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 .
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/29/2024 is being considered by the examiner.
Priority
Acknowledgement is made of applicant’s claim for priority based on EP22171059.3 dated 04/30/2022.
Drawings
The applicant’s drawings submitted are acceptable for examination purposes.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 lists “Vogt-Koyanagi-Harada syndrome” twice.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 is rejected for indefiniteness. The USPGUB (US20250299325A1) uses language in para [0084] to suggest that the diseases associated with an altered structure in the posterior eye segment are not limited: “Posterior eye segment diseases include, but are not limited to …” On the other hand, claim 8 is written such that all the listed diseases need to be able to be detected in order for the method to function properly. Therefore, the specification is inconsistent and claim 8 is indefinite. For examination purposes, the Office assumes that claim 8 should be written "... prematurity, or papilloedema."
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 9-10, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laforest (US 20190290124 A1).
Regarding claim 1, Laforest teaches in Figs. 9A and 9B: a method of diagnosing, and/or prognosing a disease associated with an altered structure in the posterior segment of the eye (“the proposed method can provide dark field images of the choroid and RPE (retinal pigmented epithelium), allowing for imaging of the choroidal tumors with enhanced contrast and choroidal microvasculature “; [0220], “Anatomical features are extracted and analyzed to detect possible abnormalities”; [0122], RPE is a constituent layer located within the posterior segment of the eye (see the first paragraph of the spec in the instant application)),
wherein the method comprises analyzing an image of the posterior segment of the eye obtained by transscleral optical imaging (TOI) for an altered structure (“FIG. 9A schematically shows the transscleral illumination method”; [0036]),
wherein the altered structure is indicative of the presence and/or progression of the disease in a subject (“Anatomical features are extracted and analyzed to detect possible abnormalities”; [0122]).
Regarding claim 3, Laforest teaches method according to claim 1. Laforest further teaches in Figs. 9A and 9B: wherein said altered structure (“RPE (retinal pigmented epithelium)”; [0220]) is determined relative to a reference that is a TOI image (“The human in-vivo fundus image is taken with transscleral illumination”; [0130]) of said posterior segment obtained from a similarly situated subject known not to have the disease or known not to be at risk of developing the disease (“the deep learning software can be trained with pathologic and nonpathologic images (in vivo or ex vivo). Furthermore, the features extraction can be applied to medical information extraction in order to help the clinician analyzing the data”; [0145]).
Regarding claim 9, Laforest teaches method according to claim 1. Laforest further teaches in Figs. 9A and 9B: the image of said posterior segment of the eye is an image of the choroid (“the proposed method can provide dark field images of the choroid”; [0220], the choriocapillaris, Bruch's membrane, retinochoroidal tissue, the neuroretinal tissue, the nerve fiber layer (“retinal nerve fiber layer (RNFL)”; [0219]), the retinal pigment epithelium (RPE) (“RPE (retinal pigmented epithelium)”; [0220]), the photorepectors (“Applications include quantitative phase imaging of the retinal layer on top of the photoreceptors”; [0219]), the ganglion cell layer (“ganglion cell layer (GCL)”; [0219]), the retinal vasculature, the subretinal space (“phase imaging of the retinal layer on top of the photoreceptors, between the inner and external limiting membranes”; [0219]), the retina (“Dark-field imaging of retinal layer”; [0159]), the macula, the lamina cribrosa, the optic disc (“obtained with the method according to an aspect of the present invention, with corresponding cross-section showing gradients for the vessels, and the optic disc;”; [0084]) or the optic nerve.
Regarding claim 10, Laforest teaches method according to claim 1. Laforest further teaches in Figs. 9A and 9B: wherein said altered structure is an alteration in the tissue structure (“Anatomical features are extracted and analyzed to detect possible abnormalities”; [0122]).
Regarding claim 13, Laforest teaches method according to claim 1. Laforest further teaches in Figs. 9A and 9B: wherein said image is an image of the retinal pigment epithelium (RPE) (“the proposed method can provide dark field images of the choroid and RPE (retinal pigmented epithelium), allowing for imaging of the choroidal tumors with enhanced contrast and choroidal microvasculature “; [0220]).
