DETAILED ACTION
Status of Claims
This is a non-final office action on the merits in response to the arguments and/or amendments filed on 14 May 2026 and the request for continued examination filed on 12 June 2026.
Claim(s) 12 is/are canceled. Claim(s) 1 and 11 is/are amended.
Claim(s) 1-11 is/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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 May 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 April 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1, which is representative of claim 11, recites an eye-related sign prediction method, comprising:
having three of more different ophthalmologists perform independent judgements with respect to a presence of an eye-related sign in a target person;
obtaining three or more individual determination values corresponding to the independent judgements;
having the three of more different ophthalmologists reach a mutual agreement on a consensus value with respect to a presence of the eye-related sign in the target person, wherein the independent judgements of the three or more different ophthalmologists include a first judgment of a majority of three or more different ophthalmologists and a second judgement of a minority of three or more different ophthalmologists, and a consensus value corresponds to a value of the second judgement of the minority;
[creating] a single diagnostic model using
obtain an image representing at least one eye;
obtaining a preprocessed image by preprocessing the image, wherein the preprocessing comprises at least one of cropping a region related to at least one eye, masking a region related to at least one eye and segmenting a region related to at least one;
based on the preprocessed image and the
determining a presence of an eye-related sign in the eye based on the consensus predicted value,
wherein the clinical image represents at least one eye of a person,
wherein the number of individual determination values is equal to the number of different ophthalmologists, and
wherein the eye-related sign is one of a conjunctival hyperemia, a conjunctival edema, a lacrimal edema, an eyelid redness or an eyelid edema.
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of gathering expert data, creating a model using the expert data, and using of the model for determining the presence of an eye-related sign. This concept describes a mental process that a researcher should follow to produce and use a model for evaluating eye-related signs similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitation set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 11 recites a device, comprising a memory; and a processor. This additional element is recited at an extremely high level of generality, and is interpreted as a generic computing device used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not integrate the abstract idea into a practical application.
The claims further recite the additional element of training the model using training data. This recitation of training is extremely general. The incorporation of training a model using training data amounts to instructions to implement the abstract idea with a generic computing device. As previously noted, such additional elements do not integrate an abstract idea into a practical application. There are no further additional elements. When considered as a combination, the additional elements amount to instructions to implement the abstract idea with a generic computing device. As such, the additional elements, both individually and as a combination, do not integrate the abstract idea into a practical application. Therefore the claims is determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not amount to significantly more. Additionally, Hall (US 5586033) demonstrates (“network is then trained with this general training data using a conventional back-propagation training algorithm” Column 11, Page 54-56) that training models with training data was conventional long before the priority date of the claimed invention. There are no further additional elements. When considered as a combination, the additional elements amount to instructions to implement the abstract idea with a generic computing device. As such, the combination of additional elements does not amount to significantly more than the abstract idea. Therefore the additional elements, when considered either individually or as a combination, do not amount to significantly more than the abstract idea. Thus the independent claims are not patent eligible.
Dependent claims 2-10 further narrow the abstract idea, but the claims continue to recite an abstract idea, albeit a narrowed one. Dependent claims 2 and 4-9 recite no further additional elements. The previously identified additional elements, individually and in combination, do not integrate the narrowed abstract idea into a practical application or amount to significantly more than the narrowed abstract idea, for the same reasons as indicated above with the independent claims. Dependent claim 3 further describe the training, but this additional element still amounts to instructions to implement the abstract idea with a generic computing device. As such, the additional elements, individually and in combination, continue to fail to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea, for the same reasons as indicated above with the independent claims. Dependent claim 10 described the model as generated using ResNet. The use of ResNet to generate the trained model still amounts to instructions to implement the abstract idea with a generic computing device. As such, this additional element does not integrate the abstract idea into a practical application. When considered in combination with the prior identified additional elements, the additional elements amount to instructions to implement the abstract idea with a generic computing device. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore this claim is directed to an abstract idea. He et al. (US 2019/0156210 A1) demonstrates (“a ResNet-101 (i.e., another conventional convolutional neural network)” [0102]) that the ResNet algorithm was conventional before the priority date of the claimed invention. As such, this additional element does not amount to significantly more. When considered in combination with the prior identified additional elements, the additional elements amount to instructions to implement the abstract idea with a generic computing device. As such, the combination of additional elements does not amount to significantly more. Therefore, as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 112(a) Rejections of claims 1-12: The limitation at issue in claim 1 is deleted without any prejudice. Claim 12 is canceled without any prejudice.
