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 Objections
Claims 6, 13, and 15 are objected to because of the following informalities: Claim 6 recites “total time on screen” in line 3, but instead should be –total time on the screen device--. Claim 13 recites “the eye tracker is configured to track individual eye gaze information” in line 3, but instead should be -- the eye tracker is configured to track the individual eye gaze information--. Claim 15 recites “wherein dwell proportion” in line 2, but instead should be –wherein the dwell proportion--. Appropriate correction is required.
Claim Interpretation
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 9-10, 17, and 20 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 limitation “first module” and “second module” in claims 9-10, 17, and 20 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is unclear as to what structure is behind the modules. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-13, 11-13, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Frazier et al. (Development and Validation of Objective, Quantitative, Eye Tracking-Based Measures of Autism Risk and Symptom Levels- 2019), hereinafter Frazier, and further in view of Frazier et al. (Social attention as a cross-cultural transdiagnostic neurodevelopmental risk marker- 2021), hereinafter Thomas, and Sasson et al. (Eye Tracking Young Children with Autism- 2012), hereinafter Sasson.
Regarding claim 1, Frazier teaches a system for screening and diagnosis of autism spectrum disorders using an English language eye-tracking paradigm (abstract), comprising: a computing device; a screen device; an eye tracking device (pg. 5, see Eye tracking Acquisition and Processing, “SMI Red250 remote eye tracker” and “19-inch LCD stimulus presentation monitor” and “SMI BeGaze software and included 5 measures that initial analyses indicated provided unique information within temporal ROI”);
and a set of stimuli paradigm (pg. 5, see Eye tracking Acquisition and Processing, Forty-four stimuli were presented using SMI Experiment Center, selected to represent 7 distinct stimulus paradigms), wherein the set of stimuli paradigm (see Figure S1, “all 44 stimuli are present here and relied upon to identify the following paradigms” (emphasis added)) are each comprised of dynamic individual faces (Fig. S1(a)), static side-by-side faces (Fig. S1(g)), joint attention bids (Fig. S1(a)), gaze following (Fig. S1(e) and S2), reciprocal interactions (Fig. S1(g)-(f)), dynamic social versus dynamic geometric images (Fig. S1(d)), and passive viewing of social or object arrays (Fig. S1(d)), and wherein the overall stimuli paradigm ends in a short gaze accuracy validation step (Fig. S2, valid eye tracking administration is performed after testing. See pg. 5, “Eye tracking evaluations were considered invalid and data were excluded if gaze to the screen during the entire experiment was tracked 60% fixation duration percent to the stimulus” (emphasis added) indicating that a validation step that ensures certain parameters are met, if not, the data is excluded).
Frazier fails to teach wherein the system is for screening and diagnosing of autism spectrum disorders using an Arabic language eye-tracking paradigm.
Thomas teaches a study to evaluate the social attention in English and Arabic speaking youth to compare social attention between children with autism spectrum disorder based on evaluating eye tracking data (abstract). The aim of the study was to examine the cross-cultural consistency of a general social attention dimension by characterizing the structure of social attention (see Discussion).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier, such that the system is for screening and diagnosing of autism spectrum disorders using an Arabic language eye-tracking paradigm, as taught by Thomas, to examine the cross-cultural consistency of general social attention among test subjects and autism subjects.
Frazier further fails to teach wherein the set of stimuli paradigm each end a short gaze accuracy validation step.
Sasson teaches an eye tracking system for young children with autism that is configured to sample at 250hz when tracking eye-tracking to track subjects oculomotor behavior which is conducive to testing young children with ASD (pg. 1, see Eye-Tracking Equipment, bullet point 3). Sasson further teaches a validation step, called “anchor,” to determine if calibration drift is occurring (pg. 3, bullet 9, “if drift exceeds 3 degrees of visual angle, re-calibration should be administered. Additionally, if multiple tasks or trials are included, re-calibration is recommended between each one to eliminate drift over the course of testing”). As such, Sasson understands that a validation step, “anchor,” should be performed during multiple tasks or trials to eliminate drift over the course of testing.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier in view of Sasson, such that the set of stimuli paradigm each end a short gaze accuracy validation step to eliminate drift over the course of testing.
