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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/25/2024 and 7/26/2024 comply with the provisions of 37 CFR 1.97. Accordingly, the examiner considered the information disclosure statement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 8, 11, 14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwiegerling et al. (US20220012459).
Regarding claim 1, Schwiegerling teaches a method comprising (Schwiegerling, figs.1-29, abstract, provided are systems and methods for measuring ocular distortion):
projecting an orientation grid into an eye of a patient (figs.1-29, paragraph [0068],”imaging the proposed pattern onto the retina and post processing the detector image provides for revealing the amount and type of distortion present in the eye. FIG. 3 shows, according to an exemplary embodiment, considerable complex distortion shown after grid projection into a human eye” ---grid projection into a human eye---means projecting an orientation grid into an eye of a patient);
capturing, by a computer system (paragraph [0050], The systems comprise computer implemented software for real-time image processing of features in the retinal image), one or more images of a retina of an eye of the patient while projecting the orientation grid into the eye of the patient (paragraph [0035] FIG. 27 shows a summary of three basic functions relating to measurement of ocular distortion according to particular exemplary aspects of the present invention. First, a known target pattern is projected onto the retinal surface. Second, an image sensor captures the image of the target on the retinal surface. Third, post processing of target fiducials back out useful information related to ocular distortion.; also see paragraph [0018], FIG. 10 shows, according to particular exemplary aspects of the present invention, four retinal images with the projected grid pattern from cohort subjects);
superimposing, by the computer system (paragraph [0050], The systems comprise computer implemented software for real-time image processing of features in the retinal image), the orientation grid onto the one or more images to obtain one or more output images (paragraph [0067] the resulting raster image will appear to have the projected target superimposed on the retinal surface); and
displaying by the computer system (paragraph [0051] provided are methods for measuring retinal shape, comprising: displaying), the one or more output images (paragraph [0051], displaying, to a subject, an image of a known distorted target pattern having characteristic features and characterized in terms of size and shape) to at least one of a surgeon and the patient (paragraph [0052] patients; paragraph [0135] display devices be described as providing a user interface, the user interface be configured to display various screens and dashboards and receive input entered into any of such screens; paragraph [0051]in front of the subject's eye; paragraph[0145] The mobile communication device 300 also includes conventional components, such as a display 314, may be implemented as conventional touch screen display).
Regarding claim 4, Schwiegerling discloses the invention as described in Claim 1 and Schwiegerling further teaches wherein further comprising displaying a fixation target (paragraph [0065] fixation target that all share a common optical path) along with the orientation grid (paragraph [0015] The dot grid pattern at location 5 is picked up along the illumination path and is conjugate to the retina by the holed mirror; paragraph [0074] The method comprises displaying, to a subject, a known grid pattern in terms of size and shape relative to the distance away from a subject's eye; paragraph [0135] display devices be described as providing a user interface, the user interface be configured to display various screens and dashboards and receive input entered into any of such screens).
Regarding claim 6, Schwiegerling discloses the invention as described in Claim 4 and further teaches wherein capturing the one or more images of the retina comprises detecting infrared light reflected from the retina while the patient fixates on the fixation target (Schwiegerling, paragraph [0094] Using near infrared (NIR) radiation; Capturing the eye in the NIR provides a high contrast pupil boundary for image processing while also minimizing ambient light noise during fundus imaging. Tracking pupil gaze direction allows for some eye orientation information and consequently, retinal area information).
Regarding claim 8, Schwiegerling discloses the invention as described in Claim 1 and further teaches wherein capturing the one or more images comprises capturing video of the retina (Schwiegerling, paragraph [0145] video capture device 318; paragraph [0046]The systems and methods may comprise software configured to analyze the captured image and automatically identify features in the target pattern.;[0043] The systems and methods may comprise an image sensor in the imaging path that records images of the target projected onto the retina).
Regarding claim 11, Schwiegerling teaches a system comprising (Schwiegerling, figs.1-29, abstract, provided are systems and methods for measuring ocular distortion):
an imaging device (paragraph [0037], FIG. 29 shows an exemplary block diagram illustrating a mobile communication device 300 that may be used to implement one or more of the computing devices of the system) configured to both (a) project an orientation grid into the eye of a patient, the orientation grid having coordinate labels in two angular dimensions (paragraph [0068] in FIG. 3, a transparent plate with a rectangular grid of dots was placed at the location)
(b) capture one or more images of a retina of the eye of the patient during (a) ((paragraph [0050], The systems comprise computer implemented software for real-time image processing of features in the retinal image; paragraph [0035] an image sensor captures the image of the target on the retinal surface; also see paragraph [0018], FIG. 10 shows, according to particular exemplary aspects of the present invention, four retinal images with the projected grid pattern from cohort subjects); and
a computer system coupled to the imaging device (paragraph [0050], The systems comprise computer implemented software for real-time image processing of features in the retinal image) and configured to:
superimpose the fixation target (paragraph [0067] the resulting raster image will appear to have the projected target superimposed on the retinal surface; paragraph [0065] fixation target that all share a common optical path) and the orientation grid onto the one or more images to obtain one or more output images (paragraph [0067] the resulting raster image will appear to have the projected target superimposed on the retinal surface); and
display the one or more output images (paragraph [0051], displaying, to a subject, an image of a known distorted target pattern having characteristic features and characterized in terms of size and shape) to at least one of a surgeon and the patient ((paragraph [0052] patients).
Regarding claim 14, Schwiegerling discloses the invention as described in Claim 11 and further teaches wherein the imaging device is configured to display a fixation target along with the orientation grid at (a) (paragraph [0065] fixation target that all share a common optical path) along with the orientation grid (paragraph [0015] The dot grid pattern at location 5 is picked up along the illumination path and is conjugate to the retina by the holed mirror; paragraph [0074] The method comprises displaying, to a subject, a known grid pattern in terms of size and shape relative to the distance away from a subject's eye; paragraph [0135] display devices be described as providing a user interface, the user interface be configured to display various screens and dashboards and receive input entered into any of such screens).
Regarding claim 16, Schwiegerling discloses the invention as described in Claim 14 and further teaches wherein the imaging device is an SLO (paragraph [0067], scanning systems) configured to capture the one or more images of the retina by detecting infrared light reflected from the retina while the patient fixates on the fixation target (Schwiegerling, paragraph [0094] Using near infrared (NIR) radiation; Capturing the eye in the NIR provides a high contrast pupil boundary for image processing while also minimizing ambient light noise during fundus imaging. Tracking pupil gaze direction allows for some eye orientation information and consequently, retinal area information).
Regarding claim 17, Schwiegerling discloses the invention as described in Claim 16 and further teaches wherein the imaging device is configured to perform (a) by projecting the orientation grid as visible light (see Schwiegerling, fig.20, paragraph [0028] the user hand-clicked centers dark gray---as visible light).
Regarding claim 18, Schwiegerling discloses the invention as described in Claim 11 and further teaches wherein the imaging device is configured to capture the one or more images by capturing video of the retina (Schwiegerling, paragraph [0145] video capture device 318; paragraph [0046]The systems and methods may comprise software configured to analyze the captured image and automatically identify features in the target pattern.;[0043] The systems and methods may comprise an image sensor in the imaging path that records images of the target projected onto the retina).
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 2-3, 5, 7 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Schwiegerling et al. (US20220012459), and further in a view of Alster (US20040075814).
Regarding claim 2, Schwiegerling discloses the invention as described in Claim 1, Schwiegerling does not explicitly teach wherein the orientation grid is a polar coordinate grid.
However, Alster teaches the analogous computer system captures one or more images of a retina of an eye of the patient (Alster, paragraph [0091] the model controller may create multiple retinal maps, varying the parameters used to generate the retinal maps and/or the methods used to produce the retinal maps; a specific retinal map may work best for instantaneous conditions. Therefore, patients can choose the retina with the best available working conditions), and further teaches wherein the orientation grid is a polar coordinate grid (Alster, paragraph [0079] FIG. 4B schematically represents a mapping grid 510 which may be formed if all the linear test patterns used in the were to be simultaneously presented on the screen 112. The grid 510 thus formed may include a plurality of lines 512-517 which intersect at a point. While the lines 512-517 are illustrated as having identical lengths, their lengths may also vary. The angles .alpha.1, .alpha.2, .alpha.3, .alpha.4, .alpha.5, and .alpha.6 may be identical to each other and may be all equal to 60.degree).
