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 § 102
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 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.
Claims 1-9, 11-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dobbles et al. (US 9452258 B2).
Regarding claims 1 and 11, Dobbles discloses an ambulatory infusion pump system 10 (figs 1 and 3) and a method of diabetes therapy, comprising:
a pump mechanism 16 configured to facilitate delivery of insulin to a user (col. 16, lines 23-27), (col.24, lines 11-16) and the step for delivery;
a communications module 14 (col. 16, lines 11-16) adapted and receiving glucose levels from a continuous glucose monitor 12 (col. 15 lines 49-60);
at least one processor 28 functionally linked to the pump mechanism and the communications module (col. 19, line 52- col. 21 line 24), the at least one processor configured to:
automatically calculates insulin doses with a closed loop delivery algorithm based on the glucose levels received from the continuous glucose monitor [col 41, lines 25-36; closed loop];
automatically delivers the insulin doses calculated by the closed loop delivery algorithm with the pump mechanism [col 41, lines 25-36; closed loop] and
wherein automatically calculating insulin doses based on the glucose levels received from the continuous glucose monitor for a current dosing calculation includes at least one of combining and filtering a plurality of glucose levels received since a previous dosing calculation [col 20, lines 23-52 (processor module comprises a digital filter infinite impulse response); and col 11 lines 22-33].
Regarding claims 2 and 12, Dobbles discloses the processor is configured to average the plurality of glucose levels received since the previous dosing calculation and to utilize the average in the current dosing calculation [col. 10 lines 3-17; data stream and processor combines the data to average it using the current dosing calculation (col.20 lines 23-52); col. 12 lines 3-12; col. 11 lines 22-33) ], and (claim 12) wherein combining the plurality of glucose levels includes averaging the plurality of glucose levels received since the previous dosing calculation and further comprising utilizing the average in the current dosing calculation [col. 10 lines 3-17; data stream data stream and processor combines the data to average it using the current dosing calculation (col.20 lines 23-52); col. 12 lines 3-12; col. 11 lines 22-33)].
Regarding claims 3 and 13, Dobbles discloses the processor is configured to filter the plurality of glucose levels by eliminating glucose levels that deviate significantly from other glucose levels in calculating insulin doses [(col. 20, lines 4-22) introduces Pubs US 2005/0043598 A1 which discloses in [0267 and 0366] as taught old and well known] which the examiner is relying on for this limitation, and (claim 13) wherein filtering the plurality of glucose levels includes eliminating glucose levels that deviate significantly from other glucose levels in calculating insulin doses [(col. 20, lines 4-22) introduces Pubs US 2005/0043598 A1 which discloses in [0267 and 0366] as taught old and well known].
Regarding claims 4 and 14, Dobbles discloses the at least one processor (receiver is operably connected to the processor) is further configured to fit a trend line to the plurality of glucose levels and determining which glucose levels deviate significantly based on the trend line, and (claim 14) further comprising fitting a trend line to the plurality of glucose levels and determining which glucose levels deviate significantly based on the trend line [(col. 20, lines 4-22) introduces Pubs US 2005/0043598 A1 which discloses in [0317,0318,0321,0383] a glucose trend deviation]. See also in Dobbles (col. 14, lines 41-65).
Regarding claims 5-7 and 15-17, Dobbles discloses further comprising fitting a trend line to the plurality of glucose levels for determining a glucose level to use in the current dosing calculation, and (claim 15) wherein the at least one processor is configured to fit a trend line to the plurality of glucose levels for determining a glucose level to use in the current dosing calculation [col. 38, lines 37-58; col. 39 line 60- col. 40 line 7; col. 40 lines 31-36]. See also in US 2005/0043598 in [0317,0321].
Regarding claims 8 and 18, Dobbles discloses the at least one processor is configured to filter the plurality of glucose levels using an infinite impulse response filter, and (claim 18) wherein filtering the plurality of glucose levels includes using an infinite impulse response filter
(col 19 line 52 -col. 20, line 52).