Examiner’s Response: Applicant's amendments filed 14 May 2026 have been fully considered and they resolve the identified issues. The rejections under 112(a) are withdrawn.
Applicant’s Argument Regarding 101 Rejections of claims 1-12:
The office alleges that the claimed subject matter falls in the sub-grouping of management personal behavior. However, at least the features "training a single diagnostic model using training data to output predictions of three or more individual determination values and a prediction of one consensus value in response to an input image, wherein the training data includes a clinical image multi-labeled with the three or more individual determination values and the one consensus value," as recited in amended independent claim 1 cannot be interpreted as organizing human activity.
Performing the features in claim 1 in the human mind is, at the very least, impractical. For instance, it is highly impractical for a human being to perform all the steps in claim 1 including “… obtaining a preprocessed image by preprocessing the image, wherein the preprocessing comprises at least one of cropping a region related to at least one eye, making a region related to at least one eye… .”
The claimed subject matter includes an additional element that reflects an improvement in the functioning of a computer or an improvement to other technology or technical field. Specifically, amended independent claim 1 recites "obtaining a preprocessed image by preprocessing the image, wherein the preprocessing comprises at least one of cropping a region related to at least one eye, masking a region related to at least one eye and segmenting a region related to at least one eye."
The system detects thyroid abnormality by training single diagnostic model.
Similar to the claims in Cardionet, independent claim 1 focuses on a specific means or method that improves detection of a presence of an eye-related sign in the eye.
The claimed subject matter does not simply automate known technology.
The Office Action fails to substantiate the rejection under Step 2B as required under the Berkheimer Memo. ... The features of independent claim 1 are not well-understood, routine or conventional.
Examiner’s Response: Applicant's arguments filed 14 May 2026 have been fully considered but they are not persuasive.
It is inherent to the Mayo/Alice analysis that there may be additional elements beyond the abstract idea. The presence of such additional elements does not per se render a claim eligible. The current and prior rejections specifically exclude the “training” from the abstract idea and the training is considered as an additional element.
First, examiner notes that the "practically performable" consideration applies to the limitations which set forth an abstract idea falling in the mental process subgrouping. However the current and prior rejection indicates that the abstract idea falls in the methods of organizing human activity subgrouping. Second, examiner notes that MPEP 2106.04(a)(2)(III)(C) specifically indicates that a claim that requires a computer may still recite a mental process. This section would be incoherent if the "practically performable" consideration applied to the claim as a whole. Third, Examiner disagrees that the human mind is incapable of preprocessing an image through cropping or masking. These operations can reasonably be achieved by tearing an image or covering an image with a piece of paper.
Per MPEP 2106.05(a), "If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification." The present disclosure does not describe or explain how to perform the preprocessing identified by Applicant. Applicant appears to rely entirely on existing knowledge to support the asserted improvement. As such, the asserted improvement does not appear to qualify as a technical improvement.
Examiner notes that applicant’s argument here does not appear to be based on the current limitations of the claims.
As noted above, and in contrast to the disclosure of the eligible Cardionet claims, the present specification’s lack of technical details of implementation indicates that the claims do not provide a technical improvement.
While mere automation of a manual processes may not be sufficient to show an improvement in computer-functionality (MPEP 2106.05(a)), lack of mere automation is not dispositive under the Mayo/Alice analysis. Further, it is not clear that the present claims are not a mere automation of a manual process of collecting data and generating a model and applying that model.
Applicant's appears to understand the Berkheimer memo as requiring a showing of conventionality for the entirety of the claim. This is incorrect. The memo states: "In a step 2B analysis, an additional element (or combination of elements) is not well-understood, routine or conventional unless the examiner finds, and expressly supports a rejection in writing with, one or more of the following:...". In other words, evidence is required when an additional element is argued to be conventional. There is simply no requirement to provide evidence of conventionality for the entirety of the claim. Such a requirement would reduce the Mayo/Alice analysis to an enhanced novelty test, which is obviously contrary to all court decisions and USPTO guidance.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 of the prior office action dated 24 September 2025.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-06-27
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