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 .
Election/Restrictions
Newly submitted claim 29 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Invention I (claims 10-11, 13, 15-18, 20-22, 26-28, and 30-34) and Invention II (claim 29) are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j).
In the instant case, the inventions as claimed have a materially different design, mode of operation, function, or effect. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
For example, invention I recites “at least one sensor configured to acquire a measure of the physiological condition” (claim 10), whereas invention II does not.
Additionally, invention II recites “wherein the neuromodulation data specifies a stimulation pattern comprising a plurality of relative amplitudes and a scaling factor for scaling the plurality of relative amplitudes to generate respective stimulation amplitudes for application to the patient”, whereas invention I does not.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits.
Accordingly, claim 29 is withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments filed 08/18/2026 have been fully considered and are not persuasive or are moot in view of new grounds of rejection.
In response to applicant's argument that Schwarz is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
In this case, Schwarz teaches an apparatus [0009] that provides stimulation to soft tissue [0009], comprising a programmer (fig. 1: 102) and teaches wherein the programmer is configured to allow adjustment of treatment parameters based on feedback [0127-0128] to minimize discomfort [0133].
This is pertinent to the particular problem with which Burdick is concerned with, since Burdick aims to iteratively optimize stimulation parameters based on feedback [0006, 0251].
Applicant argues, “Burdick operates by algorithmic selection from a library of discrete, pre-defined stimulation arms: it applies identified arms sequentially, records feedback, updates reward values, and selects a subsequent arm. Burdick, Abstract, [0009]-[0012]. Burdick's principle of operation is thus arm-switching-stopping one pre-defined stimulation arm and starting another. The claimed invention operates differently: it adjusts the stimulation parameters associated with a running task, based on a treatment result, without interrupting the task. Modifying Burdick to tune the parameters of a currently running task without interruption would not refine Burdick; it would replace Burdick's defining arm-selection mechanism with a different mode of operation, changing its principle of operation. Importing Schwarz's approach compounds the problem. Schwarz teaches stopping treatment when parameters are determined to be unsafe. Office Action at 5 (citing Schwarz [0133]). Incorporating a stop-treatment mechanism into Burdick's sustained-optimization framework, in the context of the claimed uninterrupted in-task adjustment, would render Burdick unsuitable for its intended purpose of delivering optimized, sustained neuromodulation. A person of ordinary skill would therefore have had reason not to make the proposed combination.”
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as discussed above, Burdick and Schwarz are both directed to using feedback to adjust stimulation parameters, and Schwarz teaches that treatment parameters may be adjusted [0133] based on feedback information [0133] to 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 yielded by the proposed combination, to provide wherein the at least one programmer is further configured to allow the stimulation parameters associated with the task to be adjusted, based at least in part on the treatment result, while the task is running and without interrupting 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.
Further, examiner respectfully states that there is no evidence that the proposed combination would render Burdick unsuitable for its intended purpose of delivering optimized, sustained neuromodulation, since Schwarz is merely used to teach “wherein the at least one programmer is further configured to allow the stimulation parameters associated with the task to be adjusted… while the task is running and without interrupting the task”, because allowing the stimulation parameters to be adjusted while the task is running and without interrupting the task would minimize discomfort and ensure the treatment parameters are safe, as discussed above.
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, 15-18, 21-22, 26-28, and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Burdick et al. (US 2019/0374777) in view of Schepis et al. (US 2017/0326351) 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),
the at least one dysfunction being associated with a physiological condition of the patient ([0070]: the dysfunctions would be related to a physiological condition of the patient; [0072]: motor paralysis may be caused by a neurodegenerative brain injury);
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),
at least one sensor configured to acquire a measure of the physiological condition ([0104]: any one of sensors 188, for instance, an accelerometer), and
a lead (fig. 1: 130) including at least one electrode (140),
wherein the at least one programmer is configured to communicate with the neuromodulation controller [0132-0133], the at least one programmer having at least one interface component (152; [0110]: 150 communicates with 152) that allows
a user (102) to select, start, or stop a task ([0154]: user interface can be used to select stimulation parameters), and
the at least one programmer being operable to configure stimulation parameters of the neuromodulation [0154],
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],
providing neuromodulation to the patient using the neuromodulation device according to the neuromodulation data [0058, 0083],
acquiring, using the at least one sensor ([0067]: patient response to stimuli provides feedback, which may come from sensors) and after beginning provision of the neuromodulation ([0067]: feedback is from patient’s response to stimuli and therefore must be received after beginning neuromodulation), the measure of the physiological condition ([0067]: sensor such as gyroscope may be used, which would provide a measure of a physiological condition such as a movement disorder [0005]);
determining a treatment result ([0214]: previous feedback from a patient i.e. treatment result is determined); and
wherein the at least one programmer is further configured to allow the stimulation parameters associated with the task to be adjusted ([0214]: next optimal stimulation pattern is determined based on previous feedback; [0154]), based at least in part on the treatment result ([0214]: previous feedback is used to adjust treatment; [0237]: correlation among arms based on feedback reflects condition of a patient; [0154]).
