DETAILED ACTION
Claims 1-4, 6-10, 14, 17-19, 22-24, & 26-29 are currently pending and have been examined.
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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 6-10, 14, 17-19, 22-24, & 26-29 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-4, 6-10, 14, 17-19, 22 are directed to a method (i.e., a process); and Claims 23-24 & 26-29 are directed to a system (i.e., a machine). Accordingly, Claims 1-4, 6-10, 14, 17-19, 22-24, & 26-29 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 23 includes limitations that recite at least one abstract idea. Specifically, independent claim 23 recites:
23. A retinal imaging system for assessing a retina of a patient, the system comprising:
a retinal image acquisition system; and
a retinal image processing system including a processor and a non-transitory memory device, the retinal image processing system coupled to the retinal image acquisition system;
wherein the non-transitory memory device includes instructions that when executed by the processor, cause the processor to:
acquire, via the retinal image acquisition system, one or more retinal images of the retina of the patient;
differentiate between vein vessels and artery vessels in the one or more retinal images;
identify (i) venular-adjacent amyloid-beta plaques associated with one or more vein vessels, (ii) arterial-adjacent amyloid-beta plaques associated with one or more artery vessels, or (iii) both (i) and (ii); and
evaluate a neurological and/or ocular health condition based on (i) the venular-adjacent amyloid-beta plaques, (ii) the arterial-adjacent amyloid-beta plaques, or (iii) both (i) and (ii).
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because acquiring retinal image data, analyzing the image data to differentiate between vein and artery vessels, identify amyloid plaques in the vessels, and detecting a medical condition are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind.
Accordingly, independent claim 23 and analogous independent claims 1 & 22 recite at least one abstract idea.
Furthermore, dependent claims 2-4, 6-10, 14, 17-19, 24, & 26-29 further narrow the abstract idea described in the independent claims. Claims 2-3, 10, 14, & 18 recites diagnosing the disease based on plaque values, Claims 4-9 recites identifying vein architecture. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 23 and analogous independent claims 1 & 22, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
23. A retinal imaging system for assessing a retina of a patient, the system comprising:
a retinal image acquisition system; and
a retinal image processing system including a processor and a non-transitory memory device, the retinal image processing system coupled to the retinal image acquisition system;
wherein the non-transitory memory device includes instructions that when executed by the processor, cause the processor to:
acquire, via the retinal image acquisition system, one or more retinal images of the retina of the patient;
differentiate between vein vessels and artery vessels in the one or more retinal images;
identify (i) venular-adjacent amyloid-beta plaques associated with one or more vein vessels, (ii) arterial-adjacent amyloid-beta plaques associated with one or more artery vessels, or (iii) both (i) and (ii); and
evaluate a neurological and/or ocular health condition based on (i) the venular-adjacent amyloid-beta plaques, (ii) the arterial-adjacent amyloid-beta plaques, or (iii) both (i) and (ii).
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the retinal image acquisition system, retinal image processing system including a processor and memory, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of acquiring retinal data, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional as it merely consists of transmitting data over a network (see MPEP § 2106.05(d)(II)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, independent claim 23 and analogous independent claims 1 & 22not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recites at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claim 17: This claims recites administering a treatment to the patient and amounts to merely adding the words “apply it” to the judicial exception because the treatment limitation is recited at such a high level of generality.
Claim 19: This claim recites highlighting an area for display and therefore merely represent insignificant extra-solution activity (e.g., receiving and transmitting data)(see MPEP § 2106.05(g)) and conventional activities as they merely consist of receiving and transmitting data over a network (see MPEP § 2106.05(d)(II)).
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 23 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, regarding the additional limitations of the retinal image acquisition system, retinal image processing system including a processor and memory, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of acquiring retinal data, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional as it merely consists of transmitting data over a network (see MPEP § 2106.05(d)(II)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Regarding the additional limitations of highlighting areas for display which the Examiner submits merely adds insignificant extra-solution activity to the abstract idea, the Examiner has reevaluated such limitations and determined them to not be unconventional as they merely consist of receiving and transmitting data over a network. See MPEP 2106.05(d)(II).
