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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 15th, 2025 has been entered.
Claims 1-3, 5-14, 16-17 remain pending in the application. Claims 4, 15, and 18 have been cancelled and new claims 19-21 have been added.
Response to Arguments
Applicant’s arguments and amendments, filed December 15th, 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but are not persuasive.
At pages 6-7, Applicant argues that the limitation “provide neurostimulation therapy using the IPG and the modified set of stimulation parameters” integrate the claims into a practical application”. Examiner respectfully disagrees. The provided neurostimulation therapy using the IPG and the modified parameters is provided upon a determination that the modified one or more stimulation parameters induced an improvement in the one or more neurological conditions. Because the provided neurostimulations therapy only occurs upon the determination of inducing an improvement, then if the determination is that there is no improvement induced by the modified stimulation parameters then no neurostimulation therapy (using the modified parameters) would be provided. Furthermore, the disclosure as originally filed at the effective filing date of the claimed invention discloses that a clinician can modify the neurostimulation parameters (para. [0082, 00119, 00126, 00144]). The step of providing neurostimulation therapy is merely referring to the relevant pre-existing audience of doctors who used neurostimulation therapy and neurostimulation parameters to treat patients suffering from neurological conditions. The step of providing neurostimulation therapy was known to doctors, and was routinely and conventionally used to treat neurological conditions – see the non-patent literature of record. A clinician knowledgeable in treating neurological conditions would have known and be capable to perform the routine and conventionally used treatments of neurostimulation using neurostimulation parameters. Therefore, the step of “provide neurostimulation therapy using the IPG and the modified set of stimulation parameters” is merely an instruction to “apply” the modified neurostimulation parameters using well-understood, routine, or conventional techniques in the field.
Applicant’s arguments, filed December 15th, 2025, with respect to the rejections under 35 U.S.C. 103 have been 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 specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-14, 16-17, and 19-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation “providing neurostimulation therapy using the IPG and the modified set of stimulation parameters”, in claim 1 (2-3, 5-14, 16-17, and 19-21 by virtue of dependency) is not supported/explicitly disclosed in the disclosure as originally filed. The disclosure at the time of the effective filing date discloses in para. [0078, 0119, 0126, 0174] of the specification that a lead system may include more than one lead, each having a respective number of electrodes for providing therapy according to configurable settings; programming of neurostimulation parameters (e.g., adjust the parameters, conditions for triggering delivery of neurostimulation, etc.); automatically adjusting the patient’s neurostimulation parameters; that the parameters may be modified and used to update the patient's neurostimulation system; and providing new or adjusted stimulation therapy settings for controlling the patient’s neurostimulation system. However, providing parameters for the neurostimulation and updating the neurostimulation system does not disclose, and is not the same as, providing neurostimulation using the IPG and the modified set of stimulation parameters.
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 1-3, 5-14, 16-17, and 19-21 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 1 (claims 2-3, 5-14, 16-17, 19-21 by virtue of dependency) recites the limitation “determining whether modification of the one or more stimulation parameters induces an improvement in the one or more neurological conditions”. The induced improvement is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of what is considered an induced improvement in the one or more neurological conditions. Examiner suggests relating the determination of whether the one or more stimulation parameters induces an improvement in the one or more neurological conditions to the one or more metrics calculated in line 7 of claim 1.
Claim Rejections - 35 USC § 101
Claims 1-3, 5-14, 16-17, and 19-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
guiding the patient through an exercise routine adapted to improve one or more neurological conditions of the patient by displaying exercise movements on a user device;
automatically analyzing the captured video data to calculate one or more metrics indicative of the one or more neurological conditions of the patient, wherein the guiding, capturing, and automatically analyzing are performed while the neurostimulation therapy is provided to the patient by the IPG, 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;
determining whether modification of the one or more stimulation parameters induces an improvement in the one or more neurological conditions;
set forth a judicial exception. These steps describe certain methods of organizing human activity (managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)) and a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to Certain methods of organizing human activity and a Mental Process, which is an Abstract Idea.
