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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Oath/Declaration
Oath/Declaration as filed on March 7, 2025 is noted by the Examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 8, 28, 31, 35, 62, and 70 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Iwase et al., U.S. Patent Application Publication 2022/0110521 A1 (hereinafter Iwase).
Regarding claim 1, Iwase teaches a method for performing retinal volumetric measurements based on the Early Treatment for Diabetic Retinopathy Study (ETDRS) grid , by one or more computing devices (FIGS. 1-3, and 5A-5B, paragraph[0066] of Iwase teaches in FIG. 5A, an image 510 illustrates a fundus image, and an image 511 is an enlarged image of an optic disk periphery extracted from the fundus photograph; in a case where the fundus image 510 is not captured, another image captured as a fundus front image such as an SLO image or an infrared image is displayed; a map 512 is a layer thickness map indicating the thickness of the entire retina, and is an example of a two-dimensional image of a region including an optic disk and a macular area; a grid 513 is an Early Treatment Diabetic Retinopathy Study (ETDRS) grid displayed in a superimposed manner on the layer thickness map of the entire retina; the ETDRS grid 513 displays an average value of thicknesses of the entire retina within the region in each sector; a map 514 is a layer thickness map indicating the thickness of the RNFL; in addition, information 515 indicating a range (e.g., range of 10×10 mm) of a macular area periphery is an example of information indicating a position of an analysis map for a macular area in the above-described two-dimensional image; the layer thickness map 514 is only required to be either one layer thickness map of a layer thickness map indicating the thickness of the RNFL, and a layer thickness map indicating the thickness of a composite layer of the NFL, the GCL, and the IPL (or the thickness of a composite layer of the GCL and the IPL); these layer thickness maps may be displayed to be switchable from one to another; the switching of the display may be made executable using a Split Button, for example; a button is not limited to the Split Button, and may be a Radio Button or another button that allows one of a plurality of options to be selectable; information 516 indicating a range (e.g., range of 6×6 mm) of an optic disk periphery is an example of information indicating a position of an analysis map for an optic disk in the above-described two-dimensional image; a circle 517 indicates a circle around an optic disk, and has a diameter of 3.45 mm, for example; maps 518 and 519 are a Significance map and a Deviation map each having a range of 6×6 mm indicated by the information 516, and are generated based on normative data as for the thickness of the RNFL; maps 520 and 521 are a Significance map and a Deviation map each having a range of 10×10 mm indicated by the information 515, and are generated based on normative data as for the thickness of the composite layer of the NFL, the GCL, and the IPL; and in the layer thickness maps, the Significance map, and the Deviation map, colored results are displayed in a superimposed manner on a fundus front image generated from a tomographic image in a semipermeable state (predetermined transparency) by a permeability setting, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0042]-[0065], [0067]-[0074], and [0142] of Iwase (i.e., Iwase teaches an operating process of an image processing system that displays an Early Treatment Diabetic Retinopathy Study (ETDRS) grid)): receiving an optical coherence tomography (OCT) image of a retina of a patient and ETDRS mapping information identifying one or more subfields of the ETDRS grid (S302 FIGS. 1-3, and 5A-5B, paragraph[0044] of Iwase teaches in step S302, image capturing is performed by scanning a subject's eye; a subject's eye is scanned in the following manner; if an operator selects a scan start (not illustrated), the tomographic image capturing apparatus 200 controls the drive control unit 202 to operate the galvano mirror 201, and a tomographic image target is scanned; the galvano mirror 201 includes an X scanner for a horizontal direction and the Y scanner for a vertical direction; thus, by individually changing the directions of these scanners, scanning can be performed in both directions of the horizontal direction (X) and the vertical direction (Y) in an apparatus coordinate system; then, by simultaneously changing the directions of these scanners, scanning can be performed in a combined direction of the horizontal direction and the vertical direction; and thus, scanning can be performed in an arbitrary direction on a fundus plane, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0042]-[0043], [0045]-[0074], and [0142] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of a subject’s eye, that obtains an optical coherence tomography (OCT) image called an A scan, wherein an early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in a superimposed manner on a layer thickness map of an entire retina));
segmenting the OCT image of the retina to identify one or more layer features corresponding to layers of the retina and one or more disease-associated features associated with the one or more layer features (S305 and S307 FIGS. 1-3, and 5A-5B, paragraph[0060] of Iwase teaches in the present exemplary embodiment, the description has been given of a processing flow of creating a layer thickness map in step S305, and identifying comparison ranges with, as respective centers, points corresponding to the optic disk and the macular area in step S307, but a processing flow is not limited to this; and for example, after comparison ranges with points corresponding to the optic disk and the macular area, as respective centers, are identified from a fundus front image, a layer thickness map may be created based on boundary line data included in the ranges, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0039], and [0042]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with a macular disease diagnosis, is created based on boundary line data and indicates a calculated thickness of the entire retina));
determining, based on the segmented OCT image, one or more volumetric measurements of the one or more disease-associated features, wherein the one or more volumetric measurements correspond to the ETDRS mapping information; and generating a report based on the one or more volumetric measurements (FIGS. 1-3, and 5A-5B paragraph[0065] of Iwase teaches in step S309, a captured image, a layer thickness map, and an analysis map are displayed on the display unit 600; FIGS. 5A and 5B each illustrate an example of a screen to be displayed on the display unit 600; FIGS. 5A and 5B illustrate an entire screen 505, a patient tab 501, an image capturing tab 502, a report tab 503, and a setting tab 504. Diagonal hatches of the report tab 503 indicates an active state of a report screen; in the present exemplary embodiment, the description will be given of an example in which the report screen is displayed; FIGS. 5A and 5B illustrate display examples of two types of report screens; in the present exemplary embodiment, by performing wide-area scan, an image covering an optic disk and a macular area is captured; thus, for example, FIG. 5A illustrates a report example, for example, for glaucoma diagnosis in a layout centered on an optic disk; FIG. 5B illustrates a report example for macular disease diagnosis in a layout centered on a macular area; these layouts are just examples, and the number of types is not limited to two; and a plurality of layouts suitable for intended purposes can be selected from one scan pattern, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0039], [0042]-[0064], and [0066]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with a macular disease diagnosis, is created based on boundary line data (i.e., boundary line information) and indicates a calculated thickness of the entire retina, wherein thickness of each layer is calculated based on the boundary line information and the ETDRS grid displays an average value of thickness of the entire retina, and wherein a report displays the layer thickness map and even a deviation map obtained based on the calculated thickness)).
Regarding claim 5, Iwase teaches the method of Claim 1, further comprising identifying one or more biomarkers based on the one or more volumetric measurements (FIGS. 1-3, and 5A-5B paragraph[0065] of Iwase teaches in step S309, a captured image, a layer thickness map, and an analysis map are displayed on the display unit 600; FIGS. 5A and 5B each illustrate an example of a screen to be displayed on the display unit 600; FIGS. 5A and 5B illustrate an entire screen 505, a patient tab 501, an image capturing tab 502, a report tab 503, and a setting tab 504. Diagonal hatches of the report tab 503 indicates an active state of a report screen; in the present exemplary embodiment, the description will be given of an example in which the report screen is displayed; FIGS. 5A and 5B illustrate display examples of two types of report screens; in the present exemplary embodiment, by performing wide-area scan, an image covering an optic disk and a macular area is captured; thus, for example, FIG. 5A illustrates a report example, for example, for glaucoma diagnosis in a layout centered on an optic disk; FIG. 5B illustrates a report example for macular disease diagnosis in a layout centered on a macular area; these layouts are just examples, and the number of types is not limited to two; and a plurality of layouts suitable for intended purposes can be selected from one scan pattern, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0039], [0042]-[0064], and [0066]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with a macular disease diagnosis, is created based on boundary line data (i.e., boundary line information) and indicates a calculated thickness of the entire retina, wherein thickness of each layer is calculated based on the boundary line information and the ETDRS grid displays an average value of thickness of the entire retina, and wherein a report displays the layer thickness map and even a deviation map obtained based on the calculated thickness)).
Regarding claim 8, Iwase teaches the method of Claim 1, wherein determining the one or more volumetric measurements comprises: (i) determining a total volume of the one or more disease-associated features with respect to at least one of the one or more identified subfields, (ii) determining a fluid volume of one or more fluid features with respect to at least one of the one or more identified subfields, (iii) determining a deposit volume of one or more deposit features with respect to at least one of the one or more identified subfields, (iv) determining a thickness of one or more of the layer features of the retina with respect to at least one of the one or more identified subfields, (v) determining a fluid extent of the one or more fluid features with respect to at least one of the one or more identified subfields, (vi) determining a number of one or more deposit features with respect to at least one of the one or more identified subfields, (vii) determining an area of the one or more disease-associated features with respect to at least one of the one or more identified subfields, (viii) determining a presence or an absence of the one or more disease-associated features with respect to at least one of the one or more identified subfields, or (ix) determining an area of disruption of the one or more disease-associated features with respect to at least one of the one or more identified subfields (FIGS. 1-3, and 5A-5B paragraph[0065] of Iwase teaches in step S309, a captured image, a layer thickness map, and an analysis map are displayed on the display unit 600; FIGS. 5A and 5B each illustrate an example of a screen to be displayed on the display unit 600; FIGS. 5A and 5B illustrate an entire screen 505, a patient tab 501, an image capturing tab 502, a report tab 503, and a setting tab 504. Diagonal hatches of the report tab 503 indicates an active state of a report screen; in the present exemplary embodiment, the description will be given of an example in which the report screen is displayed; FIGS. 5A and 5B illustrate display examples of two types of report screens; in the present exemplary embodiment, by performing wide-area scan, an image covering an optic disk and a macular area is captured; thus, for example, FIG. 5A illustrates a report example, for example, for glaucoma diagnosis in a layout centered on an optic disk; FIG. 5B illustrates a report example for macular disease diagnosis in a layout centered on a macular area; these layouts are just examples, and the number of types is not limited to two; and a plurality of layouts suitable for intended purposes can be selected from one scan pattern, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0039], [0042]-[0064], and [0066]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with a macular disease diagnosis, is created based on boundary line data (i.e., boundary line information) and indicates a calculated thickness of the entire retina, wherein thickness of each layer is calculated based on the boundary line information and the ETDRS grid displays an average value of thickness of the entire retina, and wherein a report displays the layer thickness map and even a deviation map obtained based on the calculated thickness)).
Regarding claim 28, Iwase teaches the method of Claim 1, wherein the OCT image comprises a time-domain optical coherence tomography (TD-OCT) image or a spectral-domain optical coherence tomography (SD- OCT) image (FIGS. 1-3, and 5A-5B, paragraph[0030] of Iwase teaches the tomographic image capturing apparatus 200 is an apparatus that captures a tomographic image of an eye portion; the tomographic image capturing apparatus 200 uses an optical coherence tomography (OCT) such as a Spectral domain OCT (SD-OCT) or a Swept Source OCT (SS-OCT), for example; the SD-OCT is an OCT that obtains an interferogram by a spectroscope using a broadband light source; in addition, the SS-OCT is an OCT that measures spectral interference by a single-channel light detector by using a high-speed wavelength sweep light source as a light source; at this time, the tomographic image capturing apparatus 200 is an example of an ophthalmologic imaging apparatus including a detection unit (not illustrated) that detects interfering light of return light from a fundus irradiated with measurement light, and reference light, and the OCT; because the tomographic image capturing apparatus 200 is a known apparatus, the detailed description will be omitted; and the description will be given of the image capturing of a tomographic image and analysis processing, which are to be performed in response to an instruction from the image processing apparatus 300, and See also at least ABSTRACT, and paragraphs[0028]-[0029], [0036], [0042]-[0044], and [0045]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus that uses spectral domain optical coherence tomography (OCT) for image capturing of a subject’s eye that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina)).
