DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This office action is in response to the amendment filed 1/9/2026.
Notice of Pre-AIA or AIA Status
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.
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.
Claims 1-7, 9-12 and 16-34 are rejected under 35 U.S.C. 103 as being unpatentable over Walsh et al. (US20190090733) in view of Khan et al. (US20220151489).
Regarding claim 1, Walsh teaches a wearable eye examination device (Walsh, figs.1-59; paragraph [0210], the main body 106 may be supported on eyewear frames; paragraph [0150] The computer system 104 may be electrically coupled to main body 106, which the user 114 positions near or onto the user's eyes…, the main body 106 can comprise a monocular system or one ocular system or optical path to the eye for performing eye scans), comprising: one or more ophthalmic imaging modalities for obtaining one or more forms of ophthalmic information (Walsh, paragraph [0369], the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both. In general, OCT images contain information about unique eye structures) of a user wearing the wearable device (Walsh, fig.10, user 114); a screen to display a video to the user wearing the wearable device (Walsh, paragraph [0170], which may present output based on scans to the user 114. The output device may include a monitor screen, in which output results are displayed; see fig.13, paragraph [0219], the computing system 1300 may also comprise one or more multimedia devices 1302, such as speakers, video cards, graphics accelerators); a gaze tracker configured to track positions of a pupil of the user viewing the screen (Walsh, paragraph [0265], an optical coherence tomography system comprises a sensor or tracker. The sensor or tracker may determine a position of the user, one or two eyes of the user, and/or one or more structures, for example, a retina, pupil, cornea, or lens of the user's eye. In some embodiments, the sensor or tracker is positioned on or attached to main body 106; [0350], The OCT-based ophthalmic testing center system can be configured to perform a variety of ophthalmic tests including but not limited to...gaze detection; [0370], With reference to FIG. 35A and FIG. 35B, the ophthalmic testing center can be configured to perform eye tracking or fixation monitoring during various ophthalmic tests by performing iris plane analyses, pupillary analyses, or anterior chamber analyses. For example, iris plane analysis is the process of determining the planar configuration, direction, tilt and/or slope of the iris tissue 3504A. When an eye changes it fixation and/or gaze to look in a new direction); and an optical adjustment module (Walsh, adjustment control 204) configured to align a region of the user's eye with the one or more ophthalmic imaging modalities based on a determined position of the pupil (Walsh, figs.1-9, [0164], the user 114 may use images from the displays in order to adjust interpupillary distance. In various embodiments, for example, proper alignment of two images presented by the displays may indicate that the interpupillary distance is appropriately adjusted...the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, the iris in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, from B-scans or C-scans of the anterior chamber. In certain embodiments, the interpupillary distance can be adjusted by control 204 until the pupils are substantially centered in both B-scans or C-scans, thereby indicating optimal optical axis alignment. In certain embodiments, the interpupillary distance can be adjusted in two axes).
Walsh does not explicitly teach wherein
a processing module (Walsh, paragraph [0164], the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils) that is configured to:
cause ophthalmic imaging of the pupil of the user wearing the wearable device to be initiated by causing the video to be displayed on the screen of the wearable device, wherein the video has a predetermined length based on a duration of the ophthalmic imaging and wherein the video directs the pupil of the user to a plurality of locations on the screen such that pupil images of one or more retinal regions of the pupil are concurrently obtained using the one or more ophthalmic imaging modalities while the video is being presented; and
in response to determining that the one or more ophthalmic imaging modalities should be realigned with a new retinal region of the pupil by the optical adjustment module based on pupil positions of the pupil determined using the gaze tracker while the video is being presented, continue the ophthalmic imaging of the pupil that includes obtaining additional pupil images of the new retinal region until the end of the video.
However, Khan teaches the analogous ophthalmic imaging technologies (Khan, figs.1-19, abstract, a modular, headset for performing ophthalmic tests on a patient comprises a removable optical module that can be replaced based on ophthalmic testing need. The fundus camera position can be automatically adjusted to align the camera with a headset wearer's eye. Software controls image capture and captured images are combined assembled and combined to provide a wide field retinal image; paragraph [0176], fundus images captured using a system as disclosed herein can be transferred to a image processing system in real time and processed), and further teaches wherein
a processing module (Khan, paragraph [0074],a module system 600;paragraph [0073], Appropriate internal software or firmware is stored in the memory 614 to allow the processor 602 interact and control the various internal components and communicate with other system components, such as components on the head mount hardware 105 and an external control system 16 or other external computer; full the ophthalmic imaging or other testing functions and return the captured image or other test data. the control and testing software required for the control system 16 or other external device can be preinstalled in an optics module 110. When the external computer is connected to the optics module 110, such as by a cable, the software needed to be run on that computer can be downloaded from the optics module 110. Likewise, an externally connected computer can be used to update the software on the optics module 110) that is configured to:
cause ophthalmic imaging of the pupil (paragraph [0074] For a module system 600 that include cameras for imaging the external or internal features of the eye, images can be captured by the module and processed and analyzed to identify potential issues retinal images) of the user wearing the wearable device (paragraph [0051], same headset 12 to be used for a wide variety of different types of eye tests) to be initiated by causing the video to be displayed on the screen of the wearable device (paragraph [0052];initiate the testing process, and receive the captured test data from the headset; paragraph [0037], FIGS. 9A and 9B illustrate sample images presented on headset displays as part of a foveated rendering process; paragraph [0078],video displays 604; paragraph [0131], to allow viewing of video displays that may also be included in the headset), wherein the video has a predetermined length based on a duration of the ophthalmic imaging and wherein the video directs the pupil of the user to a plurality of locations on the screen such that pupil images of one or more retinal regions of the pupil are concurrently obtained using the one or more ophthalmic imaging modalities while the video is being presented (see paragraph [0148] The system can be programmed to determine when sufficient images of the retina of sufficient quality have been captured so that all areas of the retina of interest appear in at least one image of acceptable quality. Under normal circumstances an average of 500-720 fundus images frames, at 24 frames per second, 30-second video length, captured by the fundus camera 1108 while the user moves their eye around can provide sufficient imaging ;paragraph [0120], test patterns can be presented in various locations within the field of view and the patient feedback indicating when the pattern becomes visible is detected and recorded; paragraph [0130] Data can be collected from a live video of the eye while the Fundus camera is taking a set of images. Eye-tracking and image processing can be used to combine images captured by the camera to generate an image that covers most or all of the retina; also see paragraph [0105], The foveated rendering can shift with the location of the pupils or where the user's gaze is directed at on the screen. The system can be configured to receive input from the eye-tracking cameras 612 at a predefined rate and the image refreshed at that same rate with foveated rendering., such as at 60 to 90 Hz, which rates may equal or be greater than the predefined rate. The decrease in image resolution based on distance in the image from the point of user gaze outward can be varied in a number of ways, such as via a smoothly varying or stepwise function.,--- thus Khan teaches wherein cause ophthalmic imaging of the pupil of the user wearing the wearable device to be initiated by causing the video to be displayed on the screen of the wearable device, wherein the video has a predetermined length based on a duration of the ophthalmic imaging and wherein the video directs the pupil of the user to a plurality of locations on the screen such that pupil images of one or more retinal regions of the pupil are concurrently obtained using the one or more ophthalmic imaging modalities while the video is being presented); and
in response to determining that the one or more ophthalmic imaging modalities should be realigned with a new retinal region of the pupil by the optical adjustment module based on pupil positions of the pupil determined using the gaze tracker while the video is being presented (paragraph [0128], Eye tracking camera systems in the headset can be used to determine when the patient's gaze is directed a target, such as a point or small image in the center of the field of view. At the initiation of a test, the system can monitor eye gaze to determine when the patient is looking steadily at the center target. Tests can be initiated after this condition is met --- in response to determining---; paragraph[0152] The image capture process continues until the system determines that the area of the retina to be imaged is adequately captured in one or more images),,continue the ophthalmic imaging of the pupil that includes obtaining additional pupil images of the new retinal region until the end of the video (paragraph[0152] The image capture process continues until the system determines that the area of the retina to be imaged is adequately captured in one or more images; paragraph [0150], these data points can be sent to the image processing system linked to the captured images; Image capture continues as a user shifts their direction of gaze, e.g., in response to instructions; see fig.13, having continue the ophthalmic imaging of the pupil that includes obtaining additional pupil images of the new retinal region until the end of the video).
Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Walsh to have the specific processing module as taught by Khan for the purpose to improve the alignment of the camera objective with a pupil the eye (Khan, paragraph [0017]).
