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 .
Response to Amendment
The following Office action in response to communications received November 17, 2025. Claims 1, 4-5, 8, 12-13, 15-16 and 21-22 have been amended. Therefore, claims 1-22 are pending and addressed below.
Applicant’s amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112 (b), set forth in the previous office action dated July 17, 2025.
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis: Independent Claim(s) 1, 5 and 12 are directed to a system for supporting the diagnosis and management of biliary atresia. This system involves receiving stool images from a body and determines the presence of biliary atresia. The system also manages usage fees and sends donations for treatment if necessary. Additionally, the system requests a doctor's confirmation if a positive result is suspected. Upon a confirmed diagnosis requiring treatment, the system funds the treatment using saved fees. The claim(s) recite(s) “receive an image of stool from a living body and usage fees; a for storing a client name, an existence of payment of a usage fee, and the received image of stool in association with each other as a personal data, the storage further storing reference images of stool; and a configured to: retrieve and extract the image of stool from the personal data; retrieve at least one reference image of stool from storage; perform image processing on the retrieved image of stool and compare a result of the image processing of the image of the stool with at least one reference image of stool; calculate of a degree of similarity between the image of stool and the at least one reference image of stool based on the comparing; determine that biliary atresia is contracted based on the degree of similarity that was calculated; based on the determining that biliary atresia is contracted, a doctor is arranged, and associating the determination that biliary atresia is contracted and the doctor with the personal data and stored; save the received usage fees and send a donation from the saved usage fees; and request a determination by the doctor if the determines that there is a suspected positive result; and when it is diagnosed that the living body needs treatment for biliary atresia as a result of a thorough examination, the pays a donation for the treatment from the usage fees saved in the storage.”
The limitations of “receive an image of stool from a living body and usage fees; a for storing a client name, an existence of payment of a usage fee, and the received image of stool in association with each other as a personal data, the storage further storing reference images of stool; and a configured to: retrieve and extract the image of stool from the personal data; retrieve at least one reference image of stool from storage; perform image processing on the retrieved image of stool and compare a result of the image processing of the image of the stool with at least one reference image of stool; calculate of a degree of similarity between the image of stool and the at least one reference image of stool based on the comparing; determine that biliary atresia is contracted based on the degree of similarity that was calculated; based on the determining that biliary atresia is contracted, a doctor is arranged, and associating the determination that biliary atresia is contracted and the doctor with the personal data and stored; save the received usage fees and send a donation from the saved usage fees; and request a determination by the doctor if the determines that there is a suspected positive result; and when it is diagnosed that the living body needs treatment for biliary atresia as a result of a thorough examination, the pays a donation for the treatment from the usage fees saved in the storage,” as drafted, is a process that, under its broadest reasonable interpretation, covers the performance of a Mental Process concepts performed in the human mind (including an observation, evaluation, judgment, opinion) and/or Certain Methods Of Organizing Human Activity which are concepts performed by managing personal behavior, relationships or interactions between people (including social activities, teaching, and following rules or instructions), but for the recitation of generic computer components. That is, other than reciting “transmitter/receiver, terminal, terminal processor, server, storage, server central processing unit,” nothing in the claim element precludes the step from practically being performed in the mind and/or managing personal behavior, relationships or interactions between people. For example, but for the “determination unit” language, “determining” in the context of this claim encompasses the user manually receiving an image from a patient, looking at an image and providing an observation, evaluation, judgment or opinion of said image. Similarly, the providing a requested opinion of a doctor of positive or negative results, covers performance of the limitation being performed in the mind and/or managing personal behavior, relationships or interactions between people, but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation being performed in the mind and/or managing personal behavior, relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Mental Processes and/or Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “transmitter/receiver, terminal, terminal processor, server, storage, server central processing unit” to perform all of the “receive an image of stool from a living body and usage fees; a for storing a client name, an existence of payment of a usage fee, and the received image of stool in association with each other as a personal data, the storage further storing reference images of stool; and a configured to: retrieve and extract the image of stool from the personal data; retrieve at least one reference image of stool from storage; perform image processing on the retrieved image of stool and compare a result of the image processing of the image of the stool with at least one reference image of stool; calculate of a degree of similarity between the image of stool and the at least one reference image of stool based on the comparing; determine that biliary atresia is contracted based on the degree of similarity that was calculated; based on the determining that biliary atresia is contracted, a doctor is arranged, and associating the determination that biliary atresia is contracted and the doctor with the personal data and stored; save the received usage fees and send a donation from the saved usage fees; and request a determination by the doctor if the determines that there is a suspected positive result; and when it is diagnosed that the living body needs treatment for biliary atresia as a result of a thorough examination, the pays a donation for the treatment from the usage fees saved in the storage” steps. The “transmitter/receiver, terminal, terminal processor, server, storage, server central processing unit” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claim 1 has the following additional elements (i.e., transmitter/receiver, server, storage, server central processing unit). Claim 5 has the following additional elements (i.e., terminal, terminal processor, server, storage, server central processing unit). Claim 12 has the following additional elements (i.e., terminal server, processor). Looking to the specification, these components are described at a high level of generality (¶ 0013; [Specific example of biliary atresia diagnosis support management system] Figure 2 is a diagram for illustrating a specific example of the biliary atresia diagnosis support management system 1 according to the present invention. A communication terminal machine is not especially limited, and, for example, a personal computer, a tablet terminal, a smartphone or the like can be used. Here, explanation will be made with a smartphone as an example.). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-4, 6-11 and 13-22 include all the limitations of the parent claims and are directed to the same abstract idea as discussed above and incorporated herein. Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Processes and/or Certain Methods of Organizing Human Activity,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claims 1-22 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Response to Arguments
Applicant’s arguments filed November 17, 2025 have been fully considered but they are not persuasive. In the remarks applicant argues:
(1) Claims 1-22 are rejected under 35 U.S.C. § 101. The Examiner alleges that claims 1-22 are rejected because the claimed invention is directed to non-statutory subject matter and is further directed to a judicial exception.
