DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response to the Non-final Office Action dated 04/08/2026, filed with the office on 07/01/2026, has been entered and made of record.
Response to Amendment
In light of Applicant’s amendment of the independent claim 1, the claim objection with respect to the claim is withdrawn.
Status of Claims
Claims 1-10 are pending. Claims 1-10 are amended.
Claim Objections
Claim 4 is objected to for minor formatting error. The claim amendments removed step (c1) label but the labels (c2) and (c3) are not removed. Please amend the claim to keep the claim language consistent.
Response to Arguments
Applicant's arguments filed on July 1, 2026, with respect to rejection of claims under 35 U.S.C. 103 has been fully considered; but they are not found persuasive. Specifically, on page 9 of its reply, Applicant argues in third paragraph that Vaghefi does not teach or suggest 3D convergence of XY and XZ planes through a connection line. Examiner respectfully disagrees. Vaghefi teaches in ¶0212: “three lines between the most (1) anterior and posterior point, (2) inferior and superior point, and (3) nasal and temporal point of the lens are drawn. The intersection between all three lines provides the mid-point of the lens”. Therefore, Vaghefi discloses converged planes XY (anterior-posterior) and XZ (superior-inferior) wherein three lines meet at the midpoint of the lens, which is the origin of the coordinate system— Vaghefi, ¶0214: “The midpoint of the lens is set as the origin in the cylindrical coordinate system”. After the planes XY and XZ are aligned, the MRI and OCT are combined to generate the model of the eye— Vaghefi, ¶0013: “common landmarks of the 3D and 2D images are identified, one of the 3D and 2D images aligned and scaled to match the other, and the 2D image warped onto the 3D image to generate the ocular mode”.
Applicant further argues in page 9, fourth paragraph that Vaghefi does not teach determining precise matching coordinates by integrating information from orthogonal planes. Since the claim language does not explicitly recite the argued precise matching coordinates and the broadest reasonable interpretation of the claim does not limit the claim language to perform precise coordinate matching, the argument is not found persuasive.
Applicant continues to argue in page 10, third paragraph that Vaghefi does not teach the claimed method that utilizes a sophisticated multi-planar algorithm that identifies a 3D coordinate at the ASCO to serve as a global registration anchor. Since the claim language does not explicitly recite the argued identifying a 3D coordinate and the broadest reasonable interpretation of the claim does not limit the claim language to identify a 3D coordinate as a global registration anchor, Applicant’s arguments are not found persuasive.
Consequently, THIS ACTION IS MADE FINAL.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over VAGHEFI REZAEI (US 2022/0058796 A1), herein referred to as Vaghefi, in view of Lee et al. (Relationship between Three-Dimensional Magnetic Resonance Imaging Eyeball Shape and Optic Nerve Head Morphology).
Regarding claim 1, Vaghefi teaches, A method for generating an optic nerve path (Vaghefi, ¶0006: “method for generating data representative of a model of an eye”) using a match (Vaghefi, ¶0081: “registering the first processed eye image data and the second processed eye image data”) of a Magnetic Resonance Imaging (MRI) image and an Optical Coherence Tomography (OCT) image, (Vaghefi, ¶0020: “the first eye image data is a 3D MRI image and the second eye image data is a 3D OCT”) comprising: selecting in, (Vaghefi, ¶0191: “image slice where features of the eye can be clearly seen (usually the slice that goes through the middle of the eye) is selected and labelled as a mid-slice”; the middle slice of an eye MRI image will have the largest eyeball) (Vaghefi, ¶0206: “At each transverse plane, the ellipsoidal fits are used to work out the boundary of the vitreous and aqueous humour on the 2D cross-sectional plane”) and the (Vaghefi, ¶0212: “optical axis passes through the centre of the coronal plane of the lens. To obtain the optical axis, three lines between the most (1) anterior and posterior point, (2) inferior and superior point, and (3) nasal and temporal point of the lens are drawn”) obtaining a center and diameter of an inscribed circle inscribed in the eyeball, (Vaghefi, ¶0018: “segmenting the macula by fitting a circle to the identified pixels. The fovea may be located