Regarding claim 2, combination Walsh-Khan discloses the invention as described in Claim 1 and Walsh further teaches wherein the one or more ophthalmic imaging modalities (described in claim 1) include at least an optical coherence tomography (OCT) and a fundus imaging module (Walsh, paragraph [0143], OCT can show additional information or data other than nonmydriatic color fundus imaging; [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking or fixation monitoring during the various structural and functional ophthalmic tests. In various embodiments, the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities).
Regarding claim 3, combination Walsh-Khan discloses the invention as described in Claim 1 and Walsh further teaches wherein the screen, when displaying the video (Walsh, described in claim 1), acts as an illumination source for the one or more ophthalmic imaging modalities (Walsh, paragraph [0153], The main body 106 may comprise one or more eyepieces, an interferometer, one or more target displays, a detector and/or an alignment system; [0163], The displays 215a and 215b may comprise one or more light sources, such as in an emissive display like an array of matrix LEDs; [0164] the user 114 may use images from the displays in order to adjust interpupillary distance; [0338], In reference to FIG. 28, the display 2810 can be a liquid crystal display and/or other display device configured to present images, dots, stimuli, or the like to a user, subject, and/or patient. The display 2810 can be located externally or internally to a main body, or housing, of the OCT-based ophthalmic testing center system 2800; [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking or fixation monitoring during the various structural and functional ophthalmic tests. In various embodiments, the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both).
Regarding claim 4, combination Walsh-Khan discloses the invention as described in Claim 1 and Walsh further teaches wherein the gaze tracker further includes:
a camera (Walsh, paragraph [0154], such as a charge-coupled device, CCD or complementary metal-oxide-semiconductor, CMOS) for capturing one or more real-time images of the pupil (Walsh, [0369], Real-time eye tracking can provide automatic, objective feedback to the OCT-based ophthalmic testing center system and allow the test to be modified in real-time; [0410] The OCT-based ophthalmic testing center system can be configured to monitor the subject's gaze using OCT and/or non-OCT imaging modalities to ensure that the subject's gaze, either demonstrated by a foveal depression under the image of the fixation target on the retina or by appropriately changing locations for other retinal features, remains fixed on the moving or dwelling target; [0451], Non-OCT imaging modalities include, without limitation, infrared imaging or scanning laser ophthalmoscopy, SLO, imaging. The OCT-based ophthalmic testing center system can also be configured to monitor the subject's gaze by tracking detectable structures within the eye using small 3D-OCT scans centered under the image of the fixation target on the retina; both OCT and non-OCT methods use various cameras to capture images, with real-time images being used in some situations); and
the processing module configured to determine a position of the pupil based on the captured real-time images of the pupil (Walsh, paragraph [0164], the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils; [0369], the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both. In general, OCT images contain information about unique eye structures, the pupil, .. and high speed OCT scans can be used to track the movement of the pupil, retinal vessels and/or other fundus structures...eye tracking is performed in real-time during testing. Real-time eye tracking can provide automatic, objective feedback to the OCT-based ophthalmic testing center system and allow the test to be modified in real-time).
Regarding claim 5, combination Walsh-Khan discloses the invention as described in Claim 4 and Walsh further teaches wherein the processing module is further configured to covert the position of the pupil into an actuation signal (Walsh, paragraph [0164], the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, the iris in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, from B-scans or C-scans of the anterior chamber; the interpupillary distance can be adjusted by control 204 until the pupils are substantially centered in both B-scans or C-scans, thereby indicating optimal optical axis alignment; paragraph [0210], the main body 106 in FIG. 10B may include an optical coherence tomography system, an alignment system, and a data acquisition device. The data acquisition device may wirelessly transmit data to a network or computer system or may use a cable to transfer control signals).
Regarding claim 6, combination Walsh-Khan discloses the invention as described in Claim 5 and Walsh further teaches wherein the optical adjustment module further includes one or more actuated optical components (Walsh, reference mirror 270a or 270b and reference mirror 273a or 273b) coupled between the position of the user's eye (Walsh, the user 114) and the ophthalmic imaging modalities (Fig. 3A; [0160], FIG. 3A shows one configuration of main body 106 comprising an optical coherence tomography system and an alignment system; (0162], A first portion of the light split at beam splitter 285a or 285b is reflected by reference mirrors 273a or 273b, reference mirrors 270a or 270b, and reference mirrors 265a or 265b. A second portion of the light split at beam splitter 285a or 285b is reflected by mirror 250a or 250b, by mirror 255a or 255b and by mirror 260a or 260b. Mirrors 255a or 255b and mirrors 250a and 250b are connected to a Z-offset adjustment stage 290b. By moving the position of the adjustment stage 290a or 290b, a different portion of the eye can be imaged. Thus, the adjustment stage 290a or 290b can adjust the difference between the optical length from the light source 240 to a portion of the sample and the optical length from the light source 240 and the reference mirror 270a or 270b and/or reference mirror 273a or 273b. This difference can be made small, for example, less than a coherence length, thereby promoting optical interference to occur. In some embodiments, the positions of one or more reference mirrors are movable in addition to or instead of the adjustment stage being movable. Thus, the length of the reference arm and/or of !he sample arm may be adjustable. The position of the adjustment stages 290a and/or 290b may be based on the signals from the device; [0164] the adjustment control 204 may comprise a handle on the main body 106, as shown in FIG. 3B. In this embodiment, rotation of the adjustment control 204 may increase or decrease the interpupillary distance. In various embodiments, the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, the iris in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, from B-scans or C-scans of the anterior chamber; the mirrors may be actuated to adjust the position), and wherein the optical adjustment module (Walsh, paragraph [0164] the adjustment control 204 may comprise a handle on the main body 106) is configured to align the region of the user's eye with the one or more ophthalmic imaging modalities by repositioning the one or more actuated optical components based on the actuation signal so that the reflected light from the region of the user's eye is aligned with optical axes of the one or more ophthalmic imaging modalities (Walsh, [0162] A first portion of the light split at beam splitter 285a or 285b is reflected by reference mirrors 273a or 273b, reference mirrors 270a or 270b, and reference mirrors 265a or 265b. A second portion of the light split at beam splitter 285a or 285b is reflected by mirror 250a or 250b, by mirror 255a or 255b and by mirror 260a or 260b. Mirrors 255a or 255b and mirrors 250a and 250b are connected to a Z-offset adjustment stage 290b. By moving the position of the adjustment stage 290a or 290b, a different portion of the eye can be imaged. Thus, the adjustment stage 290a or 290b can adjust the difference between the optical length from the light source 240 to a portion of the sample and the optical length from the light source 240 and the reference mirror 270a or 270b and/or reference mirror 273a or 273b. This difference can be made small, for example, less than a coherence length, thereby promoting optical interference to occur. In some embodiments, the positions of one or more reference mirrors, for example, reference mirror 270a or 270b and reference mirror 273a or 273b are movable in addition to or instead of the adjustment stage being movable. Thus, the length of the reference arm and/or of the sample arm may be adjustable. The position of the adjustment stages 290a and/or 290b may be based on the signals from the device, as described in more detail below; [0164] the user 114 may use images from the displays in order to adjust interpupillary distance. In various embodiments, for example, proper alignment of two images presented by the displays may indicate that the interpupillary distance is appropriately adjusted...ln certain embodiments, the adjustment control 204 may comprise a handle on the main body 106, as shown in FIG. 3B. In this embodiment, rotation of the adjustment control 204 may increase or decrease the interpupillary distance. In various embodiments, the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, the mirrors may be actuated to adjust the position for alignment with features of the user's eyes).
Regarding claim 7, combination Walsh-Khan discloses the invention as described in Claim 6 and Walsh further teaches wherein the one or more actuated optical components (Walsh, fig.3, reference mirror 270a or 270b and reference mirror 273a or 273b) include one or both of: an actuated beam splitter (Walsh, paragraph [0142], Generally, OCT employs an interferometer. Light from a light source, for example, a broadband light source, swept source, or tunable laser is split, by a beam splitter) and an actuated mirror (Walsh paragraph [0142], and a reference arm, generally comprising a mirror).
Regarding claim 9, combination Walsh-Khan discloses the invention as described in Claim 6 and Walsh further teaches wherein processing module is further configured to: determine the completion of the repositioning of the one or more actuated optical components (Walsh, reference mirror 270a or 270b and reference mirror 273a or 273b; Fig. 3A; [0164], the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, the iris in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, from B-scans or C-scans of the anterior chamber. In certain embodiments, the interpupillary distance can be adjusted by control 204 until the pupils are substantially centered in both B-scans or C-scans, thereby indicating optimal optical axis alignment); and generate an imaging instruction to the one or more ophthalmic imaging modalities (Walsh’s [0189], B-scans or C-scans through the iris plane in each eye can demonstrate the location of the pupil, or light entrance to the back of the eye. Image analysis routines, such as edge detection, could be applied to these B-scan or C-scan images to detect the borders of the pupil in each eye. The computer system 104 can be configured to automatically adjust the interpupillary distance to center these pupillary borders in the center of the B-scan or C-scan on each side; [0229], by focusing the optical coherence tomography system at different antero-posterior locations using the power optics 210, A-scan, B-scan, or 3D-OCT scan data can be collected for any of the structures of the eye that lie along the central axis; [0244], With reference to FIGS. 1, 8 and 9, the optical coherence tomography system 100 is configured to allow the user to self-administer an OCT scan of the user's eyes without dilation of the eyes, and obtain a risk assessment or diagnosis of various diseases and ailments without the engaging or involving a doctor and/or technician to align the user's eyes with the system, administer the OCT scan and/or interpret the data from the scan to generate or determine a risk assessment or diagnosis'; the alignment using the adjustment control 204 provides the instructions for OCT modalities to be performed).
Regarding claim 10, Combination Walsh-Khan discloses the invention as described in Claim 9 and Walsh further teaches wherein the one or more ophthalmic imaging modalities, upon receiving the imaging instruction (Walsh, fig.6, image, fig.8, paragraph [0202], verbal instructions using the user interface module 805), are further configured to capture both OCT scans and fundus images of the region of the user's eye (Walsh, paragraph [0244], With reference to FIGS. 1, 8 and 9, the optical coherence tomography system 100 is configured to allow the user to self-administer an OCT scan of the user's eyes without dilation of the eyes, and obtain a risk assessment or diagnosis of various diseases and ailments without the engaging or involving a doctor and/or technician to align the user's eyes with the system, administer the OCT scan and/or interpret the data from the scan to generate or determine a risk assessment or diagnosis; [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking or fixation monitoring during the various structural and functional ophthalmic tests. In various embodiments, the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both; [0410], the OCT-based ophthalmic testing center system can be configured to monitor the subject's gaze using OCT and/or non-OCT imaging modalities to ensure that the subject's gaze, either demonstrated by a foveal depression under the image of the fixation target on the retina or by appropriately changing locations for other retinal features, remains fixed on the moving or dwelling target. OCT imaging modalities can include, for example, foveal verification using small 3D-OCT scans centered on the image of the fixation target on the retina and/or foveal location using sparse 3D-OCT scans across the fundus'; the alignment using the adjustment control 204 provides the instructions for OCT modalities to be performed).
Regarding claim 11, Combination Walsh-Khan discloses the invention as described in Claim 1 and Walsh further teaches wherein the region of the user's eye includes: a central region of the retina; and a peripheral region of the retina (Walsh, [0171], the computer system 104 analyzes data received by the data acquisition device 202 in order to determine whether one or more of the adjustment stages 290a and/or 290b and/or one or more movable components and/or the powered optics 210 should be adjusted. In one instance, an A-scan is analyzed to determine a position, for example, a coarse position, of the retina such that data on the retina may be obtained by the instrument; [0229], by focusing the optical coherence tomography system at different antero-posterior locations using the power optics 210, A-scan, B-scan, or 3D-OCT scan data can be collected for any of the structures of the eye that lie along the central axis, such as, for example, the pre-cornea, cornea, anterior chamber, iris, crystalline lens, intraocular lens implant, vitreous body, retina, retinal pigment ..; [0236], 'normal" data, for example, histograms, are created for retinal thickness in each region of the retina and compare to measured, detected, scanned, or encountered values to these "normal" data , histograms to determine relative risks of retinal disease or other diseases; [0369], high speed OCT scans can be used to track the movement of the pupil, anterior segment, fovea, retinal vessels and/or other fundus structures;---thus all regions of the retina central and peripheral may be tracked and used in the system).
Regarding claim 12, Combination Walsh-Khan discloses the invention as described in Claim 1 and Walsh further teaches wherein further comprising an image processing module (Walsh, paragraph [0215], the system 1300 comprises an image processing and analysis module 1306 that carries out the functions, methods, and/or processes) configured to reconstruct widefield OCT scans and fundus images including both central and peripheral retina regions of the patient's eye based on captured OCT scans and fundus images from different regions of the user's eye during an extended ophthalmic imaging period (Walsh, [0171], the computer system 104 analyzes data received by the data acquisition device 202 in order to determine whether one or more of the adjustment stages 290a and/or 290b and/or one or more movable components and/or the powered optics 210 should be adjusted. In one instance, an A-scan is analyzed to determine a position (for example, a coarse position) of the retina such that data on the retina may be obtained by the instrument; [0229], by focusing the optical coherence tomography system at different antero-posterior locations using the power optics 210, A-scan, B-scan, or 3D-OCT scan data can be collected for any of the structures of the eye that lie along the central axis, such as, for example, the pre-cornea, cornea, anterior chamber, iris, crystalline lens, intraocular lens implant, vitreous body, retina; [0236], data are created for retinal thickness in each region of the retina and compare to measured, detected, scanned, or encountered values to these data to determine relative risks of retinal disease or other diseases; [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking or fixation monitoring during the various structural and functional ophthalmic tests. In various embodiments, the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both. In general, OCT images contain information about unique eye structures, for example, the pupil, anterior segment, fovea, retinal vessels or optic nerve, and high speed OCT scans can be used to track the movement of the pupil, and/or other fundus structures; [0388], the OCT-based ophthalmic testing center system comprises a variable focus system with a wide range of focus depth, such that the focal point is capable of simultaneously focusing, for example, on the retina and the cornea; [0410], The OCT-based ophthalmic testing center system can be configured to monitor the subject's gaze using OCT and/or non-OCT imaging modalities to ensure that the subject's gaze, either demonstrated by a foveal depression under the image of the fixation target on the retina or by appropriately changing locations for other retinal features, remains fixed on the moving or dwelling target. OCT imaging modalities can include, for example, foveal verification using small 3D-OCT scans centered on the image of the fixation target on the retina and/or foveal location using sparse 3D-OCT scans across the fundus; all regions of the retina, central and peripheral, may be tracked and used in the system using a wide range of focus).
Regarding claim 16, Combination Walsh-Khan discloses the invention as described in Claim 1 and Walsh further teaches wherein the wearable device enables fully-automatic ophthalmic imaging without the involvement of a technician (Walsh, paragraph [0244], With reference to FIGS.1, 8 and 9, the optical coherence tomography system 100 is configured to allow the user to self-administer an OCT scan of the user's eyes without dilation of the eyes, and obtain a risk assessment or diagnosis of various diseases and ailments without the engaging or involving a doctor and/or technician to align the user's eyes with the system, administer the OCT scan and/or interpret the data from the scan to generate or determine a risk assessment or diagnosis; [0343], The OCT-based ophthalmic testing center system 2800 can be configured to be fully automated and self-administered by a patient user, as opposed to a technician, photographer or physician).
Regarding claim 17, Combination Walsh-Khan discloses the invention as described in Claim 1 and Walsh further teaches wherein the wearable device is implemented as an OCT-fundus dual modality headset (Walsh, paragraph [0345] the OCT-based ophthalmic testing center system 2800 can comprise a device to be worn by the user like glasses with earstems supporting the device on top of each ear; [0211], as shown in FIG.10D, the user wears an object 1010 connected to the eyepiece. The wearable object 1010 may include a head-mounted object, a hat or an object to be positioned on a user's head. As described above, in some embodiments, the main body 106 is supported on an eyewear frame worn by the user like glasses. The wearable object 1010 may fully or partly support the main body 106 and/or may assist in aligning the main body 106 with one or both eyes of the user 114; [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking or fixation monitoring during the various structural and functional ophthalmic tests. In various embodiments, the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both; [0410],'The OCT-based ophthalmic testing center system can be configured to monitor the subject's gaze using OCT and/or non-OCT imaging modalities to ensure that the subject's gaze; OCT imaging modalities can include, for example, foveal verification using' small 3D-OCT scans centered on the image of the fixation target on the retina and/or foveal location using sparse 3D-OCT scans across the fundus).
