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 .
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.
Claim(s) 1-6 and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirota (US 20240382142 A1) in view of Heldman (US 11975195 B1).
For claim 1, Hirota teaches A system for prognosis of early cognitive decline or other neurological concerns, [entire disclosure – see at least abstract] comprising:
a plurality of testing components configured for interaction with an individual to execute one or more motor tasks by an individual,, [¶65 ¶98]
the plurality of testing components including one or more objects, and a tool configured to accommodate acquisition of the one or more objects by the individual, [tools and objects throughout ¶¶64-66 ¶¶80-81 ¶98]
the plurality of testing components further comprising a source location and a plurality of visible target locations comprising receptacles, [Fig(s). 8-9 ¶¶64-66 ¶¶80-81 ¶98]
the target locations being spatially arranged such that at least one target location is ipsilateral to a reaching extremity of the individual, at least one target location is contralateral to the reaching extremity, [Fig(s). 8]
and one target location is positioned along a midline of the individual, the source location and the target locations being spatially positioned and arranged such that the individual can reproduce a predetermined spatial sequence consistently for each trial, [Fig(s). 8]
the one or more motor tasks including engagement of upper extremities of the individual to perform the predetermined spatial sequence wherein the individual repeatedly uses the tool to acquire the one or more objects from the source location and transport the one or more objects to the target locations in accordance with the predetermined spatial sequence acquire at least one object of the plurality of testing components from a source location and transport the one or more objects to a target location, [Fig(s). 8-9 ¶¶64-66 ¶¶80-81 ¶98]
wherein for the predetermined spatial sequence the individual performs a plurality of goal-directed movements with an upper extremity between the source location and the visible target locations comprising the receptacles, variability in performance of the predetermined spatial sequence over a plurality of trials being indicative of a neurological concern and accommodating detection, diagnosis or prognosis, tracking, or screening for a neurological condition. [¶¶49-58 ¶¶90-94]
Hirota fails to teach the tool comprising a concave portion to receive one or more objects.
Heldman teaches a motor evaluation system [abstract] comprising a spoon used to receive one or more target objects for motion evaluation. [col. 34 ll. 45-65]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the system of Hirota to incorporate the spoon (and associated test configuration) of Heldman in order to aid in assessing patients to ensure more effective and practical therapies. As motivated by Heldman cols. 3-4.
For claim 2, Hirota teaches The system of claim 1,
wherein the one or more motor tasks includes a plurality of goal directed movements to visible target locations, spatially arranged such that at least one target is located ipsilateral to the reaching extremity, at least one target is located contralateral to a reaching extremity, and one target is located along the individual's midline. [Fig. 8]
For claim 3, Hirota teaches The system of claim 1,
wherein the one or more motor tasks includes a sequence of target locations to indicate an order in which the individual must transport the one or more objects, the sequence of target locations being the same across a plurality of trials of the one or more motor tasks. [Fig. 8]
For claim 4, Hirota teaches The system of claim 1, further comprising:
one or more processors configured to:
access a plurality of test scores and associated trial times corresponding to execution of one or more motor tasks by the individual, and compute a motor test score from the plurality test scores including computation of a measure of variability of the plurality of test scores over a predetermined time period that improves prediction of functional decline by quantifying trial-to-trial variability in task performance; [¶50 ¶¶90-94]
and a user interface executed by the one or more processors and configured to provide, via the user interface, a stopwatch function and a scoring function that the individual engages to accommodate aggregation of the plurality of trial times and test scores for access by the processor. [devices 5000 in Fig. 11 providing results (including on phone/smartwatch with stopwatch function) in ¶¶110-125]
For claim 5, Hirota teaches The system of claim 1,
wherein the plurality of testing components is provided with a machine-readable instruction for the predetermined spatial sequence. [¶127]
For claim 6, Hirota teaches The system of claim 5,
wherein the tool includes a handle and a repository, the repository configured to receive the one or more objects as part of the one or more motor tasks. [¶¶36-48]
For claim 9, Hirota teaches The system of claim 5,
wherein the one or more motor tasks includes a sequence of a plurality of movements of the one or more objects by the individual using the tool defining a trial. [¶¶36-48, Fig. 8]
For claim 10, Hirota teaches The system of claim 9,
wherein the processor derives the motor score from trial time and test score data associated with multiple instances of the trial, higher values being associated with a neurological concern. [¶¶36-56]
For claim 11, Hirota teaches The system of claim 1,
wherein the plurality of testing components include are disposable and packaged within a kit configured for portable and efficient testing. [Fig. 8 — objects shown are all disposable, objects discussed in ¶¶36-46 are disposable]
For claim 12, Hirota teaches The system of claim 1,
wherein the motor score reflects decreased motor task acquisition including variability across trials of the one or more motor tasks or lack of improvement of the one or more motor tasks with practice. [¶50]
For claim(s) 13, while Hirota does not specifically teach determining a standard deviation of the test scores, Hirota does generally teach assessing the individual and changes in their condition over time as cited above. Further, standard deviation calculations are commonly used in statistical assessment of individuals and their health parameters — see, e.g., the NPL cited by Hirota ¶170 (effectively incorporated by reference by Hirota, provided as pertinent prior art herewith).
