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 .
Priority
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/22/2025 and 06/24/2025 have been considered by the examiner.
Claim Objections
Claims 1, 9, 11, and 14 are objected to because of the following informalities:
In claim 1, line 15, “and an OCT imaging system…” should read “and an optical coherence tomography, OCT, imaging system…” in order to add a proper introduction to the acronym used.
In claim 9, line 1, “The use of a fixation target of an optical coherence tomography.…” should read “A fixation target of an optical coherence tomography.…” in order to properly introduce the independent claim’s new element with an indefinite article and clarify the claim structure.
In claims 10-13, line 1, “The use according to claim 9…” should read “The fixation target according to claim 9…” in order to clarify the claim structure.
In claim 11, line 23, “to set the gaze direction (151) of the eye…” should read “to set the gaze direction in order to remove the reference to the figure number in the claims.
In claim 14, line 2, “by an OCT imaging system…” should read “by an optical coherence tomography, OCT, imaging system…” in order to add a proper introduction to the acronym used.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 1-5, and 8-14 recite limitations that use words like “means” (or “step”) or similar terms with functional language and do invoke 35 U.S.C. 112(f):
Claim 1; recites the limitation, “an OCT imaging system operable to acquire the AS-OCT image…” [Line 15].
Claim 1; recites the limitation, “a fixation target arranged to fix a gaze direction of the eye…” [Line 16].
Claims 2, 3, 5, 8; recite the limitation, “controller arranged to control…” [Lines 22, 12, 20, 4, respectively].
Claim 4; recites the limitation, “the controller is arranged to determine…,” [Line 7].
Claim 8; recites the limitation, “display device arranged to display a graphic…,” [Line 4].
Claims 9, 10, 11, 12; recite the limitation, “the fixation target is used to equalise the image contrast…,” [Lines 11, 17, 12, 9, respectively].
Claim 13; recites the limitation, “which is displayed by a display device…,” [Line 18].
Claim 14; recites the limitation, “acquired by an OCT imaging system…to obtain a geometric measurement…,” [Lines 23-24].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
After a careful analysis, as disclosed above, and a careful review of the specification the following limitations in claims 1-5, and 8-14:
“OCT imaging system” (Fig. 1, #110 called OCT imaging system, Page 10-11, Lines [20-29, 1-2] – “Although the data processing hardware 150 may be provided as a component that is separate from the OCT imaging system 110, as in the present example embodiment, the data processing hardware 150 may alternatively form part of the OCT imaging system 110, with its functions performed by the controller 115, for example. The OCT imaging system 110 may, as in the present example embodiment, be a point-scan Fourier-domain OCT imaging system. However, the form of the OCT imaging system 110 is not so limited, and may alternatively take the form of a time-domain system, and may furthermore alternatively be line-scan or a full-field OCT imaging system. Further, the OCT imaging system 110 may be operable to acquire both AS-OCT images and posterior-segment OCT (PS-OCT) images of the eye 140.” Thus, the OCT imaging system does have sufficient structure associated with it wherein it is an optical imaging system whose functions are performed by a controller (processor).
“fixation target” (Fig. 1, #120 called fixation target, Page 13-14, Lines [18-30, 1-4] – “Figure 3 is a schematic illustration of an example implementation of the OCT imaging system 110, wherein the fixation target 120 takes the form of a graphic 310 which is displayed by a display device 300 forming part of the OCT imaging system 110. Although the graphic 310 takes the form of a dot in Figure 3, it will be appreciated that the form of the graphic is not so limited, and may alternatively be provides as a cross, circle or any shape onto which the eye 140 can fixate. Furthermore, the fixation target 120 may be implemented in a form other than a display device. For example, the fixation target 120 may include a light source (e.g. a light-emitting diode) attached to an actuator that is controllable by the controller 115 to move the light source relative to the eye 140 so as to control a gaze direction 151 of the eye 140 when the eye 140 fixates on the light source.” Thus, the fixation target does have sufficient structure associated with it wherein it is a graphic displayed on a monitor, or a light source controlled by a controller (processor).
“controller” (Fig. 1, #115 called controller, Page 14, Lines [14-16] – “The data processing hardware 150 and the controller 115 of the OCT imaging system 110 may be provided in any suitable form, for example as a programmable signal processing hardware 400 of the kind illustrated schematically in Figure 4.” Page 14-15, Lines [28-30, 1-4] – “The signal processing hardware 400 further comprises a processor (e.g. a Central Processing Unit, CPU, and/or a Graphics Processing Unit, GPU) 420, a working memory 430 (e.g. a random-access memory) and an instruction store 440 storing a computer program 445 comprising the computer-readable instructions which, when executed by the processor 420, cause the processor 420 to perform various functions including those of the data processing hardware 150 and/or the controller 115 of the OCT imaging system 110 described herein.” Thus, the controller does have sufficient structure associated with it wherein its functions are carried out by a processor.
“display device” (Fig. 3, #300 called display device, Page 14, Lines [18-23] – “The programmable signal processing apparatus 400 comprises a communication interface (I/F) 410 for communication data externally. Where the apparatus 400 implements the data processing hardware 150, the I/F 410 may be arranged to receive the AS-OCT image 130 from the OCT imaging system 110 and output the geometric measurement 160 and/or a graphical representation thereof (for example, as overlaid on the AS-OCT image 130) for displaying on a display, such a computer screen or the like.” Thus, the display device does have sufficient structure associated with it wherein it is a screen of a computing device.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over LI (US 20170105617 A1), hereinafter referenced as LI in view of SRINIVASAN (US 20160095752 A1), hereinafter referenced as SRINIVASAN.
Regarding claim 1, LI teaches a system (Fig. 2, #1 called optical coherence tomographic apparatus, Paragraph [0043]) arranged to process an anterior-segment optical coherence tomography, AS-OCT, image (Figs. 1-2, Paragraph [0043] - LI discloses the optical coherence tomographic apparatus 1 is used for ophthalmologic examinations for an anterior eye Ec of a subject's eyeball (subjected eye E) (see FIG. 1) such as measurements of an angle of the eye, a curvature of a cornea, a distribution of corneal thickness, an ACD, and the like, as well as for an ophthalmologic diagnosis in which a tomographic image of the anterior eye including the cornea, iris, and crystalline lens is displayed on a monitor or the like.)
comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye (Fig. 2, Paragraph [0075] – LI discloses a position of a SS of the subjected eye which is obtained by analyzing the anterior eye tomographic images acquired by the optical coherence tomographic apparatus 1 is used.), the system comprising:
data processing hardware (Fig. 2, #3 called controller, Paragraph [0046] – LI discloses the main body of the apparatus 1 comprises the controller 3.) arranged to:
process the AS-OCT image (Fig. 7, Paragraph [0077] – LI discloses in step S10, the controller 3 extracts one arbitrary B-scan image from a plurality of B-scan images (the anterior eye tomographic images including the corneal apex) stored in the memory 10.)
to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image (Fig. 7, Paragraph [0078] – LI discloses in step S11, the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS [wherein SS is scleral spur] at each side.);
and obtain the geometric measurement based on the acquired locations (Fig. 7, Paragraph [0078] – LI discloses controller 3 identifies the positions of the SS, and calculates a distance between the identified SS positions and the apex on the front surface of the crystalline lens 84. Paragraph [0079] – LI further discloses in step S12, the controller 3 connects the identified left and right SS positions with a straight line (hereinbelow referred to as “SS-line”) (see FIGS. 8A and 8B). Then, in step S13, the controller 3 draws a straight line, parallel to a visual axis Z, from a midpoint of the SS-line toward the rear surface of the cornea. In step S14, the controller 3 calculates an SPD which is a distance from a position of an intersection point of the straight line drawn in S13 and the rear surface of the cornea to the SS-line.);
Although LI further teaches and an OCT imaging system (Fig. 1, Paragraph [0048] – LI discloses FIG. 1 shows configurations of the aforementioned optical systems, that is, configurations of the OCT system 5, the anterior eye image capturing system 6, and the alignment optical system 4.)
operable to acquire the AS-OCT image (Fig. 2, Paragraph [0048] – LI discloses OCT system 5 is configured to acquire tomographic images (cross sectional images) of the anterior eye Ec by OCT.),
LI fails to explicitly teach the OCT imaging system comprising a fixation target arranged to fix a gaze direction of the eye during acquisition of the AS-OCT image such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system.
However, SRINIVASAN explicitly teaches the OCT imaging system (Fig. 7A, #646 called imaging system, Paragraph [0234] – SRINIVASAN discloses imaging system 646 may comprise one or more components of the ranging system 46 as described herein alignment and may comprise one or more components of guidance system 48 as described herein, for example the OCT system of ranging system 46 and video camera of alignment guidance system 48.)
comprising a fixation target (Fig. 7A, #119 called fixation light, Paragraph [0236] – SRINIVASAN discloses imaging system 648 comprises fixation light 119 as described herein for the patient to view when measurements are obtained.)
arranged to fix a gaze direction of the eye during acquisition of the AS-OCT image (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646.)
such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646. Paragraph [0243] – SRINIVASAN further discloses the axes of the eye that can be identified and determined with the imaging system 646 or the processor of laser system (and combinations thereof) include a fixation axis 43FA, a visual axis 43VA, a line of sight 43LOS, a pupillary axis 43PA and an optical axis 43AO. See also Fig. 12, Paragraph [0316].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI of having system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: data processing hardware arranged to: process the AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image; and obtain the geometric measurement based on the acquired locations; and an OCT imaging system operable to acquire the AS-OCT image, with the teachings of SRINIVASAN having the OCT imaging system comprising a fixation target arranged to fix a gaze direction of the eye during acquisition of the AS-OCT image such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system.
Wherein LI’s system wherein having the OCT imaging system comprising a fixation target arranged to fix a gaze direction of the eye during acquisition of the AS-OCT image such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
Regarding claim 9, LI teaches the use of a fixation target (Fig. 1, Paragraph [0056] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp.)
of an optical coherence tomography, OCT, imaging system (Figs. 1-2, Paragraph [0043] - LI discloses the optical coherence tomographic apparatus 1 is used for ophthalmologic examinations for an anterior eye Ec of a subject's eyeball (subjected eye E) (see FIG. 1) such as measurements of an angle of the eye, a curvature of a cornea, a distribution of corneal thickness, an ACD, and the like, as well as for an ophthalmologic diagnosis in which a tomographic image of the anterior eye including the cornea, iris, and crystalline lens is displayed on a monitor or the like.)
to equalise image contrast (Fig. 7, Paragraph [0077] – LI discloses in step S10, the controller 3 extracts one arbitrary B-scan image from a plurality of B-scan images (the anterior eye tomographic images including the corneal apex) stored in the memory 10. LI further discloses one B-scan image is extracted from B-scan images having contrast values equal to or larger than a predetermined contrast value.)
in representations of portions of a scleral spur of an eye (Fig. 7, Paragraph [0078] – LI discloses the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS [wherein SS is scleral spur] at each side.)
in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system (Fig. 2, Paragraph [0043] – LI discloses optical coherence tomographic apparatus 1 captures tomographic images of the anterior eye Ec of the subjected eye E by Optical Coherence Tomography (OCT).)
