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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/17/2026, 01/22/2026, 09/29/2025, 09/03/2025 The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Newly submitted claims 25, 27, 28 and 31-35 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the dependents claims are directed to non-elected invention, and reciting same limitations from originally withdrawn claims.
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 Accordingly, claims 25, 27, 28 and 31-35 are withdrawn from consideration as being directed to a non-elected invention.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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 10, 11, 18-24, 29, 30 and 36-37 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by
Napadow et al (US 2020/0139126).
As to claims 1 and 20, Napadow teaches a neurotherapy system for treating a patient with electrical stimulation (systems and methods are provided for neurostimulation timed relative to respiratory activity, abstract), wherein the system comprises:
a pulse generator (pulse generator 206, par.33, fig.1-3 and/or 906, par.96, fig.9);
at least one implantable epidural electrode (implanted epidural electrode 904, par.96, fig.9) connected to the pulse generator;
at least one signal input module, which is configured to receive at least one or more signals being indicative for blood circulation herein the burst train stimulation comprises a series of 3 to 5 pulses.
Page 11 of 16;
at least one control module, wherein the control module is connected to the pulse generator and the signal input module (controller 214 and/or 914, par.49 and par.98, fig.3 and 9);
wherein the control module is configured to adapt the electrical stimulation provided by the neurotherapy system on the basis of the one or more signals received by the signal input module (par.43-45, par.54, and controller 914 is adapted to receive the detection signal and to generate an output signal for the stimulator 906, par.98, par.101-104);
wherein the electrical stimulation provided by the pulse generator to the electrode is burst train stimulation comprising parameters including stimulation pulses having a frequency, amplitude and pulse width, wherein the pulses are delivered at 10 Hz-10 kHz and/or 200 Hz to 700 Hz (pulses or other pulse architectures may be delivered at a frequency of about 1-100 Hz , or higher frequencies including up to about 20 KHz in some applications, par.37), the amplitude is in the range of 0-1 A or 0-15V (these stimulations or others may be delivered with a non-limiting current intensity in a range of 0.25 mA to 20 mA, par.37), the pulse width is in the range of 1-500 us (each pulse may have a pulse width that, in some non-limiting examples, may vary from about 100-1000 microseconds, par.37) and repeated at the frequency 10-120 Hz (par.37).
As to claims 2 and 21, Napadow teaches the neurotherapy system, wherein the neurotherapy system further comprises at least one real-time monitoring unit, wherein the at least one real-time monitoring unit comprises at least one sensor (pulse sensors 207 and/or 907 on the extremities to measure blood pressure in peripheral arteries and derive waveforms to calculate cardiac performance, and detection device 918 is adapted to detect pulmonary activity of the individual, par.98-99, fig. 3 and fig.9).
As to claims 3 and 22, Napadow teaches the neurotherapy system, wherein the signals being indicative for blood circulation are signals indicative for oxygenation and/or blood pressure (blood pressure cuff 203 and/or 903, par.98-99, fig. 3 and fig.9) and/or cumulative firing rates from at least one brainstem control area.
As to claims 4 and 23, Napadow teaches the neurotherapy system, wherein the at least one signal input module comprises an input switch module (par.64), wherein the input switch module is configured to switch between signals indicative for blood pressure and cumulative firing rates from at least one brainstem control area (provides stimulation fibers of cervical section of vagus nerve to treat hypertension also includes firing rate, par.27, par.48 and par.52).
As to claims 5 and 24, Napadow teaches the neurotherapy system, wherein the signal input module is configured to receive baseline signals, wherein the baseline signals define at least one target value (reference threshold, par.54).
As to claims 10 and 29, Napadow teaches the neurotherapy system, wherein the signal input module is or comprises at least one sensing element configured to sense a signal indicative for a physiological parameter of a patient circulation (blood pressure cuff 203 and/or 903, par.98-99, fig. 3 and fig.9);
at least one spatial mapping module configured to link spatial electrode stimulation configurations (Config) targeting the afferent fibers in the dorsal/posterior roots to at least one physiological effect (par.26);
at least one parameter mapping module configured to prepare stimulation parameters for the control module based on input received from the sensing element and/or the spatial mapping module (par.26, par.34).
As to claims 11 and 30, Napadow teaches the neurotherapy system, wherein the system comprises at least one stimulation element (pulse generator 206, par.33, fig.1-3 and/or 906, par.96, fig.9) comprising at least one electrode array A comprising multiple electrodes E (pulse generator 206 has multiple ear electrodes 204 to stimulate the corresponding afferent nerve fibers, par.34 and/or 904, par.96).
As to claims 18 and 36, Napadow teaches the neurotherapy system, wherein the physiological parameter is at least one of oxygenation, blood pressure of the patient (measuring blood pressure of a patient with blood pressure cuff 203 and/or 903, par.98-99, fig. 3 and fig.9), spinal cord perfusion pressure of the patient, posture of the patient and/or position of the patient.
As to claims 19 and 37, Napadow teaches the neurotherapy system, or treating a patient, including for enhancing at least one autonomous function such a blood circulation and/or respiration (enhancing respiration, abstract, see whole document).
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(s) 7 and 26 is/are rejected under 35 U.S.C. 103 as being obvious over Napadow et al (US 2020/0139126) in view of Stolen et al (US 20170079598).
As to claims 4 and 23, Napadow teaches the invention substantially as claimed above, but failed to explicitly teach to comprises a linear proportional control module, wherein the linear proportional control module is configured to modify at least one of amplitude and frequency of a stimulation paradigm in response to the at least one or more signals indicative for blood circulation with a coefficient p that controls the linear proportion with which the amplitude or frequency changes.
However, Stolen teaches comprises a linear proportional control module, wherein the linear proportional control module is configured to modify at least one of amplitude and frequency of a stimulation paradigm in response to the at least one or more signals indicative for blood circulation with a coefficient p that controls the linear proportion with which the amplitude or frequency changes (See Stolen [0103], may be adjusted by changing the amplitude, pulse frequency, and/or pulse width of the neural stimulation pulses within the burst.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Napadow’s invention with comprises a linear proportional control module, wherein the linear proportional control module is configured to modify at least one of amplitude and frequency of a stimulation paradigm in response to the at least one or more signals indicative for blood circulation with a coefficient p that controls the linear proportion with which the amplitude or frequency changes as taught by Stolen’s invention to adjust therapy.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being obvious over Napadow et al (US 2020/0139126).
As to claim 38, Napadow teaches the neurotherapy system, wherein the burst train stimulation comprises a constant-current stimulator that delivers bipolar pulses (pulse width of about 200 us), for example at about 15 Hz for about 1.5 seconds (par.51), but failed to explicitly teach the burst train stimulation comprises a series of 3 to 5 pulses.
However, it would have been obvious to one having an ordinary skill in the art at the time the invention was made to deliver burst train stimulation comprises a series of 3 to 5 pulses, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art, In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 5712725596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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