DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, lines 10 - 11 recite, “a sequence of first kind of stimuli…” but should read -- a sequence of a first kind of stimuli … --.
Claim 1, lines 14 recites, “a sequence of second kind of stimuli…” but should read -- a sequence of a second kind of stimuli … --.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 - 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories (machines, manufactures, processes, and compositions of matter) of patent eligible subject matter because claims 1 - 15 are directed towards a computer program, which is considered a product with no physical or tangible form.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 - 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 1, lines 9 - 10 recite “wherein an afferent pupillary defect (APD), particularly a relative afferent pupillary defect (RAPD) is determined from a first trial session…” However, the use of “particularly” creates a situation where there is a broad recitation of a claim detail prior to the term and a narrow recitation associated with the use of “particularly,” making the metes and bounds of the claim unclear. Specifically, it is unclear if the claim requires determining if a RAPD is present in addition to determining if an APD is present to meet the claim limitations. Examiner is interpreting the claim under BRI to encompass the broader recitation prior to the use of “particularly”.
Additionally, claim 1 is directed to “a computer program” that executes a method. However, the claim does not set forth or positively claim corresponding method steps making the metes and bounds of the program unclear. For instance, claim 1 recites, “an afferent pupillary defect… is determined,” “a visual field is determined,” and “a strabismus is determined,” which does not clear set forth the step of determining the parameters or the method of determination of the parameters. Additionally, while claim 1 further includes “a system to execute a method,” the system itself is not further limiting to the computer program method despite reciting details about the system that the program is used with. Claims 2 - 15 are rejected by virtue of dependence on claim 1.
In regard to claim 3, lines 5 - 8 recite, “determining from the recorded gaze directions of the second trial session the visual field and the one or more strabismus angles by analyzing with the computer saccadic eye movements of the test person.” However, it is unclear what parameter is being determined from which data, making the metes and bounds of the claim unclear. For instance, it is unclear if a parameter is being determined from recorded gaze direction, the visual field, and one or more strabismus angles is saccadic eye movements or if the computer is being used to analyze saccadic eye movements of the test person to determine gaze direction, visual field, and one or more strabismus angles or if the parameters of visual field and one or more strabismus angles are being determined using recorded gaze directions and saccadic eye movements analyzed by a computer.
In regard to claims 4 - 15, which are directed towards a computer program for executing a method, claims 4 - 15 do not set forth or positively claim corresponding method steps making the metes and bounds of the program unclear. Further detail is required to improve the clarity of the claim language and better describe the relationship between the computer program and method.
In regard to claim 5, lines 4 - 5 recite, “wherein the pupil size and the gaze direction are recorded for both eyes, particularly at a frame rate of at least 100 Hz.” However, the use of “particularly” creates a situation where there is a broad recitation of a claim detail prior to the term and a narrow recitation associated with the use of “particularly,” making the metes and bounds of the claim unclear. As written, it is unclear if a frame rate of at least 100 Hz is a requirement of the claim limitation or a preference for sampling rate. Further clarification is required to define the metes and bounds of the claim. Examiner is interpreting the claim to mean that pupil size and gaze direction are recorded for both eyes. Claims 6 - 8 are rejected by virtue of dependence on claim 5.
In regard to claim 6, lines 5 - 6 recite, “particularly, wherein for each gaze direction block the APD and/or RAPD is determined as well.” However, the use of “particularly” creates a situation where there is a broad recitation of a claim detail prior to the term and a narrow recitation associated with the use of “particularly,” making the metes and bounds of the claim unclear. Examiner is interpreting the claim under BRI to encompass the broader recitation prior to the use of “particularly”. Claims 7 and 8 are rejected by virtue of dependence on claim 6.
In regard to claim 7, lines 1 - 2 recite, “wherein the fixation object is displayed at the same display location for the same gaze direction block” which appears to contradict claim 6, lines 4 - 5 which recite, “wherein the fixation object is displayed at different display locations for different gaze direction blocks…”. Further clarification is required.
