DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 26 January 2026.
Claim(s) 1, 2, 4, 6, 11, is/are amended. Claim(s) 12 is/are new.
Claim(s) 1-12 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 .
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims not listed below are rejected for dependency.
Amended claim 1 recites the non-original limitation “having the three or more different ophthalmologists in a same physical area or in a same virtual meeting.” The originally filed disclosure does not appear to support the identified limitation.
Applicant’s remarks do not identify support for the identified limitation. What appears to be the most relevant portions of the originally filed disclosure state:
[18] According to an embodiment of the present application, at least one of the determination values and the consensus value may be a value determined by the diagnosticians through actually meeting with the diagnostic subject with respect to the presence of the eye-related sign.
[54] According to an embodiment of the present application, at least one of the determination values and the consensus value may be a value determined by the diagnosticians through actually meeting with the diagnostic subject with respect to the presence of the eye-related sign.
[121] In the meantime, a determination value may be determined by a diagnostician through a meeting with an actual user. Specifically, a diagnostician may determine a determination value by checking an actual user with the naked eye. In this case, a diagnostic image may be obtained from a user after a diagnostician determines a determination value, or may be obtained from a user before a diagnostician meets the actual user.
[125] In the meantime, a consensus value may be determined by a plurality of diagnosticians through a meeting with an actual user. Specifically, a plurality of diagnosticians may determine a consensus value by checking an actual user with the naked eye and having a discussion. In this case, a plurality of diagnosticians may analyze an actual user independently of each other to determine respective determination values, and then have a discussion with each other and reach an agreement to determine a consensus value. In this case, a diagnostic image may be obtained from a user after a plurality of diagnosticians determines a consensus value, or may be obtained from a user before a plurality of diagnosticians meet the actual user.
[234] Accordingly, determination values and/or a consensus value included in evaluation data for evaluating the performance of a diagnostic model may be determination values and/or a consensus value that are determined by diagnosticians actually meeting and diagnosing a patient. A diagnostic image included in evaluation data may be obtained from a patient after diagnosticians actually meet and diagnose the patient or before diagnosticians meet the patient. That is, determination values and/or a consensus value to be labeled on a diagnostic image that is evaluation data may be values determined by a plurality of diagnosticians meeting and diagnosing an actual patient, rather than values determined through the diagnostic image. The details related to the diagnosticians meeting a user in person and diagnosing the user to determine determination values and a consensus value have been described above, so a redundant description will be omitted.
[235] Determination values and/or a consensus value included in training data to be used to train a diagnostic model may also be determination values and/or a consensus value determined by diagnosticians actually meeting and diagnosing a patient as described above.
[18], [54], [121], [234], and [235] only contemplate diagnosticians meeting with a patient. [125] contains the phrase “a plurality of diagnosticians through a meeting with an actual user”, but the disclosure further clarifies this saying “Specifically, a plurality of diagnosticians may determine a consensus value by checking an actual user with the naked eye and having a discussion. In this case, a plurality of diagnosticians may analyze an actual user independently of each other to determine respective determination values, and then have a discussion with each other and reach an agreement to determine a consensus value.” This disclosure does not appear to actually describe the diagnosticians meeting, but rather them each meeting with the patient and then discussing their results. Such discussion need not necessarily occur either “in a same physical area” or “in a same virtual meeting.” As such, these disclosures do not support the identified limitation. The remainder of the disclosure does not reference a “physical area” or “virtual meeting”, and similarly does not appear to support the identified limitation.
Because the claims include a non-original limitation which is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected based on the written description requirement. Claim 11 is similarly rejected.
New claim 12 recites the non-original limitation “wherein each of the individual determination values include an indication that corresponding individual determination value is obtained from an ophthalmologist having over 15 years of experience.” The originally filed disclosure does not appear to support the identified limitation.
Applicant’s remarks do not identify support for the identified limitation. What appears to be the most relevant portions of the originally filed disclosure state:
[17] According to an embodiment of the present application, the diagnosticians may be three ophthalmologists with over 15 years of experience, wherein the determination values may include three values corresponding to each diagnostician.