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 method of Schwiegerling to have polar coordinate grid as taught by Alster for the purpose of this way all the marked points maybe related to each other for performing the computations of the diagnostic criteria. In the flash test there is no need for normalization since the fixation point does not change its position on the screen 112, and therefore the locations, coordinates, of the marked locations of the distortions or modifications may be used directly without normalization (Alster, paragraph [0146]).
Regarding claim 3, combination Schwiegerling-Alster discloses the invention as described in Claim 2 and Alster further teaches wherein azimuthal angle lines of the polar coordinate grid are annotated with hour labels 1 to 12 (see Alster, fig.4B, a plurality of lines 512-517 is capable of having azimuthal angle lines of the polar coordinate grid are annotated with hour labels 1 to 12).
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 method of Schwiegerling to have polar coordinate grid as taught by Alster for the purpose of this way all the marked points maybe related to each other for performing the computations of the diagnostic criteria. In the flash test there is no need for normalization since the fixation point does not change its position on the screen 112, and therefore the locations, coordinates, of the marked locations of the distortions or modifications may be used directly without normalization (Alster, paragraph [0146]).
Regarding claim 5, Schwiegerling discloses the invention as described in Claim 4, Schwiegerling does not explicitly teach wherein further comprising instructing the patient to fixate on the fixation target.
However, Alster teaches the analogous computer system captures one or more images of a retina of an eye of the patient (Alster, paragraph [0091] the model controller may create multiple retinal maps, varying the parameters used to generate the retinal maps and/or the methods used to produce the retinal maps; a specific retinal map may work best for instantaneous conditions. Therefore, patients can choose the retina with the best available working conditions), and further teaches wherein further comprising instructing the patient to fixate on the fixation target (Alster, paragraph [0049] be instructed to bring a cursor 225 appearing on the screen to the fixation target 228).
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 method of Schwiegerling to have polar coordinate grid as taught by Alster for the purpose of this way all the marked points maybe related to each other for performing the computations of the diagnostic criteria. In the flash test there is no need for normalization since the fixation point does not change its position on the screen 112, and therefore the locations, coordinates, of the marked locations of the distortions or modifications may be used directly without normalization (Alster, paragraph [0146]).
Regarding claim 7, Schwiegerling discloses the invention as described in Claim 6, Schwiegerling does not explicitly teach wherein capturing the one or more images comprises capturing one or more images of the retina using a scanning laser ophthalmoscope (SLO).
However, Alster teaches the analogous computer system captures one or more images of a retina of an eye of the patient (Alster, paragraph [0091] the model controller may create multiple retinal maps, varying the parameters used to generate the retinal maps and/or the methods used to produce the retinal maps; a specific retinal map may work best for instantaneous conditions. Therefore, patients can choose the retina with the best available working conditions), and further teaches wherein capturing the one or more images comprises capturing one or more images of the retina using a scanning laser ophthalmoscope (SLO) (Alster, paragraph [0181] fixation target(s) may be presented to the subject by using an optical system similar to a scanning laser ophtalmoscope, SLO).
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 method of Schwiegerling to have a scanning laser ophthalmoscope as taught by Alster for the purpose of this way all the marked points maybe related to each other for performing the computations of the diagnostic criteria. In the flash test there is no need for normalization since the fixation point does not change its position on the screen 112, and therefore the locations, coordinates, of the marked locations of the distortions or modifications may be used directly without normalization (Alster, paragraph [0146]).
Regarding claim 12, Schwiegerling discloses the invention as described in Claim 11, Schwiegerling does not explicitly teach wherein the orientation grid is a polar coordinate grid.
However, Alster teaches the analogous computer system captures one or more images of a retina of an eye of the patient (Alster, paragraph [0091] the model controller may create multiple retinal maps, varying the parameters used to generate the retinal maps and/or the methods used to produce the retinal maps; a specific retinal map may work best for instantaneous conditions. Therefore, patients can choose the retina with the best available working conditions), and further teaches wherein the orientation grid is a polar coordinate grid (Alster, paragraph [0079] FIG. 4B schematically represents a mapping grid 510 which may be formed if all the linear test patterns used in the were to be simultaneously presented on the screen 112. The grid 510 thus formed may include a plurality of lines 512-517 which intersect at a point. While the lines 512-517 are illustrated as having identical lengths, their lengths may also vary. The angles .alpha.1, .alpha.2, .alpha.3, .alpha.4, .alpha.5, and .alpha.6 may be identical to each other and may be all equal to 60. degree).