Regarding claim 31, Iwase teaches the method of Claim 1, further comprising: receiving a color fundus photography (CFP) image of the retina of the patient; and generating a composite image of the retina based on the CFP image and the one or more volumetric measurements (FIGS. 1-3, 5A-5B, 8A-8B, and 11, paragraph[0066] of Iwase teaches in FIG. 5A, an image 510 illustrates a fundus image, and an image 511 is an enlarged image of an optic disk periphery extracted from the fundus photograph; in a case where the fundus image 510 is not captured, another image captured as a fundus front image such as an SLO image or an infrared image is displayed; a map 512 is a layer thickness map indicating the thickness of the entire retina, and is an example of a two-dimensional image of a region including an optic disk and a macular area; a grid 513 is an Early Treatment Diabetic Retinopathy Study (ETDRS) grid displayed in a superimposed manner on the layer thickness map of the entire retina; the ETDRS grid 513 displays an average value of thicknesses of the entire retina within the region in each sector; a map 514 is a layer thickness map indicating the thickness of the RNFL; in addition, information 515 indicating a range (e.g., range of 10×10 mm) of a macular area periphery is an example of information indicating a position of an analysis map for a macular area in the above-described two-dimensional image; the layer thickness map 514 is only required to be either one layer thickness map of a layer thickness map indicating the thickness of the RNFL, and a layer thickness map indicating the thickness of a composite layer of the NFL, the GCL, and the IPL (or the thickness of a composite layer of the GCL and the IPL); these layer thickness maps may be displayed to be switchable from one to another; the switching of the display may be made executable using a Split Button, for example; a button is not limited to the Split Button, and may be a Radio Button or another button that allows one of a plurality of options to be selectable; information 516 indicating a range (e.g., range of 6×6 mm) of an optic disk periphery is an example of information indicating a position of an analysis map for an optic disk in the above-described two-dimensional image; a circle 517 indicates a circle around an optic disk, and has a diameter of 3.45 mm, for example; maps 518 and 519 are a Significance map and a Deviation map each having a range of 6×6 mm indicated by the information 516, and are generated based on normative data as for the thickness of the RNFL; maps 520 and 521 are a Significance map and a Deviation map each having a range of 10×10 mm indicated by the information 515, and are generated based on normative data as for the thickness of the composite layer of the NFL, the GCL, and the IPL; and in the layer thickness maps, the Significance map, and the Deviation map, colored results are displayed in a superimposed manner on a fundus front image generated from a tomographic image in a semipermeable state (predetermined transparency) by a permeability setting, and See also at least ABSTRACT, and paragraphs[0026], [0028]-[0030], [0036], [0042]-[0043], and [0045]-[0065], and [0067]-[0074] of Iwase (i.e., Iwase teaches the image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image that is a fundus image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with the macular disease diagnosis, is created based on boundary line data (i.e., boundary line information) and indicates the calculated thickness of the entire retina, wherein thickness of each layer is calculated based on the boundary line information and the ETDRS grid displays the average value of thickness of the entire retina, and wherein a report displays the layer thickness map and even a deviation map obtained based on the calculated thickness)).
Regarding claim 35, Iwase teaches a system for performing retinal volumetric measurements based on the Early Treatment for Diabetic Retinopathy Study (ETDRS) grid, the system including one or more computing devices, comprising: one or more non-transitory computer-readable storage media including instructions; and one or more processors coupled to the one or more storage media, the one or more processors configured to execute the instructions to (FIGS. 1-3, and 5A-5B, paragraph[0066] of Iwase teaches in FIG. 5A, an image 510 illustrates a fundus image, and an image 511 is an enlarged image of an optic disk periphery extracted from the fundus photograph; in a case where the fundus image 510 is not captured, another image captured as a fundus front image such as an SLO image or an infrared image is displayed; a map 512 is a layer thickness map indicating the thickness of the entire retina, and is an example of a two-dimensional image of a region including an optic disk and a macular area; a grid 513 is an Early Treatment Diabetic Retinopathy Study (ETDRS) grid displayed in a superimposed manner on the layer thickness map of the entire retina; the ETDRS grid 513 displays an average value of thicknesses of the entire retina within the region in each sector; a map 514 is a layer thickness map indicating the thickness of the RNFL; in addition, information 515 indicating a range (e.g., range of 10×10 mm) of a macular area periphery is an example of information indicating a position of an analysis map for a macular area in the above-described two-dimensional image; the layer thickness map 514 is only required to be either one layer thickness map of a layer thickness map indicating the thickness of the RNFL, and a layer thickness map indicating the thickness of a composite layer of the NFL, the GCL, and the IPL (or the thickness of a composite layer of the GCL and the IPL); these layer thickness maps may be displayed to be switchable from one to another; the switching of the display may be made executable using a Split Button, for example; a button is not limited to the Split Button, and may be a Radio Button or another button that allows one of a plurality of options to be selectable; information 516 indicating a range (e.g., range of 6×6 mm) of an optic disk periphery is an example of information indicating a position of an analysis map for an optic disk in the above-described two-dimensional image; a circle 517 indicates a circle around an optic disk, and has a diameter of 3.45 mm, for example; maps 518 and 519 are a Significance map and a Deviation map each having a range of 6×6 mm indicated by the information 516, and are generated based on normative data as for the thickness of the RNFL; maps 520 and 521 are a Significance map and a Deviation map each having a range of 10×10 mm indicated by the information 515, and are generated based on normative data as for the thickness of the composite layer of the NFL, the GCL, and the IPL; and in the layer thickness maps, the Significance map, and the Deviation map, colored results are displayed in a superimposed manner on a fundus front image generated from a tomographic image in a semipermeable state (predetermined transparency) by a permeability setting, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0042]-[0065], [0067]-[0074], and [0142] of Iwase (i.e., Iwase teaches a computer including one or more processers to execute instructions from a storage medium to perform an operating process of an image processing system that displays an Early Treatment Diabetic Retinopathy Study (ETDRS) grid)):
