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 .
Response to Arguments
Applicant’s arguments filed 12/09/2025 have been fully considered but are moot in view of new grounds of rejection.
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.
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.
Claims 10-11, 13-19, and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Burdick et al. (US 2019/0374777) in view of Schwarz (US 2017/0333705).
In re claim 10, Burdick discloses
a neuromodulation method [0057] to restore at least one of
motor function ([0057]: restore movement),
autonomic function blood pressure control [0084],
bladder function [0070],
bowel function [0070], or
sexual function [0070],
comprising:
equipping a patient (fig. 2: 102) with a neuromodulation device (120; [0057]),
wherein the patient has a spinal cord injury [0057] manifesting in at least one dysfunction of
motor function ([0057]: spinal cord injury resulting in decrease in musculoskeletal function; [0084]),
blood pressure control [0084, 0070],
bladder function [0084, 0070],
bowel function [0084, 0070], or
sexual function ([0070]: sexual function is improved by activating selected spinal circuit which means patient must have some dysfunction of sexual function);
wherein the neuromodulation device comprises
a neuromodulation controller (fig. 5: 250; [0131]: 250 controls stimulation and includes 252; fig. 8),
at least one a programmer ([0110]: control unit 150 is a programmer that programs 120), and
a lead (fig. 1: 130) including at least one electrode (140),
providing neuromodulation data ([0058]: stimuli parameters for delivering stimulation waveform; [0110]: external system 150 programs 120; [0093]: neurostimulator device 120 is programmed with stimulation parameters) to the neuromodulation device [0110, 0093], and
providing neuromodulation to the patient using the neuromodulation device according to the neuromodulation data [0058, 0083],
wherein the neuromodulation data specifies neuromodulation being on top of a carrying frequency of at least 1 kHz [0198],
and wherein the at least one programmer is configured to communicate with the neuromodulation controller [0132-0133], characterized by the programmer having at least one interface component (152; [0110]: 150 communicates with 152) that allows
a user (102) to perform operations including selecting, starting, and/or stopping a task ([0154]: user interface can be used to select stimulation parameters), and
including configuring stimulation parameters of the neuromodulation [0154],
the programmer being further configured to allow adjustment of the stimulation parameters of a task ([0154]: user interface may queue up a particular sequence of stimuli while treatment is provide), thereby enabling tuning of the stimulation ([0154]: adjusting particular sequence stimulation would also tune stimulation).
Burdick fails to discloses the programmer being further configured to allow adjustment of the stimulation parameters of a task while the task is running, thereby enabling tuning of the stimulation without stopping and restarting the task.
Schwarz teaches an apparatus [0009] that provides stimulation to soft tissue [0009], comprising a programmer (fig. 1: 102), wherein the programmer is in communication with a user interface (103; [0015]: handheld), and teaches wherein the programmer is configured to allow adjustment of stimulation parameters of a task while the task is running ([0015]: parameters changed during treatment without stopping the treatment), thereby enabling tuning of the stimulation without stopping and restarting the task [0015].
Schwarz further teaches that treatment parameters may be adjusted manually [0133] based on feedback information [0133] minimize discomfort [0133], and treatment may be stopped if the treatment parameters are determined to not be safe [0133].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the neuromodulation method taught by Burdick, to provide the programmer being further configured to allow adjustment of the stimulation parameters of a task while the task is running, thereby enabling tuning of the stimulation without stopping and restarting the task, as taught by Schwarz, because treatment parameters may be adjusted manually based on feedback information to minimize discomfort and treatment may continue as long as the treatment parameters are determined to be safe.
In re claim 11, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation device is an implantable [0095-0096] pulse generator [0087].
In re claim 13, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation device is configured to provide at least one of
transcutaneous electrical stimulation,
epidural electrical stimulation [0080],
subdural electrical stimulation,
functional electrical stimulation,
intramuscular stimulation,
dorsal root ganglion stimulation, or
peripheral nervous system stimulation [0074].
In re claim 14, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the carrying frequency is between 1 and 15 kHz [0198].
In re claim 15, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation data specifies at least one of
a tonic [0108],
a burst, or
a high-frequency
waveform [0108].
In re claim 16, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation data specifies at least one of
a ramp,
mono-phasic [0091],
rectified [0227],
bi-phasic [0091],
exponential or
sawtooth [0227]
pulse shape (see above).
In re claim 17, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation data specifies at least one of
stimulation frequency [0058],
stimulation amplitude [0058],
stimulation current,
pulse width [0058], or
electrode configuration ([0058]: waveform applied via selected electrodes).
In re claim 18, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation data specifies multipolar stimulation ([0058]: multiple electrodes are used to provide stimulation which is interpreted as multipolar stimulation).
In re claim 19, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation is provided to treat pain of the patient [0005, 0198].
In re claim 21, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation device further comprises at least one sensor (fig. 2: any one of sensors 188, 190-192, 158, and 166; [0104, 0112]), wherein the sensor is at least one of
an inertial measurement unit,
an optical sensor ([0104]: light sensor),
a camera (166; [0112]),
a piezo element,
a velocity sensor,
an accelerometer [0112],
a magnetic sensor,
a torque sensor,
a pressure sensor [0104],
a displacement sensor,
a contact sensor,
an EMG measurement unit [0104],
an electroneurogram measurement unit,
a goniometer,
a Hall sensor,
a gyroscope [0104],
a motion tracking video camera, or
an infra-red camera.
In re claim 22, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the patient manifests dysfunction of motor function [0003, 0057].
In re claim 23, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the patient manifests dysfunction of blood pressure control (see in re claim 1 above).
In re claim 24, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the patient manifests dysfunction of bowel function (see in re claim 1 above).
In re claim 25, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the patient manifests dysfunction of sexual function (see in re claim 1 above).
In re claim 26, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation device further comprises a powering device [0095-0098] to provide energy to at least one component of the neuromodulation device [0095-0098].
In re claim 27, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) wherein the neuromodulation device further comprises
a communication module ([0149-0150]: external controller) and/or
telemetry module ([0094): wireless transmission].
In re claim 28, the proposed combination yields (all mapping directed to Burdick unless otherwise stated) therein the communication module and/or telemetry module includes an antenna (fig. 8: 272; [1050]) electrically coupled to at least one of a receiver or a transmitter ([0149-0150]: can receive signals and send them, therefore, there must be both a receiver and a transmitter).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Burdick et al. (US 2019/0374777) in view of Schwarz (US 2017/0333705) in view of Edgerton et al. (US 2016/0121109).
In re claim 20, the proposed combination fails to yield wherein the neuromodulation data specifies a stimulation pattern including a high-frequency modulating signal superimposed on one or both phases of a biphasic stimulation pulse.
Edgerton teaches a system for delivering stimulation [0050] to a portion of a patient’s spinal cord [0023] and teaches wherein neuromodulation data ([0084]: neuromodulation system generates first signal and second signal) specifies a stimulation pattern [0084] including a high-frequency modulating signal [0180] superimposed on one or both phases of a biphasic stimulation pulse ([0180]: biphasic signal and an overlapping high frequency pulse; [0084]).
Edgerton further teaches that a high-frequency superimposed biphasic stimulation pulse induces voluntary movement [0002].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the neuromodulation method yielded by the proposed combination, to provide wherein the neuromodulation data specifies a stimulation pattern including a high-frequency modulating signal superimposed on one or both phases of a biphasic stimulation pulse, as taught by Edgerton, because that a high-frequency superimposed biphasic stimulation pulse induces voluntary movement.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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