Although LI explicitly teaches wherein the fixation target (Fig. 1, #32 called vision-fixation lamp, Paragraph [0057]) is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image (Fig. 1, Paragraph [0056] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp. See also Paragraph [0077])
LI fails to explicitly teach such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system.
However, SRINIVASAN explicitly teaches such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646. Paragraph [0243] – SRINIVASAN further discloses the axes of the eye that can be identified and determined with the imaging system 646 or the processor of laser system (and combinations thereof) include a fixation axis 43FA, a visual axis 43VA, a line of sight 43LOS, a pupillary axis 43PA and an optical axis 43AO. See also Fig. 12, Paragraph [0316].).
.Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI of having the use of a fixation target of an optical coherence tomography, OCT, imaging system to equalise image contrast in representations of portions of a scleral spur of an eye in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system, wherein the fixation target is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of SRINIVASAN having such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system.
Wherein LI’s use of a fixation target of an optical coherence tomography, OCT, imaging system wherein having such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
Regarding claim 14, LI teaches a method of processing an anterior-segment optical coherence tomography, AS-OCT, image (Fig. 7, Paragraph [0076] – LI discloses FIG. 7 is a flowchart showing a procedure of calculating an ELP according to the calculation method of the present disclosure.)
acquired by an OCT imaging system (Fig. 7, Paragraph [0077] – LI discloses in step S10, the controller 3 extracts one arbitrary B-scan image from a plurality of B-scan images (the anterior eye tomographic images including the corneal apex) stored in the memory 10 Paragraph [0046] – LI further discloses the main body of the apparatus 1 comprises the controller 3 which includes a microcomputer including a CPU, a memory, and the like and is configured to perform overall control of the optical coherence tomographic apparatus 1.),
which comprises representations of portions of a scleral spur of an eye (Fig. 2, Paragraph [0075] – LI discloses a position of a SS of the subjected eye which is obtained by analyzing the anterior eye tomographic images acquired by the optical coherence tomographic apparatus 1 is used.),
to obtain a geometric measurement based on one or more anatomical features in the AS-OCT image (Fig. 7, Paragraph [0079] – LI discloses in step S12, the controller 3 connects the identified left and right SS positions with a straight line (hereinbelow referred to as “SS-line”) (see FIGS. 8A and 8B). Then, in step S13, the controller 3 draws a straight line, parallel to a visual axis Z, from a midpoint of the SS-line toward the rear surface of the cornea. In step S14, the controller 3 calculates an SPD which is a distance from a position of an intersection point of the straight line drawn in S13 and the rear surface of the cornea to the SS-line.),
processing the acquired AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image (Fig. 7, Paragraph [0078] – LI discloses in step S11, the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side. The controller 3 identifies the positions of the SS, and calculates a distance between the identified SS positions and the apex on the front surface of the crystalline lens 84.);
Although LI explicitly teaches and obtaining the geometric measurement based on the acquired locations in the AS-OCT image (Fig. 7, Paragraph [0079] – LI discloses in step S12, the controller 3 connects the identified left and right SS positions with a straight line (hereinbelow referred to as “SS-line”) (see FIGS. 8A and 8B). Then, in step S13, the controller 3 draws a straight line, parallel to a visual axis Z, from a midpoint of the SS-line toward the rear surface of the cornea. In step S14, the controller 3 calculates an SPD which is a distance from a position of an intersection point of the straight line drawn in S13 and the rear surface of the cornea to the SS-line.).
LI fails to explicitly teach the method comprising: acquiring the AS-OCT image whilst a gaze direction of the eye is fixed by the eye fixating on a fixation target such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system;
However, SRINIVASAN explicitly teaches the method (Fig. 12, Paragraph [0327] – SRINIVASAN discloses FIG. 12 shows a method 700 in accordance with embodiments. Further, the circuitry of system 2 as described herein, for example the processor of system 2, can be configured with instructions to perform one or more of the steps of method 700. See also Paragraph [0152].) comprising:
acquiring the AS-OCT image whilst a gaze direction of the eye is fixed by the eye fixating on a fixation target (Fig. 12, Paragraph [0316] – SRINIVASAN discloses at a step 720, patient views fixation light. At a step 725, align eye with measurement apparatus. At a step 740, measure tomography of eye without patient interface contacting eye. At a step 745, capture Iris image of eye without patient interface contacting eye. Paragraph [0236] – SRINIVASAN further discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646.)
such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646. Paragraph [0243] – SRINIVASAN further discloses the axes of the eye that can be identified and determined with the imaging system 646 or the processor of laser system (and combinations thereof) include a fixation axis 43FA, a visual axis 43VA, a line of sight 43LOS, a pupillary axis 43PA and an optical axis 43AO. See also Fig. 12, Paragraph [0316].);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI of having a method of processing an anterior-segment optical coherence tomography, AS-OCT, image acquired by an OCT imaging system, which comprises representations of portions of a scleral spur of an eye, to obtain a geometric measurement based on one or more anatomical features in the AS-OCT image, processing the acquired AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image; and obtaining the geometric measurement based on the acquired locations in the AS-OCT image, with the teachings of SRINIVASAN having the method comprising: acquiring the AS-OCT image whilst a gaze direction of the eye is fixed by the eye fixating on a fixation target such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system.
Wherein LI’s method wherein having the method comprising: acquiring the AS-OCT image whilst a gaze direction of the eye is fixed by the eye fixating on a fixation target such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced method of processing an optical coherence tomography image using a system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over LI (US 20170105617 A1), hereinafter referenced as LI in view of SRINIVASAN (US 20160095752 A1), hereinafter referenced as SRINIVASAN, further in view of PRAGER (US 8967810 B1), hereinafter referenced as PRAGER.
Regarding claim 7, LI in view of SRINIVASAN teach the system according to any preceding claim,
LI in view of SRINIVASAN fail to explicitly teach wherein the geometric measurement is a measurement of an anterior chamber angle of the eye.
However, PRAGER explicitly teaches wherein the geometric measurement is a measurement of an anterior chamber angle of the eye (Fig. 1, #30 called anterior chamber angle, Col. 3, Lines [46-47, 56-60] – PRAGER discloses FIG. 1 illustrates key anatomical landmarks and measurements for examination of the anterior chamber of the eye. Accurately determining the location of the scleral spur is important for proper evaluation of anterior chamber geometry. A proper evaluation of anterior chamber angles requires the location of scleral spur 20 to be known.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: data processing hardware arranged to: process the AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image; with the teachings of PRAGER having wherein the geometric measurement is a measurement of an anterior chamber angle of the eye.
Wherein LI’s system wherein the geometric measurement is a measurement of an anterior chamber angle of the eye.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides improved examination of the eye, since both LI and PRAGER relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and PRAGER pertains to ophthalmic diagnosis and therapy, and more particularly, its apparatus, software, means, and methods for diagnosing and treating diseases of the eye; the present invention provides for improved evaluation of anterior chamber angle by accurately and repeatedly identifying the location of the scleral spur. Please see LI (US 20170105617 A1), Paragraph [0024], and PRAGER (US 8967810 B1), Col. 1, Lines [16-22].
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over LI (US 20170105617 A1), hereinafter referenced as LI in view of SRINIVASAN (US 20160095752 A1), hereinafter referenced as SRINIVASAN, further in view of WALLACE (US 20210378507 A1), hereinafter referenced as WALLACE.
Regarding claim 8, LI in view of SRINIVASAN teach the system according to any preceding claim,
LI in view of SRINIVASAN fail to explicitly teach wherein the OCT imaging system further comprises a display device arranged to display a graphic as the fixation target, wherein the controller is arranged to control a display position of the graphic relative to the eye so as to control the gaze direction of the eye when the eye fixates on the graphic.
However, WALLACE explicitly teaches wherein the OCT imaging system (Fig. 6A, #600 called mobile communication device-based corneal topography system 600, Paragraph [0103] – WALLACE discloses FIG. 6A illustrates a side view of components of a mobile communication device-based corneal topography system according to some embodiments.)
further comprises a display device (Fig. 7A, Paragraph [0103] – WALLACE discloses the mobile communication device 605 may comprise a mobile communication device display 606.)
arranged to display a graphic as the fixation target (Fig. 1C, Paragraph [0047] – WALLACE discloses the reticle may be positioned in the video image of the patient's pupil 123. FIG. 1C is an illustration of a display screen showing a red ranging beam and a green fixation beam have been activated and are seen on a video image of the patient's cornea according to some embodiments. See also Paragraph [0109].),
wherein the controller (Fig. 6A, #615 called topography processor, Paragraph [0103] – WALLACE discloses the mobile communication device-based corneal topography system 600 may comprise a mobile communication device 605; a topography processor 615 and/or a topography printed circuit board 620.)
is arranged to control a display position of the graphic relative to the eye so as to control the gaze direction of the eye when the eye fixates on the graphic (Fig. 6A, Paragraph [0110] – WALLACE discloses the topography processor 615 may also be configured with instructions to verify that an overlap of fixation beam and the ranging beam are in alignment with a fiducial mark or cross-hairs [wherein fiducial mark or cross-hairs are a graphic] in the reflected image of the fixation beam and the ranging beam (the cross-hairs may be yellow cross-hairs in order to stand out or be distinct from a red ranging beam and green fixation beam). Fig. 2C, Paragraph [0062] – WALLACE further discloses FIG. 2C shows alignment of the eye with a ranging beam such as a laser beam focused on the cornea, in accordance with some embodiments. In some embodiments, the laser beam is inclined relative to the optical axis of the system at any suitable angle, such as an angle from about 20 degrees to about 60 degrees, such that the laser beam spot moves across the cornea 221 as the topography system moves relative to the eye along the optical axis (Z-axis) 236.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: data processing hardware arranged to: process the AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image; and an OCT imaging system operable to acquire the AS-OCT image, with the teachings of WALLACE having wherein the OCT imaging system further comprises a display device arranged to display a graphic as the fixation target, wherein the controller is arranged to control a display position of the graphic relative to the eye so as to control the gaze direction of the eye when the eye fixates on the graphic.
Wherein LI’s system wherein the OCT imaging system further comprises a display device arranged to display a graphic as the fixation target, wherein the controller is arranged to control a display position of the graphic relative to the eye so as to control the gaze direction of the eye when the eye fixates on the graphic.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and is cost efficient, portable, and easy to use, since both LI and WALLACE relate to corneal tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and WALLACE relates to a mobile communication device-based corneal topography system may comprise a mobile communication device and a corneal topography system or housing; the corneal topography system may also include additional modules or subsystems in order to perform multiple diagnostic tests on a patient's eyes; this brings at least some of the benefits described including, but not limited to portability, ease of use, lower cost and the ability to reach additional patients. Please see LI (US 20170105617 A1), Paragraph [0024], and WALLACE (US 20210378507 A1), Paragraph [0146].
