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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/03/2025 has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the first and the second retinal markers in the first and the second target area with a probe embedded in the VR headset” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Samec et al. (US PUB 2017/0323485; herein after “Samec”; in related embodiments) in view of Walsh et al. (US PUB 2011/0299034; herein after “Walsh”).
Samec and Walsh disclose augmented reality systems and methods for user health analysis including visual acuity. Therefore, they are analogous art.
Regarding claim 1, Samec teaches a method for diagnosing and monitoring progression of retinal disorders (see Abstract and para. [0345], [0350], FIGS. 6 and 9D-12), the method comprising: conducting a first scan of a retina of a patient (a first image of a first color, G, para. [0270], FIG. 8) using sensors (user sensors 24, 28, 2030, 32, 120a) and cameras (24, 28) embedded in a virtual reality (VR) headset (a wearable display system 60/2010) worn by the patient (user 90) (as shown at least in FIGS. 9D and 10, para. [0219], [0289]-[0290] and [0304]); in response to conducting the first scan, isolating a first target area of the retina (i.e., light beams across the retina of the user to form an image (scan), para. [0308], also see para. [0270] and [0360]); administering a first vision test on screens (display screen 70, FIG. 9D) of the VR headset (Diagnostic testing (1st vision test) of primary sensation may include displaying augmented reality and/or virtual reality content, providing guided imagery, and/or utilizing clinician-worn display devices, para. [0378] and para. [0350] … also a camera assembly 630 (e.g., a digital camera, including visible light and infrared light cameras) may be provided to capture images of the eye 210 and/or tissue around the eye 210 to, e.g., detect user inputs (a first vision test), para. [0268], FIG. 6); in response to administering the first vision test, detecting first retinal markers in the first target area with a probe embedded in the VR headset (i.e., cameras 24 may further be configured to image the retinas of the respective eyes, such as for diagnostic purposes and/or for orientation tracking based on the location of retinal features, such as the fovea or features of the fundus (e.g., retinal markers in the target area), para. [0307] … An example of peripheral sensor is an ultrasound probe, which may also be used to provide haptic feedback, para. [0312]); while administering the first vision test, conducting a second scan of the retina (a first image of a first color, R, para. [0270], FIG. 8 … light beams across the retina of the user to form an image (scan), para. [0308]); in response to conducting the second scan, isolating a second target area of the retina; administering a second vision test on the screens (Diagnostic testing (2nd vision test) of primary sensation may include displaying augmented reality and/or virtual reality content, providing guided imagery, and/or utilizing clinician-worn display devices, para. [0378] … also a camera assembly 630 (e.g., a digital camera, including visible light and infrared light cameras) may be provided to capture images of the eye 210 and/or tissue around the eye 210 to, e.g., detect user inputs (a second vision test), para. [0268], FIG. 6); in response to administering the second vision test, detecting second retinal markers in the second target area with the probe (para. [0270, [0312] and [0307], [0307] and [0360]); and while administering the second vision test, conducting a third scan of the retina (a first image of a first color, B, para. [0270], FIG. 8).
Samec teaches all limitations except for explicit teaching of a first and a second vision test on screens , and detecting first and second retinal markers in a first and a second target area.
However, in a related field of endeavor Walsh teaches Block 910 illustrates an optional test performed by the computer system 104 to determine the visual function and acuity of the user's eye. In certain embodiments, the visual acuity test works with or is combined with the fixation marker control system 722, and can test both eyes simultaneously or one eye at time, … and the system can be configured to detect eye movements by imaging the retina with scanning laser illumination and comparing adjacent images in time for mutual information or to determine movement of retinal features, para. [0202], FIGS. 1 and 9. Foveal verification can be performed during functional tests that instruct the subject to follow fixation targets on a display screen to ensure that the subject complies with the instructions, such as perimetry tests, extraocular motility tests, and visual acuity tests, para. [0375].
Further, the system 100 can be configured to be programmed to perform ophthalmic diagnostic tests and other testing according to a standard of care schedule prescribed by a physician, para. [0273], FIG. 1
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Samec such that to perform ophthalmic diagnostic tests and other testing to determine the visual function and acuity of the user's eye, and to determine movement of retinal features with the fixation marker control system to follow fixation targets on a display screen, and can test both eyes (target area) simultaneously, and as taught by Walsh, for the purpose of ophthalmic testing center system can be configured to perform a multitude of self-administered visual acuity tests and output the test data.
