DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 October 2025 has been entered.
Status
This First Action Final Office Action is in response to the communication filed on 28 October 2025. Claims 2-4 and 12 have been cancelled currently or previously, claims 1 and 17-19 have been amended, and no new claims have been added. Therefore, claims 1, 5-11, and 13-19 are pending and presented for examination.
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
A summary of the Examiner’s Response to Applicant’s amendment:
Applicant’s amendment overcomes the claim objection(s); therefore, the Examiner withdraws the objection(s).
Applicant’s amendment appears to overcome the previous rejection(s) under 35 USC § 112; therefore, the Examiner withdraws the rejection(s).
Applicant’s amendment does not overcome the rejection(s) under 35 USC § 101; therefore, the Examiner maintains the rejection(s) while updating phrasing in keeping with current examination guidelines.
Applicant’s amendment overcomes the rejection(s) under 35 USC §§ 102 and/or 103; therefore, the Examiner indicates allowability over the prior art.
Applicant’s arguments are found to be not persuasive; please see the Response to Arguments below.
Examiner’s Note
The Examiner notes that independent claims 1 and 17-19 recite to “acquire an operation history” and then “predict a next operation candidate” (citing claim 1, claims 18-19 using gerund phrasing for the same activity). The term “operation” can encompass at least several, and perhaps many, meanings – this may refer to a medical operation such as a surgery or procedure, or it may refer to a computer operation such as booting, rebooting, startup execution of applications, etc. (as examples), or this may refer to an operation a user performs on a computer such as copy, cut, paste, correct spelling, resizing, etc. (as other examples). Since the claim appears to encompass some, several, or multiple of these meanings, it appears to be a matter of claim breadth rather than indefiniteness. As such, the Examiner has not rejected based on indefiniteness.
At the 3 December 2024 interview summary, the Examiner noted that “Applicant indicated orally that the ‘operation history’ is referring to medical operations (not computer operations), whereas the user information is referring to the equipment operator as a user (i.e., the technician or person operating a device such as an endoscope. X-ray machine. etc.)”. However, the amendment now specifically recites to “predict a next operation candidate to be performed on the terminal device by the user having the user identification information” – i.e., computer operations that Applicant avowed were NOT part of the invention.
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, 5-11, and 13-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a device (claims 1, 5-11, and 13-16), system (claim 17), method (claim 18), and non-transitory computer-readable medium (claim 19), which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a medical care support device comprising: a processor configured to: acquire an operation history including operation information, a user identification information and personal information in a case where a user operates a terminal device installed in a medical facility, from the terminal device wherein the user identification information specifies the user who operates the terminal device and includes an attribute of the user, the personal information includes patient identification information, the operation information includes an operation target and an operation content, the operation target represents a target on which an operation of the user is performed, and the operation content represents an instruction to perform the operation of the user; delete the patient identification information in the personal information in the operation history and transmit the operation history, which includes the user identification information and without including the patient identification information in the personal information, to an external server and accumulate the deleted patient identification information in a local storage within the medical facility; receive, from the external server, a trained model that is generated by the external server wherein the trained model is initially generated from operation histories of other users having a same attribute as the user who operates the terminal device and the operation history without the patient information and corresponding to the user identification accumulated in the external server, and the attribute of the users comprises a job type of the users; read out and restore the deleted patient identification information accumulated in the local storage; receive an input operation of the user having a predetermined job type from the terminal device; predict a next operation candidate to be performed on the terminal device by the user corresponding to the predetermined job type of the user upon receiving the input operation of the user by using the trained model generated by the external server, the external server being installed outside the medical facility; in response to the input operation being displaying a layout display screen, edit a display screen of an examination data on the layout display screen based on the predicted next operation candidate to generate an edited layout display screen; make a proposal to the terminal device from the predicted next operation candidate based on the restored patient identification information; and distribute the edited layout display screen to the terminal device and instruct the terminal device to display the edited layout display screen.
