DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 .
Response to Amendment
The amendment filed on 07/22/26 have been entered. The 101 rejection of claim 13 has been withdrawn in light of claim amendments.
Response to Arguments
Applicant’s arguments filed on 07/22/26 have been fully considered but they are not persuasive.
Applicant’s response states that Fujimura's image correction part 2311 corrects only for "distortion aberration occurring in photograph images due to the optical system" (Fujimura ¶ 100), that the purpose of the correction is to determine the three-dimensional position of the eye for alignment (Fujimura ¶¶ 295–301), and that Fujimura "does not teach or even suggest . . . transforming the content of the captured 2D image to correct for distortions inherent to the imaging process itself, such as the perspective distortion that arises from the off-axis camera angle, or distortions caused by the refractive characteristics of the patient's own eye (e.g., the cornea acting as a lens)."
The examiner respectfully disagrees.
Applicant's assertion is contradicted by the express disclosure. Fujimura ¶ 115 discloses analyzer 231 provided with image correction part 2311, and ¶ 116 discloses that image correction part 2311 corrects the distortion of each photograph image, which necessarily transforms the content of that image; the corrected images are then used to specify the region corresponding to characteristic points of the iris or pupil (¶ 129). That Fujimura thereafter uses the corrected image to determine three-dimensional position describes the use made of the transformed image and does not negate the transformation. Fujimura further teaches compensating for distortion caused by characteristics of the eye, in that ¶ 297 discloses storing distance information between the cornea and the iris based on a schematic eye model such as the Gullstrand eye model, which Fujimura employs in locating the iris and pupil in the anterior eye camera images (¶¶ 295–301) because corneal refraction displaces the apparent position of the iris — the very feature Applicant contends is absent, and a finding Applicant has not traversed, ¶297 having been relied upon at page 6 of the Office Action in the rejection of claim 3 and nowhere addressed in the Remarks. Applicant's amendment of claim 3 to depend from claim 1 confirms this reading, as it places correction for the refractive properties of a cornea within the scope of the correction recited in claim 1. Fujimura also teaches compensating for distortion caused by perspective, disclosing anterior eye cameras 300A/300B arranged at different angles to the measurement axis (¶¶ 72, 135) and the merging of their images into a synthetic image (¶ 135), which requires transforming each off-axis view into a common frame of reference, as does the triangulation of three-dimensional eye position from two off-axis views (¶¶ 295–301). Because claim 1 requires only one of the two recited alternatives, teaching independently meets the limitation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5, 9-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimura (EP2845534) in further view of Kaehler (EP4141523)
.Regarding claim 1, Fujimura teaches ophthalmic imaging device (see fig. 1, 5A, 5B) comprising, an on-axis measuring unit (OCT 100) configured to record one or more measurements of an eye, the on-axis measuring unit configured to measure the eye along a measurement axis substantially coincidental to an eye axis of the eye (see fig. 1 and ¶69-¶70; ¶69 discloses the OCT unit’s optical path including collimator lens unit 40, optical-path-length changing part 41, Galvano scanner 42, focusing lens 43, mirror 44, and relay lens 45, and ¶70 discloses that the optical path length changing part is movable along the measurement axis to correct the optical path according to the eye’s axial length, supporting measurement along the eye axis; The reference discloses that the optical-path-length changing part (41) is movable and used to “correct the optical path in accordance with the axial length of the eye” ([0069]), which inherently corresponds to adjustment along the optical axis (z-direction) of the system. In ophthalmic and OCT contexts, the “axial length of the eye” is defined along the eye axis (cornea-to-retina direction), which coincides with the measurement axis of OCT depth imaging. Since OCT obtains depth information by detecting interference based on optical path length differences along this axis, a movable optical-path-length changing part that compensates for axial length necessarily enables proper measurement along the eye axis and an off-axis iris imaging unit (300, 300A, 300B) configured to record an off-axis iris image of an iris of the eye (see ¶72, ¶129; wherein ¶129 discloses that the image judging part specifies the image region corresponding to characteristic points of the iris or pupil, supporting the off-axis imaging function, and the off—axis imaging unit comprises a sensor