Additionally, the use of “particularly” in lines 5 - 8 creates a situation where there is a broad recitation of a claim detail prior to the term and a narrow recitation associated with the use of “particularly,” making the metes and bounds of the claim unclear. Examiner is interpreting the claim under BRI to encompass the broader recitation prior to the use of “particularly”.
In regard to claim 8, the use of “particularly” in lines 8 - 13 creates a situation where there is a broad recitation of a claim detail prior to the term and a narrow recitation associated with the use of “particularly,” making the metes and bounds of the claim unclear. Examiner is interpreting the claim under BRI to encompass the broader recitation prior to the use of “particularly”.
In regard to claim 9, the use of “particularly” in line 8 creates a situation where there is a broad recitation of a claim detail prior to the term and a narrow recitation associated with the use of “particularly,” making the metes and bounds of the claim unclear. Examiner is interpreting the claim under BRI to encompass the broader recitation prior to the use of “particularly”. Claims 10, 11, & 17 are rejected by virtue of dependence on claim 9.
In regard to claim 12, the use of “particularly” in lines 4 - 6 and 13 - 16 creates a situation where there is a broad recitation of a claim detail prior to the term and a narrow recitation associated with the use of “particularly,” making the metes and bounds of the claim unclear. Examiner is interpreting the claim under BRI to encompass the broader recitation prior to the use of “particularly”. Claim 13 is rejected by virtue of dependence on claim 12.
In regard to claim 16, line 9 recites, “a near-eye display, such as in VR-goggles,” but as written, it is unclear if the neuro-opthalmoscope needs to comprise VR-goggles or if this is merely an example of a form that the neuro-opthalmoscope can take, making the metes and bounds of the claim unclear.
Additionally, claim 16 is directed towards “a neuro-ophthalmoscope comprising… program code stored on the computer to execute the method according to claim 1.” However, claim 1 is directed towards a computer program, not a method. Claim 16 is indefinite as it implies a different claim scope for claim 1. Additionally, in line with the 112(b) rejection of claim 1, claim 1 fails to set forth or positively claim method steps, causing further uncertainty about the limitations of claim 16.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 3, 4, 5, 14, & 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cornsweet (US 20170007119 A1 - Cited by Applicant).
In regard to claim 1, Cornsweet discloses a computer program (paragraph [0048], see “software”) that when executed on a computer causes a system to execute a method for determining a plurality of functional ocular parameters, wherein the system comprises
an optical system with a display system that is configured to independently project a visual stimulus to a left and a right eye of a test person. Cornsweet discloses a system controlled by a computing or processing device and software that includes an optical system for displaying stimuli to the left and right eyes of a test person such that the left eye only sees the light stimuli displayed to the left eye and the right eye only sees the light stimuli displayed to the right eye (paragraph [0048]).
an eye-tracking system configured to record a gaze direction and a pupil size of the left as well as the right eye, said computer being configured to control the optical system and to receive recorded data from the eye-tracking system. Cornsweet discloses an eye-tracking system configured to monitor movements of both eyes and the size of both pupils (paragraph [0048]). Cornsweet further discloses that the eye-tracking system determines the directions of gaze of one or both eyes to determine parameters such as how well the movements of the eyes are synchronized (paragraph [0008]; paragraph [0060]).
wherein an afferent pupillary defect, particularly a relative afferent pupillary defect, is determined from a first trial session consisting of a sequence of first kind of stimuli presented to the left and the right eye of the test person eyes with the display system. Cornsweet further discloses that an operator may input patient specific information and may select one or more tests that the operator would like to perform on the patient, causing the system to generate the appropriate stimuli corresponding with the selected test or tests and monitor the movement of the eyes and/or the responses of the pupils (paragraph [0060]). The system is configured to measure a variety of metrics using these different testing protocols including RAPD (paragraphs [0047] & [0066] - [0072]).
wherein a visual field is determined from a second trial session consisting of a sequence of second kind of stimuli presented to the left and the right eye of the test person with the display system. Cornsweet additionally discloses that the testing described above can include determining visual field (paragraph [0047]).
wherein from the first and/or the second trial session a strabismus is determined as well, by determining one or more strabismus angles. Cornsweet additionally discloses that the testing described above can include determining strabismus (paragraph [0047]), where the presence of tropias and phorias, which one of ordinary skill in the art would recognize includes strabismus, is determined by changes to the gaze angle or strabismus angle of one or both eyes (paragraphs [0242] - [0245]). Examiner additionally notes that Applicant defines an angle of phoria as the strabismus angle on page 32 of the specification.