Therefore, claims 1-4, 6-10, 14, 17-19, 22-24, & 26-29 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4, 9-10, 14, 18-19, & 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koronyo “Retinal amyloid pathology and proof-of-concept imaging trial in Alzheimer's disease”.
As per claim 1, Koronyo discloses method for diagnosing a neurodegenerative disease in a patient (retinal imaging used can lead to AD diagnosis, abstract), the method comprising:
acquiring one or more retinal images of a retina of the patient (retinal images of the patients used, abstract);
identifying venular-adjacent amyloid-beta plaques in one or more venular-adjacent regions of the retina (retinal deposits of amyloid-beta associated with blood vessels identified, abstract);
calculating an amount of the venular-adjacent amyloid beta plaques (calculation of plaques with RAI performed, abstract); and
diagnosing the neurodegenerative disease based at least in part on the amount of venular-adjacent amyloid-beta plaques (diagnosis made in part with the plaque identified in vessels associated with retinal deposits, abstract).
As per claim 4, Koronyo discloses the method of claim 1, Koronyo further discloses wherein identifying venular-adjacent amyloid-beta plaques (identification of plaque threshold was set, page 12, paragraph 3) comprises (i) identifying plaques that fall within the boundaries of a threshold area adjacent to the veins (plaques falling in area adjacent to blood vessels with the specific location identified, page 12, paragraph 3), (ii) identifying a vein architecture of the retina and classifying the vein architecture, or (iii) both (i) and (ii).
As per claim 9, Koronyo discloses the method of claim 1, Koronyo further discloses wherein the one or more retinal images include images of a superior-temporal region of the retina (superior temporal region found in images, page 6, paragraph 1 ).
As per claim 10, Koronyo discloses the method of claim 1, Koronyo further discloses wherein the amount of venular-adjacent amyloid-beta plaques includes (i) a density of the amyloid-beta plaques within a threshold volume of venular-adjacent region (deposits were classified based on the amount of fluorescence shown beyond a certain threshold along blood vessels, page 12, paragraph 3), (ii) a total number of the amyloid-beta plaques within a threshold area of the venular-adjacent region, or (iii) both (i) and (ii).
As per claim 14, Koronyo discloses the method of claim 1, Koronyo further discloses wherein diagnosing the neurodegenerative disease according to the amount of venular-adjacent amyloid-beta plaques includes determining if the amount of venular-adjacent amyloid-beta plaques is greater than a threshold amount (deposits in AD patients were higher than those in healthy patients, indicating neurodegenerative disease, ·page 12, paragraph 3), the threshold amount being (i) based on an amount of arterial-adjacent amyloid beta plaques, (ii) a predetermined threshold amount, or (iii) both (i) and (ii) (threshold of fluorescent intensity is a baseline determined previously, page 12, paragraph 3).
As per claim 18, Koronyo discloses the method of claim 1, Koronyo further discloses further comprising monitoring a disease progression in the patient based on change in the amount of venular-associated amyloid-beta plaques over time (disease progression and response to therapy monitored over time based on changing retinal deposits of plaques, page 16, paragraph 5).
As per claim 19, Koronyo discloses the method of claim 1, Koronyo further discloses further comprising highlighting an area of increased venular-associated amyloid-beta plaques on the one or more retinal images (fluorescence patterns in images highlighted, page 6, paragraph 2).
As per claim 22, Koronyo discloses a method for diagnosing a· neurological and/or ocular health condition of a patient (retinal imaging used can lead to AD diagnosis, abstract), the method comprising:
acquiring one or more retinal images of a superior temporal region of a retina
of the patient (superior temporal region found in images, page 6, paragraph 1 );
calculating an amount of amyloid-beta plaques in a venular-adjacent region of the retina of the patient (calculation of plaques with RAI performed, abstract); and
diagnosing the neurological and/or ocular health condition based on the amount of amyloid-beta plaques in the venular-adjacent region (diagnosis made in part with
the plaque identified in vessels associated with retinal deposits, abstract).
