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 .
Response to Amendment
The amendment filed February 18, 2026 has been entered. Claims 1-2, 5-12 have been amended. Currently, claims 1-12 are pending for examination.
Response to Arguments
Applicant's arguments filed February 18, 2026 with respect to the 35 U.S.C. 101 rejection have been fully considered but they are not persuasive. Applicant argues on pages 8-9 that the amended claim 1 now recites, “inputting, to a trained model, a plurality of types of diagnosis/treatment information in the display time period and by identifying an output of the trained model as the first state, the trained model configured to receive an input of a plurality of types of diagnosis/treatment information and output a state”, this feature requiring computer-implemented predictive processing and is not a mere observation, evaluation, or judgement. The newly added limitations are not directed to a mental process (Step 2A, Prong I) but instead are directed to an additional element (Step 2A, Prong II). The recited steps argued by the applicant are generically recited such that it is no more than using a computer as a tool to perform the abstract idea.
Applicant's arguments filed February 18, 2026 with respect to the 35 U.S.C. 102 and 103 rejections have been fully considered but they are not persuasive to overcome the applied prior art. Applicant argues on pages 10-12 that Tamura et al. (US 2022/0130548) does not disclose the claimed invention, specifically claim 1’s now amended limitation to recite, “receive a user instruction regarding a display time period being a range of data to be displayed from among the time series data” and “identify a first state of the patient corresponding to the display time period according to the user instruction…”. Applicant argues Tamura et al. automatically generates segments of equal duration (e.g., 30 seconds; [0036-0039]) and are not user-selected display time periods. In response: as identified by the application, Tamura et al. discloses an input processing part 341 dividing an acquired electrocardiogram data into a plurality of pieces of electrocardiogram data each having a predetermined time length (e.g., 30 seconds). Tamura et al. additionally states the portion of electrocardiogram data that is acquired is a predetermined time period of 24 hours ([0036]). This selection of a predetermined time length of 30 seconds is regarded as a received user instruction. One of ordinary skill in the art would understand that a user necessarily instructs and programs the input processing part 341 to divide the electrocardiogram data into the 30 second ranges of data. Malchano et al. (US 2017/0020395) further evidences this by teaching it is known in the art for a user to instruct or program a processor for data collection purposes ([0098]).
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-12 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Regarding claim 1:
Step 1: Claim 1 is directed to an apparatus.
A medical information display apparatus comprising processing circuitry configured to:
obtain time series data related to a predetermined patient;
receive a user instruction regarding a display time period being a range of data to be displayed from among the time series data;
identify a first state of the patient corresponding to the display time period according to the user instruction by inputting, to a trained model, a plurality of types of diagnosis/treatment information in the display time period and by identifying an output of the trained model as the first state, the trained model configured to receive an input of a plurality of types of diagnosis/treatment information and output a state;
determine reference data corresponding to a second state different from the first state, based on one selected from between (i) relevant data that is of a same type as the time series data and is relevant to another patient and (ii) the time series data;
cause a display to display time series data corresponding to the display time period and the reference data, so as to be kept in correspondence with each other.
Step 2A – Prong 1: Claim 1 recites limitations directed to the judicial exception. The bolded emphasized limitations are drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. Identifying a first state of the patient and determining reference data corresponding to a second state is a matter of observation, evaluation, judgement and opinion recognized by the courts as mental processes. See MPEP 2106.04(a)(2).
