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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/6/26 has been entered.
Notice of Amendment
In response to the amendment(s) filed on 1/6/26, amended claim(s) 25 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
Claim(s) 25-46 and 48-49 is/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.
For claim 25, the claim language “a calculation formula for quantifying a predetermined movement” and “incorporating position coordinates of the virtual marker in the image data into the calculation formula corresponding to the user’s movement” does not appear to be 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of quantifying a predetermined movement, and doing that by incorporating position coordinates of the virtual marker in the image data, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Dependent claim(s) 26-46 and 48-49 fail to cure the deficiencies of independent claim 25, thus claim(s) 25-46 and 48-49 is/are rejected under 35 U.S.C. 112(a).
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.
Claim(s) 25-46 and 48-49 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 25 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 25 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “a calculation formula for quantifying a predetermined movement and a reference value for evaluating the predetermined movement, the reference value referring to a measurement value of a user’s movement calculated based on a position of at least one body part of a user,” “receive image data capturing the predetermined movement of the user,” “identify the position of the at least one body part of the user as a virtual marker corresponding to the user’s movement identified from the image data,” “compute a numerical value by incorporating position coordinates of the virtual marker in the image data into the calculation formula corresponding to the user’s movement,” “evaluate the motor function by assigning a score of existing indices based on comparison of the numerical value computed by the calculation formula with the reference value,” and “wherein the measured value of the user’s movement, which is used as the reference value, is related to the existing indices used to measure an onset and/or progression of the neuromuscular disease.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a memory unit configured to store,” “a processor configured to execute a program,” and “motion capture technology.” However, these elements are not “significantly more” because the memory and processor are generic computer structure(s), which have been held to not add significantly more according to Bliski. The motion capture technology is also well-known, routine, and conventional as evidenced by para [0018] of Applicant’s specification as originally filed in that it is broad enough to include a Microsoft Kinect. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 25 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 26-46 and 48-49 fail to cure the deficiencies of independent claim 25 by merely reciting additional abstract ideas and/or further limitations on abstract ideas already recited. Thus, claim(s) 25-46 and 48-49 is/are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 25-32, 34-36, 40-41, 43-45, and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0293805 to Kontschieder et al. (hereinafter “Kontschieder”) in view of U.S. Patent Application Publication No. 2018/0267757 to Segal and U.S. Patent Application Publication No. 2022/0330880 to Kosaka et al. (hereinafter “Kosaka”).
For claim 25, Kontschieder discloses a neuromuscular disease evaluation device for evaluating motor function related to a neuromuscular disease (Abstract), comprising:
a memory unit (912) (Fig. 9) (para [0106]) configured to store (Examiner’s Note: functional language, i.e., capable of) a calculation formula (the formula used to “calculate a plurality of motion descriptors,” in 1006 in Fig. 10) for quantifying a predetermined movement (para [0039]-[0051] give a list of different “tasks” or predetermined movements); and
a processor (900) (Fig. 9) (para [0103]) configured to execute a program stored in the memory (para [0103] and [0106]) to:
receive image data capturing the predetermined movement of the user (para [0104], i.e., via 902 in Fig. 9);
identify the position of the at least one body part of the user from the image data as a virtual marker (“reference points,” see Fig. 10 and para [0112]) (alternatively, see “body part centroids,” para [0068]) corresponding to the user’s movement identified from the image data (para [0112], [0114], [0136], and/or [0154]-[0155]);
compute a numerical value (“motion descriptors,” para [0068]) (also see para [0067]) by incorporating a characteristic of the virtual marker in the image data into the calculation formula corresponding to the user’s movement (see Fig. 10, specifically, step 1006); and
evaluate the motor function by assigning a score (“disease severity score,” para [0119]) based on the numerical value computed by the calculation formula (para [0119], specifically the quantitative determination) (also see para [0115]).
Kontschieder does not expressly disclose that the characteristic of the virtual marker is position coordinates.
However, Segal teaches that the characteristic of a virtual marker is position coordinates (para [0034]).
It would have been obvious to a skilled artisan to modify Kontschieder such that the characteristic of the virtual marker is position coordinates, in view of the teachings of Segal, because position coordinates are a suitable characteristic/parameter that can be used instead of the characteristic/parameter that is already used in Knotschider’s for its virtual marker(s) that leads to the predictable result of being able to calculate displacement, which is what Kontschieder already wants to do with the virtual marker (see para [0068] and [0113] of Kontschieder).
