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 .
Election/Restrictions
Claims 58-78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/26/2026.
Claims 45-57 are hereby under examination.
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 52-57 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 52 recites the limitation “the visual stimulus” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation “the visual stimulus” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 57 recites the limitation “the tail” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 54-56 are rejected based upon their dependencies on the rejected claims.
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 45-57 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 45-57 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04)
Prong one: Claims 45-57 recite abstract idea, as follows:
“…administering one or more visual perception tests to the subject, wherein each visual perception test comprises presentation of a series of visual stimuli to the subject, wherein the series of visual stimuli comprises an initial fixation point followed by a sequence of one or more target images, and wherein the sequence of target images in each visual perception test is designed to measure visual perceptual and/or attentional functions without relying on memory or language; obtaining: a measurement of behavioural responses during administration of the one or more visual perception tests and extracting indices of perceptual ability for each test from the behavioural responses, wherein the behavioural responses relate to identification of a characteristic of the one or more target images in the series of visual stimuli, and wherein the indices of perceptual ability relate to performance threshold and/or performance accuracy; and a simultaneous measurement of electrophysiological responses of the subject…during administration of the one or more visual perception tests and a time-based correlation of events occurring during the tests with the obtained electrophysiological responses, and extracting indices of electrophysiological responses, wherein the indices of electrophysiological responses are derived from raw EEG signals, event-related potentials and/or time-frequency spectra; and comparing the obtained perceptual ability indices, the obtained electrophysiological indices, or both, from one or more of the tests, with a comparative data set to identify deviations from normative performance in any measure or combinations of measures to create a combined index that provides an assessment of brain health in the subject; wherein the comparative data set is: a normative data set of healthy older adults with normal cognition to identify deviations from normative performance in any measure or combinations of measures to provide an assessment of brain health in the subject; or data obtained in one or more tests previously administered to the subject, to identify changes in performance in any measure or combinations of measures to provide an assessment of changes in the brain health state in the subject.
Based on the broadest reasonable interpretation, administering a visual perception test, obtaining a measurement of behavioral responses and indices of perceptual ability, obtaining a simultaneous measurement of electrophysiological responses and indices of electrophysiological responses, and comparing the obtained indices with a comparative data can be done mentally with the aid of a pen and paper. A person can administer a visual perception test by drawing it on a piece of paper. Then the person can obtain measurement of behavioral responses and electrophysiological responses on piece of paper in graph or table format, as accumulated data. The person can mathematically calculate the indices, and compare it to provided comparative data in table or graph format on a piece of paper. Then the combined index data is calculated mathematically either mentally or with a pencil and paper.
Prong two: Claims 45-57 do not include additional elements that integrate the abstract into a practical application.
The additional elements are as follows:
electroencephalography (EEG) sensors, portable EEG device
Reciting electroencephalography (EEG) sensors, portable EEG device do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality.
Therefore, claims 45-57 are ineligible at step 2A, prong two.
Step 2B of the subject matter eligibility test (see MPEP 2106.05)
Reciting electroencephalography (EEG) sensors, portable EEG device do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality.
U.S. Patent Application Publication No. US 20200008725 A1 discloses that portable EEG devices are conventional: [0098], “Common but non-limiting examples of neurophysiological sensors include a portable electroencephalograph (EEG)”
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Therefore, claims 45-57 are ineligible at step 2B.
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.
Claim 45, 47, 50 and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20030013981A1 (Gevins et. al), hereto referred as Gevins.