defining an image plane and an optical system (lens) to capture the iris image), the off-axis iris imaging unit arranged at a predetermined angle to the measurement axis (fig. 1, 5A, 5B) and comprising, a sensor defining an image plane (sensor of cameras 300), and an optical system (lens of camera 300), a processing unit configured to, correct the off-axis iris image (¶115 discloses that the analyzer 231 analyzes images obtained from the anterior eye cameras 300 and is provided with an image correction part 2311, which functions as the processing unit), by transforming the off-axis iris image to compensate for distortion caused by at least one of, perspective or characteristics of the eye (¶116, the image correction part 2311 corrects the distortion of each photograph image based on stored aberration information 212a, compensating for distortion caused by at least one of the characteristics of the optical system, perspective, or the characteristics of the eye). Fujimura does not specifically teach an optical system oriented relative to the image plane such that a focal plane of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye. However, in a similar field of endeavor, Kaehler teaches ophthalmic imaging device (fig. 4, ¶23 and ¶24) comprising, an optical system oriented relative to the image plane such that a focal plane (408) of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye (407, ¶23 discloses that the off-axis imager includes a lens configured to provide a shift offset (displacement 406) confined to the lens plane (401) while keeping the lens plane parallel to the image plane (404), leaving the focal plane (408) parallel to both lens and imager planes. This shift offset allows adjustment of the iris position without changing the image angle and permits capturing different portions of the iris image (similar to cropping). ¶24 discloses that the lens shift may range from about 1.0 mm to about 2.5 mm and may be fixed or adjustable). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the device of Fujimura with an optical system oriented relative to the image plane such that a focal plane of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye of Kaehler, for the purpose of eliminating one form of distortion from the resulting image (¶23).
Regarding claim 3, Fujimura in view of Kahler teaches the invention as set forth above and Fujimura further teaches the processing unit is configured to use a digital eye model to correct for refractive properties of a cornea (¶297 discloses that storage 212 stores distance information between the cornea and iris, which may be based on a schematic eye model such as the Gullstrand eye model. This stored digital eye model provides the necessary parameters to allow the processing unit to account for the cornea’s refractive properties when correcting the off-axis iris image).
Regarding claim 5, Fujimura in view of Kahler teaches the invention as set forth above and Fujimura further teaches the processing unit is configured to determine at least one of the characteristics of the eye using the one or more measurements performed by the on-axis measuring unit (¶50 discloses light reflected from the cornea is captured by the CCD image sensor 35, and the arithmetic and control unit 200 analyzes the position of the alignment indicator to perform automatic alignment. This demonstrates that the processing unit determines eye characteristics (such as eye position) based on measurements from the on-axis measuring unit).
Regarding claim 9, Fujimura in view of Kahler teaches the invention as set forth above and Fujimura further teaches the on-axis measuring unit comprises at least one of, an optical coherence tomography unit, an infrared placido imaging unit, an aberrometer, an optical biometer, or an auto refractor (¶54 discloses the apparatus comprises an OCT unit 100 with an optical system for obtaining OCT images of the fundus, demonstrating that the on-axis measuring unit can include an OCT system, while the overall apparatus architecture supports the inclusion of other ophthalmic measurement units as known in the field.).
Regarding claim 10, Fujimura in view of Kahler teaches the invention as set forth above and Fujimura further teaches further comprising a further off-axis imaging unit arranged at a predetermined angle to the measurement axis and at a predetermined azimuthal angle about the measurement axis with respect to the azimuthal angle of the off-axis imaging unit (¶135, discloses multiple anterior eye cameras at different angles supporting the further off-axis unit), the further off-axis imaging unit configured to record a further off-axis iris image of the iris of the eye (¶135, discloses each camera capturing anterior eye including the iris), and a processing unit configured to merge the off-axis iris image and the further off-axis iris image to generate a combined off-axis iris image (¶135, discloses merging images from multiple cameras to generate a synthetic image).