as the centre of the fitted circle”) and a center of a pair of Anterior Scleral Canal Openings (ASCOs), which are one of optic nerve measurement points, in the first MRI head image and the second MRI head image; (Vaghefi, ¶0219: “meetpoint is used to determine where the line intersects the outline of the eye and the intersection point is recorded as the attachment point of the ciliary muscle on the sclera”; ¶0227: “the radius between the previous point and the centre of the fitted circle is used”) obtaining an OCT cross-sectional image of the eyeball along a center line in an OCT eyeball image; (Vaghefi, ¶0269: “enface image is a cross-sectional compositional image derived from the OCT-A image slices at a given depth of the retina”) applying the OCT cross-sectional image of the eyeball to a simplified eyeball model (Vaghefi, ¶0163: “adding the processed OCT, PCTA and/or LS image data to the ocular model of the eye”) to correct distortion of the OCT cross-sectional image of the eyeball; (Vaghefi, ¶0246: “OCT image slice is translated so that the right edge of the first retinal layer matches the right edge of the first retinal layer on the previous OCT slice. After translation, a further step is introduced to correct for tilt between image slices”) matching the corrected OCT cross-sectional image of the eyeball to the center of the pair of ASCOs; (Vaghefi, ¶0013: “common landmarks of the 3D and 2D images are identified, one of the 3D and 2D images aligned and scaled to match the other” the pair of ASCOs are interpreted as common landmarks) generating an eyeball model through three-dimensionally modeling based on eyeball shapes of the first and second MRI head images; (Vaghefi, ¶0239: “MRI generated 3D model”) and generating an optic nerve model by three dimensionally modeling (Vaghefi, ¶0007: “combining different types of ocular imaging data to generate a model of the eye”; an optic nerve is part of a model of the eye) an optic nerve path connected to the three dimensionally modeled eyeball model. (Vaghefi, ¶0194: “extract point clouds for the boundary of the eye, the lens, the ciliary muscles, and the optic nerve attachment point”) wherein the matching the corrected OCT cross-sectional image (Vaghefi, ¶0013: “common landmarks of the 3D and 2D images are identified, one of the 3D and 2D images aligned and scaled to match the other” the pair of ASCOs are interpreted as common landmarks”) comprises: forming a first connection line connecting the center of the inscribed circle formed in the XY plane and the center of the pair of ASCOs; ; (Vaghefi, ¶0219: “meetpoint is used to determine where the line intersects the outline of the eye and the intersection point is recorded as the attachment point of the ciliary muscle on the sclera”; ¶0227: “the radius between the previous point and the centre of the fitted circle is used”) forming the inscribed circle in the XZ plane to include the first connection line; (Vaghefi, ¶0227: “obtain a more accurate fit for the optic disc, a line that extends beyond the boundary of the optic disc is drawn from the centre of the fitted circle towards the bottom edge of the image”) and merging the corrected OCT cross-sectional image of the eyeball at an intersection point where the inscribed circle formed in the XY plane, the inscribed circle in the XZ plane, and the first connection line intersect, (Vaghefi, ¶0206: “Intersection points between the two boundaries are determined using meetpoint and a complete boundary of the eye in that planar cross-section is formed by joining the fits for vitreous humour and aqueous humours at the intersection points”) and wherein the intersection point is the center of the pair of ASCOs. (Vaghefi, ¶0212: “The intersection between all three lines provides the mid-point of the lens”). However, Vaghefi does not explicitly teach, a plurality of first MRI head images and a plurality of second MRI head images.
In an analogous field of endeavor, Lee teaches a plurality of first MRI head images and a plurality of second MRI head images. (Lee, Fig. 6: “C, Sagittal and transverse sectional images of 3D—magnetic resonance imaging (MRI)”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Vaghefi using the teachings of Lee to introduce cross-section images of an eyeball in Sagittal and transverse plane. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of generating a 3D model of an eyeball. Therefore, it would have been obvious to combine the analogous arts Vaghefi and Lee to obtain the invention of claim 1.
