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
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 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 1-20 and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pena Serrada et al (U.S. 2022/0257945). Pena Serrada discloses (Fig. 1A-1B) (a) one or more electrodes (par. 0071, “Intraneural electrodes can be intrafascicular (inside the nerve fascicles) and/or interfascicular (between fascicles)”) operational to associate with at least one fascicular nerve fiber region of the subject; (b) a stimulator in electrical communication with the one or more electrodes, wherein the stimulator is operational to provide one or more electrical pulses to the one or more electrodes and thereby stimulate at least one fascicular nerve fiber region (par. 0072, “neurostimulation platform can be configured to deliver these pulses from two or more independent stimulation channels arranged in an interfering configuration, oriented perpendicular to the direction of the nerve (in a “transverse” electrode placement, where the nerve is located in between each electrode pair) so that their current paths cross each other.”); and (c) a signal processing unit (par. 0020, “processor”) in electrical communication with the one or more electrodes and the stimulator, wherein the signal processing unit is operational to measure on-target and off-target activation by the stimulated electrodes (par. 0031, “an effective start or stop of a pulse may be defined as the point at which the change in signal is first or last observable at a particular point in a given system (e.g., when a voltage or current is first measurable at a target nerve in a subject.) In some embodiments, pulses, voltages, currents, and other stimulation parameters may also be measured relative to a specified non-zero reference.”).
Regarding claim 2, Pena Serrada discloses (par. 0073) a pulse processing unit in electrical communication with the signal processing unit, wherein the pulse processing unit is operational to adjust one or more electrode stimulation parameters based on measurements from the signal processing unit; and a pulse generator in electrical communication with the pulse processing unit and one or more electrodes, wherein the pulse generator is operational to provide the one or more adjusted electrical pulses to the one or more electrodes based on one or more adjusted electrode stimulation parameters from the pulse processing unit.
Regarding claim 3, Pena Serrada discloses (par. 0117) a controller, wherein the controller is operational to control one or more stimulation parameters by the one or more electrodes.
Regarding claim 4, Pena Serrada discloses (par. 0117) the controller comprises a graphical user interface (GUI), wherein the GUI is operational to display one or more stimulation parameters by the one or more electrodes (par. 0225).
Regarding claim 5, Pena Serrada discloses (par. 0078) one or more sensors operational to assess physiological and neural responses from the subject due to the neurostimulation, and wherein the signal processing unit is operational to measure bio-signals from the one or more sensors.
Regarding claim 6, Pena Serrada discloses (par. 0078) the one or more sensors are at least a muscle activation monitor.
Regarding claim 7, Pena Serrada discloses (par. 0078) the pulse processing unit and the signal processing unit are in the form of a closed loop system.
Regarding claim 8, Pena Serrada discloses (par. 0071) the one or more electrodes comprise intrafascicular electrodes.
Regarding claim 9, Pena Serrada discloses (par. 0071) the one or more electrodes are at least intrafascicular electrodes.
Regarding claim 10, Pena Serrada discloses (par. 0071) (a) associating the at least one fascicular nerve fiber region of the nerve with one or more electrodes; (b) utilizing a stimulator in electrical communication with the one or more electrodes to provide one or more electrical pulses to the one or more electrodes and thereby stimulate the at least one fascicular nerve fiber region (par. 0072); and (c) utilizing a signal processing unit (par. 0020) in electrical communication with the one or more electrodes and the stimulator to measure on-target and off-target activation by the stimulated electrodes (par. 0031).
Regarding claim 11, Pena Serrada discloses (par. 0073) utilizing a pulse processing unit in electrical communication with the signal processing unit to adjust one or more electrode stimulation parameters based on measurements from the signal processing unit.
Regarding claim 12, Pena Serrada discloses (par. 0073) utilizing a pulse generator in electrical communication with the pulse processing unit and the one or more electrodes to provide the one or more adjusted electrical pulses to the one or more electrodes based on one or more adjusted electrode stimulation parameters from the pulse processing unit.
Regarding claim 13, Pena Serrada discloses (par. 0006) the one or more stimulation parameters are at least pulse width.
Regarding claim 14, Pena Serrada discloses (par. 0117) utilizing a controller associated with the pulse processing unit to control one or more stimulation parameters by the one or more electrodes.
Regarding claim 15, Pena Serrada discloses (par. 0117) measuring bio-signals from one or more sensors in electrical communication with the signal processing unit.
Regarding claim 16, Pena Serrada discloses (par. 0260) associating a single electrode with a single fascicle of the nerve.
Regarding claim 17, Pena Serrada discloses (par. 0260) the electrode activates the single fascicle in the nerve with more than one fascicle without activating neighboring fascicles.
Regarding claim 18, Pena Serrada discloses (par. 0260) associating a plurality of electrodes with a single fascicle of the nerve.
Regarding claim 19, Pena Serrada discloses (par. 0260) the plurality of electrodes activates a subpopulation of nerve fibers within the same fascicle.
Regarding claim 20, Pena Serrada discloses (par. 0079) stimulating peripheral nerves.
Regarding claim 23, Pena Serrada discloses (par. 0090) the method is used to treat or prevent one or more conditions in the subject.
Regarding claim 24, Pena Serrada discloses (par. 0090) the one or more conditions are at least neuropathic pain.
Regarding claim 25, Pena Serrada discloses (par. 0006) the subject is a human being.
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 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Pena Serrada et al (U.S. 2022/0257945). Pena Serrada discloses the claimed invention except for stimulating sciatic or vagus nerves. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the stimulation of the peripheral or other nerves as taught by Pena Serrada, with the stimulation of the sciatic or vagus nerves, because the applicant has not disclosed the stimulation at this location provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with the stimulation at the locations as taught by Pena Serrada, because Pena Serrada’s method treats neuropathic pain, as in the claimed invention. Therefore, it would have been an obvious matter of design choice to modify Pena Serrada to obtain the invention as specified in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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