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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of U.S. Patent Publication No. 2016/0346456 to Cefai et al. (“Cefai”).
Regarding claim 7, Brauker teaches an agent delivery system (Fig. 1) comprising a delivery device (34, [0229]) configured to delivery dosages of an agent to a user, and one or more processors (16) configured to receive a calibrated value for an analyte measurement of the user from a calibration source different from a sensor providing ongoing analyte measurements of the user (42, reference data), determine an offset (46) between the calibrated value for the analyte measurement (42) and a recently received analyte measurement from the sensor (40), wherein the offset reflects a lack of proper calibration of the sensor ([0131], the flow chart demonstrates calibration of a sensor, the need for calibration of the sensor assumes that the sensor is not properly calibrated), update past analyte measurements received from the sensor based on the offset (50), determine new dosages of the agent that would have been delivered to the user by the delivery device based on the updated past analyte measurements ([0247], the estimated analyte values, i.e., updated past analyte measurements, are used to determine the amount [0250], i.e., dosage, to the user), but does not teach the claimed calculate, modify, and determine and deliver functions.
Cefai teaches one or more processors configured to calculate a cumulative difference between new dosages and actual dosages of an agent delivered to the user by a delivery device during a past interval ([0017], difference between an intended delivery quantity and an actual delivery quantity), modify, in a control algorithm executed by the one or more processors to control the delivery device, a constraint parameter ([0018], schedule of successive pulses) used by the control algorithm in calculating dosages, to compensate for the cumulative difference, and determine and delivery next dosages of the agent to the user via the delivery device, wherein the next dosages are determined by the control algorithm with the constraint parameter as modified, such that the next dosages are increased or decreased relative to dosages that would otherwise be determined, to compensate for cumulative difference ([0018], the constraint parameter or schedule of successive pulses/dosages, which was previously made in response to the difference between intended and actual dossages, is modified in that they are decreased/stopped in response to the determination that the predetermined amount has already been delivered). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Brauker to have decreased subsequent doses as taught by Cefai in order to prevent over-delivery ([0018]) which could harm the patient.
Regarding claim 8, Brauker and Cefai teach the agent delivery system of claim 7 as shown above, Brauker further teaching the agent is insulin, glucagon, GLP-1 or an agent that modifies glucose ([0250], insulin).
Regarding claim 9, Brauker and Cefai teach the agent delivery system of claim 7 as shown above, Brauker further teaching the delivery device is an on-body insulin pump ([0378], 310).
Regarding claim 10, Brauker and Cefai teach the agent delivery system of claim 7 as shown above, Brauker further teaching the analyte is glucose ([0234]).
Regarding claim 11, Brauker and Cefai teach the agent delivery system of claim 7 as shown above, Brauker further teaching the agent includes at least one of a chemotherapeutic agent, a pain relief agent, a blood thinner agent, glucagon, a hormonal agent, a pharmaceutical agent or a therapeutic agent ([0250], insulin is a therapeutic agent given the broadest reasonable interpretation).
Regarding claim 12, Brauker and Cefai teach the agent delivery system of claim 7 as shown above, Brauker further teaching the calibrated value for the analyte measurement is a blood glucose level measurement resulting from analyzing blood extracted from the user via a different measurement mechanism than the sensor ([0260]).
Regarding claim 15, Brauker and Cefai teach the agent delivery system of claim 7 as shown above, Cefai further teaching wherein the modified constraint parameter remains modified for a predetermined period of time during future operation of the delivery device ([0018], the modification of the schedule of successive pulses would have an inherent predetermined period of time).
Allowable Subject Matter
Claims 13-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art to Brauker and Cefai do not show or suggest either alone or in combination the constraint parameter comprising an insulin on board estimate and modifying constraint parameter comprises adjusting the insulin on board estimate by the cumulative difference in combination with all the other limitations of the invention as substantially claimed.
Response to Arguments
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112(a) rejections have been withdrawn.
Applicant’s arguments and amendments with respect to art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Brauker and Cefai as shown above.
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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