Kontschieder and Segal do not expressly disclose a reference value for evaluating the predetermined movement, the reference value referring to a measurement value of a user’s movement calculated based on a position of at least one body part of the user; that the assigned score is of a score of existing indices, a comparison of the numerical value with the reference value, and wherein the measurement value of the user’s movement, which is used as the reference value, is related to existing indices used to measure an onset and/or progression of the neuromuscular disease.
However, Kosaka teaches a reference value for evaluating the predetermined movement (“a prediction value for an assessment value of the FIM,” para [0053]), the reference value referring to a measurement value of a user’s movement calculated based on a position of at least one body part of the user (“assessment value of each item of FIM at admission or at predetermined moment (first assessment value),” para [0054]); that the assigned score is of a score of existing indices (Examiner’s Note: the “Functional Independence Measurement” being an example of this disclosed at para [0033] of Applicant’s specification as originally filed) (para [0053], the term “FIM” standing for “Functional Independence Measurement,” see Abstract) (also see para [0056]), a comparison of the numerical value with the reference value (“assessment value of each item of FIM actually assessed (second assessment value)” is compared to “assessment value of each item of FIM at admission or at predetermined moment (first assessment value)” see para [0054] and [0056]-[0057]), and wherein the measurement value of the user’s movement, which is used as the reference value, is related to existing indices used to measure an onset and/or progression of the neuromuscular disease (Examiner’s Note: the “Functional Independence Measurement” being an example of this disclosed at para [0033] of Applicant’s specification as originally filed) (para [0053]) (also see para [0056]).
It would have been obvious to a skilled artisan to modify Kontschieder to include a reference value for evaluating the predetermined movement, the reference value referring to a measurement value of a user’s movement calculated based on a position of at least one body part of the user; that the assigned score is of a score of existing indices, a comparison of the numerical value with the reference value, and wherein the measurement value of the user’s movement, which is used as the reference value, is related to existing indices used to measure an onset and/or progression of the neuromuscular disease, in view of the teachings of Kosaka, for the obvious advantage of being able to objectively monitor a rehabilitation of the patient/user over time (see para [0053] of Kosaka).
For claim 26, Kontschieder further discloses wherein the body part includes at least a part of an upper body of the user (para [0042]).
For claim 27, Kontschieder further discloses wherein the body part includes at least parts of upper and lower bodies of the user (para [0042]).
For claim 28, Kontschieder further discloses wherein the upper body includes any one of head, neck, back, and arms (para [0042]).
For claim 29, Kontschieder further discloses wherein the upper body includes any one of head, neck, back, and arms (para [0042]).
For claim 30, Kontschieder discloses wherein the processor is configured to evaluate the motor function based on items related to motor function in the examination of neuromuscular diseases (para [0011] and [0130]).
For claim 31, Kontschieder further discloses wherein the processor is configured to evaluate the motor function based on items related to motor functions in a test for amyotrophic lateral sclerosis (para [0011] and [0130]).
For claim 32, Kontschieder further discloses wherein the processor is configured to evaluate the motor function based on items related to coordinating movement of the user's body parts (para [0042]) (also see para [0039]-[0051]).
For claim 34, Kontschieder further discloses wherein the processor is configured to perform evaluating for muscle atrophy (para [0011] and [0128]).
For claim 35, Kontschieder further discloses wherein the items include at least one of the following selected from language, salivation, swallowing, writing, eating actions, dressing activity/body movements, movements in bed, walking, climbing stairs, dyspnea, orthopnea, and respiratory failure (para [0041] and/or [0044]).
For claim 36, Kontschieder further discloses wherein the processing unit is configured to analyze an image (“plurality of frames,” para [0111]) of the user's body in the user's walking movement as the predetermined movement (para [0044], [0050], and/or [0127]); and the processor is configured to evaluate the walking movement and/or the quality of the walking movement as an evaluation of the motor function (para [0044], [0050], and/or [0127]).
For claim 40, Kontschieder further discloses wherein the position relates to a joint (“joint,” para [0068]).
For claim 41, Kontschieder further discloses wherein the processor is configured to analyze an image (“plurality of frames,” para [0111]) of the user's body in a walking movement of the user as the predetermined movement (para [0044], [0050], and/or [0127]); and the processor is configured to evaluate at least one movement selected from writing, eating, and dressing/body movements (para [0041]) (also see para [0052]), and a quality of such movement, by analyzing the walking movement of the user (para [0050] and [0127]) (Examiner’s Note: para [0013] of Applicant’s specification as originally filed identifying that speed is part of evaluating quality of movement) (also see para [0129] and [0135]).