Regarding claim 13, LI in view of SRINIVASAN teach the use according to Claim 9,
LI in view of SRINIVASAN fail to explicitly teach wherein the fixation target comprises a graphic which is displayed by a display device, wherein a display position of the graphic relative to the eye is controllable so as to control the gaze direction of the eye when the eye fixates on the graphic.
However, WALLACE explicitly teaches wherein the fixation target comprises a graphic (Fig. 1C, Paragraph [0047] – WALLACE discloses the reticle may be positioned in the video image of the patient's pupil 123. FIG. 1C is an illustration of a display screen showing a red ranging beam and a green fixation beam have been activated and are seen on a video image of the patient's cornea according to some embodiments. See also Paragraph [0109].)
which is displayed by a display device (Fig. 7A, Paragraph [0103] – WALLACE discloses the mobile communication device 605 may comprise a mobile communication device display 606.),
wherein a display position of the graphic relative to the eye is controllable so as to control the gaze direction of the eye when the eye fixates on the graphic (Fig. 6A, Paragraph [0110] – WALLACE discloses the topography processor 615 may also be configured with instructions to verify that an overlap of fixation beam and the ranging beam are in alignment with a fiducial mark or cross-hairs [wherein fiducial mark or cross-hairs are a graphic] in the reflected image of the fixation beam and the ranging beam (the cross-hairs may be yellow cross-hairs in order to stand out or be distinct from a red ranging beam and green fixation beam). Fig. 2C, Paragraph [0062] – WALLACE further discloses FIG. 2C shows alignment of the eye with a ranging beam such as a laser beam focused on the cornea, in accordance with some embodiments. In some embodiments, the laser beam is inclined relative to the optical axis of the system at any suitable angle, such as an angle from about 20 degrees to about 60 degrees, such that the laser beam spot moves across the cornea 221 as the topography system moves relative to the eye along the optical axis (Z-axis) 236.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having the use of a fixation target of an optical coherence tomography, OCT, imaging system to equalise image contrast in representations of portions of a scleral spur of an eye in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system, wherein the fixation target is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of WALLACE having wherein the fixation target comprises a graphic which is displayed by a display device, wherein a display position of the graphic relative to the eye is controllable so as to control the gaze direction of the eye when the eye fixates on the graphic.
Wherein LI’s use of a fixation target of an optical coherence tomography, OCT, imaging system wherein the fixation target comprises a graphic which is displayed by a display device, wherein a display position of the graphic relative to the eye is controllable so as to control the gaze direction of the eye when the eye fixates on the graphic.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and is cost efficient, portable, and easy to use, since both LI and WALLACE relate to corneal tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and WALLACE relates to a mobile communication device-based corneal topography system may comprise a mobile communication device and a corneal topography system or housing; the corneal topography system may also include additional modules or subsystems in order to perform multiple diagnostic tests on a patient's eyes; this brings at least some of the benefits described including, but not limited to portability, ease of use, lower cost and the ability to reach additional patients. Please see LI (US 20170105617 A1), Paragraph [0024], and WALLACE (US 20210378507 A1), Paragraph [0146].
Claims 2, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over LI (US 20170105617 A1), hereinafter referenced as LI in view of SRINIVASAN (US 20160095752 A1), hereinafter referenced as SRINIVASAN, further in view of ANDERSON (US 20200196863 A1), hereinafter referenced as ANDERSON.
Regarding claim 2, LI in view of SRINIVASAN teach the system according to Claim 1,
LI further teaches wherein the OCT imaging system (Fig. 1, Paragraph [0048] – LI discloses FIG. 1 shows configurations of the aforementioned optical systems, that is, configurations of the OCT system 5, the anterior eye image capturing system 6, and the alignment optical system 4.)
comprises a controller (Fig. 2, #3 called controller, Paragraph [0046])
arranged to control the OCT imaging system to acquire the AS-OCT image (Fig. 2, Paragraph [0046] – LI discloses the main body of the apparatus 1 comprises the controller 3 which includes a microcomputer including a CPU, a memory, and the like and is configured to perform overall control of the optical coherence tomographic apparatus 1, an OCT system 5 serving as a tomographic image acquisition unit for acquiring tomographic images of the anterior eye Ec, an anterior eye image capturing system 6 which configures an image capturing unit for capturing a front image of the subjected eye E, and the alignment optical system 4.),
the controller being further arranged to control the fixation target (Fig. 1, Paragraph [0046] – LI discloses the main body of the apparatus 1 comprises the controller 3 which includes a microcomputer including a CPU, a memory, and the like and is configured to perform overall control of… the alignment optical system 4 [wherein alignment optical system 4 comprises the fixation target]. See also Paragraph [0056].)
to fix the gaze direction of the eye during acquisition of the AS-OCT image (Fig. 1, Paragraph [0046] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp. See also Paragraph [0066].) by:
LI fails to explicitly teach acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
However, SRINIVASAN explicitly teaches acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.),
based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes (Fig. 12, Paragraph [0316] – SRINIVASAN discloses at a step 860, determine alignment of non-contact eye measurement reference axes in relation to contact eye measurement reference axes in response to locations of the one or more tissue structures. At a step 865, determine one or more of an orientation or a translation of the contact measurement axes of the eye in relation to non-contact measurement axes of the eye.)
and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that (Fig. 7A, Paragraph [0021] – SRINIVASAN discloses the one or more marks indicating the locations of one or more optical structures of eye can be shown on the display with the reflection of the fixation light in order for the user to determine alignment of the eye. The one or more marks may identify locations of one or more optical structures of the eye prior to contact with the patient interface, or identify locations of one or more structures of the eye contacting the patient interface such as a center of the limbus of the eye or centers of curvature of the lens of the eye, for example.),
when the gaze direction of the eye is fixed by the fixation target at the set position (Fig. 7A, Paragraph [0235] – SRINIVASAN discloses imaging system 646 can be aligned with one or more axes of the eye as described herein, for example with the patient viewing the fixation light 119. In many embodiments, the patient views fixation light 119, and the imaging system 646 is aligned with the eye in one or more of many ways as described herein.),
the axis in the AS-OCT image is aligned with the direction in the AS-OCT image (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: data processing hardware arranged to: process the AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image; the OCT imaging system comprising a fixation target arranged to fix a gaze direction of the eye during acquisition of the AS-OCT image with the teachings of SRINIVASAN having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
Wherein LI’s system wherein having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
LI in view of SRINIVASAN fail to explicitly teach acquiring an indication of a laterality of the eye; and the acquired indication of the laterality of the eye;
However, ANDERSON explicitly teaches acquiring an indication of a laterality of the eye (Fig. 3b, Paragraph [0077] – ANDERSON discloses FIG. 3b shows an example of an acquisition window/screen 345 used for acquiring (e.g., capturing) patient images. The laterality is displayed, e.g., via laterality icon(s) 361, highlighting which eye is being imaged (e.g., the right eye (oculus dexter) OD or the left eye (oculus sinister) OS).);
and the acquired indication of the laterality of the eye (Fig. 3c, Paragraph [0077] – ANDERSON discloses the GUI may include a laterality icon that specifies whether the ophthalmic information displayed in the information-display region is from a left eye or right eye of a patient, and indicates whether the specified laterality is from the patient's point of view or from a doctor's point of view. Optionally, user selection of the laterality icon toggles the laterality between the doctor's and the patient's point of view.);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: data processing hardware arranged to: process the AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image; the OCT imaging system comprising a fixation target arranged to fix a gaze direction of the eye during acquisition of the AS-OCT image with the teachings of ANDERSON having acquiring an indication of a laterality of the eye; and the acquired indication of the laterality of the eye.
Wherein LI’s system wherein having acquiring an indication of a laterality of the eye; acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and the acquired indication of the laterality of the eye.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position, improves alignment between the camera and the eye, and provides for better response times in regards to image processing along with less memory consumption, since both LI and ANDERSON relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and ANDERSON discloses a system and method for controlling an ophthalmic imaging system, and a graphical user interface (GUI) for interfacing with the ophthalmic imaging system; the present performance enhancements reduced initial image loading time by about 80%, reduced memory capacity requirements by about 30%, reduced some image processing times to the point where they were imperceptible by a user; identified manual controller is operable by a user to improve alignment between the camera and the eye. Please see LI (US 20170105617 A1), Paragraph [0024], and ANDERSON (US 20200196863 A1), Paragraph [0009, 0125, 0127, 0141].
Regarding claim 10, LI in view of SRINIVASAN teach the use according to Claim 9,
LI further teaches wherein the fixation target (Fig. 1, #32 called vision-fixation lamp, Paragraph [0057]) is used to equalise the image contrast (Fig. 7, Paragraph [0077] – LI discloses in step S10, the controller 3 extracts one arbitrary B-scan image from a plurality of B-scan images (the anterior eye tomographic images including the corneal apex) stored in the memory 10. LI further discloses one B-scan image is extracted from B-scan images having contrast values equal to or larger than a predetermined contrast value.)
by fixing the gaze direction of the eye during acquisition of the AS-OCT image (Fig. 1, Paragraph [0056] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp. See also Paragraph [0077].)
LI fails to explicitly teach such that the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system by: acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and the acquired indication of the laterality of the eye; and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
However, SRINIVASAN explicitly teaches such that the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646. Paragraph [0243] – SRINIVASAN further discloses the axes of the eye that can be identified and determined with the imaging system 646 or the processor of laser system (and combinations thereof) include a fixation axis 43FA, a visual axis 43VA, a line of sight 43LOS, a pupillary axis 43PA and an optical axis 43AO. See also Fig. 12, Paragraph [0316].) by:
acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.),
based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes (Fig. 12, Paragraph [0316] – SRINIVASAN discloses at a step 860, determine alignment of non-contact eye measurement reference axes in relation to contact eye measurement reference axes in response to locations of the one or more tissue structures. At a step 865, determine one or more of an orientation or a translation of the contact measurement axes of the eye in relation to non-contact measurement axes of the eye.)
