Office Action 1: Non-Final Rejection (2022-12-06)
Rejection types: 101 - Patent-Eligible Subject Matter, 102 - Lack of Novelty, 103 - Obviousness

CLAIMS:
WHAT IS CLAIMED IS:

1\. 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;
determining an equivalent carbohydrate value for the meal based on 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
generating an output indicative of the amount of insulin to deliver to the patient to counteract the glucose level increase caused by consumption of the meal.

2\. The system of claim 1, 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.

3\. 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.

4\. 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.

5\. The system of claim 1, wherein determining the equivalent carbohydrate value comprises:
determining a 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 the estimated protein value for the meal and the conversion factor.

6\. 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.

7\. The system of claim 5, wherein the conversion factor is determined based on a time of day that the patient consumes the meal.

8\. 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.

9\. 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.

10\. A processor-implemented method comprising:
obtaining an estimated protein value for a meal;
determining an equivalent carbohydrate value for the meal based on 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
generating an output indicative of the amount of insulin to deliver to the patient to counteract the glucose level increase caused by consumption of the meal.

11\. 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.

12\. 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.

13\. 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.

14\. The method of claim 10, wherein determining the equivalent carbohydrate value comprises:
determining a 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 the estimated protein value for the meal and the conversion factor.

15\. 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.

16\. The method of claim 14, wherein the conversion factor is determined based on a time of day that the patient consumes the meal.

17\. 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.

18\. 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;
determining an equivalent carbohydrate value for the meal based on 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
generating an output indicative of the amount of insulin to deliver to the patient to counteract the glucose level increase caused by consumption of the meal.

19\. 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.

20\. The one or more non-transitory processor-readable storage media of claim 18, wherein determining the equivalent carbohydrate value comprises:
determining a 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 the estimated protein value for the meal and 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. 29 30 31 32 33