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 method of Schwiegerling to have polar coordinate grid as taught by Alster for the purpose of this way all the marked points maybe related to each other for performing the computations of the diagnostic criteria. In the flash test there is no need for normalization since the fixation point does not change its position on the screen 112, and therefore the locations, coordinates, of the marked locations of the distortions or modifications may be used directly without normalization (Alster, paragraph [0146]).
Regarding claim 13, combination Schwiegerling-Alster discloses the invention as described in Claim 12 and further teaches wherein azimuthal angle coordinates of the polar coordinate grid are annotated with hour labels 1 to 12 (see Alster, fig.4B, a plurality of lines 512-517 is capable of having azimuthal angle lines of the polar coordinate grid are annotated with hour labels 1 to 12).
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 method of Schwiegerling to have polar coordinate grid as taught by Alster for the purpose of this way all the marked points maybe related to each other for performing the computations of the diagnostic criteria. In the flash test there is no need for normalization since the fixation point does not change its position on the screen 112, and therefore the locations, coordinates, of the marked locations of the distortions or modifications may be used directly without normalization (Alster, paragraph [0146]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Schwiegerling et al. (US20220012459), and further in a view of Freeman et al. (CN110770636, English translation attached).
Regarding claim 9, Schwiegerling discloses the invention as described in Claim 1, Schwiegerling does not explicitly teach wherein further comprising, receiving, by the computer system, patient selection of coordinates in the orientation grid corresponding to one or more angular locations of one or more shadows on the retina.
However, Freeman teaches the analogous image projection system (Freeman, abstract, an image projection system, where the image projection system is capable of being worn by a user, and a processor in communication with the camera input system and the image projection system such that the processor is capable of receiving an image from the camera input system), and further teaches wherein further comprising, receiving, by the computer system (Freeman, paragraph [0079] computer program product), patient (paragraph [0083], computer program instructions stored in a medium that enhance the vision of patients with impaired or other defects) selection of coordinates in the orientation grid corresponding to one or more angular locations (paragraph [0160], the user will select the "diagnostic" setting, where an Amsler grid---note: the standard Amsler grid is designed to cover a specific angular field of vision, typically monitoring the central 10 degrees of vision in both horizontal and vertical meridians) of one or more shadows on the retina (see Freeman, fig.22B; paragraph [0094] The defect is represented by the dark shape 24 shown in the center of figure 22B; Paragraph [0113] In this case, RGB pixels can be activated to create a "shadow" effect).
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 method of Schwiegerling to have the selection of coordinates in the orientation grid corresponding to one or more angular locations as taught by Freeman for the purpose of diagnostic tests can be used frequently because users want to improve and correct the progression of a disease. (Freeman, paragraph [0160]).
Regarding claim 19, Schwiegerling discloses the invention as described in Claim 11, Schwiegerling does not explicitly teach wherein the computer system is further configured to receive patient selection of coordinates in the orientation grid corresponding to one or more angular locations of one or more shadows on the retina.
However, Freeman teaches the analogous image projection system (Freeman, abstract, an image projection system, where the image projection system is capable of being worn by a user, and a processor in communication with the camera input system and the image projection system such that the processor is capable of receiving an image from the camera input system), and further teaches wherein teach wherein the computer system (Freeman, paragraph [0079] computer program product) is further configured to receive patient (paragraph [0083], computer program instructions stored in a medium that enhance the vision of patients with impaired or other defects) selection of coordinates in the orientation grid corresponding to one or more angular locations (paragraph [0160], the user will select the "diagnostic" setting, where an Amsler grid---note: the standard Amsler grid is designed to cover a specific angular field of vision, typically monitoring the central 10 degrees of vision in both horizontal and vertical meridians) of one or more shadows on the retina (see Freeman, fig.22B; paragraph [0094] The defect is represented by the dark shape 24 shown in the center of figure 22B; Paragraph [0113] In this case, RGB pixels can be activated to create a "shadow" effect).
