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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 1, 2026 has been entered.
Response to Amendment
In response to the amendment filed April 1, 2026, claims 1, 11, 14 and 17 are amended. No claims are cancelled and no new claims are added. Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed April 1, 2026 with respect to the prior art rejections have been fully considered but they are not persuasive.
In response to applicant's argument that Yoo is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Yoo and Sharma are in the field of applying electrical stimulation and measuring the response.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma and Wolpaw with the teachings of Yoo to have a separate arm or leg band from stimulation electrodes because it would have resulted the predictable result of being able to stimulate separated nerve sections as needed and ensuring that the associated sensed EMG activity is recorded from the respective muscle group (Yoo: [0449]).
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.
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.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20200405188 A1; previously cited by applicant) in view of Wolpaw (US 20140039571 A1; previously cited by applicant) and Yoo (US 20160263376 A1; previously cited).
With respect to claim 1, Sharma discloses a method of performing spinal reflex conditioning for an anatomical limb of a person (see paragraph 0011-0012, 0030-0036 and Fig. 1, neuromuscular electrical stimulation (NMES) system and methods), the method comprising:
evoking a spinal reflex by electrically stimulating a peripheral nerve of the anatomical limb (see paragraph 0030-0036, wearable NMES system with electrodes that provide transcutaneous electrical stimulation of the muscles where a spinal reflex is capable of being evoked) using a first set of electrodes (see paragraph 0028, electrodes #14 are divided into a second set of electrodes that are used to deliver NMES);
measuring the spinal reflex using electromyography (EMG) signals acquired from the anatomical limb (see paragraph 0030-0036, a wearable sleeve is worn on the arm with electrodes that can record EMG activity of the underlying muscles) using a second set of electrodes (see paragraph 0028, electrodes #14 are divided into a first set of electrodes that are used to detect EMG signals); and
performing vagus nerve stimulation (VNS) in response to the measured spinal reflex satisfying a positive reinforcement criterion (see paragraph 0030-0036, a nerve stimulation interface that can stimulate the vagus or other branch nerve to affect muscular and/or spinal physiology is included in NMES system).
Sharma does not specifically disclose that the reflex is a spinal reflex.
Wolpaw teaches evoked spinal reflex as a result of electrical stimulation (see paragraph 0045-0047 and 0014-0015, eliciting operant conditioning of spinal reflex pathways using electromyographic electrodes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma with the teachings of Wolpaw to have utilized spinal reflexes because it would have resulted in the predictable result of neurological rehabilitation of for users to improve central nervous system sensorimotor and/or cognitive functions (Wolpaw: see [0012]).
Sharma and Wolpaw do not specifically teach that the first set of electrodes are disposed on a first component and a second set of electrodes are disposed on a second component separate from the first component.
Yoo teaches a first set of electrodes disposed on a first component (see paragraph 0263 and 0120, #14 stimulation such as an electrode that receives stimulation signals; and see paragraph 0263, attached on the skin via an elastic band) and a second set of electrodes disposed on a second component separate from the first component (see paragraph 0449, nerve cuff which is attached to section of target nerve branch with electrode contacts).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma and Wolpaw with the teachings of Yoo to have electrodes disposed on separate components because it would have resulted the predictable result of being able to stimulate separated nerve sections as needed and ensuring that the associated sensed EMG activity is recorded from the respective muscle group (Yoo: [0449]).
With respect to claim 2, all limitations of claim 1 apply in which Sharma further teaches in [0036] that vagus nerve stimulation is given when tremor suppression has been achieved and the signal is adjusted if it has not been achieved however Sharma and Wolpaw do not specifically teach a hyperreflexia treatment wherein the positive reinforcement criterion comprises the measured spinal reflex being less than a baseline spinal reflex.
Yoo teaches a hyperreflexia treatment (see paragraph 0390, treatment of hyperreflexia) wherein a measured spinal reflex is less than a baseline (see paragraph 0171, contraction activity level relative to a pre-stimulation baseline level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma and Wolpaw with the teachings of Yoo to have a hyperreflexia treatment because it would have resulted in the predictable result of treating spinal nerve roots (Yoo: [0038]) when a baseline target is not achieved in electrical stimulation (Yoo: [0171]).
With respect to claim 3, all limitations of claim 1 apply in which Sharma further teaches in [0036] that vagus nerve stimulation is given when tremor suppression has been achieved and the signal is adjusted if it has not been achieved however Sharma and Wolpaw do not specifically teach a hyporeflexia treatment wherein the positive reinforcement criterion comprises the measured spinal reflex being greater than a baseline spinal reflex.