Independent claims 17, 18, and 19 are analyzed in the same manner as claim 1 above since claim 17 is directed to a system comprising devices and an external server performing the same or similar activities or operations as at claim 1, claim 18 is directed to a method of performing the same or similar activities or operations as at claim 1, and claim 19 is directed to a non-transitory computer readable recording medium storing an operation program of a medical care support device, the operation program comprising the same or similar activities or operations as at claim 1.
The dependent claims (claims 5-11 and 13-16) appear to be encompassed by the abstract idea of the independent claims since they merely indicate including terminal device user identification information (claim 2), if or when operation history is transmitted to the server, deleting personal information if included (claim 3), what data the operation history includes, e.g., examination data, order of examination data, change of layout, display magnification, created document type, order of creation, or time of creation, a function or order of functions used, type of examination or treatment ordered, order time (claims 5-10), instructing display of examination data on the terminal device (claim 11), proposing a display of a created document (claim 13), proposing input of operation content (claim 14), proposing display of examination or treatment ordered by the user or prompting to order the examination or treatment (claim 15), and/or making the proposal according to a time or time slot (claim 16).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of acquiring operation history information and using a model to predict and propose a candidate next operation; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
(a) Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on observing past activities, evaluating the activities and making a judgment related to what activity is predicted to be performed or preferred next;
(b) Certain methods of organizing human activity (e.g., … business relations; and/or managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions) as based on predicting a user’s behavior or activity; and
(c) Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations), as based on receiving and using a trained model – Applicant’s description does not limit the type, or indicate a particular type, of model but does indicate that the model is based on “high reference frequency for each job type” (Applicant ¶ 0090 as submitted, 0108 as published) and therefore appears to necessarily include mathematical models that include performing calculations.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are using a medical care support device with a processor , a terminal device, and an external server, using a display screen of the terminal device, and instructing the terminal device to display the edited layout display screen. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
The claims recite (and the description supports) the devices, processor(s), and server as being at a high level of generality (see Applicant ¶¶ 0116-0118 as submitted, 0134-0136 as published).
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant ¶¶ 0116-0118 as submitted, 0134-0136 as published, only indicates the processing units and/or display screen generation unit of the additional elements as “general purpose” without any indication of other components such as peripherals or displays/screens that would infer anything other than general purpose componentry.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore, the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Allowable Subject Matter
Claims 1, 4-11, and 13-19 are indicated as allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
The closest art of record appears to be Sekiguchi et al. (U.S. Patent Application Publication No. 2020/0138527, hereinafter Sekiguchi) in view of Han (European Patent Application No. EP3255573A1) and in further view of Sacolick et al. (U.S. Patent Application Publication No. 2020/0045112, hereinafter Sacolick), as indicated at the Non-Final Office Action dated 19 February 2025. However, Sekiguchi, Han, and Sacolick do not appear to discuss the entirety of the specific information being gathered and provided. The Examiner notes that even if further art were to disclose the specific information indicated, it does not appear that it would be reasonable to combine the various prior art references to arrive at the instant claimed invention. Therefore, the instant claims are indicated as allowable over the prior art.
Response to Arguments
Applicant's arguments filed 28 October 2025 have been fully considered but they are not persuasive.
Applicant first comments on the application status and amendments (Remarks at 12-13), then discusses the claim objection (Id. at 14), and then argues the 112 rejections (Id. at 14-15). However, the amendments appear to overcome the claim objection and 112 rejections; therefore, the rejections are withdrawn and the arguments are considered moot and not persuasive.
