DETAILED ACTION
Notices to Applicant
This communication is a final rejection. Claims 1-9, 11, and 13-17, as filed 05/13/2026, are currently pending and have been considered below.
Foreign benefit is generally acknowledged to JP 2023-192412 which was filed 11/10/2023.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon and the rationale supporting the rejection would be the same under either status.
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 1-9, 11, and 13-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter 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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
A medical support device comprising: a processor, wherein the processor is configured to:
acquire a plurality of pieces of processing target information corresponding to a plurality of medical examinations, from each of a plurality of devices that are each used in a corresponding medical examination and that are communicably connected to the medical support device via a network, each piece of the processing target information including a medical image obtained in the corresponding medical examination and metadata associated with the medical image,
acquire, from the metadata, device identification information for identifying the device, and processing request information for instructing recognition processing to be executed on the medical image or processing stage information indicating a processing stage of the recognition processing, (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer)
determine, based on the processing request information or the processing stage information, an execution order of the recognition processing for each medical image,
generate order information that indicates the execution order and associate the order information with the metadata of the corresponding medical image, (abstract idea – mental process; a human can mentally think about medical images in a particular order determined by the person based on various criteria)
execute the recognition processing on each medical image in an order according to the order information to generate a recognition result regarding a feature region shown in the medical image, and acquire the recognition result,
generate medical support information in which the medical image and the recognition result are associated with each other, and (abstract idea – mental process; a human can mentally think about and process medical images in a particular order determined by the person based on various criteria; to the extent that these limitations cannot be performed mentally, they amount to using computers as tools to apply the abstract idea)
transmit the medical support information to the device identified by the device identification information in an order based on the order information, (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer)
wherein the processing stage information is information indicating that a stage of the recognition processing is classified into a stage during execution of first recognition processing, a stage after execution of the first recognition processing and before or during execution of second recognition processing, and a stage after execution of the second recognition processing, and
wherein, in a case in which the processing stage information is used, the execution order is determined such that the stage during execution of the first recognition processing is earlier than the stage after execution of the first recognition processing and before or during execution of the second recognition processing, and the stage after execution of the first recognition processing and before or during execution of the second recognition processing is earlier than the stage after execution of the second recognition processing. (abstract idea – mental process; a human can mentally think about and process medical images in a particular order determined by the person based on various criteria)
2. The medical support device according to claim 1, wherein the metadata includes middle-of-examination information clarified within a period during which the corresponding medical examination is performed (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer).
3. The medical support device according to claim 1, wherein the metadata includes pre-examination information clarified before a period during which the corresponding medical examination is performed (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer).
4. The medical support device according to claim 1, wherein the metadata includes subject information on a subject who undergoes the corresponding medical examination (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer).
5. The medical support device according to claim 1, wherein the metadata includes operator information on an operator who performs the corresponding medical examination (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer).
6. The medical support device according to claim 1, wherein the medical image is obtained in the corresponding medical examination, and the metadata includes modality information on a modality used for imaging to obtain the medical image in the corresponding medical examination (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer).
7. The medical support device according to claim 1, wherein the medical image is obtained in the corresponding medical examination, the metadata includes an intermediate result of the corresponding medical examination, and the intermediate result is information specified based on the medical image obtained in the corresponding medical examination (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer).
8. The medical support device according to claim 7, wherein the intermediate result includes feature region information that is information on a first feature region shown in the medical image (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer).
9. The medical support device according to claim 8, wherein the first feature region is a lesion, and the intermediate result is a screening result of the lesion or a discrimination result of the lesion (additional element- insignificant extra-solution activity; mere data gathering; applying the abstract idea with a computer).
11. The medical support device according to claim 10, wherein the medical support information includes overlay information indicating the recognition result associated with the medical image, and the overlay information includes region information for specifying a position of the feature region in the medical image. (abstract idea – mental process).
13. The medical support device according to claim 1, wherein the recognition processing is processing of generating information on a second feature region by inputting the medical image to a trained model that receives input of an image showing a first region corresponding to the second feature region to generate information on the first region (abstract idea – mental process).
14. The medical support device according to claim 1, wherein each of the plurality of medical examinations is an endoscopy, and each of the plurality of medical images is an endoscopic image obtained in the endoscopy (additional element- insignificant extra-solution activity; mere data-gathering; applying the abstract idea with a computer).