Yoo teaches a hyperreflexia treatment (see paragraph 0390, treatment of hyperreflexia) wherein a measured spinal reflex is greater than a baseline (see paragraph 0171, contraction activity level relative to a pre-stimulation baseline level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma and Wolpaw with the teachings of Yoo to have a hyperreflexia treatment because it would have resulted in the predictable result of treating spinal nerve roots (Yoo: [0038]) when a baseline target is not achieved in electrical stimulation (Yoo: [0171]).
With respect to claim 4, all limitations of claim 2 apply in which Yoo further discloses determining the baseline spinal reflex by: repeatedly evoking the spinal reflex by electrically stimulating the peripheral nerve of the anatomical limb and measuring the spinal reflex using EMG signals acquired from the anatomical limb to generate baseline spinal reflex data (see paragraph 0125, repeatedly evoking reflex by electrically stimulating), and determining the baseline spinal reflex as a statistical average of the baseline spinal reflex data (see paragraph 0400, average data as result of stimulation is determined).
With respect to claim 5, all limitations of claim 1 apply in which Sharma further discloses wherein the spinal reflex is evoked by electrically stimulating the peripheral nerve of the anatomical limb using stimulation electrodes disposed on an armband or leg band wrapped around an upper portion of the anatomical limb (see paragraph 0005, garment is a sleeve that can be on the leg or arm; and see 0012 and Fig. 1, electrodes #14 are place on armband).
With respect to claim 6, all limitations of claim 5 apply in which Sharma further discloses wherein the anatomical limb is an arm and the spinal reflex is evoked by electrically stimulating one or more of a median peripheral nerve of the arm, a radial peripheral nerve of the arm, and/or an ulnar peripheral nerve of the arm (see paragraph 0005, garment is a sleeve that can be on the leg or arm; and see 0012 and Fig. 1, electrodes #14 are place on armband; and see paragraph 0031, vagus or other nerve branch can be stimulated to affect spinal or muscular physiology).
With respect to claim 7, all limitations of claim 5 apply in which Sharma further discloses wherein the anatomical limb is an arm and the measuring of the spinal reflex using EMG signals acquired from the anatomical limb includes acquiring EMG signals from a plurality of flexor and extensor muscles in the arm using a sleeve worn on the arm and including at least 100 electrodes (see paragraph 0014 and Fig. 1, array of electrodes of the garment is worn on anatomical region where each electrode has a corresponding anatomical location on the arm).
With respect to claim 8, all limitations of claim 1 apply in which Sharma further discloses wherein the VNS is performed using transcutaneous auricular vagus nerve stimulation (taVNS) (see paragraph 0030-0036, a nerve stimulation interface that can stimulate the vagus or other branch nerve to affect muscular and/or spinal physiology is included in NMES system; and see paragraph 0030, transcutaneous electrical stimulation is given).
With respect to claim 9, all limitations of claim 1 apply in which Sharma further discloses wherein the method is performed while the person is ambulatory (see paragraph 0011, voluntary motion of user meaning user is ambulatory and capable of movement).
With respect to claim 10, all limitations of claim 1 apply in which Sharma further discloses wherein the method is performed without volitional input from the person (see paragraph 0011, tremor-induced motion is considered involuntary movement of the user).
With respect to claim 11, Sharma discloses a system for performing spinal reflex conditioning for an anatomical limb of a person (see paragraph 0011-0012, 0030-0036 and Fig. 1, neuromuscular electrical stimulation (NMES) system), the system comprising:
stimulation electrodes arranged to electrically stimulate a peripheral nerve of the anatomical limb to evoke a spinal reflex (see paragraph 0030-0036, wearable NMES system with electrodes that provide transcutaneous electrical stimulation of the muscles where a spinal reflex is capable of being evoked);
a sleeve being wearable on the anatomical limb and including electrodes arranged to acquire EMG signals from the anatomical limb (see paragraph 0030-0036, a wearable sleeve is worn on the arm with electrodes that can record EMG activity of the underlying muscles), the sleeve being disposed separate from the stimulation electrodes (see paragraph 0012 and 0017,the electronic tremor suppression controller is connected via wires to the garment and generates the neuromuscular electrical stimulation pulses);
a vagus nerve stimulation (VNS) device (see paragraph 0030-0036, a nerve stimulation interface that can stimulate the vagus or other branch nerve to affect muscular and/or spinal physiology is included in NMES system); and
an electronic controller (see paragraph 0011-0018 and 0030-0036, electronic tremor suppression controller #16) configured to evoke a spinal reflex by electrically stimulating the peripheral nerve of the anatomical limb using the stimulation electrodes (see paragraph 0011-0018 and 0030-0036, electronic tremor suppression controller #16 generates neuromuscular electrical stimulation pulses), measure the spinal reflex using the sleeve (see paragraph 0011-0018 and 0030-0036, #16 measures EMG signals and identifies tremors), and perform VNS using the VNS device in response to the measured spinal reflex satisfying a positive reinforcement criterion (see paragraph 0011-0018 and 0030-0036, #16 can suppress tremors in the presence of a tremor migration using a nerve stimulation interface; and see paragraph 0036, a type of tremor suppression therapy is Vagus Nerve Stimulation (VNS)).