Regarding claim 2, Samec teaches conducting the first, second, and third scans comprises conducting 360-degree scans of the retina that start and end at an optic nerve of the patient (i.e., cameras 24 may further be configured to image the retinas of the respective eyes (e.g., conducting 360-degree scans), such as for diagnostic purposes and/or for orientation tracking based on the location of retinal features, such as the fovea or features of the fundus (e.g., start and end at an optic nerve), para. [0307]).
Samec in view of Walsh discloses the claimed invention except for explicit teaching of 60-degree scans of the retina that start and end at an optic nerve of the patient.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include 60-degree scans of the retina that start and end at an optic nerve, since it has been held that the provision of adjustability, where needed, involves only routine skill in the art. In re Stevens, 101 USPQ 284 (CCPA 1954).
Regarding claim 3, Samec teaches according to claim 1 further conducting the first, second, and third scans (R, G, and B images, FIG. 8) comprises monitoring the one or more of eye movements, fixation stability, or response times of the patient (i.e., to account for differences in the eye's focusing of light of different wavelengths (e.g., eye movements, fixation stability etc.), para. [0270]; further to using eye movements to provide inputs to the system, para. [0355]).
Regarding claim 4, Samec according to claim 1 further teaches conducting the first and second scans comprises identifying the first and second target areas, the first and second target areas being areas of the retina that show signs of retinal disorders (i.e., cameras 24 may further be configured to image the retinas of the respective eyes (e.g., conducting 360-degree scans), such as for diagnostic purposes and/or for orientation tracking based on the location of retinal features, such as the fovea or features of the fundus (e.g., signs of retinal disorders), para. [0307]).
Regarding claim 5, Samec according to claim 1 further teaches conducting the first, second, and third scans (R, G, and B images, FIG. 8) comprises capturing ocular movements with sub-millimeter accuracy (e.g., facial expression, eye movements, etc. (with sub-millimeter accuracy), para. [0224], [0241], [0355]).
Samec in view of Walsh discloses the claimed invention except for explicit teaching of capturing ocular movements with sub-millimeter accuracy.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the capturing ocular movements with sub-millimeter accuracy, since it has been held that the provision of adjustability, where needed, involves only routine skill in the art. In re Stevens, 101 USPQ 284 (CCPA 1954).
Regarding claim 6, Samec according to claim 1 further teaches administering the first and second vision tests comprises administering one or more of acuity level tests and color vision tests (i.e., visual acuity and color vision, para. [0270] and … Sensory tests may be performed (e.g., acuity level and color vision tests), para. [0346]).
Regarding claim 7, Samec according to claim 1 further teaches administering the first and second vision tests comprises displaying both dynamic and static stimuli to stimulate different parts of the retina (i.e., many of the tests disclosed herein utilize user data collected regarding the user's response to various stimuli, para. [0228]).
Regarding claim 8, Samec according to claim 1 further teaches administering the second vision test comprises transitioning from the first vision test before the patient completes the first vision test (i.e., the user may transition from using gestures to provide inputs to the system (e.g., selecting virtual menu items, typing on a virtual keyboard, etc.), to using their voice, to using totems, to using head pose, to using eye movements to provide inputs to the system (e.g., transitioning from the first vision test to second vision test), para. [0355]).
Samec in view of Walsh discloses the claimed invention except for explicit teaching of transitioning from the first vision test before the patient completes the first vision test.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include transitioning from the first vision test before the patient completes the first vision test, since it has been held that the provision of adjustability, where needed, involves only routine skill in the art. In re Stevens, 101 USPQ 284 (CCPA 1954).
Regarding claim 9, Samec according to claim 1 further teaches the first and second vision tests stimulate the first and second target areas of the retina, respectively (i.e., displaying (via the system 2010 of FIG. 10) vision therapy activities to stimulate visual arousal and improve eye contact (e.g., games based on increasing eye contact duration), para. [0370]).
Regarding claim 10, Samec according to claim 1 further teaches detecting the first and second retinal markers comprises transmitting and receiving ultrasound signals from the probe (peripheral sensor is an ultrasound probe, which may also be used to provide haptic feedback, para. [0312]).