Burdick fails to discloses
determining a treatment result based at least in part on a comparison of the acquired measure to a baseline for the physiological condition; and
wherein the at least one programmer is further configured to allow the stimulation parameters associated with the task to be adjusted… while the task is running and without interrupting the task.
Regarding the limitation, “determining a treatment result based at least in part on a comparison of the acquired measure to a baseline for the physiological condition”, Schepis teaches a method for non-invasively monitoring a medical condition of a patient [0006], and teaches
determining a treatment result ([0122]: threshold intensity at which a motor response is elicited in a subject receiving treatment decreases when there is improvement or alleviation of a subject’s symptoms from a medical condition, which requires determining a treatment result; [0111]) based at least in part on a comparison of an acquired measure to a baseline for a physiological condition ([0122]: treatment result is determined based on comparison of a threshold intensity to a baseline intensity; [0097]: motor response compared to baseline current; [0111]),
wherein the acquired measure comprises a measure of movement ([0122]: motor response would be movement; [0097]: motor response compared with baseline; [0106]: motor response would be a visible twitch), and
wherein the treatment result a desired therapeutic response ([0122]: treatment result may be an improvement or alleviation of a subject’s symptoms which would be a desired therapeutic response; [0111]).
Schepis further teaches that comparing the intensity with the baseline [0122, 0111] indicates that the treatment is effective at improving a medical condition [0111].
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 determining a treatment result based at least in part on a comparison of the acquired measure to a baseline for the physiological condition, wherein the acquired measure comprises a measure of movement, and wherein the treatment result a desired therapeutic response, as taught by Schepis, because comparing the intensity with a baseline indicates that the treatment is effective at improving a medical condition.
Regarding the limitation, “wherein the at least one programmer is further configured to allow the stimulation parameters associated with the task to be adjusted… while the task is running and without interrupting 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 based at least in part on a treatment result ([0132]: feedback treatment information is used to adjust therapy parameters; [0015]) while the task is running ([0015]: parameters changed during treatment without stopping the treatment) and without interrupting 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 yielded by the proposed combination, to provide wherein the at least one programmer is further configured to allow the stimulation parameters associated with the task to be adjusted, based at least in part on the treatment result, while the task is running and without interrupting 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 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 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 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).
In re claim 30, the proposed combination yields (all mapping is directed to Schepis unless otherwise stated) wherein the baseline comprises a measure of the physiological condition previously acquired from the patient ([0122]: intensity corresponds to subject’s condition and baseline intensity would be a previously acquired measure from the patient; [0097, 0111]).
In re claim 31, the proposed combination yields (all mapping is directed to Schepis unless otherwise stated) wherein determining the treatment result comprises determining whether the acquired measure, relative to the baseline, satisfies at least one criterion for effective stimulation ([0122]: acquired measure may be a motor response and improvement would be correlated with a lower threshold intensity compared to the baseline intensity; [0097, 0111]).
In re claim 32, regarding the limitation, “wherein the acquired measure comprises a measure of at least one of
movement,
blood pressure, or
an autonomic response of the patient”,
see in re claim 10 above.
In re claim 33, regarding the limitation, “wherein the treatment result indicates at least one of
a desired therapeutic response,
an ineffective response,
no response, or
a negative stimulation effect”,
see in re claim 10 above.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Burdick et al. (US 2019/0374777) in view of Schepis et al. (US 2017/0326351) 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.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Burdick et al. (US 2019/0374777) in view of Schepis et al. (US 2017/0326351) in view of Schwarz (US 2017/0333705) in view of Linden et al. (US 2020/0306528).
In re claim 34, the proposed combination fails to yield wherein the adjustment of the stimulation parameters comprises modification of at least one of
a stimulation amplitude,
a stimulation pattern,
an electrode configuration, or
a location targeted for activation.
Linden teaches a medical apparatus [0003] for delivering stimulation [0003] and teaches wherein an adjustment of stimulation parameters [0452] comprises modification of a stimulation amplitude ([0452]: accelerometer 561 may be used to make stimulation adjustments; [0042]: adjustments include amplitude to improve efficiency; [0545], 0233]).
Linden further teaches that adjusting amplitude maintains effective treatment [0453], and may be adjusted based on patient movement ([0545]: amplitude adjusted based on patient posture measured from the accelerometer).
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 adjustment of the stimulation parameters comprises modification of a stimulation amplitude, as taught by Linden, because adjusting amplitude maintains effective treatment, and may be adjusted based on patient movement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Grosskopf et al. (US 2018/0110990) discloses an implantable stimulation device (abstract) and teaches a smart watch [0018] with a motion sensor [0018] that adjusts amplitude [0018] for stimulation [0018].
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
/DAVID HAMAOUI/SPE, Art Unit 3796