STEP 2A, Prong Two
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites
capturing video data of the patient using the user device while the patient performs the displayed exercise movements; temporarily modifying, one or more stimulation parameters for the neurostimulation therapy over one or more exercise sessions while the guiding, capturing, and automatically analyzing are performed; and providing a modified set of stimulation parameters for the neurostimulation therapy provided to the patient by the IPG for long term use upon a determination that the modified one or more stimulation parameters induced an improvement in the one or more neurological conditions
which is merely adding insignificant pre-solution and extra-solution activity to the judicial exception (MPEP 2106.05(g)). The capturing video data and temporarily modifying, one or more stimulation parameters for neurostimulation therapy over one or more exercise sessions while the guiding, capturing, and automatically analyzing are performed does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the presented captured video data and modified parameters, nor does the method use a particular machine to perform the Abstract Idea.
Furthermore, the step of providing neurostimulation therapy using the IPG and the modified set of stimulation parameters is merely an instruction to “apply” the modified neurostimulation parameters using well-understood, routine, or conventional techniques in the field. The step of providing neurostimulation therapy was known to doctors, and was routinely and conventionally used to treat neurological conditions – see the non-patent literature of record. A clinician knowledgeable in treating neurological conditions would have known and be capable to perform the routine and conventionally used treatments of neurostimulation using neurostimulation parameters. Furthermore, regarding the “providing a modified set of stimulation parameters”, there is no indication as to what happens when no improvement as been determined. It is unclear if there is any providing of the modified set of stimulation parameters for the neurostimulation therapy. If no improvement has been determined, then the Examiner interprets that no neurostimulation therapy has been provided.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
capturing video data of the patient using the user device while the patient performs the displayed exercise movements;
temporarily modifying, one or more stimulation parameters for the neurostimulation therapy over one or more exercise sessions while the guiding, capturing, and automatically analyzing are performed;
providing a modified set of stimulation parameters for the neurostimulation therapy provided to the patient by the IPG for long term use upon a determination that the modified one or more stimulation parameters induced an improvement in the one or more neurological conditions;
providing neurostimulation therapy using the IPG and the modified set of stimulation parameters
The capturing, temporarily modifying, and the providing a modified set of stimulation parameters steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the capturing, temporarily modifying, and the providing a modified set of stimulation parameters steps are each recited at a high level of generality such that it amounts to insignificant pre-solution and extra-solution activity, e.g., mere data gathering and mere data outputting steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Furthermore, the step of providing neurostimulation therapy using the IPG and the modified set of stimulation parameters is merely an instruction to “apply” the modified neurostimulation parameters using well-understood, routine, or conventional techniques in the field. The step of providing neurostimulation therapy was known to doctors, and was routinely and conventionally used to treat neurological conditions – see the non-patent literature of record. A clinician knowledgeable in treating neurological conditions would have known and be capable to perform the routine and conventionally used treatments of neurostimulation using neurostimulation parameters.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-3, 5-14, 16-17, and 19-21 are directed to more abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 Zenisek (US 20220387803 A1 – previously cited), and 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).
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]); temporarily modifying, one or more stimulation parameters for the neurostimulation therapy over one or more exercise sessions while the guiding, capturing, and automatically analyzing are performed (“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”, para. [0162, 0166, 0178], figs. 25 & 30; associations between sense and stimulation electrode combinations can be determined … increase efficacy; programmer 24 may adjust one or more therapy parameters to attempt to decrease the severity or presence of the identified behavior (418), para. [0177, 0218], fig. 25); providing a modified set of stimulation parameters for the neurostimulation therapy provided to the patient by the IPG for long term use (fig. 25, “long-term treatment”, para. [0154]); and providing neurostimulation therapy using the IPG and the modified set of stimulation parameters (“IMD 324 may control therapy according to the selected therapy parameters (420)”, para. [0218-0219], fig. 25).
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, as modified by Charles hereinabove, further discloses calculating the velocities and velocity angles of anatomical region movement and/or frequencies of movement in each frame to identify which patient behaviors are present within the captured video information (para. [0090]).
