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 .
Status of Claims
In the preliminary amendment filed April 16, 2025, Applicant amended claims 6, 7, 13, and 21. Claims 17-20 and 22-24 were canceled. Claims 1-16 and 21 are pending in the current application.
Information Disclosure Statement
The information disclosure statement (IDS) received on April 16, 2025 has been considered by examiner.
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 1-16 and 21 are rejected under 35 U.S.C. 101 because the claims are not directed to patent eligible subject matter.
Claims 1-16 and 21 do fall within at least one of the four categories of patent eligible subject matter because the claims recite a machine (i.e., system) and process (i.e., a method).
Although claims 1-16 and 21 fall under at least one of the four statutory categories, it should be determined whether the claim wholly embraces a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception (See MPEP 2106 I and II).
Claims 1-16 and 21 are directed to a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea) without significantly more.
Part I: Step 2A, Prong One: Identify the Abstract Idea
Under step 2A, Prong One of the Alice framework, the claims are analyzed to determine if the claims are directed to a judicial exception. MPEP §2106.04(a). The determination consists of a) identifying the specific limitations in the claim that recite an abstract idea; and b) determining whether the identified limitations fall within at least one of the three subject matter groupings of abstract ideas (i.e., mathematical concepts, mental processes, and certain methods of organizing human activity).
The identified limitations of independent claim 1 recite
providing a motion analysis system;
obtaining kinematic and/or kinetic information of a patient with a movement disorder using the motion analysis system while the patient is performing a task;
determining biomechanical patterns of the patient based on the obtained kinematic and/or kinetic information; and
determining a management plan for the patient based on the biomechanical patterns.
The identified limitations of independent claim 9 recite
obtaining individual kinematic and/or kinetic information of a subject, wherein the kinematic and/or kinetic information of the subject is generated from a motion analysis system;
obtaining population kinematic and/or kinetic information from a population of subjects that present with similar kinematic and/or kinetic information as that of the subject, wherein the kinematic and/or kinetic information of each member of the population is generated from a motion analysis system; and
assessing the subject based on a combination of the individual kinematic and/or kinetic information and the population kinematic and/or kinetic information.
The identified limitations of independent claim 21 recite
at least one sensing device configured to obtain and transmit at least one set of motion data;
at least one synchronization clock; and
wherein the central computer contains:
a central processing unit (CPU) with storage coupled to the CPU for storing instructions that when executed by the CPU cause the CPU to:
receive the set of motion data from the motion analysis system; and
whereby the CPU is further configured to determine a management plan for the patient based on the set of motion data.
The identified limitations recite a process that, using the broadest reasonable interpretation, covers performance of the limitations in the mind (including observations, evaluation, judgement and opinion) but for the recitation of generic computer components. That is, other than reciting system, sensing device, and computer, nothing in the claim elements precludes the steps from practically being performed in the mind. For instance, but for the sensing device, “obtaining motion data” encompasses a medical professional observing and recording the movements of a patient. Thus, the claim limitations fall within the Mental Processes groupings of abstract ideas. Accordingly, the claimed invention recites an abstract idea.
Part I: Step 2A, prong two: additional elements that integrate the judicial exception into a practical application
Under step 2A, Prong Two of the Alice framework, the claims are analyzed to determine whether the claims recite additional elements that integrate the judicial exception into a practical application. In particular, the claims are evaluated to determine if there are additional elements or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claims are more than a drafting effort designed to monopolize the judicial exception.
The system, sensing device, and computer in the steps are recited at a high-level of generality (i.e., as a generic sensing device performing a generic computer function) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Dependent claims 2-8 and 10-16, when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to an abstract idea.
Since these claims are directed to an abstract idea, the Office must determine whether the remaining limitations “do significantly more” than describe the abstract idea.