15. A medical support system comprising: the medical support device according to claim 1; and a communication device that transmits the processing target information to the medical support device and that receives the medical support information (additional element- insignificant extra-solution activity; data output; applying the abstract idea with a computer).
Claims 16 and 17 are similar to claim 1 and recite the same abstract idea.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because the italicized portions are analogous to steps that a human would perform mentally or with pen and paper. For example, but for the processor language, recognition processing on each of the plurality of medical images in an order determined based on the plurality of pieces of medical examination information could be performed by a radiologist thinking about two or three imaging studies that are on his worklist, thinking about criteria to prioritize them, and then analyzing the imaging exams in the determined order.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. For example, claims 11 and 13 recites particular aspects of how the image recognition process is performed that can be performed mentally but for recitation of generic computer components.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, processor configured to perform steps amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0034] (e.g., “personal computer”), see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea. For example, acquiring and transmitting medical images and medical examination information amount to mere data gathering and selecting a particular data source or type of data to be manipulated, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For example, claims 2-9 and 14 recite details on the data that is acquired and then used for analysis. Claim recites additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields. For example, the communication device transmitting information in claim 15 amounts to receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i), performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii), electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii), and/or storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Begelman (US20230092780A1) in view of Yamatake (US20050244082A1) and Nye (US20190164285A1).
Claim interpretation
As an initial matter, the Examiner notes that the recited step “determining, based on the processing request information or the processing stage information, an execution order of the recognition processing for each medical image” contains an optional limitation in a method claim. As such, the BRI of this claim includes the branch of the claim where the underlined portion does not obtain. See MPEP 2111.04. This includes other portions of the claim that rely on the processing stage information such as the final two limitations (i.e., “wherein the processing stage information is…” and “wherein, in a case in which the processing stage information is used…”). This interpretation is represented below with strikethrough formatting.
Regarding claim 1, Begelman discloses: A medical support device comprising: a processor, wherein the processor is configured to (“One of the objectives of the present disclosure includes a control method for controlling data processing acquired from medical imaging modalities by using multiple data processors connected to the multiple medical imaging modalities via a computer network,” [0007]; “An information processing apparatus also known as a compute processing service is deployed on at least one host or a plurality of hosts, where each host includes a data processor or multiple data processors,” [0033]):
--acquire a plurality of pieces of processing target information corresponding to a plurality of medical examinations, from each of a plurality of devices that are each used in a corresponding medical examination and that are communicably connected to the medical support device via a network (“controlling data processing acquired from medical imaging modalities by using multiple data processors connected to the multiple medical imaging modalities via a computer network,” [0007]; FIG. 1),
…
--determine, based on the processing request information (“a computation for an urgent examination may take priority over a computation associated with a regular examination,” [0070]; “a particular DSL associated with the dataflow graph names allow for the compute processing service to determine an order for executing computations associated with various dataflow graphs,” [0071),
…
--execute the recognition processing on each medical image in an order according to the order information to generate a recognition result regarding a feature region shown in the medical image, and acquire the recognition result (“Any computation for volume reconstruction, feature extraction, etc,” [0035]; FIG. 15; “The host 230 (compute resource) along with the compute processing service includes two active dataflows with a minimum and maximum priority queues as well as executing vertices,” [0073]; feature extraction in [0051]),
…
--generate medical support information in which the medical image and the recognition result are associated with each other (results written back as KVS values in [0062] and FIG. 9; “An input/output vertex computation is defined as either taking, reading or writing items in the KVS. In step S390, the image reconstruction result is accumulated,” [0066]);
--transmit the medical support information to the device identified by the device identification information in an order based on the order information (“Then the client application using the client service framework receives the results when available in step S140. The client application receive results when the KVS updates,” [0061]; “To support multi-tenancy, a dataflow computation belonging to a specific imaging system can access only the imaging system's associated KVS,” [0039]; FIG. 15; priority based routing in [0070]),
Begelman does not expressly disclose but Yamatake teaches:
--each piece of the processing target information including a medical image obtained in the corresponding medical examination and metadata associated with the medical image (“As shown in FIGS. 2 and 3, the DICOM gateway 4 requested divides the received image information into the attribute information and image information containing an inspection example UID, the name of a patient, a patient ID, an acceptance number, inspection date, inspection time, and the date of birth of a patient,” [0049]),
--acquire, from the metadata, device identification information for identifying the device (load distribution “based on header information of a request” [0016]; this is viewed in light of Begelman’s clients being identified and bound to its own KVS namespace in [0062]), and processing request information for instructing recognition processing to be executed on the medical image (“based on header information of a request,” Abstract; This is viewed in light of Begelman’s teaching: “the compute processing service is able to determine data processors to perform each computation in view of (i) the specification of the type of imaging modality (CT, MRI, X-ray, Ultrasonic, etc.), (ii) a type of imaging reconstruction process to be performed, or (iii) a type of filter process to be performed” in [0071]) or processing stage information indicating a processing stage of the recognition processing (the Examiner notes that the processing stage limitation is optional).
