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 .
Applicant filed a response dated 3/19/2026 in which claims 1, 3, 13, 15, and 19-20 have been amended. Thus, the claims 1-20 are pending in the application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/19/2026 has been entered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 and 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al., US Patent Application No. 2012/0226259 in view of a non-patent literature titled “Prospective evaluation of insulin-to-carbohydrate ratio in children and adolescents with type 1 diabetes using multiple daily injection therapy, Ahmed M. Hegab (hereinafter NPL-Hegab).
Regarding claim 1, Yodfat discloses a method performed by one or more processors of a computing device for determining medical device parameters, the method comprising:
obtaining a metric of insulin dosage for a patient (Fig. 7-8, [0160]-[0172]);
determining, using at least one of a processor of a mobile device or an insulin infusion pump, at least one carbohydrate-to-insulin ratio for the patient using a model that takes, as input, the obtained metric of insulin dosage for the patient and generates the at least one carbohydrate-to-insulin ratio for the patient as an output, wherein parameters of the model were determined based on data associated with a population of patients other than the patient;
delivering, using the insulin infusion pump, insulin to the patient at a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient (abstract, [0005], [0095], Fig. 7-8, [0160]-[0172]).
Yodfat does not specifically disclose
determining, using at least one of a processor of a mobile device or an insulin infusion pump, at least one carbohydrate-to-insulin ratio for the patient using a model that takes, as input, the obtained metric of insulin dosage for the patient and generates the at least one carbohydrate-to-insulin ratio for the patient as an output, wherein parameters of the model were determined based on data associated with a population of patients other than the patient;
a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient.
However, NPL-Hegab discloses
determining, using at least one of a processor of a mobile device or an insulin infusion pump, at least one carbohydrate-to-insulin ratio for the patient using a model that takes, as input, the obtained metric of insulin dosage for the patient and generates the at least one carbohydrate-to-insulin ratio for the patient as an output, wherein parameters of the model were determined based on data associated with a population of patients other than the patient (page 2, insulin pumps, Table 1, page 4);
a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hegab. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 2, Yodfat discloses wherein the metric of insulin dosage is at least one of: a total daily dose (TDD) of insulin, a total bolus dosage of insulin, or a total dose within a predetermined time period ([0160], [0162]).
Regarding claim 3, NPL-Hegab discloses wherein the data associated with the population of patients comprises, for a given patient in the population other than the patient for whom the at least one carbohydrate-to-insulin ratio is determined using the model, an insulin dosage metric associated with the given patient and at least one carbohydrate-to-insulin ratio used by the given patient (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hegab. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 4, NPL-Hageb discloses wherein the population of patients comprise a set of patients of a similar demographic group as the patient (Table 1, page 4, Fig. 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 5, NPL-Hageb discloses wherein the similar demographic group comprises the set of patients being of a similar age as the patient (Table 1, page 4, Fig. 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 6, Yodfat discloses wherein the model comprises one or more mathematical functions that represent a decreasing carbohydrate-to-insulin ratio at a rate that is proportional to its current value (([0137]).
Regarding claim 8, Yodfat discloses providing an indication of a range of carbohydrate-to-insulin ratios spanning a predetermined confidence interval based on the data associated with the population of patients ([0014]-[0015], [0017], [0044], range boundaries, [0077], [0111], [0134], predefined range).
NPL-Hageb discloses the population of patients (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 9, Yodfat discloses wherein the indication of the range of carbohydrate-to-insulin ratios is provided when initializing or modifying use of an insulin infusion pump ([0014]-[0015], [0017], [0077], [0111]).
Regarding claim 10, Yodfat discloses wherein the obtaining the metric of insulin dosage for the patient is during operation of an insulin infusion pump, and wherein the determined at least one carbohydrate-to-insulin ratio is used to modify programming of the insulin infusion pump ([0005], [0014], [0016]-[0017], [0077], [0080]-[0081]).
Regarding claim 11, Yodfat discloses wherein the at least one carbohydrate-to-insulin ratio for the patient is determined based at least in part on an operating mode of an insulin infusion pump to use the at least one carbohydrate-to-insulin ratio, and wherein the operating mode of the insulin infusion pump comprises at least one of: a manual mode, or a fully-closed loop mode ([0005], [0014], [0016]-[0017], [0045], [0077], [0080]-[0081], [0110]).
Regarding claim 12, Yodfat discloses wherein the at least one carbohydrate-to-insulin ratio for the patient comprises a plurality of carbohydrate-to-insulin ratios, each carbohydrate-to-insulin ratio applicable to a predetermined time of day ([0016], [0023], [0030], [0114]).
Regarding claim 13, Yodfat discloses a system comprising:
one or more processors ([0173]-[0174]); and
one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance of ([0173]-[0174]):
obtaining a metric of insulin dosage for a patient (Fig. 7-8, [0160]-[0172]);
determining at least one carbohydrate-to-insulin ratio for the patient using a model that takes, as input, the obtained metric of insulin dosage for the patient and generates the at least one carbohydrate-to-insulin ratio for the patient as an output, wherein parameters of the model were determined based on data associated with a population of patients other than the patient; and
delivering, using an insulin infusion device, insulin to the patient at a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient (abstract, Fig. 7-8, [0005], [0095], pump, [0160]-[0172]).