Regarding claim 14, Laforest teaches method according to claim 1. Laforest further teaches in Figs. 9A and 9B: wherein said image is an image of the choriocapillaris (“the proposed method can provide dark field images of the choroid and RPE (retinal pigmented epithelium), allowing for imaging of the choroidal tumors with enhanced contrast and choroidal microvasculature”; [0220], the choriocapillaris is anatomically the innermost capillary layer of the choroid such that Laforests disclosure of imaging the ‘choroidal microvasculature’ encompasses imaging of the choriocapillaris, as the choriocapillaris is not a structure separate from the choroidal microvasculature.
Regarding claim 15, Laforest teaches method according to claim 1. Laforest further teaches in Figs. 9A and 9B: wherein the image is an image of the nerve fiber layer (“retinal nerve fiber layer (RNFL)”; [0219]), optic disc (“obtained with the method according to an aspect of the present invention, with corresponding cross-section showing gradients for the vessels, and the optic disc;”; [0084]) and/or retinal vasculature (“Features extraction is meant to work on retinal features such as, but not limited to, cells, nuclei and microvasculature”; [0144]).
Claims 4 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cuzzani (US 20220168361 A1).
Regarding claim 4, Cuzzani teaches: a method for
(i) evaluating the therapeutic effect in a subject of a treatment for a disease associated with an altered structure in the poster segment of the eye (“disclosed herein are methods for measuring the therapeutic effects of retinal disease therapies using improved quantitative structural and functional assessments”; [0008]), or
(ii) determining a subject's compliance with a prescribed treatment for a disease associated with an altered structure in the posterior segment of the eye, said method comprising analyzing a first and second image of the posterior segment of the eye of said subject obtained by TOI,
(a) wherein said first image is to be obtained before said treatment or prior to second image (“FIG. 4 shows color fundus imaging for cohort 1 (patients 1, 2, and 3 (Pt. 1, Pt. 2. Pt. 3) prior to treatment with a target does of 50,000 RPE cells (pre-op) and 2-months after treatment”; [0086]);
(b) wherein said second image is to be obtained after treatment or subsequent to said first image (“FIG. 4 shows color fundus imaging for cohort 1 (patients 1, 2, and 3 (Pt. 1, Pt. 2. Pt. 3) prior to treatment with a target does of 50,000 RPE cells (pre-op) and 2-months after treatment”; [0086]);
(c) wherein the analyzing the first and second image is an analysis and comparison of the structure of the posterior segment in (a) and (b) (“Color fundus imaging for cohort 1 at pre-op and 2-month time points is shown and compared in FIG. 4”; [0311]);
wherein the maintenance of or decrease in an altered structure between (a) and (b) is indicative of said treatment having therapeutic effect or said subject complying with said treatment (“the administering of the therapeutically effective amount of retinal pigment epithelium (RPE) cells results in a best corrected visual acuity (BCVA) that does not decrease as measured from a baseline for about 1 day to about 3 months, 1 day to about 15 months or from 1 day to about 24 months or from about 90 days to about 24 months”; [0010]).
Regarding claim 6, Cuzzani teaches the method according to claim 4. Cuzzani further teaches: wherein determination of the maintenance of the altered structure between (a) and (b) is (d) a determination where said altered structure is substantially unchanged between (a) and (b) of claim 4 (“the administering of the therapeutically effective amount of retinal pigment epithelium (RPE) cells results in a best corrected visual acuity (BCVA) that remains stable as measured from a baseline for about 1 day to about 15 months, or from 1 day to about 24 months or from about 90 days to about 24 months”; [0012]);
or (e) a determination where any further alteration or progression of said altered structure between (a) and (b) of claim 4 is not as severe or advanced as that between a set of reference first and second TOI images of said posterior segment obtained from a similarly situated subject known to have the disease and which subject has not been treated for said disease, wherein the reference first and second images were obtained or are to be obtained at the same interval as the first and second images of (a) and (b) of claim 4.
Regarding claim 7, Cuzzani teaches the method according to claim 4. Cuzzani further teaches: wherein said second image is to be obtained at least 2 days and no more than 730 days subsequent to said first image (“the administering of the therapeutically effective amount of retinal pigment epithelium (RPE) cells results in an increase in retinal pigmentation as measured from a baseline for at least about 2 months to about 1 year, or from 90 days to about 24 months”; [0014]).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 are rejected under 35 U.S.C. 103 as being unpatentable over Laforest (US 20190290124 A1) and further in view of Yancopoulos (US 11253572 B2).
Regarding claim 2, Laforest teaches in Figs. 9A and 9B: a method of treating a disease associated with an altered structure in the posterior eye segment, wherein the method comprises the steps of:
(a) analyzing an image of the posterior eye segment obtained by TOI (“FIG. 9A schematically shows the transscleral illumination method”; [0036]) for an altered structure, where the presence of an altered structure is indicative of the presence of the disease or the development of the disease in a subject (“Anatomical features are extracted and analyzed to detect possible abnormalities”; [0122]).
However, Laforest fails to teach: (b) administering to the subject identified as having or developing a disease according to step (a), an appropriate treatment for said disease.
However, in an alternate invention in the field of eye testing and diagnostics, Yancopoulos teaches: (b) administering to the subject identified as having or developing a disease according to step (a), an appropriate treatment for said disease (“The present invention provides methods for treating angiogenic eye disorders. The methods of the invention comprise sequentially administering to a patient multiple doses of a VEGF antagonist”; col 3 lines 38-41).
Furthermore, Yancopoulos teaches this configuration such that “The methods of the present invention are useful for treating angiogenic eye disorders in patients that have been diagnosed with or are at risk of being afflicted with an angiogenic eye disorder” (col 7 lines 34-39). As taught by Yancopoulos, administering treatment of an eye condition after diagnosis is standard practice.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Yancopoulos to provide a device in which “administering to the subject identified as having or developing a disease according to step (a), an appropriate treatment for said disease,” for the purpose of treating angiogenic eye disorders in patients that have been diagnosed with or are at risk of being afflicted with an angiogenic eye disorder (Yancopoulos, col 7 lines 34-39).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Laforest (US 20190290124 A1), as in claim 10, and further in view of Derr (US 9367915 B2).
Regarding claim 11, Laforest teaches method according to claim 10. Laforest teaches the ability to measure cell density in the spec at [0216]: “FIGS. 44 and 45 show the results of a scan in depth of a pig retina, with the different layer of the retina, and computing the cells density for the layers of nucleus.” However, Laforest does not link the measurement of cell density to the altered tissue structure as required by claim 11. Thus, Laforest fails to explicitly teach: wherein the alteration in tissue structure is an alteration in cell pattern, cell density, cell size, cell distribution or cell reflectivity.
However, in an alternate invention in the field of eye testing and diagnostics, Derr teaches: wherein the alteration in tissue structure is an alteration in cell pattern, cell density, cell size, cell distribution or cell reflectivity (“Dots representing axonal cells and connective supporting tissue are counted to determine whether or not there is reduced reflectivity—a condition consistent with glaucoma”; col 2 lines 7-11).
Furthermore, Derr teaches this configuration such that “diminished reflectivity may indicate the presence of retinal vessels or cellular loss. Therefore, it is critical to observe these focal defects if glaucoma or other ocular defects are to be detected in their earliest possible stages. In addition, the system and method analyzes and accounts for specific cell types and quantities thereof within the OCT image to similarly detect early signs of disease” (Derr, col 3 lines 42-48).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Derr to provide a device in which the alteration in tissue structure is an alteration in cell pattern, cell density, cell size, cell distribution or cell reflectivity, for the purpose of detecting early signs of disease (Derr, col 3 lines 42-48).
Regarding claim 12, Laforest teaches method according to claim 10. Laforest fails to explicitly teach: wherein said alteration in tissue structure is an alteration in tissue reflectivity that is an alteration in hyporeflective regions, hyperreflective regions, hyporeflective regions within a hyperreflective region, or any combination thereof.