Regarding claim 2, Vaghefi in view of Lee teaches, The method of claim 1, wherein the selecting the first MRI head image and the second MRI head image comprises: obtaining the plurality of first MRI head images sliced into the XY plane by capturing a head; (Vaghefi, ¶0206: “At each transverse plane, the ellipsoidal fits are used to work out the boundary of the vitreous and aqueous humour on the 2D cross-sectional plane”) obtaining the plurality of second MRI head images sliced into the XZ plane by capturing the head; (Vaghefi, ¶0212: “optical axis passes through the centre of the coronal plane of the lens. To obtain the optical axis, three lines between the most (1) anterior and posterior point, (2) inferior and superior point, and (3) nasal and temporal point of the lens are drawn”; also see Fig. 12) selecting the first MRI head image having a largest eyeball from the plurality of first MRI head images; (Vaghefi, ¶0191: “image slice where features of the eye can be clearly seen (usually the slice that goes through the middle of the eye) is selected and labelled as a mid-slice”) and selecting the second MRI head image having a largest eyeball from the plurality of second MRI head images, (Vaghefi, ¶0191: “image slice where features of the eye can be clearly seen (usually the slice that goes through the middle of the eye) is selected and labelled as a mid-slice”) wherein the plurality of first MRI head images and the plurality of second MRI head images are images of the eyeball. (Vaghefi, ¶0179: “resulting 3D MRI generated eye image corresponds to a first ocular image generated from a first imaging process, in this embodiment an MRI scan”).
Regarding claim 3, Vaghefi in view of Lee teaches, The method of claim 1, wherein the obtaining the center and the diameter of the inscribed circle comprises: selecting a MRI head image with a larger inscribed circle inscribed on the eyeball among the first and second MRI head images having a largest eyeball; (Vaghefi, ¶0191: “image slice where features of the eye can be clearly seen (usually the slice that goes through the middle of the eye) is selected and labelled as a mid-slice”) and obtaining the center of the inscribed circle, the diameter of the inscribed circle, (Vaghefi, ¶0018: “segmenting the macula by fitting a circle to the identified pixels. The fovea may be located as the centre of the fitted circle”) the pair of ASCOs, and the center of the pair of ASCOs from the MRI head image with the larger inscribed circle. (Vaghefi, ¶0219: “meetpoint is used to determine where the line intersects the outline of the eye and the intersection point is recorded as the attachment point of the ciliary muscle on the sclera”; ¶0227: “the radius between the previous point and the centre of the fitted circle is used”).
Regarding claim 4, Vaghefi in view of Lee teaches, The method of claim 1, wherein the obtaining the OCT cross-sectional image comprises: obtaining the OCT eyeball image by capturing the eyeball; (Vaghefi, ¶0269: “enface image is a cross-sectional compositional image derived from the OCT-A image slices at a given depth of the retina”) (c2) generating the center line passing through a center of an optic disk of the eyeball using an OCT program; (Vaghefi, ¶0269: “enface image is a cross-sectional compositional image derived from the OCT-A image slices at a given depth of the retina”) and (c3) obtaining the OCT cross-sectional image of the eyeball along the center line in the OCT eyeball image, (Vaghefi, ¶0227: “a line that extends beyond the boundary of the optic disc is drawn from the centre of the fitted circle”) wherein the OCT cross-sectional image of the eyeball is an OCT B-Scan image (Lee, Fig. 4: “B, B-scan OCT image”) assuming that a center of Bruch's Membrane Opening (BMO) is a center of an optic nerve. (Lee, Fig. 5: “Optic nerve head morphology. A1, Disc photograph. The dotted green line indicates the location of the OCTscan. A2, Infrared image with demarcated Bruch’s membrane opening (BMO) margin”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Vaghefi in view of Lee using the additional teachings of Lee to introduce an OCT B-scan. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of visualizing the retinal layers in high resolution. Therefore, it would have been obvious to combine the analogous arts Vaghefi and Lee to obtain the invention of claim 4.