Regarding claim 2, Frazier teaches wherein the computing device is operatively coupled to the screen device and the eye tracking device (pg. 5, see Eye tracking Acquisition and Processing, “Data were recorded using an SMI Red250 remote eye tracker (sampling at 60Hz) attached to the frame of a 1280 horizontal X 1024 vertical 19-inch LCD stimulus presentation monitor” and “Gaze metrics to each ROI were derived using SMI BeGaze software” indicating that the camera, which is connected to the screen, must be operatively connected to a computer with the software).
Regarding claims 3 and 13, Frazier teaches wherein the eye tracker is operatively coupled to the screen device, such that the eye tracker tracks individual eye gaze information for an individual looking at the screen device (pg. 5, see Eye tracking Acquisition and Processing, “Data were recorded using an SMI Red250 remote eye tracker (sampling at 60Hz) attached to the frame of a 1280 horizontal X 1024 vertical 19-inch LCD stimulus presentation monitor”).
Regarding claim 11, Frazier teaches wherein the eye tracking device is one of a Tobbi or and SMI RED250 eye tracker system (pg. 5, see Eye tracking Acquisition and Processing, “Data were recorded using an SMI Red250 remote eye tracker (sampling at 60Hz) attached to the frame of a 1280 horizontal X 1024 vertical 19-inch LCD stimulus presentation monitor”).
Regarding claim 12, Frazier teaches a method using a system for screening and diagnosis of autism spectrum disorders using an English language eye-tracking paradigm (abstract), comprising: a computing device; a screen device; an eye tracking device (pg. 5, see Eye tracking Acquisition and Processing, “SMI Red250 remote eye tracker” and “19-inch LCD stimulus presentation monitor” and “SMI BeGaze software and included 5 measures that initial analyses indicated provided unique information within temporal ROI”);
and a set of stimuli paradigm (pg. 5, see Eye tracking Acquisition and Processing, Forty-four stimuli were presented using SMI Experiment Center, selected to represent 7 distinct stimulus paradigms), wherein the set of stimuli paradigm (see Figure S1, “all 44 stimuli are present here and relied upon to identify the following paradigms” (emphasis added)) are each comprised of dynamic individual faces (Fig. S1(a)), static side-by-side faces (Fig. S1(g)), joint attention bids (Fig. S1(a)), gaze following (Fig. S1(e) and S2), reciprocal interactions (Fig. S1(g)-(f)), dynamic social versus dynamic geometric images (Fig. S1(d)), and passive viewing of social or object arrays (Fig. S1(d)), and wherein the overall stimuli paradigm ends in a short gaze accuracy validation step (Fig. S2, valid eye tracking administration is performed after testing. See pg. 5, para.[5], “Eye tracking evaluations were considered invalid and data were excluded if gaze to the screen during the entire experiment was tracked 60% fixation duration percent to the stimulus” (emphasis added) indicating that a validation step that ensures certain parameters are met, if not, the data is excluded),
the method comprising: playing one of the set of stimuli on the screen device ; tracking individual eye gaze information for an individual looking at the screen device (pg. 5, see Eye tracking Acquisition and Processing, Forty-four stimuli were presented using SMI Experiment Center, selected to represent 7 distinct stimulus paradigms); and calculating an Autism Index (AI) score based on the individual eye gaze information (pg. 5-6, see Statistical analysis, autism risk score and autism symptom score are computed).
Frazier fails to teach wherein the system is for screening and diagnosing of autism spectrum disorders using an Arabic language eye-tracking paradigm.
Thomas teaches a study to evaluate the social attention in English and Arabic speaking youth to compare social attention between children with autism spectrum disorder based on evaluating eye tracking data (abstract). The aim of the study was to examine the cross-cultural consistency of a general social attention dimension by characterizing the structure of social attention (see Discussion).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier, such that the system is for screening and diagnosing of autism spectrum disorders using an Arabic language eye-tracking paradigm, as taught by Thomas, to examine the cross-cultural consistency of general social attention among test subjects and autism subjects.
Frazier further fails to teach wherein the set of stimuli paradigm each end a short gaze accuracy validation step.
