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 .
Remarks
This action is in response to the remarks filed 07/15/2026.
Claims 1-6 and 9-24 are pending and are under consideration.
Response to Arguments
Applicant’s arguments, see page 6, filed 07/15/2026, with respect to objection of claim 2 have been fully considered and are persuasive. The objection of claim 2 has been withdrawn.
Applicant’s arguments, see page 7, filed 07/15/2026, with respect to the rejection of claims 11-14 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 11-14 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see page 7, filed 07/15/2026, with respect to the rejection of claims 17-19 under 35 U.S.C. 101 for reciting a part of a human have been fully considered and are persuasive. Claims 17-19 have been amended to recite language that overcomes this rejection. Therefore, the rejection of claims 17-19 under 35 U.S.C. 101 for reciting a part of a human has been withdrawn.
Applicant’s arguments, see page 7, filed 07/15/2026, with respect to the rejection of claims 1-21 under 35 U.S.C. 101 have been fully considered and are persuasive. Independent claim 1 has been amended to recite the limitation of “adjust a therapy of the patient based on the one or more statistics.” This limitation integrates the abstract idea into a practical application. Therefore, the rejection of claims 1-21 under 35 U.S.C. 101 has been withdrawn.
Applicant’s arguments, see page 8, filed 07/15/2026, with respect to the rejection of claims 1, 2, 5, 6, and 10-22 under 35 U.S.C. 102(a)(1) and claims 3, 4, and 7-9 under 35 U.S.C. 103 have been fully considered and are persuasive. Independent claims 1 and 22 have been amended, claims 7-8 have been cancelled, and new claims 23 and 24 have been added. Applicant argues that the amendments to the claims overcome the prior art rejections applied. Examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made, as explained in the office action below. New claims 23 and 24 are addressed in the office action below.
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, 2, 5, 6, and 10-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodall et al. (International Publication WO 2018/111997, of record), hereinafter Goodall.
Regarding claim 1, Goodall discloses a method of enhanced motor learning (e.g. Abstract), the method comprising: identifying a patient as suffering from a motor-impairment associated with a volitional movement (e.g. page 10, lines 23-27: using the system for rehabilitation after stroke); rehabilitating a motor function of the patient by: stimulating a cutaneous distribution of a patient's vagus nerve within the patient's ear with a nerve stimulating signal (e.g. page 14, lines 3-13; page 31, lines 6-7; page 37, lines 26-27); assisting the patient in performing a physical activity while the patient's vagus nerve is stimulated, wherein the nerve stimulating signal is delivered in coordination with a detected initiation of the volitional movement (e.g. page 38, lines 25-33: a dancer uses the stimulation system while dancing; page 38, line 30 – page 39, line 7: the stimulator provides neural stimulation coinciding with the dancer’s movements); monitoring one or more statistics of the patient during the physical activity (e.g. page 39, lines 8-22: the dancer’s performance is monitored through sensors and cameras) and adjust a therapy of the patient based on the one or more statistics (e.g. page 39, lines 19-20: neural stimulation parameters are modified based on the performance analysis).
Regarding claim 2, Goodall further discloses determining movement performance for the patient, and adjusting one or more parameters of the nerve stimulating signal to change the movement performance (e.g. page 39, lines 19-20: neural stimulation parameters are modified based on the performance analysis).
Regarding claim 5, Goodall further discloses wherein the physical activity is assisted by a software visualization on a mobile computer device (e.g. page 14, lines 19-21: prompting system prompts the user to perform an activity; page 17, lines 30-32: prompting system is implemented on a personal computing device).
Regarding claim 6, Goodall further discloses wherein the identifying the patient from the motor-impairment includes identifying the patient previously suffered at least one of a stroke, a spinal cord injury, or a traumatic brain injury (e.g. page 10, lines 23-27: using the system for rehabilitation after stroke).
Regarding claim 10, Goodall further discloses wherein the volitional movement is associated with a specific task (e.g. page 10, lines 23-27: using the system for learning or enhancing a new skill such as playing an instrument or performing a sports action).
Regarding claim 11, Goodall further discloses wherein the specific task is an athletic activity (e.g. page 10, lines 23-27: using the system for learning or enhancing a new skill such as playing an instrument or performing a sports action).
Regarding claim 12, Goodall further discloses wherein the specific task is a musical activity (e.g. page 10, lines 23-27: using the system for learning or enhancing a new skill such as playing an instrument or performing a sports action).