and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that (Fig. 7A, Paragraph [0021] – SRINIVASAN discloses the one or more marks indicating the locations of one or more optical structures of eye can be shown on the display with the reflection of the fixation light in order for the user to determine alignment of the eye. The one or more marks may identify locations of one or more optical structures of the eye prior to contact with the patient interface, or identify locations of one or more structures of the eye contacting the patient interface such as a center of the limbus of the eye or centers of curvature of the lens of the eye, for example.),
when the gaze direction of the eye is fixed by the fixation target at the set position (Fig. 7A, Paragraph [0235] – SRINIVASAN discloses imaging system 646 can be aligned with one or more axes of the eye as described herein, for example with the patient viewing the fixation light 119. In many embodiments, the patient views fixation light 119, and the imaging system 646 is aligned with the eye in one or more of many ways as described herein.),
the axis in the AS-OCT image is aligned with the direction in the AS-OCT image (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having the use of a fixation target of an optical coherence tomography, OCT, imaging system to equalise image contrast in representations of portions of a scleral spur of an eye in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system, wherein the fixation target is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of SRINIVASAN of having such that the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system by: acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and the acquired indication of the laterality of the eye; and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
Wherein LI’s use of a fixation target of an optical tomography, OCT, imaging system wherein having such that the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system by: acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and the acquired indication of the laterality of the eye; and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
LI in view of SRINIVASAN fail to explicitly teach acquiring an indication of a laterality of the eye; and the acquired indication of the laterality of the eye;
However, ANDERSON explicitly teaches acquiring an indication of a laterality of the eye (Fig. 3b, Paragraph [0077] – ANDERSON discloses FIG. 3b shows an example of an acquisition window/screen 345 used for acquiring (e.g., capturing) patient images. The laterality is displayed, e.g., via laterality icon(s) 361, highlighting which eye is being imaged (e.g., the right eye (oculus dexter) OD or the left eye (oculus sinister) OS).);
and the acquired indication of the laterality of the eye (Fig. 3c, Paragraph [0077] – ANDERSON discloses the GUI may include a laterality icon that specifies whether the ophthalmic information displayed in the information-display region is from a left eye or right eye of a patient, and indicates whether the specified laterality is from the patient's point of view or from a doctor's point of view. Optionally, user selection of the laterality icon toggles the laterality between the doctor's and the patient's point of view.);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having the use of a fixation target of an optical coherence tomography, OCT, imaging system to equalise image contrast in representations of portions of a scleral spur of an eye in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system, wherein the fixation target is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of ANDERSON of having acquiring an indication of a laterality of the eye; and the acquired indication of the laterality of the eye;
Wherein LI’s use of a fixation target of an optical tomography, OCT, imaging system wherein having acquiring an indication of a laterality of the eye; acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and the acquired indication of the laterality of the eye.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position, improves alignment between the camera and the eye, and provides for better response times in regards to image processing along with less memory consumption, since both LI and ANDERSON relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and ANDERSON discloses a system and method for controlling an ophthalmic imaging system, and a graphical user interface (GUI) for interfacing with the ophthalmic imaging system; the present performance enhancements reduced initial image loading time by about 80%, reduced memory capacity requirements by about 30%, reduced some image processing times to the point where they were imperceptible by a user; identified manual controller is operable by a user to improve alignment between the camera and the eye. Please see LI (US 20170105617 A1), Paragraph [0024], and ANDERSON (US 20200196863 A1), Paragraph [0009, 0125, 0127, 0141].
Regarding claim 15, LI in view of SRINIVASAN teach the method according to Claim 14,
LI further teaches further comprising setting the fixation target to fix the gaze direction of the eye during acquisition of the AS-OCT image (Fig. 1, Paragraph [0056] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp, an XY directional position detecting system for detecting positions of the subjected eye E (an corneal apex) in X and Y directions (displacements in the up-and-down direction and the right-and-left direction relative to the main body of the apparatus 1), and a Z directional position detecting system for detecting a position of the subjected eye E (the corneal apex) in the back-and-forth direction (Z direction).) by:
LI fails to explicitly teach acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
However, SRINIVASAN explicitly teaches acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.),
based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes (Fig. 12, Paragraph [0316] – SRINIVASAN discloses at a step 860, determine alignment of non-contact eye measurement reference axes in relation to contact eye measurement reference axes in response to locations of the one or more tissue structures. At a step 865, determine one or more of an orientation or a translation of the contact measurement axes of the eye in relation to non-contact measurement axes of the eye.)
and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that (Fig. 7A, Paragraph [0021] – SRINIVASAN discloses the one or more marks indicating the locations of one or more optical structures of eye can be shown on the display with the reflection of the fixation light in order for the user to determine alignment of the eye. The one or more marks may identify locations of one or more optical structures of the eye prior to contact with the patient interface, or identify locations of one or more structures of the eye contacting the patient interface such as a center of the limbus of the eye or centers of curvature of the lens of the eye, for example.),
when the gaze direction of the eye is fixed by the fixation target at the set position (Fig. 7A, Paragraph [0235] – SRINIVASAN discloses imaging system 646 can be aligned with one or more axes of the eye as described herein, for example with the patient viewing the fixation light 119. In many embodiments, the patient views fixation light 119, and the imaging system 646 is aligned with the eye in one or more of many ways as described herein.),
the axis in the AS-OCT image is aligned with the direction in the AS-OCT image (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having a method of processing an anterior-segment optical coherence tomography, AS-OCT, image acquired by an OCT imaging system, the method comprising: acquiring the AS-OCT image whilst a gaze direction of the eye is fixed by the eye fixating on a fixation target such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system; with the teachings of SRINIVASAN having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
Wherein LI’s method wherein having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and using the acquired indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye to set a position of the fixation target relative to the eye such that, when the gaze direction of the eye is fixed by the fixation target at the set position, the axis in the AS-OCT image is aligned with the direction in the AS-OCT image.
The motivation behind this modification would have been to provide an enhanced method of processing an optical coherence tomography image using a system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
LI in view of SRINIVASAN fail to explicitly teach acquiring an indication of a laterality of the eye; and the acquired indication of the laterality of the eye;
However, ANDERSON explicitly teaches acquiring an indication of a laterality of the eye (Fig. 3b, Paragraph [0077] – ANDERSON discloses FIG. 3b shows an example of an acquisition window/screen 345 used for acquiring (e.g., capturing) patient images. The laterality is displayed, e.g., via laterality icon(s) 361, highlighting which eye is being imaged (e.g., the right eye (oculus dexter) OD or the left eye (oculus sinister) OS).);
and the acquired indication of the laterality of the eye (Fig. 3c, Paragraph [0077] – ANDERSON discloses the GUI may include a laterality icon that specifies whether the ophthalmic information displayed in the information-display region is from a left eye or right eye of a patient, and indicates whether the specified laterality is from the patient's point of view or from a doctor's point of view. Optionally, user selection of the laterality icon toggles the laterality between the doctor's and the patient's point of view.);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having a method of processing an anterior-segment optical coherence tomography, AS-OCT, image acquired by an OCT imaging system, the method comprising: acquiring the AS-OCT image whilst a gaze direction of the eye is fixed by the eye fixating on a fixation target such that an axis in the AS-OCT image corresponding to a pupillary axis of the eye is aligned with a direction in the AS-OCT image corresponding to an axial imaging direction of the OCT imaging system; with the teachings of ANDERSON having acquiring an indication of a laterality of the eye; and the acquired indication of the laterality of the eye.
Wherein LI’s method wherein having acquiring an indication of a laterality of the eye; acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye, based on measurements of relative orientations of the pupillary axis and the visual axis in eyes of a sample set of eyes and the acquired indication of the laterality of the eye.
The motivation behind this modification would have been to provide an enhanced method of processing an optical coherence tomography image using a system that calculates a highly accurate estimated lens position, improves alignment between the camera and the eye, and provides for better response times in regards to image processing along with less memory consumption, since both LI and ANDERSON relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and ANDERSON discloses a system and method for controlling an ophthalmic imaging system, and a graphical user interface (GUI) for interfacing with the ophthalmic imaging system; the present performance enhancements reduced initial image loading time by about 80%, reduced memory capacity requirements by about 30%, reduced some image processing times to the point where they were imperceptible by a user; identified manual controller is operable by a user to improve alignment between the camera and the eye. Please see LI (US 20170105617 A1), Paragraph [0024], and ANDERSON (US 20200196863 A1), Paragraph [0009, 0125, 0127, 0141].
Claims 3-6, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over LI (US 20170105617 A1), hereinafter referenced as LI in view of SRINIVASAN (US 20160095752 A1), hereinafter referenced as SRINIVASAN, further in view of FINGLER (US 20170020387 A1), hereinafter referenced as FINGLER.
Regarding claim 3, LI in view of SRINIVASAN teach the system according to Claim 1,
LI further teaches wherein the AS-OCT image is a B-scan (Fig. 1, Paragraph [0077] – LI discloses the controller 3 extracts one arbitrary B-scan image from a plurality of B-scan images (the anterior eye tomographic images including the corneal apex) stored in the memory 10.)
comprising the representations of the portions of the scleral spur of the eye (Fig. 11, Paragraph [0078] – LI discloses the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side.),
and the OCT imaging system (Fig. 1, Paragraph [0048] – LI discloses FIG. 1 shows configurations of the aforementioned optical systems, that is, configurations of the OCT system 5, the anterior eye image capturing system 6, and the alignment optical system 4.)
comprises a controller (Fig. 2, #3 called controller, Paragraph [0046])
arranged to control the OCT imaging system to acquire the AS-OCT image (Fig. 2, Paragraph [0046] – LI discloses the main body of the apparatus 1 comprises the controller 3 which includes a microcomputer including a CPU, a memory, and the like and is configured to perform overall control of the optical coherence tomographic apparatus 1, an OCT system 5 serving as a tomographic image acquisition unit for acquiring tomographic images of the anterior eye Ec, an anterior eye image capturing system 6 which configures an image capturing unit for capturing a front image of the subjected eye E, and the alignment optical system 4.),
the controller being further arranged to control the fixation target (Fig. 1, Paragraph [0046] – LI discloses the main body of the apparatus 1 comprises the controller 3 which includes a microcomputer including a CPU, a memory, and the like and is configured to perform overall control of… the alignment optical system 4 [wherein alignment optical system 4 comprises the fixation target]. See also Paragraph [0056].)
to fix the gaze direction of the eye during acquisition of the B-scan (Fig. 1, Paragraph [0046] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp. See also Paragraph [0066].) by:
controlling the OCT imaging system to acquire a B-scan of at least a portion of the anterior segment of the eye (Fig. 7, Paragraph [0077] – LI discloses the controller 3 extracts one arbitrary B-scan image from a plurality of B-scan images (the anterior eye tomographic images including the corneal apex) stored in the memory 10.),
an orientation of an axis in the B-scan corresponding to the pupillary axis of the eye (Fig. 1, Paragraph [56] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp, an XY directional position detecting system for detecting positions of the subjected eye E (an corneal apex) in X and Y directions (displacements in the up-and-down direction and the right-and-left direction relative to the main body of the apparatus 1), and a Z directional position detecting system for detecting a position of the subjected eye E (the corneal apex) in the back-and-forth direction (Z direction). Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.)
relative to a direction in the B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 1, Paragraph [0063] – LI discloses based on the positional displacement amount of the corneal apex (bright point) in the X direction and the Y direction detected by the XY directional position detecting system 56 and the positional displacement amount of the subjected eye E in the Z direction detected by the Z directional position detecting system 58, the controller 3 controls the main body driver 2 and moves the main body of the apparatus 1 relative to the holding table so that those positional displacement amounts become zero. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. Due to this, the alignment unit and the auto eye tracking unit are configured.);
and using the acquired indication of the orientation to set a position of the fixation target relative to the eye during acquisition of the AS-OCT image such that (Fig. 3, Paragraph [0063] – LI discloses controller 3 is configured to move the main body of the apparatus 1 relative to the holding table so as to make the position of the corneal apex coincident with the predetermined image acquiring position at a time of starting to acquire tomographic images. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. Due to this, the alignment unit and the auto eye tracking unit are configured.),
when the gaze direction of the eye is fixed by the fixation target at the set position (Fig. 3, Paragraph [0066] – LI discloses the controller 3 starts alignments in the X, Y, Z directions by the alignment optical system 4 and the like in step S3. The controller 3 finishes the alignments in a case where a bright point for recognizing the corneal apex is coincident with the regular image acquiring position (YES in step S4).),
Although LI further teaches the axis in the B-scan is aligned with the direction in the B-scan (Fig. 3, Paragraph [0063] – LI discloses in step S5, the controller 3 executes processing of acquiring tomographic images of the anterior eye Ec by the OCT system 5. During the processing of acquiring the tomographic images, auto eye-tracking functions, and thus the main body of the apparatus 1 is moved by the alignment optical system 4 and the like so as to track the corneal apex such that the bright point for recognizing the corneal apex is constantly coincident with the regular image acquiring position (a center position of the image captured by the CCD camera 30).).
