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 § 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Galley et al. (US2013/0172707A1; hereinafter “Galley”) in view of Chovanda et al. (US2015/0157792A1; hereinafter “Chovanda”) and Shaya (US20100262434A1).
Independent claim 1 recites a method, comprising: determining a meal component of a user-specified bolus dose of insulin based at least partially on a relationship between the user-specified bolus dose of insulin and a recommended bolus dose of insulin; and determining a future insulin therapeutic parameter for a time interval based at least partially on the determined meal component. Independent claim 1 is rejected in the following manner:
A method, comprising.
Galley discloses a method context. Specifically, Galley discloses: “Referring now to FIGS. 4A and 4B, a flowchart 200 is shown of exemplary operations that can be performed by the device 10 in determining a total bolus recommendation for the user that takes into account the configuration programmed into the device 10 by the user.” (Galley ¶ [0062].)
determining a meal component of a user-specified bolus dose of insulin.
Galley discloses a user-selected bolus amount that is a meal component. Specifically, Galley discloses: “The meal bolus amount indicates a bolus amount selected by a patient to offset the effects of a meal, e.g., carbohydrate intake. In some embodiments, the meal bolus field is populated when the user overrides a meal bolus recommendation provided by the bolus calculator 22a.” (Galley ¶ [0050].) Galley does not expressly disclose that the determination of this user-selected meal-bolus amount is based on a comparison with a recommended bolus amount. Chovanda fills this gap by expressly checking the actually infused bolus against the recommended bolus and storing the actual amount according to its relationship to the recommendation. Specifically, Chovanda discloses: “At step 306, the calculated bolus is annunciated as a recommended bolus to the user. At step 308, the system checks to see if the user confirmed delivery of the recommended bolus amount. If not, the system checks the pump at step 310 to determine the amount actually infused to the user. At step 312, if the insulin amount actually infused is less than the recommended amount, the system stores this amount. At step 314, if the actual amount of insulin infused is greater than the recommended, this again is stored.” (Chovanda ¶ [0043].)
based at least partially on a relationship between the user-specified bolus dose of insulin and a recommended bolus dose of insulin.
Galley discloses recommended meal and other bolus amounts that may be adjusted by the user. Specifically, Galley discloses: “Before proceeding with insulin administration, the insulin recommendation is presented to the user as shown in FIG. 3I. More specifically, the insulin recommendation is comprised of three components: a correction amount 171, a meal amount 172 and a total amount 173 of insulin. As further explained below, the correction amount 171 is intended to lower a patient’s blood glucose level to a target value; whereas, the meal amount 172 is intended to compensate for carbohydrates consumed by the patient. The total amount 173 is equal to the sum of the correction amount and the meal amount. The recommended amounts may be adjusted by the user.” (Galley ¶ [0061].) Galley does not expressly disclose testing whether the user-specified bolus is less than or greater than the recommended bolus and preserving the user-specified amount based on that comparison. Chovanda fills this gap by expressly disclosing the less-than and greater-than tests. Specifically, Chovanda discloses: “At step 312, if the insulin amount actually infused is less than the recommended amount, the system stores this amount. At step 314, if the actual amount of insulin infused is greater than the recommended, this again is stored.” (Chovanda ¶ [0043].)
and determining a future insulin therapeutic parameter for a time interval based at least partially on the determined meal component.
Galley discloses determining a time-dependent, meal-related value from an advice-history record that includes a meal-bolus amount. Specifically, Galley discloses: “At operation 616, the bolus calculator 22 a determines a correction meal rise value based on a specific advice history record of the plurality of advice history records. As will be discussed below, the specific advice history record that is used can include: i) an event corresponding to the patient eating a meal that is greater than a snack size, ii) an event corresponding to a meal bolus amount, and iii) an event corresponding to the patient or an insulin pump 36 verifying that insulin was actually administered to the patient.” (Galley ¶ [0075].) Galley further discloses: “At operation 820, the bolus calculator 22 a determines the amount of time that has lapsed since the selected advice history record was generated. At operation 822, the bolus calculator 22 a determines whether the amount of time that has lapsed is less than the offset time defined in the selected advice history record. If the amount of time is less than the offset time, the correction meal rise value is set equal to the full amount of the meal rise value, as indicated in the action shape defining meal rise values, as shown at operation 824. As discussed, the values of the action shape may be entered by a user such as the patient or a treating physician. If, however the amount of time is greater than the offset time, the bolus calculator 22 a sets the correction meal rise value equal to an adjusted meal rise value, as shown at 826.” (Galley ¶ [0091].)
Galley does not expressly characterize this time-dependent, meal-related calculation as determination of a future insulin therapeutic parameter that is used in a future recommended bolus calculation. Shaya fills this gap by expressly determining a diabetic sensitivity factor from administered-insulin and food-intake data during an interval and using the result to update an insulin pump for a recommended bolus. Specifically, Shaya discloses: “Another embodiment of the invention enables devices to collect the basic data needed to conduct the derivation of sensitivity factors from other devices where the data resides. The collection can be achieved by cable or wireless transmission. The resulting network can also be used to update an insulin pump with new sensitivity factors for calculation of a recommended bolus dose.” (Shaya ¶ [0049].) Shaya further discloses: “Thus, in one aspect the present invention provides a method of determining at least one diabetic sensitivity factor of an individual based on at least one initial data set, the initial data set. The initial data set includes (1) a first blood glucose reading taken at a first measurement time, (2) a second blood glucose reading taken at a second measurement time following an interval after the first measurement time, (3) the insulin dose administered to the individual during the interval, and (4) a measure of the food intake by the individual during the interval. In this aspect, the method comprises transforming the at least one initial data set to generate at least one transformed data set comprising a pair of transformed variables, the first transformed variable of the pair being the difference between the first blood glucose reading and the second blood glucose reading divided by the food intake measure, and the second transformed variable of the pair being the insulin dose divided by the food intake measure. In this aspect, the method further comprises determining parameters of a functional relationship between the transformed variables and converting said parameters of the functional fit to an estimate of the individual’s at least one diabetic sensitivity factor.” (Shaya ¶ [0050].)
Motivation to combine. It would have been obvious to combine Galley with Chovanda because both disclosures concern diabetes-management systems that calculate a recommended bolus and account for the actual/user-selected bolus delivered. Chovanda expressly teaches evaluating whether its bolus recommendation “was followed by a user” and, when it was not, storing the actual bolus delivered. (Chovanda ¶ [0021].) A person of ordinary skill in the art would have been motivated to incorporate this actual-versus-recommended-bolus feedback into Galley’s advice-history record for a user-selected meal bolus, so that the record distinguishes the recommendation from the amount actually selected or delivered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted.
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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