In regard to claim 2, Cornsweet discloses the invention as set forth for claim 1, wherein executing the first trial session comprises the steps of:
Recording data comprising information on the pupil size and the gaze direction during the first trial session; Cornsweet discloses that the system monitors movements of the eyes, including gaze direction, and pupil size (paragraphs [0048] & [0058]).
Determining from the recorded data of the first trial session the APD by analyzing with the computer a temporal course of the pupil sizes of the left and the right eye; Cornsweet further discloses that the first trial session includes flashing light alternately to the left and right eye where the device monitors and measures the response of the pupils such that various measurements are compared between the flashes presented to the left and right eye (paragraphs [0067] - [0069]).
Determining from the recorded gaze directions of the first trial session the one or more strabismus angles by analyzing with the computer a size and a direction of saccadic eye movements. Cornsweet further discloses that the test results from the APD test can be used to determine the presence of tropia and/or phoria (paragraph [0244]), which one of ordinary skill in the art would recognize includes strabismus. Tropia and/or phoria is detected by the system by identifying changes in the gaze angle of one or both eyes as a saccadic movement of both eyes where the magnitude and direction of the saccadic movement are the magnitude and direction of the tropia (paragraph [0245]).
In regard to claim 3, Cornsweet discloses the invention as set forth for claim 1, wherein executing the second trial session comprises the steps of:
Recording data comprising information on the gaze direction of the test person; Cornsweet discloses that the computer program is configured to cause the device to measure the angular directions of the gaze of the eyes during testing (paragraph [0060]).
Determining from the recorded gaze directions of the second trial session the visual field and the one or more strabismus angles by analyzing with the computer saccadic eye movements of the test person. In line with the 112(b) rejection of claim 3, examiner is interpreting the claim to require that visual field and strabismus angles are determined from the recorded gaze directions. Cornsweet discloses that the device measures visual field (paragraph [0047]) and one or more strabismus angles or phoria angles (paragraphs [0144] - [0145]) by tracking the eye movement of a user, including during saccadic eye movements of the test person (paragraph [0103]).
In regard to claim 4, Cornsweet discloses the invention as set forth for claim 1, wherein each visual stimulus of the first kind of visual stimuli comprises a fixation object that is displayed on the display system at a display location of the display system, wherein the fixation object is a spatially confined graphical object that allows fixation of an eye on the fixation object. Cornsweet discloses that their system includes a display for displaying visual stimulus to the left and right eye (paragraph [0048]) where a target or fixation object is presented to one or both eyes (paragraph [0102]).
In regard to claim 5, Cornsweet discloses the invention as set forth for claim 4, wherein the first kind of visual stimuli are displayed alternatingly and repeatedly to the right and the left eye, wherein the pupil size and the gaze direction are recorded for both eyes, particularly at a frame rate of at least 100 Hz. Consistent with the 112(b) rejection of claim 5, Examiner is interpreting claim 5 to only require that the first kind of visual stimuli are displayed alternatingly and repeatedly to the right and the left eye and that the pupil size and the gaze direction are recorded for both eyes. Cornsweet discloses that the light stimuli delivered with the first kind of visual stimuli includes a flash of light delivered alternatively to the left and right eyes, where each eye receives a number of flashes (paragraph [0067]). Cornsweet further discloses that pupil size (paragraph [0069]) and gaze direction (paragraph [0060]) are recorded by the device during testing. Cornsweet additionally discloses that the sampling rate for eye tracking can be up to 500 samples per second (paragraph [0059]).
