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 Objections
Claim 1 is objected to because of the following informalities: At claim 1 line 9, --at least one--should be inserted before “sensor electrode”. At claim 1 line 10, “the delivery” should read --delivery--. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: In claim 19 line 1, “via one or processors implemented in circuitry” should read --via one or more processors implemented in circuitry--. At claim 19 line 9, --at least one-- should be inserted before “sensor electrode”. At claim 19 line 10, “the delivery” should read --delivery--. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: At claim 20 line 2, “via one or processors implemented in circuitry” should read --via one or more processors implemented in circuitry--. At claim 20 line 10, --at least one-- should be inserted before “sensor electrode”. At claim 20 line 11, “the delivery” should read --delivery--. Appropriate correction is required.
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 3, 4, 15, 17, and 18 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.
At claims 3 and 18, the limitation “the at least one sensor” renders the claims indefinite. It is unclear if this limitation is referring to the at least one “sensor electrode” or some other component of the device.
At claim 15, there is a lack of antecedent basis for the limitations “the infusion set” at line 6 and “the oxide step” at line 7.
At claim 17 line 4, there is a lack of antecedent basis for the limitation “the signal current”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10, 12-14, 16-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (WO 2013184416 A2), hereinafter Yang.
Regarding claim 1, Yang teaches a device comprising: a glucose monitor comprising at least one sensor electrode configured to sense signals indicative of interstitial glucose level of a patient ([0016]); a memory; one or more processors implemented in circuitry and in communication with the memory, the one or more processors configured to: cause delivery of a cleaning electrical current to the at least one sensor electrode, the cleaning electrical current being one or more electrochemical cleaning pulses configured to at least partially remove, in vivo and from the sensor electrode, excipients associated with the delivery of a fluid that includes insulin ([0096], [00110], [00204], [00206]).
Regarding claim 2, Yang teaches an infusion cannula configured to deliver insulin to the patient ([0097], [0098]).
Regarding claim 3, Yang teaches a device wherein the one or more processors are further configured to determine an impedance at the at least one sensor or a signal current at the at least one sensor ([00134], [00137]).
Regarding claim 4, Yang teaches a device, wherein the one or more processors are configured to cause delivery of the cleaning current responsive to a determination that the impedance at the glucose monitor satisfies an impedance threshold or a threshold rate of impedance change, or a signal electrical current from the glucose monitor satisfies a current threshold or satisfies a threshold rate of current change ([00203], [00204]).
Regarding claim 5, Yang teaches a device, wherein the one or more processors are configured to cause delivery of the cleaning current responsive to a user input to perform an electrochemical cleaning procedure ([00199, 00200]).
Regarding claim 6, Yang teaches a device wherein the one or more processors are configured to cause delivery of the cleaning current responsive to a determination that a time period has expired ([00205]).
Regarding claim 7, Yang teaches a device wherein the cleaning electrical current is configured to be sourced from a working electrode and sunk at a counter electrode of the glucose monitor ([0119]).
Regarding claim 8, Yang teaches a device wherein the cleaning electrical current is configured to be sourced from a counter electrode and sunk at a working electrode of the glucose monitor ([0119]).
Regarding claim 9, Yang teaches a device wherein the cleaning electrical current is configured to be toggled between being sourced from a counter electrode of the glucose monitor and sunk at a working electrode of the glucose monitor, and sourced from the working electrode and sunk at the counter electrode ([00119]).
Regarding claim 10, Yang teaches a device wherein the glucose monitor comprises a working electrode comprising an interference rejection membrane ([00185]).
Regarding claim 12, Yang teaches a device wherein the insulin comprises the excipients ([00281]).
Regarding claim 13, Yang teaches a device wherein excipients include one or more of phenol, m-cresol, or glycerin ([00281], [00282]).
Regarding claim 14, Yang teaches a device wherein the one or more processors are configured to perform an initialization sequence, wherein the initialization sequence includes a plurality of pulses, each pulse of the plurality of pulses defining a voltage, current, and a duration, and wherein the one or more electrochemical cleaning pulses are substantially equal to at least one of the plurality of pulses in the initialization sequence in voltage, current or duration ([0005], [00351], [00353]).
Regarding claim 16, Yang teaches a device wherein an electrochemical cleaning pulse of the one or more electrochemical cleaning pulses defines a segmented waveform, and wherein a first segment of the segmented waveform defines a voltage amplitude of from about 500 millivolts to about 1500 millivolts ([00192]).
