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 .
Drawings
The drawings received on 11/07/2024 are objected to because: at least Figures 5 and 14 do not comply with 37 CFR 1.84(p) - various text (letters, numbers, characters) are too small and are not clearly legible or have a line quality that is too light to be reproduced. Similar issues exist for the other figures. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 11, 13, 24 and 26 are 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 pre-AIA the applicant regards as the invention.
Claims 11 and 24 contain the trademark/trade name “Optos”. Optos is a medical technology brand and registered trademark.
Claims 13 and 26 contain the trademark/trade name “CenterVue EIDON and Heidelberg SPECTRALIS”. Both CenterVue EIDON and Heidelberg SPECTRALIS are legally registered, proprietary trademarks for high-tech ophthalmic imaging devices used by eye care professionals.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to describe any particular material or product. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite but would also constitute an improper use of the trademark or trade name. If the applicant responds to such a rejection by replacing the trademark or trade name with a generic term, the applicant should determine whether there is sufficient support in the application for use of a generic term. See MPEP § 2163. In the present case, the trademark/trade name is used to identify/describe the imaging device and analyzing device, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (WO 2021248253) in view of Knepper (US 2023/0270689)
Regarding claims 1 and 14, Campbell teaches a method/system for detecting cerebral amyloid angiopathy (CAA) in a subject (refer to: WO 2021248253), comprising:
capturing multiple fluorescence images of the subject's retina (methods and an apparatus for imaging and analyzing images of presumed protein deposits in the retina, [para. FIELD, page 1]; to define a scale of severity of these deposits of retinal amyloid in CAA. In the inventors’ direct observations, the presence of and severity of amyloid in the vessels of the retina is as visible in polarimetry measurements as it is in fluorescence imaging, [page 30, para 2]),
analyzing the images to detect and quantify perivascular amyloid accumulation along retinal blood vessels (the methods and apparatus described are aimed at imaging and analyzing images of presumed protein deposits in the retina, retinal tissue or retinal structures, [page 3, para 2]; FIG. 11A is an example of a vessel-associated amyloid deposit (presumed amyloid beta), stained with thioflavin S, which is inside an outer vessel wall, .. The deposit found in this subject lies within and at the top of a vessel, see FIG. 11B, [page 17]); and
determining a likelihood of CAA based on the detected perivascular amyloid accumulation (determining whether retinal deposits contain amyloid, whether or not they contain amyloid protein and subsequently whether they contain a particular subtype of amyloid protein or other protein deposits related to neurodegenerative eye … once the type(s) of amyloid protein present have been classified, the position, shape and other properties of the deposits singly or in combination can be used to classify and differentiate the likelihood that condition(s) or disease(s) are present. [SUMMARY, pages 1-2]; the measurement of the optical properties of the protein deposits within the retina …. the position of the deposit in the retina and/or the optical and/or morphological and/or fractal properties of the deposits within the retina either measured directly or imaged as part of a retinal image. [page 4, para 3]; the properties within both the raw and/or the calculated images of the retina, including the pixel-by-pixel representation … protein deposits in the retina that these condition(s) … or to diseases, [page 4, para 4], FIGS. 11 A, 11B, 11C, 11D, 12A, 12B, 13, and 14 of the present application, the present inventors use images taken in fluorescence to classify the condition of cerebral amyloid angiopathy (CAA) in the retina due to the presence of amyloid in the blood vessels. .. precede to define a scale of severity of these deposits of retinal amyloid in CAA, [page 30, para. 2]). With respect to the additional limitation of claim 14: “A processor for analyzing images”, Cambell discloses in WO 2021/248253 discloses a processor both explicitly and inherently to execute the methods for analyzing retinal images and mapping or classifying protein deposits associated with cerebral amyloid angiopathy (CAA). The patent application explicitly claims an apparatus and system for imaging and analyzing retinal structures. This structural apparatus explicitly includes a processor, computing device, or electronic processing circuitry coupled to an optical imaging system. The disclosure specifies software-driven steps for extracting optical properties (e.g., linear retardance, Fig. 2A, intensity ratios). These calculations require a physical digital signal processor (DSP) or CPU to run. techniques—such as machine learning models (Random Forests or Convolutional Neural Networks) [end of page 5 and beginning of page 6] used by the Cambell to differentiate amyloid deposits from other proteins—inherently requires a processor.
Campbell doesn’t explicitly teach using autofluorescence images.