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 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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over
Koronyo in view of publication entitled "Functional and morphological changes of the retinal vessels in Alzheimer's disease and mild cognitive impairment" by Querques G. et al. (hereinafter "Querques").
As per claim 2, Koronyo discloses the method of claim 1, Koronyo does not disclose wherein diagnosing the neurodegenerative disease comprises: identifying an amount of arterial-adjacent amyloid beta plaques in one or more arterial adjacent regions of the retina; calculating an amount of the arterial-adjacent amyloid beta plaques; and calculating a ratio between the amounts of venular-adjacent plaques and
arterial-adjacent plaques.
Querques discloses wherein diagnosing the neurodegenerative disease (diagnosis can include retinal vessels for imaging studies, page 8, paragraph 2) comprises: identifying an amount of arterial-adjacent amyloid beta plaques in one or more arterial adjacent regions of the retina (retinal artery amyloid beta plaque amount separated, Table 5); calculating an amount of the arterial-adjacent amyloid beta plaques (retinal vein amyloid beta plaque amount separated, Table 5); and calculating a ratio between the amounts of venular-adjacent plaques and arterial-adjacent plaques (artery to vein ratio calculated to determine the ratio of dilation which was decrease in AD patients, page 4, paragraph 4).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the diagnosis of Koronyo to include ratio of artery to vein dilation, as taught by Querques, because this ratio is decrease in AD and mild cognitive impairment (Querques, page 4, paragraph 4).
As per claim 3, Koronyo discloses the method of claim 1, Koronyo does not disclose wherein diagnosing the neurodegenerative disease comprises differentiating venular-adjacent amyloid-beta plaques from arterial-associated amyloid-beta plaques. Querques discloses wherein diagnosing the neurodegenerative disease (diagnosis can include retinal vessels for imaging studies, page 8, paragraph 2) comprises differentiating venular-adjacent amyloid-beta plaques from arterial-associated amyloid-beta plaques (differentiation of artery vs. vein plaques is used as typical signals of AD, page 7, paragraph 1).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the diagnosis of Koronyo to include artery and vein distinction, as taught by, because the distinction of arteries show a larger reduction in vessel response in AD and mild cognitive impairment (Querques, page 8, paragraph 3).
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Koronyo in view of Querques in view of publication entitled "Accuracy and Reliability in Differentiating Retinal Arteries and Veins Using Widefield En Face OCT Angiography" by lshibazawa A. (hereinafter "lshibazawa").
As per claim 6, Koronyo and Querques disclose the method of claim 5, Koronyo does not disclose wherein identifying the vein architecture comprises identifying (i) one or more primary vein vessels, (ii) one or more primary vein branches, (iii) one or more secondary vein vessels, (iv) one or more secondary vein branches, (v) one or more tertiary vein vessels, or (vi) any combination of (i)-(v).
lshibazawa discloses wherein identifying the vein architecture comprises identifying (i) one or more primary vein vessels, (ii) one or more primary vein branches,
(iii) one or more secondary vein vessels, (iv) one or more secondary vein branches, (v) one or more tertiary vein vessels, or (vi) any combination of (i)-(v) (structure was determined as veins were distinguished as being first, second and third order veins based on presence of hypointense areas, crossing, and tracing, page 3, column 1, paragraph 2; column 2, paragraph 1 ).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the vein architecture of Koronyo to include identifying primary and secondary veins, as taught by lshibazawa, because identifying the differences between primary and secondary veins allows for the prediction of systemic diseases (lshibazawa, page 1, column 2, paragraph 1 ).
