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 amendment filed November 6, 2025, claims 1-3 are amended. Claims 4-5, 9-40 and 44-49 are cancelled and no new claims are added. Claims 1-3, 6-8 and 41-43 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed November 6, 2025, with respect to the objections to the specification and the claims have been fully considered and are persuasive in view of the amendments. The objections to the specification and the claims has been withdrawn.
Applicant’s arguments, see Remarks, filed November 6, 2025, with respect to rejection of claims under 35 U.S.C 112b have been fully considered and are persuasive in view of the amendments. The rejection of claims 5 and 17-18 under 35 U.S.C 112b has been withdrawn. However a new rejection under 35 U.S.C 112b has been made as explained below.
Applicant's arguments filed November 6, 2025 have been fully considered but they are not persuasive with respect to the rejection of claims under 35 U.S.C 101.
In response to applicant’s arguments that the claims are not directed to an abstract idea, Examiner respectfully disagrees. Applicant argues that the claims do not recite an abstract idea. However, applicant is conflating the abstract idea with the elements of the claim that are in addition to the abstract idea (i.e. the additional elements). The eligibility analysis does not require the capability of the additional elements to be practically performed in the mind. In this case, the claim limitations that constitute as abstract idea that is part of the Mathematical Concepts and/or Mental Processes group (the judicial exceptions) are identified as being “generating a value of the biomarker of the disease based on the obtained motion data; and assessing the value of the biomarker of the disease and, based on the assessment, outputting information related to the state of the disease” as an experienced clinician can perform the claimed step of generating by mentally noting a value by looking at collected data. The experienced clinician can then assess the value and note information about the data based on the assessment. It is not too burdensome as to be impractical to be performed in the human mind with a pen/pencil and paper. Thus, the claims can be readily interpreted as being a mere application of a mental process on a computer.
In response to applicant’s arguments that the claims are directed to significantly more than the abstract idea because they represent an improvement to a technological field, Examiner respectfully disagrees. The claimed limitations of “generating and assessing” does not improve the technology as the improvement to the technology cannot be in the abstract idea. MPEP 2106.05a. “[L]imitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.” MPEP 2106.05(h). “[T]he additional element in Flook ... was not sufficient to make the claim eligible, because it was merely an incidental or token addition to the claim that did not alter or affect how the process steps of calculating the alarm limit value were performed.” There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for “generating and assessing”.
In response to applicant’s arguments that the additional elements integrate the judicial exception into a practical application, Examiner respectfully disagrees. The additional elements are identified as being “at least one motion sensor”. Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by the Non-Patent literature cited previously. When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Applicant's arguments filed November 6, 2025 have been fully considered but they are not persuasive with respect to the prior art rejections.
In response to applicant’s arguments on p. 9 that the prior art does not teach or suggest the amended limitations, Examiner respectfully disagrees. Kurillo teaches in [0037] that patients with neuromuscular disease are the ones being measured which is interpreted to teach “wherein the disease includes a neuromuscular, a neurological disease, a neurodegenerative disease, a musculoskeletal disease, epilepsy, dystonia, ataxia, degenerative system disease, cardiovascular disease, and degenerative system diseases”. Kurillo further teaches a knee workspace (see paragraph 0013, workspace analysis for joints/segments of body which includes knee joint); a joint workspace (see paragraph 0013, workspace analysis for joints/segments of body); a joint angle distribution (see paragraph 0060, kinematics data in the form of joint locations and angles from various locations are used as inputs for body tracking algorithms which form a distribution); a hip orbit (see paragraph 0013, range of motion at different joints including hip); a hip orbit during walking or an instructed movement (see paragraph 0013, range of motion at different joints including hip; and see paragraph 0041, functional workspace movements done with protocol which is an instructed movement), and a head orbit (see paragraph 0013, range of motion at different joints including neck which is part of head) which meets the amended claimed limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-8 and 41-43 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.
