DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
2. The specification is objected to because of the following informality:
Paragraph [0017], lines 1-2, should read “plots for ellipticity (Figures 10A and 10[[C]]D) and toricity (Figs. 10[[D]]C and 10F)”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
3. The following is a quotation of the appropriate paragraphs of 35 USC 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
4. Claims 1-3, 5, 11-15, and 17-20 are rejected under 35 USC 102(a)(1) as being anticipated by Benson et al. (US 20230029661 A1).
Regarding claim 1, Benson discloses a computer-based method ([0103], processor) comprising:
obtaining an optical coherence tomography (OCT) data set for an OCT scan of a cornea and a sclera ([0102], “profile…is generated by scanning the OCT beam…from the sclera-cornea junction”),
wherein the OCT scan uses radial scan lines with a common center point ([0102], “scanning the OCT beam radially outwards…from the sclera-cornea junction”; Fig. 3a); and
generating one or more topography maps based on the OCT data set ([0103], trabecular meshwork map).
Regarding claim 2, Benson discloses wherein the center point corresponds to a center of the cornea (Fig. 3a).
Regarding claim 3, Benson discloses wherein the radial scan lines include at least four meridians (Fig. 3a).
Regarding claim 5, Benson discloses wherein the OCT dataset includes axial scans along the radial scan lines ([0049]-[0050] & [0100]-[0101]), and wherein the method further comprises locating a limbal junction between the cornea and the sclera ([0100]-[0103], sclera-cornea junction) based on radial profiles of the central moments of the axial scans ([0100]-[0103]).
Regarding claim 11, Benson discloses a computer-based method ([0103], processor) comprising:
obtaining a three-dimensional (3D) volumetric scan of an eye ([0103], trabecular meshwork map),
wherein the volumetric scan corresponds to a corneal region and a scleral region of the eye ([0102], sclera-cornea junction); and
locating a limbal junction or an external topographical limbus based on the 3D volumetric scan ([0102], sclera-cornea boundary).
Regarding claim 12, Benson discloses wherein the 3D volumetric scan is an optical coherence tomography (OCT) scan ([0102]).
Regarding claim 13, Benson discloses wherein the OCT scan uses radial scan lines ([0102] & Fig. 3a).
Regarding claim 15, Benson discloses wherein the limbal junction is located based on central moments of axial scans of the 3D volumetric scan ([0101]-[0103]).
Regarding claim 17, Benson discloses a system comprising:
an optical coherence tomography (OCT) system ([0105]) to acquire an OCT dataset of an eye ([0102]-[0103]);
a logic subsystem ([0103], processor); and
a data holding subsystem ([0103], to hold the map data) comprising non-transitory machine-readable instructions stored thereon that are executable by the logic subsystem to:
obtain, via the OCT system, an OCT data set for an OCT scan of a cornea and a sclera ([0102]),
wherein the OCT scan uses radial scan lines with a common center point ([0102], “scanning the OCT beam radially outwards…from the sclera-cornea junction”); and
generate one or more topography maps based on the OCT data set ([0103], trabecular meshwork map).
Regarding claim 18, Benson discloses wherein the center point corresponds to a center of the cornea (Fig. 3a).
Regarding claim19, Benson discloses wherein the radial scan lines include at least four meridians (Fig. 3a).
Regarding claim 20, Benson discloses wherein the OCT dataset includes axial scans along the radial scan lines ([0049]-[0050] & [0100]-[0101]), and wherein the instructions are further executable by the logic subsystem to locate a limbal junction between the cornea and the sclera ([0100]-[0103], sclera-cornea junction) based on radial profiles of the central moments of the axial scans ([0100]-[0103]).
5. Claims 1-4, 10-13, 15, 17-19, and 24 are rejected under 35 USC 102(a)(1) as being anticipated by Sanders et al. (US 20200041817 A1).
Regarding claim 1, Sanders discloses a computer-based method ([0091]) comprising:
obtaining an optical coherence tomography (OCT) data set for an OCT scan of a cornea and a sclera ([0074]),
wherein the OCT scan uses radial scan lines with a common center point ([0094]); and
generating one or more topography maps based on the OCT data set ([0074]-[0075]).
Regarding claim 2, Sanders discloses wherein the center point corresponds to a center of the cornea ([0012] & Fig. 1A).
Regarding claim 3, Sanders discloses wherein the radial scan lines include at least four meridians ([0012] & Fig. 1A).
Regarding claim 4, Sanders discloses wherein the radial scan lines are at least 14 millimeters long ([0094], “12 mm to 24 mm diameter”).
Regarding claim 10, Sanders discloses displaying the one or more topographical maps or measuring one or more topographic parameters based on a coordinate system referenced to a best-fit topographic limbal circle ([0075]).