Part II. Determine whether any Element, or Combination, Amounts to“Significantly More” than the Abstract Idea itself
Under Part II, the steps of the claims, when considered individually and as an ordered combination, do not improve another technology or technical field, do not improve the functioning of the computer itself, and are not enough to qualify as "significantly more". For example, the steps require no more than a conventional computer to perform generic computer functions. As stated above, the system, sensing device, and computer in the steps are recited at a high-level of generality (i.e., as a generic sensing device performing a generic computer function) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Therefore, based on the two-part Mayo analysis, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself. Claims 1-16 and 21, when considered individually and as an ordered combination, are rejected as ineligible subject matter under 35 U.S.C. 101.
Dependent claims 2-8 and 10-16 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional claims do no recite significantly more than an abstract idea.
Claim Rejections - 35 USC § 102
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 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 1-16 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagner et al. (US 2016/0262685 A1).
Regarding claim 1, Wagner discloses a method of determining a management plan for a patient with a movement disorder, the method comprising:
providing a motion analysis system (Paragraph [0028]: The invention generally relates to motion analysis systems and methods of use thereof. FIG. 1 shows an exemplary motion analysis system 100 );
obtaining kinematic and/or kinetic information of a patient with a movement disorder using the motion analysis system while the patient is performing a task (Paragraph [0028]: receive motion data while the subject 104 is performing a task…calculates kinematic and/or kinetic information about motion data, and outputs the kinematic and/or kinetic information for purposes of assessing a movement disorder);
determining biomechanical patterns of the patient based on the obtained kinematic and/or kinetic information (Paragraph [0156]: the motion analysis suite can determine the response of the joint to the clinician provided manipulation by assessing patterns of movement such as explained above (for example the magnitude of movement along a path length, directional response, power in response)); and
determining a management plan for the patient based on the biomechanical patterns (Paragraph [0161]: the clinician has analyzed the patient with the motion analysis system and the patient demonstrates positive signs for asymmetric bradykinesia, gait abnormalities… The doctor sends the patient home with a prescription for 1-dopa and tells the patient to come back in 8 to 12 weeks (or a typical period for a patient who is responsive to the drug to begin responding to the medication)).
Regarding claim 2, Wagner discloses the method according to claim 1, wherein the management plan comprises at least one of changes to an existing therapy regimen, generation of a new therapy regimen, guidance on physical therapy, guidance on movement types to be performed while the patient is performing an activity, or combinations thereof (Paragraph [0096]: measures could be used to determine characteristics of movement (such as quality and/or kinematics) at a baseline visit and used to evaluate the impact of a therapy throughout the course a treatment paradigm).
Regarding claim 3, Wagner discloses the method according to claim 1, further comprising:
obtaining additional kinematic and/or kinetic information of the patient at a subsequent point in time (Paragraph [0096]); and
updating the management plan based on the additional kinematic and/or kinetic information (Paragraph [0096]).
Regarding claim 4, Wagner discloses the method according to claim 1, wherein the task is selected from the group consisting of: discrete flexion of a joint; discrete extension of a joint; continuous flexion of a joint; continuous extension of a joint; flexion of a joint; extension of a hand; walking; abduction of a joint, adduction of a joint, rotation of a joint, circumduction, pronation, supination, deviation, rotation, stabilizing a joint, reaching, grasping, flexion, extension, abduction, adduction, medial (internal) rotation, lateral (external) rotation, circumduction, pronation, supination, radial deviation (or radial flexion), ulnar deviation (or ulnar flexion), opposition, reposition, dorsiflexion, plantarflexion, inversion, eversion, walking, running, pivoting, leg swing, arm swing, bending, reaching, twisting, sitting to standing, standing, squatting, holding a prone position, holding a static position, lying to sitting, stepping up or down, weight shifting, postural sway, tilting, turning, nodding, pushes or pulls, carrying or lifting, walking on slippery or uneven surfaces, visual challenges, dual-tasking, or combinations thereof (Paragraph [0089]).
