The drug may be a blood glucose lowering drug. The drug may be, for example, insulin. The first parameter may correspond to carbohydrate content of a meal and the second parameter may correspond to an expected speed of overall glucose absorption from the meal by the user”); and
causing delivery of insulin to the patient, with an insulin delivery device (Paragraph 0069:  “the insulin pump is configured to wirelessly transmit information relating to insulin delivery to the handheld device 12”), based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal (Paragraph 0020:  “The method may further include displaying at least some of the drug administration information on a display unit”).
However, Weinert does not teach converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor; and
determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value.
Singley teaches converting an estimated protein value into a corresponding carbohydrate value by applying an estimated protein value to a mathematical function (shown in step 208) or by dividing the estimated protein value by a conversion factor (CFP multiplier) [0025] (Fig 2); and determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value (step 210) [0026] (Fig 2).
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the method of Weinert to include steps comprising converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor; and determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Regarding claim 11, Weinert in view of Singley teach the method of claim 10, and Weinert further teaches wherein determining the amount of insulin to deliver to the patient (Paragraph 0023:  “The drug may be a blood glucose lowering drug. The drug may be, for example, insulin. The first parameter may correspond to carbohydrate content of a meal and the second parameter may correspond to an expected speed of overall glucose absorption from the meal by the user”) comprises:
predicting, based on the equivalent carbohydrate value for the meal, amounts of glucose to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal (Paragraph 0077:  “the estimate of the expected speed of overall glucose absorption parameter, the shape and duration of the glucose absorption profile may be mapped to the composition of the meal”); and
determining, based on the predicted amounts of glucose to be absorbed into the bloodstream, a bolus dosage of insulin to deliver to the patient (Paragraph 0023:  “The drug may be a blood glucose lowering drug. The drug may be, for example, insulin. The first parameter may correspond to carbohydrate content of a meal and the second parameter may correspond to an expected speed of overall glucose absorption from the meal by the user”).
Regarding claim 12, Weinert in view of Singley teach the method of claim 11, and Weinert further teaches wherein determining the amount of insulin to deliver to the patient comprises:
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient (Paragraph 0121:  “Information is entered into a database … In such cases, the other bolus-related information may include, for example, but should not be limited to, number of meal compensation or correction boluses administered, amount of each bolus administered, time between administered boluses and time of administration of first bolus”), and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin (Paragraph 0157:  “ Any such stored information may be evaluated immediately or in the future, and/or may be re-evaluated when new entries or updates are made to the database and/or to the one or more system control algorithms. Examples of user feedback entered into the system 10 include, but are not limited to, any of the information illustrated in FIG. 13”:  the prior bolus dose is a database entry which is used in the system algorithms used for bolus control).
Regarding claim 14, Weinert in view of Singley teach the method of claim 10, however Weinert does not teach determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor.
Singley teaches determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient [0025]; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor [0025 – 0027].
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the steps of Weinert to cause the determining the equivalent carbohydrate value by:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Regarding claim 16, Weinert in view of Singley teach the method of claim 14, however Weinert does not teach the conversion factor is determined based on a time of day that the patient consumes the meal.
Singley teaches the conversion factor is determined based on a time of day that the patient consumes the meal [0025, 0027, 0061] (Fig 3).
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the steps Weinert to determine the conversion factor based on a time of day that the patient consumes the meal, because doing so would help track a patient’s meal times, as recognized by Singley [0061].
Regarding claim 17, Weinert in view of Singley teach the system of claim 10, and Weinert further teaches wherein the instructions, when executed by the one or more processors, cause performance of:
obtaining an estimated fat value for the meal (Paragraph 0010:  “meal size values for each of the fat amount, protein amount and carbohydrate amount”);
determining, based on the estimated fat value, a glucose absorption rate resulting from consumption of the meal, wherein determining the amount of insulin to deliver to the patient is based on the equivalent carbohydrate value for the meal and is further based on the glucose absorption rate resulting from consumption of the meal (Paragraph 0077).
Regarding claim 18, Weinert teaches one or more non-transitory processor-readable storage media storing instructions, which, when executed by one or more processors [abstract, 0015], cause performance of:
obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal (Paragraph 0010:  “meal size values for each of the fat amount, protein amount and carbohydrate amount”);
determining, based on the equivalent carbohydrate value for the meal, an amount of insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal (Paragraph 0023:  “The drug may be a blood glucose lowering drug. The drug may be, for example, insulin. The first parameter may correspond to carbohydrate content of a meal and the second parameter may correspond to an expected speed of overall glucose absorption from the meal by the user”); and
causing delivery of insulin to the patient, with an insulin delivery device (Paragraph 0069:  “the insulin pump is configured to wirelessly transmit information relating to insulin delivery to the handheld device 12”), based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal (Paragraph 0020:  “The method may further include displaying at least some of the drug administration information on a display unit”).
However, Weinert does not teach converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor; and
determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value.
Singley teaches converting an estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function (shown in step 208) or by dividing the estimated protein value by a conversion factor (CFP multiplier) [0025] (Fig 2); and
determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value (step 210) [0026] (Fig 2).