Regarding claim 11, Sanders discloses a computer-based method ([0091]) comprising:
obtaining a three-dimensional (3D) volumetric scan of an eye ([0074]),
wherein the volumetric scan corresponds to a corneal region and a scleral region of the eye ([0074]); and
locating a limbal junction or an external topographical limbus based on the 3D volumetric scan ([0066]).
Regarding claim 12, Sanders discloses wherein the 3D volumetric scan is an optical coherence tomography (OCT) scan ([0074]).
Regarding claim 13, Sanders discloses wherein the OCT scan uses radial scan lines (Fig. 1A).
Regarding claim 15, Sanders discloses wherein the limbal junction is located based on central moments of the axial scans of the 3D volumetric scan (Fig. 9B).
Regarding claim 17, Sanders discloses a system comprising:
an optical coherence tomography (OCT) system ([0074]);
a logic subsystem ([0091] & [0098], processor); and
a data holding subsystem ([0091] & [0098], memory) comprising non-transitory machine-readable instructions stored thereon that are executable by the logic subsystem to:
obtain, via the OCT system, an OCT data set for an OCT scan of a cornea and a sclera ([0074]),
wherein the OCT scan uses radial scan lines with a common center point (Fig. 1A); and
generate one or more topography maps based on the OCT data set ([0074]-[0075]).
Regarding claim 18, Sanders discloses wherein the center point corresponds to a center of the cornea ([0012] & Fig. 1A).
Regarding claim 19, Sanders discloses wherein the radial scan lines include at least four meridians ([0012] & Fig. 1A).
Regarding claim 24, Sanders discloses wherein the instructions are further executable by the logic subsystem to display the one or more topographical maps or measure one or more topographic parameters based on a coordinate system reference to a best-fit topographic limbal circle ([0075]).
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 USC 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
7. The factual inquiries for establishing a background for determining obviousness under 35 USC 103 are summarized as follows:
1) Determining the scope and contents of the prior art.
2) Ascertaining the differences between the prior art and the claims at issue.
3) Resolving the level of ordinary skill in the pertinent art.
4) Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claim 4 is rejected under 35 USC 103 as being unpatentable over Benson in view of Sanders.
Regarding claim 4, Benson fails to explicitly disclose wherein the radial scan lines are at least 14 millimeters long.
However, Sanders teaches a similar method for performing corner-scleral OCT scans ([0074]), and discloses wherein a radial scan line is at least 14 millimeters long ([0094], “12 mm to 24 mm diameter”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Benson and Sanders such that the radial scan lines were at least 14 mm long, motivated by characterizing irregularities of the eye ([0094]).
9. Claims 6, 16, and 21 are rejected under 35 USC 103 as being unpatentable over Benson in view of Juan et al. (US 9395558 B2).
Regarding claim 6, Benson discloses locating an external topographic limbus ([0100]-[0103], sclera-cornea junction) based on the one or more topographical maps ([0102]-[0103], trabecular meshwork map).
Benson fails to explicitly disclose curve fitting of a conjunctival surface in the sclera and a corneal surface in the cornea.
However, Juan teaches a method for performing OCT scans of the cornea and sclera (column 45 lines 20-33), and discloses curve fitting of a conjunctival surface in the sclera and a corneal surface in the cornea (column 18 lines 27-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Benson and Juan such that curve fitting of a conjunctival surface in the sclera and corneal surface were used to locate an external topographic limbus, motivated by determining the shape of an eye.
Regarding claim 16, Benson discloses wherein the external topographic limbus is located ([0100]-[0103], sclera-cornea junction).
Benson fails to explicitly disclose curve fitting of a conjunctival surface in the scleral region and a corneal surface in the corneal region.
However, Juan teaches a method for performing OCT scans of the cornea and sclera (column 45 lines 20-33), and discloses curve fitting of a conjunctival surface in the sclera and a corneal surface in the cornea (column 18 lines 27-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Benson and Juan such that curve fitting of a conjunctival surface in the sclera and corneal surface were used to locate an external topographic limbus, motivated by determining the shape of an eye.
Regarding claim 21, Benson discloses wherein the instructions are further executable by the logic subsystem to locate an external topographic limbus ([0100]-[0103], sclera-cornea junction) based on the one or more topographical maps ([0102]-[0103], trabecular meshwork map).
Benson fails to explicitly disclose curve fitting of a conjunctival surface in the sclera and a corneal surface in the cornea.
However, Juan teaches a method for performing OCT scans of the cornea and sclera (column 45 lines 20-33), and discloses curve fitting of a conjunctival surface in the sclera and a corneal surface in the cornea (column 18 lines 27-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Benson and Juan such that curve fitting of a conjunctival surface in the sclera and corneal surface were used to locate an external topographic limbus, motivated by determining the shape of an eye.