Wu, as modified by Charles hereinabove, does not expressly disclose determining whether modification of the one or more stimulation parameters induces an improvement in the one or more neurological conditions based on one or more automatically calculated metrics; and providing a modified set of stimulation parameters for the neurostimulation therapy provided to the patient by the IPG for long term use upon a determination that the modified one or more stimulation parameters induced an improvement in the one or more neurological conditions.
However, Zenisek discloses determining whether modification of the one or more stimulation parameters induces an improvement in the one or more neurological conditions based on one or more automatically calculated metrics (revised stimulation parameters may be evaluated as producing either an improvement or decrease of the effectiveness of the stimulation therapy using the velocity values, para. [0058]); and providing a modified set of stimulation parameters for the neurostimulation therapy provided to the patient by the IPG for long term use upon a determination that the modified one or more stimulation parameters induced an improvement in the one or more neurological conditions (cycling parameters (duration of cycling); stimulation parameter settings 242; relatively long-term treatment; efficacy indications … particular electrode combination is recommended to a user and/or a set of stimulation parameters are recommended to a user and presented to the user via the programmer; para. [0034, 0050, 0061, 0073-0074]). Zenisek further discloses the system 100 and IMD 16 may be configured to deliver objectively efficacious therapy results for one or more diseases or disorders (para. [0058]).
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 method further comprises determining whether modification of the one or more stimulation parameters induces an improvement in the one or more neurological conditions based on one or more automatically calculated metrics; and providing a modified set of stimulation parameters for the neurostimulation therapy provided to the patient by the IPG for long term use upon a determination that the modified one or more stimulation parameters induced an improvement in the one or more neurological conditions, in view of the teachings of Zenisek, as this would aid in recommending and delivering objectively efficacious therapy results for one or more diseases or disorders by evaluating whether stimulation parameters provide either an improvement or decrease of the effectiveness of the stimulation therapy.
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 and Zenisek hereinabove, does not expressly disclose 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.
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 and Zenisek 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.
Regarding claim 5, Wu, as modified by Charles, Zenisek, and Hu 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, Zenisek, and Hu hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Zenisek, and Hu 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, Zenisek, and Hu 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 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, Zenisek, and Hu hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Zenisek, and Hu 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, Zenisek, and Hu 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, Zenisek, and Hu 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, Zenisek, and Hu 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, Zenisek, and Hu, as applied to claim 1 above, and further in view of Giuffrida (US 10966652 B1).
Regarding claim 2, Wu, as modified by Charles, Zenisek, and Hu hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Zenisek, and Hu hereinabove, does not expressly disclose wherein the automatically analyzing comprises: determining one or more balance characteristics of the patient.
However, Giuffrida 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, Zenisek, and Hu hereinabove, such that the automatically analyzing comprises: determining one or more balance characteristics of the patient, in view of the teachings of Giuffrida, 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, col. 3 lines 60-67).
Regarding claim 3, Wu, as modified by Charles, Zenisek, and Hu hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Zenisek, and Hu hereinabove, does not expressly disclose wherein the automatically analyzing comprises: determining one or more gait characteristics of the patient.
However, Giuffrida 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, Zenisek, and Hu hereinabove, such that the automatically analyzing comprises: determining one or more gait characteristics of the patient, in view of the teachings of Giuffrida, 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, col. 3 lines 60-67).
Regarding claim 6, Wu, as modified by Charles, Zenisek, and Hu 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, Zenisek, and Hu hereinabove, does not expressly disclose applying the calculated movement metrics to one or more trained neural networks.
However, Giuffrida 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, Zenisek, and Hu 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, as this would aid in determining scores of kinematic features used for the diagnosis or treatment of the subject (Giuffrida, col. 6 lines 16-25).
Regarding claim 16, Wu, as modified by Charles, Zenisek, and Hu hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Zenisek, and Hu hereinabove, does not expressly disclose the method further comprising: providing an analysis of patient movement during the exercise session calculated by one or more trained artificial intelligence models.
However, Giuffrida discloses providing an analysis of patient movement during the exercise session 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, Zenisek, and Hu hereinabove, such that the method further comprises: providing an analysis of patient movement during the exercise session calculated by one or more trained artificial intelligence models, in view of the teachings of Giuffrida, as this would aid in determining scores of kinematic features used for the diagnosis or treatment of the subject (Giuffrida, col. 6 lines 16-25).