Regarding claim 5, Wagner discloses the method according to claim 1, wherein the movement disorder is selected from the group consisting of: Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Alzheimer's Disease, Tics, Parkinson's Disease, Huntington's Disease, Muscular Dystrophy, Cerebral Palsy, Stroke, Myasthenia Gravis, Peripheral Neuropathy, Ataxia, Friedreich's Ataxia, Dystonia, Restless Leg Syndrome, Polio (Poliomyelitis), Guillain-Barr6 Syndrome, Post-Polio Syndrome, Rheumatoid Arthritis, Osteoarthritis, Lupus, Tardive Dyskinesia, Chorea, Hemiballismus, Wilson's Disease, Brachial Plexus Injury, Tetanus, Motor Neuron Disease, Bell's Palsy, Essential Tremor, Orthostatic Tremor, Rett Syndrome, Spinocerebellar Ataxia, Spinal Muscular Atrophy, Primary Lateral Sclerosis (PLS), Charcot-Marie-Tooth Disease, Complex Regional Pain Syndrome (CRPS), Fibromyalgia, Progressive Supranuclear Palsy, Myoclonus, Phantom Limb Pain, Syringomyelia, Trigeminal Neuralgia, Osteoporosis, Ankylosing Spondylitis, Gout, Paget's Disease of Bone, Lyme Disease, Botulism, Tourette's Syndrome, Prion Diseases, Creutzfeldt-Jakob Disease, Stiff Person Syndrome (SPS), Dermatomyositis, Scleroderma, Batten Disease, Narcolepsy, Chronic Fatigue Syndrome (CFS), Machado-Joseph Disease, Benign Essential Blepharospasm, Foot Drop, Carpal Tunnel Syndrome, Peripheral Artery Disease, Reflex Sympathetic Dystrophy Syndrome, Pantothenate Kinase-Associated Neurodegeneration (PKAN), Mitochondrial Myopathies, Paraneoplastic Syndromes of the Nervous System, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Progressive Multifocal Leukoencephalopathy, Transverse Myelitis, Myotonic Dystrophy, Cervical Spondylosis, Behget's Disease, Pseudotumor Cerebri, Krabbe Disease, Neurofibromatosis, Acoustic Neuroma, Vestibular Neuritis and Labyrinthitis, Vertigo, Meniere's Disease, Chronic Paroxysmal Hemicrania, Antiphospholipid Syndrome (APS), Neuralgia, Paralysis, Postural Orthostatic Tachycardia Syndrome (POTS), Shy-Drager Syndrome, Vasculitis, Hemifacial Spasm, Isaacs' Syndrome, Marfan Syndrome, Osteogenesis Imperfecta, Ehlers-Danlos Syndromes, Alkaptonuria, Spasticity, Athetosis, Hyperkinesias, Hypokinesias, Meralgia Paresthetica, Restless Arms Syndrome, Piriformis Syndrome Spinal Cord Injury, Traumatic Brain Injury, Brain Injury, Diabetes, Cardiovascular Condition, Pulmonary Condition, Balance Ailment, Impingement Syndromes, Joint Replacement, Bone Fusion, bone fracture, joint injury, Trauma, Peripheral Nerve Injury, Post Surgery Injury, Declined Motor Performance, Stuttering, Spasticity, Parkinsonianism, Catatonia, Post-Traumatic Stress Disorder, Stroke, Cognitive Decline, Motor Dysfunction, Motor Performance Decline, Autism, Chronic Pain Syndrome, Epilepsy, Stroke, Auditory Hallucinations, Movement Disorders, Neurodegenerative Disorders, Pain Disorders, Metabolic Disorders, Addictive Disorders, Psychiatric Disorders, Traumatic Nerve Injury, and/or Sensory Disorders (Paragraph [0093]).
Regarding claim 6, Wagner discloses the method according to claim 1, further comprising: performing physical therapy on the patient based on the therapy management plan (Paragraph [0096]);
obtaining additional kinematic and/or kinetic information of the patient at a subsequent point in time (Paragraph [0096]); and
updating the therapy management plan based on the additional kinematic and/or kinetic information (Paragraph [0096]).
Regarding claim 7, Wagner discloses the method according to claim 1, wherein the kinematic and/or kinetic information is obtained while the patient is performing at least one of upper limb motor tasks, lower limb motor tasks, walking, standing still, or combinations thereof (Paragraph [0089]).
