DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
This action is Non-Final.
Election/Restrictions
Applicant’s election of Invention I (Claims 1-9, 17-20) in the reply filed on 4/8/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 10-16 are hereby withdrawn from further consideration.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yao et al. (Yao, US 2014/0063461).
Regarding claim 17 Yao teaches a non-transitory computer-readable media storing data instructions, which when executed by one or more processing devices (see at least [0043] “The system controller 38 is communicatively connected to the tracking and imaging system 42 via a wired or wireless connection and is structured and operable to execute PLR software, i.e., one or more PLR programs and/or algorithms. Execution of the PLR software controls and coordinates the operations of various components of the tracking and imaging system 46 to store subject eye location data, high resolution pupil stimulus and response data, and other PLR data received from the tracking and imaging system 46, and utilizes the received data to accurately compute pupil latency and other PLR information.”), cause the one or more processing devices to:
capture a video of one or more eyes (see at least [0062], Figure 10);
emit a light stimulus (see at least Figure 10, [0062]);
synchronize the video to the light stimulus (see at least [0069]);
analyze the video for measuring a pupillary response to the light stimulus (see at least [0072]);
compare the pupillary response to one or more metrics (see at least [0072]); and
generate an output based on comparing the pupillary response to the one or more metrics, the output including a recommendation related to autism spectrum disorder (see at least [0072] “The final assessment is provided as a probability number based on known clinical data that indicates the likelihood of the subject 14 being developmentally delayed.”).
Regarding claim 19, Yao teaches wherein the pupillary response includes at least one of a time measurement of pupil constriction, an amplitude measurement of the pupil constriction, and a time measurement for returning to a baseline pupil diameter (see at least [0072]).
Regarding claim 20, Yao teaches further comprising additional data instructions, which when executed by the one or more processing devices, further cause the one or more processing devices to: perform eye tracking to validate the output (see at least [0012]).
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.
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. 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al. (Yao, US 2014/0063461) in view of Hakoshima et al. (Hakoshima, US 2021/0290133).
Regarding claim 1, Yao teaches a device for screening for autism spectrum disorder (see at least [0008]), the device comprising:
a housing configured for portable use (see at least Figure 5-7 interpreted as components of at least 10, capable of being moved from one location to another);
one or more cameras mounted to the housing (see at least Figures 5-6 cameras 18/22 positioned in/with 10);
one or more light sources mounted to the housing (see at least Figures 5-6 optical simulation light source 34, subject illumination device 20 positioned in/with 10; additional light sources include element 50);
one or more processing devices (see at least Figures 6, 8 processor 150); and
computer-readable media storing software instructions that, when executed by the one or more processing devices (see at least [0043] “The system controller 38 is communicatively connected to the tracking and imaging system 42 via a wired or wireless connection and is structured and operable to execute PLR software, i.e., one or more PLR programs and/or algorithms. Execution of the PLR software controls and coordinates the operations of various components of the tracking and imaging system 46 to store subject eye location data, high resolution pupil stimulus and response data, and other PLR data received from the tracking and imaging system 46, and utilizes the received data to accurately compute pupil latency and other PLR information.”), cause the one or more processing devices to:
capture a video of one or more eyes using the one or more cameras (see at least [0062], Figure 10);
emit a light stimulus using the one or more light sources (see at least Figure 10, [0062]);
synchronize the video to the light stimulus (see at least [0069]);
analyze the video for measuring a pupillary response to the light stimulus (see at least [0072]);
compare the pupillary response to one or more metrics (see at least [0072]); and
generate an output based on comparing the pupillary response to the one or more metrics, the output including a recommendation related to autism spectrum disorder (see at least [0072] “The final assessment is provided as a probability number based on known clinical data that indicates the likelihood of the subject 14 being developmentally delayed.”).
However, the limitations of one or more processing devices housed inside the housing are not directly taught.
Hakoshima teaches a related system for evaluating gaze of subjects that may have autism (see at least [0003]-[0004], claim 4, Figures 1-7), and teaches that the processor structures, imaging structures, and display structures can be integrated into a single device, which reasonably teaches one or more processing devices housed inside the housing (see at least [0043] In the embodiment, the display device 101 and the computer system 20 are separated devices. Furthermore, the display device 101 and the computer system 20 may also be integrated.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as an obvious variation to separate components to integrate separate components to a combined device as suggested in the prior art in order to reduce system complexity. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”).
Regarding claim 3, the limitations are met by Yao in view of Hakoshima, where Yao teaches wherein the pupillary response is measured for both left and right eyes (see at least [0048], [0052], [0054], [0066], [0068], [0073]).
