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
Claims 1-22, filed 12/04/2023, are currently pending and are under consideration.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2, line 1, “The method of enhanced of claim 1” should read “The method of claim 1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 depends on itself. For examination purposes, claim 11 will be understood to depend on independent claim 1.
Claims 12-14 are rejected based on their dependency on claim 11.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method for enhanced motor learning. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed towards a method and thus meets the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 recites a method of enhanced motor learning, comprising monitoring statistics of the patient during a physical activity. The claims recite the following step that is abstract:
Monitoring statistics of the patient during the physical activity (mental process),
The limitation for enhanced motor learning, as drafted in claims 1-21, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper or with a generic computer. For example, enhancing motor learning in the context of this claim encompasses the user monitoring the patient during a physical activity.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The recited additional elements are:
Stimulating a patient’s vagus nerve,
Assisting the patient in performing a physical activity,
Using a powered exoskeleton (claim 3),
Using a virtual reality headset (claim 4), and
Using electrodes for the stimulation (claims 17 and 18).
The steps of stimulating a patient’s vagus nerve and assisting the patient in performing a physical activity are insignificant extra-solution activity (see MPEP 2106.05(g)).
The additional elements of a powered exoskeleton, virtual reality headset, and electrodes are recited at a high level of generality (i.e., as generic elements used to perform the insignificant extra solution activity of data gathering). The powered exoskeleton, virtual reality headset, and electrodes provide generic structure for the insignificant, extra-solution activity of data gathering.
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of a powered exoskeleton, virtual reality headset, and electrodes amounts to no more than generically claimed computer components which enable the above-identified abstract idea to be conducted by performing the basic functions of automating mental tasks. The powered exoskeleton, virtual reality headset, and electrodes provide generic structure for the insignificant, extra-solution activity of data gathering. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Further, it is routine, conventional, and well-known to use powered exoskeleton, virtual reality headset, and electrodes to assist users and provide stimulation, as taught by the art rejections in the office action below.
The additional elements do not amount to more than generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP 2106.05(h). Therefore, the claims are not patent eligible.
Claims 2-21 depend on claim 1 recite the same abstract idea as claim 1 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2, 20, and 21 (i.e. receiving data, analyzing data, and adjusting parameters) are simply further data gathering and data analysis steps. The limitations of claim 5 (i.e. providing software visualization) is simply a data output/visualization step. The limitations of claims 6-14 (i.e. specifying patient conditions and specific tasks) are simply clarifying the types of patients and tasks to be performed. The limitations of claims 15, 16, 18, and 19 (i.e. specifying the type and location of stimulation) are simply providing further details for the extra-solution activity of providing stimulation. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
Claims 17-19 are rejected under 35 U.S.C. 101 because they are drawn to non-statutory subject matter. Applicant recites part of a human, i.e. “wherein the first electrode and the second electrode are attached to the concha of the patient’s ear” (claim 17, lines 2-3), “the first and second electrode are attached to the patient’s left ear” (claim 18, lines 1-2), “wherein the stimulation is provided to the auricular branch of the vagus nerve” (claim 19, lines 1-2). Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The dependent claims inherit the deficiency.
The examiner suggests using the phrase “configured to”. For example, the limitation of claim 17 would read: “wherein the first electrode and the second electrode are configured to be attached to the concha of the patient’s ear”. The limitation of claim 18 would read: “the first and second electrode are configured to be attached to the patient’s left ear”, and the limitation of claim 19 would read: “wherein the stimulation is configured to be provided to the auricular branch of the vagus nerve”.
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 10-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodall et al. (International Publication WO 2018/111997), hereinafter Goodall.
Regarding claim 1, Goodall discloses a method of enhanced motor learning (e.g. Abstract), the method comprising: 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 (e.g. page 38, lines 25-33: a dancer uses the stimulation system while dancing); and 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).
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 patient previously suffered a stroke (e.g. page 10, lines 23-27: using the system for rehabilitation after stroke).
Regarding claim 10, Goodall further discloses wherein the patient is neurologically normal and wants to enhance motor performance of 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 specific task 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 wherein the stimulation is provided via a first electrode and a second electrode, wherein the first electrode and the second electrode are attached to the concha of the patient's ear (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 first electrode and the second electrode are attached 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 stimulation is provided to the auricular branch of the vagus nerve where the vagus nerve travels in the pinna of the ear (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 an electrical stimulation device including 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), wherein the electrical stimulation device is configured to provide an electrical current to a patient's vagus nerve 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).
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), 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), 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), 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), 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]).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al. (International Publication WO 2018/111997), 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), hereinafter Edgerton’752.
Regarding claim 7, Goodall fails to disclose wherein the patient previously suffered a spinal cord injury. 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 suffered a spinal cord injury (e.g. Par. [0034]: stimulation applied to facilitate restoration of locomotion for users suffering from spinal cord injuries).
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 suffered from a spinal cord injury as taught by Edgerton’752 to provide stimulation to treat paralysis caused by injury (e.g. Edgerton’752, par. [0010]).
Regarding claim 8, Goodall fails to disclose wherein the patient previously suffered a traumatic brain injury. 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 suffered a traumatic brain injury (e.g. Par. [0035]: stimulation applied to facilitate restoration of locomotion for users suffering from brain injury).
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 suffered from a traumatic brain injury as taught by Edgerton’752 to provide stimulation to treat paralysis caused by injury (e.g. Edgerton’752, par. [0010]).
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) discloses a system for neurorehabilitation with vagus nerve stimulation.
Simon et al. (US 11,191,953) discloses systems and methods for vagal nerve stimulation.
Covalin et al. (US 2021/0213286) discloses a neurostimulation device wearable around the ear of the patient.
Howard (US 2019/0381314) discloses transcutaneous nerve stimulation to enhance speed and quality of cognitive brain function.
Goodall et al. (US 2018/0169411) discloses a prompting system for enhancing learning with neural modulation.
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.
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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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