Claims 1-3 recites “wherein the disease includes a neuromuscular, a neurological disease, a neurodegenerative disease, a musculoskeletal disease, epilepsy, dystonia, ataxia, degenerative system disease, cardiovascular disease, and degenerative system diseases”. A lack of clarity arises as it is unclear whether how the disease can include every disease listed in the claim or if one is selected from the group of diseases listed. This causes the meaning of the claim to be unclear. For the purposes of examination, it is interpreted that only one of the diseases listed is selected. Examiner suggests amending the claim to “wherein the disease includes a neuromuscular, a neurological disease, a neurodegenerative disease, a musculoskeletal disease, epilepsy, dystonia, ataxia, degenerative system disease, cardiovascular disease, or degenerative system diseases”.
Claims 6-7 and 41-43 are rejected by virtue of dependence on claim 1 and because they inherit and do not remedy the deficiencies of claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 6-8 and 41-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-3, 6-8 and 41-43 are all within at least one of the four categories.
The independent claim 1 recites:
generate a value of the biomarker of the disease based on the obtained motion data;
assess the value of the biomarker of the disease or other state and, based on the assessment output information related to the state of the disease or other state.
The independent claim 2 recites:
generating a value of the biomarker of the disease based on the obtained motion data; and
assessing the value of the biomarker of the disease and, based on the assessment, outputting information related to the state of the disease.
The independent claim 3 recites:
generating a value of the biomarker of the disease based on the obtained motion data; and
assessing the value of the biomarker of the disease and, based on the assessment, outputting information related to the biomarker.
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019. See footnotes 14 and 15.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018) (performing a resampled statistical analysis to generate a resampled distribution).
The claimed steps of generating and assessing can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
With respect to the pending claims, for example, an experienced clinician can perform the claimed step of generating by mentally noting a value by looking at collected data. The experienced clinician can then assess the value and note information about the data based on the assessment. Thus, the claims can be readily interpreted as being a mere application of a mental process on a computer.
Regarding the dependent claims 6-8 and 41-43, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
This judicial exception (abstract idea) in claims 6-8 and 41-43 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for obtaining, generating, assessing and outputting merely invoke a computer as a tool.
The data-gathering step (obtaining) and the data-output step (outputting) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for obtaining, generating, assessing and outputting.
The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide an assessment on a calculated value.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for obtaining, generating, assessing and outputting. The claims do not apply the obtained data to a particular machine. Rather, the data is merely output in an post-solution step.
The additional elements are identified as follows: at least one motion sensor
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
the non-patent literature cited by applicant:
Inam et al., "The 10-metre gait speed as a functional biomarker in amyotrophic lateral sclerosis," Amyotrophic Lateral Sclerosis, 11(6):558-561, 2010.
Kang et al., "Robotic Assay of Arm Reaching Movements in Diverse Neurologic Populations: Can Movement Features Be Reliable, Disease-Specific Diagnostic Biomarkers?" IEEE International Conference on Rehabilitation Robotics, 2015, pp. 925-930.
Kuhner et al., "Correlations between Motor Symptoms across Different Motor Tasks, Quantified via Random Forest Feature Classification in Parkinson's Disease," Frontiers in Neurology 8(607):1-9, with supplementary material (2 pages), November 2017.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-7 and 41-43 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kurillo (US 20130324857 A1; previously cited by applicant).