Regarding claim 11, Fujimura in view of Kahler teaches the invention as set forth above and Fujimura further teaches the sensor and the optical system of the off-axis imaging unit are arranged such that the iris lies substantially within a depth of field of the optical system (see fig. 5A, ¶72, illustrating off-axis cameras 300A and 300B oriented such that the iris P of the eye E lies within the optical focus of the lenses f).
Regarding claim 12, Fujimura teaches a method for imaging an eye using an ophthalmic imaging device (fig. 1, 5A, 5B), the method comprising, recording, using an on-axis measuring unit (OCT 100) of the ophthalmic imaging device, one or more measurements of the eye, the on-axis measuring unit configured to measure the eye along measurement axis substantially coincidental to an eye axis of the eye (see fig. 1 and ¶69-¶70; ¶69 discloses the OCT unit’s optical path including collimator lens unit 40, optical-path-length changing part 41, Galvano scanner 42, focusing lens 43, mirror 44, and relay lens 45, and ¶70 discloses that the optical path length changing part is movable along the measurement axis to correct the optical path according to the eye’s axial length, supporting measurement along the eye axis; The reference discloses that the optical-path-length changing part (41) is movable and used to “correct the optical path in accordance with the axial length of the eye” ([0069]), which inherently corresponds to adjustment along the optical axis (z-direction) of the system. In ophthalmic and OCT contexts, the “axial length of the eye” is defined along the eye axis (cornea-to-retina direction), which coincides with the measurement axis of OCT depth imaging. Since OCT obtains depth information by detecting interference based on optical path length differences along this axis, a movable optical-path-length changing part that compensates for axial length necessarily enables proper measurement along the eye axis.); recording, using an off-axis iris imaging unit (300, 300A, 300B) of the ophthalmic imaging device, an off-axis iris image of an iris of the eye (see ¶72, ¶129; wherein ¶129 discloses that the image judging part specifies the image region corresponding to characteristic points of the iris or pupil, supporting the off-axis imaging function, and the off—axis imaging unit comprises a sensor defining an image plane and an optical system (lens) to capture the iris image), the off-axis iris imaging unit arranged at a predetermined angle to the measurement axis (fig. 1, 5A, 5B), wherein the off-axis iris imaging unit comprises, a sensor defining an image plane (sensor of cameras 300), and an optical system (lens of camera 300), and, correcting, in a processing unit of the ophthalmic imaging device, the off-axis iris image (¶115 discloses that the analyzer 231 analyzes images obtained from the anterior eye cameras 300 and is provided with an image correction part 2311, which functions as the processing unit), by transforming the off-axis iris image to compensate for distortion caused by at least one of : perspective or characteristics of the eye (¶116, the image correction part 2311 corrects the distortion of each photograph image based on stored aberration information 212a, compensating for distortion caused by at least one of the characteristics of the optical system, perspective, or the characteristics of the eye). Fujimura does not specifically teach an optical system oriented relative to the image plane such that a focal plane of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye. However, in a similar field of endeavor, Kaehler teaches a method (fig. 4, ¶23 and ¶24) comprising, an optical system oriented relative to the image plane such that a focal plane (408) of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye (407, ¶23 discloses that the off-axis imager includes a lens configured to provide a shift offset (displacement 406) confined to the lens plane (401) while keeping the lens plane parallel to the image plane (404), leaving the focal plane (408) parallel to both lens and imager planes. This shift offset allows adjustment of the iris position without changing the image angle and permits capturing different portions of the iris image (similar to cropping). ¶24 discloses that the lens shift may range from about 1.0 mm to about 2.5 mm and may be fixed or adjustable). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the method of Fujimura with an optical system oriented relative to the image plane such that a focal plane of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye of Kaehler, for the purpose of eliminating one form of distortion from the resulting image (¶23).
