DETAILED ACTION
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 .
Status of Claims
This action is in response to the reply received 1/22/2026.
Claims 1, 9-10, 18, 19 were amended 1/22/2026.
Claim 20 was added 1/22/2026.
Claims 1-20 are currently pending and have been examined.
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 1-20 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.
Claims 1-20 are drawn to a method, a device, non-transitory recording medium which are statutory categories of invention (Step 1: YES).
Independent claims 1, 9, 10,18, and 19 recite acquires auto-generated findings obtained by processing on medical information, acquires [first] interpretation findings created by a first interpretation doctor based on the medical information, [acquires second interpretation findings created by a second interpretation doctor different form the first doctor based on the medical information], compares the auto-generated findings with at least one of the [first interpretation finding and the second] interpretation findings, presents to a user a result of comparison between the auto-generated findings and the at least one interpretation findings based on a predetermined workflow, and allows the predetermined workflow to be set based on a user operation by displaying and receiving the user operation, allowing the user to define and set the predetermined workflow by allowing a user to switch whether or not to present the first interpretation findings to the second interpretation doctor at a time of creating the second interpretation findings [and to switch whether or not to present the auto-generated findings to the first interpretation doctor and the second interpretation doctor at a time of creating the first interpretation findings and the time of creating the second interpretation findings], wherein the predetermined workflow is adaptable to at least one of a facility in which is disposed, a reliability of the auto-generated findings, experience, and preference of the first interpretation doctor, and experience and preference of the second interpretation doctor.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that “For the final diagnosis of a patient, for example, a clinician may make a determination by comprehensively taking into consideration examination data, medical examination data, and the like obtained from various examinations, medical examinations, and the like in addition to the determination of a doctor who creates the "definitive diagnostic information".” (see: specification paragraph 55). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address “in the interpretation diagnosis method for improving the interpretation quality by comparing the result of computer processing (AI analysis) with the determination result of the user (doctor or interpretation doctor) during interpretation…perform efficient interpretation by focusing on differences in findings while referring to other findings or when it is necessary to perform careful interpretation without being affected by other findings, it is possible to customize the interpretation workflow appropriately according to the user's request.” (see: specification paragraph 73). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “an operation interface”, “display”, “interpretation terminal/another interpretation terminal”, “interpretation management device”, “hardware processor”, “workflow setting screen”, “computer”, “non-transitory recording medium”, are recited at a high level of generality (e.g., that the receiving and comparing is performed using generic computer components with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, Figure 2, Figure 4 and
Paragraph 20, where “The analysis device 3 is a device that performs various analyses on a medical image, which is medical information, and is an interpretation management device in the present embodiment. The analysis device 3 is configured as a PC, a mobile terminal, or a dedicated device.”
Paragraph 34, where “The hardware processor 31 includes a central processing unit (CPU), a random access memory (RAM), and the like, and performs overall control of the operation of each unit of the analysis device 3. Specifically, the CPU reads various processing programs stored in a program storage 321 of the storage 32, loads the processing programs to the RAM, and executes various kinds of processing according to the programs. In the present embodiment, the hardware processor 31 implements various functions as described below in cooperation with the programs”
Paragraph 46, where “[The interpretation terminal 4 is, for example, a computer device that includes a hardware processor, an operation interface, a display, a storage, a communicator, and the like and that reads a medical image, which is medical information, from the image server 5 or the like and displays the medical image for interpretation”
Paragraphs 11-12, where “According to another aspect, a non-transitory recording medium storing a computer readable program causes a computer to perform.”
Paragraph 27, where “The operation interface 35 is, for example, a keyboard including various keys, a pointing device such as a mouse, or a touch panel attached to the display 36. The operation interface 35 can be operated for input by the user. Specifically, the operation interface 35 outputs an operation signal input by a key operation on a keyboard, a mouse operation, or a touch operation on a touch panel to the hardware processor 31. In the present embodiment, as will be described later, the user can customize a desired workflow (specific procedures for interpretation and the like), and the operation interface 35 receives the user's input operation and outputs an operation signal according to the input to the hardware processor 31.”
Paragraph 28, where “The display 36 includes a monitor, such as a liquid crystal display (LCD), and displays various screens according to instructions of a display signal input from the hardware processor 31. The number of monitors is not limited to one, and a plurality of monitors may be provided. As will be described later, the display 36 appropriately displays various kinds of information based on display data output from the hardware processor 31.”
Paragraph 29, where “In the present embodiment, the user can customize a desired workflow (specific procedures for interpretation and the like) as described above, and a workflow setting screen 361 (see FIGS. 4, 6, and 8 as an example of the workflow setting screen 361) for inputting and setting the "predetermined workflow" is displayed on the display 36.”
Paragraph 84, where “In the present embodiment, in FIG. 1, the analysis device 3, the interpretation terminal 4, and the image server 5 are illustrated as separate and independent devices. However, the analysis device 3 and the image server 5 or the analysis device 3, the interpretation terminal 4, and the image server 5 may be configured as one device or one system.”
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claims 2-8, 11-17, 20 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are directed to an abstract idea without significantly more. Claims 2-6, 8, 11-15, 17, 20 recite associating, extracting, comparing and displaying the data findings on the generically recited computing system as shown in the parent claims above.
Claims 7 and 16 further recite “wherein the hardware processor allows setting of whether or not to display the auto-generated findings or that at least one interpretation findings” (paragraph 44 of the specification) is based on a predetermined workflow (i.e., algorithm) running on the generic computing device and doesn’t offer significantly more than the abstract idea. Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Response to Arguments
The arguments field 1/22/2026 have been fully considered.
Regarding the arguments pertaining to the 112 rejections, these arguments are persuasive. The amendments overcome the 112 rejections and they have been withdrawn.
Regarding the arguments pertaining to the 103 rejection, these arguments are persuasive. The amendments overcome the prior art of Nakamura (US 2019/0156947 A1), Chiang (US 20170323074 A1), Sheffer (US 2015/0066539 A1), and Sommer (WO 2022/033706 A1). A new prior art search was conducted and found the prior art of Goltra (WO 2014145697 A1) that teaches filtering medical information through workflows on an interface, but does not teach that a predetermined workflow is set by a user based on the facility. The 103 rejections have been withdrawn.
Regarding the arguments pertaining to the 101 rejection, these arguments are not persuasive. Applicant argues that the workflow being customized by the user provides a practical application as it solves a technical problem. Examiner respectfully disagrees, as the workflow as claimed does not provide significantly more to the abstract idea. The workflow’s data is adaptable, however the interface itself is not positively recited as having an improvement in which a technical problem could be solved by a technical solution. Further, changing workflow data on a generic interface does not provide a practical application. The 101 rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Goltra (WO 2014145697 A1) teaches filtering medical information through workflows on an interface, but does not teach that a predetermined workflow is set by a user based on the facility.
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.
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/K.A.S./Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686
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