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
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-29 and 31-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2016/0162662 A1 to Monirabbasi et al. (“Monirabbasi”) in view of US 2017/0164881 A1 to Fujita et al. (“Fujita”).
As to claims 21 and 31 (the method claims are treated with the apparatus claims, mutatis mutandis) microneedle array-based analyte monitoring device, comprising:
a working electrode (Fig 30, element 502);
a reference electrode (Fig 30, element 506);
a counter electrode (Fig 39, element 504) ; and
a controller configured to transition the microneedle array-based analyte monitoring device to a mode of operation based on a comparison of a counter electrode voltage at the counter electrode and a sensing current indicative of a redox reaction of an analyte at a surface of the working electrode (see [0325]-[0334] – “The sensor resistance Rs can be obtained indirectly by measuring the analog sensor signal Isig and the counter electrode voltage Vcnt and then calculating the resistance, Rs=Vcnt/Isig…. In preferred embodiments, the sensor is recalibrated or replaced when the change in the sensor resistance Rs since the last calibration exceeds a threshold, or the rate of change of the sensor resistance dRs/dt exceeds another threshold. In particular embodiments, the rate of change of the sensor resistance dRs /dt may be compared to two thresholds as shown in FIG. 32.”).
Monirabbasi suggests that microneedles may be used in such a system, but it is not explicitly clear that such microelectrodes comprise
a first microneedle comprising a working electrode,
a second microneedle comprising a reference electrode, and
a third microneedle comprising a counter electrode.
Fujita discloses such microneedle electrodes (see Figs 3-5A-B, elements 1, 2, 3 and [0073]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the electrode and controller of Monirabbasi with the microneedles of Fujita given the explicit suggestion to do so given by Monirabbasi given that such a combination would amount to the application of a known technique to a known device ready for improvement to yield the predictable result that is a microneedle electrode sensing system that can determine when a sensor needs calibration or is at its end of life.
As to claims 22 and 32, Monirabbasi further discloses wherein the controller is configured to transition the microneedle array-based analyte monitoring device to the mode of operation in response to the counter electrode voltage meeting or exceeding one of a threshold rate of change and a threshold compliance limit (see [0330]).
As to claims 23 and 33, Monirabbasi further discloses wherein the mode of operation corresponds to a correlation between the counter electrode voltage and the sensing current (see Fig 32).
As to claims 24 and 34, Monirabbasi further discloses wherein when a rate of change of the counter electrode voltage exceeds the threshold rate of change and corresponds with a rate of change of the sensing current, the mode of operation comprises disregarding the sensing current (see Fig 32 – a recalibration requirement inherently disregards the sensing current).
As to claims 25 and 35, Monirabbasi further discloses wherein the mode of operation comprises considering the sensing current to determine an analyte concentration when the rate of change of the counter electrode voltage is less than the threshold rate of change (see Fig 32 – sensing current is always used to determine analyte concentration under normal operating conditions).
As to claims 26 and 36, Monirabbasi further discloses wherein the rate of change of the counter electrode voltage exceeding the threshold rate of change and corresponding with the rate of change of the sensing current is indicative of a pressure-induced attenuation, and
wherein the mode of operation comprises considering the sensing current to determine an analyte concentration when a source of the pressure-induced attenuation is removed (see [0333] – a brief anomalous signal like a pressure-induced attenuation over a brief time will be ignored).
As to claims 27 and 37, Monirabbasi further discloses wherein when the counter electrode voltage meets the threshold compliance limit, the mode of operation comprises discontinuing application of a potential between the working electrode and the reference electrode (the limitations of claim do not require the particularities of this claim given that the threshold rate of change may be used to transition from one mode to another rather than the threshold compliance limit).
As to claims 28 and 38, Monirabbasi further discloses wherein when a rate of change of the counter electrode voltage exceeds the threshold rate of change and deviates from a rate of change of the sensing current, the mode of operation comprises discontinuing application of a potential between the working electrode and the reference electrode (see Fig 32 – replacing the sensor inherently involves discontinuing application of a potential between the working electrode and the reference electrode given that these elements are removed (i.e., disconnected from power) and replaced).