However, in an alternate invention in the field of eye testing and diagnostics, Derr teaches: wherein said alteration in tissue structure is an alteration in tissue reflectivity that is an alteration in hyporeflective regions, hyperreflective regions, hyporeflective regions within a hyperreflective region, or any combination thereof (Derr describes the ‘hot dots’ and ‘cold dots’ as more reflective and less reflective respectively. Col 2 lines 19-17 show that a glaucomatous experiences an alteration in hyporeflective regions: “In a healthy RNFL, there are more nerve cells than there are supporting cells (hence, more hot dots than cold dots) and axons are more reflective than other cell types due to their perpendicular orientation with respect to the light source. However, in glaucoma disease progression, loss of axons occurs, which translates to a reduced number of hot dots on an OCT image and a smaller spread between hot and cold dots”).
Furthermore, Durr teaches this configuration such that “Such diminished reflectivity translates to fewer hot dots in the OCT image. As reflectivity diminishes, the hot dots become increasingly sparse. In a similar manner to that described above, the system quantifies the number of hot dots present to determine the likelihood of glaucoma existing” (Derr, col 7 lines 44-48).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Derr to provide a device in which said alteration in tissue structure is an alteration in tissue reflectivity that is an alteration in hyporeflective regions, hyperreflective regions, hyporeflective regions within a hyperreflective region, or any combination thereof, for the purpose of determining the likelihood of glaucoma existing (Derr, col 7 lines 44-48).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Laforest (US 20190290124 A1), as in claim 13, and further in view of Borodic (US 20180296651 A1).
Regarding claim 16, Laforest teaches method according to claim 13. Laforest fails to explicitly teach: wherein said disease is age-related macular degeneration (AMD) and said altered structure is an alteration in RPE cell density, RPE cell size, hyperreflective regions, hyporeflective regions, and/or hyporeflective regions within a hyperreflective region.
However, in an alternate invention in the field of macular degeneration treatment, Borodic teaches: wherein said disease is age-related macular degeneration (AMD) and said altered structure is an alteration in RPE cell density, RPE cell size, hyperreflective regions, hyporeflective regions, and/or hyporeflective regions within a hyperreflective region (“Clinical assessment may be made based on one or more of the following: family history, fundus inspection using photography, SD OCT, with careful evaluation of the status of the retinal pigment epithelium for defective signs, including but not limited to presence of pigment in fundoscopy, pigment migration anteriorly into the neuro-retina (intra-retinal hyper pigment), presence and volume of drusen, focal intra retinal hyper reflection, sub drusenoid deposits, sub-drusenoid hyperreflectivity, dynamic reduction in drusen volume, second eye staging for severity, hypo reflectivity, choroidal neovascularization, hypo pigmentation, discontinuity and disappearance of OCT reflectivity lines (e.g., IS-OS, external nuclear layer, RPE layer), retinal and choroidal thickness or associated components, dynamic changes in any measurements, thickening of reflectivity lines, cyst formation, and any configuration of fluid formations”; [0005], “There are risk factors for the development and progression of AMD that may be used in connection with the disclosed methods. For example, possible risk factors that may be considered include but are not limited to: number and volume of drusen and drusenoid lesions, extent and position of geographic atrophy in target or contralateral eye, number and position of hyper-reflective foci into the neuroretina (either position over drusen-drusenoids), loss and disorganization of continuity of IS-OS line or outer nuclear layer, hyper or hypo pigmentation, hyper-reflectivity and deposits within the drusens, dynamic changes in number and size of drusens, soft drusen, hyperreflective foci, IS-OS lines ONL, and presence and number of pseudo-drusen”; [0212]).
Furthermore, Borodic teaches this configuration such that “Prior to administering the disclosed formulations to a patient, a clinical assessment may be made by a qualified medical practitioner to evaluate whether treatment according to the disclosed methods is appropriate” (Borodic, [0005]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Borodic to provide a device in which said disease is age-related macular degeneration (AMD) and said altered structure is an alteration in RPE cell density, RPE cell size, hyperreflective regions, hyporeflective regions, and/or hyporeflective regions within a hyperreflective region, for the purpose of evaluating whether treatment according to the disclosed methods is appropriate (Borodic, [0005]).
