DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Accounting
Applicant's arguments, filed 01/20/2026, have been fully considered.
The following rejections are newly applied. They constitute the complete set presently being applied to the instant application.
Applicant’s election of claims 1-14 without traverse in the reply filed on 06/17/2025 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-14 are hereby under examination.
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 1-3, 6-10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2020/0029802 by Lane et al. (hereinafter “Lane ‘802”) in view of US Patent Publication 2018/0136486 by Macnamara et al. – previously cited (hereinafter “Macnamara”).
Regarding claim 1, Fig. 3 of Lane ‘802 teaches a vision screening device (Lane teaches vision screening system 300), comprising: a radiation source configured to generate color stimuli ([0058-0060], second display unit component 216 may display visible light in colors. It is noted that the embodiments of servers 202 and 302 (systems 200 and 300, respectively) are similar and may perform similar functions. Therefore, second display unit component 216 is interpreted as similar to second display unit component 316. All corresponding components across devices 200 and 300 are interpreted as containing the same details.); a sensor configured to capture radiation reflected by an eye of a patient (image/video sensor array component 312); a processor operably connected to the radiation source and the sensor (processor(s) 304); and memory storing instructions that, when executed by the processor, cause the processor to ([0039]; instructions stored on computer readable media 310 can program the processor to perform functions): cause the radiation source to present a first stimulus, and a second stimulus different from the first color stimulus, to the patient during a period of time ([0058]; the second display unit component is configured to display one or more graphical representations during a vision test.), and generate an output indicative of the visual ability of the patient ([0057, 0080], a diagnosis recommendation related to the output of the vision screening may be generated and displayed to the user).
Lane ‘802 does not teach the first stimulus and second stimulus being color stimuli; the sensor being caused to capture: first radiation reflected by the eye and responsive to the first color stimulus, and second radiation reflected by the eye and responsive to the second color stimulus; determine, based on the first radiation, a first value of a measurement associated with the eye; determine, based on the second radiation, a second value of the measurement; and the output being based at least in part on the first value and the second value or the output being indicative of an ability of the patient to distinguish between the first color stimulus and the second color stimulus.
Macnamara teaches a system configured to perform the method of screening for color deficiencies by displaying a projected Ishihara color plate as a vision test. The Ishihara color test projects a circle with dots in two colors (color plate) making a number or shape within the circle that may be distinguishable from each other for viewers with normal color vision but difficult or impossible to see for viewers who have a color perception deficiency. The method displays the color plate for a period of up to one, five, ten seconds or longer while tracking the gaze (i.e., measurement) of the patient for each color stimulus to determine an indication if the number or shape was seen by the patient (i.e., if the patient can distinguish between the first and second color stimuli) ([0278-0281]). This test allows the system to determine if the user saw the number or shape, indicating ability to distinguish between the first and second color stimuli, without conscious input from the patient ([0281]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Lane ‘802 such that the first and second stimuli would be color stimuli; the sensor to be caused to capture: first radiation reflected by the eye and responsive to the first color stimulus, and second radiation reflected by the eye and responsive to the second color stimulus; determine, based on the first radiation, a first value of a measurement associated with the eye; determine, based on the second radiation, a second value of the measurement; and the output to be based at least in part on the first value and the second value and the output to be indicative of an ability of the patient to distinguish between the first color stimulus and the second color stimulus, as this would allow for the determination of the patient’s ability to distinguish between the first and second color stimuli without conscious input from the patient, as taught by Macnamara ([0281]).
Regarding claim 2, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 1, wherein the radiation source is a first radiation source (Lane ‘802, [0059]; the LED array of the second display unit component includes one or more visible LEDs), the vision screening device further comprising a second radiation source configured to emit near-infrared (NIR) radiation (Lane ‘802, [0059]; second display unit component may also comprise one or more near-infrared LEDs), wherein the instructions further cause the processor to: cause the second radiation source to emit NIR radiation during the period of time (Lane ‘802, [0077]; Gaze is determined by shining infrared light on the patient’s eye. Therefore to determine gaze the infrared radiation must be emitted during the period of time).
