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
Claim(s) 12-17,20-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wechter et al (2017/0106197) and Rooney (2007/0073353).
12. (New) A neural stimulation device comprising:
at least one neural electrode comprising at least two electrical contacts and intended to
be implanted on at least one nerve; (see at least ¶73,75 of Wechter)
a current pulse generator connected to the at least one neural electrode via a current
distributor; (see at least ¶75 of Wechter which teaches output circuit 212 that produces stimulation pulses and the control circuit 214 distributes the stimulation pulses according to a specified pattern)
a storage element configured to contain a library of sequences, each sequence
comprising a time series of current pulses associated with a configuration of electrical
contacts; (see at least ¶87,97,106 of Wechter which teaches library of stimulation waveforms; see also at least figure 9)
a sequencer configured to apply neural activation to the at least one neural electrode,
said neural activation comprising at least two interleaved sequences. (see at least ¶94 of Wechter which teaches sequences of pulses for a specific therapy, and figures 29,30 which apply the stimulation according to the sequence selected by the user. Rooney teaches interleaving stimulation pulses, see at least ¶23. It would have been obvious to use such interleaving since it reduces accommodation, as explained in Rooney.
13. (New) The neural stimulation device according to claim 12, wherein the
sequences are interleaved alternately such that one of said sequences begins before another of
said sequences ends. (such is considered to be an obvious design choice yielding predictable results. The one of ordinary skill in the art would understand that a certain amount of experimentation is necessary in order to personalize the stimulation pattern for the specific patient’s condition)
14. (New) The neural stimulation device according to claim 12, wherein the
sequences to be interleaved comprise the same number of intervals, these intervals having the
same duration. (such is considered to be an obvious design choice yielding predictable results. The one of ordinary skill in the art would understand that a certain amount of experimentation is necessary in order to personalize the stimulation pattern for the specific patient’s condition)
15. (New) The neural stimulation device according to claim 12, further comprising a
controller configured to drive a succession of neural activations. (see at least ¶77 and figure 3 of Wechter which teaches a programming control device 316)
16. (New) The neural stimulation device according to claim 15, wherein the controller
configures the sequencer and then activates the sequences to be interleaved. (see at least figures 29,30 of Wechter which shows a sequence of stimulation waveforms chosen whereby the controller uses such selection to cause the stimulation to then deliver stimulation waveforms according to the selected sequence)
17. (New) The neural stimulation device according to claim 12, wherein the at least
one neural electrode comprises a plurality of electrical contact configurations. (see at least ¶73 of Wechter)
20. (New) The neural stimulation device according to claim 12, in which the
sequences comprise a succession of 5 to 100 current pulses, the said pulses being repeated at
a frequency comprised between 1 Hz and 1 kHz. (such is considered to be an obvious design choice yielding predictable results. The one of ordinary skill in the art would understand that a certain amount of experimentation is necessary in order to personalize the stimulation parameters for the specific patient’s condition)
21. (New) The neural stimulation device according to claim 12, wherein the sequence
library contains sequences personalized for a patient. (see at least ¶97 of Wechter)
22. (New) A neurostimulation method including:
the selection of at least two sequences from a sequence library, each sequence
comprising a time series of current pulses associated with a configuration of electrical
contacts; (see at least ¶89 of Wechter, which teaches user defined patterns of pulses, and ¶73-75 of Wechter which teaches sequences of pulses, and¶97 which teaches a library of specific waveform types)
the application of neural activation to at least one neural electrode comprising at least
two electrical contacts and intended to be implanted on at least one nerve, (see at least ¶73-75 of Wechter)
said neural activation comprising the interleaving of the at least two sequences and the addressing of the pulses of current from the at least two sequences to the at least two electrical contacts by a current distributor. (Wechter teaches a control circuit 214 that distributes the stimulation pulses according to a specified pattern. Rooney teaches interleaving stimulation pulses, see at least ¶23. It would have been obvious to use such interleaving since it reduces accommodation, as explained in Rooney.
23. (New) The neurostimulation method according to claim 22, wherein the sequences
are interleaved by applying alternately such that one of said sequences begins before another
of said sequences ends. (such is considered to be an obvious design choice yielding predictable results. The one of ordinary skill in the art would understand that a certain amount of experimentation is necessary in order to personalize the stimulation pattern for the specific patient’s condition)
24. (New) The neurostimulation method according to claim 22, further comprising
repeating the application of neural activation. (such is considered to be an obvious design choice yielding predictable results. The one of ordinary skill in the art would understand that a certain amount of experimentation is necessary in order to personalize the stimulation pattern for the specific patient’s condition)
25. (New) A neural activation including:
interleaving of at least two sequences chosen from a sequence library, each sequence
comprising a time series of current pulses associated with a current distribution between
several electrical contacts; (at least ¶73-75,78,94,97 of Wechter teaches a library including sequences of stimulation pulses, and the control circuit 214 distributes the stimulation pulses according to a specified pattern. Rooney teaches interleaving stimulation pulses, see at least ¶23. It would have been obvious to use such interleaving since it reduces accommodation, as explained in Rooney.)
addressing the current pulses of the at least two sequences to the at least two electrical
contacts of a neural electrode intended to be implanted on a nerve. (see at least ¶73-75 of Wechter that teaches various electrodes, where the sequences of stimulation pulses can be chosen, and stored for a particular patient. Once the sequences of pulses are configured and chosen by the user, the electrodes are addressed depending upon how the pules were assigned to each electrode, see at least ¶75 which teaches the stimulation control circuit 214, and figures 28-30 of Wechter)
26. (New) The neural activation according to claim 25, wherein the sequences are
interleaved alternately such that one of said sequences begins before another of said
sequences ends. (such is considered to be an obvious design choice yielding predictable results. The one of ordinary skill in the art would understand that a certain amount of experimentation is necessary in order to personalize the stimulation pattern for the specific patient’s condition)
Claim(s) 18,19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wechter et al (2017/0106197) and Rooney (2007/0073353), and further in view of Woods et al (2003/0114899).
18. (New) The neural stimulation device according to claim 12, wherein the current
pulses are load-balanced biphasic stimuli. (see at least ¶90 of Woods. It would have been obvious to use such with the device of Wechter since it would produce predictable results such as a balanced signal applied to the patient, leaving no residual charge)
19. (New) The neural stimulation device according to claim 18, wherein the first
phase of the load-balanced biphasic stimuli has an amplitude of between 10 µA and 6000 µA
and a duration of between 5 us and 1 ms. (such is considered to be an obvious design choice yielding predictable results. The one of ordinary skill in the art would understand that a certain amount of experimentation is necessary in order to personalize the stimulation parameters for the specific patient’s condition)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Scott M. Getzow whose telephone number is (571)272-4946. The examiner can normally be reached M-F 9-5.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792