Campbell and Knepper both work in the field of quantifying retinal amyloid.
Knepper teaches autofluorescence images (it has become possible to quantitate retinal β-amyloid in vivo in living subjects using fundus autofluorescence photography with blue light autofluorescence and curcumin as a contrast agent., [0012]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Cambell and use autofluorescence images capabilities as taught by Knepper for the predictable advantage of having the ability to track beta-amyloid in retinal CNS tissue in living patients to create opportunities for clinical trials for Alzheimer's disease to use retinal beta-amyloid as a surrogate endpoint. Because this method is significantly more accessible and without the dangers of methods currently used to identify beta-amyloid”, as taught by Knepper in [0012] and [0104].
Regarding claims 3 and 16, modified Campbell teaches the method according to claim 1 or 14 (see above), further comprising: applying an image quality filter to eliminate low quality images (the raw images taken when different light polarizations are incident onto the deposits and the captured light is filtered by additional optical elements that interact with polarized light, [page 60, para. 3]).
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. in view of Knepper as applied to claims 1 and 14 above, and further in view of Wei et al. (US 8205991).
Regarding claims 2 and 15, modified Campbell teaches the method/system according to claim 1 or 14 (see above), further comprising: creating a standardized region of interest using a registration function and detection of optic nerve head and fovea (amyloid protein deposits within the vessels, allow an accurate visualization of the deposits as inside of outside a vessel. Because the deposits can be sparse, following imaging, segmentation of the blood vessels and increased magnification of candidate areas of the vessels should be undertaken, [page 51; para 2]).
The modified Campbell doesn’t explicitly teach a region of interest using a registration function and detection of optic nerve head and fovea.
Campbell and Wei both work in the field of eye examination.
Wei teaches a region of interest using a registration function and detection of optic nerve head and fovea (utilize a baseline image upon which the registration is performed as in step 209. … FIG. 3 shows an example of baseline scan pattern 300 that can be utilized to acquire a sequence of OCT images. Scan pattern 300, which in this case includes horizontal scans 303 and vertical scans 305, can be arranged to substantially cover the eye features of interest, for example, the fovea or optic nerve head, [C-3, L-54-62]; A baseline image can also be used for the examination of the optic nerve head, [C-5, L-46-47]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the modified method of Cambell and use a registration function and detection of optic nerve head and fovea, as taught by Wei for the predictable advantage of the registration methods can be utilized to compute the new point location B with respect to a probably different point A [C-5, L-39-41] and also utilize a baseline image upon which the registration is performed and utilized for a progressive analysis, for example of baseline scan pattern that can be utilized to acquire a sequence of OCT images, [C-3, L-54-62].
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. in view of Knepper as applied to claims 1 and 14 above, and further in view of Minamide et al. (US 2023/0218165).
Regarding claims 4 and 17, modified Campbell teaches the method/system according to claim 1 or 14 (see above). The modified Campbell doesn’t explicitly teach the method further comprising: detecting retinal hemorrhage and vessel tortuosity.
Campbell and Minamide both work in the field of eye examination.
Minamide teaches the method comprising: detecting retinal hemorrhage and vessel tortuosity (detected from ocular image data of a patient feature related to a fundus blood vessel may, for example, include any one or more of a distribution, thickness (blood vessel diameter), tortuosity (features on blood vessel running), bleeding (hemorrhage), and other blood vessel features, in some examples, features such as rupture (break) of a retinal microvessel, hemorrhage, or a running abnormality, [0111]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the modified method of Cambell comprising: detecting retinal hemorrhage and vessel tortuosity, as taught by Minamide for the predictable advantage of detecting a state (condition) of the circulatory system of a patient in a non-invasive manner, [0004].
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. in view of Knepper as applied to claims 1 and 14 above, and
further in view of Scheibler et al. (US 2018/0271363).
Regarding claims 5 and 18, modified Campbell teaches the method/system according to claim 1 or 14 (see above). The modified Campbell doesn’t explicitly the method further comprising detecting retinal edema using optical coherence tomography (OCT).
Campbell and Scheibler both work in the field of eye examination.