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the processor-readable storage media storing instructions of Weinert to cause converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a conversion factor; and
determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Regarding claim 19, Weinert in view of Singley teach the limitations of claim 18, and Weinert further teaches wherein determining the amount of insulin to deliver to the patient comprises:
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient (Paragraph 0121:  “Information is entered into a database … In such cases, the other bolus-related information may include, for example, but should not be limited to, number of meal compensation or correction boluses administered, amount of each bolus administered, time between administered boluses and time of administration of first bolus”), and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin (Paragraph 0157:  “ Any such stored information may be evaluated immediately or in the future, and/or may be re-evaluated when new entries or updates are made to the database and/or to the one or more system control algorithms. Examples of user feedback entered into the system 10 include, but are not limited to, any of the information illustrated in FIG. 13”:  the prior bolus dose is a database entry which is used in the system algorithms used for bolus control).
Regarding claim 20, Weinert in view of Singley teach the limitations of claim 18, however Weinert does not teach determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor.
Singley teaches determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient [0025]; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor [0025 – 0027].
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the steps of Weinert to cause the determining the equivalent carbohydrate value by:
determining the conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Claim(s) 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Weinert in view of Singley as applied to claims 2 and 11 above, and further in view of Mazlish (US 20180200439 A1) (cited in previous Office Action).
Regarding claim 4, Weinert in view of Singley teach the system of claim 2, however they fail to teach wherein determining the amount of insulin to deliver to the patient comprises:
identifying a plurality of candidate dosages; for each candidate dosage of the plurality of candidate dosages, predicting a respective amount of time within a target range for the patient's glucose levels; and selecting a candidate dosage that results in a maximum amount of time within the target range.
Mazlish teaches wherein determining an amount of insulin to deliver to the patient comprises:
identifying a plurality of candidate dosages (Paragraph 20:  “ For example, such personalization may include generating multiple insulin delivery profiles and projected blood glucose levels for each of the insulin delivery profiles, and selecting the profile that closely tracks towards a target blood glucose level”);
for each candidate dosage of the plurality of candidate dosages, predicting a respective amount of time within a target range for the patient's glucose levels (Paragraph 0022:  “Methods and systems provided herein can use a model to predict multiple future blood glucose levels for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on prediction of which profile or rate will approximate a target blood glucose level, or more specifically, select the profile that minimizes the differences between the predicted future blood glucose values and one or more target blood glucose values”); and
selecting a candidate dosage that results in a maximum amount of time within the target range (Paragraph 0022:  “In some cases, the profile that minimizes, lessens, or lowers variations from one or more target blood glucose levels in the future may be selected”).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Weinert in view of Singley to incorporate the multiple candidate dosages of Mazlish, because it allows for the best and most optimal treatment to be given to a patient to control their blood glucose level (Paragraph 0022 of Mazlish).
Regarding claim 13, Weinert in view of Singley teach the method of claim 11, however they fail to teach wherein determining the amount of insulin to deliver to the patient comprises:
identifying a plurality of candidate dosages; for each candidate dosage of the plurality of candidate dosages, predicting a respective amount of time within a target range for the patient's glucose levels; and selecting a candidate dosage that results in a maximum amount of time within the target range.
Mazlish teaches wherein determining an amount of insulin to deliver to the patient comprises:
identifying a plurality of candidate dosages (Paragraph 20:  “ For example, such personalization may include generating multiple insulin delivery profiles and projected blood glucose levels for each of the insulin delivery profiles, and selecting the profile that closely tracks towards a target blood glucose level”);
for each candidate dosage of the plurality of candidate dosages, predicting a respective amount of time within a target range for the patient's glucose levels (Paragraph 0022:  “Methods and systems provided herein can use a model to predict multiple future blood glucose levels for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on prediction of which profile or rate will approximate a target blood glucose level, or more specifically, select the profile that minimizes the differences between the predicted future blood glucose values and one or more target blood glucose values”); and
selecting a candidate dosage that results in a maximum amount of time within the target range (Paragraph 0022:  “In some cases, the profile that minimizes, lessens, or lowers variations from one or more target blood glucose levels in the future may be selected”).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Weinert in view of Singley to incorporate the multiple candidate dosages of Mazlish, because it allows for the best and most optimal treatment to be given to a patient to control their blood glucose level (Paragraph 0022 of Mazlish).
Claim(s) 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Weinert in view of Singley as applied to claim 5 and 14 above, and further in view of US 5836312 A to Moore.
Regarding claim 6, Weinert in view of Singley teach the system of claim 5, however they do not teach the conversion factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient.
Moore teaches a conversion factor is determined based on historical meal data and further based on historical glucose level data for the patient [abstract; col 7, ln 57 – col 8, ln 15; col 8, ln 35 – col 9, ln 2].
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the system of Weinert and Singley to determine the conversion factor based on historical meal data for the patient and historical glucose level data for the patient, because doing so would help adjust the conversion factor according to a plurality of physiological measurements, as recognized by Moore [col 6, ln 24 – col 7, ln 22].
Regarding claim 15, Weinert in view of Singley teach the method of claim 14, however they do not teach the conversion factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient.
Moore teaches a conversion factor is determined based on historical meal data and further based on historical glucose level data for the patient [abstract; col 7, ln 57 – col 8, ln 15; col 8, ln 35 – col 9, ln 2].