As per claim 8, Koronyo and Querques disclose the method of claim 5, Koronyo does not disclose wherein the one or more venular-adjacent regions includes areas adjacent to but not within the one or more primary vein vessels, the one or more primary vein branches, the one or more secondary vein vessels, the one or more secondary vein branches, the one or more tertiary vein vessels, or any combination thereof. lshibazawa discloses wherein the one or more venular-adjacent regions includes areas adjacent to but not within the one or more primary vein vessels, the one or more primary vein branches, the one or more secondary vein vessels, the one or more secondary vein branches, the one or more tertiary vein vessels, or any combination thereof (arteries were identified in the adjacent regions and near vein vessels and can show occlusions, page 10, column 1, paragraph 2, 3).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the venular adjacent regions of Koronyo to include arteries adjacent to primary and secondary veins, as taught by lshibazawa, because changes in the regions surrounding primary and secondary vein vessels can indicate diabetic retinopathy and other diseases (lshibazawa, page 10, paragraph 3).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Koronyo in view of US 2020/0241012 A1 to Abbvie Deutschland GMBH & Co. KG. (hereinafter "AD").
As per claim 17, Koronyo discloses the method of claim 1, Koronyo does not disclose further comprising administering a treatment to the patient responsive to diagnosis of the neurodegenerative disease.
AD discloses administering a treatment to the patient responsive to diagnosis of the neurodegenerative disease (treatment administered to patient diagnosed with neurodegenerative disease, paragraph [0009]).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the diagnosis of Koronyo to include administering treatment after diagnosis, as taught by AD, because treating the disease upon diagnosis allows for analysis of disease progression {AD, paragraph [0002]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/100169 A1 to Retispec Inc. (hereinafter "Relispec") in view of Querques.
As per claim 23, Retispec discloses a retinal imaging system for assessing a retina of a patient (assessing diseases in the eye with the detection device, paragraph [7]), the system comprising:
a retinal image acquisition system (image of retina obtained for analysis, paragraph [7]); and
a retinal image processing system including a processor and a non-transitory memory device (processor configured to execute instructions stored in the memory, paragraph [14]), the retinal image processing system coupled to the retinal image acquisition system (image device for eye connected to processing system, paragraph [14]);
wherein the non-transitory memory device includes instructions that when executed by the processor (non-transitory storage mediums for memory executable by the processors, paragraph [11 OJ), cause the processor to:
acquire, via the retinal image acquisition system, one or more retinal images of the retina of the patient (images of the retina acquired, paragraph [9]); differentiate between artery vessels in the one or more retinal images (arterial vessels identified in imaged, paragraph [93]);
identify (i) venular-adjacent amyloid-beta plaques associated with one or more vein vessels, (ii) arterial-adjacent amyloid-beta plaques associated with one or more artery vessels (amyloid beta plaques by arterial vessels identified, paragraph [93], [97]), or (iii) both (i) and (ii); and
evaluate a neurological and/or ocular health condition based (evaluating AD pathologies is done around these landmarks, paragraph [93]) on (i) the venular-adjacent amyloid-beta plaques, (ii) the arterial-adjacent amyloid-beta plaques (amyloid beta plaques by arterial vessels identified, paragraph [93], [97]), or (iii) both (i) and (ii).
Retispec does not disclose differentiating between vein and artery vessels.
Querques discloses differentiating between vein and artery vessels (differentiation between venular and arteriole regions done with imaging, page 2, paragraph 11 ).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the imaging of Retispec to include differentiating veins and arteries, as taught by Querques, because differentiating these vessels allows for identification of morphological changes in the respective areas which can indicate disease (Querques, page 2, paragraph 2).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Retispec in view of Querques as applied to claim 23 above, and in further view of Koronyo.
As per claim 24, Relispec and Querques discloses the retinal imaging system of claim 23, Retispec further discloses wherein evaluating neurological and/or ocular health condition based on the venular-adjacent amyloid-beta plaques, (ii) the arterial-adjacent amyloid-beta plaques (amyloid beta plaques by arterial vessels identified, paragraph [93], [97]), or (iii) both (i) and (ii). Retispec does not disclose determining a venular-adjacent amyloid-beta plaque count based on the venular-adjacent amyloid-beta plaques associated with the one or more vein vessel; and diagnosing a neurological and/or ocular disease based on the venular-adjacent amyloid-beta plaque count.
