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 Objections
Claim 3 objected to because of the following informalities: Claim 3 is dependent on claim 2, however claim 2 has been cancelled so dependency is improper. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Simon (US 20220266015 A1) in view of Kim (AU 2015202180 A1) (both cited previously) and further in view of Poltorak(US 20210338973 A1).
Regarding claim 19, Simon discloses a stimulation system for changing cerebral spinal fluid flow rates through the brain comprising: a stimulator, the stimulator comprising a first electrode designed to stimulate a cranial nerve by creating a stimulator output(a stimulator including an electrode[abstract]); a modulator designed to provide a stimulation wave form to the stimulator(modulation unit for producing the electrical voltage/current profile of the stimulating, blocking and/or modulating impulse to the electrodes[0063]); a power controller designed to control the power of the stimulation wave to the stimulator(Nerve stimulating/modulating device 302 may be externally powered and/or recharged or may have its own power source 320[0062]); a communications module designed to receive instructions executable by one of the stimulator, the modulator system, or the power controller to change the stimulation wave; a vasomotion sensor(the computer program will then send data to the docking station, giving it the instructions needed to perform instrument diagnostic tests of the stimulator and docking station and to make the stimulator ready for the stimulation session[0117]) (Devices, systems and methods for treating various disorders and medical conditions through noninvasive stimulation of a nerve. A system comprises a stimulator including an electrode configured to contact an outer skin surface of a patient and an energy source coupled to the housing, The energy source generates an electrical impulse and the stimulator transmits the electrical impulse from the electrode transcutaneously through an outer skin surface of the patient to a selected nerve within the patient. The system further includes an application on a mobile device that receives data from a remote source. The mobile device couples to the stimulator and the application causes the mobile device to transmit the data to the stimulator[abstract]. In a preferred embodiment, the pulse generator 310 may be implemented using a power source 320 and a control unit 330 having, for instance, a processor, a clock, a memory, etc., to produce a pulse train 420 to the electrodes 340 that deliver the stimulating, blocking and/or modulating impulse 410 to the nerve[0062]. The preferred sensors will include ones ordinarily used for ambulatory monitoring. For example, the sensors may comprise those used in conventional Holter and bedside monitoring applications, for monitoring heart rate and variability, ECG, respiration depth and rate, core temperature, hydration, blood pressure, brain function, oxygenation, skin impedance, and skin temperature[0131]). The recitation “for changing cerebral spinal fluid flow rates through the brain” is an intended use recitation that fails to further define the claimed invention over that of the prior art. Simon fails to disclose wherein the stimulator output is configured to modulate cerebral spinal fluid flow in the brain.
However, Kin teaches “ non-specific stimulation refers to the fact that the stimulation energy is provided to all spinal levels including the nerves and the spinal cord generally and indiscriminately. Even if the epidural electrode is reduced in size to simply stimulate only one level, that electrode will apply stimulation energy indiscriminately to everything (i.e., all nerve fibers and other tissues) within the range of the applied energy 8. Moreover, larger epidural electrode arrays may alter cerebral spinal fluid (CSF) flow thus further altering local neural excitability states”(Background of Invention, Paragraph [0007]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the stimulation system of Simon with the neurostimulation systems of Kim. Doing so would specify the modulation or stimulation of the cerebral spinal fluid flow in the brain to alter neural states.
Simon further fails to disclose the cloud module or cloud connection in the system. However, Poltorak teaches the sensor signals are advantageously transmitted back to the user device to adjust the regime of stimulation. Of course, the communication path may be indirect to the user device, or the analysis of the signals may be remote from the user device, e.g., in a cloud computing center[0557].
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the stimulation system of Simon with the cloud center of Poltorak. Doing so would allow for the data obtained in the cloud during stimulation in order to back everything up to a remote device with no risk of data loss.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable by Simon(US 20220266015 A1) in view of Kim(AU 2015202180 A1) (both cited previously)..
Regarding claim 20, Simon teaches a stimulation method for changing cerebral spinal fluid flow rates through the brain, comprising: stimulating a nerve; modulating the stimulation; controlling the power of the stimulation; communicating stimulation instructions between a remote device and the stimulator(Devices, systems and methods for treating various disorders and medical conditions through noninvasive stimulation of a nerve. A system comprises a stimulator including an electrode configured to contact an outer skin surface of a patient and an energy source coupled to the housing, The energy source generates an electrical impulse and the stimulator transmits the electrical impulse from the electrode transcutaneously through an outer skin surface of the patient to a selected nerve within the patient. The system further includes an application on a mobile device that receives data from a remote source. The mobile device couples to the stimulator and the application causes the mobile device to transmit the data to the stimulator[abstract]. In a preferred embodiment, the pulse generator 310 may be implemented using a power source 320 and a control unit 330 having, for instance, a processor, a clock, a memory, etc., to produce a pulse train 420 to the electrodes 340 that deliver the stimulating, blocking and/or modulating impulse 410 to the nerve[0062]). Simon fails to disclose wherein the stimulator output is configured to modulate cerebral spinal fluid flow in the brain.
However, Kin teaches “ non-specific stimulation refers to the fact that the stimulation energy is provided to all spinal levels including the nerves and the spinal cord generally and indiscriminately. Even if the epidural electrode is reduced in size to simply stimulate only one level, that electrode will apply stimulation energy indiscriminately to everything (i.e., all nerve fibers and other tissues) within the range of the applied energy 8. Moreover, larger epidural electrode arrays may alter cerebral spinal fluid (CSF) flow thus further altering local neural excitability states”(Background of Invention, Paragraph [0007]).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the stimulation system of Simon with the neurostimulation systems of Kim. Doing so would specify the modulation or stimulation of the cerebral spinal fluid flow in the brain to alter neural states.
Allowable Subject Matter
Claims 1, 4-5, 7-15, and 21-23 are allowed over the prior art.
The following is a statement of reasons for the indication of allowable subject matter: It is in the opinion of the examiner that the art of record neither anticipated nor renders obvious the claimed material “a power controller designed to control the power of the stimulation wave to the first electrode and configured to control current amplitude between 100 microamps and 40 milliamps; a communications module integrated with the stimulator; an arterial pulsatility sensor; wherein the temporally patterned stimulation is configured to enhance cerebral arterial pulsatility to increase cerebrospinal fluid penetration into brain tissue and enhance glymphatic clearance” in combination with the rest of the independent claimed limitations.
Claim 3 is objected to as being dependent upon a cancelled base claim, but would be allowable if rewritten in independent form or proper dependent form, including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/20/2025, with respect to claim 1 have been fully considered and are persuasive. The 103 rejections of claim 1 and its dependent claims have been withdrawn in view of the amendments. However, amendments to claims 19 and 20 do not overcome the previous 103 rejections and the prior arguments with the art of record still stands.
Examiner’s Note
A telephone call was made to John M. Berns on 11/20/2025 to discuss a potential examiners amendment to further prosecution. No decision was made due to a lack of response.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796