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the system of Weinert and Singley to determine the conversion factor based on historical meal data for the patient and historical glucose level data for the patient, because doing so would help adjust the conversion factor according to a plurality of physiological measurements, as recognized by Moore [col 6, ln 24 – col 7, ln 22].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5836312 A, US 20080294373 A1, and US 20200268968 A1 are mentioned because they disclose systems and methods for determining glycose level changes and insulin needs based on carbohydrate and protein intake. US 20120315609 A1 and US 20210205534 A1 are mentioned because they disclose systems and methods for monitoring food intake.

APPLICANT REBUTTAL: REMARKS
Claims 1, 5, 10, 14, 18, and 20 are amended. Claims 1-20 remain pending. Applicant respectfully requests reconsideration in view of the remarks presented below.
Interview Summary
Applicant thanks the Examiner for the telephonic interview conducted January 11, 2024. Participating in the interview were Examiner Raymond P. Dulman and Applicant's representative, Arthi Srinivasan (Reg. No. 73,675). During the interview, Applicant'srepresentative discussed the rejection of independent claim 1 under 35 U.S.C. § 103 in light of a proposed amendment to claim 1. The Examiner indicated that the proposed amendment would overcome the current rejection but that further search would be needed. Applicant notes similar amendments to those discussed during the interview have been made to the independent claims herein.
No agreement regarding allowability was reached.
The Objection to Claims 5,
14, and 20
Claims 5, 14, and 20 were objected to due to informalities. Applicant has amended these claims to recite "converting
the estimated
protein
value"
as requested by the Office.
Accordingly, Applicant respectfully requests that the objection be withdrawn.
Claim Rejections Under 35 U.S.C.
&
The Office Action rejected claims 1-3, 5, 7-12, 14, and 16-20 under 35 U.S.C. § 103 as
being unpatentable over Weinert (U.S. Publication No. 20070179434 Al, hereinafter WEINERT) in view of Singley (U.S. Publication No. 20050187749 A1, hereinafter STINGLEY). Claims 4 and 13 are rejected under 35 U.S.C. § 103 as being unpatentable over WEINERT in view of SINGLEY as applied to claims 2 and 11, and further in view of Mazlish (U.S. Publication No. 20180200439 Al, hereinafter MAZLISH). Claims 6 and 15 are rejected under 35 U.S.C. § 103 as being unpatentable over WEINERT in view of SINGLEY as applied to claims 5 and 14, and further in view of Moore (U.S. Patent No. 5836312 A, hereinafter MOORE).
Without conceding in the basis of the rejection, and solely to expedite prosecution of this application, Applicant has amended independent claims 1, 10, and 18 to recite, inter alia,
"converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a
p
atient-s
p
ecific
conversion factor." Support for this amendment can be found in at least paragraph [0080] of the originally filed specification.
In rejecting independent claim 1, prior to the current amendments, the Office correctly acknowledged that Weinert does not disclose or suggest "converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a carbohydrate value." However, the Office asserted that Singley discloses this feature. (Office Action, page 5).
Singley states that "the grams of carbs from proteins can be calculated by taking the food weight of the food being weighed by the scale and multiplying it by a multiplier appropriate for the weight units being used to weigh the food. For example, it is known that 1 ounce of a 'protein food' (e.g., meat, poultry, etc.) equals 4.2 grams of carbs from protein. Thus, if we have
3 ounces of chicken, we can calculate that we have 12.6 grams carbs from that protein." (Singley, paragraph [0025]). In other words, Singley describes using a fixed carbs from protein value for a given food. Nowhere does Singley disclose or suggest using a
p
atient-s
p
ecific conversion factor
to "convert the estimated protein value into a corresponding carbohydrate value."
Moreover, Applicant notes that during the telephonic interview, the Examiner agreed the amendment to independent claims 1, 10, and 18 would overcome the current rejection over Weinert in view of Singley.
Accordingly, Applicant respectfully submits that independent claims 1, 10, and 18 are allowable. Moreover, Applicant respectfully submits that dependent claims 2-9, 11-17, 19, and 20, each of which depend from one of independent claims 1, 10, and 18 are allowable for at least the same reasons independent claims 1, 10, and 18 are allowable.
Dependent Claims 6 and
IS
Applicant respectfully submits dependent claims 6 and 15, which recite "wherein the
conversion factor is determined based on historical meal data for the patient and further based on
historical glucose level data for the patient" are allowable for at least a second reason.
In rejecting dependent claims 6 and 15, the Office conceded that Weinert and Singley fail to disclose or suggest that the conversion factor is determined based on historical meal data and historical glucose level data, but asserted that Moore discloses this feature. (Office Action, page 21).
The cited portion of Moore describes "determining whether [an] information string
relates to a consumed item or measured physiological parameter," which is "stored along with time data coupled thereto in a subdirectory directed to the physiological measurement." In other words, the cited portion of Moore merely describes techniques for generating a log of items consumed and physiological data, and makes no mention of
"a conversion factor,"
let alone one used to "convert [an] estimated protein value into a corresponding carbohydrate value." The cited portion of Moore is entirely unrelated to converting an estimated protein value into a corresponding carbohydrate value, and accordingly cannot and does not disclose or suggest that a conversion factor for performing such a conversion is "determined based on historical meal data for the patient and further based on historical glucose level data for the patient."