Koronyo discloses determining a venular-adjacent amyloid-beta plaque count based on the venular-adjacent amyloid-beta plaques associated with the one or more vein vessel (calculation of plaques with RAI performed and plaque identified in vessels associated with retinal deposits, abstract); and diagnosing a neurological and/or ocular disease based on the venular-adjacent amyloid-beta plaque count (diagnosis made in part with the plaque identified in vessels associated with retinal deposits, abstract).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the diagnosis of AD of Retispec to include counting amyloid beta plaques, as taught by Koronyo, because the build-up of these plaques when compared to controls would indicate AD (Koronyo, abstract).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/100169 A1 to Retispec Inc. (hereinafter "Retispec") in view of Querques as applied to claim 23 above, and in further view of "Accuracy and Reliability in Differentiating Retinal Arteries and Veins Using Widefield En Face OCT Angiography" by lshibazawa A. (hereinafter "lshibazawa").
As per claim 26, Retispec and Querques the retinal imaging system of claim 23, but do not expressly teach wherein the one or more vein vessels include (i) one or more primary vein vessels, (ii) one or more primary vein branches, (iii) one or more secondary vein vessels, (iv) one or more secondary vein branches, (v) one or more tertiary vein vessels, or (vi) any combination of (i)-(v).
lshibazawa teaches wherein identifying the vein architecture comprises identifying (i) one or more primary vein vessels, (ii) one or more primary vein branches,
(iii) one or more secondary vein vessels, (iv) one or more secondary vein branches, (v) one or more tertiary vein vessels, or (vi) any combination of (i)-(v) (structure was determined as veins were distinguished as being first, second and third order veins based on presence of hypointense areas, crossing, and tracing, page 3, column 1, paragraph 2; column 2, paragraph 1 ).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the vein architecture of Retispec and Querques to include identifying primary and secondary veins, as taught by lshibazawa, because identifying the differences between primary and secondary veins allows for the prediction of systemic diseases (lshibazawa, page 1, column 2, paragraph 1 ).
Prior Art Rejection
All of the cited references fail to expressly teach or suggest, either alone or in combination, the features found within dependent claims 7 & 27-29. In particular, the cited prior art of record fails to expressly teach or suggest the combination of:
wherein the identification of the one or more primary vein branches, the one or more secondary vein vessels, the one or more secondary vein branches, and the one or more tertiary vein vessels is based at least in part on a diameter of the one or more primary vein vessels and a branching of the one or more primary vein vessels; wherein evaluating neurological and/or ocular health condition based on venular-adjacent amyloid-beta plaques and/or arterial- adjacent amyloid-beta plaques comprises: determining a venular-adjacent amyloid-beta plaque count and an arterial-adjacent amyloid-beta plaque count; and diagnosing a neurological and/or ocular disease based on the venular-adjacent amyloid- beta plaque count and the arterial-adjacent amyloid-beta plaque count.
The most relevant prior art of record includes:
Koronyo “Retinal amyloid pathology and proof-of-concept imaging trial in Alzheimer’s disease” teaches to quantitative and detailed histological report of retinal Aβ deposits and the pathological hallmarks of AD, including their distribution and ultrastructure in AD patients, together with the demonstrated feasibility to noninvasively image and quantify retinal amyloid deposits in living patients.
Querques “Functional and morphological changes of the retinal vessels in Alzheimer's disease and mild cognitive impairment” teaches to quantitatively investigate the retinal vessels in these disorders, using dynamic vessel analyzer (DVA) and optical coherence tomography angiography (OCTA) analysis.
Retispec (WO 2019/100169 A1) teaches to a non-invasive light-based detection system that is easily operable and accessible by clinicians for screening patient populations for early detection of AD-associated pathologies, diagnosis, and tracking of patient response to preventative or treatment interventions. It is an object to perform detection without exogenous fluorescing agents, dyes, or tracers.
Debuc (US20220079506) teaches to the diagnosis of cognitive impairment (CI). More specifically, this disclosure relates to the correlation between the retinal vascular complexity and neurodegenerative changes in patients with CI using a multimodal approach.
Conclusion
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/Jonathan Ng/ Primary Examiner, Art Unit 3619