receive an optical coherence tomography (OCT) image of a retina of a patient and ETDRS mapping information identifying one or more subfields of the ETDRS grid (S302 FIGS. 1-3, and 5A-5B, paragraph[0044] of Iwase teaches in step S302, image capturing is performed by scanning a subject's eye; a subject's eye is scanned in the following manner; if an operator selects a scan start (not illustrated), the tomographic image capturing apparatus 200 controls the drive control unit 202 to operate the galvano mirror 201, and a tomographic image target is scanned; the galvano mirror 201 includes an X scanner for a horizontal direction and the Y scanner for a vertical direction; thus, by individually changing the directions of these scanners, scanning can be performed in both directions of the horizontal direction (X) and the vertical direction (Y) in an apparatus coordinate system; then, by simultaneously changing the directions of these scanners, scanning can be performed in a combined direction of the horizontal direction and the vertical direction; and thus, scanning can be performed in an arbitrary direction on a fundus plane, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0042]-[0043], [0045]-[0074], and [0142] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of a subject’s eye, that obtains an optical coherence tomography (OCT) image called an A scan, wherein an early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in a superimposed manner on a layer thickness map of an entire retina));
segment the OCT image of the retina to identify one or more layer features corresponding to layers of the retina and one or more disease-associated features detectable from the OCT image (S305 and S307 FIGS. 1-3, and 5A-5B, paragraph[0060] of Iwase teaches in the present exemplary embodiment, the description has been given of a processing flow of creating a layer thickness map in step S305, and identifying comparison ranges with, as respective centers, points corresponding to the optic disk and the macular area in step S307, but a processing flow is not limited to this; and for example, after comparison ranges with points corresponding to the optic disk and the macular area, as respective centers, are identified from a fundus front image, a layer thickness map may be created based on boundary line data included in the ranges, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0039], and [0042]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with a macular disease diagnosis, is created based on boundary line data and indicates a calculated thickness of the entire retina));
determine, based on the segmented OCT image, one or more volumetric measurements of the one or more disease-associated features associated with at least one of the layer features and corresponding to the ETDRS mapping information; and generate a report based on the one or more volumetric measurements (FIGS. 1-3, and 5A-5B paragraph[0065] of Iwase teaches in step S309, a captured image, a layer thickness map, and an analysis map are displayed on the display unit 600; FIGS. 5A and 5B each illustrate an example of a screen to be displayed on the display unit 600; FIGS. 5A and 5B illustrate an entire screen 505, a patient tab 501, an image capturing tab 502, a report tab 503, and a setting tab 504. Diagonal hatches of the report tab 503 indicates an active state of a report screen; in the present exemplary embodiment, the description will be given of an example in which the report screen is displayed; FIGS. 5A and 5B illustrate display examples of two types of report screens; in the present exemplary embodiment, by performing wide-area scan, an image covering an optic disk and a macular area is captured; thus, for example, FIG. 5A illustrates a report example, for example, for glaucoma diagnosis in a layout centered on an optic disk; FIG. 5B illustrates a report example for macular disease diagnosis in a layout centered on a macular area; these layouts are just examples, and the number of types is not limited to two; and a plurality of layouts suitable for intended purposes can be selected from one scan pattern, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0039], [0042]-[0064], and [0066]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with a macular disease diagnosis, is created based on boundary line data (i.e., boundary line information) and indicates a calculated thickness of the entire retina, wherein thickness of each layer is calculated based on the boundary line information and the ETDRS grid displays an average value of thickness of the entire retina, and wherein a report displays the layer thickness map and even a deviation map obtained based on the calculated thickness)).
Regarding claim 62, Iwase teaches the system of Claim 35, wherein the OCT image comprises a time-domain optical coherence tomography (TD-OCT) image or a spectral-domain optical coherence tomography (SD- OCT) image(FIGS. 1-3, and 5A-5B, paragraph[0030] of Iwase teaches the tomographic image capturing apparatus 200 is an apparatus that captures a tomographic image of an eye portion; the tomographic image capturing apparatus 200 uses an optical coherence tomography (OCT) such as a Spectral domain OCT (SD-OCT) or a Swept Source OCT (SS-OCT), for example; the SD-OCT is an OCT that obtains an interferogram by a spectroscope using a broadband light source; in addition, the SS-OCT is an OCT that measures spectral interference by a single-channel light detector by using a high-speed wavelength sweep light source as a light source; at this time, the tomographic image capturing apparatus 200 is an example of an ophthalmologic imaging apparatus including a detection unit (not illustrated) that detects interfering light of return light from a fundus irradiated with measurement light, and reference light, and the OCT; because the tomographic image capturing apparatus 200 is a known apparatus, the detailed description will be omitted; and the description will be given of the image capturing of a tomographic image and analysis processing, which are to be performed in response to an instruction from the image processing apparatus 300, and See also at least ABSTRACT, and paragraphs[0028]-[0029], [0036], [0042]-[0044], and [0045]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus that uses spectral domain optical coherence tomography (OCT) for image capturing of a subject’s eye that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina)).