Regarding claim 13, Fujimura teaches a non-transitory memory comprising program code configured to control a processor of an ophthalmic imaging device (controller 210, fig. 3) such that the ophthalmic imaging device performs the following steps, recording, using an on-axis measuring unit of the ophthalmic imaging device, one or more measurements of an eye, the on-axis measuring unit configured to measure the eye along measurement axis substantially coincidental to an eye axis of the eye (see fig. 1 and ¶69-¶70; ¶69 discloses the OCT unit’s optical path including collimator lens unit 40, optical-path-length changing part 41, Galvano scanner 42, focusing lens 43, mirror 44, and relay lens 45, and ¶70 discloses that the optical path length changing part is movable along the measurement axis to correct the optical path according to the eye’s axial length, supporting measurement along the eye axis; The reference discloses that the optical-path-length changing part (41) is movable and used to “correct the optical path in accordance with the axial length of the eye” ([0069]), which inherently corresponds to adjustment along the optical axis (z-direction) of the system. In ophthalmic and OCT contexts, the “axial length of the eye” is defined along the eye axis (cornea-to-retina direction), which coincides with the measurement axis of OCT depth imaging. Since OCT obtains depth information by detecting interference based on optical path length differences along this axis, a movable optical-path-length changing part that compensates for axial length necessarily enables proper measurement along the eye axis.); recording, using an off-axis iris imaging unit (300, 300A, 300B) of the ophthalmic imaging device, an off-axis iris image of an iris of the eye (see ¶72, ¶129; wherein ¶129 discloses that the image judging part specifies the image region corresponding to characteristic points of the iris or pupil, supporting the off-axis imaging function, and the off—axis imaging unit comprises a sensor defining an image plane and an optical system (lens) to capture the iris image), the off-axis iris imaging unit arranged at a predetermined angle to the measurement axis (fig. 1, 5A, 5B), wherein the off-axis iris imaging unit comprises, a sensor defining an image plane (sensor of cameras 300), and an optical system (lens of camera 300), and, correcting the off-axis iris image (¶115 discloses that the analyzer 231 analyzes images obtained from the anterior eye cameras 300 and is provided with an image correction part 2311, which functions as the processing unit), by transforming the off-axis iris image to compensate for distortion caused by at least one or: perspective or characteristics of the eye (¶116, the image correction part 2311 corrects the distortion of each photograph image based on stored aberration information 212a, compensating for distortion caused by at least one of the characteristics of the optical system, perspective, or the characteristics of the eye). Fujimura does not specifically teach an optical system oriented relative to the image plane such that a focal plane of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye. However, in a similar field of endeavor, Kaehler teaches a computer program product (fig. 4, ¶23 and ¶24) comprising an optical system oriented relative to the image plane such that a focal plane (408) of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye (407, ¶23 discloses that the off-axis imager includes a lens configured to provide a shift offset (displacement 406) confined to the lens plane (401) while keeping the lens plane parallel to the image plane (404), leaving the focal plane (408) parallel to both lens and imager planes. This shift offset allows adjustment of the iris position without changing the image angle and permits capturing different portions of the iris image (similar to cropping). ¶24 discloses that the lens shift may range from about 1.0 mm to about 2.5 mm and may be fixed or adjustable). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the computer program product of Fujimura with an optical system oriented relative to the image plane such that a focal plane of the off-axis iris imaging unit substantially coincides with an iris plane of the iris of the eye of Kaehler, for the purpose of eliminating one form of distortion from the resulting image (¶23).
Regarding claim 14, Fujimura in view of Kahler teaches the invention as set forth above and Fujimura further teaches correcting the off-axis iris image (¶115 discloses that the analyzer 231 analyzes images obtained from the anterior eye cameras 300 and is provided with an image correction part 2311, which functions as the processing unit) by transforming the off-axis iris image to compensate for distortion caused by at least one of: perspective, characteristics of the optical system or characteristics of the eye (¶116, the image correction part 2311 corrects the distortion of each photograph image based on stored aberration information 212a, compensating for distortion caused by at least one of the characteristics of the optical system, perspective, or the characteristics of the eye).