Regarding claim 18, Combination Walsh-Khan discloses the invention as described in Claim 1 and Walsh further teaches wherein the wearable device enables fully-automatic ophthalmic imaging without requiring the user's cooperation (see Walsh, this claim recites similar limitations as those in corresponding dependent claim 16 and is rejected based on the same teachings and rationale).
Regarding claim 19, Walsh teaches a method of performing fully automatic ophthalmic imaging (Walsh figs.1-59, paragraph [0070], a processing module coupled to the detector and configured to perform an analysis to automatically detect the causes of amblyopia based on optical coherence tomography measurements obtained using said interferometer; and an output device electrically coupled to the processing module, said output device configured to output results of the amblyopia analysis to the subject through the output device.., paragraph [0071], to automatically detect strabismus based on optical coherence tomography measurements obtained using said interferometer; and an output device electrically coupled to the processing module, said output device configured to output results of the strabismus analysis to the subject through the output device; paragraph [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking… the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both. In general, OCT images contain information about unique eye structures), the method comprising:
displaying a video (Walsh, paragraph [0222], Such a device may have a browser module implemented as a module that uses text, graphics, audio, video, and other media to present data and to allow interaction with data via the network 1310) on a screen (Walsh, paragraph [0338], to FIG. 28, the display 2810 can be a liquid crystal display and/or other display device);
determining a real-time position of the patient's pupil (Walsh, paragraph [0369], to track the movement of the pupil,… eye tracking is performed in real-time during testing. Real-time eye tracking can provide automatic);
converting the real-time position of the patient's pupil into a control signal to cause one or more ophthalmic imaging modalities to realign with a new retinal region of the patient's eye (Walsh, paragraph [0210], the main body 106 in FIG. 10B may include an optical coherence tomography system, an alignment system, and a data acquisition device. The data acquisition device may wirelessly transmit data to a network or computer system or may use a cable to transfer control signals; paragraph [0202], During the scanning of the eye, the scan control and analysis module 824 could be configured to detect at block 913 whether there has been a shift in the position of the main body 106 relative to the user. In one embodiment, the scan control and analysis module 824 can detect (in real-time, substantially real-time, or with a delay) whether a shift has occurred based on what the values the module 824 expects to receive during the scanning process. For example, as the scan control and analysis module 824 scans the retina, the module 824 expects to detect a change in signal as the scanning process approaches the optic nerve, for example, based on the location of the fixation target; paragraph [0369], in real-time during testing. Real-time eye tracking can provide automatic, objective feedback to the OCT-based ophthalmic testing center system and allow the test to be modified in real-time. For example, if the ophthalmic testing center system determines that a subject is not gazing in the right direction during testing, the subject can be given instructions to conform to the testing protocol. In various embodiments, eye tracking is performed after testing during a post-processing phase. Post-processing eye tracking can be used to quantify data/results and/or remove unreliable data/results. In certain embodiments, the OCT-based ophthalmic testing center system can be configured to rerun an ophthalmic test based on the results of a post-processing eye tracking analysis.., eye tracking can be performed during various ophthalmic tests using OCT data to assist in determining the function of the eye); and
capturing additional ophthalmic images of the new retinal region using the one or more ophthalmic imaging modalities (Walsh, [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking or fixation monitoring during the various structural and functional ophthalmic tests. In various embodiments, the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both; [0410], The OCT-based ophthalmic testing center system can be configured to monitor the subject's gaze using OCT and/or non-OCT imaging modalities to ensure that the subject's gaze, either demonstrated by a foveal depression under the image of the fixation target on the retina or by appropriately changing locations for other retinal features, remains fixed on the moving or dwelling target. OCT imaging modalities can include, for example, foveal verification using small 3D-OCT scans centered on the image of the fixation target on the retina and/or foveal location using sparse 3D-OCT scans across the fundus; [0452], In reference to FIG. 44, in various embodiments, other analyses can comprise edge detection of the vitreoretinal interface to detect the foveal depression, edge detection of the vitreoretinal interface and retinal pigment…, to determine retinal thickness, edge detection of other retinal features, or topographic or thickness slope calculations followed by 2D registration to previous maps, among other analyses. In the absence of a foveal or optic nerve depression, the OCT-based ophthalmic testing center system can be configured to use relative slopes of the retinal surface to determine and/or indicate eye movement away from either the past fundus position or the position at the start of the test'; the system can realign with various retinal features to provide new imaging).
But Walsh does not explicitly teach wherein displaying the video on the screen associated with a wearable device to initiate ophthalmic imaging of a pupil of a patient wearing the wearable device, wherein the video guides an eye of the patient to a plurality of locations on the screen, and wherein the video has a predetermined length based on a duration of the ophthalmic imaging;
concurrently capturing ophthalmic images of one or more retinal regions of the pupil using one or more ophthalmic imaging modalities currently while the video is being displayed.
However, Khan teaches the analogous ophthalmic imaging technologies (Khan, figs.1-19, abstract, a modular, headset for performing ophthalmic tests on a patient comprises a removable optical module that can be replaced based on ophthalmic testing need. The fundus camera position can be automatically adjusted to align the camera with a headset wearer's eye. Software controls image capture and captured images are combined assembled and combined to provide a wide field retinal image; paragraph [0176], fundus images captured using a system as disclosed herein can be transferred to a image processing system in real time and processed), and further teaches wherein
wherein displaying a video on a screen associated with a wearable device to initiate ophthalmic imaging of a pupil of a patient wearing the wearable device, wherein the video guides an eye of the patient to a plurality of locations on the screen, and wherein the video has a predetermined length based on a duration of the ophthalmic imaging (see Khan, paragraph [0148] The system can be programmed to determine when sufficient images of the retina of sufficient quality have been captured so that all areas of the retina of interest appear in at least one image of acceptable quality. Under normal circumstances an average of 500-720 fundus images frames, at 24 frames per second, 30-second video length, captured by the fundus camera 1108 while the user moves their eye around can provide sufficient imaging ;paragraph [0120], test patterns can be presented in various locations within the field of view and the patient feedback indicating when the pattern becomes visible is detected and recorded; paragraph [0130] Data can be collected from a live video of the eye while the Fundus camera is taking a set of images. Eye-tracking and image processing can be used to combine images captured by the camera to generate an image that covers most or all of the retina; also see paragraph [0105], The foveated rendering can shift with the location of the pupils or where the user's gaze is directed at on the screen. The system can be configured to receive input from the eye-tracking cameras 612 at a predefined rate and the image refreshed at that same rate with foveated rendering., such as at 60 to 90 Hz, which rates may equal or be greater than the predefined rate. The decrease in image resolution based on distance in the image from the point of user gaze outward can be varied in a number of ways, such as via a smoothly varying or stepwise function.,--- thus Khan teaches a video on a screen associated with a wearable device to initiate ophthalmic imaging of a pupil of a patient wearing the wearable device, wherein the video guides an eye of the patient to a plurality of locations on the screen, and wherein the video has a predetermined length based on a duration of the ophthalmic imaging);
concurrently capturing ophthalmic images of one or more retinal regions of the pupil using one or more ophthalmic imaging modalities currently while the video is being displayed (paragraph [0128], Eye tracking camera systems in the headset can be used to determine when the patient's gaze is directed a target, such as a point or small image in the center of the field of view. At the initiation of a test, the system can monitor eye gaze to determine when the patient is looking steadily at the center target. Tests can be initiated after this condition is met ; paragraph[0152] The image capture process continues until the system determines that the area of the retina to be imaged is adequately captured in one or more images---thus Khan teaches concurrently capturing ophthalmic images of one or more retinal regions of the pupil using one or more ophthalmic imaging modalities currently while the video is being displayed).
Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Walsh to have the specific processing module as taught by Khan for the purpose to improve the alignment of the camera objective with a pupil the eye (Khan, paragraph [0017]).
Regarding claim 20, Combination Walsh-Khan discloses the invention as described in Claim 19 and Khan further teaches wherein the one or more ophthalmic imaging modalities include at least an optical coherence tomography (OCT) and a fundus imaging module (see Walsh, this claim recites similar limitations as those in corresponding dependent claim 2 and is rejected based on the same teachings and rationale).