Scheibler teaches the method further comprising: detecting retinal edema using optical coherence tomography (OCT), (Macular edema is an example of elevated retinal thickness which is often related to other diseases such as diabetes. Macular edema can be related to other diseases such as age-related macular degeneration, uveitis, blockage of retinal vasculature, and glaucoma, for example. It would be helpful to know quickly if a medication is not working or requires re-administration so that treatment can be modified accordingly and vision preserved. One approach used to measure the thickness of the retina is optical coherence tomography (OCT), [0003]; Diseases related to an abnormal retinal thickness (RT) include glaucoma and macular edema, systems and methods disclosed herein relate to the use of optical coherence tomography (OCT) to measure the RT or RLT at multiple points in time, a patient measures their RT or RLT at multiple time points to track the progression of an ophthalmological disease such as glaucoma or macular edema over time, [0078-0079]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the modified method of Cambell further comprising detecting retinal edema using improved optical coherence tomography (OCT) systems and measure thickness of the retina. Ideally, such systems would be compact, handheld, provide in-home monitoring, allowing the patient to measure himself or herself, as taught by Scheibler for the predictable advantage of evaluating retinal thickness, i.e. Macular edema, which can be related to diseases such as age-related macular degeneration, uveitis, blockage of retinal vasculature, and glaucoma, for example. It would be helpful to know quickly if a medication is not working or requires re-administration so that treatment can be modified accordingly [0003-0005].
Claims 6, 7, 9, 10, 11, 12, 19, 20, 22, 23, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. in view of Dumitrascu et al. (NPL “Sectoral segmentation of retinal amyloid imaging in subjects with cognitive decline”, Alzheimer’s Dement; hereinafter Dumitrascu-2020, copy attached) and further in view of Dumitrascu et al. (NPL “Retinal Venular Tortuosity Jointly with Retinal Amyloid Burden Correlates with Verbal Memory Loss: A Pilot Study”, hereinafter Dumitrascu-2021; copy attached).
Regarding claims 6 and 19, Campbell teaches a method/system for detecting a cerebral amyloid angiopathy (CAA) condition of a subject (refer to: WO 2021248253), comprising:
i. capturing multiple images of a retina of the subject (methods and an apparatus for imaging and analyzing images of presumed protein deposits in the retina, [para. FIELD, page 1]),
ix. using individual elements and a combined data vector to predict the likelihood of CAA of the subject (once the type(s) of amyloid protein present have been classified, the position, shape and other properties of the deposits singly or in combination can be used to classify and differentiate the likelihood that condition(s) or disease(s) are present, [para. 1 of Summary]; differences within the images or a subset of images or differences in the images themselves of the retina may be classified into categories of conditions or diseases, either affecting only the retina and thus vision or it could be inferred from the identification of one or more proteins or protein deposits that these conditions or diseases are also affecting or likely to affect the brain and giving rise to either prodromal conditions [para. 5 of Summary]; amyloid beta in the retinas of those who have other conditions of the brain, including cerebral amyloid angiopathy (herein referred to as CAA, [page 30, para. 2]).
With respect to the additional limitation of claim 19: “wherein a processor uses individual elements”, Cambell discloses, in WO 2021/248253 discloses a processor both explicitly and inherently to execute the methods for analyzing retinal images and mapping or classifying protein deposits associated with cerebral amyloid angiopathy (CAA). The patent application explicitly claims an apparatus and system for imaging and analyzing retinal structures. This structural apparatus explicitly includes a processor, computing device, or electronic processing circuitry coupled to an optical imaging system. The disclosure specifies software-driven steps for extracting optical properties (e.g., linear retardance, Fig. 2A, intensity ratios). These calculations require a physical digital signal processor (DSP) or CPU to run. techniques—such as machine learning models (Random Forests or Convolutional Neural Networks) [end of page 5 and beginning of page 6] used by the Cambell to differentiate amyloid deposits from other proteins—inherently requires a processor.
Campbell doesn’t explicitly teach
ii. creating a standardized region of interest of the multiple images using a registration function, image quality assessment, and detection of optic nerve head (ONH) and fovea.
iii. applying an image filter and blink detector to eliminate images that are of low image quality,
iv. performing background correction on the images.
v. applying a vessel detection algorithm on the images.
vi. applying a probability density function (PDF) fit of the retina and segmentation of retinal auto fluorescence.
vii. detecting any retinal hemorrhage and retinal vessel tortuosity.
viii. detecting any retinal edema by optical coherence tomography (OCT)
Campbell and Dumitrascu-2020 both work in the field of eye examination.