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 .
Claim Rejections - 35 USC § 101
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent (see MPEP 2106). A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation “non-transitory to the claim instead of “processor-readable” limitation.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding Step 1, claims 1-20 are all within at least one of the four categories.
Regarding Step 2A (prong 1), the independent claims (1, 10, and 18) recites:
determining an equivalent carbohydrate value for the meal based on 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
generating an output indicative of the amount of insulin to deliver to the patient to counteract the glucose level increase caused by consumption of the meal.
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.  See footnotes 14 and 15.
“A mathematical relationship is a relationship between variables or numbers.  A mathematical relationship may be expressed in words ….”  October 2019 Update: Subject Matter Eligibility, II. A. i.  “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.”  Id. at II. A. ii.  “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.”  Id. at II. A. iii.  See for example, SAP m., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018) (performing a resampled statistical analysis to generate a resampled distribution).
The claimed steps of detecting and generating can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
The idea of determining equivalent carbohydrate values for a meal and generating an insulin does based on the values could be performed with simple calculations as claimed.
Regarding Step 2A (prong 2):
This judicial exception (abstract idea) in claims 1-20 is not integrated into a practical application because:
•The abstract idea amounts to simply implementing the abstract idea on a computer.  For example, the recitations regarding the generic computing components for obtaining and generating merely invoke a computer as a tool.
•The data-gathering step (obtaining) and the data-output step (generating) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
•There is no improvement to a computer or other technology.  “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that improved [the] existing technological process, unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for outputting and generating.
•The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition.  Rather, the abstract idea is utilized to determine a relationship among data to provide a medical measurement.
•The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer obtaining, determining, and generating. The claims do not apply the obtained response measurement to a particular machine. Rather, the data is merely output in an post-solution step.
Regarding Step 2B:
The additional elements are identified as follows: sensors and a processor.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s Background Information in the Specification
Applicant's specification (Pg. 15, Paragraph 0056) which discloses that the processor and memory comprise generic computer components that are configured to perform the generic computer functions (obtaining and generating) that are well-understood, routine, and conventional activities previously known to the pertinent industry; and
the non-patent literature cited herewith (Feasibility of an implanted, closed-loop,
blood-glucose control device” by Fletcher, 2001), which discloses the “glucose sensor to complete the artificial pancreas, investigators have prepared control algorithms with which to operate the required feedback loop.  The systems do not require much computing power relative to that presently available. A 1993 study used an Intel processor at 5 MHz, compared with the 200-MHz processors now carried by most electronics stores.” (Pg. 15);
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.  Furthermore, the court decisions discussed in MPEP § 2106.05(d)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea.  Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually.  There is no indication that the combination of elements improves the functioning of a computer or improves any other technology.  Their collective functions merely provide conventional computer implementation.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry.
Claims 2 and 11 are steps that are also abstract as determining glucose absorbed based on predicted equivalent carbohydrate values is a mental process that can be performed with simple calculation using a generic computer as a tool.
Claims 3 and 12 are steps that are additional data output that is WURC through retrieving prior data from a device.
Claims 4 and 13 are steps that are also abstract as identifying and selecting the best candidate dosage is a mental process that can be performed by looking at the data output.
Claims 5 and 14 are steps that are also abstract as determining equivalent carbohydrate values based on a conversion factor is a mental process that can be performed with simple calculation using a generic computer as a tool.
Claims 6 and 15 are steps that are additional data output that is WURC through retrieving prior data from a device.
Claims 7 and 16 are steps that are also abstract as determining a conversion factor based upon a timeframe is a mental process that can be performed by looking at prior data.
Claims 8 and 17 are steps that are also abstract as determining equivalent carbohydrate values based on a fat value of a meal is a mental process that can be performed with simple calculation using a generic computer as a tool.
Claim 9 is steps that are also abstract as determining a tuning factor based upon a historical data is a mental process that can be performed by looking at prior data.
Claim 19 is steps that are also abstract as determining glucose absorbed based on predicted equivalent carbohydrate values is a mental process that can be performed with simple calculation using a generic computer as a tool and steps that are additional data output that is WURC through retrieving prior data from a device.
Claim 20 is steps that are also abstract as determining equivalent carbohydrate values based on a conversion factor is a mental process that can be performed with simple calculation using a generic computer as a tool and steps that are additional data output that is WURC through retrieving prior data from a device.
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea.  A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-12, and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weinert (US 20070179434 A1).
Regarding claims 1, 10, and 18, Weinert teaches a system/method/non-transitory processor-readable media storing instructions (Paragraph 0001:  “systems for determining insulin administration information based on a user input of user-related feed forward information”) 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 (Paragraph 0010:  “meal size values for each of the fat amount, protein amount and carbohydrate amount”);
determining an equivalent carbohydrate value for the meal based on the estimated protein value (Paragraph 0010:  “the carbohydrate content in the form of meal size values for each of the fat amount, protein amount and carbohydrate amount” and Paragraph 0077);
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
generating an output indicative of the amount of insulin to deliver to the patient 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”).