In regard to claim 14, Cornsweet discloses the invention as set forth for claim 1, wherein the functional ocular parameters that are determined further comprise a fusional amplitude of the test person (paragraph [0047], see “vergence fusional amplitude”); wherein for determining the fusional amplitude, the method further comprises the steps of:
Executing a third trial session, wherein the third trial session comprises a third kind of visual stimuli that are presented with the optical system simultaneously to the left and the right eye of the test person; Cornsweet discloses a primary test for determining vergence (paragraph [0200], table 0002, see “Vergence” and “Vergence, fusional amplitude”) where an image is presented to both eyes of the test person (paragraph [0083]).
Recording data during the third trial session comprising information on the gaze direction; Cornsweet further discloses that the system records data on parameters including gaze angle or direction (paragraph [0083]).
Determining from the recorded gaze direction of the third trial session at least a fusional amplitude by analyzing with the computer a vergence eye movement of the test person in response to the presented third kind of visual stimuli of the third trial session. Cornsweet discloses a that fusional amplitude is determined from vergence testing (paragraph [0200], table 0002, see “Vergence” and “Vergence, fusional amplitude”).
In regard to claim 15, Cornsweet discloses the invention as set forth for claim 1, wherein the functional ocular parameters that are determined further comprise a visual acuity of the test person (paragraph [0149]). Cornsweet further discloses that the method further comprises the steps of:
executing a fourth trial session, wherein the fourth trial session comprises a plurality of fourth kind of visual stimuli that are presented with the optical system to the left and/or the right eye of the test person; Cornsweet discloses that a visual test where a grating consisting of vertical lines, may drift horizontally across the display, while the patient's eye movements are recorded (paragraphs [0147] - [0149]).
recording data during the fourth trial session comprising information on the gaze direction; Cornsweet specifically discloses that the patient’s eye movements are recorded (paragraph [0147]) and which includes gaze direction (paragraph [0060]).
determining from the recorded data of the fourth trial session at least the visual acuity by analyzing with the computer a movement of the left and the right eye of the test person in response to the presented fourth kind of visual stimuli of the fourth trial session. Cornsweet discloses that visual acuity is determined by measuring and analyzing a patient’s eye movements in response to varied grating visual stimuli where it is determined that a patient can see the grating when the eyes move in a characteristic way, making a series of smooth movements in the direction of motion of the grating and small saccadic movements in the opposite direction (paragraphs [0147] - [0149]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 - 7 are rejected under 35 U.S.C. 103 as being unpatentable over Cornsweet (US 20170007119 A1 - Cited by Applicant) ) as applied to claim 5 above, in view of Stewart (US 20120008091 A1).
In regard to claim 6, Cornsweet discloses the invention as set forth for claim 5. While Cornsweet discloses that their system displays light stimulus in a variety of different locations in order to map pupil perimetry or visual field (paragraph [0087]) and that light stimuli is delivered alternately to the left and right eyes to detect RAPD (paragraph [0067]), they do not specify that the first trial session comprises a plurality of gaze direction blocks, wherein in each gaze direction block the first kind of visual stimulus is repeatedly and alternatingly presented to right and the left eye, wherein the fixation object is displayed at different display locations for different gaze direction blocks, particularly, wherein for each gaze direction block the APD and/or RAPD is determined as well.
However, Stewart teaches a computer program and system (FIG. 1, component 20) that controls a pupillary imaging device (FIG. 1, component 40) that outputs a series of stimuli to the eyes of a patient and concurrently records image data corresponding to the response of the pupils to each stimuli. Stewart further teaches that RAPD can be determined from multiple light flashes (paragraph [0051]) where a series of flashes includes a plurality of flashes that different from one another based on pattern and/or location in the visual field (paragraph [0036]). One of ordinary skill in the art would recognize that different locations in the visual field would meet the limitation of displaying stimuli at different locations for different gaze direction blocks.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the computer program and system disclosed by Cornsweet with the teaching of Stewart that visual stimulus can be delivered at a variety of locations or gaze direction blocks because Cornsweet already indicates that their computer program and system can perform multiple tests where the instrument generates appropriate stimuli based on the selected tests (paragraph [0060]) and modifying the computer program and system disclosed by Cornsweet with the teachings of Stewart would be considered combining prior art elements according to known methods to yield the predictable result of assessing RAPD.
