DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Amendment Entered
This Office action is responsive to the Amendment filed on June 23rd, 2026. The examiner acknowledges the amendments to claims 1, 6, 10, 11, 13, 14, and 16.
Claims 1-3, 5-14, 16-17, and 19-21 remain pending in the application.
Response to Arguments
Applicant's arguments and amendments, filed June 23rd, 2026, with respect to the rejections under 35 U.S.C. 112 have been fully considered. The rejections under 35 U.S.C. 112 are withdrawn.
Applicant's arguments and amendments, filed June 23rd, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered and are persuasive. The rejections under 35 U.S.C. 101 are withdrawn.
Applicant's arguments, filed June 23rd, 2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter with respect to “modifying one or more stimulation parameters for the neurostimulation therapy by processing patient input data, including the rigidity score, with a machine learning (ML) model trained to generate, based at least in part on the rigidity score, one or more adjusted stimulation parameters for the IPG” specifically challenged in the argument.
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.
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, 8-9, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US 20140371599 A1 – previously cited) in view of Charles (US 20200188672 A1 – previously cited), further in view of Hu (Hu, Z., Hao, M., Xu, S. et al. Evaluation of tremor interference with control of voluntary reaching movements in patients with Parkinson’s disease. J NeuroEngineering Rehabil 16, 38 (2019). https://doi.org/10.1186/s12984-019-0505-0), and further in view of Giuffrida (US 20130123684 A1).
Regarding claim 1, Wu discloses A method of providing a neurostimulation therapy to a patient using an implantable pulse generator (IPG) (implantable medical device (IMD) 324 … deep brain stimulation; spinal cord stimulation, para. [0138, 0163], fig. 19), comprising: guiding the patient (“instruct”, para. [0044, 0060-0062], fig. 2) through a routine adapted to (Examiner’s Note: functional language/intended use, i.e., capable of) improve one or more neurological conditions of the patient (“routine of passive and active motor tasks”; “instruct patient 12 to perform these actions”; “movements”, para. [0044, 0060-0062], fig. 2) by displaying exercise movements (“display 32 … present physical commands”, para. [0044, 0060-0062], fig. 2) on a user device (computing device 30, fig. 2); capturing video data of the patient using the user device while the patient performs the displayed exercise movements (“video information is captured of patient movement”, para. [0049-0052, 0061-0062], as seen in fig. 2); automatically analyzing the captured video data to calculate one or more metrics indicative of the one or more neurological conditions of the patient (“analyzed”; “automatically analyze video information … calculate one or more movement parameters”, para. [0063, 0092]), wherein the guiding, capturing, and automatically analyzing are performed while the neurostimulation therapy is provided to the patient by the IPG (figs. 25 & 30, “appropriate therapy for the detected behavior was being delivered when the behavior was detected”, para. [0242]), the one or more metrics include a rigidity score (“overall body rigidity”, “objective measure of patient movement”, para. [0130-0133, 0158]); modifying one or more stimulation parameters for the neurostimulation therapy by processing patient input data, including the rigidity score (“behaviors identifiable ... overall body rigidity”; “a different therapy to be delivered to patient 12A based on the indication of the patient behavior during the second period of time”; “parameters”; “feedback control … adjust the therapy”; programmer 24 may adjust one or more therapy parameters ... (418), para. [0133, 0162, 0177-0178, 0218-0221], figs. 25 & 30) to generate, based at least in part on the rigidity score, one or more adjusted stimulation parameters for the IPG (““behaviors identifiable ... overall body rigidity”; “select therapy parameters ... processor 350 ... determine ... one or more values of the patient parameter ... select or adjust one or more therapy parameters”, para. [0133, 0218-0221], step 418 & 496, figs. 25 & 30); and generating, by the IPG, one or more electrical stimulation pulses having the one or more adjusted stimulation parameters to provide the neurostimulation therapy with the one or more adjusted stimulation parameters (step 420, figs 25, “generate and deliver electrical pulses ... stimulation pulses ... therapy parameter values”; “adjust one or more therapy parameters ... transmit the updated therapy parameters to IMD 324 ... control therapy according to the selected therapy parameters (420)”, para. [0142, 0177-0179, 0218-0221], fig. 30).
Wu does not expressly disclose the exercise routine adapted to improve one or more neurological conditions of the patient.