Sasson teaches an eye tracking system for young children with autism that is configured to sample at 250hz when tracking eye-tracking to track subjects oculomotor behavior which is conducive to testing young children with ASD (pg. 1, see Eye-Tracking Equipment, bullet point 3). Sasson further teaches a validation step, called “anchor,” to determine if calibration drift is occurring (pg. 3, bullet 9, “if drift exceeds 3 degrees of visual angle, re-calibration should be administered. Additionally, if multiple tasks or trials are included, re-calibration is recommended between each one to eliminate drift over the course of testing”). As such, Sasson understands that a validation step, “anchor,” should be performed during multiple tasks or trials to eliminate drift over the course of testing.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier in view of Sasson, such that the set of stimuli paradigm each end a short gaze accuracy validation step to eliminate drift over the course of testing.
Regarding claim 18, Frazier teaches wherein the individual looking at the screen device is located about 60 to 65 cm from the screen device, and wherein the individual looking at the screen device looks at the screen device at a visual angle of about 18.8 degrees (pg. 5, “Children were seated alone or in their parent’s lap approximately 65cm from the LCD display and viewed stimuli subtending a visual angle of ~18.8°”).
Regarding claim 19, Frazier teaches wherein the individual eye gaze information tracked is tracked for 3-5 minutes (pg. 2, see Method, “a 5- minute video”).
Claims 4-5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Frazier-Thomas-Sasson, as applied to claims 3 and 12, further in view of Mihali et al. (US 20260130614), hereinafter Mihali.
Regarding claims 4 and 14, Frazier teaches herein the individual eye gaze information tracked is calibrated using 2-, 5-, or 9-point calibrations starting with 5 or 9-point depending on a functional level of the individual looking at the screen device (pg. 4, see Eye Tracking Acquisition, “Two 5-point calibrations were obtained at fixed times throughout the experiment, once at the beginning and once approximately 2 minutes into the stimulus presentation. Additional calibrations could be inserted if the examiner judged that gaze capture accuracy had been lost when observing the participant’s gaze as depicted on the experimental control monitor” (emphasis added)), and wherein the individual eye gaze information tracked is provided with position accuracy to 0.4° (pg. 4, see Eye Tracking Acquisition, “Maximum spatial resolution was 0.1° with gaze position accuracy of 0.5°” indicating that the position accuracy ranges from 0.4°-0.6°), but fails to teach wherein the individual eye gaze information tracked is comprised of binocular gaze, 3D eye position, pupil, and timestamp data collected at a sampling rate of 250Hz.
Mihali teaches that various systems in the art for tracking both eyes or gaze of a user (¶[0073]). These systems are configured to track 3D eye positions and pupils when “presenting visual content that is sensitive to the location of the viewer (e.g. when content is intended to be presented specifically at the location of the user's or users' eye(s))”.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier-Thomas-Sasson, such that the individual eye gaze information tracked is comprised of binocular gaze, 3D eye position, and pupils, as taught by Mihali, when presenting visual content that is sensitive to the location of the viewer.
Frazier-Thomas-Mihali fail to explicitly teach that the tracked information includes timestamp data and collecting data at a sampling rate of 250Hz. Frazier does however teach that in the validation step, the amount of time in percent is tracked to exclude or include data, which requires a timestamp mechanism to make the determination (See pg. 5). However, for simplicity, Sasson is relied upon to explicitly teach the limitation.
Sasson teaches an eye tracking system for young children with autism that is configured to sample at 250hz when tracking eye-tracking to track subjects oculomotor behavior which is conducive to testing young children with ASD (pg. 1, see Eye-Tracking Equipment, bullet point 3). Further, Sasson teaches “Most eye-tracking systems yield raw data files that include, at a minimum, a timestamp, X and Y coordinates of the point of regard (sometimes for both eyes), the distance from the display or stimulus, along with an index that characterizes an event or change in stimulus presentation” (pg. 3, see Analysis, bullet point 1).
Therefore, it would have been obvious to one of ordinary at the time the invention was effectively filed to have modified the system of Frazier-Thomas-Sasson-Mihali, such that the tracked information includes timestamp data and collecting data at a sampling rate of 250Hz, as taught by Sasson, because it is prevalent in eye tracking analysis and conducive to testing oculomotor behavior of young children.
Regarding claim 5, Frazier teaches wherein the computing device is configured to play one of the set of stimuli paradigm (pg. 4, see Eye Tracking Acquisition).
Claims 6-7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Frazier in view of Thomas, Sasson, and Mihali, as applied to claim 5, further in view of Munoz et al. (US 20240366131), hereinafter Munoz.