Regarding claims 9 and 19, Dobbles discloses the at least one processor is further configured to filter the plurality of glucose levels by omitting glucose levels that are not physiologically possible in calculating insulin doses, and (claim 19) wherein filtering the plurality of glucose levels includes omitting glucose levels that are not physiologically possible in calculating insulin doses (see in US 2005/0043598 [0324,0339, 0366,0383, 0401]).
Regarding claim 20, Dobbles discloses further comprising utilizing glucose levels from past dosing intervals in calculating insulin doses (fig 13, (col. 44, lines 31-64)).
Regarding claim 21, Dobbles discloses the at least one processor is further configured to receive one or more physiological parameters of the user comprising one or more of a weight of the user, a total daily insulin of the user, an insulin sensitivity factor of the user, a carbohydrate ratio of the user, and an insulin action time of the user; and omitting the glucose levels that are not physiologically possible is based on the one or more physiological parameters of the user (col. 14 line 41 - col .15 line 15).
Response to Arguments
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive.
Applicant’s arguments narrower than the claims. The claims are broad and there is not enough structural and/or functional language in the claims to further differentiate applicant’s invention from the claims.
With respect to applicant’s arguments that Dobbles et al does not disclose “…automatically calculating insulin doses based on the glucose levels received from the continuous glucose monitor for a current dosing calculation includes at least one of combining and filtering a plurality of glucose levels received since a previous dosing calculation.”, the examiner disagrees.
Dobbles discloses, in the Summary of Invention, a continuous glucose monitor for a current dosing calculation for a current dosing calculation (based on the internally derived data (data measured and/or processed by the system (col. 14 lines 41-65) which could be old or new data evaluated as it is received by controller module) collected via electronics module with a controller module to iteratively determine insulin therapy; columns 1-2; column 4.
In column 6 lines 56-66, Dobbles refers to time interval measurements for the continuous glucose sensor and sensing period (col. 7 lines16). See also column 11, line 63- column 12 lines 2 which refers to a single point in time. See also column 20, lines 4-column 21, line 24 set forth that values by the processor are averaged (combined) over the over the acquisition time due the continuity of the current measurement. In column 10, lines 3-17, refers to raw data stream and data stream relates to analyte concentration measured by the analyte sensor which comprises individual measurements taken at a time intervals. The processor module 28 can be configured to transmit any combination of raw and/or filtered data (column 20, lines 65-66). In figure 1 (col. 15 line 58-col 16 line 10, Dobbles states the glucose sensor 12 uses any known method to provide an output signal indicative of the concentration of the glucose. The output signal is typically a raw data stream that is used to provide a useful value of the measured glucose concentration to a host or doctor, for example. A receiver 14 is provided that receives and processes the raw data stream, including calibrating, validating, and displaying meaningful glucose values to a host, such as described in more detail below. Then, there is a delivery device (col 16 lines 11-60) to deliver insulin based on the glucose level based on internally derived data (col 17 lines 12-14).
Dobbles further discloses “the current dosing calculation includes at least one of combining and filtering a plurality of glucose levels received since a previous dosing calculation.”. In col. 11 lines 22-33, Dobbles discloses combining or filtering data of glucose levels via an equation in which previous averages are part of the next filtered output. More particularly, the generation of a series of observations whereby the value of each observation is partly dependent on the values of those that have immediately preceded it. In column 20, lines 4-66, set forth that the processor module collects measure analyte values, store and the average them. In column 23, lines 24-28, states the receiver 14 processes data from continuous glucose sensor. Lastly, US Pubs 2005/0027463 cited in column 22 line 67 which is incorporated by reference goes into the details of a system and methods for glucose measurements where the glucose sensor collects data and then combines the data (averaged) using a recursive filter ([0293-0297]) like in Dobbles (col 11 lines 22-33) since a previous dosing calculation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
THIS ACTION IS MADE FINAL. 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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 3pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights