DETAILED ACTION
Claims 1-4, 6-10, 14, 17-19, 22-24, & 26-29 are currently pending and have been examined.
This action is in response to the amendment filed on 4/23/2026.
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, the one or more retinal images including detecting an administered contrast agent;
identify, on the one or more of the retinal images, a vein architecture of the retina by identifying at least a primary vein vessel and at least two secondary vein vessels splitting from the primary vein vessel;
identify venular-adjacent amyloid-beta plaques adjacent to distal vein vessels in the retina that are downstream from where the primary vein vessel splits into the at least two secondary vein vessels;
calculate an amount of the venular-adjacent amyloid beta plaques adjacent to the distal vein vessels; and
evaluate a neurological and/or ocular health condition based on the venular-adjacent amyloid-beta plaques adjacent to the distal vein vessels.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because identifying and analyzing the image data to differentiate between vein and artery vessel architecture, identify and calculating 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, the one or more retinal images including detecting an administered contrast agent;
identify, on the one or more of the retinal images, a vein architecture of the retina by identifying at least a primary vein vessel and at least two secondary vein vessels splitting from the primary vein vessel;
identify venular-adjacent amyloid-beta plaques adjacent to distal vein vessels in the retina that are downstream from where the primary vein vessel splits into the at least two secondary vein vessels;
calculate an amount of the venular-adjacent amyloid beta plaques adjacent to the distal vein vessels; and
evaluate a neurological and/or ocular health condition based on the venular-adjacent amyloid-beta plaques adjacent to the distal vein vessels.
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 recite 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.
Prior Art Rejection
All of the cited references fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: identifying, on the one or more of the retinal images, a vein architecture of the retina by identifying at least a primary vein vessel and at least two secondary vein vessels splitting from the primary vein vessel; identifying venular-adjacent amyloid-beta plaques adjacent to distal vein vessels in the retina that are downstream from where the primary vein vessel splits into the at least two secondary vein vessels; calculating an amount of the venular-adjacent amyloid beta plaques adjacent to the distal vein vessels; and diagnosing the neurodegenerative disease based at least in part on the amount of venular- adjacent amyloid-beta plaques adjacent to the distal vein vessels.
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.
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. § 101 rejection on pages 8-11 in regards to Claims 1-4, 6-10, 14, 17-19, 22-24, & 26-29 have been considered but are not persuasive. Applicant argues that:
The claims do not recite a mental process because a human cannot perform the acquisition and classification steps without specialized imaging and processing hardware.
The Examiner, however, asserts that the claims do not specify how specialized imaging and processing hardware is required to perform the limitations above. Furthermore, the acquisition step has been classified as 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 Examiner also argues that the claims or the specification do not provide any detail regarding how the classification steps cannot be practically performed in the human mind or via pen and paper.
The claims are integrated into a practical application and are significantly more because they provide a specific improvement to the technical field of retinal-based diagnosis.
The Examiner asserts that the identified judicial exception alone cannot provide the improvement – see MPEP 2106.05(a). Here, the purported improvement of retinal-based diagnosis (e.g. a recite mental process) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. The claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology.
Applicant’s arguments on pages 11-15 regarding Claims 1-4, 6-10, 14, 17-19, 22-24, & 26-29 being rejected under 35 USC § 103(a) have been fully considered and are persuasive. The 103 rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Huang (US 11682484 B2) teaches to improved methods for analysis of images of the vitreous and/or retina and/or choroid obtained by optical coherence tomography and to methods for making diagnoses of retinal disease based on the reflectivity profiles of various vitreous and/or retinal and/or choroidal layers of the retina.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
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/Jonathan Ng/ Primary Examiner, Art Unit 3619
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