With respect to claim 1, Kurillo discloses
A system for monitoring the state of a disease or other state of a person using a biomarker (see paragraph 0012-0013, system to measure physical function such as range of motion for diagnosis), the system comprising:
a motion data obtaining unit configured to obtain from at least one motion sensor motion data from a person having the disease or other state (see paragraph 0068, camera with full body tracking capabilities that captures subjects; and see paragraph 0053, motion characteristics are measured and recorded; and see paragraph 0037, depth-sensing camera that captures user’s 3D information and extracts body kinematics such as motion capture; and see paragraph 0063, system has depth sensing camera in patient side module #52),
a generating unit configured to generate a value of the biomarker of the disease based on the obtained motion data (see paragraph 0037, workspace analysis test measures reachable workspace envelope based on data from camera; and see paragraph 0063-0066, patient side module has subsystem for rending reachable space and range of motion measurements along with joint angle measurements), and
an assessing unit configured to assess the value of the biomarker of the disease and, based on the assessment, to output information related to the state of the disease or other state (see paragraph 0047, workspace analysis test uses algorithm; and see paragraph 0063-0066, patient side module has communication subsystem that is connected to a doctor module where data is displayed and analyzed on assessor’s side),
wherein the disease includes a neuromuscular, a neurological disease, a neurodegenerative disease, a musculoskeletal disease, epilepsy, dystonia, ataxia, degenerative system disease, cardiovascular disease, and degenerative system diseases (see 112b rejection above; and see paragraph 0037, method of measuring reachable workspace for patients with neuromuscular disease)
wherein the biomarker is one of:
A knee workspace (see paragraph 0013, workspace analysis for joints/segments of body which includes knee joint)
A joint workspace (see paragraph 0013, workspace analysis for joints/segments of body)
An average peak velocity
A joint angle distribution (see paragraph 0060, kinematics data in the form of joint locations and angles from various locations are used as inputs for body tracking algorithms which form a distribution)
An extremity velocity profile
A hip orbit (see paragraph 0013, range of motion at different joints including hip)
A hip orbit during walking or an instructed movement (see paragraph 0013, range of motion at different joints including hip; and see paragraph 0041, functional workspace movements done with protocol which is an instructed movement), or
A head orbit (see paragraph 0013, range of motion at different joints including neck which is part of head).; or
wherein the biomarker is any one of a variance in the joint velocity of the knee rotation, a power spectrum of a dominant hip flexion and a non-dominant hip abduction, a correlation between a dominant and a non-dominant hip flexion joint velocities, or a combination thereof.
With respect to claim 2, Kurillo discloses
A method of monitoring the state of a disease using a biomarker (see paragraph 0012-0013, system to measure physical function such as range of motion for diagnosis; and see paragraph 0037, method of measuring reachable workspace for patients with neuromuscular disease), the method comprising:
obtaining from at least one motion sensor motion data from a person having the disease (see paragraph 0068, camera with full body tracking capabilities that captures subjects; and see paragraph 0053, motion characteristics are measured and recorded; and see paragraph 0037, depth-sensing camera that captures user’s 3D information and extracts body kinematics such as motion capture; and see paragraph 0063, system has depth sensing camera in patient side module #52),
generating a value of the biomarker of the disease based on the obtained motion data (see paragraph 0037, workspace analysis test measures reachable workspace envelope based on data from camera; and see paragraph 0063-0066, patient side module has subsystem for rending reachable space and range of motion measurements along with joint angle measurements), and
assessing the value of the biomarker of the disease and, based on the assessment, outputting information related to the state of the disease (see paragraph 0047, workspace analysis test uses algorithm; and see paragraph 0063-0066, patient side module has communication subsystem that is connected to a doctor module where data is displayed and analyzed on assessor’s side,
wherein the disease includes a neuromuscular, a neurological disease, a neurodegenerative disease, a musculoskeletal disease, epilepsy, dystonia, ataxia, degenerative system disease, cardiovascular disease, and degenerative system diseases (see 112b rejection above; and see paragraph 0037, method of measuring reachable workspace for patients with neuromuscular disease)
wherein the biomarker is one of:
A knee workspace (see paragraph 0013, workspace analysis for joints/segments of body which includes knee joint)
A joint workspace (see paragraph 0013, workspace analysis for joints/segments of body)
An average peak velocity
A joint angle distribution (see paragraph 0060, kinematics data in the form of joint locations and angles from various locations are used as inputs for body tracking algorithms which form a distribution)
An extremity velocity profile
A hip orbit (see paragraph 0013, range of motion at different joints including hip)
A hip orbit during walking or an instructed movement (see paragraph 0013, range of motion at different joints including hip; and see paragraph 0041, functional workspace movements done with protocol which is an instructed movement), or
A head orbit (see paragraph 0013, range of motion at different joints including neck which is part of head).; or
wherein the biomarker is any one of a variance in the joint velocity of the knee rotation, a power spectrum of a dominant hip flexion and a non-dominant hip abduction, a correlation between a dominant and a non-dominant hip flexion joint velocities, or a combination thereof.