Applicant then argues the 101 rejection (Remarks at 15-17), alleging “the claimed disclosure contributes to technical improvement and is integrated to a practical application” (Id. at 15), apparently since the specification indicates “a prediction optimized for each individual user” and “a larger sample can be collected” (Id. at 16, emphasis at original argument). However, there is no indication of optimization at the claims, there is no indication regarding what a sample “can” be larger than (i.e., there is no relative size requirement for any sample of data), and there is no actual requirement regarding any size or amount of data that may, or would be, used – the claims merely predict for a user based on “other users having a same attribute as the user … [where] the attribute … comprises a job type” (at amended claim 1), which really is just modeling based on similar users.
Applicant then alleges that “[t]he claimed invention also prevents a risk of leakage of personal information by removing the personal information from training data” (Remarks at 16); however, at least HIPAA (see Pierce at pertinent prior art not relied on below) appears to indicate that entities that would provide “medical care support” as claimed would apparently already be legally required to not reveal or disclose the personal information indicated as including patient identification information.
Applicant then alleges “the claimed invention has at least a technical improvement in how a machine learning model is trained without leaking personal information externally” (Remarks at 16); however, merely limiting the training data to that which is required to train the model without actually breaching legal confidentiality requirements does not appear to constitute an improvement to machine learning.
Applicant then alleges “the restored personal information is relevant to the output of the trained model because it allows the medical care support device to utilize patient-specific or user-specific information when applying the trained model's predictions” (Id.). However, this is apparently the nature of ALL modeling – the model is trained (i.e., using control data) and then used with, in this instance, the specific information considered (i.e., the test data) so as to use the model to predict based on the test information. This also is merely using a model.
Applicant then alleges that “The trained model as claimed has higher prediction accuracy than a conventional model in the field of medical care” (Id.); however, there is no indication of any requirement or achievement of accuracy – the instant model may have very little if any comparable data for users of the same job type, or may have significant data, or the data may not be readily translatable or applicable to the facility of concern. There simply is no indication of any level of accuracy being achieved or possible, other than the conclusory argument that accuracy is possible.
Merely including “more” data for training MIGHT possibly produce better accuracy, but certainly does not assure it – the claims are literally merely predicting what layout screen might possibly be desired by a user, and every facility, user, type of medical procedure, etc. may influence that choice or available options. It appears that merely adequate data (and not a lot, or more, data) from one user or one facility may well provide a far more accurate indication of what that particular user would want for a next computer layout screen.
As indicated earlier, at least Electric Power Group indicates that defining the data does not garner eligibility, and SAP v. Investpic indicates that even if a process of collecting and analyzing information is limited to particular content, or a particular source, that limitations does not make the collection and analysis other than abstract (Id., slip op. at p. 10, lines 18-24, 898 F.3d 1161, 1167).
Therefore, merely defining the data does not make the claimed abstract idea any less abstract and does not overcome the 101 rejection.
Therefore, the Examiner is not persuaded by Applicant’s argument.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kaji, Daisuke, JP2010108388A, as indicating the Problem to be Solved is “To reduce an operation burden of a user by a simple method”, where the Solution is indicated as “This information processing apparatus is provided with: a storage means for storing the history of operations performed in the past medical examination; and a control means for executing processing of potential semantic analysis using the stored operation history, predicting an operation to be next performed from an operation newly performed based on the analysis result, and performing display for suggesting the predicted operation as the next operation candidate onto a display means”.
Kaji, Daisuke, JP2010108388A, translation from Global Dossier, indicating the Problem as “To reduce an operation load of a user by a simple method” and the Means for solving as “A storage unit configured to store a history of an operation performed during a past medical examination; and a [sic] information processing apparatus comprising: And a control means (step S13) for executing latent semantic analysis processing by using the stored operation history, predicting an operation to be performed next from a newly performed operation on the basis of the analysis result, and displaying a display for proposing the predicted operation as a next operation candidate on a display means”.