Regarding claims 2 and 11, Weinert 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 claims 3 and 12, Weinert 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 and 14, Weinert teaches wherein determining the equivalent carbohydrate value comprises:
determining a conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient (Paragraph 0082); and
determining the equivalent carbohydrate for the meal based on the estimated protein value for the meal and the conversion factor (Paragraph 0081-0083).
Regarding claims 6 and 15, Weinert teaches wherein the conversion 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 claims 7 and 16, Weinert teaches wherein the conversion factor is determined based on a time of day that the patient consumes the meal (Paragraph 00120, 00130-00132:  meal time and type is used to adjust the maps).
Regarding claims 8 and 17, Weinert 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 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 19, Weinert 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”);
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”); and
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 teaches wherein determining the equivalent carbohydrate value comprises:
determining a conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient (Paragraph 0082); and
determining the equivalent carbohydrate for the meal based on the estimated protein value for the meal and the conversion factor (Paragraph 0081-0083),
wherein the conversion 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).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Weinert in view of Mazlish (US 1 A1).
Regarding claim 4 and 13, Weinert fails to teach 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.
Mazlish teaches wherein determining the bolus dosage 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/method of Weinert 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).
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 .
Response to Arguments
Applicant’s arguments, see pg. 8-12 of remarks, filed March 1st, 2023, with respect to the rejection(s) of claim(s) 1-3, 5-12, and 14-20 under 35 U.S.C. 102(a)(1) 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 Thukral (US 20090006061 A1).  Thukral teaches an explicit conversion of protein content to equivalent carbohydrates (Paragraph 0213:  “Proteins and fat are converted to an equivalent carbohydrate amount”).
The amendment adding the use of an insulin device also helped overcome the outstanding 101 rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA  to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-12, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weinert (US 20070179434 A1) in view of Thukral (US 20090006061 A1).
Regarding claims 1, 10, and 18, Weinert teaches a system/method/non-transitory processor-readable media storing instructions (Paragraph 0001:  “systems for determining insulin administration information based on a user input of user-related feed forward information”) 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 (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”).
Weinert fails to explicitly teach determining an equivalent carbohydrate value for the meal based on converting the estimated protein value into a corresponding carbohydrate value.
Thukral teaches determining an equivalent carbohydrate value for the meal based on converting the estimated protein value into a corresponding carbohydrate value (Paragraph 0213:  “Proteins and fat are converted to an equivalent carbohydrate amount”).  I would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the equivalent carbohydrate calculation of Weinert to incorporate the explicit conversion of protein value to equivalent carbohydrates taught by Thukral, because it helps to find the best and most accurate values for insulin to counter the gut glucose concentration (Paragraph 0214 of Thukral).
Regarding claims 2 and 11, Weinert 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 claims 3 and 12, Weinert 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 and 14, Weinert teaches wherein determining the equivalent carbohydrate value comprises:
determining a conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient (Paragraph 0082); and
determining the equivalent carbohydrate for the meal (Paragraph 0081-0083).
Weinert fails to explicitly converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor.
Thukral teaches converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor  (Paragraph 0213 and Paragraphs 0200-0230:  “Proteins and fat are converted to an equivalent carbohydrate amount”:  see equations and conversion inherently requires a factor).  I would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the equivalent carbohydrate calculation of Weinert to incorporate the explicit conversion of protein value to equivalent carbohydrates taught by Thukral, because it helps to find the best and most accurate values for insulin to counter the gut glucose concentration (Paragraph 0214 of Thukral).
Regarding claims 6 and 15, Weinert teaches wherein the conversion 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 claims 7 and 16, Weinert teaches wherein the conversion factor is determined based on a time of day that the patient consumes the meal (Paragraph 00120, 00130-00132:  meal time and type is used to adjust the maps).
Regarding claims 8 and 17, Weinert 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 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 19, Weinert 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”);
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”); and
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 teaches wherein determining the equivalent carbohydrate value comprises:
determining a conversion factor for converting protein to a parameter approximating an effect of the protein on glucose levels of the patient (Paragraph 0082); and
wherein the conversion 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).
Weinert fails to explicitly converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor.
Thukral teaches converting the estimated protein value for the meal into the corresponding carbohydrate value using the conversion factor  (Paragraph 0213 and Paragraphs 0200-0230:  “Proteins and fat are converted to an equivalent carbohydrate amount”:  see equations and conversion inherently requires a factor).  I would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the equivalent carbohydrate calculation of Weinert to incorporate the explicit conversion of protein value to equivalent carbohydrates taught by Thukral, because it helps to find the best and most accurate values for insulin to counter the gut glucose concentration (Paragraph 0214 of Thukral).
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Weinert and Thukral as applied to claims 1 and 10 above, and further in view of Mazlish (US 20180200439 A1).
Regarding claim 4 and 13, Weinert and Thukral fail to teach 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.
Mazlish teaches wherein determining the bolus dosage 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/method of Weinert and Thukral 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).
Conclusion
THIS ACTION IS MADE FINAL.  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 mailing date of this final action.