Regarding claim 8, Wagner discloses the method according to claim 7, wherein the kinematic and/or kinetic information assesses at least one of bradykinesia, tremor, postural instability, or gait (Paragraph [0098]).
Regarding claim 9, Wagner discloses a method for assessing a subject, the method comprising:
obtaining individual kinematic and/or kinetic information of a subject, wherein the kinematic and/or kinetic information of the subject is generated from a motion analysis system (Paragraph [0028]: receive motion data while the subject 104 is performing a task…calculates kinematic and/or kinetic information about motion data, and outputs the kinematic and/or kinetic information for purposes of assessing a movement disorder);
obtaining population kinematic and/or kinetic information from a population of subjects that present with similar kinematic and/or kinetic information as that of the subject, wherein the kinematic and/or kinetic information of each member of the population is generated from a motion analysis system (Paragraph [0095]: A test subject is then evaluated using the motion analysis system of the invention and their kinematic and/or kinetic information is compared against the appropriate population in the reference set, e.g., the test subject data is matched to the data of a population within the reference set having the same or similar age, gender, and body type as that of the subject ); and
assessing the subject based on a combination of the individual kinematic and/or kinetic information and the population kinematic and/or kinetic information (Paragraph [0095]: The reference set of data could be based on previous measurements taken from the patient currently being assessed. A test subject is then evaluated using the motion analysis system of the invention and their kinematic and/or kinetic information is compared against the appropriate population in the reference set ).
Regarding claim 10, Wagner discloses the method according to claim 9, wherein assessing comprises diagnosing the subject with a movement disorder (Paragraph [0095]).
Regarding claim 11, Wagner discloses the method according to claim 9, wherein assessing comprises determining severity of an existing movement disorder of the subject (Paragraph [0095]).
Regarding claim 12, Wagner discloses the method according to claim 11, wherein the method is performed at least one additional time at a later point in time (Paragraph [0156]).
Regarding claim 13, Wagner discloses the method according to claim 1, wherein prior to the obtaining step, the method further comprises providing stimulation of neural tissue of the subject (Paragraph [0172]).
Regarding claim 14, Wagner discloses the method according to claim 13, wherein the method is repeated after the subject has received stimulation of their neural tissue (Paragraph [0094]).
Regarding claim 15, Wagner discloses the method according to claim 13, wherein the stimulation is non-invasive transcranial stimulation (Paragraph [0172]).
Regarding claim 16, Wagner discloses the method according to claim 15, wherein the stimulation comprises a combination of electrical and mechanical stimulation (Paragraph [0173]).
Regarding claim 21, Wagner discloses a system comprised of at least one motion analysis system connected to a central computer wherein the motion analysis system comprises:
at least one sensing device configured to obtain and transmit at least one set of motion data (Paragraph [0088]: receive motion data from the external body motion sensor related to the at least one joint of the subject while the subject is performing the task );
at least one synchronization clock (Paragraph [0086]: A variety of timing signals can be used in synchronization. In the simplest form, the individual components of the system run on the same clock(s) (or individual clocks that were synchronized prior to, during, and/or after data acquisition)); and
wherein the central computer contains:
a central processing unit (CPU) with storage coupled to the CPU for storing instructions that when executed by the CPU cause the CPU to (Paragraph [0088]: The motion analysis system 100 includes a central processing unit (CPU) 103 with storage coupled to the CPU for storing instructions that when executed by the CPU cause the CPU to execute various functions ):
receive the set of motion data from the motion analysis system (Paragraph [0088]: the CPU is caused to receive a first set of motion data from the image capture device related to at least one joint of a subject while the subject is performing a task and receive a second set of motion data); and
whereby the CPU is further configured to determine a management plan for the patient based on the set of motion data (Paragraph [0096]: measures could be used to determine characteristics of movement (such as quality and/or kinematics) at a baseline visit and used to evaluate the impact of a therapy throughout the course a treatment paradigm).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHINYERE MPAMUGO whose telephone number is (571)272-8853. The examiner can normally be reached Monday-Friday, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHINYERE MPAMUGO/Primary Examiner, Art Unit 3685
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