Regarding claims 6 and 15, Frazier teaches wherein the computing device is configured to calculate dwell proportion based on the individual eye gaze information tracked, wherein dwell proportion is a percentage of on target region relative to total time on screen of the one of the set of stimuli paradigm played ( See pg. 5, “Eye tracking evaluations were considered invalid and data were excluded if gaze to the screen during the entire experiment was tracked 60% fixation duration percent to the stimulus” (emphasis added) indicating that a percentage of how long the subject was looking at the stimulus compared to the total time is determined), and wherein the computing device is configured to collect information on visits to regions-of-interest based on the individual eye gaze information tracked (See pg. 5, Eye Tracking Acquisition and Processing), but fails to teach saccade average length, saccade peak velocity, and blink frequency based on the individual eye gaze information tracked. Sasson teaches oculomotor dynamics, i.e. saccade, is used in the ASD analysis, but fails to mention the specific saccade parameters (see pg. 3, Analysis, bullet point 6-7).
Munoz teaches a system for detecting brain disorders including autism (abstract and ¶[0018]). Muno re-affirms Sasson because they propose “Oculomotor biomarkers (i.e., features) have been found and used to diagnose various neurodegenerative disorders” (¶[0042-43]). The oculomotor features range from saccade average length, saccade peak velocity, and blink frequency/rate (table 1 and ¶[0059-62]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier-Thomas-Sasson-Mihali, such that saccade average length, saccade peak velocity, and blink frequency based on the individual eye gaze information is tracked, as taught by Munoz, because they are useful in diagnosing neurodegenerative disorders.
Regarding claim 7, Frazier teaches wherein the computing device is configured to calculate an Autism Index (AI) score (pg. 5-6, see Statistical analysis, autism risk score and autism symptom score are computed).
Claims 8-10 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Frazier in view of Thomas and Sasson, as applied to claims 1 and 12, further in view of Klin et al. (US 20160262613), hereinafter Klin.
Regarding claims 8 and 16, Frazier-Thomas-Sasson fail to teach wherein the set of stimuli paradigm is comprised of a first and second module.
Klin teaches a system and method for assessing infant and child development based on eye tracking data (abstract). Klin teaches that there are two modes (interpreted as the claimed modules), an infant mode and a toddler mode, to accommodate the differences in sitting positions, which also requires accommodating the display and eye tracker (¶[0081,0083,0171]). Moreover, the images can be anu suitable visual image, including movies (¶[0078]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier-Thomas-Sasson, such that the set of stimuli paradigm is comprised of a first and second module, as taught Klin, to accommodate the different natural physical capabilities of the subject being tested.
Regarding claim 9, Frazier teaches using 44 different photo and videos in English to measure symptom levels related to ADOS-2 modules.
Klin teaches that the first module comprises any suitable image, including static photos, videos, and/or movies in English (¶[0078]) and configured to for use with nonverbal and very young individuals (¶[0171], infants 2-6 months). Therefore, the 44 images and videos of Frazier can be presented to the infant in mode 1.
Regarding claim 10, Frazier teaches using 44 different photo and videos in English to measure symptom levels related to ADOS-2 modules.
Klin teaches that the second module comprises any suitable image, including static photos, videos, and/or movies in English (¶[0078]) and configured to for use with verbal individuals (¶[0171], toddler 9-36 months, which the ADOS considers as verbal and known to one of ordinary skill in the art. Regardless, Klin’s invention can be used with both verbal and nonverbal individuals and the recited limitation does not expressly require only verbal individuals). Therefore, the 44 images and videos of Frazier can be presented to the toddler in mode 2.
Regarding claim 17, Frazier teaches using 44 different photo and videos in English to measure symptom levels related to ADOS-2 modules.
Klin teaches that the first module comprises any suitable image, including static photos, videos, and/or movies in English (¶[0078]) and configured to for use with nonverbal and very young individuals (¶[0171], infants 2-6 months). Therefore, the 44 images and videos of Frazier can be presented to the infant in mode 1.