Regarding claim 17, Laforest teaches method according to claim 13. Laforest fails to explicitly teach: wherein said disease is central serous chorioretinopathy and said altered structure is an alteration of the RPE and the choriocapillaris.
However, in an alternate invention in the field of macular degeneration treatment, Borodic teaches: wherein said disease is central serous chorioretinopathy (“Other forms of disease of the retina can be targets for botulinum toxin given by extra orbital and/or per-orbital method, including: … 9. Central serous retinopathy”; [0157] and [0166], ‘central serous chorioretinopathy’ and ‘central serous retinopathy’ are known synonyms in the art) and said altered structure is an alteration of the RPE and the choriocapillaris (“In each of the above diseases disruptions of the retinal pigment epithelium can occur causing damage to photoreceptors by leakage of choroidal fluid containing cytokines, leukocytes, antibodies and various immune reacting agents destructive to photoreceptors leading to visual loss and blindness”; [0179]. Leakage of choroidal fluid arises from a breakdown in the integrity of the choriocapillaris such that Borodic disclosure of ‘leakage of choroidal fluid’ is a disclosure of an alteration of the choriocapillaris itself).
Furthermore, Borodic teaches this configuration such that “In each of the above diseases disruptions of the retinal pigment epithelium can occur causing damage to photoreceptors by leakage of choroidal fluid containing cytokines, leukocytes, antibodies and various immune reacting agents destructive to photoreceptors leading to visual loss and blindness” (Borodic, [0179]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Borodic to provide a device in which said disease is central serous chorioretinopathy and said altered structure is an alteration of the RPE and the choriocapillaris, for the purpose of monitoring disruptions of the retinal pigment epithelium to prevent visual loss and blindness (Borodic, [0179]).
Claims 18 are rejected under 35 U.S.C. 103 as being unpatentable over Laforest (US 20190290124 A1), as in claim 15, and further in view of Huang (US 7905599 B2).
Regarding claim 18, Laforest teaches method according to claim 15. Laforest fails to explicitly teach: said disease is glaucoma and said altered structure is an alteration of the nerve fiber layer, or alteration of the optic disc morphology.
However, in an alternate invention in the field of eye testing and diagnostics, Huang teaches: said disease is glaucoma (“the present invention provides a method of training a machine classifier for glaucoma”; col 2 lines 62-63) and said altered structure is an alteration of the nerve fiber layer, or alteration of the optic disc morphology (“the damages associated with glaucoma generally include thinning of the inner retinal layers in the macula region and the nerve fiber layer around the optic disc, as well as enlarged cup and reduced rim in the optic nerve head”; col 2 lines 24-27).
Furthermore, Huang teaches this configuration such that “Glaucoma is the second leading cause of blindness in the U.S. It is characterized by loss of retinal ganglion cells, thinning of the retinal nerve fiber layer, or cupping of the optic disc. Conventional tests are based on measurements of intraocular pressure and visual field tests. Because there may be significant structural loss before functional loss begin to manifest, these tests often miss early stages of the disease. In theory, diagnosis based on structural loss should be able to detect glaucoma at a stage earlier than detectable visual field defects” (Huang, col 1 lines 35-44).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Huang to provide a device in which said disease is glaucoma and said altered structure is an alteration of the nerve fiber layer, or alteration of the optic disc morphology, for the purpose of detecting glaucoma at a stage earlier than detectable visual field defects (Huang, col 1 lines 35-44).
Claims 19 are rejected under 35 U.S.C. 103 as being unpatentable over Laforest (US 20190290124 A1), as in claim 15, and further in view of Yancopoulos (US 11253572 B2).
Regarding claim 19, Laforest teaches method according to claim 15. Laforest fails to explicitly teach: wherein said disease is diabetic retinopathy and the altered structure is an alteration of the retinal vasculature.
However, in an alternate invention in the field of eye testing and diagnostics, Yancopoulos teaches: wherein said disease is diabetic retinopathy and the altered structure is an alteration of the retinal vasculature (“The anatomical state of the retinal vasculature of the study eye was evaluated by funduscopic examination”; col 12 lines 44-45, “diabetic retinopathy, a disease affecting the blood vessels of the retina”; col 7 lines 49-50).