Regarding claim 3, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 1, wherein the radiation source comprises at least one of: color light emitting diodes (LEDs) (Lane ‘802, [0059-0060]; second display unit component may comprise an LED array, visible color LEDs may be present); an organic light emitting display (OLED) screen (Lane ‘802, [0058]; second display unit component may comprise an active matrix organic light emitting display (AMOLED)); or a liquid crystal display (LCD) screen (Lane ‘802, [0058], second display unit component may comprise an LCD).
Regarding claim 6, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 1, wherein the measurement comprises a refractive error of the eye or a gaze direction of the eye (See the rejection of claim 2, the measurement can comprise a gaze direction of the eye).
Regarding claim 7, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 2, wherein the first radiation source comprises color light emitting diodes (LEDs) (Lane ‘802, [0060]; second display unit component may comprise an LED array, visible color LEDs may be present), the second radiation source comprises near-infrared (NIR) LEDs (Lane ‘802, [0059]; second display unit component may also comprise one or more near-infrared LEDs), and the color LEDs and the NIR LEDs are interspersed in a pattern on an LED array of the vision screening device (Lane ‘802, [0059]; “In some examples, the visible LEDs may be positioned between, and be substantially co-planar with, the near-infrared LEDs in the LED array”).
Regarding claim 8, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 1, wherein the first color stimulus comprises a first color pattern (dots of the background color of the Ishihara color plate as taught by Macnamara [0278]), and the second color stimulus comprises a second color pattern (dots of the number or shape of the Ishihara color plate as taught by Macnamara [0278]), the first and second color patterns configured to cause a difference between the first value and the second value when observed by a patient exhibiting trichromat color vision (Macnamara, [0278, 0281]; The gaze would not be focused on any specific color stimuli color if no difference was detected. If a patient exhibits trichromat vision (i.e., normal color vision), then the patient would fixate their gaze on the second color stimulus, causing a difference in gaze measurement values.).
Regarding claim 9, Lane ‘802 in view of Macnamara teach the vision screening device of claim 1, wherein the output includes an indication of: passed screening, additional screening required. Lane ‘802 teaches that the diagnosis recommendation component may evaluate the measurements to provide a recommendation to the user regarding the vision of the patient (e.g., whether the patient passed the test, requires additional screening, etc.). ([0018]).
The combination of Lane ‘802 and Macnamara does not teach the output including an indication of a type of color vision deficiency.
In the combination of Lane ‘802 and Macnamara, the test is for color vision deficiency (Macnamara [0278]), therefore it would be obvious to report the results of the vision screening test if the test indicated a color vision deficiency. This would communicate diagnostic results of the test to the user.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the output of the system taught by Lane ‘802 in view of Macnamara to include an indication of a type of color vision deficiency, as this would communicate diagnostic results of the test to the user.
Regarding claim 10, Figs. 3-4 of Lane ‘802 teaches a vision screening device (vision screening system 300), comprising: a housing (Fig. 4 shows an embodiment of a vision screening device 400 according to some implementations that includes some or all components described with reference to the vision screening device of Fig. 3. Fig. 4 shows housing 402); a first display disposed at a first end of the housing and configured to generate color stimuli (second display unit 406 is considered to be at the first end and is analogous to the second display unit component. [0058-0060], The second display unit component may display visible light in colors.); a second display disposed at a second end of the housing opposite the first end (Fig. 4, first display unit 404 is on the opposite end of second display unit 406. First display unit 404 is considered to be analogous to the first display unit component 314); a sensor configured to capture radiation reflected by an eye of a patient (image/video sensor array component 312);
a processor operably connected to the first display, the second display, and the sensor (processor(s) 304); and memory storing instructions that, when executed by the processor, cause the processor to ([0039]; instructions stored on computer readable media 310 can program the processor to perform functions): cause the radiation source to present a first stimulus, and a second stimulus different from the first color stimulus, to the patient during a period of time ([0058]; the second display unit component is configured to display one or more graphical representations during a vision test.), generate an output comprising at least one of a diagnosis or a recommendation associated with the patient ([0080, 0084], a diagnosis recommendation related to the output of the vision screening may be generated and displayed to the user), and present the output via the second display ([0080, 0084]; an indication related to the output/diagnosis recommendation of the vision test may be generated and displayed to the tester via first display unit component).