Sharma does not specifically disclose that the reflex is a spinal reflex.
Wolpaw teaches evoked spinal reflex as a result of electrical stimulation (see paragraph 0045-0047 and 0014-0015, eliciting operant conditioning of spinal reflex pathways using electromyographic electrodes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma with the teachings of Wolpaw to have utilized spinal reflexes because it would have resulted in the predictable result of neurological rehabilitation of for users to improve central nervous system sensorimotor and/or cognitive functions (Wolpaw: see [0012]).
Sharma and Wolpaw do not specifically teach that the stimulation electrodes are disposed on a band wearable on the anatomical limb and a sleeve separate from the band.
Yoo teaches stimulation electrodes (see paragraph 0263 and 0120, #14 stimulation such as an electrode that received stimulation signals) that is attached to the skin via an elastic band (see paragraph 0263) disposed separate from a sleeve (see paragraph 0449, nerve cuff which is attached to section of target nerve branch with electrode contacts).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma and Wolpaw with the teachings of Yoo to have a separate arm or leg band from stimulation electrodes because it would have resulted the predictable result of being able to stimulate separated nerve sections as needed and ensuring that the associated sensed EMG activity is recorded from the respective muscle group (Yoo: [0449]).
With respect to claim 12, all limitations of claim 11 apply in which Sharma further discloses in [0036] that vagus nerve stimulation is given when tremor suppression has been achieved and the signal is adjusted if it has not been achieved however Sharma and Wolpaw do not specifically teach wherein the electronic controller is configured to perform the VNS using the VNS device in response to one of: the measured spinal reflex being less than a baseline spinal reflex whereby the system is configured to treat hyperreflexia, or the measured spinal reflex being greater than a baseline spinal reflex whereby the system is configured to treat hyporeflexia.
Yoo teaches a hyperreflexia treatment (see paragraph 0390, treatment of hyperreflexia) wherein a measured spinal reflex is less than a baseline (see paragraph 0171, contraction activity level relative to a pre-stimulation baseline level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma and Wolpaw with the teachings of Yoo to have a hyperreflexia treatment because it would have resulted in the predictable result of treating spinal nerve roots (Yoo: [0038]) when a baseline target is not achieved in electrical stimulation (Yoo: [0171]).
With respect to claim 13, all limitations of claim 11 apply in which Sharma further discloses wherein the VNS device comprises one of: a transcutaneous auricular vagus nerve stimulation (taVNS) device (see paragraph 0030-0036, a nerve stimulation interface that can stimulate the vagus or other branch nerve to affect muscular and/or spinal physiology is included in NMES system; and see paragraph 0030, transcutaneous electrical stimulation is given); or an implanted VNS stimulator having lead wires electrically coupled with the vagus nerve.
With respect to claim 14, all limitations of claim 11 apply in which Sharma further discloses where the band is an armband or a leg band (see paragraph 0005, garment is a sleeve that can be on the leg or arm; and see 0012 and Fig. 1, electrodes #14 are place on armband).
With respect to claim 16, all limitations of claim 11 apply in which Sharma further discloses wherein the sleeve includes at least 100 electrodes arranged to acquire spatially resolved EMG signals from the anatomical limb (see paragraph 0014 and Fig. 1, array of electrodes of the garment is worn on anatomical region).