Regarding claim 13, Goodall further discloses wherein the specific task is a surgical activity (e.g. page 10, lines 31-33: system is used by a healthcare provider).
Regarding claim 14, Goodall further discloses wherein the volitional movement includes complex motor movement (e.g. page 10, lines 23-27: using the system for learning or enhancing a new skill such as playing an instrument or performing a sports action, which are understood to be complex motor movements; page 61, line 24 – page 62, line 7: describing Fig. 33 which shows a flow diagram of a method of training a subject to perform a complex motor task).
Regarding claim 15, Goodall further discloses wherein the stimulation is electrical stimulation of the vagus nerve (e.g. page 14, lines 3-13; page 31, lines 6-7; page 37, lines 26-27).
Regarding claim 16, Goodall further discloses wherein the stimulation is vibrotactile stimulation of the vagus nerve (e.g. page 60, lines 25-27: vibrotactile device can be used).
Regarding claim 17, Goodall further discloses attaching a first electrode and a second electrode to the concha of the patient's ear, the stimulation is provided via the first electrode and the second electrode (e.g. page 37, lines 9-12: delivering stimulation to the concha of the ear; page 37, lines 18-27: bipolar electrode configuration).
Regarding claim 18, Goodall further discloses wherein the attaching first electrode and the second electrode includes attaching the first electrode and the second electrode to the patient's left ear (e.g. Fig. 32: stimulation device 3205 shown on left ear of the user; page 37, lines 18-27: bipolar electrode configuration on each ear).
Regarding claim 19, Goodall further discloses wherein the attaching first electrode and the second electrode includes positioning the first electrode and the second electrode such that the stimulation is provided to the auricular branch of the vagus nerve (e.g. page 51, lines 6-12: providing stimulation to the auricular branch of the vagus nerve; page 31, lines 9-11: delivering stimulation to a neural structure innervating a pinna of the ear).
Regarding claim 20, Goodall further discloses receiving a plurality of patient attributes associated with the patient, analyzing the plurality of patient attributes, and determining one or more parameters of the nerve stimulating signal based on the analyzed patient attributes (e.g. page 39, lines 8-20: the training system monitors and processes the user’s attributes and modifies the stimulation parameters).
Regarding claim 21, Goodall further discloses receiving a plurality of monitored statistics of the patient from previous treatments, analyzing the plurality of monitored statistics, and determining one or more parameters of the nerve stimulating signal based on the analyzed monitored statistics (e.g. page 51, lines 20-22: stimulation controlled based on performance evaluation and comparison to previous performances; page 52, lines 10-13: performance evaluation is applied and uses previous stored data; page 59, lines 15-22: using previous data).
Regarding claim 22, Goodall discloses a system for enhanced motor learning (e.g. Abstract), the system comprising one or more electrodes (e.g. page 14, lines 3-13; page 31, lines 6-7; page 37, lines 26-27; page 37, lines 9-12: delivering stimulation to the concha of the ear; page 37, lines 18-27: bipolar electrode configuration); and a computer device (e.g. Abstract: system implemented with a computing device) configured to provide, via the electrodes, an electrical current to a vagus nerve of a patient suffering from a motor-impairment associated with a volitional movement (e.g. page 10, lines 23-27: using the system for rehabilitation after stroke), the electrical current provided with an electrical signal during a physical activity (e.g. page 14, lines 3-13; page 31, lines 6-7; page 37, lines 26-27; page 38, lines 25-33: a dancer uses the stimulation system while dancing), wherein the electrical signal is configured to stimulate a cutaneous distribution of a patient's vagus nerve within the patient's ear with a nerve stimulating signal (e.g. page 14, lines 3-13; page 31, lines 6-7; page 37, lines 26-27); assist the patient in performing the physical activity while the patient's vagus nerve is stimulated, wherein the nerve stimulating signal is delivered in coordination with a detected initiation of the volitional movement (e.g. page 38, lines 25-33: a dancer uses the stimulation system while dancing; page 38, line 30 – page 39, line 7: the stimulator provides neural stimulation coinciding with the dancer’s movements); monitor one or more statistics of the patient during the physical activity (e.g. page 39, lines 8-22: the dancer’s performance is monitored through sensors and cameras); and adjust a therapy of the patient based on the one or more statistics (e.g. page 39, lines 19-20: neural stimulation parameters are modified based on the performance analysis).
