DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Invention I, Claims 1-10 in the reply filed on 6/16/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “determine glucose cost of candidate basal insulin delivery dosages” in lines 2-3. It is unclear what the scope of this limitation means. For purposes of examination it is interpreted that any sort of function/calculation being done for calculate the basal insulin delivery dosage would meet the limitation of “determine glucose cost of candidate basal insulin delivery dosages”.
Claims 8-10 are rejected due to their dependency on claim 7.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jepson et al. (US 20210205534).
Regarding Claim 1, Jepson teaches (Fig 25) An insulin delivery device for delivering insulin to a user, comprising:
a non-transitory computer-readable storage medium storing processor-executable instructions (see [0417] teaching methods involving non-transitory computer readable medium storage/code/instructions);
a processor (2502; see [0358-0359] teaching 2502 is a computing device) for executing the processor-executable instructions to cause the processor to:
receive rate of change (ROC) data regarding an ROC of a glucose level of the user (see [0364] teaching receiving a ROC); and
perform at least one of the following:
use the ROC data without using glucose level data to determine basal insulin delivery dosages (See [0374-0375] teaching how the dosages are being determined based on glucose concentration ROC, and the predictive glucose concentration. This is considered to be different than the “glucose level data”, furthermore [0374] teaches based on if the glucose concentration ROC is rising the application will continue to determine the bolus dose, this is considered to the “basal insulin deliver dose”);
use the ROC data without using the glucose level data to detect an imminent hypoglycemic event or an imminent hyperglycemic (As described in [0370], the glucose concentration is determining a ROC (rate of change), therefore the calculations done in [0379] teaching detecting of current or imminent hyperglycemic episode is interpreted to be done with the same rate of changes in glucose concentration rather than glucose level data).
Regarding Claim 2, Jepson teaches the insulin delivery device of claim 1, where the processor uses the ROC data without using glucose level data to determine basal insulin delivery dosages, the processor-executable instructions cause the processor to analyze the ROC data to identify that a projected glucose level increase is projected (see [0092-0095] teaching how the processor is analyzing data to identify projected increase).
Regarding Claim 3, Jepson teaches the insulin delivery device of claim 2, wherein the processor- executable instructions further cause the processor to increase an insulin delivery rate by the insulin delivery device to the user to compensate for the projected glucose level increase (see [0092-0095] teaching how the processor is analyzing data to identify projected increase)
Regarding Claim 4, Jepson teaches the insulin delivery device of claim 2, wherein a magnitude of the increase of insulin delivery rate depends upon the ROC data and a target glucose level of the user (See [0094-0095] and [0186]).
Regarding Claim 5, Jepson teaches the insulin delivery device of claim 1, where the processor uses the ROC data without using glucose level data to determine basal insulin delivery dosages, the processor-executable instructions cause the processor to analyze the ROC data to identify that a projected glucose level decrease is projected (see [0092-0095] teaching how the processor is analyzing data to identify projected decrease).
Regarding Claim 6, Jepson teaches the insulin delivery device of claim 5, wherein the processor- executable instructions further cause the processor to decrease an insulin delivery rate by the insulin delivery device to the user to compensate for the projected glucose level decrease (See [0092-0095] teaching how the processor is analyzing data to identify projected decrease).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jepson (US 20210205534) in view of Cinar et al. (US 20110106011 hereinafter “Cinar”).
Regarding Claim 7, Jepson teaches the insulin delivery device of claim 1, the processor-executable instructions cause the processor to predict a ROC for a time period from the rates of change of preceding time periods (see Fig 25 and [0097], [0365]).
Jepson does not specify where the processor uses the ROC data without using the glucose level data to determine glucose cost of candidate basal insulin delivery dosages.
Cinar teaches (see [0060] and [0116]) that a processor uses a cost function to determine the best insulin delivery dosages and that the ROC data could be used in this determination of the cost function.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Jeposn such that the processor uses the ROC data without using the glucose level data to determine glucose cost of candidate basal insulin delivery dosages as taught by Cinar. One of ordinary skill in the art would have been motivated to do so as this is an alternative method of using ROC values to predict/detect hypoglycemic events (Cinar [0116]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jepson in view of Cinar as applied to claim 7 above, and further in view of Mazlish et al. (US 20180200435 hereinafter “Mazlish”).
Regarding Claim 8, the combination of Jepson and Cinar teaches all elements of claim 7 as described above. The combination does not specify the insulin delivery device wherein the processor- executable instructions further cause the processor to use a cost function that predicts costs of candidate insulin doses using the predicted ROC for the time period.
Mazlish teaches [0251-0252] that processors may use cost functions to predict insulin dosages for blood glucose targets and different time segments.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of the modified Jepson such that the processor- executable instructions further cause the processor to use a cost function that predicts costs of candidate insulin doses using the predicted ROC for the time period as taught by Mazlish. One of ordinary skill in the art would have been motivated to do so in order to use a suitable cost function based on the specific predicted blood glucose delivery profiles (Mazlish [0251]).
Regarding Claim 9, the combination of Jepson, Cinar and Mazlish teaches the insulin delivery device of claim 8, wherein the cost function includes a glucose cost component that is determined based on the predicted ROC for the time period (See Mazlish [0251-0252] teaching a glucose cost component for a particular time period).
Regarding Claim 10, the combination of Jepson, Cinar and Mazlish teaches the insulin delivery device of claim 8, wherein the processor- executable instructions further cause the processor to choose a selected one of the candidate insulin doses with a lowest cost as determined by the cost function and to cause the selected one of the insulin doses to be delivered to the user (See Mazlish [0199] teaching selecting the lowest cost determined by the cost function).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Doyle (US 20160256087) teaches a glucose rate increase detector used to determine/monitor meal detection and changes due to meals.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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