Lane ‘802 does not teach the first stimulus and second stimulus being color stimuli; the sensor being caused to capture: first radiation reflected by the eye and responsive to the first color stimulus, and second radiation reflected by the eye and responsive to the second color stimulus; determine, based on the first radiation, a first value of a measurement associated with the eye; determine, based on the second radiation, a second value of the measurement;
or the output being based at least in part on the first value and the second value.
Macnamara teaches a system configured to perform the method of screening for color deficiencies by displaying a projected Ishihara color plate as a vision test. The Ishihara color test projects a circle with dots in two colors (color plate) making a number or shape within the circle that may be distinguishable from each other for viewers with normal color vision but difficult or impossible to see for viewers who have a color perception deficiency. The method displays the color plate for a period of up to one, five, ten seconds or longer while tracking the gaze (i.e., measurement) of the patient for each color stimulus to determine an indication if the number or shape was seen by the patient (i.e., if the patient can distinguish between the first and second color stimuli) ([0278-0281]). This test allows the system to determine if the user saw the number or shape, indicating ability to distinguish between the first and second color stimuli, without conscious input from the patient ([0281]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Lane ‘802 such that the first and second stimuli would be color stimuli; the sensor caused to capture: first radiation reflected by the eye and responsive to the first color stimulus, and second radiation reflected by the eye and responsive to the second color stimulus; determine, based on the first radiation, a first value of a measurement associated with the eye; determine, based on the second radiation, a second value of the measurement; and the output to be based at least in part on the first value and the second value, as this would allow for the determination of the patient’s ability to distinguish between the first and second color stimuli without conscious input from the patient, as taught by Macnamara ([0281]).
Regarding claim 14, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 10, wherein the first and second color stimuli comprise at least one of: black figures on a white background, the black figures including a color fringe; graphics of a first color on a background of a second color different from the first color (Macnamara, [0278]; the Ishihara plate features background dots of one color and number/shape dots of another color); color dot patterns (Macnamara, [0278]; the Ishihara plate features color dot patterns); or time-varying color images (Macnamara, [0278]; The hues in the Ishihara plate may change incrementally).
Claims 4-5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lane ‘802 in view of Macnamara, as applied to claims 3 and 10, in view of US Patent Publication 2019/0125183 by Lane et al. – previously cited (hereinafter “Lane ‘183”) and Spot Vision VS100 user manual (2018) – previously cited (hereinafter “VS100 Manual”).
Regarding claim 4, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 3, but does not teach wherein the color LEDs are disposed proximate a perimeter of a view window, and the view window is disposed at a first end of the vision screening device, the first and second radiation reflected by the eye passing to the sensor via the view window.
Fig. 4 of Lane ‘183 teaches a device with an LED array disposed on a second display unit. The second display unit features an LED array coplanar with near-infrared LEDs ([0048]). The device comprises an image sensor that is disposed within the housing, where light (i.e., radiation) comes from the patient’s eyes ([0062]). Lane ‘183 describes a commercial embodiment of this device as the Spot Vision Screener VS100 ([0060]). The VS100 manual (Page 10; front view of the Vision Screener) teaches a front glass disposed on the exterior of the second display unit. The front glass would be in between the interior of the device (containing the LED array and the image sensor) and the exterior device (where the patient’s eyes are). Therefore, the perimeter (i.e., edge of facing the interior of the housing) of the glass (i.e., view window) would be proximate the LED array and the radiation reflected from the patient’s eyes would be pass to the sensor via the glass. The glass disposed between the patient and the interior components of the device can protect the electronic components from elements such as dust while allowing radiation to pass through.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Lane ‘802 and Macnamara such that the color LEDs are disposed proximate a perimeter of a view window, and the view window is disposed at a first end of the vision screening device, the first and second radiation reflected by the eye passing to the sensor via the view window, as taught by Lane ‘183 and the VS100 manual, to protect the electronic components of the device from elements such as dust while allowing radiation to pass through.