LI fails to explicitly teach acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by controlling the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining, as the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye,
However, SRINIVASAN explicitly teaches acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.) by:
by controlling the fixation target to set the gaze direction of the eye (Fig. 3A, Paragraph [0188] – SRINIVASAN discloses assembly 62 of system 2 may comprise a fixation light 119 that provides visible light for the patient to fixate during measurement, alignment and treatment of the eye, for example.)
such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0235-236] – SRINIVASAN discloses imaging system 646 can be aligned with one or more axes of the eye as described herein, for example with the patient viewing the fixation light 119. In many embodiments, the patient views fixation light 119, and the imaging system 646 is aligned with the eye in one or more of many ways as described herein. SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646. Paragraph [0243] – SRINIVASAN further discloses the axes of the eye that can be identified and determined with the imaging system 646 or the processor of laser system (and combinations thereof) include a fixation axis 43FA, a visual axis 43VA, a line of sight 43LOS, a pupillary axis 43PA and an optical axis 43AO. See also Fig. 12, Paragraph [0316].);
and determining, as the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.),
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: data processing hardware arranged to: process the AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image; the OCT imaging system comprising a fixation target arranged to fix a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of SRINIVASAN having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by controlling the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining, as the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye.
Wherein LI’s system wherein having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by controlling the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining, as the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
LI in view of SRINIVASAN fail to explicitly teach calibration, wherein the calibration B-scan is parallel to the B-scan,
However, FINGLER explicitly teaches calibration (Fig. 7, Paragraph [0040] – FINGLER discloses FIG. 7 schematically illustrates four B-scans, two B-scan clusters, and one B-scan cluster set by way of example that may be used for the calculation of an OCT phase sensitive B-scan registration [wherein registration is calibration].),
wherein the calibration B-scan is parallel to the B-scan (Fig. 7, Paragraph [0071] – FINGLER discloses each B-scan may be located along the same transverse axis or another transverse axis (the x-axis or the y-axis) that may be parallel to those of other B-scans within the B-scan cluster set. Each B-scan may form a plane perpendicular to one of the transverse axes, and each B-scan plane may thereby be parallel to that of the other B-scans. Paragraph [0103] – FINGLER further discloses cumulative axial shift for each B-scan within a B-scan cluster may be calculated by using any method. A reference B-scan [wherein reference B-scan is calibration B-scan] may be chosen and other B-scans within the cluster may be aligned with this reference B-scan. This reference B-scan may be any B-scan within a B-scan cluster. For example, the reference B-scan may be the first formed B-scan belonging to the B-scan cluster.),
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having a system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: an OCT imaging system operable to acquire the AS-OCT image, with the teachings of FINGLER having calibration, wherein the calibration B-scan is parallel to the B-scan.
Wherein LI’s system wherein having controlling the OCT imaging system to acquire a calibration B-scan of at least a portion of the anterior segment of the eye, wherein the calibration B-scan is parallel to the B-scan, an orientation of an axis in the calibration B-scan corresponding to the pupillary axis of the eye relative to a direction in the calibration B-scan corresponding to the axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and improves processing options, since both LI and FINGLER relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and FINGLER discloses an OCT system with phase sensitive B-scan registration; the phase-sensitive B-scan registration method may comprise aligning the axial (z-axis direction) component of the motion to minimize the motion effects on the OCT signal (“axial alignment method”), this method may allow improved processing options and statistical outlier analysis for isolating data from the B-scans with largest motion noise. Please see LI (US 20170105617 A1), Paragraph [0024], and FINGLER (US 20170020387 A1), Paragraph [0016, 0080-0082].
Regarding claim 4, LI and SRINIVASAN in view of FINGLER teach the system according to Claim 3,
LI further teaches wherein the controller (Fig. 2, #3 called controller, Paragraph [0046]) is arranged to determine the orientation of the axis in the B-scan relative to the direction in the B-scan (Fig. 1, Paragraph [0060] – LI discloses controller 3, based on the detection by the position sensor 38, finds positional displacement amount of the detected corneal apex (bright point) in the X direction and the Y direction (positional displacement amount from the center of the screen of the monitor 7) relative to the regular image acquiring position.) by:
identifying a representation of an anatomical feature of the eye within the B-scan (Fig. 1, Paragraph [0063] – LI discloses the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. See also Fig. 11, Paragraph [0078].)
for determining the orientation of the axis in the B-scan relative to the direction in the B-scan (Figs. 5A-B, Paragraph [0067] – LI discloses the tomographic images are scanned with a B-scan direction as a radial direction and a C-scan direction as a circumferential direction. At this occasion, even if the subjected eye E moves, the positional relationship between the main body of the apparatus 1 and the subjected eye E is maintained constant by the auto eye tracking.);
and determining the orientation of the axis in the B-scan relative to the direction in the B-scan based on the identified representation of the anatomical feature of the eye (Fig. 1, Paragraph [0063] – LI discloses based on the positional displacement amount of the corneal apex (bright point) in the X direction and the Y direction detected by the XY directional position detecting system 56 and the positional displacement amount of the subjected eye E in the Z direction detected by the Z directional position detecting system 58, the controller 3 controls the main body driver 2 and moves the main body of the apparatus 1 relative to the holding table so that those positional displacement amounts become zero. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well.).
LI in view of SRINIVASAN fail to explicitly teach calibration.
However, FINGLER explicitly teaches calibration (Fig. 7, Paragraph [0040] – FINGLER discloses FIG. 7 schematically illustrates four B-scans, two B-scan clusters, and one B-scan cluster set by way of example that may be used for the calculation of an OCT phase sensitive B-scan registration [wherein registration is calibration]. See also Paragraph [0103].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having a system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: an OCT imaging system operable to acquire the AS-OCT image, with the teachings of FINGLER having calibration.
Wherein LI’s system wherein the controller is arranged to determine the orientation of the axis in the calibration B-scan relative to the direction in the calibration B-scan by: identifying a representation of an anatomical feature of the eye within the calibration B-scan for determining the orientation of the axis in the calibration B-scan relative to the direction in the calibration B-scan; and determining the orientation of the axis in the calibration B-scan relative to the direction in the calibration B-scan based on the identified representation of the anatomical feature of the eye.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and improves processing options, since both LI and FINGLER relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and FINGLER discloses an OCT system with phase sensitive B-scan registration; the phase-sensitive B-scan registration method may comprise aligning the axial (z-axis direction) component of the motion to minimize the motion effects on the OCT signal (“axial alignment method”), this method may allow improved processing options and statistical outlier analysis for isolating data from the B-scans with largest motion noise. Please see LI (US 20170105617 A1), Paragraph [0024], and FINGLER (US 20170020387 A1), Paragraph [0016, 0080-0082].
Regarding claim 5, LI in view of SRINIVASAN teach the system according to Claim 1,
LI further teaches wherein the OCT imaging system (Fig. 1, Paragraph [0048] – LI discloses FIG. 1 shows configurations of the aforementioned optical systems, that is, configurations of the OCT system 5, the anterior eye image capturing system 6, and the alignment optical system 4.)
comprises a controller (Fig. 2, #3 called controller, Paragraph [0046])
arranged to control the OCT imaging system to acquire the AS-OCT image (Fig. 2, Paragraph [0046] – LI discloses the main body of the apparatus 1 comprises the controller 3 which includes a microcomputer including a CPU, a memory, and the like and is configured to perform overall control of the optical coherence tomographic apparatus 1, an OCT system 5 serving as a tomographic image acquisition unit for acquiring tomographic images of the anterior eye Ec, an anterior eye image capturing system 6 which configures an image capturing unit for capturing a front image of the subjected eye E, and the alignment optical system 4.),
the controller being further arranged to control the fixation target (Fig. 1, Paragraph [0046] – LI discloses the main body of the apparatus 1 comprises the controller 3 which includes a microcomputer including a CPU, a memory, and the like and is configured to perform overall control of… the alignment optical system 4 [wherein alignment optical system 4 comprises the fixation target]. See also Paragraph [0056].)
to fix the gaze direction of the eye during acquisition of the B-scan (Fig. 1, Paragraph [0046] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp. See also Paragraph [0066].) by:
controlling the OCT imaging system (Fig. 2, Paragraph [0046]) to acquire a first B-scan of a first cross-section of at least a portion of the anterior segment of the eye (Fig. 1, Paragraph [0048] – LI discloses OCT system 5 is configured to acquire tomographic images (cross sectional images) of the anterior eye Ec by OCT.),
and a second B-scan of a second cross-section of at least a portion of the anterior segment of the eye (Fig. 1, Paragraph [0048] – LI discloses OCT system 5 is configured to acquire tomographic images (cross sectional images) of the anterior eye Ec by OCT.),
determining a first orientation of a first axis in the first B-scan corresponding to the pupillary axis of the eye relative to a first direction in the first B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 1, Paragraph [0061] – LI discloses depending on a position of the subjected eye E in the back-and-forth direction (Z direction) relative to the main body of the apparatus 1, an incident position of the reflected light which enters the line sensor 41 varies. Due to this, by detecting the incident position, the position (distance) of the subjected eye E in the Z direction relative to the main body of the apparatus 1 is detected. Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.);
determining a second orientation of a second axis in the second B-scan corresponding to the pupillary axis of the eye relative to a second direction in the second B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 1, Paragraph [0061] – LI discloses depending on a position of the subjected eye E in the back-and-forth direction (Z direction) relative to the main body of the apparatus 1, an incident position of the reflected light which enters the line sensor 41 varies. Due to this, by detecting the incident position, the position (distance) of the subjected eye E in the Z direction relative to the main body of the apparatus 1 is detected. Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.);
and using the acquired indication of the orientation to set a position of the fixation target relative to the eye during acquisition of the AS-OCT image such that (Fig. 3, Paragraph [0063] – LI discloses controller 3 is configured to move the main body of the apparatus 1 relative to the holding table so as to make the position of the corneal apex coincident with the predetermined image acquiring position at a time of starting to acquire tomographic images. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. Due to this, the alignment unit and the auto eye tracking unit are configured.),
when the gaze direction of the eye is fixed by the fixation target at the set position (Fig. 3, Paragraph [0066] – LI discloses the controller 3 starts alignments in the X, Y, Z directions by the alignment optical system 4 and the like in step S3. The controller 3 finishes the alignments in a case where a bright point for recognizing the corneal apex is coincident with the regular image acquiring position (YES in step S4).),
LI fails to explicitly teach acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye based on the determined first orientation and the determined second orientation; the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system.