Regarding claim 5, Vaghefi in view of Lee teaches, The method of claim 1, wherein the applying the OCT cross-sectional image comprises: applying the OCT cross-sectional image of the eyeball to the simplified eyeball model; (Vaghefi, ¶0269: “enface images are averaged to obtain flattened enface representations of the multiple layers of choriocapillaris perfusion within the 10-23 micron range”) obtaining a nodal length (NL) based on an axial length measured in a MRI head image with a larger eyeball among the first MRI head image and the second MRI head image; (Lee, page 533, col. 2, ¶04: “The eyeball’s 3D shape was determined by (1) the horizontal width along the x-axis; (2) the vertical height along the y-axis; and (3) the axial length along the z-axis”) obtaining a relative nodal length using the nodal length; (Lee, Fig.1: “To determine the deviations from the spherical shape, the lengths were measured in the horizontal (x), vertical (y), and axial (z) directions”) obtaining a refractive half-angle using the relative nodal length; (Lee, page 534, col.1, ¶02: “angle was measured based on the right-eye orientation, with the nasal horizontal midline as 0”) and correcting the distortion of the OCT cross-sectional image of the eyeball using the refractive half-angle, (Vaghefi, ¶0193: “The angle between the line and the x-axis (θ.sub.rot) is used to rotate the cropped image using imrotate”) wherein the corrected OCT cross-sectional image of the eyeball has a predetermined curvature. (Vaghefi, ¶0205: “new set of data points which better captures the curvature of the aqueous humour is consolidated for a second round of surface fitting”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Vaghefi in view of Lee using the additional teachings of Lee to introduce measuring lengths from an MRI image. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of correcting the distortion in the scan data. Therefore, it would have been obvious to combine the analogous arts Vaghefi and Lee to obtain the invention of claim 5.
Regarding claim 6, Vaghefi in view of Lee teaches, The method of claim 3, wherein in the matching the corrected OCT cross-sectional image, the inscribed circle in the XY plane is formed based on the center of the inscribed circle in the MRI head image with the larger inscribed circle. (Vaghefi, ¶0018: “segmenting the macula by fitting a circle to the identified pixels. The fovea may be located as the centre of the fitted circle”).
Regarding claim 7, Vaghefi in view of Lee teaches, The method of claim 3, wherein the generating the eyeball model comprises: forming a gaze reference line connecting a center of the eyeball and a center of an iris in the MRI head image with the larger inscribed circle inscribed in the eyeball among the first MRI head image and the second MRI head image; (Vaghefi, ¶0212: “An optical axis is created by plotting a line from the most anterior point to the most posterior point of the lens through the mid-point of the lens”) forming a plurality of first reference planes perpendicular to the gaze reference line; (Vaghefi, ¶0212: “The optical axis passes through the centre of the coronal plane of the lens”) forming a plurality of first ellipses on the plurality of first reference planes spaced apart from each other, respectively; (Vaghefi, ¶0227: “new set of data points which approximates the boundary of the optic disc are then fitted to an ellipse using the fit ellipse”) forming an ocular surface surrounding the plurality of first ellipses; (Vaghefi, ¶0199: “a group of 3D data points which estimate the boundary surface of the vitreous humour based on MRI imaging. This set of 3D data points is then fitted to an ellipsoid”) forming a BMO with a thickness of 0.004 mm from an inner surface of the ocular surface; (Vaghefi, ¶0269: “The Bruch's membrane (BM) is identified… thickness of the choriocapillaris ranges from 10-23 microns below the Bruch's membrane”) sequentially forming a choroid (Vaghefi, ¶0252: “ght reflectance of the surface of moving red blood cells for imaging the microvasculature of the retina and choroid”) and a sclera with a predetermined thickness from an outer surface of the ocular surface; (Vaghefi, ¶0218: “narrower aqueous humour due to presence of ciliary attachment) will follow the path of ciliary muscle attachment between the sclera and the lens equator”) and generating the three-dimensionally modeled eyeball model. (Vaghefi, ¶0006: “generating data representative of a model of an eye”).