Regarding claim 15, Fujimura in view of Kaehler teaches the invention a set forth above and Fujimura further teaches correcting, using a digital eye model, for refractive properties of a cornea (¶297 discloses that storage 212 stores distance information between the cornea and iris, which may be based on a schematic eye model such as the Gullstrand eye model. This stored digital eye model provides the necessary parameters to allow the processing unit to account for the cornea’s refractive properties when correcting the off-axis iris image).
Regarding claim 17, Fujimura in view of Kaehler teaches the invention a set forth above and Fujimura further teaches further comprising determining at least one of the characteristics of the eye using the one or more measurements performed by the on-axis measuring unit (¶50 discloses light reflected from the cornea is captured by the CCD image sensor 35, and the arithmetic and control unit 200 analyzes the position of the alignment indicator to perform automatic alignment. This demonstrates that the processing unit determines eye characteristics (such as eye position) based on measurements from the on-axis measuring unit).
Claims 4, 8, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimura (EP2845534) in further view of Kaehler (EP4141523) as applied to claims 3 and 15 above, further in view of Okada et al. (US 20150335234).
Regarding claim 4, Fujimura in view of Kaehler teaches the invention a set forth above but does not specifically teach the digital eye model is a parametrized digital eye model including at least one of the following characteristics of the eye: a diameter of the eye, a curvature of an anterior corneal surface, a curvature of a posterior corneal surface, a thickness profile of a cornea, an astigmatism of the cornea, or a curvature of the iris. However, in a similar field of endeavor, Okada teaches the ophthalmic imaging device (¶93-¶94, ¶98 and ¶102), wherein the digital eye model is a parametrized digital eye model including at least one of the following characteristics of the eye: a diameter of the eye, a curvature of an anterior corneal surface, a curvature of a posterior corneal surface, a thickness profile of a cornea, an astigmatism of the cornea, or a curvature of the iris (¶93-¶94 disclose that model eyes such as the Gullstrand, Navarro, or Le Grand models include specific parameters for the eye, including distances and dimensions, which can represent the diameter of the eye. As disclosed in ¶98 and ¶102, the thickness of the cornea (t2), the curvature radius of the anterior corneal surface (r1), he curvature radius of the posterior corneal surface (r2), and optical characteristics including astigmatism may be measured or obtained from the model. Further, the curvature of the iris or pupil can be determined from OCT or other imaging data of the anterior eye segment). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the device of Fujimura in view of Kaehler with the digital eye model is a parametrized digital eye model including at least one of the following characteristics of the eye: a diameter of the eye, a curvature of an anterior corneal surface, a curvature of a posterior corneal surface, a thickness profile of a cornea, an astigmatism of the cornea, or a curvature of the iris of Okada for the purpose of using a parametrized digital eye model including characteristics such as corneal curvature, thickness, and eye diameter (¶93. ¶102, ¶104) to accurately correct off-axis iris images for variations between individual eyes.
Regarding claim 8, Fujimura in view of Kaehler teaches the invention set forth above but does not specifically teach a processing unit configured to generate a personalized digital eye model of the eye of a patient, using the one or more measurements of the eye and the off-axis iris image. However, in a similar field of endeavor, Okada teaches the ophthalmic imaging device comprising a processing unit configured to generate a personalized digital eye model of the eye of a patient, using the one or more measurements of the eye and the off-axis iris image (¶93 to ¶101 discloses the standard model eye parameters (e.g., corneal thickness, curvature, pupil position) can be used to calculate distances and positions for eye measurements and ¶102 further discloses that measured values of the eye, obtained from OCT imaging and anterior eye imaging, can replace model values to generate a patient-specific, personalized digital eye model). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the ophthalmic imaging device of Fujimura in view of Kaehler with a processing unit configured to generate a personalized digital eye model of the eye of a patient, using the one or more measurements of the eye and the off-axis iris image of Okada, for the purpose of generating a personalized digital eye model using measurements of the eye and off-axis iris images to improve the accuracy of calculation and corrections by replacing generic model parameters with patent-specific anatomical data (¶93-¶102).