It is noted that the second display as taught by Lane ‘802 in view of Macnamara is considered to be disposed at the first end of the device, therefore the view window would also be disposed at the first end of the device.
Regarding claim 5, Lane ‘802 in view of Macnamara in view of Lane ‘183 and the VS100 manual teaches the vision screening device of claim 4, further comprising a display unit disposed at a second end of the vision screening device opposite the first end (Lane ‘802, Fig. 4; first display unit 404 is on the opposite end of second display unit 406 (corresponding to second display unit component 316. First display unit 404 is considered to be analogous to the first display unit component 314), the display unit being configured to display the output associated with the patient (Lane ‘802, ([0080, 0084]; an indication related to the output/diagnosis recommendation of the vision test may be generated and displayed to the tester via first display unit component).
Regarding claim 11, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 10, but does not teach wherein the first display is disposed below, adjacent to, or above a view window of the vision screening device, the first and second radiation reflected by the eye passing to the sensor via the view window.
Fig. 4 of Lane ‘183 teaches a device with an LED array disposed on a second display unit. The second display unit features an LED array coplanar with near-infrared LEDs ([0048]). The device comprises an image sensor that is disposed within the housing, where light (i.e., radiation) comes from the patient’s eyes ([0062]). Lane describes a commercial embodiment of this device as the Spot Vision Screener VS100. The VS100 manual (Page 10; front view of the Vision Screener) teaches a front glass disposed on the exterior of the second display unit. The front glass would be in between the interior of the device (containing the LED array and the image sensor) and the exterior device (where the patient’s eyes are). Therefore, the perimeter edge of the glass (i.e., view window) facing the interior of the housing would be adjacent the LED array of second display unit 158 (i.e. first display) and the first and second radiation reflected from the patient’s eyes would be pass to the sensor via the glass. The glass disposed between the patient and the interior components of the device can protect the electronic components from elements such as dust while allowing radiation to pass through.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Lane ‘802 in view of Macnamara such that the first display is disposed below, adjacent to, or above a view window of the vision screening device, the first and second radiation reflected by the eye passing to the sensor via the view window, as taught by Lane ‘183 and the VS100 manual, to protect the electronic components of the device from elements such as dust while allowing radiation to pass through.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lane ‘802 in view of Macnamara, as applied to claim 10, in view of Lane ‘183.
Regarding claim 12, Lane ‘802 in view of Macnamara teaches the vision screening device of claim 10, but does not teach wherein the first display is transparent, and the first and second radiation reflected by the eye pass to the sensor via the first display.
Lane ‘183 teaches that the image sensor array may be positioned in the interior of the housing and orthogonal to the second display unit (i.e., first display). In this positioning, the radiation from the patient’s eyes pass through a substantially transparent substrate of the second display unit to get to the image sensor ([0062]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Lane ‘802 in view of Macnamara such that the first display is transparent, and the first and second radiation reflected by the eye pass to the sensor via the first display, as taught by Lane ‘183.
The configuration according to Lane ‘183 is a known configuration to detect radiation from the eyes of a patient with a sensor, therefore combining of Lane ‘802, Macnamara, and Lane ‘183 comprises combining prior art elements according to known methods to yield predictable results (See MPEP 2143.I.A).
Regarding claim 13, Lane ‘802 in view of Macnamara in view of Lane ‘183 teaches the vision screening device of claim 12, wherein the first display generates the color stimuli by reflecting radiation from an LED array or a third display. The device of claim 12 is configured such that the second display unit comprises an LED array that projects an image onto a substantially transparent substrate (Lane ‘183; [0062]). The image is viewed by the patient by the image being reflected off of the substrate.
Response to Arguments
Applicant’s arguments, filed 01/20/2026 have been fully considered.
Applicant’s arguments regarding the eligibility of Wiggerman as prior art under 35 U.S.C. 102(a)(1) and 102(a)(2) is acknowledged. This argument is found persuasive. The claims limitations are rejected on new grounds above. Therefore, the Office action is non-final in view of the applicant’s arguments.
Conclusion
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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