Dumitrascu-2020, in a non-patent literature published in Alzheimer's & Dementia, "Sectoral segmentation of retinal amyloid imaging in subjects with cognitive decline” disclosed the steps:
i. capturing multiple images of a retina (At least 18 images of the superior retina were taken for each eye, [paragraph 2.3, Retinal amyloid imaging],
ii. creating a standardized region of interest of the multiple images using a registration function, image quality assessment, and detection of optic nerve head (ONH) and fovea (A common region of interest (ROI) was applied with a field of view of 50 degrees positioned on the image center, using fovea and optic nerve head centers as reference points to correct for eye rotation, with a zone around the fovea and optic nerve head masked, [paragraph 2.3, Retinal amyloid imaging]),
iii. applying an image filter and blink detector to eliminate images that are of low image quality; (software selected the eight highest quality images for further processing, i.e. the software performs image quality filtering and screening; [paragraph 2.3, Retinal amyloid imaging]),
iv. performing background correction on the images (These eight images were aligned and combined to reduce noise and further processed to reduce background variability and to maximize dynamic range, [paragraph 2.3, Retinal amyloid imaging]),
vi. applying a probability density function (PDF) fit of the retina and segmentation of retinal auto fluorescence (Crucially, it processes the ROI pixels into a mathematically characterized probability density function (PDF) histogram to segment abnormally intense signals, [paragraph 2.3, Retinal amyloid imaging]),
viii. detecting any retinal edema by optical coherence tomography (OCT), (Drusenoid structures can also be found in the peripheral retina in cognitively impaired individuals, A drusenoid structure, which may contain Aβ, can be potentially distinguished from a retinal amyloid plaque spatially and morphologically by using spectral domain optical coherence tomography, [paragraph 4. Discussion]. It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Campbell to include steps as taught by Dumitrascu for the predictable advantage of automatically quantify retinal amyloid count (RAC) and area in the super-otemporal retinal sub‐regions and performed correlation analyses with cognitive and brain volumetric parameters, as taught by Dumitrascu et al. in [paragraph Methods].
The modified Campbell doesn’t explicitly teach the steps:
v. applying a vessel detection algorithm on the images.
vii. detecting any retinal hemorrhage and retinal vessel tortuosity.
Campbell and Dumitrascu-2021 both work in the field of eye examination.
Dumitrascu et al. hereinafter Dumitrascu-2021, in a non-patent literature published in MDPI, " Retinal Venular Tortuosity Jointly with Retinal Amyloid Burden Correlates with Verbal Memory Loss: A Pilot Study” disclosed the steps:
v. applying a vessel detection algorithm on the images, (The set of retinal images were processed using an automated retinal fluorescence measurement software system. A combination of algorithms, including background correction, followed by characterization of the corrected retina using a mixture model, were used to identify pixels that were abnormally bright, [paragraph 2.3, Retinal amyloid quantification]),
vii. detecting any retinal hemorrhage and retinal vessel tortuosity, (The branching angle and tortuosity of vessels within the region of interest were calculated, [paragraph 2.2 Retinal imaging]; For each centerline, several geometric features, including the vessel tortuosity index (VTI), vessel inflection index, and branching angle, were non-automatically quantified. The VTI was calculated for each centerline based on a combination of local and global centerline geometric variables, as explained previously, that can detect alterations in the retinal vessels’ curvature with pixel-level accuracy. Equation (1) shows the formula for the VTI. [paragraph 2.4, Retinal Vascular Quantification], It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the modified method of Campbell to include steps as taught by Dumitrascu-2021 for the predictable advantage of getting a more comprehensive indicator of cognitive performance, and facilitating more extensive clinical trials as well as improving the detection of early dementia, as taught by Dumitrascu et al. in [paragraph Discussion].
Regarding claims 7 and 20, modified Campbell teaches the method/system according to claim 6 or 19 (see above). Dumitrascu-2021 teaches using the individual elements and combined data vector to predict the likelihood of Amyloid Related Imaging Abnormalities (ARIA-E and ARIA-H), (Two or more retinal vascular abnormalities were associated in a dose-response manner with an increased risk of disabling dementia in a prior study [49]. It is possible that combined amyloid–vascular indexes are better discriminators of cognitive function, with the potential for use as outcome measures in AD and mixed dementia trials. [paragraph 4, Discussion]).