Regarding claim 21, Combination Walsh-Khan discloses the invention as described in Claim 19 and Walsh further teaches wherein determining the real-time position of the patient's pupil includes: capturing one or more real-time images of the patient's pupil; and determining the position of the patient's pupil based on the captured real-time images (Walsh, [0265], Accordingly, an optical coherence tomography system comprises a sensor or tracker. The sensor or tracker may determine a position of the user, one or two eyes of the user, and/or one or more structures, for example, a retina, pupil, cornea, or lens, of the user's eye. In some embodiments, the sensor or tracker is positioned on or attached to main body 106; [0350], The OCT-based ophthalmic testing center system can be configured to perform a variety of ophthalmic tests, for example, via execution of the testing modules 2818, including but not limited to...gaze detection; [0369], eye tracking is performed in real-time during testing. Real-time eye tracking can provide automatic, objective feedback to the OCT-based ophthalmic testing center system and allow the test to be modified in real-time; [0370], With reference to FIG. 35A and FIG. 35B, the ophthalmic testing center can be configured to perform eye tracking or fixation monitoring during various ophthalmic tests by performing iris plane analyses, pupillary analyses, or anterior chamber analyses. For example, iris plane analysis is the process of determining the planar configuration, direction, tilt and/or slope of the iris tissue 3504A. When an eye changes it fixation and/or gaze to look in a new direction, the slope of the iris plane 3504A containing the pupil changes in a similar manner to a satellite dish pointing in a new direction; real-time eye tracking may be performed).
Regarding claim 22, Combination Walsh-Khan discloses the invention as described in Claim 19 and Walsh further teaches wherein determining the real-time position of the patient's pupil includes using a gaze tracker (Walsh, [0265], Accordingly, an optical coherence tomography system comprises a sensor or tracker. The sensor or tracker may determine a position of the user, one or two eyes of the user, and/or one or more structures, for example, a retina, pupil, cornea, or lens, of the user's eye. In some embodiments, the sensor or tracker is positioned on or attached to main body 106; [0350], The OCT-based ophthalmic testing center system can be configured to perform a variety of ophthalmic tests, for example, via execution of the testing modules 2818, including but not limited to...gaze detection; [0369], eye tracking is performed in real-time during testing. Real-time eye tracking can provide automatic, objective feedback to the OCT-based ophthalmic testing center system and allow the test to be modified in real-time; [0370], With reference to FIG. 35A and FIG. 35B, the ophthalmic testing center can be configured to perform eye tracking or fixation monitoring during various ophthalmic tests by performing iris plane analyses, pupillary analyses, or anterior chamber analyses. For example, iris plane analysis is the process of determining the planar configuration, direction, tilt and/or slope of the iris tissue 3504A. When an eye changes it fixation and/or gaze to look in a new direction, the slope of the iris plane 3504A containing the pupil changes in a similar manner to a satellite dish pointing in a new direction).
Regarding claim 23, Combination Walsh-Khan discloses the invention as described in Claim 19 and Walsh further teaches wherein causing the one or more ophthalmic imaging modalities to realign with a new retinal region of the patient's eye includes repositioning one or more optical components (Walsh, reference mirror 270a or 270b and reference mirror 273a or 273b) disposed between the patient's eye and the one or more ophthalmic imaging modalities so that the reflected light from the new retinal region of the patient's eye is aligned with optical axes of the one or more ophthalmic imaging modalities (Walsh, [0160], FIG. 3A shows one configuration of main body 106 comprising an optical coherence tomography system and an alignment system; [0162], A first portion of the light split at beam splitter 285a or 285b is reflected by reference mirrors 273a or 273b, reference mirrors 270a or 270b, and reference mirrors 265a or 265b. A second portion of the light split at beam splitter 285a or 285b is reflected by mirror 250a or 250b, by mirror 255a or 255b and by mirror 260a or 260b. Mirrors 255a or 255b and mirrors 250a and 250b are connected to a Z-offset adjustment stage 290b. By moving the position of the adjustment stage 290a or 290b, a different portion of the eye can be imaged. Thus, the adjustment stage 290a or 290b can adjust the difference between the optical length from the light source 240 to a portion of the sample and the optical length from the light source 240 and the reference mirror 270a or 270b and/or reference mirror 273a or 273b. This difference can be made small, for example, less than a coherence length, thereby promoting optical interference to occur. In some embodiments, the positions of one or more reference mirrors, for example, reference mirror 270a or 270b and reference mirror 273a or 273b, are movable in addition to or instead of the adjustment stage being movable. Thus, the length of the reference arm and/or of the sample arm may be adjustable. The position of the adjustment stages 290a and/or 290b may be based on the signals from the device, as described in more detail below; [0164], In certain embodiments, the adjustment control 204 may comprise a handle on the main body 106, as shown in FIG. 3B. In this embodiment, rotation of the adjustment control 204 may increase or decrease the interpupillary distance. In various embodiments, the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, the iris in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, from B-scans or C-scans of the anterior chamber; [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking or fixation monitoring during the various structural and functional ophthalmic tests. In various embodiments, the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both; [0410] The OCT-based ophthalmic testing center system can be configured to monitor the subject's gaze using OCT and/or non-OCT imaging modalities to ensure that the subject's gaze, either demonstrated by a foveal depression under the image of the fixation target on the retina or by appropriately changing locations for other retinal features, remains fixed on the moving or dwelling target. OCT imaging modalities can include, for example, foveal verification using small 3O-0CT scans centered on the image of the fixation target on the retina and/or foveal location using sparse 3O-OCT scans across the fundus; [0452], In reference to FIG. 44, in various embodiments, other analyses can comprise edge detection of the vitreoretinal interface to detect the foveal depression, edge detection of the vitreoretinal interface and retinal pigment…to determine retinal thickness, edge detection of other retinal features, or topographic or thickness slope calculations followed by 20 registration to previous maps, among other analyses. In the absence of a foveal or optic nerve depression, the OCT-based ophthalmic testing center system can be configured to use relative slopes of the retinal surface to determine and/or indicate eye movement away from either the past fundus position or the position at the start of the test'; the system can realign with various retinal features to provide new imaging).
Regarding claim 24, Combination Walsh-Khan discloses the invention as described in Claim 23 and Walsh further teaches wherein prior to capturing the ophthalmic images, the method further comprises: determining completion of the repositioning of the one or more actuated optical components (Walsh, reference mirror 270a or 270b and reference mirror 273a or 273b; Fig. 3A; [0164], the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, the iris in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, from B-scans or C-scans of the anterior chamber.' In certain embodiments, the interpupillary distance can be adjusted by control 204 until the pupils are substantially centered in both B-scans or C-scans, thereby indicating optimal optical axis alignment); and generating an imaging instruction to the one or more ophthalmic imaging modalities to trigger imaging functions of the one or more ophthalmic imaging modalities (Walsh, [0189], B-scans or C-scans through the iris plane in each eye can demonstrate the location of the pupil, or light entrance to the back of the eye. Image analysis routines, such as edge detection, could be applied to these B-scan or C-scan images to detect the borders of the pupil in each eye. The computer system 104 can be configured to automatically adjust the interpupillary distance to center these pupillary borders in the center of the B-scan or C-scan on each side; [0229], For example, by focusing the optical coherence tomography system at different antero-posterior locations using the power optics 210, A-scan, B-scan, or 3O-OCT scan data can be collected for any of the structures of the eye that lie along the central axis; [0244], With reference to FIGS. 1, 8 and 9, the optical coherence tomography system 100 is configured to allow the user to self-administer an OCT scan of the user's eyes without dilation of the eyes, and obtain a risk assessment or diagnosis of various diseases and ailments without the engaging or involving a doctor and/or technician to align the user's eyes with the system, administer the OCT scan and/or interpret the data from the scan to generate or determine a risk assessment or diagnosis; the alignment using the adjustment control 204 provides the instructions for OCT modalities to be performed).
Regarding claim 25, Combination Walsh-Khan discloses the invention as described in Claim 19 and Walsh further teaches wherein the method further comprises extending a duration of the ophthalmic imaging procedure by displaying relaxing and entertaining content on the screen (Walsh,[0313], the fixation targets, such as simple or other shapes/objects, for example, houses, balls, animals, or the like, or movies may be projected into the eyes of the subjecUpatient to facilitate self0adjustment by the subjecUpatient; [0386], the OCT-based ophthalmic testing center system can be configured to present animated or transient targets, such as movies, to the user; [0517], The OCT-based ophthalmic testing center system can be configured to progressively increase the stereodisparity between paired images by shifting these images outwards, for example along the epipolar line that relates the two images, until the subject presses the button to indicate stereopsis or verbally says 'Yes.' Real world images, movies or simple targets, such as circles or the like, could be used as stereo paired images; content that is relaxing and entertaining is subjective; by using movies, a form of entertainment that may be relaxing to a viewer, the user can administer the self-test in a pleasant manner).