In regard to claim 7, Cornsweet as modified discloses the invention as set forth for claim 6, wherein the fixation object is displayed at the same display location for the same gaze direction block, wherein the size and the direction of the saccadic eye movement is determined from the recorded saccadic eye movement each time the first kind of stimulus switches from the left to the right eye or vice versa, particularly wherein the at least one strabismus angle is determined for each gaze direction block, such that the at least one strabismus angle is determined in relation to a gaze direction. Cornsweet discloses that a target or fixation object is presented to one or both eyes where the target is displayed for a time period in one location and then is presented at a different location in a different gaze direction block of one of eight positions (paragraph [0102]). The system tracks different parameters associated with each eye as it follows the fixation object to assess saccadic eye movement, including direction of the eye movement (paragraph [0103]) and gaze angle between the two eyes to measure phoria or strabismus (paragraph [0103]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Cornsweet (US 20170007119 A1 - Cited by Applicant) in view of Stewart (US 20120008091 A1) as applied to claim 6 above, and further in view of Griffiths ( Helen Griffiths et al., “The effect of distractors on saccades and adaption of saccades in strabismus,” VISION RESEARCH, 21 October 2011 - Cited by Applicant).
In regard to claim 8, Cornsweet as modified discloses the invention as set forth for claim 6, wherein in each gaze direction block for each eye and for each presented first kind of stimulus, the size and the direction of the saccadic eye movement is determined, particularly wherein the at least one strabismus angle is determined for each gaze direction block, such that the strabismus angle is determined in relation to a gaze direction. Cornsweet discloses that a target or fixation object is presented to one or both eyes where the target is displayed for a time period in one location and then is presented at a different location in a different gaze direction block of one of eight positions (paragraph [0102]). The system tracks different parameters associated with each eye as it follows the fixation object to assess saccadic eye movement, including direction and amplitude of the eye movement (paragraph [0103]) and gaze angle between the two eyes to measure phoria or strabismus (paragraph [0103]). While Cornsweet discloses displaying a fixation object to each eye to assess saccadic eye movement, they do not specify a subsequent presentation of the first kind of visual stimulus of the same gaze direction block, the display location of the fixation object is adjusted, such as to compensate the saccadic eye movement in size and direction as determined from a previously presented first kind of stimulus of the gaze direction block, particularly until the saccadic eye movement is minimized in the same gaze direction block, particularly wherein the at least one strabismus angle corresponds to the adjusted display location.
However, Griffiths teaches the use of a feedback system where the position of the target or fixation object projected to the eye of the user is varied or adjusted depending on the angle of strabismus (page 2415, Section “6.3. Procedure”, paragraphs 1 - 2) to minimize saccadic eye movements (Page 2405, “Abstract”).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the computer program and system of Cornsweet as modified with the teaching that a feedback system can be incorporated into optical testing procedures that include adjusting the position of a fixation object projected to the eye based on the angle of strabismus as taught by Griffiths because it would be considered combining prior art elements according to known methods to yield the predictable result of delivering stimulus to the eyes during optical testing.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cornsweet (US 20170007119 A1 - Cited by Applicant) ) as applied to claim 1 above, in view of Zur (US 6406437 B1).