For claim 43, Kontschieder further discloses wherein the processor is configured to perform determining the degree of progression of the neuromuscular disease based on the evaluation (para [0115]-[0116]).
For claim 44, Kontschieder further discloses wherein the processor is configured to perform determining a patient group based on the progression of motor dysfunction based on the evaluation (para [0117]).
For claim 45, Kontschieder further discloses wherein the neuromuscular disease includes amyotrophic lateral sclerosis (para [0011] and [0130]).
For claim 48, Kontschieder further discloses wherein the neuromuscular diseases include one of Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, spinocerebellar degeneration, progressive supranuclear palsy, multiple system atrophy, multiple sclerosis, neuromyelitis optica, Adrenoleukodystrophy, metachromatic leukodystrophy, hyper glutaric acidemia type I, phenylketonuria, GM1 gangliosidosis, GM2 gangliosidosis, mucolipidosis type II (I-cell disease), Angelman syndrome, Krabbe disease, Batten disease, mucopolysaccharidosis, Rett disease, Niemann-Pick disease A,B,C, spinal cord injury, inclusion body myositis, myasthenia gravis, hereditary spastic paraplegia, primary lateral sclerosis, Charcot-Marie-Tooth disease, spinal muscular atrophy, Friedreich's ataxia, dermatomyositis, polymyositis, Guillain-Barre syndrome, chronic inflammatory, demyelinating polyneuritis, Lambert-Eaton myasthenia, multifocal motor neuropathy, anti-MAG peripheral neuropathy, facioscapulohumeral dystrophy, muscular dystrophy, myotonic dystrophy, Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy, spinal and bulbar atrophy, mitochondrial disease, Leigh's encephalomyelopathy, MELAS (Mitochondrial myopathy, Encephalopathy, Lactic acidosis, stroke-like episodes syndrome), fragile X-associated tremor/ataxia syndrome (FXTAS), Pelizaeus-Merzbacher disease (PMD), neuritis or myelitis caused by a virus or bacteria, cerebral infarction, cervical spondylosis, or spondylosis (para [0011] and [0130]).
Claim(s) 33, 39, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kontschieder in view of Segal and Kosaka, and further in view of “Upper Extremity 3D Reachable Workspace Assessment in ALS by Kinect sensor,” by Oskarsson et al. (hereinafter “Oskarsson”).
For claim 33, Kontschieder further discloses wherein the processor is configured to evaluate the motor function based on items related to motor function (para [0011] and [0130]).
Kontschieder, Segal, and Kosaka do not expressly disclose that the motor function is included in ALS Functional Rating Scale (ALSFRS-R).
However, Oskarsson teaches motor function included in ALS Functional Rating Scale (ALSFRS-R) (Abstract).
It would have been obvious to a skilled artisan to modify Kontschieder such that the motor function is included in ALS Functional Rating Scale (ALSFRS-R), in view of the teachings of Oskarsson, for the obvious advantage of using a standardized scale where scores can be compared objectively.
For claim 39, Kontschieder further discloses wherein the evaluation is performed in connection with the walking movements (para [0044], [0050], and/or [0127]) and with items related to motor function (para [0011] and [0130]).
Kontschieder, Segal, and Kosaka do not expressly disclose that the motor function is included in ALS Functional Rating Scale (ALSFRS-R).
However, Oskarsson teaches motor function included in ALS Functional Rating Scale (ALSFRS-R) (Abstract).
It would have been obvious to a skilled artisan to modify Kontschieder such that the motor function is included in ALS Functional Rating Scale (ALSFRS-R), in view of the teachings of Oskarsson, for the obvious advantage of using a standardized scale where scores can be compared objectively.
For claim 46, Kontschieder, Segal, and Kosaka do not expressly disclose wherein the processor is configured to evaluate a range of motion of joints of the user.
However, Oskarsson teaches evaluating range of motion of joints (first paragraph on page 4).
It would have been obvious to a skilled artisan to modify Kontschieder wherein the processor is configured to evaluate a range of motion of joints of the user, in view of the teachings of Oskarsson, because range of motion is a suitable parameter to evaluate that would lead to the predictable result of being able to evaluate/diagnose a user for ALS.
Claim(s) 37-38, 42, and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kontschieder in view Segal and Kosaka, and further in view of of JP 2017-205-134 to Yasukawa et al. (hereinafter “Yasukawa”).
For claim 37, Kontschieder, Segal, and Kosaka do not expressly disclose wherein in connection with the evaluation of the quality of the walking movement, the user is evaluated for at least one of the following: walking speed, stride length, arm swing, leg swing, phase difference of each joint marker of the whole body, neck nod, back bend, body side swing, body wobble (front to back and side to side).