Furthermore, Yancopoulos teaches the breadth of this configuration such that “The methods of the present invention can be used to treat any angiogenic eye disorder. The expression “angiogenic eye disorder,” as used herein, means any disease of the eye which is caused by or associated with the growth or proliferation of blood vessels or by blood vessel leakage” (Yancopoulos, col 5 lines 31-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Yancopoulos to provide a device in which “wherein said disease is diabetic retinopathy and the altered structure is an alteration of the retinal vasculature,” for the purpose of treating and detecting angiogenic eye disorders in patients (Yancopoulos, col 5 lines 31-35).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Laforest (US 20190290124 A1), as in claim 1, and further in view of Zee (US 8787638 B2).
Regarding claim 20, Laforest teaches method according to claim 1. Laforest fails to explicitly teach: wherein said altered structure is indicative of geographic atrophy, drusen, reticular pseudo-drusen, neovasculature and/or retinal pigment epithelium degeneration.
However, in an alternate invention in the field of retinal image analysis, Zee teaches: wherein said altered structure (“(d) comparing the one or more factors obtained from step (c) with those of a control, a change of the factors is an indication of the presence, progression and/or treatment effect of the disease in the subject”; col 3 lines 35-38) is indicative of geographic atrophy, drusen, reticular pseudo-drusen, neovasculature and/or retinal pigment epithelium degeneration (“the abnormal patterns may include hemorrhages, exudates, new vessels, microaneurysm, proliferative vitreoretinopathy or any combination thereof”; col 10 lines 60-63).
Furthermore, Zee teaches this configuration such that “We developed an automated disease detection system using retinal images. We first generate all possible risk factors from color images that may associated with diabetes retinopathy, stroke and/or other diseases” (Zee, col 2 lines 56-59) and further teaches “the automatic system correlated well with the clinical retina characteristics and their interaction. With such correlations, we demonstrated that the automatic analytical system captured the clinically important characteristics over and above the level that can be done manually, this can be expanded to other eye diseases with possible clinical interpretation” (Zee, col 1 lines 47-52).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Zee to provide a device in which said altered structure is indicative of geographic atrophy, drusen, reticular pseudo-drusen, neovasculature and/or retinal pigment epithelium degeneration, for the purpose of automatic analytical system capturing the clinically important characteristics over and above the level that can be done manually (Zee, col 1 lines 47-52).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cuzzani (US 20220168361 A1), as in claim 4, and further in view of Laforest (US 20190290124 A1).
Regarding claim 5, Cuzzani teaches the method according to claim 4. Cuzzani fails to teach: wherein said altered structure is a structure altered relative to that determined from analysis of a TOI image of said posterior segment obtained from a similarly situated subject known not to have the disease or known not to be at risk of developing the disease.
However, in an alternate invention in the field of eye testing and diagnostics, Laforest teaches: wherein said altered structure (“RPE (retinal pigmented epithelium)”; [0220]) is a structure altered relative to that determined from analysis of a TOI image (“The human in-vivo fundus image is taken with transscleral illumination”; [0130]) of said posterior segment obtained from a similarly situated subject known not to have the disease or known not to be at risk of developing the disease (“the deep learning software can be trained with pathologic and nonpathologic images (in vivo or ex vivo)”; [0145]).
Furthermore, Laforest teaches this configuration such that “Anatomical features are extracted and analyzed to detect possible abnormalities” (Laforest, [0122]). Further, “the features extraction can be applied to medical information extraction in order to help the clinician analyzing the data” (Laforest, [0145]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cuzzani to incorporate the teachings of Laforest to provide a device in which said altered structure is a structure altered relative to that determined from analysis of a TOI image of said posterior segment obtained from a similarly situated subject known not to have the disease or known not to be at risk of developing the disease, for the purpose of detecting possible abnormalities (Laforest, [0122]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Laforest (US 20190290124 A1), as in claim 1, and further in view of Bavik (US 20140039048 A1).
