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.
Claims 1, 3-5, 7-20 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over VOJKAN
et al. EP: EP 4306161 A1, hereinafter Vojkan.
Regarding claim 1, Vojkan teaches a system for controlling selective stimulation of neural tissue
(10) of a subject, said system comprising: a first electrode arrangement (114), comprising a plurality of electrodes, wherein different electrodes of the plurality of electrodes are configured to be arranged in different electrode locations in relation to a first longitudinal position of the neural tissue (10) (fig. 2; paragraph 33 and 123-126); The electrodes of the first pair of electrodes 114 may be displaced in relation to each other along a longitudinal direction of the nerve 10.
a second electrode arrangement (134), comprising at least one electrode and configured to be arranged at a second longitudinal position of the neural tissue (10) (fig. 2; paragraph 33 and 123-126); The electrodes of the second pair of electrodes 134 may also be displaced in relation to each other along a longitudinal direction of the nerve 10.
and a stimulation signal generating unit (110), wherein the stimulation signal generating unit (110) is configured to generate a first intermittent current waveform comprising a first pulse and a second intermittent current waveform comprising a second pulse, wherein the first pulse comprises a first frequency and the second pulse comprises a second frequency, wherein the second frequency is different from the first frequency (fig. 2; paragraph 91-98); The first intermittent current waveform may comprise a varying signal defining the first frequency within each of the first pulses. Similarly, the second intermittent current waveform comprises a varying signal defining the second frequency within each of the second pulses.
wherein the stimulation signal generating unit (110) is configured to output the first intermittent current waveform to a first pair of electrodes of the first electrode arrangement (114) and the second intermittent current waveform to a second pair of electrodes of the first electrode arrangement (134), thereby causing interferential stimulation of a plurality of nerve fibers of the neural tissue (10) (fig. 2; paragraph 90-133 and 155-191); The interferential signal 52 has a frequency content including the first frequency and the second frequency. Further, the amplitude of the interferential signal 52 is modulated by a difference between the first frequency and the second frequency, X-Y, defining a beat frequency of the interferential signal 52.
wherein the interferential stimulation of each of the nerve fibers of the plurality of nerve fibers is configured to activate stimulation of the nerve fiber at a specific time point, thereby initiating propagation of signals through the neural tissue (10) towards the second longitudinal position (fig. 2; paragraph 90-133 and 155-191); The control unit 160 may further be configured to synchronize the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 such that the first waveform, the second waveform and the third waveform are output simultaneously or almost simultaneously with a desired time relation to each other.
wherein the stimulation signal generating unit is configured to generate a blocking pulse and to output the blocking pulse to the at least one electrode of the second electrode arrangement (134), thereby temporally selectively blocking propagation of signals through the neural tissue (10) at the second longitudinal position (fig. 2; paragraph 55, 69, 90-133 and 155-191). The first frequency and the second frequency may, while not causing generation of signals in the nerve or part of the nervous system, be configured to block a signal transported by the nerve or the part of the nervous system.
Regarding claim 3, Vojkan teaches wherein the stimulation signal generating unit (110) is
configured to generate the blocking pulse comprising at least a pulse width for defining a time duration during which temporally selectively blocking propagation of signals through the neural tissue (10) occurs (fig. 2; paragraph 55, 69, 90-133 and 155-191); The control unit 160 may further be configured to synchronize the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 such that the first waveform, the second waveform and the third waveform are output simultaneously or almost simultaneously with a desired time relation to each other. The first frequency and the second frequency may, while not causing generation of signals in the nerve or part of the nervous system, be configured to block a signal transported by the nerve or the part of the nervous system.
Regarding claim 4, Vojkan teaches wherein the blocking pulse is achieved by anodal blocking
(fig. 2, paragraph 298, 300). Each stimulation waveform can comprise a series of continuous pulses, intermittent pulses, and/or spurious pulses. In some embodiments, implantable device 200 delivers a multiphasic pulse comprising at least two cathodic pulses and/or anodic pulses, with or without any time between each pulse.
Regarding claim 5, Vojkan teaches wherein the second electrode arrangement (134) comprises a
plurality of electrodes, and wherein different electrodes of the plurality of electrodes are configured to be arranged in different electrode locations in relation to the second longitudinal position of the neural tissue (10) (fig. 2; paragraph 33 and 123-126); The electrodes of the second pair of electrodes 134 may also be displaced in relation to each other along a longitudinal direction of the nerve 10.
Regarding claim 7, Vojkan teaches wherein the system further comprises a third electrode
Arrangement (144), comprising at least one electrode and configured to be arranged at a third longitudinal position of the neural tissue (10), and wherein the second longitudinal position of the neural tissue (10) is located in a first direction along the neural tissue (10) in relation to the first longitudinal position and the third longitudinal position of the neural tissue (10) is located in a second direction along the neural tissue (10) in relation to the first longitudinal position, wherein the second direction is opposite to the first direction (fig. 2; paragraph 91-104 and 119-134). The third current generator may be configured to generate a third waveform and to output the third waveform to the third pair of electrodes 144. The third pair of electrodes 144 are arranged in a third location in relation to the nerve 10.