However, Yasukawa teaches wherein in connection with the evaluation of the quality of the walking movement, the user is evaluated for at least one of the following: walking speed, stride length, arm swing, leg swing, phase difference of each joint marker of the whole body, neck nod, back bend, body side swing, body wobble (para [0054]) (also see para [0055]-[0058]).
It would have been obvious to a skilled artisan to modify Kontschieder wherein in connection with the evaluation of the quality of the walking movement, the user is evaluated for at least one of the following: walking speed, stride length, arm swing, leg swing, phase difference of each joint marker of the whole body, neck nod, back bend, body side swing, body wobble, in view of the teachings of Yasukawa, because such characteristics are suitable parameters for the walking tests disclosed in Kontschieder by which to evaluate a user’s neurocognitive ability, which is what Kontschieder wants to do.
For claim 38, Kontschieder, Segal, and Kosaka do not expressly disclose wherein at least one of the following is evaluated in connection with the evaluation of the quality of the walking movement: walking speed, arm swing, leg swing, phase difference of each joint marker of the whole body, neck nodding, back bending, and body side swing.
However, Yasukawa teaches disclose wherein at least one of the following is evaluated in connection with the evaluation of the quality of the walking movement: walking speed, arm swing, leg swing, phase difference of each joint marker of the whole body, neck nodding, back bending, and body side swing (para [0054]) (also see para [0055]-[0058]).
It would have been obvious to a skilled artisan to modify Kontschieder wherein at least one of the following is evaluated in connection with the evaluation of the quality of the walking movement: walking speed, arm swing, leg swing, phase difference of each joint marker of the whole body, neck nodding, back bending, and body side swing, in view of the teachings of Yasukawa, because such characteristics are suitable parameters for the walking tests disclosed in Kontschieder by which to evaluate a user’s neurocognitive ability, which is what Kontschieder wants to do.
For claim 42, Kontschieder further discloses wherein the user's walking (para [0044], [0050], and/or [0127]) is evaluated in conjunction (para [0052]) with the evaluation of the quality of writing, eating actions, or dressing activity/body movement activities (para [0041]).
Knotschieder, Segal, and Kosaka do not expressly disclose that the evaluation of walking includes the evaluation of arm swing.
However, Yasukawa teaches that the evaluation of walking includes the evaluation of arm swing (para [0054]) (also see para [0055]-[0058]).
It would have been obvious to a skilled artisan to modify Kontschieder such that the evaluation of walking includes the evaluation of arm swing, in view of the teachings of Yasukawa, because such characteristics are suitable parameters for the walking tests disclosed in Kontschieder by which to evaluate a user’s neurocognitive ability, which is what Kontschieder wants to do.
For claim 49, Kontschieder, Segal, and Kosaka do not expressly disclose wherein at least one of the following is evaluated in connection with the evaluation of the quality of the walking movement of the user: forward left-right leg and backward left-right leg swing, forward left-right arm and backward right-right arm swing, and an angle of ankle motion.
However, Yasukawa teaches evaluating one of the following in connection with the evaluation of the quality of the walking movement of the user: forward left-right leg and backward left-right leg swing, forward left-right arm and backward right-right arm swing, and an angle of ankle motion (para [0054]) (also see para [0055]-[0058]).
It would have been obvious to a skilled artisan to modify Kontschieder wherein at least one of the following is evaluated in connection with the evaluation of the quality of the walking movement of the user: forward left-right leg and backward left-right leg swing, forward left-right arm and backward right-right arm swing, and an angle of ankle motion, in view of the teachings of Yasukawa, because such characteristics are suitable parameters for the walking tests disclosed in Kontschieder by which to evaluate a user’s neurocognitive ability, which is what Kontschieder wants to do.
Response to Arguments
Applicant’s arguments filed 1/6/26 have been fully considered.
With respect to the 101 rejections, the arguments will be treated in the order they were presented. With respect to the first argument, “computation processing,” “calculation formula “mathematical model,” “computer-based processing,” are all abstract ideas. Performing computations, calculations, or math can all be done in the human mind and there is nothing in the claim language that limits the processing/computation to be outside of the human mind. With respect to the second argument, “objective and reproducible motor-function evaluation” is not a technology, it’s an abstract idea. Additionally, extraction of virtual markers from captured image data and numerical quantification of the user’s movement using a defined calculation formula are also abstract ideas that just relate to information and do not result in a tangible improvement to a concrete technology. As a result, the 101 rejection is maintained.
With respect to the 103 rejections, Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 1/6/26.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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