As to claims 45 and 52, Gevins teaches administering one or more visual perception tests to the subject, wherein each visual perception test comprises presentation of a series of visual stimuli to the subject, wherein the series of visual stimuli comprises an initial fixation point ([0112], "A small fixation dot was continuously present at the center of the screen") followed by a sequence of one or more target images ([0112], "The identity of the letter and its spatial position varied randomly from trial to trial”), and wherein the sequence of target images in each visual perception test is designed to measure visual perceptual and/or attentional functions without relying on memory or language ([0254], "The subject's neural activity is measured while performing an attention-demanding task”);
obtaining: a measurement of behavioural responses during administration of the one or more visual perception tests and extracting indices of perceptual ability for each test from the behavioural responses, wherein the behavioural responses relate to identification of a characteristic of the one or more target images in the series of visual stimuli, and wherein the indices of perceptual ability relate to performance threshold and/or performance accuracy ([0043], "between test sessions, measurements of speed, accuracy and other features of task performance with brain wave (electroencephalogram or EEG)"; the examiner notes, measurements of speed, accuracy and other features are is interpreted as perceptual ability indices); and
a simultaneous measurement of electrophysiological responses of the subject using electroencephalography (EEG) sensors during administration of the one or more visual perception tests and a time-based correlation of events occurring during the tests with the obtained electrophysiological responses ([0044], "amplitude of the subject's EEG frontal midline theta activity"), and extracting indices of electrophysiological responses, wherein the indices of electrophysiological responses are derived from raw EEG signals, event-related potentials and/or time-frequency spectra ([0044], "5) the peak time of the subject's Contingent Negative Variation, N100, P200, P300, N400, P600 and Slow Wave evoked potential peaks elicited by the task stimuli"); and
comparing the obtained perceptual ability indices, the obtained electrophysiological indices, or both, from one or more of the tests, with a comparative data set ([0051], "determine whether a subject's baseline state is within normal limits by comparing the subject's baseline state to the baseline states of a normative group of subjects" ) to identify deviations from normative performance in any measure or combinations of measures to create a combined index that provides an assessment of brain health in the subject ([0145], "The composite Neurocognitive Function Change (NCFC) index provides a summary score indicating direction and degree of change in neurocognitive status from a baseline state."); wherein the comparative data set is:
a normative data set of healthy older adults with normal cognition to identify deviations from normative performance in any measure or combinations of measures to provide an assessment of brain health in the subject; or data obtained in one or more tests previously administered to the subject, to identify changes in performance in any measure or combinations of measures to provide an assessment of changes in the brain health state in the subject ([0051], "normative group of subjects"; [0221], "In this study, 12 healthy, high functioning individuals between the ages of 62 and 75 years (average age 68.3 years) were recruited from the community").
wherein each visual perception test comprises one or more trials, wherein each trial comprises the steps of: a. presenting the visual stimulus to the subject; b. recording the behavioural response by the subject and/or the EEG response to brain activity during the trial ([0044], refer to the whole paragraph).
As to claim 47, Gevins teaches the assessment of brain health comprises determination of mild cognitive impairment ([0109], " This indicates that task-related EEG variables can be used to detect neurofunctional states associated with mild and transient cognitive impairment.").
As to claim 50, Gevins teaches the assessment of brain health comprises an assessment of changes in brain health over a period of time to track progression of disease, to track effects of treatments or behavioural interventions, or to predict changes in perceptual and cognitive status ([0021], "Repeatedly measure fundamental neurocognitive functions of a subject in order to measure changes due to diseases").
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 46 and 53-57 are rejected under 35 U.S.C. 103 as being unpatentable over Gevins as applied to claim 45 above, and further in view of Roudaia, E., Farber, L. E., Bennett, P. J., & Sekuler, A. B. (2011). The effects of aging on contour discrimination in clutter. Vision Research, 51(9), 1022–1032, hereto referred as Roudaia.
Claim 45 is taught as above.
As to claim 46, Gevins teaches using a visual task (Gevins, [0112], "The identity of the letter and its spatial position varied randomly from trial to trial."). However, Gevins does not teach that the one or more visual perception tests are selected from a Contours in Clutter test, a Face Identification test, an Emotion Recognition in Biological Motion test, and a Central and Peripheral Divided Attention test. Roudaia teaches a relevant art of assessing brain function in a subject (Roudaia, title). Roudaia teaches one or more visual perception tests are selected from a Contours in Clutter test, a Face Identification test, an Emotion Recognition in Biological Motion test, and a Central and Peripheral Divided Attention test (Roudaia, pg. 1022, "contours embedded in visual clutter."). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gevins in view of Roudaia to include the contours in clutter test because doing so would allow assessment of the brain function to detect and discriminate contours in a cluttered background, which are one of known methods of brain health assessment, and Gevins already teaches various methods of recording EEG while performing visual tasks (Gevins, [0112]).