As to claims 29 and 39, Monirabbasi further discloses an analog front end configured to maintain a fixed potential relationship between the working electrode and the reference electrode and to allow the counter electrode voltage to swing to sustain a redox reaction at the working electrode (see Fig 7).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monirabbasi in view of Fujita as applied to claim 21 above, and further in view of US 2007/0151868 A1 to Staib et al. (“Staib”).
As to claim 30, neither Monirabbasi nor Fujita discloses
a fourth microneedle comprising a second working electrode,
wherein the mode of operation is further based on a second sensing current indicative of a redox reaction at a surface of the second working electrode.
However, in a similar invention, Staib discloses
a fourth microneedle comprising a second working electrode (see Fig 2, elements 2 and 3),
wherein the mode of operation is further based on a second sensing current indicative of a redox reaction at a surface of the second working electrode (see [0024]-[0030]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the invention of Monirabbasi/Fujita with the second working electrode and mode of operation based on its sensing current as disclosed by Staib in order to achieve the predictable result of increasing measurement accuracy across a wide range of analyte concentrations.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monirabbasi in view of Fujita and further in view of US 2009/0057148 A1 to Wieder et al. (“Wieder”).
As to claim 40, Monirabbasi discloses a microneedle array-based analyte monitoring device, comprising:
a working electrode (Fig 30, element 502);
a reference electrode (Fig 30, element 506);
a counter electrode (Fig 39, element 504) ; and
a controller configured to transition the microneedle array-based analyte monitoring device to a mode of operation based on a counter electrode voltage at the counter electrode,
wherein, when a rate of change of the counter electrode voltage exceeds a threshold rate of change and corresponds with a rate of change of a sensing current at a surface of the working electrode, the mode of operation comprises disregarding the sensing current (see [0325]-[0334] – “The sensor resistance Rs can be obtained indirectly by measuring the analog sensor signal Isig and the counter electrode voltage Vcnt and then calculating the resistance, Rs=Vcnt/Isig…. In preferred embodiments, the sensor is recalibrated or replaced when the change in the sensor resistance Rs since the last calibration exceeds a threshold, or the rate of change of the sensor resistance dRs/dt exceeds another threshold. In particular embodiments, the rate of change of the sensor resistance dRs /dt may be compared to two thresholds as shown in FIG. 32.” Examiner notes that requiring replacement or recalibration comprises disregarding the sensing current.),
Monirabbasi suggests that microneedles may be used in such a system, but it is not explicitly clear that such microelectrodes comprise
a first microneedle comprising a working electrode,
a second microneedle comprising a reference electrode, and
a third microneedle comprising a counter electrode.
Fujita discloses such microneedle electrodes (see Figs 3-5A-B, elements 1, 2, 3 and [0073]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the electrode and controller of Monirabbasi with the microneedles of Fujita given the explicit suggestion to do so given by Monirabbasi given that such a combination would amount to the application of a known technique to a known device ready for improvement to yield the predictable result that is a microneedle electrode sensing system that can determine when a sensor needs calibration or is at its end of life.
Neither Monirabbasi nor Fujita discloses
wherein, when the counter electrode voltage meets a threshold compliance limit, the mode of operation comprises discontinuing application of a potential between the working electrode and the reference electrode.
However, Wieder teaches when the counter electrode voltage meets a threshold compliance limit, the mode of operation comprises discontinuing application of a potential between the working electrode and the reference electrode (see [0027]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the sensor of Monirabbasi/Fujita with the discontinuing application of a potential between the working electrode and the reference electrode after meeting a threshold compliance limit as taught by Wieder in order to provide the predictable result of preventing damage to the sensor.
Given that both Monirabbasi and Fujita disclose the separate instances of disregarding/discontinuing the operation of the potential when either the exceeding of a threshold rate of change and corresponds with a rate of change of a sensing current at a surface of the working electrode or when the counter electrode voltage meets a threshold compliance limit, it would have been obvious to discontinue application of the potential between the working electrode and the reference electrode as an application of simple logic to provide the predictable result preventing bad readings from being relied upon and/or preventing damage to the sensor.
Conclusion
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791