In regard to claim 9, Cornsweet discloses the invention as set forth for claim 1, wherein each visual stimulus of the second kind of visual stimuli comprises a luminance object displayed on a uniform background at a relative position on the display system wherein during the second trial session the luminance object of second kind of visual stimulus is displayed sequentially at a plurality of selected relative positions wherein the second kind of visual stimuli are displayed alternatingly or sequentially to the right and the left eye, particularly wherein the respective other eye is presented with a neutral stimulus that is identical to the second kind of stimulus without the luminance object, wherein each time the luminance object is displayed at a selected relative position, it is determined, whether the test person has detected the luminance object at the selected relative position. Cornsweet discloses a pupil perimetry test for mapping visual field where a small fixation point is presented at substantially the center of the field of view to one or both eyes. A second small luminance object, at a different location and visible to one eye, is briefly illuminated against a dimly lighted background and the pupil response is recorded where the second luminance object is presented at different locations to assess the perimetry of the eyes (paragraph [0087]). Cornsweet further discloses that the neutral stimulus, in this case a small fixation point, is presented to both eyes while a second bright spot is displayed to only one eye at different locations in order to assess perimetry or visual field by detecting changes to pupil constriction when the light stimulus is detected by the eye (paragraph [0087]).
While Cornsweet discloses a test for assessing perimetry or visual field that includes the projection of a luminance object to an eye, they do not specify that if the test person has detected the luminance object, the luminance object is subsequently displayed at a different selected relative position, wherein the luminance object is displayed at the selected relative position again at a later trial with a decreased luminance or if the test person has not detected the luminance object at the selected relative position, the luminance object is displayed repeatedly at the selected relative position with increasing luminance until the test person has detected the luminance object, such that for each selected relative position a luminance detection threshold for each eye of the test person is determined, such that the visual field is determined in form of a threshold perimetric measurement.
However, Zur teaches a method and system for assessing visual field that includes threshold mapping of the visual field where light intensity or luminance is varied from a low value to a high value to discover the threshold between a user’s ability to see or not see within an intensity range. Stimuli is iteratively presented and repeated for each tested intensity (Column 3, paragraph 4).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the computer program and system disclosed by Cornsweet with the teaching of Zur that luminance can be varied at the same position to determine a threshold perimetric measurement because Cornsweet already indicates that their computer program and system can perform multiple tests where the instrument generates appropriate stimuli based on the selected tests (paragraph [0060]) and modifying the computer program and system disclosed by Cornsweet with the teachings of Zur would be considered combining prior art elements according to known methods to yield the predictable result of assessing a visual field of a user.
Claims 10 - 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cornsweet (US 20170007119 A1 - Cited by Applicant) ) in view of Zur (US 6406437 B1) as applied to claim 9 above, and further in view of Maddess (WO 2009059380 A1).
In regard to claim 10, Cornsweet as modified discloses the invention as set forth for claim 9. While Cornsweet discloses that detecting changes to pupil constriction when the light stimulus is detected by the eye is used to assess perimetry or visual field (paragraph [0087]) and additionally that their system is able to map eye movement (paragraph [0037]) and measure parameters related to saccadic eye movement including relative saccadic response differences and saccade velocity (paragraph [0039]), they do not specify that the luminance object is deemed detected by the test person, if a saccadic eye movement toward the displayed luminance object is recorded by the eye-tracking system within a first time interval during which the luminance object is displayed and wherein the luminance object stimulus is deemed not detected by the test person if no saccadic eye movement toward the luminance object is recorded by the eye- tracking system within a second time interval that is longer than the first time interval.
However, Maddess teaches that visual field of a user can be assessed by analyzing responses of the pupil or movements of the eyes (paragraph [0149] - [0150]). One of ordinary skill in the art would recognize that a saccade would be considered eye movement.
It would have been obvious to one of ordinary skill in the art to have modified the computer program and system disclosed by Cornsweet as modified with the teaching of Maddess that visual field of a user can be assessed by analyzing the movement of the eyes of the user instead of pupil response of the user because Cornsweet already discloses that their system includes an eye tracking module (paragraph [0037]) and can further assess saccadic eye movement (paragraph [0039]), modifying the method of determining a visual field by analyzing the movement of the eyes instead of pupil response would be considered the simple substitution of one known element for another to obtain the predictable result of assessing visual field of a user.