As to claim 53, Gevins-Roudaia teaches the one or more visual perception tests includes the Contours in Clutter test (Gevins, [0112]; Roudaia, pg. 1022, "contours embedded in visual clutter."). However, Gevins does not teach the details of the contours in clutter test. Roudaia teaches the details of the contours in clutter test, including:
the visual stimulus comprises a sequence of images (Roudaia, pg. 1024, Fig. 1),
each image comprising an array of oriented visual stimulus elements in which a subset of stimulus elements forms a target contour through alignment of neighboring elements (Roudaia, pg. 1023, "The stimuli consisted of a square region of pseudo-randomly distributed Gabor patches that contained a global pattern in the shape of a C in the center."); wherein
the visibility of the target contour is varied between trials by altering the display characteristics to measure an ability of the subject to perceive the target contour within a cluttered background (Roudaia, pg. 1023, "All Gabors were created by multiplying a 3c/deg sine wave grating of 60% contrast by a circular Gaussian envelope whose full width at half height was 0.25 deg."); and
wherein the subject identifies an element of the target contour to exhibit knowledge of the shape and/or location of the definable contour (pg. 1024, " discriminate the global orientation of the ‘‘C’’ contour ").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gevins in view of Roudaia to include the details of the contours in clutter test because doing so would allow assessment of the brain function to detect and discriminate contours in a cluttered background, which are one of known methods of brain health assessment, and Gevins already teaches various methods of recording EEG while performing visual tasks (Gevins, [0112]).
As to claim 54, Gevins-Roudaia teaches a measure of the subject's tolerance for clutter in performing the task and/or the electrophysiological response is compared with the comparative data set, in isolation or in combination with other measures (Gevins, [0051], "determine whether a subject's baseline state is within normal limits by comparing the subject's baseline state to the baseline states of a normative group of subjects"; Roudaia, Fig. 4).
As to claim 55, Gevins does not teach the details of contour clutter test. Roudaia teaches the degree of clutter is varied across trials to determine the degree of clutter that yields a specified level of accuracy (Roudaia, Fig. 1, Aligned, Phase, Radial). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gevins in view of Roudaia to include the degree of clutter is varied across trials because doing so would allow a more detailed assessment of the brain function to detect and discriminate contours in a cluttered background.
As to claim 56, Gevins does not teach the details of contour, but Roudaia teaches that the target contour is a spiral-shaped contour formed through alignment of the orientations of the subset of stimulus elements along a spiral path (Roudaia, Fig. 1, Aligned and Phase stimulus condition shows generally spiral shaped contours). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gevins in view of Roudaia to include spiral-shaped contour formed through alignment of the orientations of the subset of stimulus elements along a spiral path because doing so would allow a more detailed assessment of the brain function to detect and discriminate contours in a cluttered background of various degrees.
As to claim 57, Gevins-Roudaia teaches the subject is prompted to report whether the tail of the spiral-shaped contour is on the left or right side of the image (Roudaia, pg. 1024, "the four possible locations of the gap (lower left, upper left, upper right, lower right, respectively)").
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Gevins as applied to claim 45 above, and further in view of US20110063571A1 (Duffy, Charles J), hereto referred as Duffy.
Claim 45 is taught as above.
As to claim 48, Gevins teaches assessment of brain health (Gevins, [0084], "An equation is then computed, preferably using a neural network or other type of statistical decision function, that weights and combines the outputs of the classes of expert rules into a Neurocognitive Function Change (NCFC) score that distinguishes baseline from altered states in each normative group of subjects."). However, Gevins does not teach that the assessment comprises neurodegenerative disorder. Duffy teaches relevant art of visual contrast testing (Duffy, Abstract). Duffy teaches the assessment of brain health comprises determination of a neurodegenerative disorder, wherein the neurodegenerative disorder is classical Alzheimer's disease, Alzheimer's disease with posterior cortical atrophy, Lewy Body disease, frontotemporal dementia, or vascular dementia (Duffy, [0142], "Alzheimer's Disease, Parkinson's Disease, dementia"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gevins in view of Duffy to include the assessment of brain health comprises determination of a neurodegenerative disorder, wherein the neurodegenerative disorder is classical Alzheimer's disease because Gevins already teaches assessment of brain health and the method, and Duffy narrows down the categories of brain health to be assessed.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Gevins as applied to claim 45 above, and further in view of US20210267530A1 (Grosselin et. al), hereto referred as Grosselin.
Claim 45 is taught as above.
As to claim 51, Gevins teaches using an EEG device (Gevins, [0115], "EEG was continuously recorded from 28 scalp electrodes using a digitally linked-mastoids reference."), but does not necessarily teach that the measure of the electrophysiological responses is carried out using a portable EEG device. Grosselin teaches a solution to relevant problem of gathering EEG data. Grosselin teaches using portable EEG (Grosselin, [0023], "immediate feedback to a user of a portable EEG system"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gevins in view of Grosselin to include the measure of the electrophysiological responses is carried out using a portable EEG device because doing so would be more convenient for measurement, as recognized by Grosselin (Grosselin, [0023], “so as to improve the positioning of the electrodes of EEG system if necessary.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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/ELINA SOHYUN JANG/ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791