With respect to claim 17, Sharma discloses a non-transitory storage medium storing instructions readable and executable by an electronic processor to perform spinal reflex conditioning for an anatomical limb of a person by operations including (see paragraph 0011-0012, 0030-0036 and Fig. 1, neuromuscular electrical stimulation (NMES) system; and see paragraph 0018, non-transitory storage medium stores software comprising instructions that are readable and executable by processor to perform disclosed tremor suppression):
evoking a spinal reflex by energizing stimulation electrodes to electrically stimulate a peripheral nerve of the anatomical limb (see paragraph 0030-0036, wearable NMES system with electrodes that provide transcutaneous electrical stimulation of the muscles where a spinal reflex is capable of being evoked);
measuring the spinal reflex using electromyography (EMG) signals acquired from the anatomical limb using electrodes disposed on a sleeve configured to be worn on the limb (see paragraph 0030-0036, a wearable sleeve is worn on the arm with electrodes that can record EMG activity of the underlying muscles) and separate from the stimulation electrodes (see paragraph 0028, electrodes #14 are divided into a second set of electrodes that delivers NMES and a first set of electrodes that detects the EMG);
determining whether the measured spinal reflex satisfies a positive reinforcement criterion (see paragraph 0011-0018 and 0030-0036, #16 can suppress tremors in the presence of a tremor migration using a nerve stimulation interface; and see paragraph 0036, a type of tremor suppression therapy is Vagus Nerve Stimulation (VNS)); and
controlling a vagus nerve stimulation (VNS) device to deliver VNS to a vagus nerve of the person in response to the measured spinal reflex satisfying the reinforcement criterion (see paragraph 0030-0036, a nerve stimulation interface that can stimulate the vagus or other branch nerve to affect muscular and/or spinal physiology is included in NMES system).
With respect to claim 18, all limitations of claim 17 apply in which Sharma further teaches in [0036] that vagus nerve stimulation is given when tremor suppression has been achieved and the signal is adjusted if it has not been achieved however Sharma and Wolpaw do not specifically teach wherein the reinforcement criterion comprises the measured spinal reflex being less than a baseline spinal reflex.
Yoo teaches a hyperreflexia treatment (see paragraph 0390, treatment of hyperreflexia) wherein a measured spinal reflex is less than a baseline (see paragraph 0171, contraction activity level relative to a pre-stimulation baseline level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma and Wolpaw with the teachings of Yoo to have a hyperreflexia treatment because it would have resulted in the predictable result of treating spinal nerve roots (Yoo: [0038]) when a baseline target is not achieved in electrical stimulation (Yoo: [0171]).
With respect to claim 19, all limitations of claim 17 apply in which Sharma further teaches in [0036] that vagus nerve stimulation is given when tremor suppression has been achieved and the signal is adjusted if it has not been achieved however Sharma and Wolpaw do not specifically teach wherein the reinforcement criterion comprises the measured spinal reflex being greater than a baseline spinal reflex.
Yoo teaches a hyperreflexia treatment (see paragraph 0390, treatment of hyperreflexia) wherein a measured spinal reflex is greater than a baseline (see paragraph 0171, contraction activity level relative to a pre-stimulation baseline level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma and Wolpaw with the teachings of Yoo to have a hyperreflexia treatment because it would have resulted in the predictable result of treating spinal nerve roots (Yoo: [0038]) when a baseline target is not achieved in electrical stimulation (Yoo: [0171]).
With respect to claim 20, all limitations of claim 18 apply in which Yoo further discloses wherein the instructions are further readable and executable by the electronic processor to: generating baseline spinal reflex data by repeatedly evoking the spinal reflex by controlling the energizing the stimulation electrodes to electrically stimulate the peripheral nerve of the anatomical limb and measuring the spinal reflex using EMG signals acquired from the anatomical limb using the electrodes of the sleeve (see paragraph 0125, repeatedly evoking reflex by electrically stimulating); and determining the baseline spinal reflex as a statistical average of the baseline spinal reflex data (see paragraph 0400, average data as result of stimulation is determined).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Wolpaw and Yoo as applied to claims 11 above, and further in view of Simon (US 20200038655 A1; previously cited).
With respect to claim 15, all limitations of claim 11 apply in which Sharma, Wolpaw and Yoo do not specifically disclose wherein the system is a battery-powered mobile system configured to provide muscle spasticity conditioning while the person is ambulatory.
Simon teaches a battery powered mobile system (see paragraph 0107 and Figs 5A/5B, battery power source with power level controller is attached to self-contained stimulator) configured to provide muscle spasticity conditioning while the person is ambulatory (see paragraph 0015, NMES stimulation to augment strength of muscles while person is ambulatory).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sharma, Wolpaw and Yoo with the teachings of Simon to have a system be battery powered because it would have resulted in the predictable result of recording physiological signals from ambulatory patients (Simon: see [0101]).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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