DETAILED ACTION
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 1-22 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.
As to claim 1, the claim recites “a duration of insulin action settings” three separate times using the indefinite article: in the preamble, in the determining step, and the modifying step. It’s unclear whether these recitations refer to a single (i.e. same) duration of insulin action or to two or three distinct ones. For examination purposes, all recitations are construed as referring to a single duration of insulin action setting.
Claims 8 and 15 have similar issues to claim 1 above.
Claim 8 also recites “monitor a number of glucose measurements of a user” and “determine a rate of change of the number of glucose measurements” and thereafter recites “as a result of determining the rate of change of the number of blood glucose measurements is a negative rate of change”. It is unclear whether “blood glucose measurements” refers to the previously recited “glucose measurements” or to a distinct set of measurements. For purposes of examination, it is understood to be the same.
Claim 16 recites “prior to determining timing of the insulin dose, comparing the confidence value to a positive confidence value threshold”. However, claim 15, which this claim depends upon, already recites comparing the modified confidence value to a confidence value to a confidence threshold value. It’s unclear whether this comparison is the same comparison of claim 15, further characterized to being a positive threshold, or whether this requires a second and additional comparison to a differently recited threshold. For purposes of examination, it’s understood to be the same comparison.
Allowable Subject Matter
Claims 1-22 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The prior art of record fails to teach and/or fairly suggest, in combination with all other recited limitations, as a result of determining the rate of change the glucose values is a negative rate of change, modify the confidence value.
Response to Arguments
Applicant’s arguments filed 3/30/26 have been fully considered and are persuasive. The previous rejections have been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Walsh et al. (“Confusion Regarding Duration of Insulin Action: A Potential Source for Major Insulin Dose Errors by Bolus Calculators”) teaches that DIA (active insulin time) starts as soon as a bolus is given and ends when a bolus is no longer lowering the glucose and that when a short DIA is entered as a pump setting, the user’s residual bolus insulin on board appears to be gone from the body when it remains to lower the glucose. Accordingly, it teaches that a negative glucose rate of change in glucose that is observed while the insulin onboard is calculated as zero would be inaccurate. However, it does not teach the modification of a confidence value of the duration of insulin action.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/18/26
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