Step 2A – Prong 2: Claim 1 recites additional elements that do not integrate the exception into a practical application of the exception because they are either directed to insignificant extra-solution activity or are generically recited such that it is no more than using a computer as a tool to perform the abstract idea. The underlined emphasized limitations of a medical information display apparatus, the processing circuitry and the trained model are recited at a high level of generality to perform the abstract idea and are merely regarded as including instructions to implement the abstract idea on a computer, or merely using a computer as a tool to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). Obtaining time series data, receiving a display time period, and using a display to display time series data corresponding to the display time period and the reference data does not integrate the exception into a practical application of the exception because it does not amount to more than generally linking the use of the exception to a particular technological environment or field of use. See MPEP 2106.05(h). Further, the judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. The medical information display apparatus and processing apparatus are recited at a high level of generality to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). Furthermore the medical information display apparatus and causing a display to present time series data are well-understood, routine, and conventional elements as evidenced by and not limited to Woo et al. (US 2019/0328268) disclosing, “a conventional patient monitoring device receives and displays at least one biometric signal (or bio signal) among electrocardiogram (ECG)” ([0003]). The processing circuitry is a well-understood, routine, and conventional element as evidenced by and not limited to Abolghasemiam et al. (US 2024/0156389) disclosing, “processing unit may receive a number of biomedical signals from a subject, including electrocardiogram (ECG)…and may send them for further processing to a conventional processor.” ([0047]). Obtaining time series data, receiving a display time period, and displaying time series data corresponding to the display time period and the reference data is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). The emphasized elements do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 2-10 depend on and recite the same abstract idea as claim 1. Furthermore, claims 2-6, 8-10 only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). Claim 7 is directed to the processing circuitry being configured to cause the display to display data in a time period closest to the display time period among the reference data. This limitation is beyond the judicial exception but does not integrate the judicial exception into a practical application or recites significantly more than the judicial exception recited in claim 1, for the same reasons as recited above in Step 2A – Prong 2 and Step 2B.
Regarding claim 11:
Step 1: Claim 11 is directed to a method reciting substantially the same limitations as claim 1.
Steps 2A - Prong 1-2, 2B: the judicial exceptions and additional elements identified for claim 1 correspond to the judicial exceptions and additional elements recited in claim 11 and are similarly not eligible under 35 U.S.C. 101.
Regarding claim 12:
Step 1: Claim 12 is directed to an apparatus reciting substantially the same limitations as claim 1.
Steps 2A - Prong 1-2, 2B: the judicial exceptions and additional elements identified for claim 1 correspond to the judicial exceptions and additional elements recited in claim 12 and are similarly not eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claim(s) 1-3, 5-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamura et al. (US 2022/0130548) or alternatively, over Tamura et al. (US 2022/0130548) as evidenced by Malchano et al. (US 2017/0020395).
Regarding claim 1, Tamura et al. discloses a medical information display apparatus comprising processing circuitry 34 (fig. 2) configured to: obtain time series data (“electrocardiogram data” [0025]) related to a predetermined patient (“whole electrocardiogram data of a patient” [0036]; fig. 3); receive a display time period being arrange of data to be displayed from among the time series data (“divided electrocardiogram” [0038]; fig. 3; “divided ECG ID 330” fig. 4); identify a first state (“portion suspected of indicating heart disease”) of the patient corresponding to the display time period by inputting, to a trained model ([0027]), a plurality of types of diagnosis/treatment information in the display time period and by identifying an output of the trained model as the first state, the trained model configured to receive an input of a plurality of types of diagnosis/treatment information and output a state ([0027], [0032-0034], [0039]); determine reference data corresponding to a second state (“normal” ([0050]); “accuracy of determining the presence or absence of abnormality” [0039]) different from the first state, based on one selected from relevant data that is the time series data (“electrocardiogram data” [0050], [0060]); and cause a display to display time series data corresponding to the display time period and the reference data, so as to be kept in correspondence with each other (“normal electrocardiogram data can be displayed along with the abnormal electrocardiogram data” [0050]; “displays waveform images of a plurality of consecutive pieces of divided electrocardiogram data including normal divided electrocardiogram data and abnormal divided electrocardiogram data which include a waveform portion suspected of indicating heart disease” [0060]). Tamura et al. does not expressly disclose the display time period being a range of data to be displayed from among the time series data is received by a user instruction. However Tamura et al. discloses an input processing part 341 dividing an acquired electrocardiogram data into a plurality of pieces of electrocardiogram data each having a predetermined time length (e.g., 30 seconds). Tamura et al. additionally states the portion of electrocardiogram data that is acquired is a predetermined time period of 24 hours ([0036]). This selection of a predetermined time length of 30 seconds is regarded as a received user instruction. One of ordinary skill in the art would understand or find it obvious that a user necessarily instructs and programs the input processing part 341 to divide the electrocardiogram data into the 30 second ranges of data. Alternatively, Malchano et al. (US 2017/0020395) further evidences this by teaching it is known in the art for a user to instruct or program a processor for data collection purposes ([0098]), and one of ordinary skill in the art before the effective filing date of the claimed invention would understand or find it obvious that a user would instruct or program the input processing part 341 to divide the electrocardiogram data into the 30 second ranges of data.