Regarding claim 16, Fujimura in view of Kaehler teaches the invention a set forth above but does not specifically teach the digital eye model is a parametrized digital eye model including at least one of the following characteristics of the eye: a diameter of the eye, a curvature of an anterior corneal surface, a curvature of a posterior corneal surface, a thickness profile of a cornea, an astigmatism of the cornea, or a curvature of the iris. However, in a similar field of endeavor, Okada teaches the ophthalmic imaging device (¶93-¶94, ¶98 and ¶102), wherein the digital eye model is a parametrized digital eye model including at least one of the following characteristics of the eye: a diameter of the eye, a curvature of an anterior corneal surface, a curvature of a posterior corneal surface, a thickness profile of a cornea, an astigmatism of the cornea, or a curvature of the iris (¶93-¶94 disclose that model eyes such as the Gullstrand, Navarro, or Le Grand models include specific parameters for the eye, including distances and dimensions, which can represent the diameter of the eye. As disclosed in ¶98 and ¶102, the thickness of the cornea (t2), the curvature radius of the anterior corneal surface (r1), he curvature radius of the posterior corneal surface (r2), and optical characteristics including astigmatism may be measured or obtained from the model. Further, the curvature of the iris or pupil can be determined from OCT or other imaging data of the anterior eye segment). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the device of Fujimura in view of Kaehler with the digital eye model is a parametrized digital eye model including at least one of the following characteristics of the eye: a diameter of the eye, a curvature of an anterior corneal surface, a curvature of a posterior corneal surface, a thickness profile of a cornea, an astigmatism of the cornea, or a curvature of the iris of Okada for the purpose of using a parametrized digital eye model including characteristics such as corneal curvature, thickness, and eye diameter (¶93. ¶102, ¶104) to accurately correct off-axis iris images for variations between individual eyes.
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimura (EP2845534) in further view of Kaehler (EP4141523) as applied to claim 1 above, and further in view of Okada (EP2932888) (hereinafter Okada’888).
Regarding claim 6, Fujimura in view of Kaehler teaches the invention as set forth above but does not specifically teach a processing unit configured to determine a tilt of the eye, relative to the measurement axis, using the off-axis iris image; and generate an untitled off-axis iris image by transforming the off-axis iris image based on the tilt of the eye. However, in a similar field of endeavor, Okada’888 teaches the ophthalmic imaging device further comprising a processing unit (¶108 and ¶109) configured to, determine a tilt of the eye, relative to the measurement axis, using the off-axis iris image; and generate an untitled off-axis iris image by transforming the off-axis iris image based on the tilt of the eye (¶108 and ¶109 discloses, the analyzer 231 analyzes photographic images captured by the anterior eye cameras 300A/300B to obtain the three-dimensional position and displacement information of the eye, which includes tilt relative to the measurement axis and further disclosed in ¶110, the image correction part 2311 corrects distortions in the photographic images, allowing the processing unit to transform the off-axis iris image to generate an untilted off-axis iris image). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the optical imaging device of Fujimura in view of Kaehler with a processing unit configured to determine a tilt of the eye, relative to the measurement axis, using the off-axis iris image; and generate an untitled off-axis iris image by transforming the off-axis iris image based on the tilt of the eye of Okada’888, for the purpose of monitoring the XYZ, rotation and tip/tilt of the IOL in the eye in real time (¶110).
Regarding claim 18, Fujimura in view of Kaehler teaches the invention as set forth above but does not specifically teach determining a tilt of the eye, relative to the measurement axis, using the off-axis iris image; and generating an untilted off-axis iris image by transforming the off-axis iris image based on the tilt of the eye. However, in a similar field of endeavor, Okada’888 teaches the ophthalmic imaging device further comprising the method, further comprising, determining a tilt of the eye, relative to the measurement axis, using the off-axis iris image; and generating an untilted off-axis iris image by transforming the off-axis iris image based on the tilt of the eye (¶108 and ¶109 discloses, the analyzer 231 analyzes photographic images captured by the anterior eye cameras 300A/300B to obtain the three-dimensional position and displacement information of the eye, which includes tilt relative to the measurement axis and further disclosed in ¶110, the image correction part 2311 corrects distortions in the photographic images, allowing the processing unit to transform the off-axis iris image to generate an untilted off-axis iris image). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the method of Fujimura in view of Kaehler with determining a tilt of the eye, relative to the measurement axis, using the off-axis iris image; and generating an untilted off-axis iris image by transforming the off-axis iris image based on the tilt of the eye of Okada’888, for the purpose of monitoring the XYZ, rotation and tip/tilt of the IOL in the eye in real time (¶110).