Accordingly, in view of this evidence, Examiner takes official notice that calculating of standard deviation of a subject’s scores would be well known and common at the time of filing. As such, claim(s) 13 is obvious in view of Hirota.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirota in view of Heldman and Burmistrov (US 20220089086 A1).
For claim(s) 7-8, Hirota fails to teach grip force and electrodermal sensors.
Burmistrov teaches a mental state assessment system for daily use which includes grip force and electrodermal sensors. [¶55]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the system of Hirota to incorporate the grip force and skin sensors of Burmistrov in order to help judge a mental and emotional state of the individual for better mental assessment. As motivated by Burmistrov ¶¶55-56 and ¶118.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hirota (US 20240382142 A1).
For claim 19, Hirota teaches A kit for prognosis of early cognitive decline or other neurological concerns, comprising:
a container, a plurality of testing elements including one or more objects and a plurality of receptacles, the container configured for secure storage and transport of the plurality of testing elements, the plurality of testing elements being configured for interaction with an individual to execute one or more motor tasks comprising engagement of upper extremities of the individual to acquire the one or more objects from a source location and transport the one or more objects to the plurality of receptacles arranged at distinct spatial locations according to a predetermined spatial sequence;
and an instruction for guiding an individual to complete one or more motor tasks using the plurality of testing elements according to a predetermined spatial sequence, the instruction describing repeated performance of the motor tasks over a plurality of trials with the one or more objects being transported between the source location and the plurality of receptacles in the predetermined spatial sequence such that variability in performance of the motor tasks across the plurality of trials is indicative of a neurological concern.
[tasks and feedbacking throughout ¶¶38-118 — esp. ¶53, ¶65, ¶98, ¶¶112-116 constitute(s), under BRI, a form of the kit as claimed with at least some form of container, target objects, and instructions for the individual]
For claim 20, Hirota teaches The kit of claim 19, further comprising a tool configured for storage within the container that accommodates goal-directed movements of the one or more objects defined by the sequence. [tasks and feedbacking throughout ¶¶38-118 — esp. ¶53, ¶65, ¶98, ¶¶112-116 constitute(s), under BRI, a form of the kit as claimed with at least some form of container, target objects, and instructions for the individual]
Response to Arguments
Applicant's 1/9/26 arguments with respect to the prior art rejection of claim(s) 13 and 19-20 have been fully considered but they are not persuasive.
Applicant argues in remarks p. 16 that Hirota fails to teach providing a kit with test components and instructions for executing a reproducible trial. Examiner respectfully sub mits that such an argument is not consistent with the BRI of claim(s) 19 which recites that there is an instruction for ‘guiding an individual to complete one or more motor tasks…the instruction describing repeated performance of the motor tasks’. In that Hirota teaches feedbacking to the patient throughout ¶¶38-118 esp. ¶¶112-116 including an explicit teaching of feedback pertaining to a “performance” of a daily task, then Hirota can be clearly said to teach instructions which ‘describe repeat performance of the motor tasks’ and where Hirota specifically details the ‘periodic’ evaluation of the individual as in Hirota ¶64 and ¶82.
Applicant requests evidence for the official notice taken for claim(s) 13 in remarks p. 17. Examiner provides the following examples of standard deviation calculations of performance assessments / test scores:
US 20160262685 A1 - ¶102 ¶103 ¶109 ¶113 ¶122
US 20110046498 A1 - ¶172 ¶200 ¶381
US 20190353501 A1 - ¶¶25-26 ¶¶74-75 ¶¶114-119
Applicant argues in remarks p. 16-17 that the combination of Hirota and Burmistrov does not make obvious claim(s) 7-8. Examiner respectfully disagrees. Applicant’s position rests on the ‘anchoring’ context of claim(s) 7-8. However, such an argument does not clearly link to the specific language of the claim(s) — instead it is only an assertion that the references do not teach the claimed features in the same context. Examiner respectfully submits that such a basis of argument is not a proper showing of nonobviousness. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). No improper evidence has been relied upon in the rejection — all portions of the rejection in question were constructed using the teachings of the references and in consideration of the level of ordinary skill.
That Burmistrov’s system is for emotional inference in a vehicle does not serve as evidence of destructive inoperability with Hirota. Instead, the motivation to incorporate the teachings of Burmistrov would be recognized by one of ordinary skill in the art.
For claim(s) 1-3 and 9-12 Applicant’s arguments with respect to the prior art have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
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