However, SRINIVASAN explicitly teaches acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.) by:
by using the fixation target to set the gaze direction of the eye (Fig. 3A, Paragraph [0188] – SRINIVASAN discloses assembly 62 of system 2 may comprise a fixation light 119 that provides visible light for the patient to fixate during measurement, alignment and treatment of the eye, for example.)
such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0235-236] – SRINIVASAN discloses imaging system 646 can be aligned with one or more axes of the eye as described herein, for example with the patient viewing the fixation light 119. In many embodiments, the patient views fixation light 119, and the imaging system 646 is aligned with the eye in one or more of many ways as described herein. SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646. Paragraph [0243] – SRINIVASAN further discloses the axes of the eye that can be identified and determined with the imaging system 646 or the processor of laser system (and combinations thereof) include a fixation axis 43FA, a visual axis 43VA, a line of sight 43LOS, a pupillary axis 43PA and an optical axis 43AO. See also Fig. 12, Paragraph [0316].);
and determining the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye based on the determined first orientation and the determined second orientation (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface. At a step 860, determine alignment of non-contact eye measurement reference axes in relation to contact eye measurement reference axes in response to locations of the one or more tissue structures. At a step 865, determine one or more of an orientation or a translation of the contact measurement axes of the eye in relation to non-contact measurement axes of the eye.);
the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: data processing hardware arranged to: process the AS-OCT image to acquire respective locations in the AS-OCT image of the representations of the portions of the scleral spur of the eye in the AS-OCT image; the OCT imaging system comprising a fixation target arranged to fix a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of SRINIVASAN having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye based on the determined first orientation and the determined second orientation; the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system.
Wherein LI’s system wherein having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye based on the determined first orientation and the determined second orientation; the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
LI in view of SRINIVASAN fail to explicitly teach wherein a plane of the first cross-section is perpendicular to a plane of the second cross-section, calibration.
However, FINGLER explicitly teaches wherein a plane of the first cross-section is perpendicular to a plane of the second cross-section (Fig. 2, Paragraph [0071] – FINGLER discloses each B-scan may be located along the same transverse axis or another transverse axis (the x-axis or the y-axis) that may be parallel to those of other B-scans within the B-scan cluster set. Each B-scan may form a plane perpendicular to one of the transverse axes. See also Paragraph [0061].),
calibration (Fig. 7, Paragraph [0040] – FINGLER discloses FIG. 7 schematically illustrates four B-scans, two B-scan clusters, and one B-scan cluster set by way of example that may be used for the calculation of an OCT phase sensitive B-scan registration [wherein registration is calibration]. See also Paragraphs [0071, 0103].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having a system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: an OCT imaging system operable to acquire the AS-OCT image, with the teachings of FINGLER having wherein a plane of the first cross-section is perpendicular to a plane of the second cross-section, calibration.
Wherein LI’s system wherein having controlling the OCT imaging system to acquire a first calibration B-scan of a first cross-section of at least a portion of the anterior segment of the eye, and a second calibration B-scan of a second cross-section of at least a portion of the anterior segment of the eye, wherein a plane of the first cross-section is perpendicular to a plane of the second cross-section, determining a first orientation of a first axis in the first calibration B-scan corresponding to the pupillary axis of the eye relative to a first direction in the first calibration B-scan corresponding to the axial imaging direction of the OCT imaging system; determining a second orientation of a second axis in the second calibration B-scan corresponding to the pupillary axis of the eye relative to a second direction in the second calibration B-scan corresponding to the axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and improves processing options, since both LI and FINGLER relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and FINGLER discloses an OCT system with phase sensitive B-scan registration; the phase-sensitive B-scan registration method may comprise aligning the axial (z-axis direction) component of the motion to minimize the motion effects on the OCT signal (“axial alignment method”), this method may allow improved processing options and statistical outlier analysis for isolating data from the B-scans with largest motion noise. Please see LI (US 20170105617 A1), Paragraph [0024], and FINGLER (US 20170020387 A1), Paragraph [0016, 0080-0082].
Regarding claim 6, LI and SRINIVASAN in view of FINGLER teach the system according to Claim 5,
LI further teaches wherein the controller (Fig. 2, #3 called controller, Paragraph [0046]) is arranged to determine the orientation of the first axis in the first B-scan relative to the first direction in the first B-scan (Fig. 7, Paragraph [0078] – LI discloses the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side. FIG. 10 is a diagram showing a schematic structure of an anterior eye of a normal subjected eye.) by:
identifying a representation of a first anatomical feature of the eye within the first B-scan (Fig. 7, Paragraph [0078] – LI discloses in step S11, the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side [wherein SS is scleral spur, which can be an anatomical feature of the eye]. FIG. 10 is a diagram showing a schematic structure of an anterior eye of a normal subjected eye. Then, FIG. 11 is a diagram showing a structure of an angle area of the anterior eye which is present within an area A of FIG. 10, and indicating positional relationships among the cornea 80, a scleral 81, the iris 82, a Ciliary body 83, the crystalline lens 84, the SS, a trabecular meshwork TM, and a Schwalbe's line SL. As shown in FIG. 11, the SS is located in a deep portion of the angle area of the subjected eye.)
for determining the orientation of the first axis in the first B-scan corresponding to the pupillary axis of the eye relative to the first direction in the first B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 7, Paragraph [0079] – LI discloses in step S12, the controller 3 connects the identified left and right SS positions with a straight line (hereinbelow referred to as “SS-line”) (see FIGS. 8A and 8B). Then, in step S13, the controller 3 draws a straight line, parallel to a visual axis Z, from a midpoint of the SS-line toward the rear surface of the cornea. Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.);
and determining the orientation of the first axis in the first B-scan corresponding to the pupillary axis of the eye relative to the first direction in the first B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 7, Paragraph [0079] – LI discloses in step S12, the controller 3 connects the identified left and right SS positions with a straight line (hereinbelow referred to as “SS-line”) (see FIGS. 8A and 8B). Then, in step S13, the controller 3 draws a straight line, parallel to a visual axis Z, from a midpoint of the SS-line toward the rear surface of the cornea. Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.)
based on the representation of the first anatomical feature of the eye within the first B-scan (Fig. 7, Paragraph [0078] – LI discloses in step S11, the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side. FIG. 10 is a diagram showing a schematic structure of an anterior eye of a normal subjected eye. Then, FIG. 11 is a diagram showing a structure of an angle area of the anterior eye which is present within an area A of FIG. 10, and indicating positional relationships among the cornea 80, a scleral 81, the iris 82, a Ciliary body 83, the crystalline lens 84, the SS, a trabecular meshwork TM, and a Schwalbe's line SL. As shown in FIG. 11, the SS is located in a deep portion of the angle area of the subjected eye.),
and wherein the controller (Fig. 2, #3 called controller, Paragraph [0046]) is arranged to determine the orientation of the second axis in the second B-scan relative to the second direction in the second B-scan (Fig. 7, Paragraph [0078] – LI discloses the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side. FIG. 10 is a diagram showing a schematic structure of an anterior eye of a normal subjected eye.) by:
identifying a representation of a second anatomical feature of the eye within the second B-scan (Fig. 7, Paragraph [0078] – LI discloses in step S11, the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side [wherein SS is scleral spur, which can be an anatomical feature of the eye]. FIG. 10 is a diagram showing a schematic structure of an anterior eye of a normal subjected eye. Then, FIG. 11 is a diagram showing a structure of an angle area of the anterior eye which is present within an area A of FIG. 10, and indicating positional relationships among the cornea 80, a scleral 81, the iris 82, a Ciliary body 83, the crystalline lens 84, the SS, a trabecular meshwork TM, and a Schwalbe's line SL. As shown in FIG. 11, the SS is located in a deep portion of the angle area of the subjected eye.)
for determining the orientation of the second axis in the second B-scan corresponding to the pupillary axis of the eye relative to the second direction in the second B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 7, Paragraph [0079] – LI discloses in step S12, the controller 3 connects the identified left and right SS positions with a straight line (hereinbelow referred to as “SS-line”) (see FIGS. 8A and 8B). Then, in step S13, the controller 3 draws a straight line, parallel to a visual axis Z, from a midpoint of the SS-line toward the rear surface of the cornea. Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.);
and determining the orientation of the second axis in the second B-scan corresponding to the pupillary axis of the eye relative to the second direction in the second B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 7, Paragraph [0079] – LI discloses in step S12, the controller 3 connects the identified left and right SS positions with a straight line (hereinbelow referred to as “SS-line”) (see FIGS. 8A and 8B). Then, in step S13, the controller 3 draws a straight line, parallel to a visual axis Z, from a midpoint of the SS-line toward the rear surface of the cornea. Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.)
Although LI further teaches based on the representation of the second anatomical feature of the eye within the second B-scan (Fig. 7, Paragraph [0078] – LI discloses in step S11, the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side. FIG. 10 is a diagram showing a schematic structure of an anterior eye of a normal subjected eye. Then, FIG. 11 is a diagram showing a structure of an angle area of the anterior eye which is present within an area A of FIG. 10, and indicating positional relationships among the cornea 80, a scleral 81, the iris 82, a Ciliary body 83, the crystalline lens 84, the SS, a trabecular meshwork TM, and a Schwalbe's line SL. As shown in FIG. 11, the SS is located in a deep portion of the angle area of the subjected eye.).
LI in view of SRINIVASAN fail to explicitly teach calibration.
However, FINGLER explicitly teaches calibration (Fig. 7, Paragraph [0040] – FINGLER discloses FIG. 7 schematically illustrates four B-scans, two B-scan clusters, and one B-scan cluster set by way of example that may be used for the calculation of an OCT phase sensitive B-scan registration [wherein registration is calibration].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having a system arranged to process an anterior-segment optical coherence tomography, AS-OCT, image comprising representations of portions of a scleral spur of an eye to obtain a geometric measurement of the eye, the system comprising: an OCT imaging system operable to acquire the AS-OCT image, with the teachings of FINGLER having calibration.