It would have been obvious to one of ordinary skill in the art before the effective filing date to expand Begelman’s task allocation to include the metadata feature of Yamatake because including metadata would ensure that tasks are more accurately assigned and would allow the image to be accessed “at high speed…regardless of the increase of the image data” (Yamatake Abstract).
Begelman does not expressly disclose but Nye teaches:
--generate order information that indicates the execution order and associate the order information with the metadata of the corresponding medical image (“Thus, rules can be created to determine image/exam priority, and those rules can be stored such as in a DICOM header of an image sent to the PACS 1044. An AI model can be used to set a score or a flag in the DICOM header (e.g., tag the DICOM header) to be used a rule to prioritize those exams. Thus, a DICOM header tag (e.g., reflecting the score or flag, etc.) can be used to build priority rules,” [0142]; “AI processing provides instant notification at the imaging device 1010 as well as longer-term prioritization determining an ordering of images, exams, and/or other data for review,” [0143]),
It would have been obvious to one of ordinary skill in the art before the effective filing date to expand the task allocation of Begelman and Yamatake to include the storage of order information in the metadata of Nye because this would allow the system to handle “cross-modality prioritization of exams in a worklist” (Nye [0143]).
Additionally, it can be seen that each element is taught by either Begelman, Yamatake, or Nye. The features of Yamatake and Nye do not affect the normal functioning of the elements of the claim which are taught by Begelman. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Begelman with the teachings of Yamatake and Nye since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Subject Matter Free from Prior Art
Claims 1-9, 11, 13-15, and 17 are not anticipated or obvious in view of the prior art.
The prior art does not teach or suggest determining the execution order based on the screening/discrimination distinction between two recognition stages where the execution order is determined such that the lesion screening stage is ordered earlier than the lesion discrimination stage. The closest prior art is Begelman, Yamatake, Nye, and Hsieh (US20180144465A1). The references teach priority/urgency-based scheduling (Begelman), header-based routing (Yamatake), AI priority score in image metadata (Nye), and lesion screening/diagnosis (Hsieh). No prior art teaches or suggests an ordering rule predicated on clinical screening followed by discrimination in the context of these claims.
Response to arguments
Applicant's arguments filed 05/13/2026 have been fully considered and are discussed below.
Regarding the subject matter ineligibility rejections, Applicant argues that the claimed invention is not directed to the abstract idea of “prioritization” because it solves the technical problem server overload and time lag due to communication traffic. Remarks pages 15-16. This technical benefit arises because of “a series of concrete processing sequences”, namely, (i) acquiring medical images and metadata, (ii) using that data to generate order information, (iii) executing recognition processing according to the order information, (iv) generating medical support information, and (v) transmitting the medical support information based on the order information. Id. This argument is not persuasive.
A concrete sequence of processing steps such as gathering data, analyzing the data, and outputting results as in steps (i)-(v) does not make the sequence any less abstract. Steps (i) and (v) are mere extra-solution activity, namely, data gathering and output. Steps (ii)-(iv) recite prioritization judgement and mental processing steps that are merely performed on a computer. The asserted technical effect of avoiding overload and time-lag problems are the same types of a problems that a human would have when receiving multiple requests and deciding how to handle them. The claims merely recite that an execution order is determined and that results are transmitted in that order, but recites no technical implementation details. A person performing these claimed steps by thinking about the request and institutional prioritization policies would obtain the asserted improvement, so it is not technical as claimed.
Regarding the prior art rejections, Applicant’s arguments with respect to claim 16 are moot in view of the rejection above including Nye. The arguments regarding the other claims are generally persuasive.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office Action (See MPEP 706.07(a)). Accordingly, 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 extension fee 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 JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant, can be reached on (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624
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