Regarding claim 11, Samec according to claim 1 further teaches conducting the first, second, and third scans (R, G, and B images, FIG. 8), isolating the first and second target areas, and detecting the first and second retinal markers occurs real-time as the patient responds to the first and second vision tests (i.e., the health system is capable of diagnosis and/or treatment (e.g., detecting the first and second retinal markers), as well as longitudinal and real-time monitoring, para. [0345], also see para. [0227], [0233] and [0392]).
Regarding claim 12, Samec according to claim 1 further teaches collecting a first input and a second input from the patient in response to the first and second vision tests, respectively (i.e., a camera assembly 630 (e.g., a digital camera, including visible light and infrared light cameras) may be provided to capture images of the eye 210 and/or tissue around the eye 210 to, e.g., detect user inputs (first and second input from the patient) and/or to monitor the physiological state of the user, para. [0268], FIG. 6).
Regarding claim 13, Samec according to claim 12 further teaches comparing first and second input to a database (i.e., a database 632 where the data (input data) may be analyzed and/or stored, para. [0347], FIG. 12).
Regarding claim 14, Samec according to claim 1 further teaches comparing the first and second retinal markers to a database (i.e., a database 632 where the data (for retinal markers) may be analyzed and/or stored, para. [0347], FIG. 12).
Regarding claim 15, Samec teaches a virtual reality (VR) headset (a wearable display system 60/2010, FIGS. 9D and 10) for diagnosing and monitoring progression of retinal disorders (see Abstract), the VR headset comprising: a plurality of sensors (user sensors 24, 28, 2030, 32, 120a) and a plurality of cameras (24, 28) (as shown at least in FIGS. 9D and 10, para. [0219], [0289]-[0290] and [0304]), both the plurality of sensors and the plurality of cameras being configured to scan a retina of a patient wearing the VR headset (a first image of a first color, G, para. [0270], FIG. 8 … light beams across the retina of the user to form an image, para. [0308]); screens configured to display vision tests for the patient (Diagnostic testing (1st vision test) of primary sensation may include displaying augmented reality and/or virtual reality content, providing guided imagery, and/or utilizing clinician-worn display devices, para. [0378] and para. [0350] … also a camera assembly 630 (e.g., a digital camera, including visible light and infrared light cameras) may be provided to capture images of the eye 210 and/or tissue around the eye 210 to, e.g., detect user inputs (a first vision test), para. [0268], FIG. 6); and a probe configured to detect retinal markers on the retina (an example of peripheral sensor is an ultrasound probe, which may also be used to provide haptic feedback, para. [0312]).
Samec teaches all limitations except for explicit teaching of screens configured to display vision tests for the patient; and a probe configured to detect retinal markers on the retina.
However, in a related field of endeavor Walsh teaches Block 910 illustrates an optional test performed by the computer system 104 to determine the visual function and acuity of the user's eye. In certain embodiments, the visual acuity test works with or is combined with the fixation marker control system 722, and can test both eyes simultaneously or one eye at time, … and the system can be configured to detect eye movements by imaging the retina with scanning laser illumination and comparing adjacent images in time for mutual information or to determine movement of retinal features, para. [0202], FIGS. 1 and 9. Foveal verification can be performed during functional tests that instruct the subject to follow fixation targets on a display screen to ensure that the subject complies with the instructions, such as perimetry tests, extraocular motility tests, and visual acuity tests, para. [0375].
Further, the system 100 can be configured to be programmed to perform ophthalmic diagnostic tests and other testing according to a standard of care schedule prescribed by a physician, para. [0273], FIG. 1
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Samec such that to perform ophthalmic diagnostic tests and other testing to determine the visual function and acuity of the user's eye, and to determine movement of retinal features with the fixation marker control system to follow fixation targets on a display screen, and can test both eyes (target area) simultaneously, and as taught by Walsh, for the purpose of ophthalmic testing center system can be configured to perform a multitude of self-administered visual acuity tests and output the test data.
Regarding claim 16, Samec according to claim 15 further teaches the plurality of sensors comprises a plurality of infrared sensors (i.e., user sensors 24 (e.g., infrared, UV, other non-visible light, and/or visible light cameras), para. [0303]-[0304]).