CITED REFERENCE SUMMARIES: Ref US20180200439A1: Claims:
A method of insulin delivery, the method comprising: obtaining one or more blood glucose readings from a flash glucose monitor, the blood glucose readings obtained in response to a user invocation of the flash glucose monitor; generating a plurality of insulin delivery profiles of insulin delivery actions over a plurality of diurnal time segments based on the one or more blood glucose readings; selecting one of the delivery profiles that is projected to approximate a target blood glucose level; and providing the selected delivery profile to be utilized with an insulin delivery device to deliver the selected delivery profile to the user.
obtaining one or more blood glucose readings from a flash glucose monitor, the blood glucose readings obtained in response to a user invocation of the flash glucose monitor;
generating a plurality of insulin delivery profiles of insulin delivery actions over a plurality of diurnal time segments based on the one or more blood glucose readings;
selecting one of the delivery profiles that is projected to approximate a target blood glucose level; and
providing the selected delivery profile to be utilized with an insulin delivery device to deliver the selected delivery profile to the user.
The method of claim 1 , further comprising adjusting one or more user-specific diurnal-specific parameters based on the selected delivery profile.
The method of claim 2 , further comprising excluding one or more diurnal time segments from having associated user-specific diurnal-specific parameters adjusted based on the flash glucose monitor not being invoked during the one or more excluded diurnal time segments.
The method of claim 1 , further comprising receiving the one or more blood glucose monitor readings from the flash glucose monitor in response to the user invoking the flash glucose monitor.
The method of claim 1 , further comprising exiting a closed-loop delivery mode such that the selected delivery profile delivers a predetermined baseline basal rate based on a predetermined period of time elapsing without invocation of the flash glucose monitor.
The method of claim 1 , further comprising entering a closed-loop delivery mode based on the user invoking the flash glucose monitor.
The method of claim 6 , wherein the closed-loop delivery mode is one of a hybrid closed-loop mode and a full closed-loop mode.
The method of claim 1 , further comprising delivering insulin according to the selected delivery profile with the insulin delivery device.
A method of insulin delivery, the method comprising: obtaining one or more blood glucose readings from a flash glucose monitor, the blood glucose readings obtained in response to a request of the flash glucose monitor; generating a plurality of insulin delivery profiles of insulin delivery actions over a plurality of diurnal time segments based on the one or more blood glucose readings; selecting one of the delivery profiles that is projected to approximate a target blood glucose level; and providing the selected delivery profile to be utilized with an insulin delivery device to deliver the selected delivery profile to the user.
obtaining one or more blood glucose readings from a flash glucose monitor, the blood glucose readings obtained in response to a request of the flash glucose monitor;
An insulin delivery system comprising: an insulin delivery device configured to deliver insulin to a user; a flash glucose monitor configured to obtain one or more blood glucose readings from the user; and a controller configured to perform or control performance of operations, the operations comprising: obtaining one or more blood glucose readings from the flash glucose monitor; generating a plurality of insulin delivery profiles of insulin delivery actions over a plurality of diurnal time segments based on the one or more blood glucose readings; selecting one of the delivery profiles that is projected to approximate a target blood glucose level; and providing the selected delivery profile to be utilized with the insulin delivery device to deliver a least a portion of the selected delivery profile to the user.
an insulin delivery device configured to deliver insulin to a user;
a flash glucose monitor configured to obtain one or more blood glucose readings from the user; and
a controller configured to perform or control performance of operations, the operations comprising: obtaining one or more blood glucose readings from the flash glucose monitor; generating a plurality of insulin delivery profiles of insulin delivery actions over a plurality of diurnal time segments based on the one or more blood glucose readings; selecting one of the delivery profiles that is projected to approximate a target blood glucose level; and providing the selected delivery profile to be utilized with the insulin delivery device to deliver a least a portion of the selected delivery profile to the user.
obtaining one or more blood glucose readings from the flash glucose monitor;
providing the selected delivery profile to be utilized with the insulin delivery device to deliver a least a portion of the selected delivery profile to the user.
The system of claim 10 , wherein the operations further comprise delivering insulin according to the selected delivery profile with the insulin delivery device.
The system of claim 10 , wherein the insulin delivery device comprises an insulin pump assembly configured to supply an at least partially continuous subcutaneous insulin infusion therapy to the user.
The system of claim 10 , wherein the insulin delivery device comprises a bolus administering device configured to supply discrete insulin doses to the user.
The system of claim 13 , wherein the bolus administering device comprises an insulin pen.
The system of claim 10 , wherein the controller is integrated with the insulin delivery device.
The system of claim 10 , wherein the controller comprises a separate device from the insulin delivery device.
The system of claim 16 , wherein the separate device of the controller is configured to communicate with the insulin delivery device to provide the selected delivery profile.
The system of claim 10 , wherein the controller is configured to enable a user to at least one of modify or input data relating to the selected delivery profile.
The system of claim 10 , the flash glucose monitor is configured to provide the blood glucose readings in response to a user request of the flash glucose monitor.
The system of claim 19 , the flash glucose monitor is configured to be invoked via near field communication (NFC) by the user.
Ref US20070179434A1: Claims:
A system for determining drug administration information, the system comprising: an input device providing for user input of feed forward information having a first parameter component and a second parameter component, a data storage device having stored therein a map correlating values of the first and second parameter components to drug administration information, and a processor responsive to user input of the feed forward information to determine corresponding drug administration information according to the map.
an input device providing for user input of feed forward information having a first parameter component and a second parameter component,
a data storage device having stored therein a map correlating values of the first and second parameter components to drug administration information, and
a processor responsive to user input of the feed forward information to determine corresponding drug administration information according to the map.
The system of claim 1 further comprising a display unit, and wherein the processor is configured to display at least some of the corresponding drug administration information on the display unit.
and wherein the processor is configured to display at least some of the corresponding drug administration information on the display unit.
The system of claim 1 wherein the input device includes a display unit, and wherein the processor is configured to control the display unit to display a graphical user interface having a first axis defined by values of the first parameter component and a second axis defined by values of the second parameter component, the graphical user interface providing for the user input of feed forward information in the form of a single user selection of a corresponding pair of values of the first and second parameter components.
and wherein the processor is configured to control the display unit to display a graphical user interface having a first axis defined by values of the first parameter component and a second axis defined by values of the second parameter component, the graphical user interface providing for the user input of feed forward information in the form of a single user selection of a corresponding pair of values of the first and second parameter components.
The system of claim 3 wherein the graphical user interface includes a touch responsive interface providing for the single user selection of the corresponding pair of values of the first and second parameter components.
The system of claim 3 wherein the graphical user interface defines a grid-type user interface providing for the single user selection of discrete pairs of values of the first and second parameter components.
The system of claim 3 wherein the graphical user interface defines a continuous function of the first and second parameter components.
The system of claim 1 wherein the input device includes a display unit, and wherein the processor is configured to control the display unit to display a graphical user interface having a first axis defined by a plurality of identifiers of the first parameter component and a second axis defined by values of the second parameter component, the graphical user interface providing for the user input of feed forward information in the form of user selection of pairs of each of the plurality of identifiers of the first parameter component and corresponding values of the second parameter component.
and wherein the processor is configured to control the display unit to display a graphical user interface having a first axis defined by a plurality of identifiers of the first parameter component and a second axis defined by values of the second parameter component, the graphical user interface providing for the user input of feed forward information in the form of user selection of pairs of each of the plurality of identifiers of the first parameter component and corresponding values of the second parameter component.
The system of claim 7 wherein the graphical user interface includes a touch responsive interface providing for the user selection of the pairs of each of the plurality of identifiers of the first parameter component and corresponding values of the second parameter component.
The system of claim 7 wherein the graphical user interface defines a grid-type user interface providing for the user selection of discrete pairs of each of the plurality of identifiers of the first parameter component and corresponding values of the second parameter component.
The system of claim 1 wherein the drug is a blood glucose lowering drug.
The system of claim 10 wherein the drug is insulin.
The system of claim 11 wherein the input device is configured to provide for user input of feed forward information in the form of meal information having the first parameter component corresponding to carbohydrate content and the second parameter component corresponding to an expected speed of overall glucose absorption from the meal by the user.
The system of claim 12 wherein the input device includes a display unit, and wherein the processor is configured to control the display unit to display a graphical user interface having a first axis defined by values of the carbohydrate content values and a second axis defined by values of the expected speed of overall glucose absorption from the meal by the user, the graphical user interface providing for the user input of feed forward information in the form of a single user selection of a corresponding pair of the carbohydrate content and expected speed values.
and wherein the processor is configured to control the display unit to display a graphical user interface having a first axis defined by values of the carbohydrate content values and a second axis defined by values of the expected speed of overall glucose absorption from the meal by the user, the graphical user interface providing for the user input of feed forward information in the form of a single user selection of a corresponding pair of the carbohydrate content and expected speed values.
The system of claim 13 wherein the processor is configured to control the display unit to display the values of the carbohydrate content in the form of direct estimates of carbohydrate weight.
The system of claim 13 wherein the processor is configured to control the display unit to display the values of the carbohydrate content in the form of meal size values.
The system of claim 15 wherein the processor is configured to control the display unit to display the values of the carbohydrate content in the form of meal size values relative to a reference meal size.