However, Charles discloses the exercise routine adapted to improve one or more neurological conditions of the patient (exercise program is performed … improvements in motor symptoms, mental and emotional functions, daily living activities, and quality of life; Parkinson's disease, para. [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu such that the method further comprises the exercise routine adapted to improve one or more neurological conditions of the patient, in view of the teachings of Charles, as this would in providing improvements in motor symptoms, mental and emotional functions, daily living activities, and quality of life by incorporating the exercise programs of Charles.
Wu further discloses identifying different behaviors (rigidity/ overall body rigidity) present in the same frames and/or same patient motions, that the identified patient behaviors may be used as an objective measure of patient movement (para. [0130-0133, 0158]), and that the IMD 324 is configured to determine a therapy for a patient from a patient behavior identified from both video information and the values of one or more patient parameters monitored by non-video sensors/accelerometers (para. [0220-0221, 0225-0227]).
Wu, as modified by Charles hereinabove, does not disclose a rigidity score calculated based at least in part by using a movement trajectory profile, and the movement trajectory profile is calculated based at least in part on a time derivative of acceleration data.
However, Hu directed to the evaluation of tremor interference with control of voluntary reaching movements in patients with Parkinson’s disease discloses one or more metrics including a rigidity score (pages 6-8, Statistical analysis & Discussion, “identify the contributing factors among tremor, bradykinesia and rigidity to RT and MT based on UPDRS scores”, Tables 1 & 4-5 & Abstract, methods) calculated based at least in part by using a movement trajectory profile (figs. 2-3 & Table 3), and the movement trajectory profile is calculated based at least in part on a time derivative of acceleration data (Discussion, “developed quantitative methods to evaluate motor performance indices in PD patients with tremor …empirically verified smoothing model of minimum jerk trajectory (MJT) [16] to extract the voluntary movements from tremor corrupted movements in PD patients with tremor” & Abstract, methods).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles hereinabove, such that the one or more metrics include a rigidity score calculated based at least in part by using a movement trajectory profile, and the movement trajectory profile is calculated based at least in part on a time derivative of acceleration data, in view of the teachings of Hu, as this would aid developing quantitative methods to evaluate motor performance indices in PD patients with tremor and identifying the contributing factors among tremor, bradykinesia and rigidity to reaction time and movement time based on UPDRS scores.
Wu, as modified by Charles and Hu hereinabove, does not expressly disclose that the one or more stimulation parameters are modified by processing patient input data, including the rigidity score, with a machine learning (ML) model trained to generate, based at least in part on the rigidity score, one or more adjusted stimulation parameters for the IPG.
However, Giuffrida directed to system and method for tuning the parameters of a therapeutic medical device discloses that one or more stimulation parameters are modified by processing patient input data, including the rigidity score, with a machine learning (ML) model trained to generate, based at least in part on the rigidity score, one or more adjusted stimulation parameters for the IPG (“complete assessment of the DBS tuning ... rigidity”; “tuning algorithm ... computing ... utilizes symptom severity data ... suggested stimulation parameter settings ... artificial neural network 14”; “rigidity ... tuning map 20”, para. [0026, 0059, 0061, 0064-0066], figs. 3 & 5, see also para. [0071-0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles and Hu hereinabove, such that the one or more stimulation parameters are modified by processing patient input data, including the rigidity score, with a machine learning (ML) model trained to generate, based at least in part on the rigidity score, one or more adjusted stimulation parameters for the IPG, in view of the teachings of Giuffrida, as this would aid in computing the suggested/adjusted stimulation parameters and minimizing programming iterations to reduce surgical and outpatient tuning session time by incorporating the tuning algorithm of Giuffrida (Giuffrida, para. [0064-0066]).
Regarding claim 5, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1, wherein the automatically analyzing comprises: quantifying one or more tremor characteristics of the patient (frequency; identify tremor, para. [0119, 0131-0132]).
Regarding claim 8, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose wherein the exercise routine comprises patient movements adapted to improve smoothness of movement for the patient.
However, Charles discloses wherein the exercise routine comprises patient movements adapted to improve smoothness of movement for the patient (“exercise program … improving flexibility and range of motion for people experiencing rigidity”, para. [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the exercise routine comprises patient movements adapted to improve smoothness of movement for the patient, in view of the teachings of Charles, as this would aid in providing improvements in flexibility and range of motion for people experiencing rigidity by incorporating the exercise programs of Charles.
Regarding claim 9, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose wherein the exercise routine comprises patient movements adapted to improve gait of the patient.