Regarding claim 70, Iwase teaches a non-transitory computer-readable medium comprising instructions for performing retinal volumetric measurements based on the Early Treatment for Diabetic Retinopathy Study (ETDRS) grid, the instructions, when executed by one or more processors of one or more computing devices, cause the one or more processors to (FIGS. 1-3, and 5A-5B, paragraph[0066] of Iwase teaches in FIG. 5A, an image 510 illustrates a fundus image, and an image 511 is an enlarged image of an optic disk periphery extracted from the fundus photograph; in a case where the fundus image 510 is not captured, another image captured as a fundus front image such as an SLO image or an infrared image is displayed; a map 512 is a layer thickness map indicating the thickness of the entire retina, and is an example of a two-dimensional image of a region including an optic disk and a macular area; a grid 513 is an Early Treatment Diabetic Retinopathy Study (ETDRS) grid displayed in a superimposed manner on the layer thickness map of the entire retina; the ETDRS grid 513 displays an average value of thicknesses of the entire retina within the region in each sector; a map 514 is a layer thickness map indicating the thickness of the RNFL; in addition, information 515 indicating a range (e.g., range of 10×10 mm) of a macular area periphery is an example of information indicating a position of an analysis map for a macular area in the above-described two-dimensional image; the layer thickness map 514 is only required to be either one layer thickness map of a layer thickness map indicating the thickness of the RNFL, and a layer thickness map indicating the thickness of a composite layer of the NFL, the GCL, and the IPL (or the thickness of a composite layer of the GCL and the IPL); these layer thickness maps may be displayed to be switchable from one to another; the switching of the display may be made executable using a Split Button, for example; a button is not limited to the Split Button, and may be a Radio Button or another button that allows one of a plurality of options to be selectable; information 516 indicating a range (e.g., range of 6×6 mm) of an optic disk periphery is an example of information indicating a position of an analysis map for an optic disk in the above-described two-dimensional image; a circle 517 indicates a circle around an optic disk, and has a diameter of 3.45 mm, for example; maps 518 and 519 are a Significance map and a Deviation map each having a range of 6×6 mm indicated by the information 516, and are generated based on normative data as for the thickness of the RNFL; maps 520 and 521 are a Significance map and a Deviation map each having a range of 10×10 mm indicated by the information 515, and are generated based on normative data as for the thickness of the composite layer of the NFL, the GCL, and the IPL; and in the layer thickness maps, the Significance map, and the Deviation map, colored results are displayed in a superimposed manner on a fundus front image generated from a tomographic image in a semipermeable state (predetermined transparency) by a permeability setting, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0042]-[0065], [0067]-[0074], and [0142] of Iwase (i.e., Iwase teaches a computer including one or more processers to execute instructions from a storage medium to perform an operating process of an image processing system that displays an Early Treatment Diabetic Retinopathy Study (ETDRS) grid)):
receive an optical coherence tomography (OCT) image of a retina of a patient and ETDRS mapping information identifying one or more subfields of the ETDRS grid (S302 FIGS. 1-3, and 5A-5B, paragraph[0044] of Iwase teaches in step S302, image capturing is performed by scanning a subject's eye; a subject's eye is scanned in the following manner; if an operator selects a scan start (not illustrated), the tomographic image capturing apparatus 200 controls the drive control unit 202 to operate the galvano mirror 201, and a tomographic image target is scanned; the galvano mirror 201 includes an X scanner for a horizontal direction and the Y scanner for a vertical direction; thus, by individually changing the directions of these scanners, scanning can be performed in both directions of the horizontal direction (X) and the vertical direction (Y) in an apparatus coordinate system; then, by simultaneously changing the directions of these scanners, scanning can be performed in a combined direction of the horizontal direction and the vertical direction; and thus, scanning can be performed in an arbitrary direction on a fundus plane, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0042]-[0043], [0045]-[0074], and [0142] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of a subject’s eye, that obtains an optical coherence tomography (OCT) image called an A scan, wherein an early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in a superimposed manner on a layer thickness map of an entire retina));
segment the OCT image of the retina to identify one or more layer features corresponding to layers of the retina and one or more disease-associated features detectable from the OCT image (S305 and S307 FIGS. 1-3, and 5A-5B, paragraph[0060] of Iwase teaches in the present exemplary embodiment, the description has been given of a processing flow of creating a layer thickness map in step S305, and identifying comparison ranges with, as respective centers, points corresponding to the optic disk and the macular area in step S307, but a processing flow is not limited to this; and for example, after comparison ranges with points corresponding to the optic disk and the macular area, as respective centers, are identified from a fundus front image, a layer thickness map may be created based on boundary line data included in the ranges, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0039], and [0042]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with a macular disease diagnosis, is created based on boundary line data and indicates a calculated thickness of the entire retina));
determine, based on the segmented OCT image, one or more volumetric measurements of the one or more disease-associated features associated with at least one of the layer features and corresponding to the ETDRS mapping information; and generate a report based on the one or more volumetric measurements (FIGS. 1-3, and 5A-5B paragraph[0065] of Iwase teaches in step S309, a captured image, a layer thickness map, and an analysis map are displayed on the display unit 600; FIGS. 5A and 5B each illustrate an example of a screen to be displayed on the display unit 600; FIGS. 5A and 5B illustrate an entire screen 505, a patient tab 501, an image capturing tab 502, a report tab 503, and a setting tab 504. Diagonal hatches of the report tab 503 indicates an active state of a report screen; in the present exemplary embodiment, the description will be given of an example in which the report screen is displayed; FIGS. 5A and 5B illustrate display examples of two types of report screens; in the present exemplary embodiment, by performing wide-area scan, an image covering an optic disk and a macular area is captured; thus, for example, FIG. 5A illustrates a report example, for example, for glaucoma diagnosis in a layout centered on an optic disk; FIG. 5B illustrates a report example for macular disease diagnosis in a layout centered on a macular area; these layouts are just examples, and the number of types is not limited to two; and a plurality of layouts suitable for intended purposes can be selected from one scan pattern, and See also at least ABSTRACT, and paragraphs[0028]-[0030], [0036], [0039], [0042]-[0064], and [0066]-[0074] of Iwase (i.e., Iwase teaches an image capturing apparatus, which is for image capturing of the subject’s eye, that obtains the optical coherence tomography (OCT) image called the A scan, wherein the early treatment diabetic retinopathy study (ETDRS) grid, which define sectors of the grid, is displayed in the superimposed manner on the layer thickness map of the entire retina, wherein the layer thickness map, which is based on identifying comparison ranges with points corresponding to an optic disk and macular area that is associated with a macular disease diagnosis, is created based on boundary line data (i.e., boundary line information) and indicates a calculated thickness of the entire retina, wherein thickness of each layer is calculated based on the boundary line information and the ETDRS grid displays an average value of thickness of the entire retina, and wherein a report displays the layer thickness map and even a deviation map obtained based on the calculated thickness)).