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 method of Schwiegerling to have the selection of coordinates in the orientation grid corresponding to one or more angular locations as taught by Freeman for the purpose of diagnostic tests can be used frequently because users want to improve and correct the progression of a disease. (Freeman, paragraph [0160]).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schwiegerling et al. (US20220012459), and further in a view of Freeman et al. Xiong et al. (CN112862782, English translation attached).
Regarding claim 10, Schwiegerling discloses the invention as described in Claim 9, Schwiegerling does not explicitly teach wherein further comprising, receiving, by the computer system, a treatment plan for one or more vitreous floaters in the eye.
However, Xiong teaches the analogous human eye vitreous image (Xiong, abstract, The method comprises the following steps: collecting a human eye vitreous image; preprocessing the human eye vitreous body image..), and further teaches wherein further comprising, receiving, by the computer system (Xiong, paragraph [0026], The present invention also provides a computer-readable storage medium, characterized in that the computer-readable storage medium stores a computer program, which, when executed by a processor), a treatment plan (paragraph [0044], assisting doctors in making treatment plans) for one or more vitreous floaters in the eye (paragraph [0008] human eye vitreous body image; paragraph [0026] The present invention also provides a computer-readable storage medium, characterized in that the computer-readable storage medium stores a computer program, which, when executed by a processor, implements the above-described method for classifying the degree of vitreous opacity in the human eye ).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the apparatus of Schwiegerling to have a treatment plan for one or more vitreous floaters in the eye as taught by Xiong for the purpose to be helped to quickly make clinical diagnosis and intervention, the doctor is assisted to make a treatment scheme, the speed of distinguishing the vitreous opacity degree is increased, and misdiagnosis caused by subjective factors of the doctor is reduced (Xiong, abstract).
Regarding claim 20, Schwiegerling discloses the invention as described in Claim 19, Schwiegerling does not explicitly teach wherein the computer system is further configured to receive a treatment plan for one or more vitreous floaters in the eye of the patient.
However, Xiong teaches the analogous human eye vitreous image (Xiong, abstract, The method comprises the following steps: collecting a human eye vitreous image; preprocessing the human eye vitreous body image..), and further teaches wherein the computer system (Xiong, paragraph [0026], The present invention also provides a computer-readable storage medium, characterized in that the computer-readable storage medium stores a computer program, which, when executed by a processor) is further configured to receive a treatment plan (paragraph [0044], assisting doctors in making treatment plans) for one or more vitreous floaters in the eye (paragraph [0008] human eye vitreous body image; paragraph [0026] The present invention also provides a computer-readable storage medium, characterized in that the computer-readable storage medium stores a computer program, which, when executed by a processor, implements the above-described method for classifying the degree of vitreous opacity in the human eye ).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the apparatus of Schwiegerling to have a treatment plan for one or more vitreous floaters in the eye as taught by Xiong for the purpose to be helped to quickly make clinical diagnosis and intervention, the doctor is assisted to make a treatment scheme, the speed of distinguishing the vitreous opacity degree is increased, and misdiagnosis caused by subjective factors of the doctor is reduced (Xiong, abstract).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schwiegerling et al. (US20220012459), and further in a view of Walsh et al. (US20210386285).
Regarding claim 15, Schwiegerling discloses the invention as described in Claim 14, Schwiegerling does not explicitly teach wherein the computer system is further configured to audibly instruct the patient to fixate on the fixation target.
However, Walsh teaches the analogous ophthalmic testing system (Walsh, abstract, ophthalmic testing center system can be configured to perform a multitude of self-administered functional and/or structural ophthalmic tests and output the test data ), and further teaches wherein the computer system is further configured to audibly instruct the patient to fixate on the fixation target (paragraph [0387] the OCT-based ophthalmic testing center system can be configured to instruct the user by audibly to look straight ahead at the fixation targets throughout the examination).
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 Schwiegerling with the specific function to instruct the user by audibly as taught by Walsh for the purpose of providing self-administered and/or administered with the assistance of a layperson (Walsh, paragraph [0004]).
Conclusion
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