Klin teaches that the second module comprises any suitable image, including static photos, videos, and/or movies in English (¶[0078]) and configured to for use with verbal individuals (¶[0171], toddler 9-36 months, which the ADOS considers as verbal and known to one of ordinary skill in the art. Regardless, Klin’s invention can be used with both verbal and nonverbal individuals and the recited limitation does not expressly require only verbal individuals). Therefore, the 44 images and videos of Frazier can be presented to the toddler in mode 2. The claimed limitations do not require that the exact amount of stimuli are required, instead, it is interpreted as the minimum. Moreover, the claimed limitations do not require that the 21 and 24 stimuli be different from each other.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Frazier in view of Munoz, Klin, Mihali, and Sasson.
Regarding claim 20, Frazier teaches a method of calculating an Autism Index (AI) score, the method comprising: collecting individual eye gaze information for an individual looking at one of a set of stimuli paradigm; collecting information on visits to regions-of-interest (pg. 5, see Eye tracking Acquisition and Processing, Forty-four stimuli were presented using SMI Experiment Center, selected to represent 7 distinct stimulus paradigms),
calculating a dwell proportion based on the individual eye gaze information (See pg. 5, “Eye tracking evaluations were considered invalid and data were excluded if gaze to the screen during the entire experiment was tracked 60% fixation duration percent to the stimulus” (emphasis added) indicating that a percentage of how long the subject was looking at the stimulus compared to the total time is determined);
wherein the individual eye gaze information tracked is calibrated using 2-, 5-, or 9-point calibrations starting with 5 or 9-point depending on a functional level of the individual looking at the screen device ((pg. 4, see Eye Tracking Acquisition, “Two 5-point calibrations were obtained at fixed times throughout the experiment, once at the beginning and once approximately 2 minutes into the stimulus presentation. Additional calibrations could be inserted if the examiner judged that gaze capture accuracy had been lost when observing the participant’s gaze as depicted on the experimental control monitor” (emphasis added);
wherein the individual eye gaze information tracked is provided with position accuracy to 0.4° (pg. 4, see Eye Tracking Acquisition, “Maximum spatial resolution was 0.1° with gaze position accuracy of 0.5°” indicating that the position accuracy ranges from 0.4°-0.6°); and
wherein dwell proportion is a percentage of on target region relative to total time on screen of the one of the set of stimuli paradigm played (See pg. 5, “Eye tracking evaluations were considered invalid and data were excluded if gaze to the screen during the entire experiment was tracked 60% fixation duration percent to the stimulus” (emphasis added) indicating that a percentage of how long the subject was looking at the stimulus compared to the total time is determined).
Frazier fails to teach collecting information on visits to saccade average length, saccade peak velocity, and blink frequency based on the individual eye gaze information; wherein the set of stimuli paradigm is comprised of a first module and a second module; wherein the first module is comprised of 21 different photo and short video stimuli entirely in Arabic or entirely in English; wherein the first module is configured for use with nonverbal and very young individuals; wherein the second module is comprised of 24 different photo and short video stimuli entirely in Arabic or entirely in English; wherein the second module is configured for use with verbal individuals; wherein the individual eye gaze information tracked is comprised of binocular gaze, 3D eye position, pupil, and timestamp data collected at a sampling rate of 250Hz.
As stated above, Frazier fails to teach collecting information on visits to saccade average length, saccade peak velocity, and blink frequency based on the individual eye gaze information.
Munoz teaches a system for detecting brain disorders including autism (abstract and ¶[0018]). Muno re-affirms Sasson because they propose “Oculomotor biomarkers (i.e., features) have been found and used to diagnose various neurodegenerative disorders” (¶[0042-43]). The oculomotor features range from saccade average length, saccade peak velocity, and blink frequency/rate (table 1 and ¶[0059-62]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Frazier, such that saccade average length, saccade peak velocity, and blink frequency based on the individual eye gaze information is tracked, as taught by Munoz, because they are useful in diagnosing neurodegenerative disorders.
Frazier-Munoz fail to teach wherein the set of stimuli paradigm is comprised of a first module and a second module; wherein the first module is comprised of 21 different photo and short video stimuli entirely in English; wherein the first module is configured for use with nonverbal and very young individuals; and
wherein the second module is comprised of 24 different photo and short video stimuli entirely in English; wherein the second module is configured for use with verbal individuals.
Frazier teaches using 44 different photo and videos in English to measure symptom levels related to ADOS-2 modules.