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 29, 36, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Iwase, in view of Debuc, U.S. Patent Application Publication 2011/0275931 A1 (hereinafter Debuc).
Regarding claim 2, Iwase teaches the method of Claim 1, but does not expressly teach wherein the one or more layer features comprise a Bruch's membrane (BM), a boundary of myoid and ellipsoid inner segments (BMEIS), a ganglion cell layer-inner plexiform layer (GCL-IPL), an inner boundary outer photoreceptor (IB-OPR) layer, an outer boundary outer photoreceptor (OB-OPR) layer, an inner boundary retinal pigment epithelium (IB-RPE) layer, an outer boundary retinal pigment epithelium (OB-RPE) layer, an internal limiting membrane (ILM), an inner plexiform layer-inner nuclear layer (IPL-INL), an inner plexiform layer-outer nuclear layer (IPL-ONL), an inner segment/outer segment junction (ISJ-OSJ) layer, outer plexiform layer-Henle's fiber layer (OPL-HFL), or an retinal nerve fiber layer-ganglion cell layer (RNFL-GCL).
However, Debuc teaches wherein the one or more layer features comprise a Bruch's membrane (BM), a boundary of myoid and ellipsoid inner segments (BMEIS), a ganglion cell layer-inner plexiform layer (GCL-IPL), an inner boundary outer photoreceptor (IB-OPR) layer, an outer boundary outer photoreceptor (OB-OPR) layer, an inner boundary retinal pigment epithelium (IB-RPE) layer, an outer boundary retinal pigment epithelium (OB-RPE) layer, an internal limiting membrane (ILM), an inner plexiform layer-inner nuclear layer (IPL-INL), an inner plexiform layer-outer nuclear layer (IPL-ONL), an inner segment/outer segment junction (ISJ-OSJ) layer, outer plexiform layer-Henle's fiber layer (OPL-HFL), or an retinal nerve fiber layer-ganglion cell layer (RNFL-GCL) (paragraph[0272] of Debuc teaches in an effort to obtain quantitative data of intraretinal structures a software tool was developed for Stratus OCT retinal image analysis (OCTRIMA); OCTRIMA is able to minimize segmentation errors and give quantitative information of intraretinal structures; and the software can distinguish 7 layers of the retina on OCT images based on their optical densities: the retinal nerve fiber layer (RNFL), the ganglion cell+inner plexiform layer complex (GCL+IPL), the inner nuclear layer (INL), the outer plexiform layer (OPL), the outer nuclear layer (ONL), the inner-outer segment border (IS/OS) and the retinal pigment epithelial layer (RPE), and See also at least ABSTRACT (i.e., Debuc teaches a software tool that can distinguish layers of a retina on OCT images such as a ganglion cell+inner cell plexiform layer complex)).
Furthermore, Iwase and Debuc are considered to be analogous art because they are from the same field of endeavor with respect to a system for capturing an image, and involve the same problem of capturing the image for suitable diagnosis. Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the system and method of Iwase based on Debuc wherein the one or more layer features comprise a Bruch's membrane (BM), a boundary of myoid and ellipsoid inner segments (BMEIS), a ganglion cell layer-inner plexiform layer (GCL-IPL), an inner boundary outer photoreceptor (IB-OPR) layer, an outer boundary outer photoreceptor (OB-OPR) layer, an inner boundary retinal pigment epithelium (IB-RPE) layer, an outer boundary retinal pigment epithelium (OB-RPE) layer, an internal limiting membrane (ILM), an inner plexiform layer-inner nuclear layer (IPL-INL), an inner plexiform layer-outer nuclear layer (IPL-ONL), an inner segment/outer segment junction (ISJ-OSJ) layer, outer plexiform layer-Henle's fiber layer (OPL-HFL), or an retinal nerve fiber layer-ganglion cell layer (RNFL-GCL). One reason for the modification as taught by Debuc is for assessing early signs of diabetic retinopathy in an image (paragraph[0002] of Debuc). The same motivation and rationale to combine for claim 2 mentioned above, in light of corresponding statement of grounds of rejection, applies to each dependent claim mentioned in the corresponding statement of grounds of rejection.
Regarding claim 29, Iwase teaches the method of Claim 1,; but does not expressly teach wherein the OCT image comprises an image of a fovea of the patient captured by an OCT ophthalmoscope, and wherein the image of the fovea was further divided into three concentric circles with diameters of approximately 1 millimeter (mm), approximately 3mm, and approximately 6mm, respectively, in accordance with the ETDRS grid.