Yodfat does not specifically disclose
determining at least one carbohydrate-to-insulin ratio for the patient using a model that takes, as input, the obtained metric of insulin dosage for the patient and generates the at least one carbohydrate-to-insulin ratio for the patient as an output, wherein parameters of the model were determined based on data associated with a population of patients other than the patient; and
delivering, using an insulin infusion device, insulin to the patient at a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient.
However, NPL-Hageb discloses
determining at least one carbohydrate-to-insulin ratio for the patient using a model that takes, as input, the obtained metric of insulin dosage for the patient and generates the at least one carbohydrate-to-insulin ratio for the patient as an output, wherein parameters of the model were determined based on data associated with a population of patients other than the patient (Table 1, page 4); and
delivering, using an insulin infusion device, insulin to the patient at a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 14, Yodfat discloses wherein the model comprises one or more mathematical functions that represent a decreasing carbohydrate-to-insulin ratio at a rate that is proportional to its current value ([0137]).
Regarding claim 18, NPL-Hageb discloses wherein the set of patients comprises patients of a similar demographic group as the patient (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 15, Yodfat discloses a method performed by one or more processors of a computing device for determining medical device parameters, the method comprising:
obtaining a total daily dose (TDD) of insulin for a patient (Fig. 7-8, [0160]-[0172]); and
determining, using at least one of a processor of a mobile device or an insulin infusion device, at least one carbohydrate-to-insulin ratio for the patient based on relationships of carbohydrate-to-insulin ratios to TDD for a set of patients other than the patient, wherein the carbohydrate-to-insulin ratio is less than 25 grams/unit for a TDD less than 10 units, and wherein the carbohydrate to insulin ratio is greater than 5 grams/unit for a TDD between 85 units and 105 units; and
delivering, using the insulin infusion device, insulin to the patient at a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient (abstract, [0005], [0095], pump, Fig. 7-8, [0160]-[0172]).
Moreover, Examiner notes that wherein the carbohydrate-to-insulin ratio is less than 25 grams/unit for a TDD less than 10 units, and wherein the carbohydrate to insulin ratio is greater than 5 grams/unit TDD between 85 units and 105 units is clearly an aesthetic design change (see MPEP § 2144.04). The design change that relates to ornamentation only and have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art.
Yodfat does not specifically disclose
determining at least one carbohydrate-to-insulin ratio for the patient using a model that takes, as input, the obtained metric of insulin dosage for the patient and generates the at least one carbohydrate-to-insulin ratio for the patient as an output, wherein parameters of the model were determined based on data associated with a population of patients other than the patient; and
delivering, using an insulin infusion device, insulin to the patient at a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient.
However, NPL-Hageb discloses
determining, using at least one of a processor of a mobile device or an insulin infusion device, at least one carbohydrate-to-insulin ratio for the patient based on relationships of carbohydrate-to-insulin ratios to TDD for a set of patients other than the patient, wherein the carbohydrate-to-insulin ratio is less than 25 grams/unit for a TDD less than 10 units, and wherein the carbohydrate to insulin ratio is greater than 5 grams/unit for a TDD between 85 units and 105 units (Table 1, page 4); and
delivering, using the insulin infusion device, insulin to the patient at a dosage determined based on the at least one carbohydrate-to-insulin ratio for the patient (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 16, NPL-Hageb discloses wherein the at least one carbohydrate-to-insulin ratio is obtained from a look-up table (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 17, NPL-Hageb discloses wherein the look-up table includes a plurality of potential carbohydrate-to-insulin ratios for a given TDD, each potential carbohydrate-to-insulin ratio applicable to a different percentile of a set of patients used to generate the look-up table (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 19, NPL-Hageb discloses providing an indication of a plurality of carbohydrate-to-insulin ratios, each carbohydrate-to-insulin ratio of the plurality of carbohydrate-to-insulin ratios corresponding to a different percentile for patients of the set of patients using the TDD, the percentile indicating a percentage of patient of the set of patients that utilize a carbohydrate-to-insulin ratio that is at least the corresponding carbohydrate-to-insulin ratio associated with the percentile (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Regarding claim 20, Yodfat discloses
receiving an input carbohydrate-to-insulin ratio for the patient;
determining, based on the plurality of carbohydrate-to-insulin ratios each corresponding to the different percentile that the input carbohydrate-to-insulin ratio is outside of a predetermined percentile range; and
in response to determining that the input carbohydrate-to-insulin ratio is outside of the predetermined percentile range, providing a warning (abstract, Fig. 7-8, [0106], alert, [0111], [0134], [0160]-[0172]).
NPL-Hageb discloses
receiving an input carbohydrate-to-insulin ratio for the patient;
determining, based on the plurality of carbohydrate-to-insulin ratios each corresponding to the different percentile that the input carbohydrate-to-insulin ratio (Table 1, page 4).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat to include the above-noted disclosure of NPL-Hageb. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al., US Patent Application No. 2012/0226259 in view of NPL-Hageb in view of Grosman et al., US Patent Application No. 2022/0257859.
Regarding claim 7, Grosman discloses wherein the one or more mathematical functions approximates an exponential decay ([0086]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Yodfat and NPL-Hageb to include the above-noted disclosure of Grosman. The motivation for combining these references would have been to determine appropriate amount of insulin for a patient.
Response to Arguments
Examiner withdraws 35 U.S.C. 101 rejection of claims 1-20 in view of the amendment/argument.
Applicant's arguments filed dated 3/19/2026 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-6, 8-14, and 18 under 35 U.S.C. 103, Applicant’s arguments are moot in view of the new grounds of rejection presented above in this office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684
Prosecution Insights