DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 2-21 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Bonnecaze et al. (US 6579690 B1), as evidence of Brauker et al (US 20050192557 A1).
Regarding claims 2, 13, Bonnecaze discloses a system and a method for controlling delivery of insulin (fig 25; col. 55, lines 5-24), the system and method comprising:
monitoring one or more parameters associated with delivery of insulin via a medication delivery device 260 according to a control algorithm, wherein the one or more parameters include a monitored analyte level (col 55, lines 25-36);
detecting a signal level associated with the monitored analyte level (col 55, lines 25-36);
detecting an adverse signal condition based on the one or more parameters (col. 45, line 63- col 45 line 19);
executing a corrective action based on the detection of the adverse signal condition (col 55 lines 37-51). The processor (col. 5 lines 8- 20) is in communication with the delivery device, and a memory (col. 45 lines 42-62) coupled to the processor and storing instructions, when executed by the processor, cause the processor to perform the steps cited above.
Regarding claims 3 and 14, wherein the adverse signal condition comprises signal dropout or signal attenuation (col. 45, line 63- col 45, line 19; col 55, lines 52-67; col. 56 lines 1-22).
Regarding claim 4, wherein the adverse signal condition is associated with an impending hypoglycemic condition (col. 45, line 63- col 46 line 19).
Regarding claim 5, further comprising detecting the adverse signal condition based on a predictive model (col. 45, lines 42-62; col. 55, lines 52-67; col. 56 lines 1-22).
Regarding claims 6 and 15, further comprising determining a predictive analyte response level based on the predictive model, and wherein the detection of the adverse signal condition is based on a comparison of the predictive analyte response level to the monitored analyte level via the processor. (col. 45, lines 42-62; col. 55, lines 52-68)
Regarding claim 7, wherein the corrective action comprises prompting the user to enter a blood glucose measurement (col. 53, lines 11-32; data has been entered and saved by patient input of events such as hypoglycemic episodes; col. 44, lines 33-45; col 54, line 56 - col. 55, line 3).
Regarding claim 8, wherein the corrective action comprises modifying an analyte level alarm (col. 37 lines 28-47; col. 44 lines 9-23).
Regarding claim 9, wherein the corrective action comprises disabling an analyte level alarm (col. 37 lines 28-47; col. 44 lines 9-23; col. 45, line 63 – col. 46, line 67; col 47, lines 9-36; col. 54, lines 29-39).
Regarding claim 10, wherein the corrective action comprises instructing the user to delay a calibration for a period of time (col. 44, line 33 – col. 45, line 41).
Regarding claim 11, further comprising issuing a notification associated with the adverse signal condition (col 51, lines 18-37; notification on the display to “Eat Sugar, etc.).
Regarding claims 12 and 16, wherein the control algorithm comprises a closed loop control algorithm (figs 21-22; column 42, line 42- column 43, line 55; comprises a closed loop control algorithm).
Regarding claim 17, wherein the corrective action comprises one or more of prompting the user to enter a blood glucose measurement (col. 53, lines 11-32; data has been entered and saved by patient input of events such as hypoglycemic episodes; col. 44, lines 33-45), modifying an analyte level alarm (col. 37 lines 28-47; col. 44 lines 9-23), disabling an analyte level alarm (col. 37 lines 28-47; col. 44 lines 9-23; col. 45, line 63 – col. 46, line 67; col 47, lines 9-36), or instructing the user to delay a calibration for a period of time(col. 44, line 33 – col. 45, line 41).
Regarding claim 18, Bonnecaze discloses an integrated system 250 in figure 25, wherein the medication delivery device is capable of having a processor as evidence of Brauker et al (US 20050192557 A1); ([0136-0137, 0142,0146, 0159, 0184] in figure 8 (82,112)).
Regarding claim 19, further comprising a data processing device (154, 256; fig 22 and fig 25) comprising a display, wherein the data processing device is in wireless communication (fig 25) with the medication delivery device, and wherein the data processing device comprises the processor. (See also fig 17 and fig 22, data is transmitted to receiver/display 46,48).
Regarding claim 20, wherein the medication delivery device comprises an external infusion pump or an on-body patch pump (col. 55, lines 37-51).
Regarding claim 21, Bonnecaze discloses a non-transitory computer-readable medium (col. 53. Line 11-32; col. 53, line 55- col. 54, line 22) having instructions stored thereon that, when executed by at least one computing device, cause the at least one computing device to perform operations comprising:
monitor one or more parameters associated with delivery of insulin according to a control algorithm, wherein the one or more parameters include a monitored analyte level;
detect a signal level associated with the monitored analyte level; detect an adverse signal condition based on the one or more parameters; and
execute a corrective action based on the detection of the adverse signal condition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
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- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783