Regarding claim 23, Goodall discloses a method of enhancing performance of a motor task of a person via an exercise program (e.g. Abstract), the method comprising: stimulating a cutaneous distribution of a patient's vagus nerve within the person's ear with a nerve stimulating signal (e.g. page 14, lines 3-13; page 31, lines 6-7; page 37, lines 26-27); guiding the person in performing a physical activity while the person's vagus nerve is stimulated, wherein the nerve stimulating signal is delivered in coordination with a detected initiation of the volitional movement, the volitional movement associated with the motor task (e.g. page 38, lines 25-33: a dancer uses the stimulation system while dancing; page 38, line 30 – page 39, line 7: the stimulator provides neural stimulation coinciding with the dancer’s movements); monitoring one or more statistics of the patient during the physical activity (e.g. page 39, lines 8-22: the dancer’s performance is monitored through sensors and cameras); and adjust the exercise program of the person based on the one or more statistics (e.g. page 39, lines 19-20: neural stimulation parameters are modified based on the performance analysis).
Regarding claim 24, Goodall further discloses stimulating the cutaneous distribution of a patient's vagus nerve via a vibration (e.g. page 60, lines 25-27: vibrotactile device can be used).
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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al. (International Publication WO 2018/111997, of record), hereinafter Goodall, as applied to claim 1 above, and further in view of Edgerton et al. (US Patent Application Publication 2018/0280693 – APPLICANT CITED ON IDS, of record), hereinafter Edgerton.
Regarding claim 3, Goodall fails to disclose wherein the physical activity is assisted by a powered exoskeleton that assists and/or guides the physical activity of the patient. Edgerton, in a similar field of endeavor, is directed towards using a neuromodulation stimulator and a robotic exoskeleton. Edgerton discloses using a powered exoskeleton to assist the user in performing a physical activity (e.g. Abstract; Pars. [0171]-[0173]: powered exoskeleton for providing assistance in locomotion to the user; Fig. 1: exoskeleton with trunk portion 110 and lower leg supports 112; Fig. 2: powered orthotic system 200).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Goodall to include the exoskeleton as taught by Edgerton because doing so would allow the user to supplement neurostimulation with the exoskeleton to assist the user in standing and walking (e.g. Edgerton, par. [0005]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al. (International Publication WO 2018/111997, of record), hereinafter Goodall, as applied to claim 1 above, and further in view of Goldwasser et al. (US Patent Application Publication 2017/0224990 – APPLICANT CITED ON IDS, of record), hereinafter Goldwasser.
Regarding claim 4, Goodall fails to disclose wherein the physical activity is assisted by a virtual reality headset. Goldwasser, in a similar field of endeavor, is directed towards neuromodulation. Goldwasser discloses using a virtual reality headset to control the neuromodulation (e.g. Par. [0781]; Par. [0075]: device is worn during daily activities).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Goodall to include the virtual reality headset as taught by Goldwasser in order to introduce a sensory experience during the stimulation (e.g. Goldwasser, par. [0781]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al. (International Publication WO 2018/111997, of record), hereinafter Goodall, as applied to claim 1 above, and further in view of Edgerton et al. (US Patent Application Publication 2014/0296752 – APPLICANT CITED ON IDS, of record), hereinafter Edgerton’752.
Regarding claim 9, Goodall fails to disclose wherein the patient previously suffers from multiple sclerosis. Edgerton’752, in a similar field of endeavor, is directed towards inducing motor control in mammals through stimulation. Edgerton’752 discloses wherein the patient previously suffers from multiple sclerosis (e.g. Par. [0010]; Par. [0046]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Goodall to include wherein the patient previously suffers from multiple sclerosis as taught by Edgerton’752 to provide stimulation to control motor faculties affected by multiple sclerosis (e.g. Edgerton’752, par. [0010]; par. [0046]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Badran et al. (US 2022/0296889, of record) discloses a system for neurorehabilitation with vagus nerve stimulation.
Simon et al. (US 11,191,953, of record) discloses systems and methods for vagal nerve stimulation.
Covalin et al. (US 2021/0213286, of record) discloses a neurostimulation device wearable around the ear of the patient.
Howard (US 2019/0381314, of record) discloses transcutaneous nerve stimulation to enhance speed and quality of cognitive brain function.
Goodall et al. (US 2018/0169411, of record) discloses a prompting system for enhancing learning with neural modulation.
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 SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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