Younkes et al. (U.S. Patent Application Publication No. 2006/0026035, hereinafter Younkes) discusses “If in step 308 Health Care Provider 102 determines that external assistance from Medical Facility 138 is not needed, but that further external assistance is needed, then Health Care Provider 102 determines in step 312 if the best external assistance for performing the current step in the treatment can be obtained from a medical society. If yes, then Health Care Provider 102, utilizing any of the various input means to Computer 108 enumerated above, establishes a Communication Link 144 with Medical Society 142 in step 314. Communication Link 144 may be a telephone line for a voice call, an Internet connection, a WAN or LAN network connection, a wireless connection, satellite link, or any other suitable communication channel. Typically, Medical Society 142 will maintain intelligent data sources, such as individuals, databases, or neural networks containing guidelines, procedures, or other didactic material on how to perform the treatment, and hopefully the particular step in question. Health Care Provider 102 may query the intelligent data source until Health Care Provider 102 has the information needed to perform the current step of the treatment” (Younkes at 0032, see also Figs. 3A and 3B).
Guédon et al., 'It is Time to Prepare the Next patient' Real-Time Prediction of Procedure Duration in Laparoscopic Cholecystectomies. J Med Syst. 2016 Dec;40(12):271. doi: 10.1007/s10916-016-0631-1. Epub 2016 Oct 14. PMID: 27743243; PMCID: PMC5065600, downloaded 20 April 2024 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5065600/, indicating at least that “Operating Room (OR) scheduling is crucial to allow efficient use of ORs. Currently, the predicted durations of surgical procedures are unreliable and the OR schedulers have to follow the progress of the procedures in order to update the daily planning accordingly. The OR schedulers often acquire the needed information through verbal communication with the OR staff, which causes undesired interruptions of the surgical process. The aim of this study was to develop a system that predicts in real-time the remaining procedure duration and to test this prediction system for reliability and usability in an OR.” (at Abstract).
Dvorak et al. (U.S. Patent No. 8,972,272, hereinafter Dvorak) describes “A room-based terminal near the patient's bedside is used to supplement the operation of a patient care computing device to improve contemporaneous data capture and information accessibility during a healthcare provider's rounds. The particular benefits of the stationary terminal and patient care computing device augment each other in providing superior workflow.” (at Abstract), including that “Referring to FIG. 9 and FIG. 3, tapping on the display area 36 of the room-based terminal 34 in the area of a display module 160 transmits the touch screen coordinates 100 to the format engine 92. There, it may be mapped to particular display modules 160 to invoke an enlarged view 161 of that display module 160 expanding the portion of display area 36 used and providing greater detail to the information.” (Dvorak at column:lines 12:18-25; citation hereafter by number only) and “Referring now to FIG. 11, as noted above, tapping on display modules 160c, in the manner described above, provides an enlarged view 161c of the data of the display module 160c presenting more detailed information, in this case, time series graphs of all vitals together with a quantitative table of this and additional information.” (Dvorak at 13:12-17).
Lutich (U.S. Patent Application Publication No. 2018/0285510) discusses that “IC modeling program 206 can manage a set of interfaces (e.g., graphical user interface(s), application program interface(s), etc.) that enable system users to interact with IC modeling program 206. Further, IC modeling program 206 can manage (e.g., store, retrieve, create, manipulate, organize, present, etc.) data, through several modules contained within a layout adjustment system 220 (i.e., modules 222) and/or a training system 230 (i.e., modules 232). Layout adjustment system 220 and training system 230 are shown by example as being sub-systems of IC modeling program 206” (Lutich at 0036).
Pierce, Rob, What is HIPAA Compliance? Certification? A Summary of HIPAA, Linford & Co. LLP, dated 14 November 2018, downloaded 11 February 2026 from https://linfordco.com/blog/what-is-hipaa-compliance/, indicating “The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the Secretary of the U.S. Department of Health and Human Services (HHS) to develop regulations protecting the privacy and security of protected health information” (at p. 3), where the privacy rule “[p]rotects US citizens personally identifiable health information from unauthorized disclosure or use. The Privacy Rule applies to covered entities and business associates of covered entities” (Id.).
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685