Regarding claim 17, Yang teaches a device wherein the cleaning electrical current is a first cleaning electrical current, wherein the one or more processors are further configured to determine whether the first cleaning electrical current caused the signal current to match or fall within a threshold matching percentage of an expected signal current, and wherein, responsive to a determination that the signal current does not fall within the threshold matching percentage of the expected signal current, the one or more processors are further configured to cause delivery of a second cleaning electrical current ([00200], [00242]-[00245]).
Regarding claim 19, Yang teaches a method comprising: determining, via one or processors implemented in circuitry and in communication with a memory of a device comprising a glucose monitor, that a cleaning electrical current should be delivered to at least one sensor electrode of the glucose monitor, wherein the at least one sensor electrode is configured to sense signals indicative of interstitial glucose level of a patient ([0015], [0016]); and causing delivery of the cleaning electrical current to the at least one sensor electrode, the cleaning electrical current being one or more electrochemical cleaning pulses configured to at least partially remove, in vivo and from the sensor electrode, excipients associated with the delivery of a fluid that includes insulin (([0096], [00110], [00204], [00206]).
Regarding claim 20, Yang teaches a method comprising: determining, via one or processors implemented in circuitry and in communication with a memory of a device comprising a glucose monitor ([0096]), that a cleaning electrical current should be delivered to at least one sensor electrode of the glucose monitor, wherein the at least one sensor electrode is configured to sense signals indicative of interstitial glucose level of a patient ([0015], [0016]); and causing delivery of the cleaning electrical current to the at least one sensor electrode, the cleaning electrical current being one or more electrochemical cleaning pulses configured to at least partially remove, in vivo and from the sensor electrode, excipients associated with the delivery of a fluid that includes insulin ([00204], [00206]).
Claim Rejections - 35 USC § 103
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 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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (WO 2013184416 A2), hereinafter Yang, as applied to claim 1 above in view of Li et al. (US 20190357827 A1), hereinafter Li.
Yang discloses all of the elements of the current invention discussed above except a working electrode comprising platinum. Li teaches an analyte sensing device which has a working electrode comprising platinum ([0422], [0427]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to utilize a platinum working electrode like that of Li with a device like that of Yang due to platinum electrodes being stronger and less likely to break or fail due to stress (Li, [0464]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (WO 2013184416 A2), hereinafter Yang, as applied to claim 1 above in view of Nardiello et al. (“Pulsed amperometric detection at glassy carbon electrodes: A new waveform for sensitive and reproducible determination of electroactive compounds”), hereinafter Nardiello.
Yang discloses all of the elements of the current invention discussed above except a device, wherein the segmented waveform includes a first segment, wherein the one or more processors are configured to detect an electroactive species based on the first segment, wherein the segmented waveform further includes a second segment configured to oxidize an analyte associated with the delivery of insulin through the infusion set, and a third segment configured to reduce an oxide layer formed during the oxide step to at least partially regenerate the glucose monitor. Nardiello teaches a device wherein the first segment of the segmented waveform is used to detect analytes, the second segment is configured to oxidize an analyte, and the third segment is configured to reduce the surface redox groups on the electrode to clean the electrode surface (Figure 4, page 4 column 1, page 4 column 2 section 3.2). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to combine a device like that of Yang with the cyclic voltammetry method of Nardiello in order to effectively clean the electrode surface before measurement.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (WO 2013184416 A2), hereinafter Yang, as applied to claim 1 above in view of Wiktorowicz et al. (US 20210391050 A1), hereinafter Wiktorowicz.
Yang discloses all of the elements of the current invention discussed above except a device, wherein the glucose monitor is configured to sense a change in impedance or signal current at the at least one sensor and determine that the change is due to delivery of a bolus dosage of insulin. Wiktorowicz teaches a device which detects a bolus of insulin and adjusts glucose monitoring ([0056], [0074], [0076]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to combine a sensor like that of Yang with a configuration like that of Wiktorowicz to prevent the patient from becoming hyperglycemic and to maintain a regular blood sugar.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R UCHITEL whose telephone number is (571)305-5153. The examiner can normally be reached Mon-Fri from 8:30am – 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, can be reached at telephone number (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/ Supervisory Patent Examiner
Art Unit 3791
/EMILY R UCHITEL/ Examiner, Art Unit 3791
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