Klin teaches a system and method for assessing infant and child development based on eye tracking data (abstract). Klin teaches that there are two modes (interpreted as the claimed modules), an infant mode and a toddler mode, to accommodate the differences in sitting positions, which also requires accommodating the display and eye tracker (¶[0081,0083,0171]). Moreover, the images can be anu suitable visual image, including movies (¶[0078]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier-Munoz, such that the set of stimuli paradigm is comprised of a first and second module, as taught Klin, to accommodate the different natural physical capabilities of the subject being tested.
Klin teaches that the first module comprises any suitable image, including static photos, videos, and/or movies in English (¶[0078]) and configured to for use with nonverbal and very young individuals (¶[0171], infants 2-6 months). Therefore, the 44 images and videos of Frazier can be presented to the infant in mode 1.
Klin teaches that the second module comprises any suitable image, including static photos, videos, and/or movies in English (¶[0078]) and configured to for use with verbal individuals (¶[0171], toddler 9-36 months, which the ADOS considers as verbal and known to one of ordinary skill in the art. Regardless, Klin’s invention can be used with both verbal and nonverbal individuals and the recited limitation does not expressly require only verbal individuals). Therefore, the 44 images and videos of Frazier can be presented to the toddler in mode 2. The claimed limitations do not require that the exact amount of stimuli are required, instead, it is interpreted as the minimum. Moreover, the claimed limitations do not require that the 21 and 24 stimuli be different from each other.
Frazier-Munoz-Klin fail to teach wherein the individual eye gaze information tracked is comprised of binocular gaze, 3D eye position, pupil, and timestamp data collected at a sampling rate of 250Hz.
Mihali teaches that various systems in the art for tracking both eyes or gaze of a user (¶[0073]). These systems are configured to track 3D eye positions and pupils when “presenting visual content that is sensitive to the location of the viewer (e.g. when content is intended to be presented specifically at the location of the user's or users' eye(s))”.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Frazier-Munoz-Klin, such that the individual eye gaze information tracked is comprised of binocular gaze, 3D eye position, and pupils, as taught by Mihali, when presenting visual content that is sensitive to the location of the viewer.
Frazier-Munoz-Klin-Mihali fail to explicitly teach that the tracked information includes timestamp data and collecting data at a sampling rate of 250Hz. Frazier does however teach that in the validation step, the amount of time in percent is tracked to exclude or include data, which requires a timestamp mechanism to make the determination (See pg. 5, para.[5]). However, for simplicity, Sasson is relied upon to explicitly teach the limitation.
Sasson teaches an eye tracking system for young children with autism that is configured to sample at 250hz when tracking eye-tracking to track subjects oculomotor behavior which is conducive to testing young children with ASD (pg. 1, see Eye-Tracking Equipment, bullet point 3). Further, Sasson teaches “Most eye-tracking systems yield raw data files that include, at a minimum, a timestamp, X and Y coordinates of the point of regard (sometimes for both eyes), the distance from the display or stimulus, along with an index that characterizes an event or change in stimulus presentation” (pg. 3, see Analysis, bullet point 1).
Therefore, it would have been obvious to one of ordinary at the time the invention was effectively filed to have modified the system of Frazier-Munoz-Klin-Mihali, such that the tracked information includes timestamp data and collecting data at a sampling rate of 250Hz, as taught by Sasson, because it is prevalent in eye tracking analysis and conducive to testing oculomotor behavior of young children.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alcaniz teaches ASD treatment, training programs on desktop devices for social competences, emotional recognition, anxiety, and phobias using implicit measures, such as eye tracking, have shown effectiveness and improvement in ASD populations. Eye gaze as a biomarker in the recognition of autism spectrum disorder using virtual reality and machine learning: A proof of concept for diagnosis- 2021
Greene teaches eye tracking has the potential to function as a valid predictor and treatment outcome measure for use with individuals with ASD of varying ages and levels of impairment. Dynamic Eye Tracking as a Predictor and Outcome Measure of Social Skills Intervention in Adolescents and Adults with Autism Spectrum Disorder- 2020
Vaughan teaches diagnostic and therapeutic modules as disclosed herein can receive data from a plurality of sources, such as data acquired from the group consisting of genetic data, floral data, a sleep sensor, a wearable anklet sleep monitor, a booty to monitor sleep, and eye tracking of the subject. The diagnostic module may diagnose autism-related speech delay. US 2023009286
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