Dependent Claims 7 and 16
Applicant respectfully submits that dependent claims 7 and 16, which recite "the
conversion factor is determined based on a time of day that the user consumes the meal," are allowable for at least a second reason.
In rejecting dependent claims 7 and 16, the Office asserted that Singley discloses this
feature. Singley states "[t]he tool can record the event with the following pieces of information: Time of meal, Foods and weights, Meal bolus computation, BG reading, time of BG reading (pre meal), meal type (Breakfast, lunch, dinner), HBG adjustment, & LBG adjustment (if any)." (Singley, paragraph [0061], cited by the Office).
Applicant respectfully submits that Singley merely states that time of day can be
recorded, and makes no mention of a
conversion factor being determined based on the time of
day
,
as recited in dependent claims 7 and 16.
For at least these reasons, Applicant respectfully requests reconsideration and withdrawal of the rejections of the claims under 35 U.S.C. § 103.
Conclusion

NEXT OFFICE ACTION: 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 .
Acknowledgement of Amendments
This Office Action is responsive to the amendment filed 02/14/2024. The examiner acknowledges the amendments to claims 1, 5, 10, 14, 18, and 20. Claims 1 - 20 are subject to examination hereinbelow.
Response to Arguments
Applicant’s arguments, see pg 9, filed 02/14/2024, with respect to the objections of claims 5, 14, and 20 have been fully considered and are persuasive.  The objections of claims 5, 14, and 20 have has been withdrawn.
Applicant’s arguments, see pg 10 - 11, filed 02/14/2024, with respect to the rejection(s) of claim(s) 1, 6 – 7, 10, 15 – 16, and 18 under 35 USC 103 have been fully considered and are persuasive.  Therefore, the rejection has been withdrawn.  However, upon further consideration, a new ground(s) of rejection is made in view of US 20090006129 A1 to Thukral, et al. (hereinafter Thukral).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090006129 A1 to Thukral, et al. (hereinafter Thukral) in view of US 20050187749 A1 to Singley (cited in previous Office Action).
Thukral teaches a system [abstract] comprising:
one or more processors (16, 34) [0063-0064] (Fig 2); and
one or more processor-readable storage media (78) storing instructions [0073] (Fig 3) which, when executed by the one or more processors, cause performance of:
obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal [0146];
converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a patient-specific conversion factor ([0212 -0213], the estimated protein value is inherently converted to an equivalent carbohydrate amount using some sort of mathematical function taking into account the patient-specific conversion factor of their gut glucose absorption based on what type of meal the patient is eating);
determining, based on the equivalent carbohydrate value for the meal, an amount of insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal (846) [0163, 0212-0213, 0236] (Fig 9); and
causing delivery of insulin to the patient (850), with an insulin delivery device, based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal [0163] (Fig 9).
However, Thukral does not teach determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value.
Singley teaches determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value (step 210) [0026] (Fig 2).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify Thukral to determine an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Regarding claim 2, Thukral in view of Singley teach the system of claim 1, and Thukral further teaches determining the amount of insulin to deliver to the patient comprises:
predicting, based on the equivalent carbohydrate value for the meal, amounts of glucose to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal [0212-0213]; and
determining, based on the predicted amounts of glucose to be absorbed into the bloodstream, a bolus dosage of insulin to deliver to the patient [0163, 0213] (Fig 9).
Regarding claim 3, Thukral in view of Singley teach the system of claim 2, and Thukral further teaches determining the amount of insulin to deliver to the patient comprises:
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient ([0142 - 0144], basal insulin dosage delivered prior to an event such as a patient exercising or eating a meal), and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin ([0142-0144], bolus dosage compensation for an event such as exercising or eating a meal is based on a prior basal dosage of insulin to help a patient maintain a target basal glucose).
Regarding claim 4, Thukral in view of Singley teach the system of claim 2, and Thukral further teaches determining the bolus dosage comprises:
identifying a plurality of candidate dosages [0135, 0182];
for each candidate dosage of the plurality of candidate dosages, predicting a respective amount of time within a target range for the patient's glucose levels [0135, 0182] (Fig 9); and
selecting a candidate dosage that results in a maximum amount of time within the target range ([0182], a candidate dosage is selected which best places the patient’s glucose levels in the target glucose zone).
Regarding claim 5, Thukral in view of Singley teach the system of claim 1, and Thukral further teaches determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting the estimated protein value to a parameter approximating an effect of the protein on glucose levels of the patient [0212]; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor [0212].
Regarding claim 6, Thukral in view of Singley teach the system of claim 5, and Thukral further teaches the conversion factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient ([0143 - 0144, 0147, 0153, 0212- 0213], meal compensator uses historical meal data and historical glucose level data to determine the glucose absorption/protein equivalent carbohydrate conversion for proteins for the current meal).
Regarding claim 7, Thukral in view of Singley teach the system of claim 5, and Thukral further teaches the conversion factor is determined based on a time of day that the patient consumes the meal [0172, 0212].