However, Charles discloses wherein the exercise routine comprises patient movements adapted to improve gait of the patient (“exercise programs … rehabilitation programs … improving gait speed”, para. [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the exercise routine comprises patient movements adapted to improve gait of the patient, in view of the teachings of Charles, as this would aid in improving gait speed by incorporating the exercise/rehabilitation programs of Charles.
Regarding claim 19, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1, wherein the rigidity score is at least partly based on detecting a deviation from the movement trajectory profile (“compare the one or more movement parameters of the period of time to respective criteria for each of a plurality of predetermined patient behaviors … identify … predetermined patient behaviors”; “rigidity”; “objective measure of patient movement”, para. [0056, 0130-0133, 0158] & Hu, pages 6-8, Tables 4-5).
Regarding claim 21, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1, wherein the rigidity score is at least partly based on detecting a muscle tone of the patient (“rigidity”; “physiological parameters of patient 12A (e.g., muscle activity or muscle tone)”; “objective measure of patient movement”, para. [0130-0133, 0151, 0158]).
Claims 2-3, 6, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Charles, Hu, and Giuffrida, as applied to claim 1 above, and further in view of Giuffrida (US 10966652 B1) (herein Giuffrida 652).
Regarding claim 2, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose wherein the automatically analyzing comprises: determining one or more balance characteristics of the patient.
However, Giuffrida 652 directed to system and method for scoring movement disorder symptoms discloses wherein the automatically analyzing comprises: determining one or more balance characteristics of the patient (objective quantification of … gait and balance disruptions; rating gait and balance disturbances … algorithm … videotaped, col. 3 line 60 - col. 4 line 27 & col. 10 lines 44-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the automatically analyzing comprises: determining one or more balance characteristics of the patient, in view of the teachings of Giuffrida 652, as this would aid in objectively quantifying movement disorders for the diagnosis and treatment of patients who exhibit the symptoms of Parkinson’s disease (Giuffrida 652, col. 3 lines 60-67).
Regarding claim 3, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose wherein the automatically analyzing comprises: determining one or more gait characteristics of the patient.
However, Giuffrida 652 directed to system and method for scoring movement disorder symptoms discloses wherein the automatically analyzing comprises: determining one or more gait characteristics of the patient (objective quantification of … gait and balance disruptions; rating gait and balance disturbances … algorithm … videotaped, col. 3 line 60 - col. 4 line 27 & col. 10 lines 44-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the automatically analyzing comprises: determining one or more gait characteristics of the patient, in view of the teachings of Giuffrida 652, as this would aid in objectively quantifying movement disorders for the diagnosis and treatment of patients who exhibit the symptoms of Parkinson’s disease (Giuffrida 652, col. 3 lines 60-67).
Regarding claim 6, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1, wherein the automatically analyzing comprises: detecting anatomical landmarks of the patient during performance of the displayed exercise movements (determine one or more sample areas of respective anatomical regions; selection of a sample area representative of an anatomical region (e.g., head 14, torso 16, arm 18A, or arm 18B) … defined by one or more processors; analyze each of the other plurality of frames for respective areas corresponding to the sample area, para. [0046, 0050]); analyzing patient movements in detected anatomical landmarks to calculate a plurality of movement metrics (calculate one or more movement parameters (e.g., velocity, angle of movement, or frequency of movement) of the anatomical region, para. [0056]).
Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose applying the calculated plurality of movement metrics to one or more trained neural networks.
However, Giuffrida 652 directed to system and method for scoring movement disorder symptoms discloses applying the calculated movement metrics to one or more trained neural networks (“training algorithm … artificial neural network”; processing the at least one kinematic feature using a trained algorithm to determine a score, col. 5 lines 50-54 & col. 6 lines 16-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the automatically analyzing further comprises: applying the calculated movement metrics to one or more trained neural networks, in view of the teachings of Giuffrida 652, as this would aid in determining scores of kinematic features used for the diagnosis and treatment of the subject (Giuffrida 652, col. 6 lines 16-25).
Regarding claim 16, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose the method further comprising: providing an analysis of patient movement during the exercise routine calculated by one or more trained artificial intelligence models.
However, Giuffrida 652 directed to system and method for scoring movement disorder symptoms discloses providing an analysis of patient movement during the exercise routine calculated by one or more trained artificial intelligence models (“training algorithm … artificial neural network”; processing the at least one kinematic feature using a trained algorithm to determine a score, col. 5 lines 50-54 &col. 6 lines 16-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the method further comprises: providing an analysis of patient movement during the exercise routine calculated by one or more trained artificial intelligence models, in view of the teachings of Giuffrida 652, as this would aid in determining scores of kinematic features used for the diagnosis or treatment of the subject (Giuffrida 652, col. 6 lines 16-25).