Wherein LI’s system wherein the controller is arranged to determine the orientation of the first axis in the first calibration B-scan relative to the first direction in the first calibration B-scan by: identifying a representation of a first anatomical feature of the eye within the first calibration B-scan for determining the orientation of the first axis in the first calibration B-scan corresponding to the pupillary axis of the eye relative to the first direction in the first calibration B-scan corresponding to the axial imaging direction of the OCT imaging system; and determining the orientation of the first axis in the first calibration B-scan corresponding to the pupillary axis of the eye relative to the first direction in the first calibration B-scan corresponding to the axial imaging direction of the OCT imaging system based on the representation of the first anatomical feature of the eye within the first calibration B-scan, and wherein the controller is arranged to determine the orientation of the second axis in the second calibration B-scan relative to the second direction in the second calibration B-scan by: identifying a representation of a second anatomical feature of the eye within the second calibration B-scan for determining the orientation of the second axis in the second calibration B-scan corresponding to the pupillary axis of the eye relative to the second direction in the second calibration B-scan corresponding to the axial imaging direction of the OCT imaging system; and determining the orientation of the second axis in the second calibration B-scan corresponding to the pupillary axis of the eye relative to the second direction in the second calibration B-scan corresponding to the axial imaging direction of the OCT imaging system based on the representation of the second anatomical feature of the eye within the second calibration B-scan.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and improves processing options, since both LI and FINGLER relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and FINGLER discloses an OCT system with phase sensitive B-scan registration; the phase-sensitive B-scan registration method may comprise aligning the axial (z-axis direction) component of the motion to minimize the motion effects on the OCT signal (“axial alignment method”), this method may allow improved processing options and statistical outlier analysis for isolating data from the B-scans with largest motion noise. Please see LI (US 20170105617 A1), Paragraph [0024], and FINGLER (US 20170020387 A1), Paragraph [0016, 0080-0082].
Regarding claim 11, LI in view of SRINIVASAN teach the use according to Claim 9,
LI further teaches wherein the AS-OCT image is a B-scan (Fig. 1, Paragraph [0077] – LI discloses the controller 3 extracts one arbitrary B-scan image from a plurality of B-scan images (the anterior eye tomographic images including the corneal apex) stored in the memory 10.)
comprising the representations of the portions of the scleral spur of the eye (Fig. 11, Paragraph [0078] – LI discloses the controller 3 analyzes angle areas positioned on right and left sides of the cornea in the extracted B-scan image, and detects a position of the SS at each side.),
and the fixation target (Fig. 1, #32 called vision-fixation lamp, Paragraph [0057]) is used to equalise the image contrast by fixing the gaze direction of the eye during acquisition of the AS-OCT image (Fig. 1, Paragraph [0056] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp. See also Paragraph [0077])
such that the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned (Fig. 1, Paragraph [56] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp, an XY directional position detecting system for detecting positions of the subjected eye E (an corneal apex) in X and Y directions (displacements in the up-and-down direction and the right-and-left direction relative to the main body of the apparatus 1), and a Z directional position detecting system for detecting a position of the subjected eye E (the corneal apex) in the back-and-forth direction (Z direction). Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.)
with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system (Fig. 1, Paragraph [0063] – LI discloses based on the positional displacement amount of the corneal apex (bright point) in the X direction and the Y direction detected by the XY directional position detecting system 56 and the positional displacement amount of the subjected eye E in the Z direction detected by the Z directional position detecting system 58, the controller 3 controls the main body driver 2 and moves the main body of the apparatus 1 relative to the holding table so that those positional displacement amounts become zero. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. Due to this, the alignment unit and the auto eye tracking unit are configured.) by:
acquiring a B-scan of at least a portion of the anterior segment of the eye (Fig. 7, Paragraph [0077] – LI discloses the controller 3 extracts one arbitrary B-scan image from a plurality of B-scan images (the anterior eye tomographic images including the corneal apex) stored in the memory 10.),
an orientation of an axis in the B-scan corresponding to the pupillary axis of the eye (Fig. 1, Paragraph [56] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp, an XY directional position detecting system for detecting positions of the subjected eye E (an corneal apex) in X and Y directions (displacements in the up-and-down direction and the right-and-left direction relative to the main body of the apparatus 1), and a Z directional position detecting system for detecting a position of the subjected eye E (the corneal apex) in the back-and-forth direction (Z direction). Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.)
relative to a direction in the B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 1, Paragraph [0063] – LI discloses based on the positional displacement amount of the corneal apex (bright point) in the X direction and the Y direction detected by the XY directional position detecting system 56 and the positional displacement amount of the subjected eye E in the Z direction detected by the Z directional position detecting system 58, the controller 3 controls the main body driver 2 and moves the main body of the apparatus 1 relative to the holding table so that those positional displacement amounts become zero. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. Due to this, the alignment unit and the auto eye tracking unit are configured.);
and using the acquired indication of the orientation to set a position of the fixation target relative to the eye during acquisition of the AS-OCT image such that (Fig. 3, Paragraph [0063] – LI discloses controller 3 is configured to move the main body of the apparatus 1 relative to the holding table so as to make the position of the corneal apex coincident with the predetermined image acquiring position at a time of starting to acquire tomographic images. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. Due to this, the alignment unit and the auto eye tracking unit are configured.),
when the gaze direction of the eye is fixed by the fixation target at the set position (Fig. 3, Paragraph [0066] – LI discloses the controller 3 starts alignments in the X, Y, Z directions by the alignment optical system 4 and the like in step S3. The controller 3 finishes the alignments in a case where a bright point for recognizing the corneal apex is coincident with the regular image acquiring position (YES in step S4).),
Although LI further teaches the axis in the B-scan is aligned with the direction in the B-scan (Fig. 3, Paragraph [0063] – LI discloses in step S5, the controller 3 executes processing of acquiring tomographic images of the anterior eye Ec by the OCT system 5. During the processing of acquiring the tomographic images, auto eye-tracking functions, and thus the main body of the apparatus 1 is moved by the alignment optical system 4 and the like so as to track the corneal apex such that the bright point for recognizing the corneal apex is constantly coincident with the regular image acquiring position (a center position of the image captured by the CCD camera 30).).
LI fails to explicitly teach acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction (151) of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining, as the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye,
However, SRINIVASAN explicitly teaches acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.) by:
by using the fixation target to set the gaze direction (151) of the eye (Fig. 3A, Paragraph [0188] – SRINIVASAN discloses assembly 62 of system 2 may comprise a fixation light 119 that provides visible light for the patient to fixate during measurement, alignment and treatment of the eye, for example.)
such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0235-236] – SRINIVASAN discloses imaging system 646 can be aligned with one or more axes of the eye as described herein, for example with the patient viewing the fixation light 119. In many embodiments, the patient views fixation light 119, and the imaging system 646 is aligned with the eye in one or more of many ways as described herein. SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646. Paragraph [0243] – SRINIVASAN further discloses the axes of the eye that can be identified and determined with the imaging system 646 or the processor of laser system (and combinations thereof) include a fixation axis 43FA, a visual axis 43VA, a line of sight 43LOS, a pupillary axis 43PA and an optical axis 43AO. See also Fig. 12, Paragraph [0316].);
and determining, as the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.),
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having the use of a fixation target of an optical coherence tomography, OCT, imaging system to equalise image contrast in representations of portions of a scleral spur of an eye in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system, wherein the fixation target is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of SRINIVASAN of having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction (151) of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining, as the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye.
Wherein LI’s use of a fixation target of an optical tomography, OCT, imaging system wherein having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction (151) of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining, as the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
LI in view of SRINIVASAN fail to explicitly teach calibration, wherein the calibration B-scan is parallel to the B-scan,
However, FINGLER explicitly teaches calibration (Fig. 7, Paragraph [0040] – FINGLER discloses FIG. 7 schematically illustrates four B-scans, two B-scan clusters, and one B-scan cluster set by way of example that may be used for the calculation of an OCT phase sensitive B-scan registration [wherein registration is calibration].),
wherein the calibration B-scan is parallel to the B-scan (Fig. 7, Paragraph [0071] – FINGLER discloses each B-scan may be located along the same transverse axis or another transverse axis (the x-axis or the y-axis) that may be parallel to those of other B-scans within the B-scan cluster set. Each B-scan may form a plane perpendicular to one of the transverse axes, and each B-scan plane may thereby be parallel to that of the other B-scans. Paragraph [0103] – FINGLER further discloses cumulative axial shift for each B-scan within a B-scan cluster may be calculated by using any method. A reference B-scan [wherein reference B-scan is calibration B-scan] may be chosen and other B-scans within the cluster may be aligned with this reference B-scan. This reference B-scan may be any B-scan within a B-scan cluster. For example, the reference B-scan may be the first formed B-scan belonging to the B-scan cluster.),
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having the use of a fixation target of an optical coherence tomography, OCT, imaging system to equalise image contrast in representations of portions of a scleral spur of an eye in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system, wherein the fixation target is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of FINGLER of having calibration, wherein the calibration B-scan is parallel to the B-scan.
Wherein LI’s use of a fixation target of an optical tomography, OCT, imaging system wherein having acquiring a calibration B-scan of at least a portion of the anterior segment of the eye, wherein the calibration B-scan is parallel to the B-scan, an orientation of an axis in the calibration B-scan corresponding to the pupillary axis of the eye relative to a direction in the calibration B-scan corresponding to the axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and improves processing options, since both LI and FINGLER relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and FINGLER discloses an OCT system with phase sensitive B-scan registration; the phase-sensitive B-scan registration method may comprise aligning the axial (z-axis direction) component of the motion to minimize the motion effects on the OCT signal (“axial alignment method”), this method may allow improved processing options and statistical outlier analysis for isolating data from the B-scans with largest motion noise. Please see LI (US 20170105617 A1), Paragraph [0024], and FINGLER (US 20170020387 A1), Paragraph [0016, 0080-0082].
Regarding claim 12, LI in view of SRINIVASAN teach the use according to Claim 9,
LI further teaches wherein the fixation target (Fig. 1, #32 called vision-fixation lamp, Paragraph [0057]) is used to equalise the image contrast by fixing the gaze direction of the eye during acquisition of the AS-OCT image (Fig. 1, Paragraph [0056] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp. See also Paragraph [0077])
such that the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned (Fig. 1, Paragraph [56] – LI discloses alignment optical system 4 comprises a vision-fixation lamp optical system for suppressing a movement of the eyeball (subjected eye E) as much as possible by making the subject stare at a vision-fixation lamp, an XY directional position detecting system for detecting positions of the subjected eye E (an corneal apex) in X and Y directions (displacements in the up-and-down direction and the right-and-left direction relative to the main body of the apparatus 1), and a Z directional position detecting system for detecting a position of the subjected eye E (the corneal apex) in the back-and-forth direction (Z direction). Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.)