The system of claim 13 wherein the processor is configured to control the display unit to display the values of the expected speed in the form of meal duration values.
The system of claim 17 wherein the processor is configured to control the display unit to display the values of the expected speed in the form of meal duration values relative to a reference meal duration.
The system of claim 13 wherein the processor is configured to control the display unit to display the values of the expected speed in the form of total glycemic index values.
The system of claim 12 wherein the input device includes a display unit, and wherein the processor is configured to control the display unit to display a graphical user interface having a first axis defined by values of the carbohydrate content and a second axis defined by values of the expected speed of overall glucose absorption from the meal by the user, the graphical user interface providing for the user input of feed forward information in the form of user selection of corresponding pairs of the carbohydrate content and expected speed values.
and wherein the processor is configured to control the display unit to display a graphical user interface having a first axis defined by values of the carbohydrate content and a second axis defined by values of the expected speed of overall glucose absorption from the meal by the user, the graphical user interface providing for the user input of feed forward information in the form of user selection of corresponding pairs of the carbohydrate content and expected speed values.
The system of claim 20 wherein the processor is configured to control the display unit to display the values of the expected speed in the form of a fat amount, a protein amount and a carbohydrate amount, and to display the values of the carbohydrate content in the form of meal size values for each of the fat amount, protein amount and carbohydrate amount.
The system of claim 21 wherein the graphical user interface provides for the user input of feed forward information in the form of user selection a meal size value in terms of fat amount, a meal size in terms of protein amount and a meal size in terms of carbohydrate amount.
The system of claim 22 wherein the processor is configured to control the display unit to display the meal size values in the form of fat amount, protein amount and carbohydrate amount relative to reference meal size values in terms of fat, protein and carbohydrate amounts respectively.
The system of claim 1 wherein the input device is configured to provide for user input of additional feed forward information in the form of exercise information, and wherein the data storage device has stored therein an additional map correlating the exercise information to modification information, and wherein the processor is responsive to user input of the exercise information to modify the corresponding drug administration information according to the modification information determined via the additional map.
and wherein the data storage device has stored therein an additional map correlating the exercise information to modification information,
and wherein the processor is responsive to user input of the exercise information to modify the corresponding drug administration information according to the modification information determined via the additional map.
The system of claim 1 wherein the input device is configured to provide for user input of additional feed forward information in the form of user stress information, and wherein the data storage device has stored therein an additional map correlating the user stress information to modification information, and wherein the processor is responsive to user input of the stress information to modify the corresponding drug administration information according to the modification information determined via the additional map.
and wherein the data storage device has stored therein an additional map correlating the user stress information to modification information,
and wherein the processor is responsive to user input of the stress information to modify the corresponding drug administration information according to the modification information determined via the additional map.
The system of claim 1 wherein the input device is configured to provide for user input of additional feed forward information in the form of user illness information, and wherein the data storage device has stored therein an additional map correlating the user illness information to modification information, and wherein the processor is responsive to user input of the illness information to modify the corresponding drug administration information according to modification information determined via the additional map.
and wherein the data storage device has stored therein an additional map correlating the user illness information to modification information,
and wherein the processor is responsive to user input of the illness information to modify the corresponding drug administration information according to modification information determined via the additional map.
The system of claim 1 wherein the input device is configured to provide for user input of additional feed forward information in the form of user menstrual cycle information, and wherein the data storage device has stored therein an additional map correlating the user menstrual cycle information to modification information, and wherein the processor is responsive to user input of the user menstrual cycle information to modify the corresponding drug administration information according to the modification information determined via the additional map.
and wherein the data storage device has stored therein an additional map correlating the user menstrual cycle information to modification information,
and wherein the processor is responsive to user input of the user menstrual cycle information to modify the corresponding drug administration information according to the modification information determined via the additional map.
The system of claim 1 wherein the processor is configured to monitor occurrences of user acceptance and rejection of the drug administration information determined according to the map, and to determine whether the system is acceptable for use by the user based at least in part on the occurrences of user acceptance and rejection of the drug administration information.
The system of claim 28 wherein, if the processor determines that the system is acceptable for use by the user, the processor is configured to determine whether the system requires recalibration based at least in part on the occurrences of user acceptance 
[Truncated to input limit]