Regarding claim 8, Vojkan teaches wherein the stimulation signal generating unit (110)
comprises a first current generator (112), configured to generate the first intermittent current waveform and a second current generator (132), configured to generate the second intermittent current waveform (fig. 2; paragraph 91-98 and 107-118). The second stimulation generating module 132 may comprise a second current generator, which may be connected to a second pair of electrodes 134.
Regarding claim 9, Vojkan teaches wherein the stimulation signal generating unit comprises a
third current generator, configured to generate the blocking pulse (fig. 2; paragraph 55, 69, 91-104 and 119-134). The third current generator may be configured to generate a third waveform and to output the third waveform to the third pair of electrodes 144. The third pair of electrodes 144 are arranged in a third location in relation to the nerve 10.
Regarding claim 10, Vojkan teaches wherein the system is configured to be at least partially
implanted in the subject (fig. 2; paragraph 194). The device 100 is suitable for being implanted (for which energy saving is particularly important in order to ensure long lifetime of the implanted device or avoid frequent charging of the implanted device).
Regarding claim 11, Vojkan teaches wherein the stimulation generating unit (110) is configured
to generate a first frequency and a second frequency, respectively, being in a range of 100 Hz-1 MHz, such as 10 kHz-100 kHz (fig. 2; paragraph 184-185). The first waveform is a sinusoidal signal having a first frequency of 10 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 11 kHz and an amplitude of 1 mV.
Regarding claim 12, Vojkan teaches wherein the stimulation signal generating unit is configured
to generate the first intermittent current waveform and the second intermittent current waveform with a difference in frequency in a range of 1 Hz - 10 kHz, such as 1 - 5 kHz (fig. 2; paragraph 184-185). The first waveform is a sinusoidal signal having a first frequency of 10 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 11 kHz and an amplitude of 1 mV. The difference is 1 kHz.
Regarding claim 13, Vojkan teaches wherein the stimulation signal generating unit is configured
to generate the first intermittent current waveform and the second intermittent current waveform with a time duration of the first pulse and the second pulse corresponding to a portion of a period of a beat frequency (fig. 2; paragraph 184-185). In the second time interval, the first waveform is a sinusoidal signal having a first frequency of 10 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 10.2 kHz and an amplitude of 1 mV. The first and second waveforms are synchronized with a common phase relation of 90° at start of the first time interval.
Regarding claim 14, Vojkan teaches wherein the first pulse and the second pulse are sinusoidal
signals (fig. 2; paragraph 184-185). The first waveform is a sinusoidal signal having a first frequency of 10 kHz and an amplitude of 1 mV. The second waveform is a sinusoidal signal having a second frequency of 11 kHz and an amplitude of 1 mV. The difference is 1 kHz.
Regarding claim 15, Vojkan teaches further comprising a carrier arrangement (170) configured
to conform to an outer surface of the neural tissue (10), wherein the first electrode arrangement (114) and the second electrode arrangement (134) are arranged in the carrier arrangement (170) (fig. 2; paragraph 33 and 123-127). The device 100 may comprise a carrier 170, such as in the form of a cuff, in which the first pair of electrodes 114, the second pair of electrodes 134.
Regarding claim 16, Vojkan teaches wherein the carrier arrangement (170) comprises a first
carrier unit and a second carrier unit, each configured to conform to the outer surface of the neural tissue (10), wherein the first electrode arrangement (114) is arranged in the first carrier unit and the second electrode arrangement (134) is arranged in the second carrier unit (fig. 2; paragraph 33 and 123-127). The device comprises a carrier configured to be arranged in relation to the nerve or the part of the nervous system, wherein the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes are mounted in or on the carrier. Therefore, inside the carrier may be the first carrier unit and the outside of the carrier may by the second carrier unit.
Regarding claim 17, Vojkan teaches wherein the carrier arrangement (170) has a form of a cuff
configured to be arranged around a nerve (10) (fig. 2; paragraph 33 and 123-127); The device 100 may comprise a carrier 170, such as in the form of a cuff, in which the first pair of electrodes 114, the second pair of electrodes 134.