Regarding claim 26, Combination Walsh-Khan discloses the invention as described in Claim 19 and Walsh further teaches wherein the ophthalmic imaging procedure is performed without the involvement of a technician (Walsh [0244], With reference to FIGS. 1, 8 and 9, the optical coherence tomography system 100 is configured to allow the user to self-administer an OCT scan of the user's eyes without dilation of the eyes, and obtain a risk assessment or diagnosis of various diseases and ailments without the engaging or involving a doctor and/or technician to align the user's eyes with the system, administer the OCT scan and/or interpret the data from the scan to generate or determine a risk assessment or diagnosis; [0343], The OCT-based ophthalmic testing center system 2800 can be configured to be fully automated and self-administered by a patient user, as opposed to a technician, photographer or physician).
Regarding claim 27, Combination Walsh-Khan discloses the invention as described in Claim 19 and Walsh further teaches wherein the ophthalmic imaging procedure is performed without requiring the patient's cooperation (Walsh [0244], With reference to FIGS. 1, 8 and 9, the optical coherence tomography system 100 is configured to allow the user to self-administer an OCT scan of the user's eyes without dilation of the eyes, and obtain a risk assessment or diagnosis of various diseases and ailments without the engaging or involving a doctor and/or technician to align the user's eyes with the system, administer the OCT scan and/or interpret the data from the scan to generate or determine a risk assessment or diagnosis; [0343], The OCT-based ophthalmic testing center system 2800 can be configured to be fully automated and self-administered by a patient user, as opposed to a technician, photographer or physician'; the patient can self-administer the test, but the process is fully automated to remove patient actions).
Regarding claim 28, Combination Walsh-Khan discloses the invention as described in Claim 19 and Walsh further teaches wherein the ophthalmic imaging procedure is performed at a patient's home (Walsh, paragraph [0343], The OCT-based ophthalmic testing center system 2800 can be configured to be fully automated and self-administered by a patient user, as opposed to a technician, photographer or physician. In certain embodiments, patients can take OCT-based ophthalmic testing center system 2800 to their homes and transmit electronic images of their self-administered examination to their physician via a communications network for an evaluation, risk assessment and/or diagnosis).
Regarding claim 29, Walsh teaches an ophthalmic imaging headset (Walsh, figs.1-59, paragraph [0345] the OCT-based ophthalmic testing center system 2800 can comprise a device to be worn by the user like glasses, with earstems supporting the device on top of each ear, like goggles with a strap that extends around the back of the head, Other designs and alternatives of structures to interface with the user's eyes are possible without departing from the spirit and/or scope of the disclosure; paragraph [0211], The wearable object 1010 may include a head-mounted object, a hat or an object to be positioned on a user's head; paragraph [0369], the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities), comprising: one or more ophthalmic imaging modalities for obtaining one or more forms of ophthalmic information of a user (Walsh, figs.1-59, user 114) wearing the headset; a screen for displaying a video to the user wearing the headset to catch and hold the user's attention to one or more locations on the screen (Walsh, [0153] The main body 106 may comprise one or more eyepieces, an interferometer, one or more target displays, a detector and/or an alignment system; [0163] The displays 215a and 215b may comprise one or more light sources, such as in an emissive display like an array of matrix LEDs; [0164] the user 114 may use images from the displays in order to adjust interpupillary distance; [0222] Such a device may have a browser module implemented as a module that uses text, graphics, audio, video, and other media to present data and to allow interaction with data via the network 1310; [0338] In reference to FIG. 28, the display 2810 can be a liquid crystal display and/or other display device configured to present images, dots, stimuli, or the like to a user, subject, and/or patient. The display 2810 can be located externally or internally to a main body, or housing, of the OCT-based ophthalmic testing center system 2800; stimulus and other media may be presented for the user to focus on); and an optical adjustment module configured to maintain optical access of the one or more ophthalmic imaging modalities to one or more regions of interest of one or both eyes of the user (See Walsh, this claim recites similar limitations as those in corresponding in claim 2 and is rejected based on the same teachings and rationale).
Walsh does not explicitly teach wherein
a processing module that is configured to:
cause ophthalmic imaging of the pupil of the user wearing the wearable device to be initiated by causing the video to be displayed on the screen of the wearable device, wherein the video has a predetermined length based on a duration of the ophthalmic imaging and wherein the video directs the pupil of the user to a plurality of locations on the screen such that pupil images of one or more retinal regions of the pupil are concurrently obtained using the one or more ophthalmic imaging modalities while the video is being presented; and
in response to determining that the one or more ophthalmic imaging modalities should be realigned with a new region of interest the pupil based on pupil positions of the pupil while the video is being presented, continue the ophthalmic imaging of the pupil that includes obtaining additional pupil images of the new region of interest until the end of the video.
However, Khan teaches the analogous ophthalmic imaging technologies (Khan, figs.1-19, abstract, a modular, headset for performing ophthalmic tests on a patient comprises a removable optical module that can be replaced based on ophthalmic testing need. The fundus camera position can be automatically adjusted to align the camera with a headset wearer's eye. Software controls image capture and captured images are combined assembled and combined to provide a wide field retinal image; paragraph [0176], fundus images captured using a system as disclosed herein can be transferred to a image processing system in real time and processed), and further teaches wherein
a processing module (Khan, paragraph [0074],a module system 600;paragraph [0073], Appropriate internal software or firmware is stored in the memory 614 to allow the processor 602 interact and control the various internal components and communicate with other system components, such as components on the head mount hardware 105 and an external control system 16 or other external computer; full the ophthalmic imaging or other testing functions and return the captured image or other test data. the control and testing software required for the control system 16 or other external device can be preinstalled in an optics module 110. When the external computer is connected to the optics module 110, such as by a cable, the software needed to be run on that computer can be downloaded from the optics module 110. Likewise, an externally connected computer can be used to update the software on the optics module 110) that is configured to:
cause ophthalmic imaging of the pupil (paragraph [0074] For a module system 600 that include cameras for imaging the external or internal features of the eye, images can be captured by the module and processed and analyzed to identify potential issues retinal images) of the user wearing the wearable device (paragraph [0051], same headset 12 to be used for a wide variety of different types of eye tests) to be initiated by causing the video to be displayed on the screen of the wearable device (paragraph [0052];initiate the testing process, and receive the captured test data from the headset; paragraph [0037], FIGS. 9A and 9B illustrate sample images presented on headset displays as part of a foveated rendering process; paragraph [0078],video displays 604; paragraph [0131], to allow viewing of video displays that may also be included in the headset), wherein the video has a predetermined length based on a duration of the ophthalmic imaging and wherein the video directs the pupil of the user to a plurality of locations on the screen such that pupil images of one or more retinal regions of the pupil are concurrently obtained using the one or more ophthalmic imaging modalities while the video is being presented (see paragraph [0148] The system can be programmed to determine when sufficient images of the retina of sufficient quality have been captured so that all areas of the retina of interest appear in at least one image of acceptable quality. Under normal circumstances an average of 500-720 fundus images frames, at 24 frames per second, 30-second video length, captured by the fundus camera 1108 while the user moves their eye around can provide sufficient imaging ;paragraph [0120], test patterns can be presented in various locations within the field of view and the patient feedback indicating when the pattern becomes visible is detected and recorded; paragraph [0130] Data can be collected from a live video of the eye while the Fundus camera is taking a set of images. Eye-tracking and image processing can be used to combine images captured by the camera to generate an image that covers most or all of the retina; also see paragraph [0105], The foveated rendering can shift with the location of the pupils or where the user's gaze is directed at on the screen. The system can be configured to receive input from the eye-tracking cameras 612 at a predefined rate and the image refreshed at that same rate with foveated rendering., such as at 60 to 90 Hz, which rates may equal or be greater than the predefined rate. The decrease in image resolution based on distance in the image from the point of user gaze outward can be varied in a number of ways, such as via a smoothly varying or stepwise function.,--- thus Khan teaches wherein cause ophthalmic imaging of the pupil of the user wearing the wearable device to be initiated by causing the video to be displayed on the screen of the wearable device, wherein the video has a predetermined length based on a duration of the ophthalmic imaging and wherein the video directs the pupil of the user to a plurality of locations on the screen such that pupil images of one or more retinal regions of the pupil are concurrently obtained using the one or more ophthalmic imaging modalities while the video is being presented); and
in response to determining that the one or more ophthalmic imaging modalities should be realigned with a new region of interest the pupil based on pupil positions of the pupil while the video is being presented (paragraph [0128], Eye tracking camera systems in the headset can be used to determine when the patient's gaze is directed a target, such as a point or small image in the center of the field of view. At the initiation of a test, the system can monitor eye gaze to determine when the patient is looking steadily at the center target. Tests can be initiated after this condition is met --- in response to determining---; paragraph [0152] The image capture process continues until the system determines that the area of the retina to be imaged is adequately captured in one or more images),
continue the ophthalmic imaging of the pupil that includes obtaining additional pupil images of the new region of interest until the end of the video (paragraph[0152] The image capture process continues until the system determines that the area of the retina to be imaged is adequately captured in one or more images; paragraph [0150], these data points can be sent to the image processing system linked to the captured images; Image capture continues as a user shifts their direction of gaze, e.g., in response to instructions; see fig.13, having continue the ophthalmic imaging of the pupil that includes obtaining additional pupil images of the new retinal region until the end of the video).
Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Walsh to have the specific processing module as taught by Khan for the purpose to improve the alignment of the camera objective with a pupil the eye (Khan, paragraph [0017]).
Regarding claim 30, Combination Walsh-Khan discloses the invention as described in Claim 29 and Walsh further teaches wherein the one or more ophthalmic imaging modalities include at least an optical coherence tomography (OCT) for capturing posterior segment images of the one or both eyes of the user and a fundus imaging module for capturing retinal images of the one or both eyes of the user (Walsh, [0141], The terms "optical coherence tomography" and "OCT" generally refer to an interferometric technique for imaging samples, in some cases, with micrometer lateral resolution. This non-invasive optical tomographic imaging technique is used in ophthalmology to provide cross-sectional images of the eye, and more particularly the posterior of the eye; [0369], the OCT-based ophthalmic testing center system can be configured to perform automatic eye tracking or fixation monitoring during the various structural and functional ophthalmic tests. In various embodiments, the OCT-based ophthalmic testing center system can be configured to perform eye tracking based on OCT imaging modalities, non-OCT imaging modalities, or a combination of both. In general, OCT images contain information about unique eye structures, for example, the pupil, anterior segment, fovea, retinal vessels or optic nerve, and high speed OCT scans can be used to track the movement of the pupil, anterior segment, fovea, retinal vessels and/or other fundus structures'; [0410], 'The OCT-based ophthalmic testing center system can be configured to monitor the subject's gaze using OCT and/or non-OCT imaging modalities to ensure that the subject's gaze, either demonstrated by a foveal depression under the image of the fixation target on the retina or by appropriately changing locations for other retinal features, remains fixed on the moving or dwelling target. OCT imaging modalities can include, for example, foveal verification using small 3D-OCT scans centered on the image of the fixation target on the retina and/or foveal location using sparse 3D-OCT scans across the fundus; [0433], In the absence of a foveal or optic nerve depression, for example, for subjects suffering from retinal disease, the relative slopes of the retinal surface can be used to indicate eye movement away from either the past fundus position).
Regarding claim 31, Combination Walsh-Khan discloses the invention as described in Claim 29 and Walsh further teaches wherein further comprising a gaze tracker configured to track and determine positions of pupils of the one or both eyes (Walsh,[0265], Accordingly, in some embodiments, an optical coherence tomography system, for example, that of FIG. 1 or 3, comprises a sensor or tracker. The sensor or tracker may determine a position of the user, one or two eyes of the user, and/or one or more structures, for example, a retina, pupil, cornea, or lens, of the user's eye. In some embodiments, the sensor or tracker is positioned on or attached to main body 106; [0350], The OCT-based ophthalmic testing center system can be configured to perform a variety of ophthalmic tests, for example, via execution of the testing modules 2818, including but not limited to...gaze detection; [0370], With reference to FIG. 35A and FIG. 358, the ophthalmic testing center can be configured to perform eye tracking or fixation monitoring during various ophthalmic tests by performing iris plane analyses, pupillary analyses, or anterior chamber analyses. For example, iris plane analysis is the process of determining the planar configuration, direction, tilt and/or slope of the iris tissue 3504A. When an eye changes it fixation and/or gaze to look in a new direction, the slope of the iris plane 3504A containing the pupil changes in a similar manner to a satellite dish pointing in a new direction).
Regarding claim 32, Combination Walsh-Khan discloses the invention as described in Claim 31 and Walsh further teaches wherein the optical adjustment module is configured to maintain the optical access of the one or more ophthalmic imaging modalities to the one or more regions of interest of the one or both eyes of the user based on the determined positions of the pupils of the one or both eyes (Walsh, paragraph [0164], the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, the iris in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, from B-scans or C-scans of the anterior chamber. In certain embodiments, the interpupillary distance can be adjusted by control 204 until the pupils are substantially centered in both B-scans or C-scans, thereby indicating optimal optical axis alignment; [0229], For example, by focusing the optical coherence tomography system at different antero-posterior locations using the power optics 210, A-scan, 8-scan, or 3D-OCT scan data can be collected for any of the structures of the eye that lie along the central axis; [0244], With reference to FIGS. 1, 8 and 9, the optical coherence tomography system 100 is configured to allow the user to self-administer an OCT scan of the user's eyes without dilation of the eyes, and obtain a risk assessment or diagnosis of various diseases and ailments without the engaging or involving a doctor and/or technician to align the user's eyes with the system, administer the OCT scan and/or interpret the data from the scan to generate or determine a risk assessment or diagnosis).
Regarding claim 33, Combination Walsh-Khan discloses the invention as described in Claim 29 and Walsh further teaches wherein the optical adjustment module includes one or both of: an actuated beam splitter; and an actuated mirror (see Walsh, this claim recites similar limitations as those in corresponding dependent claim 7 and is rejected based on the same teachings and rationale).
Regarding claim 34, Combination Walsh-Khan discloses the invention as described in Claim 29 and Walsh further teaches wherein the optical adjustment module includes a stationary beam splitter (Walsh, paragraph [0162], A first portion of the light split at beam splitter 285a or 285b is reflected by reference mirrors 273a or 273b, reference mirrors 270a or 270b, and reference mirrors 265a or 265b. A second portion of the light split at beam splitter 285a or 285b is reflected by mirror 250a or 250b, by mirror 255a or 255b and by mirror 260a or 260b. Mirrors 255a or 255b and mirrors 250a and 250b are connected to a Z-offset adjustment stage 290b. By moving the position of the adjustment stage 290a or 290b, a different portion of the eye can be imaged. Thus, the adjustment stage 290a or 290b can adjust the difference between the optical length from the light source 240 to a portion of the sample and the optical length from the light source 240 and the reference mirror 270a or 270b and/or reference mirror 273a or 273b. This difference can be made small, for example, less than a coherence length, thereby promoting optical interference to occur. In some embodiments, the positions of one or more reference mirrors (for example, reference mirror 270a or 270b and reference mirror 273a or 273b) are movable in addition to or instead of the adjustment stage being movable. Thus, the length of the reference arm and/or of the sample arm may be adjustable. The position of the adjustment stages 290a and/or 290b may be based on the signals from the device, as described in more detail below; [0164], In certain embodiments, the adjustment control 204 may comprise a handle on the main body 106, as shown in FIG. 3B. In this embodiment, rotation of the adjustment control 204 may increase or decrease the interpupillary distance. In various embodiments, the adjustment control 204 may be controlled electronically by processors within the main body 106 based on the detected position of the pupils, the iris in one eye or both eyes, or lens region in at least one eye, by using, for example, edge detection algorithms, from B-scans or C-scans of the anterior chamber'; the mirrors may be actuated to adjust the position, while the beam splitter may remain stationary).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Walsh et al. (US20190090733) in view of Khan et al. (US20220151489), and further in view of Cheng (CN111084605).
Regarding claim 8, Combination Walsh-Khan discloses the invention as described in Claim 7, Walsh does not explicitly teaches wherein the actuated beam splitter is positioned between the user's eye and the screen and is configured to transmit a first portion of the incident light toward the user's eye and reflect a second portion of the incident light toward the actuated mirror.