With respect to claim 3, Kurillo discloses
A method of monitoring a biomarker of an individual to be tested for a disease or having a disease (see paragraph 0012-0013, system to measure physical function such as range of motion for diagnosis; and see paragraph 0037, method of measuring reachable workspace for patients with neuromuscular disease), the method comprising:
obtaining from at least one motion sensor motion data from a person having the disease (see paragraph 0068, camera with full body tracking capabilities that captures subjects; and see paragraph 0053, motion characteristics are measured and recorded; and see paragraph 0037, depth-sensing camera that captures user’s 3D information and extracts body kinematics such as motion capture; and see paragraph 0063, system has depth sensing camera in patient side module #52),
generating a value of the biomarker of the disease based on the obtained motion data (see paragraph 0037, workspace analysis test measures reachable workspace envelope based on data from camera; and see paragraph 0063-0066, patient side module has subsystem for rending reachable space and range of motion measurements along with joint angle measurements),
assessing the value of the biomarker of the disease and, based on the assessment, outputting information related to the biomarker (see paragraph 0047, workspace analysis test uses algorithm; and see paragraph 0063-0066, patient side module has communication subsystem that is connected to a doctor module where data is displayed and analyzed on assessor’s side),
wherein the disease includes a neuromuscular, a neurological disease, a neurodegenerative disease, a musculoskeletal disease, epilepsy, dystonia, ataxia, degenerative system disease, cardiovascular disease, and degenerative system diseases (see 112b rejection above; and see paragraph 0037, method of measuring reachable workspace for patients with neuromuscular disease)
wherein the biomarker is one of:
A knee workspace (see paragraph 0013, workspace analysis for joints/segments of body which includes knee joint)
A joint workspace (see paragraph 0013, workspace analysis for joints/segments of body)
An average peak velocity
A joint angle distribution (see paragraph 0060, kinematics data in the form of joint locations and angles from various locations are used as inputs for body tracking algorithms which form a distribution)
An extremity velocity profile
A hip orbit (see paragraph 0013, range of motion at different joints including hip)
A hip orbit during walking or an instructed movement (see paragraph 0013, range of motion at different joints including hip; and see paragraph 0041, functional workspace movements done with protocol which is an instructed movement), or
A head orbit (see paragraph 0013, range of motion at different joints including neck which is part of head).; or
wherein the biomarker is any one of a variance in the joint velocity of the knee rotation, a power spectrum of a dominant hip flexion and a non-dominant hip abduction, a correlation between a dominant and a non-dominant hip flexion joint velocities, or a combination thereof.
With respect to claim 6, all limitations of claim 1 apply in which Kurillo further discloses wherein the disease is a muscular dystrophy (see paragraph 0037, method of measuring reachable workspace for patients with neuromuscular disease; and see paragraph 00836, patient with muscular dystrophy are measured).
With respect to claim 7, all limitations of claim 1 apply in which Kurillo further discloses wherein the disease is Duchenne Muscular Dystrophy (see paragraph 0037, method of measuring reachable workspace for patients with neuromuscular disease; and see paragraph 00836, patient with Duchene muscular dystrophy are measured).
With respect to claim 41, all limitations of claim 1 apply in which Kurillo further discloses wherein the information related to the state of the disease is information related to the evolution of the disease over time (see paragraph 0014 and 0086, monitoring of disease/injury progression over time)
With respect to claim 42, all limitations of claim 1 apply in which Kurillo further discloses wherein the information related to the state of the disease is independent from a confounder (see paragraph 0044, location of trackers are detected independently from one another to not affect each position during motion capture)
With respect to claim 43, all limitations of claim 1 apply in which Kurillo further discloses wherein the biomarker is derived from force production measures or from upper body focused
measures (see paragraph 0041, body trunk movements are upper body focused measures which clinicians can measure for movement).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kurillo as applied to claim 1 above, and further in view of Fallon (US 20100169409 A1; previously cited).
With respect to claim 8, all limitations of claim 1 apply in which Kurillo further discloses wherein the disease is ataxia (see paragraph 0037, method of measuring reachable workspace for patients with neuromuscular disease; and see paragraph 0054, ataxia can be measured)
Kurillo does not specifically disclose that the disease is Friedreich’s ataxia.
Fallon teaches ataxia in the form of Friedreich’s ataxia (see paragraph 0094, Friedreich’s ataxia).
It would have bene obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kurillo with the teachings of Fallon to have used Friedreich’s ataxia because it would have resulted in the predictable result of monitoring movement for a neurological disease (Fallon: see [0094]).
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