Regarding claim 8, Laforest teaches method according to claim 10. Laforest fails to teach to: wherein said disease associated with an altered structure in the posterior segment of the eye is uveitis, glaucoma, macular edema, macular hole, macular pucker, diabetic macular edema, diabetic retinopathy, diabetic eye diseases, retinopathy, age-related macular degeneration (AMD), wet AMD, dry AMD, early AMD, intermediate AMD, central serous chorioretinopathy, scleritis, optic nerve degeneration, geographic atrophy, choroidal disease, ocular sarcoidosis, optic neuritis, choroidal neovascularization, retinitis pigmentosa, retinal tears, Stargardt disease, ocular cancer, retinitis, corneal ulcers, cataract, infection with a virus, infection with fungi, parasitic infection, bacterial infection, sarcoidosis, retinal vein occlusion, central retinal vein occlusion, branch retinal vein occlusion, retinal vascular disease, Vogt-Koyanagi-Harada syndrome, Behcet's disease, idiopathic retinal vasculitis, Vogt-Koyanagi-Harada Syndrome, acute posterior multifocal placoid pigment epitheliopathy (APMPPE), presumed ocular histoplasmosis syndrome (POHS), birdshot chroidopathy, Multiple Sclerosis, sympathetic opthalmia, punctate inner choroidopathy, pars planitis, iridocyclitis diabetic retinopathy, retinopathy of prematurity (ROP), ischemic vasculopathies, inherited retinal dystrophies, retinal detachment, aberrant angiogenesis, retinal angiomatous proliferation (RAP), intraretinal microvascular abnormalities, pre-retinal neovascularization, choroidal angiogenesis, choroidal vasculopathy stroke, hypertension, diabetes, cardiovascular disease, prematurity, and papilloedema.
However, in an alternate invention in the field of ophthalmic diseases Bavik teaches, as best understood: wherein said disease associated with an altered structure in the posterior segment of the eye is (“In one embodiment, the retinal neovascularization is associated with one or more retinopathies including, but not limited to”; [0031]) uveitis (“uveitis”; [0031]), glaucoma (“neovascular glaucoma”; [0066]), macular edema (“Macular edema”; [0092]), diabetic macular edema (“diabetic macular edema”; [0065]), diabetic retinopathy (“diabetic retinopathy”; [0065]), diabetic eye diseases (para [0032]), retinopathy (“retinopathy”; [0012]), age-related macular degeneration (AMD) (“Age-related Macular Degeneration (AMD)”; [0147]), wet AMD (“wet aged-related macular degeneration”; [0143]), dry AMD (the "dry" form of advanced AMD”; [0148]), early AMD (“early stage of AMD”; [0146]), geographic atrophy (“Central geographic atrophy”; [0148]), ocular sarcoidosis (“sarcoidosis”; [0031]), choroidal neovascularization (“choroidal neovascularization”; [0148]), retinitis pigmentosa (“retinitis pigmentosa”; [0031]), retinal tears (“retinal tears”; [0165]), cataract (“cataract”; [0122]), sarcoidosis (“sarcoidosis”; [0031]), retinal vein occlusion (“retinal vein occlusion”; [0031]), retinopathy of prematurity (ROP) (“retinopathy of prematurity”; [0032]), birdshot chroidopathy (“birdshot retinochoroidopathy”; [0031]), retinal detachment (“chronic retinal detachment”; [0031]), diabetes (“diabetes”; [0032]).
Bavik further teaches this configuration such that “as the symptoms of diabetic retinopathy are generally not visible in this stage, it is recommended that regular retinal screening eye tests should be done to monitor the signs of progression to more serious stages of retinopathy” (Bavik, [0099]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Laforest to incorporate the teachings of Bavik to provide a device which satisfies the conditions of claim 8, for the purpose of monitoring the signs and progression of eye pathologies (Bavik, [0099]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20150258120 A1: teaches to the known synonyms of ‘central serous chorioretinopathy’ and ‘central serous retinopathy’ in para [0152]: “central serous chorioretinopathy (CSC) (also known as central serous retinopathy (CSR)).” Relevant to claim 17.
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/RUBY L KAUFFMAN/Examiner, Art Unit 2872
/WILLIAM R ALEXANDER/Primary Examiner, Art Unit 2872
