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
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) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bohm et al. (USPN 2012/0078071-Cited by the Applicant).
Regarding claims 1, 9, 14-15, a method of continuously in vivo detecting an analyte in a body fluid over a time span ([0005]) using an analyte sensor with a working electrode that performs an electrochemical detection reaction with the analyte ([0227]) and a further electrode having a redox material composition with silver and silver chloride, the method comprising the following steps: i. monitoring a standard sensor signal derived by using the analyte sensor in a standard operation mode ([0175], [0189], “normal” operation mode), wherein, in the standard operation mode, potentiostatic measurements are performed for detecting the analyte with the analyte sensor, wherein a potential of the working electrode with respect to the further electrode is set to a predetermined standard operating potential and wherein a current through the working electrode and the further electrode is determined ([0126]); and ii. comparing the standard sensor signal with a threshold ([0218], the time span in normal mode considered as a threshold for the standard signal), thereby determining if a change of the analyte sensor from the standard operation mode into an economy operation mode is required ([0218], “low power mode”).
Regarding claim 2, the analyte is selected from the group consisting of glucose, lactate and glutamate ([0126]).
Regarding claim 3, iii. switching from the standard operation mode into the economy operation mode if, in step ii., it is determined that the change of the operation mode of the analyte sensor from the standard operation mode into the economy operation mode is required, wherein an economy sensor signal is generated in the economy operation mode ([0216], [0218]).
Regarding claim 4, the economy operation mode is performed either for a predetermined economy time span or until at least one condition for switching back from the economy operation mode into the standard operation mode is fulfilled ([0216], [0218]).
Regarding claim 5, in the economy operation mode, at least one economy sensor signal is generated by performing galvanostatic measurements for detecting the analyte with the analyte sensor, wherein a current through the working electrode and the further electrode is set to a predetermined economy current value, wherein an operating potential of the working electrode with respect to the further electrode is determined ([0246]).
Regarding claim 6, the predetermined economy current value is chosen not to exceed an electric threshold current through the working electrode and the further electrode occurring when the standard sensor signal equals the threshold ([0246]).
Regarding claim 7, iv. monitoring, when the analyte sensor is used in the economy operation mode, the economy sensor signal; and v. comparing the economy sensor signal with an economy threshold, thereby determining if a change of the analyte sensor from the economy operation mode back into the standard operation mode is required. vi. switching from the economy operation mode back into the standard operation mode if, in step v., it is determined that the change from the economy operation mode back into the standard operation mode is required ([0216], [0218]).
Regarding claim 8, the standard sensor signal and the economy sensor signal each are selected from the group consisting of electrical signals generated by the analyte sensor, electrical signals generated for regulating the analyte sensor, and secondary signals derived from electrical signals generated by the analyte sensor or for regulating the analyte sensor ([0216], [0218]).
Regarding claim 10, the further electrode comprises at least one layer comprising the redox material composition ([0246]).
Regarding claim 11, electrode is at least partially coated by an insulating material ([0264]).
Regarding claim 12, the insulating material leaves open at least one window through which the further electrode is accessible for the analyte ([0265]).
Regarding claim 13, the electrochemical analyte sensor comprises at least one membrane that is permeable for the analyte to be detected, the membrane at least partially surrounding the working electrode and the further electrode ([0229], [0297]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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