Regarding claim 17, Wu, as modified by Charles, Hu, Giuffrida and Giuffrida 652 hereinabove, discloses the method of claim 16 providing a report to a clinician (notification to the clinician, para. [0245]) detailing changes in the one or more neurological conditions of the patient as detected during multiple exercise sessions (monitor the progression of a disease using identified patient behaviors; generated behavior information 52; track changes in one or more symptoms and/or disease progression … notification to the clinician, para. [0057, 0072, 0245]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Charles, Hu, and Giuffrida, as applied to claim 1 above, and further in view of Harry (US 20140364678 A1).
Regarding claim 7, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose wherein the exercise routine comprises patient movements adapted to improve balance of the patient.
However, Harry discloses wherein the exercise routine comprises patient movements adapted to improve balance of the patient (“balance enhancement training regimens”, para. [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the exercise routine comprises patient movements adapted to improve balance of the patient, in view of the teachings of Harry, as this would aid in balance enhancement by incorporating the balance enhancement training regimens of Harry.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Charles, Hu, and Giuffrida, as applied to claim 1 above, and further in view of Brouns (US 20210290955 A1).
Regarding claim 10, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose the method further comprising: displaying by a patient device, video of the patient performing displayed exercise movements simultaneously to guiding the patient through the exercise routine.
However, Brouns directed to devices, systems, and methods for neuromodulation discloses displaying by a patient device (graphical presentation module 14, 114, 214, para. [0127]), video of the patient performing displayed exercise movements simultaneously to guiding the patient through the exercise routine (as seen in fig. 12, “display the recorded locomotion images for the patient together with the reference locomotion images for the patient”; “synchronize and/or superimpose”, para. [0127]). Brouns further discloses that the optimal outcome pattern can be movements of a healthy subject or intended movements of the patient and the user could see which muscles need more and/or less activation to match the optimal outcome pattern, for example, an optimal walking pattern (para. [0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the method further comprises: displaying by a patient device, video of the patient performing displayed exercise movements simultaneously to guiding the patient through the exercise routine, in view of the teachings of Brouns, as this would aid in enabling a user to see which muscles need more and/or less activation to match the optimal outcome pattern (Brouns, para. [0127]).
Regarding claim 11, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose the method further comprising: displaying by a patient device, video of a representation of the patient performing displayed exercise movements simultaneously to guiding the patient through the exercise routine.
However, Brouns directed to devices, systems, and methods for neuromodulation discloses displaying by a patient device (graphical presentation module 14, 114, 214, para. [0127]), video of a representation of the patient performing displayed exercise movements simultaneously to guiding the patient through the exercise routine (as seen in fig. 12, “display the recorded locomotion images for the patient together with the reference locomotion images for the patient”; “synchronize and/or superimpose”, para. [0127]). Brouns further discloses that the optimal outcome pattern can be movements of a healthy subject or intended movements of the patient and the user could see which muscles need more and/or less activation to match the optimal outcome pattern, for example, an optimal walking pattern (para. [0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the method further comprises: displaying by a patient device, video of a representation of the patient performing displayed exercise movements simultaneously to guiding the patient through the exercise routine, in view of the teachings of Brouns, as this would aid in enabling a user to see which muscles need more and/or less activation to match the optimal outcome pattern (Brouns, para. [0127]).
Regarding claim 12, Wu, as modified by Charles, Hu, Giuffrida, and Brouns hereinabove, discloses the method of claim 11. Wu, as modified by Charles, Hu, Giuffrida, and Brouns hereinabove, does not expressly disclose wherein the representation of the patient comprises one or more graphical user interface (GUI) elements defined by anatomical landmarks of the patient.
However, Brouns discloses wherein the representation of the patient comprises one or more graphical user interface (GUI) elements defined by anatomical landmarks of the patient (fig. 14, avatar A … displayed with one or more discrete joints”, para. [0131]). Brouns further discloses that the optimal outcome pattern can be movements of a healthy subject or intended movements of the patient and the user could see which muscles need more and/or less activation to match the optimal outcome pattern, for example, an optimal walking pattern (para. [0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, Giuffrida, and Brouns hereinabove, such that the representation of the patient comprises one or more graphical user interface (GUI) elements defined by anatomical landmarks of the patient, in view of the teachings of Brouns, as this would aid in enabling a user to see which muscles need more and/or less activation to match the optimal outcome pattern (Brouns, para. [0127]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Charles, Hu, and Giuffrida, as applied to claim 1 above, and further in view of Firlik (US 7856264 B2).