with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system (Fig. 1, Paragraph [0063] – LI discloses based on the positional displacement amount of the corneal apex (bright point) in the X direction and the Y direction detected by the XY directional position detecting system 56 and the positional displacement amount of the subjected eye E in the Z direction detected by the Z directional position detecting system 58, the controller 3 controls the main body driver 2 and moves the main body of the apparatus 1 relative to the holding table so that those positional displacement amounts become zero. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. Due to this, the alignment unit and the auto eye tracking unit are configured.) by:
acquiring a first B-scan of a first cross-section of at least a portion of the anterior segment of the eye (Fig. 1, Paragraph [0048] – LI discloses OCT system 5 is configured to acquire tomographic images (cross sectional images) of the anterior eye Ec by OCT.),
and a second B-scan of a second cross-section of at least a portion of the anterior segment of the eye (Fig. 1, Paragraph [0048] – LI discloses OCT system 5 is configured to acquire tomographic images (cross sectional images) of the anterior eye Ec by OCT.),
determining a first orientation of a first axis in the first B-scan corresponding to the pupillary axis of the eye relative to a first direction in the first B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 1, Paragraph [0061] – LI discloses depending on a position of the subjected eye E in the back-and-forth direction (Z direction) relative to the main body of the apparatus 1, an incident position of the reflected light which enters the line sensor 41 varies. Due to this, by detecting the incident position, the position (distance) of the subjected eye E in the Z direction relative to the main body of the apparatus 1 is detected. Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.);
determining a second orientation of a second axis in the second B-scan corresponding to the pupillary axis of the eye relative to a second direction in the second B-scan corresponding to the axial imaging direction of the OCT imaging system (Fig. 1, Paragraph [0061] – LI discloses depending on a position of the subjected eye E in the back-and-forth direction (Z direction) relative to the main body of the apparatus 1, an incident position of the reflected light which enters the line sensor 41 varies. Due to this, by detecting the incident position, the position (distance) of the subjected eye E in the Z direction relative to the main body of the apparatus 1 is detected. Paragraph [0090] – LI further discloses the position of the corneal apex, the corneal thickness, the thickness T of the crystalline lens, the depth position of the SS, the equator position of the crystalline lens and the like may be calculated based on “vertex normal”, “line of sight”, “pupillary axis”, “fixation axis” or the like instead of visual axis Z.);
and using the acquired indication of the orientation to set a position of the fixation target relative to the eye during acquisition of the AS-OCT image such that (Fig. 3, Paragraph [0063] – LI discloses controller 3 is configured to move the main body of the apparatus 1 relative to the holding table so as to make the position of the corneal apex coincident with the predetermined image acquiring position at a time of starting to acquire tomographic images. Further, the controller 3 moves the main body of the apparatus 1 so as to track the corneal apex so that a positional relationship between the corneal apex and the main body of the apparatus 1 is maintained constant while tomographic images are being acquired as well. Due to this, the alignment unit and the auto eye tracking unit are configured.),
when the gaze direction of the eye is fixed by the fixation target at the set position (Fig. 3, Paragraph [0066] – LI discloses the controller 3 starts alignments in the X, Y, Z directions by the alignment optical system 4 and the like in step S3. The controller 3 finishes the alignments in a case where a bright point for recognizing the corneal apex is coincident with the regular image acquiring position (YES in step S4).),
LI fails to explicitly teach acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye based on the determined first orientation and the determined second orientation; the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system.
However, SRINIVASAN explicitly teaches acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface.) by:
by using the fixation target to set the gaze direction of the eye (Fig. 3A, Paragraph [0188] – SRINIVASAN discloses assembly 62 of system 2 may comprise a fixation light 119 that provides visible light for the patient to fixate during measurement, alignment and treatment of the eye, for example.)
such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0235-236] – SRINIVASAN discloses imaging system 646 can be aligned with one or more axes of the eye as described herein, for example with the patient viewing the fixation light 119. In many embodiments, the patient views fixation light 119, and the imaging system 646 is aligned with the eye in one or more of many ways as described herein. SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646. Paragraph [0243] – SRINIVASAN further discloses the axes of the eye that can be identified and determined with the imaging system 646 or the processor of laser system (and combinations thereof) include a fixation axis 43FA, a visual axis 43VA, a line of sight 43LOS, a pupillary axis 43PA and an optical axis 43AO. See also Fig. 12, Paragraph [0316].);
and determining the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye based on the determined first orientation and the determined second orientation (Fig. 7A, Paragraph [0272] - SRINIVASAN discloses locations and orientations of the tissue structures of the eye determined with measurements of the eye prior to coupling with the patient interface can be mapped from the coordinate system 650 to the coordinate 150 and shown on the display with the image of the eye coupled to patient interface. Paragraph [0316] – SRINIVASAN further discloses at a step 855, identify the one or more tissue structures of eye measured with patient interface contacting eye comprising one or more of... line of sight of eye, pupillary axis of eye, visual axis of eye, nodal axis of eye, center of curvature of anterior corneal surface, center of curvature of posterior corneal surface, center of curvature of lens anterior surface, or lens posterior surface. At a step 860, determine alignment of non-contact eye measurement reference axes in relation to contact eye measurement reference axes in response to locations of the one or more tissue structures. At a step 865, determine one or more of an orientation or a translation of the contact measurement axes of the eye in relation to non-contact measurement axes of the eye.);
the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system (Fig. 7A, Paragraph [0236] – SRINIVASAN discloses fixation light 119 allows the patient to fixate in order to align the axes of the coordinate system 150 of the eye with one or more reference axes of the coordinate system 650 of imaging system 646.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having use of a fixation target of an optical coherence tomography, OCT, imaging system to equalise image contrast in representations of portions of a scleral spur of an eye in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system, wherein the fixation target is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of SRINIVASAN of having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye based on the determined first orientation and the determined second orientation; the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system.
Wherein LI’s use of a fixation target of an optical coherence tomography, OCT, imaging system wherein having acquiring an indication of an orientation of the pupillary axis of the eye relative to a visual axis of the eye by: by using the fixation target to set the gaze direction of the eye such that the visual axis of the eye is aligned with the axial imaging direction of the OCT imaging system; and determining the indication of the orientation of the pupillary axis of the eye relative to the visual axis of the eye based on the determined first orientation and the determined second orientation; the axis in the AS-OCT image corresponding to the pupillary axis of the eye is aligned with the direction in the AS-OCT image corresponding to the axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and provides accurate, distortion-free corneal topography measurements, since both LI and SRINIVASAN relate to optical coherence tomography systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and SRINIVASAN relates generally to photodisruption induced by a pulsed laser beam and the location of the photodisruption so as to treat a material, such as a tissue of an eye; embodiments as described herein can provide improved placement of intraocular lenses in relation to treatment axes and the nodal points of the eye, such that the placed lens can provide a post surgical eye having similar nodal points to the pre-operative eye in order to provide improved accuracy of correction and decreased aberrations with the replacement lens. Please see LI (US 20170105617 A1), Paragraph [0024], and SRINIVASAN (US 20160095752 A1), Paragraph [0004, 0016].
LI in view of SRINIVASAN fail to explicitly teach wherein a plane of the first cross-section is perpendicular to a plane of the second cross-section, calibration.
However, FINGLER explicitly teaches wherein a plane of the first cross-section is perpendicular to a plane of the second cross-section (Fig. 2, Paragraph [0071] – FINGLER discloses each B-scan may be located along the same transverse axis or another transverse axis (the x-axis or the y-axis) that may be parallel to those of other B-scans within the B-scan cluster set. Each B-scan may form a plane perpendicular to one of the transverse axes. See also Paragraph [0061].),
calibration (Fig. 7, Paragraph [0040] – FINGLER discloses FIG. 7 schematically illustrates four B-scans, two B-scan clusters, and one B-scan cluster set by way of example that may be used for the calculation of an OCT phase sensitive B-scan registration [wherein registration is calibration]. See also Paragraphs [0071, 0103].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of LI in view of SRINIVASAN of having use of a fixation target of an optical coherence tomography, OCT, imaging system to equalise image contrast in representations of portions of a scleral spur of an eye in an anterior-segment OCT, AS-OCT, image acquired by the OCT imaging system, wherein the fixation target is used to equalise the image contrast by fixing a gaze direction of the eye during acquisition of the AS-OCT image, with the teachings of FINGLER of having wherein a plane of the first cross-section is perpendicular to a plane of the second cross-section, calibration.
Wherein LI’s use of a fixation target of an optical coherence tomography, OCT, imaging system wherein having acquiring a first calibration B-scan of a first cross-section of at least a portion of the anterior segment of the eye, and a second calibration B-scan of a second cross-section of at least a portion of the anterior segment of the eye, wherein a plane of the first cross-section is perpendicular to a plane of the second cross-section, determining a first orientation of a first axis in the first calibration B-scan corresponding to the pupillary axis of the eye relative to a first direction in the first calibration B-scan corresponding to the axial imaging direction of the OCT imaging system; determining a second orientation of a second axis in the second calibration B-scan corresponding to the pupillary axis of the eye relative to a second direction in the second calibration B-scan corresponding to the axial imaging direction of the OCT imaging system.
The motivation behind this modification would have been to provide an enhanced optical coherence tomography system that calculates a highly accurate estimated lens position and improves processing options, since both LI and FINGLER relate to optical coherence tomography imaging systems, wherein LI relates to an anterior eye tomographic image capturing apparatus configured to determine a power of an intraocular lens implanted by a cataract surgery by using a tomographic image of an anterior eye; since an appropriate [estimated lens position] ELP can be calculated regardless of a preoperative state of an angle of the subjected eye, a further highly accurate [intraocular lens] IOL power can be determined, and FINGLER discloses an OCT system with phase sensitive B-scan registration; the phase-sensitive B-scan registration method may comprise aligning the axial (z-axis direction) component of the motion to minimize the motion effects on the OCT signal (“axial alignment method”), this method may allow improved processing options and statistical outlier analysis for isolating data from the B-scans with largest motion noise. Please see LI (US 20170105617 A1), Paragraph [0024], and FINGLER (US 20170020387 A1), Paragraph [0016, 0080-0082].
Conclusion
Listed below are the prior arts made of record and not relied upon but are considered pertinent to applicant’s disclosure.
HORN et al. (US 20180168445 A1) - An optical coherence tomography (OCT) system includes a light source configured to generate an OCT beam and a beam splitter, configured to split the OCT beam into a reference beam and an imaging beam, direct the reference beam toward a reflector, and direct the imaging beam toward a scanner. The system includes a linear actuator, such as a piezoelectric or voice coil, configured to move the reflector to adjust the length of the reference beam and the scanner, configured to scan the imaging beam onto a target surface at a plurality of scan angles, wherein the scanner and target surface are separated by a sample distance that varies at each of the scan angles. The system further includes an OCT controller....… Fig. 1, Abstract.
BAGHERINIA et al. (US 20160317012 A1) - The present application discloses methods and systems to track the anterior segment while establishing a position of the delay which will permit good control of the placement of anterior segment structures. This allows accurate dewarping by maximizing the amount of corneal surface that is imaged as well as reducing or eliminating overlap between real and complex conjugate images present in frequency-domain optical coherence tomography. A method to dewarp surfaces given partial corneal surface information is also disclosed.......… Fig. 1, Abstract.
KURTZ et al. (US 20090137988 A1) - Techniques, systems are described for performing laser eye surgery. In one aspect, a method for improving an optical function of an eye includes preparing the eye for surgery by determining an optical characteristic of the eye. Laser marking pulses are applied to generate a laser mark in a region of the eye in relation to the determined optical characteristic. Also, a surgical procedure is performed in a surgical region selected in relation to the generated laser mark.......… Fig. 1, Abstract.
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/BEZAWIT NOLAWI SHIMELES/Examiner, Art Unit 2673
/CHINEYERE WILLS-BURNS/Supervisory Patent Examiner, Art Unit 2673
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