In regard to claim 11, Cornsweet as modified discloses the invention as set forth for claim 10, wherein the at least one strabismus angle is determined for the selected relative position from the saccadic eye movement and in particular from the amplitude and the direction of the saccadic eye movement, when the second kind of stimulus switches from the left to the right eye or from the right to the left eye, and if the luminance object is deemed detected by both eyes, or wherein the at least one strabismus angle is determined for the selected relative position by subtracting the gaze directions of the left and right eye from each other. Cornsweet discloses that the strabismus or phoria angle is determined by measuring the amplitude of the difference in gaze angle between the left and right eye (paragraph [0103]).
Claims 12 - 13 are rejected under 35 U.S.C. 103 as being unpatentable over Cornsweet (US 20170007119 A1 - Cited by Applicant) as applied to claim 4 above, in view of Bhandari (WO 2020240577 A1 - Cited by Applicant).
In regard to claim 12, Cornsweet discloses the invention as set forth for claim 4. Cornsweet does not disclose performing a gaze direction reset routine, wherein said routine comprises the steps of:
Particularly, determining whether the selected relative display position is located outside of a physical tracking limit of the eye tracking system or a physical display limit of the display system and if yes:
presenting a supra-threshold object, such as the fixation object or the luminance object with a supra-threshold luminance that lies above the luminance detection threshold at a current gaze direction of the eye
moving the supra-threshold object to a new display location along a trajectory with a predefined horizontal and vertical speed.
particularly, hiding the supra-threshold object;
particularly, performing the method steps of the previous embodiment at the selected relative position that was determined to lie outside of the physical display limit or the physical tracking limit of the eye tracker before the gaze reset routine has been performed.
However, Bhandari teaches a test for evaluating eye movements in response to stimuli that determines the ability of a user’s eye to follow a target across a visual field (paragraphs [0044] - [0045]) where a supra-threshold object or target (paragraph [0045]) is displayed to the user and moved along the left and right directions for the left and right eye at a predefined velocity or speed (paragraph [0045]). Examiner notes that consistent with the 112(b) rejection issued for claim 12, the claim scope of claim 12 is unclear due to the uncertainty that arises from the recitation of a broad claim detail and an additional narrow claim detail associated with the phrase “particularly”. Therefore, the examiner is interpreting the claim under BRI to require performing a gaze direction reset routine.
It would have been obvious to one of ordinary skill in the art to have modified the computer program and system disclosed by Cornsweet with the teaching of a test comprising a gaze direction reset routine as taught by Bhandari because Cornsweet already indicates that their computer program and system can perform multiple tests where the instrument generates appropriate stimuli based on the selected tests (paragraph [0060]) and modifying the computer program and system disclosed by Cornsweet with the teachings of Bhandari would be considered combining prior art elements according to known methods to yield the predictable result of assessing a visual field of a user.
In regard to claim 13, Cornsweet as modified discloses the invention as set forth for claim 12, wherein during the gaze reset routine, the supra-threshold object moves with a predefined velocity pattern along a horizontal direction and a vertically direction, wherein a deviation between a velocity of the detected eye movement following the supra-threshold object and the velocity pattern of the supra-threshold object is determined for each supra-threshold object movement direction, wherein from the deviation a gain of smooth pursuit eye movement is determined from the gaze reset routine. Bhandari teaches that a supra-threshold object or target moves with a defined velocity pattern along a horizontal direction (paragraph [0045] - [0046]; FIG. 3). In addition to a horizontal smooth pursuit eye movement test, Bhandari additional teaches that a vertical smooth pursuit test or asymmetrical smooth pursuit test can be used to assess optical parameters (paragraph [0043]). Bhandari further teaches that velocity gain or pursuit gain is measured based on the ration of eye velocity to the target velocity (paragraph [0045]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cornsweet (US 20170007119 A1 - Cited by Applicant) in view of Walsh (US 20110299034 A1 - Cited by Applicant).
