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 Amendment
This office action is responsive to the amendment filed on 1/15/26. As directed by the amendment: claims 1-3, 6-11, and 13 have been amended, claims 14-16 have been cancelled, and no new claims have been added. Thus, claims 1-13 and 17-20 are presently pending in this application, claims 17-20 being withdrawn from consideration.
The amendments to the claims are sufficient to overcome the claim objection from the prior action. Claim 13 will now be treated on the merits.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) from the prior action, except as noted below for claims 9 and 10.
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 9, 10, and 13 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.
Regarding claim 9, “the number of blood glucose readings” and “the high threshold or low threshold” lack antecedent basis. Note that claim 9 depends from claim 1, and cannot rely on claim 4 for antecedent basis for these limitations.
Claim 10 depends from claim 9 and is rejected for the same reasons as claim 9.
Regarding claim 13, “the recommended adjustment to the manually-administered basal dose for the subsequent day” lacks antecedent basis.
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.
Claim(s) 1-6, 9, and 10 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Booth et al. (US 9233204).
Regarding claim 1, Booth et al. discloses a method comprising: receiving a quantity of an initial basal dose of insulin (receiving previous day’s bed time recommended basal dose; col. 5, ln. 3-7); determining, during the course of a day, that a blood glucose excursion has occurred based on one or more blood glucose readings (col. 9, ln. 47-60) from a continuous blood glucose monitor (col. 11, ln. 62 – col. 12, ln. 11); calculating a bolus dose of insulin to address the blood glucose excursion (col. 9, ln. 47-60); and based on the blood glucose excursion, recommending an adjustment to the quantity of the initial basal dose of insulin to create a subsequent basal dose of insulin for delivery on a subsequent day (col. 4, ln. 66 – col. 5, ln. 25: prior “correction dose” factors in to recommendation for basal dose for the next day), the adjustment being a function of a total daily insulin (TDI) requirement for a user (col. 5, ln. 40-48; additionally, since the adjustment is a quantity of insulin relative to the total basal amount, it is inherently a function of TDI).
Regarding claim 2, Booth et al. discloses the bolus dose is administered by an automated insulin delivery (AID) device and the initial basal dose is administered by a manual insulin pen, or the initial basal dose is administered by the AID device and the bolus dose is administered by the manual insulin pen (col. 5, ln. 64 – col. 6, ln. 6; col. 9, ln. 47 – col. 10, ln. 28; col. 13; ln. 3-33).
Regarding claim 3, Booth et al. discloses informing the user of the recommended adjustment prior to administration of subsequent the basal dose of insulin for the subsequent day on a display device (fig. 6F; col. 6, ln. 53-54; col. 46, ln. 61 – col. 47, ln. 15).
Regarding claims 4 and 9 (9 as best understood), Booth et al. discloses a blood glucose excursion is determined to have occurred after receiving a predetermined number of blood glucose readings above a high threshold or a predetermined number of blood glucose readings below a low threshold (col. 9, ln. 47-60), wherein the adjustment to the initial basal dose for the next day is based on the number of blood glucose readings exceeding the high threshold or low threshold (col. 4, ln. 66 – col. 5, ln. 25: prior “correction dose” factors in to recommendation for basal dose for the next day).
Regarding claim 5, Booth et al. discloses the blood glucose readings are received from a wirelessly connected continuous glucose monitor (col. 16, ln. 18-28).
Regarding claim 6, Booth et al. discloses the quantity of the initial basal dose of insulin is received from a wirelessly connected insulin pen. (col. 3, ln. 56-65; col. 13, ln. 3-56).
Regarding claim 10, as best understood, Booth et al. discloses the adjustment is a percentage of the user’s total daily insulin requirement (the value of the adjustment will inherently be a percentage relative to the value of the total daily insulin requirement; see also col. 5, ln. 40-48).
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.
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Booth et al. in view of Mastrototaro et al. (US 8454576).
Regarding claim 7, Booth et al. discloses the method as claimed, except for the bolus dose of insulin is calculated based on a total daily insulin and insulin on board and the quantity of the initial basal dose is assumed to be no greater than 50% of a total daily insulin requirement. However, Mastrototaro et al. teaches calculating bolus dose of insulin is based on a total daily insulin and insulin on board and the quantity of the basal dose is assumed to be no greater than 50% of a total daily insulin requirement (col. 17, ln. 31-45; col. 11, ln. 24-33). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Booth et al, as taught by Mastrorotaro et al., since Mastrototaro et al. teaches basal insulin is intended to account primarily for baseline insulin needs of the body, and to utilize total insulin (the remaining 50%) and IOB to avoid overdose.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Booth et al. in view of Mastrototaro et al., and further in view of Estes (US 20140107607).
Regarding claim 8, Booth et al. discloses utilizing both long and fast acting insulin and considering prior dosages of both types during dose analysis (col. 7, ln. 39 – col. 8, ln. 28), as modified above, Mastrototaro et al. teaches utilizing IOB, but Booth et al. in view of Mastrototaro et al. fails to specifically teach the insulin on board is a sum of long-acting insulin administered in the initial basal dose adjusted for a time since administration of the initial basal dose based on a decay rate for long-acting insulin and rapid-acting insulin delivered as bolus doses adjusted for a time since administration of each bolus dose based on a decay rate for rapid-acting insulin. However, Estes teaches that insulin on board must account for time decay for accuracy and total insulin present in the body (par. 0180). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Booth et al. in view of Mastrototaro et al. method to account for all types of insulin delivered previously as well a their decay rates, as taught by Estes, for the purpose of providing sufficient data for IOB to be accurately calculated to, as noted previously, avoid ovedose.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Booth et al. in view of El-Khatib et al. (US 20130245547).
Regarding claims 11-13 (13 as best understood), Booth et al. discloses the method as claimed, including calculating a maximum adjustment to a basal dose of insulin (col. 4, ln. 66 – col. 5, ln. 25), except for the calculating comprising: averaging one or more factors selected from a group consisting of a total insulin quantity of delivery in a previous day, an average insulin need of a user over time, an average expected variation in the insulin need of the user, and an average maximum insulin compensation that can be provided by an AID system; and the factors are weighted such that the maximum adjustment is a weighted average. However, El-Khatib et al. teaches utilization of weighted average of insulin need of a user over time in order to adjust basal infusion rate (claims 6-9; abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Booth et al. to utilize weighted average insulin need over time, as taught by El-Khatib et al., for the purpose of adapting administration due to long term changes in patient’s needs (abstract).
Response to Arguments
Applicant's arguments filed 1/15/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments, on pg. 8-9 of the Remarks, that the claimed invention is “simpler” than that disclosed by Booth et al. since Booth et al. discloses additional steps or factors, Examiner respectfully disagrees. Examiner points to the cited passages provided in claim 1 above which describe the factors that lead to determination of a correction insulin dose in Booth et al., which includes a blood glucose excursion, and notes that supposed additionally method steps or complexity argued by Applicant does not preclude Booth et al. from disclosing the steps as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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