DETAILED ACTION
Claims 1-14 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/11/2026 has been entered.
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 1-14 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 1-11 are directed to a method (i.e., a process); Claim 12 is directed to a CRM (i.e., a manufacture); & Claims 13-14 are directed to a system (i.e., a machine). Accordingly, claims 1-14 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 13 includes limitations that recite at least one abstract idea. Specifically, independent claim 13 recites:
13. A computer system, comprising:
one or more processors,
one or more non-transitory computer readable media storing instructions configured to cause the one or more processors to-determine cardiac functional indices for a patient by:
receiving an image of a fundus of the patient;
encoding the received image into a joint latent space determined by a multi-channel variational auto-encoder (mcVAE), wherein the mcVAE is trained using training data comprising one or more retinal images and one or more cardiac magnetic resonance images;
decoding from the joint latent space a representation of the patient's heart;
providing the representation decoded from the joint latent space to a neural network configured to generate cardiac functional indices; and
outputting the cardiac functional indices generated by the neural network in response to receiving the decoded representation of the patient's heart.
The Examiner submits that the foregoing underlined limitations constitute “mathematical concepts” because encoding image data into a joint latent space, decoding the joint latent space data, and generating cardiac functional indices are considered mathematical calculations because the broadest reasonable interpretation of the claims in light of the specification encompasses mathematical calculations. For example, Applicant’s specification describes encoding and decoding image data using various statistical techniques such a multi-channel variational autoencoder and neural networks.
Accordingly, independent claim 13 and analogous independent claims 1 & 12 recite at least one abstract idea.
Furthermore, dependent claims 2-11 & 14 further narrow the abstract idea described in the independent claims. Claims 2-4 recites the representation data, claims 5 & 11 recites processing data for the neural network, claim 8 recites determining the cardiac indices and risk. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 13 and analogous independent claims 1 & 12, 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”):
13. A computer system, comprising:
one or more processors,
one or more non-transitory computer readable media storing instructions configured to cause the one or more processors to-determine cardiac functional indices for a patient by:
receiving an image of a fundus of the patient;
encoding the received image into a joint latent space determined by a multi-channel variational auto-encoder (mcVAE), wherein the mcVAE is trained using training data comprising one or more retinal images and one or more cardiac magnetic resonance images;
decoding from the joint latent space a representation of the patient's heart;
providing the representation decoded from the joint latent space to a neural network configured to generate cardiac functional indices; and
outputting the cardiac functional indices generated by the neural network in response to receiving the decoded representation of the patient's heart.
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 processor, computer readable media; 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 limitations of the multi-channel variational auto-encoder (mcVAE) trained on retinal image and cardiac image data and the neural network; the Examiner submits that these limitations amount to no more than a recitation of the words “apply it” (or an equivalent), because the claims recite only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished (see MPEP § 2106.05(f)).
Regarding the additional limitation of receiving image data and outputting the indices, 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 13 and analogous independent claims 1 & 12 do not 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:
Claims 6-7 & 10: These claims recite the neural network; the Examiner submits that these limitations amount to no more than a recitation of the words “apply it” (or an equivalent), because the claims recite only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished (see MPEP § 2106.05(f)).
Claim 14: This claim recites a wearable device to capture image data and thus do no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the at least one abstract idea is performed (see MPEP § 2106.05(h)).
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 1 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 processor, computer readable media; 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 limitations of the neural network; the Examiner submits that these limitations amount to no more than a recitation of the words “apply it” (or an equivalent), because the claims recite only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished (see MPEP § 2106.05(f)). Regarding the additional limitation of receiving image data and outputting the indices, 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 Examiner has reevaluated such limitation and determined it to not be unconventional 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.
Therefore, claims 1-14 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: receiving an image of a fundus of the patient; encoding the received image into a joint latent space determined by a multi-channel variational auto-encoder (mcVAE), wherein the mcVAE is trained using training data comprising one or more retinal images and one or more cardiac magnetic resonance images; providing the representation decoded from the joint latent space to a neural network configured to generate cardiac functional indices; and outputting the cardiac functional indices generated by the neural network in response to receiving the decoded representation of the patient's heart.
The most relevant prior art of record includes:
Arterys (2018/0259608) teaches automated segmentation of anatomical structures, such as the human heart. The systems and methods employ convolutional neural networks (CNNs) to autonomously segment various parts of an anatomical structure represented by image data, such as 3D MRI data.
Welch Allyn (US20160058284) teaches to a fundus imaging system functions to create a digital image of a patient's P eye fundus. As used herein, “fundus” refers to the eye fundus and includes the retina, optic nerve, macula, vitreous, choroid and posterior pole.
Response to Arguments
Applicant’s arguments on pages 6-11 regarding claims 1-14 being rejected under 35 USC § 101 have been fully considered but they are not persuasive. Applicant claims that:
The limitation regarding the joint latent space determined by a multi-channel variational auto-encoder amounts to steps beyond pure mathematical calculations and integrates the exception into a practical application.
The Examiner, however, asserts that limitation of the multi-channel varational auto-encoder (mcVAE) trained on various image data provides nothing more than mere instructions to implement an abstract idea on a generic computer and amounts to reciting a judicial exception with the words “apply it” (or an equivalent). The trained mcVAE is used to generally apply the abstract idea without placing any limits on how the trained mcVAE functions. Rather, these limitations only recite the outcome of determining a joint latent space and do not include any details about how the determination is accomplished. See MPEP 2106.05(f). There is no detail in the claim that reflects the solution but instead the intended outcome of the trained mcVAE model.
The claims recite specific steps that directly address a technical problem via a technical solution of acquiring a representation of a patient’s heart from an image of a fundus of the patient.
The Examiner is not persuaded. The specification clearly outlines that the problem the instant application is attempting to solve is more accurately determining the risk patient’s risk of adverse cardiovascular events (see Applicant’s specification at pg. 3). An improvement to the abstract idea of determining the risk patient’s risk of adverse cardiovascular events does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating "it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) 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.").
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zee (US20120257164) teaches to a method and device for diagnosing and/or predicting the presence, progression and/or treatment effect of a disease characterized by retinal pathological changes in a subject.
Peng (US20190180441) teaches to obtaining a model input comprising one or more fundus images, each fundus image being an image of a fundus of an eye of a patient; processing the model input using a fundus image processing machine learning model, wherein the fundus image processing machine learning model is configured to process the model input comprising the one or more fundus image to generate a model output; and processing the model output to generate health analysis data.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/Primary Examiner, Art Unit 3619
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