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 .
Election/Restrictions
Claims 41-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 19, 2025. Currently claims 1-11 and 41-49 are pending in this application, with claims 41-19 withdrawn from consideration.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ackermann (WO 2020/010020) in view of Palmer (US 8,121,703).
Regarding claim 1, Ackermann discloses a system for electrically modulating tissue comprising:
a current generator (e.g. [0072]; direct current generator);
at least one implantable working electrode, the at least one implantable working electrode configured to be in electrical communication with the current generator (e.g. [0081]; implantable electrode in electrical communication with the current generator);
a controller configured to signal the current generator (e.g. [0081]; a controller) to:
generate a set of currents with a set of initial polarities to be delivered to the working electrodes for a time period (e.g. [0081]; generating a first current with a first polarity proximal to the at least one electrode and generating a second current with a second polarity proximal to the at least one electrode sufficient to increase the amount of stored charge in the at least one electrode); and
wherein the magnitudes of the currents are less than a threshold current amplitude corresponding to a current amplitude required to achieve acute blockade in neural tissue (e.g. [0010]; the system puts the target nerve(s) in a state of acute nerve block; [0079] sensing the amount of at least one of the first component and the second component and ceasing delivering the first direct current when the amount of the first component reaches a predetermined minimum threshold value) and
cause neural suppression in the neural tissue after the time period (e.g. [0013]; putting the target nerves in a state of acute nerve suppression.; [0030] delivering a prolonged block to neural tissue).
Ackermann fails to disclose at least one indifferent electrode. Palmer discloses that indifferent electrodes are well known in the art of implanted medical devices (e.g. col 4, ln 54-56; indifferent electrode that is relatively distant from the electrode contacts). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system, as disclosed by Ackermann, as to include at least one indifferent electrode, as disclosed by Palmer, to improve the electrical contacts and be an efficient electrode arrangement.
Regarding claim 2, Ackermann additionally disclose wherein the time period is a predetermined time period, as the time period is chosen by the clinician.
Regarding claim 3, Ackermann further discloses wherein the controller is configured to signal the current generator to generate the set of currents in a closed loop mode of operation, an open loop mode of operation, or other mode of operation (e.g. Figure 63, para [0356] blocking and non-blocking phases)
Regarding claim 4, Ackermann further discloses wherein the controller is configured to signal the current generator to cause neural suppression in the neural tissue after the time period and without causing sensory deficit (e.g. [0253] localizing the pain block to specific regions of the body can also help preserve normal sensory function in other regions of the body).
Regarding claim 5, Ackermann further discloses wherein the set of currents is sufficient to modulate electrically excitable tissue (e.g. [0009] the system modulates the electrical potential near the nerve to put the nerve tissue; [0086] charge into excitable tissue without damaging the excitable tissue).
Regarding claim 6, Ackermann further discloses wherein the at least one implantable working electrode comprises a high charge capacity material (e.g. [0225]; electrode contact itself can be fabricated of a high charge capacity material).
Regarding claim 7, Ackermann further discloses wherein the controller is further configured to signal the current generator to generate a bias current (e.g. [0320] charge exchanged between the working and counter electrodes may be slightly biased such that more charge is being deposited on the counter electrode than on the working electrode with each cycle).
Regarding claim 8, Ackermann further discloses wherein the bias current operates in an anodic polarity (e.g. [0079] first direct current can be an anodic or cathodic current and the second direct current can be a cathodic or an anodic current; [0235] in Phase 1, charge can be delivered to the electrode cell with a given polarity Phase 1 is anodic).
Regarding claim 9, Ackermann further discloses wherein the bias current operates in a cathodic polarity (para [0079]- The first direct current can be an anodic or cathodic current and the second direct current can be a cathodic or an anodic current.; para [0235]- In Phase 1, charge can be delivered to the electrode cell with a given polarity. Phase 1 is either cathodic).
Regarding claim 10, Ackermann further discloses wherein the current generator is configured to generate the bias current that biases the working electrode voltages cathodically (e.g. [0079] first direct current can be an anodic or cathodic current.; Figure 1C, [0235] current can be associated with charge delivered to the electrode cell-nerve interface, In Phase 1, charge can be delivered to the electrode cell with a given polarity Phase 1 is either cathodic).
Regarding claim 11, Ackermann further discloses wherein the current generator is configured to generate the bias current that biases the indifferent electrode voltages anodically (e.g. [0079] first direct current can be an anodic or cathodic current).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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