However, Debuc teaches wherein the OCT image comprises an image of a fovea of the patient captured by an OCT ophthalmoscope, and wherein the image of the fovea was further divided into three concentric circles with diameters of approximately 1 millimeter (mm), approximately 3mm, and approximately 6mm, respectively, in accordance with the ETDRS grid (FIG. 5A, paragraph[0015] of Debuc teaches FIG. 5A shows the automatic segmentation results obtained for a 6 mm diameter retinal scan at 90 degrees (radial lines protocol) through the fovea for a diabetic patient (51 years old, OD) with mild retinopathy. The boundaries detected are superimposed on the original OCT image, for the abbreviations see the text. Segmentation results were performed using OCTRIMA software. FIG. 5B shows the OCTRIMA thickness maps for the patient data shown in FIG. 5A. The middle panel shows the total retinal thickness map. The lower panel shows the thickness map for the intraretinal layers. An OCTRIMA macular map is divided into nine zones that correspond to the ETDRS regions: fovea within a diameter of 1 mm centered on the foveola; pericentral ring, the circular band from the central 1 mm to 3 mm, divided into four quadrants i.e. superior, inferior, temporal, and nasal; and peripheral ring from 3 mm up to 6 mm, divided into the same quadrants (i.e., Debuc teaches a retinal scan through a fovea for a diabetic patient, and thickness maps the patient data wherein the thickness maps are divided into zones that correspond to ETDRS regions having circular bands from 1mm to 3mm and from 3mm to 6mm)).
Regarding claim 36, Iwase teaches the system of Claim 35, but does not expressly teach wherein the one or more layer features comprise a Bruch's membrane (BM), a boundary of myoid and ellipsoid inner segments (BMEIS), a ganglion cell layer-inner plexiform layer (GCL-IPL), an inner boundary outer photoreceptor (IB-OPR) layer, an outer boundary outer photoreceptor (OB-OPR) layer, an inner boundary retinal pigment epithelium (IB-RPE) layer, an outer boundary retinal pigment epithelium (OB-RPE) layer, an internal limiting membrane (ILM), an inner plexiform layer-inner nuclear layer (IPL-INL), an inner plexiform layer-outer nuclear layer (IPL-ONL), an inner segment/outer segment junction (ISJ-OSJ) layer, outer plexiform layer-Henle's fiber layer (OPL-HFL), or an retinal nerve fiber layer-ganglion cell layer (RNFL-GCL).
However, Debuc teaches wherein the one or more layer features comprise a Bruch's membrane (BM), a boundary of myoid and ellipsoid inner segments (BMEIS), a ganglion cell layer-inner plexiform layer (GCL-IPL), an inner boundary outer photoreceptor (IB-OPR) layer, an outer boundary outer photoreceptor (OB-OPR) layer, an inner boundary retinal pigment epithelium (IB-RPE) layer, an outer boundary retinal pigment epithelium (OB-RPE) layer, an internal limiting membrane (ILM), an inner plexiform layer-inner nuclear layer (IPL-INL), an inner plexiform layer-outer nuclear layer (IPL-ONL), an inner segment/outer segment junction (ISJ-OSJ) layer, outer plexiform layer-Henle's fiber layer (OPL-HFL), or an retinal nerve fiber layer-ganglion cell layer (RNFL-GCL) (paragraph[0272] of Debuc teaches in an effort to obtain quantitative data of intraretinal structures a software tool was developed for Stratus OCT retinal image analysis (OCTRIMA); OCTRIMA is able to minimize segmentation errors and give quantitative information of intraretinal structures; and the software can distinguish 7 layers of the retina on OCT images based on their optical densities: the retinal nerve fiber layer (RNFL), the ganglion cell+inner plexiform layer complex (GCL+IPL), the inner nuclear layer (INL), the outer plexiform layer (OPL), the outer nuclear layer (ONL), the inner-outer segment border (IS/OS) and the retinal pigment epithelial layer (RPE), and See also at least ABSTRACT (i.e., Debuc teaches a software tool that can distinguish layers of a retina on OCT images such as a ganglion cell+inner cell plexiform layer complex)).
Regarding claim 63, Iwase teaches the system of Claim 35,; but does not expressly teach wherein the OCT image comprises an image of a fovea of the patient captured by an OCT ophthalmoscope, and wherein the image of the fovea was further divided into three concentric circles with diameters of approximately 1 millimeter (mm), approximately 3mm, and approximately 6mm, respectively, in accordance with the ETDRS grid.
However, Debuc teaches wherein the OCT image comprises an image of a fovea of the patient captured by an OCT ophthalmoscope, and wherein the image of the fovea was further divided into three concentric circles with diameters of approximately 1 millimeter (mm), approximately 3mm, and approximately 6mm, respectively, in accordance with the ETDRS grid (FIG. 5A, paragraph[0015] of Debuc teaches FIG. 5A shows the automatic segmentation results obtained for a 6 mm diameter retinal scan at 90 degrees (radial lines protocol) through the fovea for a diabetic patient (51 years old, OD) with mild retinopathy. The boundaries detected are superimposed on the original OCT image, for the abbreviations see the text. Segmentation results were performed using OCTRIMA software. FIG. 5B shows the OCTRIMA thickness maps for the patient data shown in FIG. 5A. The middle panel shows the total retinal thickness map. The lower panel shows the thickness map for the intraretinal layers. An OCTRIMA macular map is divided into nine zones that correspond to the ETDRS regions: fovea within a diameter of 1 mm centered on the foveola; pericentral ring, the circular band from the central 1 mm to 3 mm, divided into four quadrants i.e. superior, inferior, temporal, and nasal; and peripheral ring from 3 mm up to 6 mm, divided into the same quadrants (i.e., Debuc teaches a retinal scan through a fovea for a diabetic patient, and thickness maps the patient data wherein the thickness maps are divided into zones that correspond to ETDRS regions having circular bands from 1mm to 3mm and from 3mm to 6mm)).
Claims 17 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Iwase, in view of Peyman, U.S. Patent Application Publication 2022/0240779 A1 (hereinafter Peyman).
Regarding claim 17, Iwase teaches the method of Claim 1, further comprising; but does not expressly teach classifying the patient, based on the one or more volumetric measurements, as having diabetic retinopathy (DR) or as having diabetic macula edema (DME).