This rejection is respectfully traversed.
It is respectfully submitted that claim 1 explicitly recites obtaining an image of feces, performing image processing on the obtained image, and comparing the processed result with at least one reference image. The image processing corresponds to a transformation and, therefore, goes beyond a mere abstract idea. Accordingly, the claimed invention qualifies as statutory subject matter.
Claim 1 recites a system comprising a server that receives an image of stool from a user device and performs image processing to determine whether the infant or neonate is affected by biliary atresia. Specifically, the server includes a determination unit that analyzes the received image and compares it with reference stool images to assess similarity and detect color changes.
As described in the specification (see paragraphs [0062], [0102], and [0103]), this image processing involves technical operations such as similarity analysis and color change detection, which constitute a transformation of data and are not merely abstract ideas.
Furthermore, claim 5 recites a change analysis unit that compares previously submitted stool images with newly submitted ones to detect changes over time. This temporal image comparison and analysis is a concrete and technical process that contributes to the diagnostic support functionality of the system (see paragraph [0102]).
The claimed invention is not merely a mental process or abstract idea. It is implemented using specific hardware and software components (see paragraphs [0073], [0094], and [0111]), and it provides a practical application in the field of medical diagnostics. The image processing transforms raw image data into diagnostic information, which is then used to guide further medical evaluation and treatment, including physician review and precision testing.
Accordingly, the claims recite significantly more than a judicial exception and are directed to statutory subject matter.
Therefore, for at least these reasons, Applicant respectfully submits that Applicant's claim 1, and for similar reasons claims 5 and 12, together with claims dependent thereon, comply with the requirements of 35 U.S.C. § 101.
Accordingly, reconsideration and withdrawal of this rejection are respectfully requested.
In response to argument (1), Examiner respectfully disagrees. After careful consideration of the Applicant's remarks, the rejection of claims 1–22 under 35 U.S.C. § 101 is maintained. The arguments that the claims recite statutory subject matter and constitute significantly more than a judicial exception do not overcome the rejection when analyzed under the USPTO's two-prong eligibility framework. Under Step 2A, Prong One, claim 1 recites the abstract concepts of receiving an image, processing and comparing it to references to determine a medical condition, which constitutes a mental process and an abstract idea. The additional administrative steps of managing data, arranging doctors, and handling financial transactions are further examples of organizing human activity, another judicial exception. Under Step 2A, Prong Two, the generic computer components and high-level image processing described do not integrate these exceptions into a *specific* practical application, as they merely apply conventional techniques in a known field without any technical improvement. Finally, under Step 2B, the recited elements—including storing images, requesting doctor determinations, and processing payments—are well-understood, routine, and conventional activities that fail to supply an inventive concept. The claimed data transformation relates to an abstract diagnostic analysis, not to an improvement in computer functionality. Therefore, the claims are directed to ineligible subject matter, and reconsideration of the rejection is not warranted.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pub. No.: US 20190133472 A1 to KIM et al.; According to another exemplary embodiment of the present disclosure, a method for monitoring a pressure in a biliary tract includes: receiving a measured value of a pressure in a biliary tract from a stent for a biliary tract having a pressure sensor mounted therein, by a subcutaneous implant medical device; collecting the measured value of the pressure at a predetermined cycle and transmitting collected information to an external device, by the subcutaneous implant medical device; and analyzing the collected information to expect a timing of biliary obstruction, and providing expected information to the patient, by the external device.
Pub. No.: US 20060022834 A1 to Rosenfeld et al.; A system and method for observing patients in geographically dispersed health care locations. A patient is assigned to a health care location comprising a patient visual monitoring system, a patient audio receiver, and a patient controller. The visual monitoring system is responsive tri-axially to command signals received via a patient controller connected to the network. The patient controller sends patient imaging data and patient audio data to a remote command center via the network. A computerized patient care management system comprising the remote command center monitors patient data, patient imaging data, and patient audio data determines from the patient data, the patient imaging data, and the patient audio data if intervention with the selected patient is warranted.
Pub. No.: US 20060064324 A1 to Rosenfeld et al.; A video visitation system and method for dispersed health care locations. A patient data server, a teleconferencing server, a patient visual monitoring system and a visitor visual monitoring system are connected to a network. A patient data server receives patient data indicative of the condition of a patient and serves the patient data continuously and in real time to the teleconferencing server. The patient visual monitoring system acquires patient imaging data from a patient location and conveys the patient imaging data to the teleconferencing server. The visitor visual monitoring system acquires visitor imaging data from a visitor location and conveys the visitor imaging data to the teleconferencing server. The patient visual monitoring system displays the visitor imaging data and the visitor visual monitoring system simultaneously displays patient imaging data and the continuous real time feed of the patient data.
THIS ACTION IS MADE FINAL. 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 EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683