Regarding claim 17, Samec teaches according to claim 16 further each infrared sensor of the plurality of infrared sensors has a pixel density of less than 8 μm (i.e., a video may include many frames, with each frame having millions of pixels (e.g., with pixel density of less than 8 μm), and specifically programmed computer hardware is necessary to process the video data to provide a desired image processing task or application in a commercially reasonable amount of time, para. [0392).
Samec in view of Walsh discloses the claimed invention except for explicit teaching of infrared sensors has a pixel density of less than 8 μm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include infrared sensors has a pixel density of less than 8 μm, since it has been held that the provision of adjustability, where needed, involves only routine skill in the art. In re Stevens, 101 USPQ 284 (CCPA 1954).
Regarding claim 18, Samec teaches according to claim 15 further each camera of the plurality of cameras (26304) is positioned at an angle that is 45 degrees above a transverse plane of an eye (210) of the patient (as shown in FIGS. 6 and 9D).
Regarding claim 19, Samec according to claim 15 further teaches the probe comprises ultrasound sensors (an example of peripheral sensor is an ultrasound probe, which may also be used to provide haptic feedback, para. [0312]).
Regarding claim 20, Samec teaches a system for diagnosing and monitoring progression of retinal disorders (see Abstract), the system comprising: a virtual reality (VR) headset (a wearable display system 60/2010, FIGS. 9D and 10) having sensors (user sensors 24, 28, 2030, 32, 120a), cameras (24, 28), screens (70) (as shown at least in FIGS. 9D and 10, para. [0219], [0289]-[0290] and [0304]), and a probe (an ultrasound probe (para. [0312]); and a computing device (processor 140/150) in electronic communication (link 130) with the VR headset (as shown at least in FIGS. 9D, para. [0291]), wherein the computing device is configured to (a) scan a retina of a patient wearing the VR headset (e.g., generating image information, processing data), para. [0292] … Iris and retina imaging or scanning may be performed, para. [0307] … light beams across the retina of the user to form an image, para. [0308]), (b) isolate target areas of the retina (see para. [0270], [0308] and [0360]), (c) administer vision tests on screens of the VR headset that stimulate the target areas (i.e., displaying (via the system 2010 of FIG. 10) vision therapy activities to stimulate visual arousal and improve eye contact (e.g., games based on increasing eye contact duration), para. [0370]), and (d) detect retinal markers in the target areas with the probe (para. [0270, [0312] and [0307], [0307] and [0360]).
Samec teaches all limitations except for explicit teaching of administer vision tests on screens of the VR headset that stimulate the target areas, and detect retinal markers in the target areas with the probe..
However, in a related field of endeavor Walsh teaches Block 910 illustrates an optional test performed by the computer system 104 to determine the visual function and acuity of the user's eye. In certain embodiments, the visual acuity test works with or is combined with the fixation marker control system 722, and can test both eyes simultaneously or one eye at time, … and the system can be configured to detect eye movements by imaging the retina with scanning laser illumination and comparing adjacent images in time for mutual information or to determine movement of retinal features, para. [0202], FIGS. 1 and 9. Foveal verification can be performed during functional tests that instruct the subject to follow fixation targets on a display screen to ensure that the subject complies with the instructions, such as perimetry tests, extraocular motility tests, and visual acuity tests, para. [0375].
Further, the system 100 can be configured to be programmed to perform ophthalmic diagnostic tests and other testing according to a standard of care schedule prescribed by a physician, para. [0273], FIG. 1
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Samec such that to perform ophthalmic diagnostic tests and other testing to determine the visual function and acuity of the user's eye, and to determine movement of retinal features with the fixation marker control system to follow fixation targets on a display screen, and can test both eyes (target area) simultaneously, and as taught by Walsh, for the purpose of ophthalmic testing center system can be configured to perform a multitude of self-administered visual acuity tests and output the test data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. MAEDA et al. (US PUB 2018/0020910) teaches “a portable visual acuity examination device comprises a mounting unit that can be mounted in front of eyes either using or not using eyeglasses, a visual target displaying unit that uses an organic EL display panel, a display controlling unit that changes the visual target displayed on the displaying unit, an inputting unit for visual target viewing results, and a transmitting unit for measurement results. “, see Abstract.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MUSTAK CHOUDHURY whose telephone number is (571)272-5247. The examiner can normally be reached on M-F 8AM-5PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached on (571)272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MUSTAK CHOUDHURY/Primary Examiner, Art Unit 2872
July 15, 2026
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