Regarding claim 4, the limitations are met by Yao in view of Hakoshima, where Yao teaches diodes that have ability to generate light stimulus as a flash of white light (see at least [0008], [0061] includes white [0070], [0073]), but the rejection does not directly address wherein the one or more light sources include an array of light-emitting diodes that generate the light. Hakoshima teaches that the light source can be an array LED (as illustrated in Figures 1-2 [0034]). It would have been obvious to one of ordinary skill the art before the effective filing date of the claimed invention as an obvious substitution of one known light source for another in order to stimulate eyes for known testing procedures.
Regarding claim 5, the limitations are met by Yao in view of Hakoshima, where Yao teaches wherein the one or more light sources include a display screen that generates the light stimulus as an image (see at least Figures 5-6, [0044], [0061]).
Regarding claim 6, the limitations are met by Yao in view of Hakoshima, where Yao teaches wherein the one or more light sources include near-infrared light emitters for measuring refractive error of the one or more eyes (see at least [0046] capable of intended use).
Regarding claim 7, the limitations are met by Yao in view of Hakoshima, where Yao teaches wherein the pupillary response includes at least one of a time measurement of pupil constriction, an amplitude measurement of the pupil constriction, and a time measurement for returning to a baseline pupil diameter (see at least [0072]).
Regarding claim 8, the limitations are met by Yao in view of Hakoshima, where Yao teaches wherein the computer-readable media further stores software instructions which, when executed by the one or more processing devices, further cause the one or more processing devices to: capture the video when the housing is held about 3 feet to about 5 feet away from the one or more eyes (see at least [0062], Figure 10, [0014], [0040] claimed range is within range of the prior art).
Regarding claim 9, the limitations are met by Yao in view of Hakoshima, where Yao teaches wherein the computer-readable media further stores software instructions which, when executed by the one or more processing devices, further cause the one or more processing devices to: perform eye tracking to validate the output (see at least [0012]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yao et al. (Yao, US 2014/0063461) in view of Hakoshima et al. (Hakoshima, US 2021/0290133) as applied to claim 1 above, and further in view of Devani (US 2022/0218198).
Regarding claim 2, the limitations are met by Yao in view of Hakoshima, except the limitations of further cause the one or more processing devices to: perform a screening test for eye vision, an eye disease, or an eye abnormality are not directly taught.
Devani teaches a related system for measuring pupillary responses (see title and abstract), and teaches that PLR results can be used in addition to applications of ASD to also identify glaucoma which is an eye disease and reasonably reads on the limitations the one or more processing devices to: perform a screening test for eye vision, an eye disease, or an eye abnormality (see at least [0220] “Pupillary Light Reflex (PLR) describes the constriction and subsequent dilation of the pupil in response to light, which can serve as an important metric of autonomic nervous system function. The measurement of PLR can be used as an indicator of abnormalities with various nervous system pathways in the neurological system (and potentially other systems) and subsequently for detection of developing disease purposes. For example, alcoholism, mental health disorders such as seasonal affective disorders, schizophrenia and generalized anxiety disorder, Alzheimer's and Parkinson's diseases, autism spectrum disorders, as well as glaucoma and autonomic neuropathies associated with diabetes may result in anomalies in PLR, including changes and trends in PLR over time including, in some examples, with respect to a baseline measurement.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of comparing changes/trends in PLR metrics over time or to baseline values in order to identify potential eye disease in addition to potential ASD in order to identify early different potential patient conditions with a single system.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yao et al. (Yao, US 2014/0063461) as applied to claim 17 above, and further in view of Devani (US 2022/0218198).
Regarding claim 18, the limitations are met by Yao, except the limitations of further comprising additional data instructions, which when executed by the one or more processing devices, further cause the one or more processing devices to: perform a screening test for eye vision, an eye disease, or an eye abnormality are not directly taught.
Devani teaches a related system for measuring pupillary responses (see title and abstract), and teaches that PLR results can be used in addition to applications of ASD to also identify glaucoma which is an eye disease and reasonably reads on the limitations additional data instructions, which when executed by the one or more processing devices, further cause the one or more processing devices to: perform a screening test for eye vision, an eye disease, or an eye abnormality (see at least [0220] “Pupillary Light Reflex (PLR) describes the constriction and subsequent dilation of the pupil in response to light, which can serve as an important metric of autonomic nervous system function. The measurement of PLR can be used as an indicator of abnormalities with various nervous system pathways in the neurological system (and potentially other systems) and subsequently for detection of developing disease purposes. For example, alcoholism, mental health disorders such as seasonal affective disorders, schizophrenia and generalized anxiety disorder, Alzheimer's and Parkinson's diseases, autism spectrum disorders, as well as glaucoma and autonomic neuropathies associated with diabetes may result in anomalies in PLR, including changes and trends in PLR over time including, in some examples, with respect to a baseline measurement.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of comparing changes/trends in PLR metrics over time or to baseline values in order to identify potential eye disease in addition to potential ASD in order to identify early different potential patient conditions with a single system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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