Regarding claim 8, Thukral in view of Singley teach the system of claim 5, and Thukral further teaches wherein the instructions, when executed by the one or more processors, cause performance of:
obtaining an estimated fat value for the meal [0212];
determining, based on the estimated fat value, a glucose absorption rate resulting from consumption of the meal [0212 -0213],
wherein determining the amount of insulin to deliver to the patient is based on the equivalent carbohydrate value for the meal and is further based on the glucose absorption rate resulting from consumption of the meal [0212 -0213].
Regarding claim 9, Thukral in view of Singley teach the system of claim 8, and Thukral further teaches determining the glucose absorption rate comprises:
determining an absorption rate tuning factor for approximating an effect of fat on the glucose absorption rate [0212- 0213]; and
determining the glucose absorption rate based on the estimated fat value for the meal and the absorption rate tuning factor [0212 -0213],
wherein the absorption rate tuning factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient ([0143 - 0144, 0147, 0153, 0212- 0213], meal compensator uses historical meal data and historical glucose level data to determine the glucose absorption rate).
Regarding claim 10, Thukral teaches a processor-implemented method [abstract, 0063-0064] comprising:
obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal [0146];
converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a patient-specific conversion factor ([0212 -0213], the estimated protein value is inherently converted to an equivalent carbohydrate amount using some sort of mathematical function taking into account the patient-specific conversion factor of their gut glucose absorption based on what type of meal the patient is eating);
determining, based on the equivalent carbohydrate value for the meal, an amount of insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal (846) [0163, 0212-0213, 0236] (Fig 9); and
causing delivery of insulin to the patient (850), with an insulin delivery device, based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal [0163] (Fig 9).
However, Thukral does not teach determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value.
Singley teaches determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value (step 210) [0026] (Fig 2).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify Thukral to determine an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Regarding claim 11, Thukral in view of Singley teach the method of claim 10, and Thukral further teaches determining the amount of insulin to deliver to the patient comprises:
predicting, based on the equivalent carbohydrate value for the meal, amounts of glucose to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal [0212-0213]; and
determining, based on the predicted amounts of glucose to be absorbed into the bloodstream, a bolus dosage of insulin to deliver to the patient [0163, 0213] (Fig 9).
Regarding claim 12, Thukral in view of Singley teach the method of claim 11, and Thukral further teaches determining the amount of insulin to deliver to the patient comprises:
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient ([0142 - 0144], basal insulin dosage delivered prior to an event such as a patient exercising or eating a meal), and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin ([0142-0144], bolus dosage compensation for an event such as exercising or eating a meal is based on a prior basal dosage of insulin to help a patient maintain a target basal glucose).
Regarding claim 13, Thukral in view of Singley teach the method of claim 11, and Thukral further teaches determining the bolus dosage comprises:
identifying a plurality of candidate dosages [0135, 0182];
for each candidate dosage of the plurality of candidate dosages, predicting a respective amount of time within a target range for the patient's glucose levels [0135, 0182] (Fig 9); and
selecting a candidate dosage that results in a maximum amount of time within the target range ([0182], a candidate dosage is selected which best places the patient’s glucose levels in the target glucose zone).
Regarding claim 14, Thukral in view of Singley teach the method of claim 10, and Thukral further teaches determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting the estimated protein value to a parameter approximating an effect of the protein on glucose levels of the patient [0212]; and
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor [0212].
Regarding claim 15, Thukral in view of Singley teach the method of claim 14, and Thukral further teaches the conversion factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient ([0143 - 0144, 0147, 0153, 0212- 0213], meal compensator uses historical meal data and historical glucose level data to determine the glucose absorption/protein equivalent carbohydrate conversion for proteins for the current meal).
Regarding claim 16, Thukral in view of Singley teach the method of claim 14, and Thukral further teaches the conversion factor is determined based on a time of day that the patient consumes the meal [0172, 0212].
Regarding claim 17, Thukral in view of Singley teach the method of claim 10, and Thukral further teaches wherein the instructions, when executed by the one or more processors, cause performance of:
obtaining an estimated fat value for the meal [0212];
determining, based on the estimated fat value, a glucose absorption rate resulting from consumption of the meal [0212 -0213],
wherein determining the amount of insulin to deliver to the patient is based on the equivalent carbohydrate value for the meal and is further based on the glucose absorption rate resulting from consumption of the meal [0212 -0213].
Regarding claim 18, Thukral teaches one or more non-transitory processor-readable storage media storing instructions [0073] which, when executed by one or more processors [0063-0064], cause performance of:
obtaining an estimated protein value for a meal and an estimated carbohydrate value for the meal [0146];
converting the estimated protein value into a corresponding carbohydrate value by applying the estimated protein value to a mathematical function or by dividing the estimated protein value by a patient-specific conversion factor ([0212 -0213], the estimated protein value is inherently converted to an equivalent carbohydrate amount using some sort of mathematical function taking into account the patient-specific conversion factor of their gut glucose absorption based on what type of meal the patient is eating);
determining, based on the equivalent carbohydrate value for the meal, an amount of insulin to deliver to a patient to counteract a glucose level increase caused by consumption of the meal (846) [0163, 0212-0213, 0236] (Fig 9); and
causing delivery of insulin to the patient (850), with an insulin delivery device, based on generating an output indicative of the amount of insulin to counteract the glucose level increase caused by consumption of the meal [0163] (Fig 9).