Regarding claim 18, Vojkan teaches a method for controlling selective nerve stimulation of
neural tissue (10) of a subject, said method comprising: providing a first intermittent current waveform comprising a first frequency to a first pair of electrodes of a first electrode arrangement (114) at a first longitudinal position of the neural tissue (fig. 2; paragraph 33, 91-98, and 123-126); The electrodes of the first pair of electrodes 114 may be displaced in relation to each other along a longitudinal direction of the nerve 10. The first intermittent current waveform may comprise a varying signal defining the first frequency within each of the first pulses
providing a second intermittent current waveform comprising a second frequency to a second pair of electrodes of the first electrode arrangement (134) at the first longitudinal position of the neural tissue (10) (fig. 2; paragraph 33, 91-98, and 123-126); The electrodes of the second pair of electrodes 134 may also be displaced in relation to each other along a longitudinal direction of the nerve 10. The second intermittent current waveform comprises a varying signal defining the second frequency within each of the second pulses.
stimulating a plurality of nerve fibers of the neural tissue (10) using interferential stimulation based on interference between the first intermittent current waveform and the second intermittent current waveform (fig. 2; paragraph 90-133 and 155-191); The interferential signal 52 has a frequency content including the first frequency and the second frequency. Further, the amplitude of the interferential signal 52 is modulated by a difference between the first frequency and the second frequency, X-Y, defining a beat frequency of the interferential signal 52.
wherein the interferential stimulation of each of the nerve fibers of the plurality of nerve fibers is configured to activate stimulation of the nerve fiber at a specific time point, thereby initiating propagation of signals through the neural tissue towards a second longitudinal position (fig. 2; paragraph 90-133 and 155-191); The control unit 160 may further be configured to synchronize the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 such that the first waveform, the second waveform and the third waveform are output simultaneously or almost simultaneously with a desired time relation to each other.
and providing a blocking pulse to a second electrode arrangement (134), thereby temporally selectively blocking of propagation of signals through the neural tissue (10) at a second longitudinal position of the neural tissue (10) (fig. 2; paragraph 55, 69, 90-133 and 155-191). The first frequency and the second frequency may, while not causing generation of signals in the nerve or part of the nervous system, be configured to block a signal transported by the nerve or the part of the nervous system.
Regarding claim 19, Vojkan teaches further comprising synchronizing the blocking pulse with
respect to the interferential stimulation, such that temporally selectively blocking of propagation of signals through the neural tissue is achieved (fig. 2; paragraph 55, 69, 90-133 and 155-191); The control unit 160 may further be configured to synchronize the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 such that the first waveform, the second waveform and the third waveform are output simultaneously or almost simultaneously with a desired time relation to each other. The first frequency and the second frequency may, while not causing generation of signals in the nerve or part of the nervous system, be configured to block a signal transported by the nerve or the part of the nervous system.
Regarding claim 20, Vojkan teaches further comprising synchronizing the first pulse and the
second pulse, such that an interferential signal is provided (fig. 2; paragraph 55, 69, 90-133 and 155-191); The control unit 160 may further be configured to synchronize the first stimulation generating module 112, the second stimulation generating module 132, and the third stimulation generating module 142 such that the first waveform, the second waveform and the third waveform are output simultaneously or almost simultaneously with a desired time relation to each other. The interferential signal 52 has a frequency content including the first frequency and the second frequency. Further, the amplitude of the interferential signal 52 is modulated by a difference between the first frequency and the second frequency, X-Y, defining a beat frequency of the interferential signal 52.
Claim Rejections - 35 USC § 103
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Vojkan in view of MISHRA
et al. US Pub.: US 20240278022 A1, hereinafter Mishra.
Regarding claim 2, Vojkan does not teach wherein the blocking pulse is configured to
hyperpolarize the neural tissue at the second longitudinal position, such that the propagation of signals through the neural tissue is prevented.
Mishra teaches an apparatus for enhance stimulation waveforms and further teaches wherein the blocking pulse is configured to hyperpolarize the neural tissue at the second longitudinal position, such that the propagation of signals through the neural tissue is prevented (paragraph 214). Stimulation elements 260 can be positioned to hyperpolarize and/or block innervated sections of the muscle that will then propagate an activating and/or inhibiting stimulus along the nerve fibers recruiting muscle tissue remote from the site of stimulation and/or modulate nerve activity (including inhibiting nerve conduction, improving nerve conduction and/or improving muscle activity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulses of Vojkan to hyperpolarize the neural tissue at any given electrode arrangement from Mishra for the benefit of inhibiting nerve conduction, improving nerve conduction and/or improving muscle activity.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Vojkan in view of PLACHTA
et al. US Pub.: US 20170304630 A1, hereinafter Plachta.
Regarding claim 6, Vojkan does not teach wherein the stimulation signal generating unit is
configured to generate a repolarization pulse and to output the repolarization pulse to the at least one electrode of the second electrode arrangement following the blocking pulse.
Plachta teaches an implantable electrode assembly and further teaches wherein the
stimulation signal generating unit is configured to generate a repolarization pulse and to output the repolarization pulse to the at least one electrode of the second electrode arrangement following the blocking pulse (paragraph 97). In the same manner as the first function generator F1, the second function generator F2 is also capable of producing individual pulses which are each composed of a polarizing (charging) and a repolarizing (discharging) rectangular signal portion.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulses of Vojkan to repolarize the neural tissue at any given electrode arrangement from Plachta for the benefit of significantly improving the performance and safety of neural recording and stimulation system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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/T.J.T./Examiner, Art Unit 3792
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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