In regard to claim 16, Cornsweet discloses a neuro-ophthalmoscope comprising
an optical system with a display system that is configured to independently project a visual stimulus to a left and a right eye of a test person. Cornsweet discloses a system controlled by a computing or processing device and software that includes an optical system for displaying stimuli to the left and right eyes of a test person such that the left eye only sees the light stimuli displayed to the left eye and the right eye only sees the light stimuli displayed to the right eye (paragraph [0048]).
an eye-tracking system configured to record a gaze direction and a pupil size of the left as well as the right eye. Cornsweet discloses an eye-tracking system configured to monitor movements of both eyes and the size of both pupils (paragraph [0048]). Cornsweet further discloses that the eye-tracking system determines the directions of gaze of one or both eyes to determine parameters such as how well the movements of the eyes are synchronized (paragraph [0008]; paragraph [0060]).
a computer configured to control the optical system and to receive recorded data from the eye-tracking system, as well as program code stored on the computer to execute the method according to claim 1. Cornsweet discloses that the system is controlled by a computing or processing device and software (paragraph [0048]).
particularly, wherein the optical system and the eye-tracking system is comprised in a near-eye display, such as in VR-goggles, wherein the near-eye display further comprises for each eye a lens assembly. Cornsweet discloses a near-eye display comprising individual displays for both eyes (paragraph [0051]; FIG. 1, component 104)
While Cornsweet discloses a near-eye display, they do not specify that the near-eye display further comprises for each eye a lens assembly that is adjustable such that optical aberrations of each eye of a test person may be compensated by the lens assembly.
However, Walsh teaches a near-eye display (FIG. 3A) that can be configured to be worn like VR-goggles (paragraph [0347]) that additionally comprises adjustable lens assemblies (FIG. 3A, component 210; paragraph [0167]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the neuro- ophthalmoscope disclosed by Cornsweet with the teaching of Walsh that a near-eye display can comprise with adjustable lens assemblies because having adjustable lens assemblies allows for the optical correction for users who need adjustments, such as users with glasses that are removed during testing, to provide more ideal conditions during optical testing (paragraph [0167]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cornsweet (US 20170007119 A1 - Cited by Applicant) ) in view of Zur (US 6406437 B1) as applied to claim 9 above, and further in view of Walsh (US 20110299034 A1 - Cited by Applicant)
In regard to claim 17, Cornsweet as modified discloses the invention as set forth for claim 9. Cornsweet does not specify the performance of a gaze direction reset routine, wherein said routine comprises the steps of:
determining whether the selected relative display position is located outside of a physical tracking limit of the eye tracking system or a physical display limit of the display system and if yes:
presenting a supra-threshold object, such as the fixation object or the luminance object with a supra-threshold luminance that lies above the luminance detection threshold at a current gaze direction of the eye,
moving the supra-threshold object to a new display location along a trajectory with a predefined horizontal and vertical speed.
hiding the supra-threshold object;
performing the method steps of the previous embodiment at the selected relative position that was determined to lie outside of the physical display limit or the physical tracking limit of the eye tracker before the gaze reset routine has been performed.
However, Walsh teaches that visual field testing can include blind spot or unvisualized area testing where the luminance objects or supra-threshold objects are presented in an anticipated blind spot or hiding the objects and then moving the spots until they can be seen by the user (paragraph [0562]). Eye tracking is used to monitor the user’s results and determine visual field (paragraph [0562]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the computer program and system of Cornsweet as modified with the teachings of Walsh that include a testing protocol for visual field testing where a limit of the display is identified and a luminance object is moved because Cornsweet already indicates that their computer program and system can perform multiple tests where the instrument generates appropriate stimuli based on the selected tests (paragraph [0060]) and modifying the computer program and system disclosed by Cornsweet as modified with the teachings of Walsh would be considered combining prior art elements according to known methods to yield the predictable result of assessing a visual field of a user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Blaha (US 12161410 B2) discloses a multimodal optical parameter testing method that includes assessment of visual field and strabismus using an optical display (FIG. 2A).
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./
Examiner, Art Unit 3791