However, Peyman teaches classifying the patient, based on the one or more volumetric measurements, as having diabetic retinopathy (DR) or as having diabetic macula edema (DME) (paragraph[0445] of Peyman teaches in one embodiment, DFR, AI and Metaverse used with a fluidic lens camera (U.S. Pat. No. 9,016,860, which is incorporated by reference herein in its entirety) or any other camera can be provided with or without a bot, to obtain within a few second multiple information, such as the name, patient's disease, medications, or family history almost simultaneously, such as patient's recognition, the visual aberration of the eye, correct the aberration, provide a prescription, while the OCT system attached to the camera can diagnose a normal cornea versus a keratoconus by its steep image, evaluate the status of a cataract measuring the density of the lens substance and grade it, presence or absence of diabetic retinopathy by abnormal microaneurysms of the retinal vessels, bleeding, or changes in the thickness of the retinal layers or presence or absence of the sub-retinal fluid, or presence or absence of the age related macular degeneration by loss of retinal pigment epithelium or reflecting drusen under the RPE, or presence or absence of abnormal or leaky capillaries or the density of the retinal capillaries, or loss of retinal capillaries or to run a pressure test (U.S. Pat. Nos. 10,736,571 and 7,828,440, which are incorporated by reference herein in their entireties) to evaluate retinal oxygenation and recovery of the circulation or loss of the retinal ganglion cells around the optic nerve head or loss of peripapillary capillaries, or central retina or peripheral retina in glaucoma, diabetic, presence or absence of a tumor, presence or absence of a retinal detachment, status of the retinal ganglion cells, inner and outer retinal nuclear layer, status of the photoreceptors of the retina, sub-retina fluid, intra-retinal fluid and differentiate it from a retinal or sub-retinal hemorrhage, status of the age related macular degeneration etc., all done in less than one ten seconds, saving patients and doctors time and even providing suggestions for the follow up and treatment to a doctor to decide and confirm or provide new medication(s) while maintaining the patient security (i.e., Peyman teaches an OCT system attached to a camera that can evaluate presence or absence of diabetic retinopathy at least based on changes in thickness of retinal layers)).
Furthermore, Iwase and Peyman are considered to be analogous art because they are from the same field of endeavor with respect to a system for capturing an image, and involve the same problem of capturing the image for suitable diagnosis. Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the method of Iwase based on Peyman for classifying the patient, based on the one or more volumetric measurements, as having diabetic retinopathy (DR) or as having diabetic macula edema (DME). One reason for the modification as taught by Peyman is to have a telemedicine system with dynamic imaging and/or facial recognition capabilities (paragraph[0003] of Peyman).
Regarding claim 51, Iwase teaches the system of Claim 35, wherein the instructions further comprise instructions to; but does not expressly teach classify the patient, based on the one or more volumetric measurements, as having diabetic retinopathy (DR) or as having diabetic macula edema (DME).
However, Peyman teaches classify the patient, based on the one or more volumetric measurements, as having diabetic retinopathy (DR) or as having diabetic macula edema (DME) (FIG. 15, paragraph[0445] of Peyman teaches in one embodiment, DFR, AI and Metaverse used with a fluidic lens camera (U.S. Pat. No. 9,016,860, which is incorporated by reference herein in its entirety) or any other camera can be provided with or without a bot, to obtain within a few second multiple information, such as the name, patient's disease, medications, or family history almost simultaneously, such as patient's recognition, the visual aberration of the eye, correct the aberration, provide a prescription, while the OCT system attached to the camera can diagnose a normal cornea versus a keratoconus by its steep image, evaluate the status of a cataract measuring the density of the lens substance and grade it, presence or absence of diabetic retinopathy by abnormal microaneurysms of the retinal vessels, bleeding, or changes in the thickness of the retinal layers or presence or absence of the sub-retinal fluid, or presence or absence of the age related macular degeneration by loss of retinal pigment epithelium or reflecting drusen under the RPE, or presence or absence of abnormal or leaky capillaries or the density of the retinal capillaries, or loss of retinal capillaries or to run a pressure test (U.S. Pat. Nos. 10,736,571 and 7,828,440, which are incorporated by reference herein in their entireties) to evaluate retinal oxygenation and recovery of the circulation or loss of the retinal ganglion cells around the optic nerve head or loss of peripapillary capillaries, or central retina or peripheral retina in glaucoma, diabetic, presence or absence of a tumor, presence or absence of a retinal detachment, status of the retinal ganglion cells, inner and outer retinal nuclear layer, status of the photoreceptors of the retina, sub-retina fluid, intra-retinal fluid and differentiate it from a retinal or sub-retinal hemorrhage, status of the age related macular degeneration etc., all done in less than one ten seconds, saving patients and doctors time and even providing suggestions for the follow up and treatment to a doctor to decide and confirm or provide new medication(s) while maintaining the patient security, and See also at least ABSTRACT, and paragraph[0103] of Peyman (i.e., Peyman teaches an OCT system that is attached to a camera and includes computer-readable storage media that stores instructions executable to evaluate presence or absence of diabetic retinopathy at least based on changes in thickness of retinal layers)).
Furthermore, Iwase and Peyman are considered to be analogous art because they are from the same field of endeavor with respect to a system for capturing an image, and involve the same problem of capturing the image for suitable diagnosis. Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the system of Iwase based on Peyman to classify the patient, based on the one or more volumetric measurements, as having diabetic retinopathy (DR) or as having diabetic macula edema (DME). One reason for the modification as taught by Peyman is to have a telemedicine system with dynamic imaging and/or facial recognition capabilities (paragraph[0003] of Peyman).
Potentially Allowable Subject Matter
Claims 3-4, 6, 30, and 37-38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, because for each of claims 3-4, 6, 30, and 37-38 the prior art references of record do not teach the combination of all element limitations as presently claimed.
Conclusion
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/ABDUL-SAMAD A ADEDIRAN/Primary Examiner, Art Unit 2621
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