Claims 7, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimura (EP2845534) in further view of Kaehler (EP4141523) as applied to claims 1 and 12 above, and further in view of Neal et al. (US 20210267799).
Regarding claim 7, Fujimura in view of Kaehler teaches the invention as set forth above but does not specifically teach to simultaneously record at least one of the measurements of the eye and the off-axis iris image. However, in a similar field of endeavor, Neal teaches the ophthalmic imaging device, configured to simultaneously record at least one of the measurements of the eye and the off-axis iris image (¶54, the eye tracking system 200 uses images of the eye to determine the eye’s position and orientation in real time, applying calibration offsets and gains immediately during image capture and ¶106 describes that during diagnostics, the eye tracking system tracks the position and rotation of the eye while images of the eye are captured and stored, demonstrating that the system records eye measurements and eye images concurrently.). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the ophthalmic imaging device of Fujimura in view of Kaehler with to simultaneously record at least one of the measurements of the eye and the off-axis iris image of Neal, for the purpose of simultaneously record eye measurements and off-axis iris images to ensure that eye positional and rotational data correspond accurately to the captured images, enabling precise alignment and reliable diagnostics (¶54 and ¶106).
Regarding claim 19, Fujimura in view of Kaehler teaches the invention as set forth above but does not specifically teach further comprising simultaneously recording at least one of the measurements of the eye and the off-axis iris image. However, in a similar field of endeavor, Neal teaches the method, further comprising simultaneously recording at least one of the measurements of the eye and the off-axis iris image (¶54, the eye tracking system 200 uses images of the eye to determine the eye’s position and orientation in real time, applying calibration offsets and gains immediately during image capture and ¶106 describes that during diagnostics, the eye tracking system tracks the position and rotation of the eye while images of the eye are captured and stored, demonstrating that the system records eye measurements and eye images concurrently.). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the method of Fujimura in view of Kaehler with further comprising simultaneously recording at least one of the measurements of the eye and the off-axis iris image of Neal, for the purpose of simultaneously record eye measurements and off-axis iris images to ensure that eye positional and rotational data correspond accurately to the captured images, enabling precise alignment and reliable diagnostics (¶54 and ¶106).
Regarding claim 20, Fujimura in view of Kaehler teaches the invention as set forth above but does not specifically teach generating a personalized digital eye model of the eye of a patient, using the one or more measurements of the eye and the off-axis iris image. However, in a similar field of endeavor, Neal teaches the method, further comprising generating a personalized digital eye model of the eye of a patient, using the one or more measurements of the eye and the off-axis iris image (¶54, the eye tracking system 200 uses images of the eye to determine the eye’s position and orientation in real time, applying calibration offsets and gains immediately during image capture and ¶106 describes that during diagnostics, the eye tracking system tracks the position and rotation of the eye while images of the eye are captured and stored, demonstrating that the system records eye measurements and eye images concurrently.). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the method of Fujimura in view of Kaehler with generating a personalized digital eye model of the eye of a patient, using the one or more measurements of the eye and the off-axis iris image of Neal, for the purpose of simultaneously record eye measurements and off-axis iris images to ensure that eye positional and rotational data correspond accurately to the captured images, enabling precise alignment and reliable diagnostics (¶54 and ¶106).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hirose et al. (US 12,470,685) teaches an ophthalmic information processing apparatus.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY DUONG whose telephone number is (571)270-0534. The examiner can normally be reached Monday-Friday from 9:00 AM to 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached at (571)270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HENRY DUONG/Primary Patent Examiner, Art Unit 2872 09/05/26
Prosecution Insights