However, Thukral does not teach determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value.
Singley teaches determining an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value (step 210) [0026] (Fig 2).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify Thukral to determine an equivalent carbohydrate value for the meal by adding the estimated carbohydrate value for the meal to the corresponding carbohydrate value associated with the estimated protein value, because doing so would help calculate a bolus of insulin for a meal based on both the carbohydrate and protein content of a meal, as recognized by Singley [0027].
Regarding claim 19, Thukral in view of Singley teach the one or more non-transitory processor-readable storage media of claim 18, and Thukral further teaches determining the amount of insulin to deliver to the patient comprises:
predicting, based on the equivalent carbohydrate value for the meal, amounts of glucose to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal [0212-0213];
determining, based on the predicted amounts of glucose to be absorbed into the bloodstream, a bolus dosage of insulin to deliver to the patient [0163, 0213] (Fig 9); and
prior to determining the bolus dosage, obtaining an amount of a basal dosage of insulin previously delivered to the patient ([0142 - 0144], basal insulin dosage delivered prior to an event such as a patient exercising or eating a meal), and wherein determining the bolus dosage is further based on the amount of the basal dosage of insulin ([0142-0144], bolus dosage compensation for an event such as exercising or eating a meal is based on a prior basal dosage of insulin to help a patient maintain a target basal glucose).
Regarding claim 20, Thukral in view of Singley teach the one or more non-transitory processor-readable storage media of claim 18, and Thukral further teaches teaches determining the equivalent carbohydrate value comprises:
determining the conversion factor for converting the estimated protein value to a parameter approximating an effect of the protein on glucose levels of the patient [0212];
determining the equivalent carbohydrate for the meal based on converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor [0212],
wherein the conversion factor is determined based on historical meal data for the patient and further based on historical glucose level data for the patient ([0143 - 0144, 0147, 0153, 0212- 0213], meal compensator uses historical meal data and historical glucose level data to determine the glucose absorption/protein equivalent carbohydrate conversion for proteins for the current meal).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.  Accordingly, THIS ACTION IS MADE FINAL.  See MPEP § 706.07(a).  Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action.  In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action.  In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.

CITED REFERENCE SUMMARIES: Ref US20050187749A1: Claims:
A computer-based method for calculation of insulin levels based upon about-to-be-consumed food, comprising the steps of: identifying the about-to-be-consumed food in a first processing device; weighing said about-to-be-consumed food and inputting said weight into said first processing device; obtaining nutritional information regarding said about-to-be-consumed food from said first processing device; using said first processing device, calculating the total grams of carbohydrates in said about-to-be-consumed food; obtaining personal information regarding a consumer of said about-to-be-consumed food from said first processing device; calculating an insulin dose for said consumer based on said total grams of carbohydrates and said personal information; and displaying said calculated insulin dose via said first processing device.
identifying the about-to-be-consumed food in a first processing device;
weighing said about-to-be-consumed food and inputting said weight into said first processing device;
obtaining nutritional information regarding said about-to-be-consumed food from said first processing device;
using said first processing device, calculating the total grams of carbohydrates in said about-to-be-consumed food;
obtaining personal information regarding a consumer of said about-to-be-consumed food from said first processing device;
calculating an insulin dose for said consumer based on said total grams of carbohydrates and said personal information; and
displaying said calculated insulin dose via said first processing device.
The method of claim 1 , wherein said step of calculating the total grams of carbohydrates includes: calculation of carbohydrates from non-protein sources.
calculation of carbohydrates from non-protein sources.
The method of claim 2 , wherein said step of calculating the total grams of carbohydrates further includes: calculation of carbohydrates from protein sources.
calculation of carbohydrates from protein sources.
The method of claim 3 , further comprising a scale, coupleable to said first processing device, for weighing said about-to-be-consumed food and inputting the weight of said about-to-be-consumed food to said first processing device.
The method of claim 4 , wherein said first processing device is a portable processing device, coupleable to a second processing device, wherein said nutritional information and personal information is stored on said second processing device and transferred to said first processing device by a synchronization process.
The method of claim 5 , wherein said insulin dose calculation is performed using an algorithm stored on said first processing device.
The method of claim 6 , wherein said algorithm is stored on said first processing device during said synchronization process.
The method of claim 1 , wherein said first processing device is coupleable to an insulin pump, and wherein when said first processing device is coupled to said insulin pump, said calculated insulin dose is automatically input to said insulin pump to set said insulin pump to deliver said calculated insulin dose to a patient using said insulin pump.
A computer-based system for calculation of insulin levels based upon about-to-be-consumed food, comprising: means for identifying the about-to-be-consumed food in a first processing device; means for weighing said about-to-be-consumed food and inputting said weight into said first processing device; means for obtaining nutritional information regarding said about-to-be-consumed food from said first processing device; means for calculating, using said first processing device, the total grams of carbohydrates in said about-to-be-consumed food; means for obtaining personal information regarding a consumer of said about-to-be-consumed food from said first processing device; means for calculating an insulin dose for said consumer based on said total grams of carbohydrates and said personal information; and means for displaying said calculated insulin dose via said first processing device.
means for identifying the about-to-be-consumed food in a first processing device;
means for weighing said about-to-be-consumed food and inputting said weight into said first processing device;
means for obtaining nutritional information regarding said about-to-be-consumed food from said first processing device;
means for calculating, using said first processing device, the total grams of carbohydrates in said about-to-be-consumed food;
means for obtaining personal information regarding a consumer of said about-to-be-consumed food from said first processing device;
means for calculating an insulin dose for said consumer based on said total grams of carbohydrates and said personal information; and
means for displaying said calculated insulin dose via said first processing device.