Regarding claim 8, Vaghefi in view of Lee teaches, The method of claim 1, further comprising three-dimensionally modeling an ASCO model on the corrected OCT cross-sectional image (Vaghefi, ¶246: “the OCT image slice is translated… correct for tilt between image slices”) of the eyeball between the generating the eyeball model (Vaghefi, ¶0176: “combining data representative of the eye obtained from multiple modalities into a virtual model of the eye”) and the generating the optic nerve model. (Vaghefi, ¶0007: “combining different types of ocular imaging data to generate a model of the eye”; an optic nerve is part of a model of the eye).
Regarding claim 9, Vaghefi in view of Lee teaches, The method of claim 8, wherein the three-dimensionally modeling the ASCO model on the corrected OCT cross-sectional image of the eyeball comprises: forming a line segment to distinguish a BMO, a Choroid Opening, and an ASCO in the corrected OCT cross-sectional image; (Lee, Fig. 8: “The dotted green lines indicate the location of the OCT scans”) forming a normal line passing through a center point of the line segment and then forming a vertical plane perpendicular to the normal line; (Lee, page 534, col. 2, ¶03: “The torsion degree was defined as the deviation of the long axis of the clinical disc margin from the reference line, which was set perpendicularly to the foveal-BMO axis”) and three-dimensionally modeling the ASCO model by connecting the vertical plane through which a central part is penetrated and the line segment of the ASCO. (Vaghefi, ¶0007: “generate a model of the eye”; also see Fig. 12”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Vaghefi in view of Lee using the additional teachings of Lee to introduce forming lines to distinguish different features of the eye. A person skilled in the art would be motivated to combine the known elements as described above and achieve the predictable result of correctly identifying the elements of an image of an eye. Therefore, it would have been obvious to combine the analogous arts Vaghefi and Lee to obtain the invention of claim 9.
Regarding claim 10, Vaghefi in view of Lee teaches, The method of claim 1, wherein the generating the optic nerve model (Vaghefi, ¶0007: “combining different types of ocular imaging data to generate a model of the eye”; an optic nerve is part of a model of the eye) comprises: obtaining a center point of an optic nerve root based on the first MRI head image and the second MRI head image; (Vaghefi, ¶0194: “extract point clouds for the boundary of the eye, the lens, the ciliary muscles, and the optic nerve attachment point”) forming a second connection line connecting the pair of ASCOs and the center point of the optic nerve root; (Vaghefi, ¶0222: “line in the middle of the band represents the axis of the optical nerve and where the line intersects the vitreous humour boundary is assigned as the middle of the optic nerve head or optic disc”) forming a plurality of second reference planes dividing the second connection line into five parts; (Vaghefi, ¶0222: “generate multiple bands of lines which are considered as part of the optic nerve attachment”) forming a plurality of second ellipses on the plurality of second reference planes using the first MRI head image and the second MRI head image; (Vaghefi, ¶0205: “The 3D ellipsoid fits for the vitreous humour and aqueous humour are used to work out the 2D fits to the vitreous and aqueous humours on the cross-sections of these slices”) forming a reference line connecting centers of the plurality of second ellipses; (Vaghefi, ¶0227: “the centre of the fitted circle is used to estimate the position of the new point at the current angle step. The new set of data points which approximates the boundary of the optic disc are then fitted to an ellipse using the fit ellipse”) forming the optic nerve path surrounding the plurality of second ellipses; (Vaghefi, ¶0222: “The 3D ellipsoidal fit to the vitreous humour is used to identify the data points of the vitreous humour fitted boundary on the cross-section of the image slice. A line is drawn… within the region of the optic nerve head or attachment”) extending an end of the optic nerve path to a sclera; (Vaghefi, ¶0219: “meetpoint is used to determine where the line intersects the outline of the eye and the intersection point is recorded as the attachment point of the ciliary muscle on the sclera for each of the sampling angles”) forming an interior of the optic nerve path by reflecting a preset thickness of the optic nerve path; (Vaghefi, ¶0222: “If the number of pixels is bigger than 3, the line is considered to be within the region of the optic nerve head or attachment”) and forming the three-dimensionally modeled optic nerve model. (Vaghefi, ¶0239: “generated 3D model… align with the orientation of the optic nerve axis”).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MEHRAZUL ISLAM/Examiner, Art Unit 2662
/Siamak Harandi/Primary Examiner, Art Unit 2662
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