However, Cheng teaches the analogous eye examination device (Cheng,fig.1, abstract, the technical scheme of the hand-held fundus camera with the navigation capable of automatically tracking the target has the following key points: a fundus lens further comprises an artificial star lighting board, and a retina map board match the retina; the retina map board and the artificial star lighting board are sequentially arranged on one side of a spectroscopic optical path; lamps, which are corresponding to various positions on the retina map board, are arranged on the artificial star lighting board; the artificial star lighting board is electrically connected with a touch display; and light from the lamps on the artificial star lighting board reaches the human eye through the retina map board, the spectroscopic optical path and an eyepiece, so that the problem that the angle between the fundus camera and the human eye needs to be adjusted for many times by a doctor when pictures of required retinal areas are taken by using existing medium fundus cameras is solved), and further teaches wherein the actuated beam splitter (Cheng, fig.1, beam splitter has been referred as the prism 14; paragraph [0026], dichroic prism 14) is positioned between the user's eye (Cheng, fig.1, eye 1; paragraph [0023], the doctor places the fundus lens 1 on the patient's eye ) and the screen (Cheng, fig.1, screen 8; paragraph [0023], screen 8) and is configured to transmit a first portion of the incident light (see annotated image, Cheng, fig.1, first portion of the incident light ) toward the user's eye (Cheng, fig.1, eye 1) and reflect a second portion of the incident light toward the actuated mirror (see annotated image, Cheng, fig.1, the second portion of the incident light from eye 1 toward the mirror 13).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Walsh with the specific structure as taught by Cheng for the purpose to provide a handheld fundus camera that is simple to operate, can improve the efficiency of doctors, and can guide the human eye to rotate to the appropriate position and automatically track the target (Cheng, paragraph [0007]).
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Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Walsh et al. (US20190090733) in view of Khan et al. (US20220151489), and further in view of Samec et al. (US20160270656).
Regarding claim 13, Combination Walsh-Khan discloses the invention as described in Claim 1, Walsh does not explicitly teaches wherein the wearable device is implemented as a virtual reality (VR) headset.
However, Samec teaches the analogous wearable eye examination device (Samec, figs.1-29, paragraph [0725], Ophthalmoscope/Funduscope; paragraph [0726], a wearable augmented reality device configured to be used by a wearer, said device comprising: an augmented reality head-mounted ophthalmic system comprising an augmented reality display platform, said augmented reality head-mounted ophthalmic system configured to pass light from the world into an eye of a wearer wearing the head-mounted system, wherein said augmented reality head-mounted ophthalmic system is configured to capture an image of an illuminated portion of the wearer's eye for analysis to monitor health of the wearer's eye, detect abnormalities of the eye or other health problems...), and further teaches wherein the wearable device (Samec, fig.3, the wearable device) is implemented as a virtual reality VR headset (Samec, fig.3, paragraph [1432], a speaker (66) may be coupled to the frame (64) in the depicted configuration and positioned adjacent the ear canal of the user; paragraph [1419] Disclosed are methods and systems for diagnosing and/or treating health ailments of patients through a user-wearable health system, e.g., a user-wearable ophthalmic device that interacts with the user's eyes.; paragraph [1511] the ophthalmic system is a VR head mounted display system; [0682] The device of Embodiments 45-47, wherein the frame includes one or more ear stems)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Walsh with the specific function as taught by Samec for the purpose to provide unique access to a user's eyes and head. Given that the health system interacts with the user's eye to allow the user to perceive 3D virtual content (Samec, paragraph [1435]).
Regarding claim 14, Combination Walsh-Khan discloses the invention as described in Claim 1 Walsh does not explicitly teaches wherein the wearable device allows for performing ophthalmic imaging on the user over an extended examination period facilitated by the content of the displayed video.
However, Samec teaches the analogous wearable eye examination device (Samec, figs.1-29, paragraph [0725], Ophthalmoscope/Funduscope; paragraph [0726], a wearable augmented reality device configured to be used by a wearer, said device comprising: an augmented reality head-mounted ophthalmic system comprising an augmented reality display platform, said augmented reality head-mounted ophthalmic system configured to pass light from the world into an eye of a wearer wearing the head-mounted system, wherein said augmented reality head-mounted ophthalmic system is configured to capture an image of an illuminated portion of the wearer's eye for analysis to monitor health of the wearer's eye, detect abnormalities of the eye or other health problems...), and further teaches the wearable device allows for performing ophthalmic imaging on the user over an extended examination period facilitated by the content of the displayed video (Samec, paragraph[1335] The device of any of the above embodiments, wherein the device is configured to acquire test results based at least in part on measurements of the eye of the wearer while playing a video game; [1337], The device of any of the above embodiments, wherein the device is configured to present video game wherein portions of the video game are presented from a variety of depth planes and to perform tests, examinations, or procedures on the eye of the wearer based on measurements of the eye when playing the video game presented from the variety of depth planes) and the comfort of the user wearing the headset (Samec, paragraph [0682], The device of Embodiments 45-47, wherein the frame includes one or more ear stems; in fig.3, paragraph [1432], a speaker 66 may be coupled to the frame 64 in the depicted configuration and positioned adjacent the ear canal of the user).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Walsh with the specific function as taught by Samec for the purpose to provide unique access to a user's eyes and head. Given that the health system interacts with the user's eye to allow the user to perceive 3D virtual content (Samec, paragraph [1435]).
Regarding claim 15, Combination Walsh-Khan-Samec discloses the invention as described in Claim 14 and Samec further teaches wherein the extended examination period facilitates capturing multiple OCT scans and fundus images of multiple regions of the user's eye to improve image qualities of the ophthalmic imaging (Samec, paragraph [1484] the ophthalmic system may store one or more images that may be retrieved by the ophthalmic system. In some embodiments, the images may be pre-loaded or generated by the ophthalmic system. In some embodiments, the images may be part of a moving image; the images may be feed from another source external to the ophthalmic system, e.g., remote data repository 72; or in combination, the images may be obtained based on ambient light in front of the ophthalmic system, as described herein. The image may be projected by the ophthalmic system to the user, and may be modified by the software included in the ophthalmic system. The ophthalmic system may generate one or more 2D images to be presented to the eye of a user, and the system may be configured to modify these images prior to projecting the images based on the optical prescription of the user. In some embodiments, as described below for an embodiment of the ophthalmic system comprising a waveguide stack, different image content projected at different focal depths provides the user a 3D perception of images. Thus, each image may be a 2D representation of an image at a different focal depth. Each image may be modified individually by software included in the ophthalmic system. For example, the pattern or collection of pixels that form each image can be modified to counter, offset, or reduce effects of errors introduced by the eye; paragraph [2016] The wearable device 2350 configured as an OCT system, may be used to visualize retinal topography, deep fundus imaging (i.e., detecting lesions), retinal pigment…, changes and other age related macular degeneration, visualize retinal vasculature, visualize blood flow in the fundus of the eye, visualize shape and structure of blood vessels in the fundus of the eye, etc. The wearable device 2350 may also be used to provide a multi-spectral image comparison, which can be advantageous in improving visual discrimination of retinal and sub-retinal features through spectral and depth enhanced differential visibility; [2026], the wearable device 2350 can be configured to periodically perform an OCT examination or when the device 2350 detects that the user 2360 is having difficulties with vision or trouble focusing. In various embodiments, the system 2350 can be configured to perform an OCT examination of the eye 2320 at irregular time intervals. For example, the wearable device 2350 can be configured to perform an OCT examination a few times an hour, a few times a week, a few times a month, a few times a year, etc..; the system 2350 can also be configured to be used in a doctor's office or a hospital as an OCT examination. In contrast to a traditional table/bench top OCT system, the wearable device 2350 can be worn by a user 2360. The wearable device 2350 configured as an OCT system can be lightweight, compact and less bulky than a traditional table/bench top OCT system).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Walsh with the specific function as taught by Samec for the purpose to provide unique access to a user's eyes and head. Given that the health system interacts with the user's eye to allow the user to perceive 3D virtual content (Samec, paragraph [1435]).
Response to argument/amendment
Applicant’s arguments with respect to claims have been considered but are moot because the arguments do not apply to any of the references or portions of the reference being used in the current rejections.
Examiner's Note
Regarding the references, the Examiner cites particular figures, paragraphs, columns and line numbers in the reference(s), as applied to the claims above. Although the particular citations are representative teachings and are applied to specific limitations within the claims, other passages, internally cited references, and figures may also apply. In preparing a response, it is respectfully requested that the Applicant fully consider the references, in their entirety, as potentially disclosing or teaching all or part of the claimed invention, as well as fully consider the context of the passage as taught by the reference(s) or as disclosed by the Examiner.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KUEI-JEN LEE EDENFIELD whose telephone number is (571)272-3005. The examiner can normally be reached Mon. -Thurs 8:00 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Pham can be reached on 571-272-3689. The fax phone number for the organization where this application or proceeding is assigned is 571-273- 8300.
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/KUEI-JEN L EDENFIELD/
Examiner, Art Unit 2872
/THOMAS K PHAM/Supervisory Patent Examiner, Art Unit 2872
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