The system of claim 9 , wherein said means for calculating the total grams of carbohydrates includes: means for calculating carbohydrates from non-protein sources.
means for calculating carbohydrates from non-protein sources.
The system of claim 10 , wherein said means for calculating the total grams of carbohydrates further includes: means for calculating carbohydrates from protein sources.
means for calculating carbohydrates from protein sources.
The system of claim 11 , further comprising a scale, coupleable to said first processing device, for weighing said about-to-be-consumed food and inputting the weight of said about-to-be-consumed food to said first processing device.
The system of claim 12 , wherein said first processing device is a portable processing device, coupleable to a second processing device, wherein said nutritional information and personal information is stored on said second processing device and transferred to said first processing device by a synchronization process.
The system of claim 13 , wherein said insulin dose calculation is performed using an algorithm stored on said first processing device.
The system of claim 14 , wherein said algorithm is stored on said first processing device during said synchronization process.
The system of claim 9 , wherein said first processing device is coupleable to an insulin pump, and wherein when said first processing device is coupled to said insulin pump, said calculated insulin dose is automatically input to said insulin pump to set said insulin pump to deliver said calculated insulin dose to a patient using said insulin pump.
A computer-based computer program product for calculation of insulin levels based upon about-to-be-consumed food, the computer program product comprising a computer-readable storage medium having computer-readable program code embodied in the medium, the computer-readable program code comprising: computer-readable program code that identifies the about-to-be-consumed food in a first processing device; computer-readable program code that determines the weight of said about-to-be-consumed food and inputs said weight into said first processing device; computer-readable program code that obtains nutritional information regarding said about-to-be-consumed food from said first processing device; computer-readable program code that, using said first processing device, calculates the total grams of carbohydrates in said about-to-be-consumed food; computer-readable program code that obtains personal information regarding a consumer of said about-to-be-consumed food from said first processing device; computer-readable program code that calculates an insulin dose for said consumer based on said total grams of carbohydrates and said personal information; and computer-readable program code that enables display of said calculated insulin dose via said first processing device.
computer-readable program code that identifies the about-to-be-consumed food in a first processing device;
computer-readable program code that determines the weight of said about-to-be-consumed food and inputs said weight into said first processing device;
computer-readable program code that obtains nutritional information regarding said about-to-be-consumed food from said first processing device;
computer-readable program code that, using said first processing device, calculates the total grams of carbohydrates in said about-to-be-consumed food;
computer-readable program code that obtains personal information regarding a consumer of said about-to-be-consumed food from said first processing device;
computer-readable program code that calculates an insulin dose for said consumer based on said total grams of carbohydrates and said personal information; and
computer-readable program code that enables display of said calculated insulin dose via said first processing device.
The computer program product of claim 17 , wherein said computer-readable program code that calculates the total grams of carbohydrates includes: computer-readable program code that calculates carbohydrates from non-protein sources.
computer-readable program code that calculates carbohydrates from non-protein sources.
The computer program product of claim 18 , wherein said computer-readable program code that calculates the total grams of carbohydrates further includes: computer-readable program code that calculates carbohydrates from protein sources.
computer-readable program code that calculates carbohydrates from protein sources.
The computer program product of claim 19 , further comprising a scale, coupleable to said first processing device for weighing said about-to-be-consumed food and inputting the weight of said about-to-be-consumed food to said first processing device.
The computer program product of claim 20 , wherein said first processing device is a portable processing device, coupleable to a second processing device, wherein said nutritional information and personal information is stored on said second processing device and transferred to said first processing device by a synchronization process.
The computer program product of claim 21 , wherein said insulin dose calculation is performed using an algorithm stored on said first processing device.
The computer program product of claim 22 , wherein said algorithm is stored on said first processing device during said synchronization process.
The computer program product of claim 17 , wherein said first processing device is coupleable to an insulin pump, and wherein when said first processing device is coupled to said insulin pump, said calculated insulin dose is automatically input to said insulin pump to set said insulin pump to deliver said calculated insulin dose to a patient using said insulin pump.