Regarding claim 17, Wu, as modified by Charles, Zenisek, Hu, and Giuffrida 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, Zenisek, and Hu, as applied to claim 1 above, and further in view of Harry (US 20140364678 A1).
Regarding claim 7, Wu, as modified by Charles, Zenisek, and Hu hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Zenisek, and Hu 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, Zenisek, and Hu 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, Zenisek, and Hu, as applied to claim 1 above, and further in view of Brouns (US 20210290955 A1).
Regarding claim 10, Wu, as modified by Charles, Zenisek, and Hu hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Zenisek, and Hu hereinabove, does not expressly disclose the method further comprising: displaying by the patient device, video of the patient performing displayed exercise movements simultaneously to guiding the patient through the exercise routine.
However, Brouns discloses displaying by the 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, Zenisek, and Hu hereinabove, such that the method further comprises: displaying by the 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, Zenisek, and Hu hereinabove, discloses the method of claim 1. Wu, as modified by Charles, Zenisek, and Hu hereinabove, does not expressly disclose the method further comprising: displaying by the patient device, video of a representation of the patient performing displayed exercise movements simultaneously to guiding the patient through the exercise routine.
However, Brouns discloses displaying by the 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, Zenisek, and Hu hereinabove, such that the method further comprises: displaying by the 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, Zenisek, Hu, and Brouns hereinabove, discloses the method of claim 11. Wu, as modified by Charles, Zenisek, Hu, 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, Zenisek, Hu, 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]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Charles, Zenisek and Hu, as applied to claim 1 above, and further in view of Firlik (US 7856264 B2).
Regarding claim 13, Wu, as modified by Charles, Zenisek, and Hu hereinabove, discloses the method of claim 1, further comprising: detecting one or more deviations of patient movements from the display 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 display 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, Zenisek, and Hu 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, Zenisek, and Hu hereinabove, such that the method further comprises providing feedback to the patient upon detection of one or more deviations of patient movements from the display 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, Zenisek, Hu, 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, Zenisek, Hu, and Firlik hereinabove, discloses the method of claim 13. Wu, as modified by Charles, Zenisek, Hu, and Firlik hereinabove, does not expressly disclose wherein the feedback comprises haptic feedback using the wearable device of the patient.
However, Mason discloses wherein the feedback comprises haptic feedback using the 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, Zenisek, Hu, and Firlik hereinabove, such that the feedback comprises haptic feedback using the 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, Zenisek, and Hu, 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, Zenisek, and Hu 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, Zenisek, and Hu 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, Zenisek, and Hu 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:
T Flash, N Hogan. The coordination of arm movements: an experimentally confirmed mathematical model. Journal of Neuroscience 1 July 1985, 5 (7) 1688-1703; DOI: 10.1523/JNEUROSCI.05-07-01688.1985 directed to formulating a mathematical model to predict both the qualitative features and the quantitative details observed experimentally in planar, multijoint arm movements;
Busse, Monica & Wiles, Charles & van deursen, Robert. (2005). Muscle co-activation in neurological conditions. Physical Therapy Reviews. 10. 247-253. 10.1179/108331905X78915 directed to investigating whether antagonist co-activation changed a) with the degree of muscle weakness and b) with the nature of the neurological lesion causing weakness;
Teshuva, I., Hillel, I., Gazit, E. et al. Using wearables to assess bradykinesia and rigidity in patients with Parkinson’s disease: a focused, narrative review of the literature. J Neural Transm 126, 699–710 (2019). https://doi.org/10.1007/s00702-019-02017-9 directed to a review of using wearable technologies for the objective assessment of motor symptoms in Parkinson’s disease (PD);
Standford (US 20160081609 A1) directed to a method for testing movement associated with a movement disorder such as rigidity (fig. 5, para. [0023, 0058-0063]);
Giuffrida (US 8187209 B1) directed to a method of measuring the severity of a subject's movement disorder (see fig. 11).
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791