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 .
Response to Amendment
In response to the amendment filed December 9, 2025, 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 December 9, 2025 have been fully considered but they are not persuasive with respect to the amended limitation “using a first set of electrodes” and “using a second set of electrodes”. Sharma (US 20200405188 A1; previously cited by applicant) teaches in [0028] teaches that the electrodes #14 can be divided into a first set of electrodes and a second set of electrodes which meets the amended limitation.
Applicant's arguments filed December 9, 2025 have been fully considered but they are not persuasive with respect to the amended limitation “the sleeve being disposed separate from the stimulation electrodes”. Sharma teaches in [0012] that the electronic tremor suppression controller is connected via wires to the garment and further in [0017] that the electrode tremor suppression controller generates the neuromuscular electrical stimulation pulses which is interpreted to be the stimulation electrodes and as such the sleeve is dispose separate from the electrodes which meets the amended limitation.
Applicant's arguments filed December 9, 2025 have been fully considered but they are not persuasive with respect to the amended limitation “separate from the stimulation electrodes”. Sharma teaches in [0028] that electrodes #14 are divided into two sets which includes a second set of electrodes that delivers NMES and a first set of electrodes that detects the EMG which meets the amended limitation.
Applicant’s arguments, see Remarks, filed December 9, 2025, with respect to amended limitation “an armband or leg band disposed separate from the sleeve” in claim 14 has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yoo (US 20160263376 A1).
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, 5-11, 13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20200405188 A1; cited by applicant) in view of Wolpaw (US 201400395714 A1; cited by applicant).
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]).
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 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]).
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 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).
Claims 2-4, 12, 14 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Wolpaw as applied to claims 1, 11 and 17 respectively above, and further in view of Yoo (US 20160263376 A1).
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 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 14, all limitations of claim 11 apply in which Sharma further discloses an armband or leg band, wherein the stimulation electrodes are arranged on an armband or leg band to contact 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).
Sharma does not disclose that the armband or leg band is disposed separate from the sleeve.
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 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 as applied to claims 11 above, and further in view of Simon (US 20200038655 A1).
With respect to claim 15, all limitations of claim 11 apply in which Sharma and Wolpaw 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 and Wolpaw 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
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.
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/N.N.P./Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791