Ref US5836312A: Claims:
A method for adjudging the effect of consumptions over a period of time on one or more physiological parameters comprising: marking consumables with consumable identifiers to identify the consumable; correlating said consumable identifiers with data pertaining to the contents of said consumables by data processing means; storing said consumable identifiers coupled with the data pertaining to the contents of said consumables in a first data storage unit; inputting said consumable identifiers into a second data storage unit upon consumption of said consumables and along with the amount of consumable consumed and the time of consumption; transmitting the information stored in said second data storage unit to a central processing unit electronically coupled to said first data storage unit; computationally co-processing the information stored in said first data storage unit with said information stored in said second data storage unit; computationally resolving physiological algorithms relating one or more physiological parameters to said computationally co-processed information utilizing said computationally co-processed information; providing a read-out of the effect of consumptions over a period on time on physiological parameters based on said computational resolution of said physiological algorithms.
marking consumables with consumable identifiers to identify the consumable;
correlating said consumable identifiers with data pertaining to the contents of said consumables by data processing means;
storing said consumable identifiers coupled with the data pertaining to the contents of said consumables in a first data storage unit;
inputting said consumable identifiers into a second data storage unit upon consumption of said consumables and along with the amount of consumable consumed and the time of consumption;
transmitting the information stored in said second data storage unit to a central processing unit electronically coupled to said first data storage unit;
computationally co-processing the information stored in said first data storage unit with said information stored in said second data storage unit;
computationally resolving physiological algorithms relating one or more physiological parameters to said computationally co-processed information utilizing said computationally co-processed information;
providing a read-out of the effect of consumptions over a period on time on physiological parameters based on said computational resolution of said physiological algorithms.
The method of claim 1 wherein said input of consumable identifiers into said second data storage unit step further includes the step of electronically scanning the consumable identifier.
The method of claim 1 further comprising the step of: providing an advisory action based on said read-out which suggests the deletion of the minimum number of consumables from said consumptions over a period of time which would result in a calculated algorithmically-derived physiological parameter which more nearly approximates the theoretical ideal value of said physiological parameter for said consumer.
The method of claim 1 further comprising the step of: inputting physiological measurements into said second data storage unit along with the time of said physiological measurement.
A portable apparatus for acquiring and processing information relative to the consumptions of a consumer comprising: (a) a power supply means for powering said portable apparatus; (b) a data processing means electronically coupled to said power supply means for co-processing digital data streams; (c) a first memory means electronically coupled to said data processing means for storing programs used in said data processing means; (d) a first input means electronically coupled to said data processing means for electronically-scanning consumable identifiers and converting said consumable identifiers into a digital data stream; (e) a second input means electronically coupled to said data processing means for manually inputting the amount of consumable consumed and the time of consumption, and converting said input into a digital data stream; (f) a second memory means for storing information co-processed by said data processing means from said first and second inputting means; (g) a display means electronically coupled to said data processing means for displaying information stored in said first and second memory means; (h) a connector means electronically coupled to said data processing means for permitting flow of data between said apparatus and an external data processing unit.
(a) a power supply means for powering said portable apparatus;
(b) a data processing means electronically coupled to said power supply means for co-processing digital data streams;
(c) a first memory means electronically coupled to said data processing means for storing programs used in said data processing means;
(d) a first input means electronically coupled to said data processing means for electronically-scanning consumable identifiers and converting said consumable identifiers into a digital data stream;
(e) a second input means electronically coupled to said data processing means for manually inputting the amount of consumable consumed and the time of consumption, and converting said input into a digital data stream;
(f) a second memory means for storing information co-processed by said data processing means from said first and second inputting means;
(g) a display means electronically coupled to said data processing means for displaying information stored in said first and second memory means;
(h) a connector means electronically coupled to said data processing means for permitting flow of data between said apparatus and an external data processing unit.
The apparatus of claim 5 further comprising a clock means electronically coupled to said second input means for providing time of each input to said second memory means of data from said second input means.
The apparatus of claim 5 further comprising a clock means electronically coupled to said first input means for providing time of each input to said second memory means of data from said first input means.
The apparatus of claim 5 further comprising a third memory means electronically coupled to said data processing means for storing data correlating consumable identifiers to consumption information related to the ingredients of a consumable.
The apparatus of claim 5 further comprising a third input means electronically coupled to said data processing means for inputting measurements of physiological parameters, and converting said input into a digital data stream.
A computer-assisted system for analyzing the consumption habits of a consumer in regard to physiological status comprising: a first data processing means for co-processing consumable identifier information with information pertaining to the amount of consumable consumed and the time of consumption; a first data storage means electronically coupled to said first data processing means for storing said co-processed information from said first data processing means; a second data processing means electronically coupled to said first data processing means for co-processing consumable identifiers with consumption information related to the consumable and for co-processing the same with information stored in said first data storage means; a second data storage means electronically coupled to said second data processing means for storing co-processed information from said second data processing means; a third data storage means coupled to a second processing means for storing physiological algorithms relating consumption information over time to one or more physiological parameters; and wherein said second data processing means utilizes said co-processed information in said first and second data storage means to resolve said physiological algorithms stored in said third data storage means.
a first data processing means for co-processing consumable identifier information with information pertaining to the amount of consumable consumed and the time of consumption;
a first data storage means electronically coupled to said first data processing means for storing said co-processed information from said first data processing means;
a second data processing means electronically coupled to said first data processing means for co-processing consumable identifiers with consumption information related to the consumable and for co-processing the same with information stored in said first data storage means;
a second data storage means electronically coupled to said second data processing means for storing co-processed information from said second data processing means;
a third data storage means coupled to a second processing means for storing physiological algorithms relating consumption information over time to one or more physiological parameters;
and wherein said second data processing means utilizes said co-processed information in said first and second data storage means to resolve said physiological algorithms stored in said third data storage means.
Ref US20200268968A1: Claims:
A computer-implemented method of predicting a blood glucose level of a subject, the method comprising: (1) receiving and storing a plurality of historical data records represent
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