Regarding claim 13, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1, further comprising: detecting one or more deviations of patient movements from the displayed exercise movements (“head center moves … distance threshold”; “compare … threshold, para. [0115, 0124], fig. 11); and providing feedback upon detection of one or more deviations of patient movements from the displayed exercise movements (identified patient behavior from video information 50 may be used as feedback during the initial, and subsequent programming session, para. [0151]). Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not expressly disclose providing feedback to the patient.
However, Firlik directed to systems and methods for patient interactive neural stimulation discloses providing feedback to the patient (visual and/or auditory patient performance feedback; “visual feedback … to the patient 10”, col. 14 lines 35-63 & col. 18 lines 15-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove,, such that the method further comprises providing feedback to the patient upon detection of one or more deviations of patient movements from the displayed exercise movements, in view of the teachings of Firlik, as this would aid in providing visual patient performance feedback including motivational or behavior reinforcement feedback to the patient.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Charles, Hu, Giuffrida, and Firlik, as applied to claim 13 above, and further in view of Mason (US 20210134427 A1).
Regarding claim 14, Wu, as modified by Charles, Hu, Giuffrida, and Firlik hereinabove, discloses the method of claim 13. Wu, as modified by Charles, Hu, Giuffrida, and Firlik hereinabove, does not expressly disclose wherein the feedback comprises haptic feedback using a wearable device of the patient.
However, Mason directed to a method and system for creating an immersive enhanced reality-driven exercise experience for a user discloses wherein the feedback comprises haptic feedback using a wearable device of the patient (one or more wearable tactile or haptic feedback devices, para. [0186]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, Giuffrida, and Firlik hereinabove, such that the feedback comprises haptic feedback using a wearable device of the patient, in view of the teachings of Mason, as this would aid in providing tactile or haptic feedback to the patient by incorporating the wearable tactile or haptic feedback device of Mason.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Charles, Hu, and Giuffrida, as applied to claim 1 above, and further in view of Kwon (Kwon Y, Kim J-W, Ho Y, et al. Analysis of antagonistic co-contractions with motorized passive movement device in patients with Parkinson’s disease. Bio-Medical Materials and Engineering. 2014;24(6):2291-2297. doi:10.3233/BME-141042).
Regarding claim 20, Wu, as modified by Charles, Hu, and Giuffrida hereinabove, discloses the method of claim 1.
Wu further discloses identifying different behaviors (rigidity/ overall body rigidity) present in the same frames and/or same patient motions, that the identified patient behaviors may be used as an objective measure of patient movement (para. [0130-0133, 0158]), that the clinician may evaluate the efficacy based on one or more physiological parameters of patient 12A (e.g., muscle activity or muscle tone), and that sensors may include EMG sensors and strain or force gauges to detect muscle movement or flexation (para. [0151, 0227]).
Wu, as modified by Charles, Hu, and Giuffrida hereinabove, does not disclose wherein the rigidity score is at least partly based on determining a co-contraction profile for agonist and antagonist muscles of the patient.
However, Kwon directed to the analysis of antagonistic co-contractions with motorized passive movement device in patients with Parkinson's disease discloses wherein the rigidity score is at least partly based on determining a co-contraction profile for agonist and antagonist muscles of the patient (pages 2294-2996, 2.2 Subjects and experiments, “rigidity score”; & 2.3 Analysis of co-contraction, “co-contraction index (CCI)”; & 3. Results and Discussion, “co-contraction of antagonistic muscles acting about the wrist joint is enhanced in patients with PD … enhanced co-contraction is associated with the passive resistance, rigidity”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wu, as modified by Charles, Hu, and Giuffrida hereinabove, such that the rigidity score is at least partly based on determining a co-contraction profile for agonist and antagonist muscles of the patient, in view of the teachings of Kwon, as this would aid in quantifying the extent to which each muscle pair was co-contracting associated with rigidity by incorporating the co-contraction index.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Heldman (US 11786730 B1) directed to a system and method for tuning the parameters of a therapeutic medical device ; Moffitt (US 20190329051 A1) directed to neuromodulation systems, devices, and methods.
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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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