10. Claims 7-8 and 22 are rejected under 35 USC 103 as being unpatentable over Benson in view of Sindt et al. (US 20170082869 A1), and further in view of Wagner et al. (“Golden angle based scanning for robust corneal topography with OCT.” Biomedical optical express 8.2 (2017): 475-483)
Regarding claim 7, Benson fails to disclose generating a metric of limbal ellipticity and toricity from a best-fit limbal circle.
However, Sindt teaches a process for scanning and mapping eye surfaces ([0015]), and discloses wherein limbal ellipticity and toricity is measured from a best-fit limbal circle ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Benson and Sindt such that a metric of limbal ellipticity and toricity was generated, motivated by defining the shape of an eye.
Modified Benson fails to explicitly disclose using a decomposition of a topographic limbus deviation.
However, Wagner teaches using OCT for mapping eye surfaces (Abstract), and discloses using Zernike polynomials (1. Introduction, paragraph 3) to assess topographic deviations (2.2.1. Scan system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine modified Benson and Wagner such that a metric of limbal ellipticity and toricity was generated using a decomposition of a topographic limbus deviation, motivated by defining the shape of an eye.
Regarding claim 8, modified Benson discloses wherein the decomposition is a Zernike decomposition (Wagner - 1. Introduction, paragraph 3).
Regarding claim 22, Benson fails to disclose wherein the instructions are further executable by the logic subsystem to generate a metric of limbal ellipticity and toricity from a best-fit limbal circle.
However, Sindt teaches a process for scanning and mapping eye surfaces ([0015]), and discloses wherein limbal ellipticity and toricity is measured from a best-fit limbal circle ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Benson and Sindt such that a metric of limbal ellipticity and toricity was generated, motivated by defining the shape of an eye.
Modified Benson fails to explicitly disclose using a decomposition of a topographic limbus deviation.
However, Wagner teaches using OCT for mapping eye surfaces (Abstract), and discloses using Zernike polynomials (1. Introduction, paragraph 3) to assess topographic deviations (2.2.1. Scan system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine modified Benson and Wagner such that a metric of limbal ellipticity and toricity was generated using a decomposition of a topographic limbus deviation, motivated by defining the shape of an eye.
11. Claims 9 and 23 are rejected under 35 USC 103 as being unpatentable over Sanders in view of Wagner.
Regarding claim 9, Sanders discloses wherein the one or more topographical maps include a conjunctival surface elevation map ([0075]).
Sanders fails to explicitly disclose wherein the method further comprises generating supplemental data for the OCT dataset using polynomial fitting of the conjunctival surface elevation map in a region of the sclera.
However, Wagner teaches using OCT for mapping eye surfaces (Abstract), and discloses generating datasets using polynomial fitting (1. Introduction, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Sanders and Wagner such that supplemental data for the OCT dataset was generated using polynomial fitting of the conjunctival surface elevation map in a region of the sclera, motivated by defining the shape of an eye.
Regarding claim 23, Sanders discloses wherein the one or more topographical maps include a conjunctival surface elevation map ([0075]).
Sanders fails to explicitly disclose wherein the instructions are further executable by the logic subsystem to generate supplemental data for the OCT dataset using polynomial fitting of the conjunctival surface elevation map in a region of the sclera.
However, Wagner teaches using OCT for mapping eye surfaces (Abstract), and discloses generating datasets using polynomial fitting (1. Introduction, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Sanders and Wagner such that supplemental data for the OCT dataset was generated using polynomial fitting of the conjunctival surface elevation map in a region of the sclera, motivated by defining the shape of an eye.
12. Claim 14 is rejected under 35 USC 103 as being unpatentable over Benson in view of McNabb et al. (“Quantitative topographic curvature maps of the posterior eye utilizing optical coherence tomography.” Retina 41.4 (2021): 804-811).
Regarding claim 14, Benson fails to explicitly disclose wherein the 3D volumetric scan covers an area of at least 14 millimeters by 14 millimeters.
However, McNabb teaches a method for performing 3D volumetric OCT eye scans (Abstract: Methods), and discloses wherein the scans cover an area of at least 14 millimeters by 14 millimeters (Methods: OCT Imaging System).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Benson and McNabb such that the 3D volumetric scans were to cover an area of at least 14 millimeters by 14 millimeters, motivated by providing “parameters for correction of optical distortions in OCT images” (Methods: OCT Imaging System).
Conclusion
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daniel Jeffery Jordan whose telephone number is 571-270-7641. The examiner can normally be reached 9:30a-6:00p.
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/D. J. J./Examiner, Art Unit 2872
/STEPHONE B ALLEN/Supervisory Patent Examiner, Art Unit 2872