[53] According to an embodiment of the present application, the diagnosticians may be three ophthalmologists with over 15 years of experience, wherein the determination values may include three values corresponding to each diagnostician.
[117] Diagnosticians may be determined among the people with a particular level or more of experience, depending on a diagnostic subject and/or a diagnosis disease. For example, it was found through investigation that in the field of eye disease diagnosis, the average diagnosis accuracy of ophthalmologists with over 15 years of experience was about 86.24%, the average diagnosis accuracy of ophthalmology fellows with less than 5 years of experience was about 73.27%, and the average accuracy of ophthalmology residents was 56.04%. Accordingly, it is preferable that a diagnostician who derives information related to a disease and/or a sign to be used to train a diagnostic model with an eye disease as a diagnosis sign is determined as an ophthalmologist with over 15 years of experience to ensure the accuracy of the diagnostic model.
While the preceding disclosures describe an ophthalmologist with more than 15 years of experience, they do not describe or suggest indications that the individual determination values are obtained from such an ophthalmologist. As such, these disclosures do not support the identified limitation. The remainder of the originally filed disclosure similarly does not support the identified limitation.
Because the claims include a non-original limitation which is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention at the time of filing. Therefore the claim is rejected based on the written description requirement.
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 1-12 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 in a same physical area or in a same virtual meeting 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;
based on the 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 data, generating a model, 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.
Response to Arguments
Applicant’s Argument Regarding 101 Rejections of claims 1-11:
At least the features of “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 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.
The Office alleges that the claimed subject matter is directed to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions. However, amended independent claim 1 recites specific features that methods that cannot be performed in the human mind.
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.
Applicant asserts that the combination of elements for each claim, taken individually and as a whole, amount to significantly more than an abstract idea.
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. Specifically, the features of new independent claim 1 are not disclosed, taught or suggested by the prior art of record.
The way of obtaining a consensus value by having the three or more different ophthalmologist in the same physical area or in the same virtual meeting reach a mutual agreement on the consensus value with respect to a presence of the eye-related sign in the target person, is NOT well-understood, routine or conventional.
Examiner’s Response: Applicant's arguments filed 26 January 2026 have been fully considered but they are not persuasive.
Examiner notes that the presence of additional elements because the abstract idea does not exclude the claim from reciting an abstract idea. Thus the presence of training does not exclude the claim from setting forth a method of organizing human activity.
Examiner notes that the rejection indicates that the claims set forth a concept that is analogous to the mental process of the neurologist given in MPEP 2106.04(a)(2)(II)(C). Further, examiner notes that the rejection specifically indicates that the claims set forth a concept falling in the method of organizing human activity subgrouping. The “practically performable” consideration applies to the mental processes subgrouping.
Examiner notes that applicant’s argument fails to identify the additional element that reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field.
Applicant’s argument amounts to an assertion that the claim are eligible. Examiner notes that the additional elements of the claims have been specifically considered in the rejection above, and they do not amount to significantly more than the abstract idea.
Examiner notes that Applicant’s argument disregards the specific citation provided for the conventionality of training models with training data. Further, Examiner notes that the Berkheimer requirements do not require providing evidence that the claim as a whole is conventional, but only that evidence must be provided for additional elements which are identified as conventional. Further, any argument for eligibility based on the claim as a whole being unconventional reduces the Mayo/Alice analysis to an enhanced novelty test clearly contrary to CAFC eligibility decisions.
The identified feature is considered part of the abstract idea. It is thus not an additional element, and it’s conventionality is not relevant to the eligibility of the claim.
Applicant’s Argument Regarding 103 Rejections of claims 1-11: The cited references do not teach or suggest “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.
Examiner’s Response: Applicant's arguments filed 26 January 2026 have been fully considered and they are persuasive. The rejections under 103 are withdrawn.
Conclusion
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 Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-02-20