Regarding claims 9 and 22, modified Campbell teaches the method/system according to claim 6 or 19 (see above). Dumitrascu-2020, teaches wherein the step of applying an image filter and blink detector eliminates images of low image quality due to cataracts and lid obstructions (applying an image filter and blink detector to eliminate images that are of low image quality; (software selected the eight highest quality images for further processing, i.e. the software performs image quality filtering and screening; [paragraph 2.3, Retinal amyloid imaging]),
Regarding claims 10 and 23, modified Campbell teaches the method/system according to claim 6 or 19 (see above), wherein the steps a-h are performed in a camera which captures multiple images, (a given optical imaging modality used to image the retina, [page 29, para. 2], mage taken with any type of incident light which makes the deposits visible, [page 3, para. 2]).
Regarding claims 11 and 24, modified Campbell teaches the method/system according to claim 6 or 19 (see above), wherein step a is performed using an Optos wide field retinal imaging device, (performing wide field imaging of the retina using light to illuminate the retina with sufficient field size, [page 6, para. 3]).
Regarding claims 12 and 25, modified Campbell teaches the method/system according to claim 6 or 19 (see above), further including the step of quantifying amyloid along blood vessels (severity of cerebral amyloid angiopathy within the blood vessels of the retina can also be categorized from images of amyloid protein within the blood vessels of the retina (see FIGS. 11 A, 11 B,11 C, 11 D, 12A, 12B and 13 of the present application, [page 50, para. 3] and [page 52, para. 3])
Claims 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. in view of Dumitrascu-2020 and Dumitrascu-2021, as applied to claims 6 and 19 above, and further in view of Knepper (US 2023/0270689).
Regarding claims 8 and 21, modified Campbell teaches the method/system according to claim 6 or 19 (see above). The modified Campbell doesn’t explicitly teach, wherein the capturing multiple images of a retina captures images in blue auto fluorescence (AF), green AF, color, infrared (IR), and OCT.
Campbell and Knepper both work in the field of quantifying retinal amyloid.
Knepper teaches wherein the capturing multiple images of a retina captures images in blue auto fluorescence (AF), green AF, color, infrared (IR), and OCT (multi-color immunofluorescence measurements, [0079], an argon laser at 635 nm, [0082], extravascular, bright-red to brown in color, [0087], using fundus blue-light autofluorescence (FAF) photography and curcumin as a contrast agent. Imaging can be performed on most conventional ocular coherence tomography (OCT) systems with autofluorescence capabilities, [0104]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the method of modified Cambell wherein the capturing multiple images of a retina captures images in blue auto fluorescence (AF), green AF, color, infrared (IR), and OCT, as taught by Knepper for the predictable advantage of having the ability to track beta-amyloid in retinal CNS tissue in living patients to create opportunities for clinical trials for Alzheimer's disease to use retinal beta-amyloid as a surrogate endpoint. Because this method is significantly more accessible and without the dangers of methods currently used to identify beta-amyloid”, as taught by Knepper in [0012] and [0104].
Claims 13 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. in view of Dumitrascu-2020 and Dumitrascu-2021 as applied to claims 6 and 19 above, and further in view of O’Callaghan et al. (US 2022/ 0362402).
Regarding claims 13 and 26, modified Campbell teaches the method/system according to claim 6 and 19 (see above), The modified Campbell teaches doesn’t explicitly teach, wherein step a is performed using a CenterVue Eidon or Heidelberg Spectralis device.
Campbell and O’Callaghan both work in the field of eye examining.
O’Callaghan teaches wherein step a is performed using a CenterVue Eidon or Heidelberg Spectralis device (Anterior segment OCT may be performed using a Heidelberg Spectralis OCT HRA or OCT Plus with eye tracking and HEYEX image capture and analysis software, [0116]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the method of modified Cambell wherein step a is performed using a CenterVue Eidon or Heidelberg Spectralis device, as taught by O’Callaghan for the predictable advantage of it is known to the art as a high-resolution, TrueColor confocal scanner used to take digital images of the human retina
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. i) Stamile et al. US 20150320313; Portable Medical Device And Method For Quantitative Retinal Image Analysis Through A Smartphone. ii) Barbut et al.
(US 20200038412), METHODS OF TREATING ALZHEIMER'S DISEASE USING AMINOSTEROL COMPOSITIONS, iii) KORONYO et al. (EP 2323696), OPTICAL METHOD FOR THE DETECTION OF ALZHEIMER'S DISEASE.
Changing the independent claims 6 and 19 from comprising to consisting the steps appear to overcome the rejection as written.
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/R.A/Examiner, Art Unit 2872
/BALRAM T PARBADIA/Primary Examiner, Art Unit 2872