Regarding claim 2, Tamura et al. discloses the processing circuitry is further configured to: identify the first state by using at least one piece of diagnosis/treatment information (“the portion suspected of indicating disease” [0028]) in the time series data (“generating abnormal electrocardiogram data corresponding to a portion of the electrocardiogram data including the portion suspected of indicating disease” [0028]); and determine the reference data by using at least one piece of diagnosis/treatment information that is included in the one selected from the time series data and that is of a same type as the at least one piece of diagnosis/treatment information in the time series data related to the predetermined patient (“determining whether or not there is a portion suspected of indicating heart disease in the input electrocardiogram data… outputs information indicating whether the input electrocardiogram data is normal or abnormal” [0032]).
Regarding claim 3, Tamura et al. discloses wherein the diagnosis/treatment information includes one or both of: a subjective symptom related to the patient or said another patient; and details of a diagnosis/treatment event related to the patient (“a plurality of pieces of abnormal electrocardiogram data to the doctor's device 2 in association with information indicating the time at which electrocardiogram data corresponding to each of the portions suspected of indicating disease was measured” [0028]; “marker M is information for identifying the waveform portion determined to be suspected of indicating heart disease” [0058]) or said another patient.
Regarding claim 5, Tamura et al. discloses wherein the processing circuitry is further configured to: determine the second state by inputting, to the trained model, a plurality of types of diagnosis/treatment information in a time period different from the display time period 331, 332 (fig. 4); and determine time series data corresponding to the second state as the reference data ([0050], [0060]).
Regarding claim 6, Tamura et al. discloses wherein the processing circuitry is further configured to cause the display to further display the second state (“normal electrocardiogram data can be displayed along with the abnormal electrocardiogram data” [0050], [0060], figs. 4 and 8).
Regarding claim 7, Tamura et al. discloses wherein the processing circuitry is further configured to cause the display to display reference data of a time period closest to the display time period (“display control part 343 may increase the number of pieces of divided electrocardiogram data to be displayed on the screen of the doctor's device 2 beyond the default number so that normal electrocardiogram data can be displayed along with the abnormal electrocardiogram data.” [0050]; fig. 4 displays reference data 331-332 closest to display time period 330).
Regarding claim 8, Tamura et al. discloses wherein the processing circuitry is further configured to determine the reference data, while regarding a state farthest away from the first state in a diagnosis/treatment sense, as the second state (“a large number of pieces of normal electrocardiogram data (i.e., electrocardiogram data in which a disease does not appear) and abnormal electrocardiogram data (i.e., electrocardiogram data in which a disease appears)” [0027]).
Regarding claim 9, Tamura et al. discloses wherein the processing circuitry is further configured to: determine a plurality of second states 331, 332 (figs. 4 and 8, regarded as normal); and determine the reference data, based on differences between the first state 330 (figs. 4 and 8, regarded as abnormal-see marker M) and the plurality of second states and temporal closeness between a plurality of time periods respectively corresponding to the plurality of second states and the display time period (“display control part 343 may increase the number of pieces of divided electrocardiogram data to be displayed on the screen of the doctor's device 2 beyond the default number so that normal electrocardiogram data can be displayed along with the abnormal electrocardiogram data.” [0050]; fig. 4 displays reference data 331-332 closest to display time period 330).
Regarding claim 10, Tamura et al. discloses wherein the processing circuitry is further configured to: identify, when the display time period is changed, a third state (“abnormal”) corresponding to a post-change display time period; determine reference data corresponding to a fourth state (“normal”) that is different from the third state and is identified in accordance with the change made to the display time period, based on one selected from between relevant data that is of a same type as the time series data; and cause the display to display time series data corresponding to the post-change display time period and the reference data corresponding to the fourth state so as to be kept in correspondence with each other (“When a plurality of pieces of abnormal electrocardiogram data are included in the electrocardiogram data, the operation information acquisition part 344 acquires operation information for displaying the waveform image of the abnormal electrocardiogram data other than the abnormal electrocardiogram data whose waveform image is displayed on the doctor's device 2.” [0077]; interpreted as selecting a different abnormal divided ECG data to display, that is a changed display time period from the display time period of claim 1).
Regarding claim 11, Tamura et al. discloses a medical information display method comprising: obtaining time series data (“electrocardiogram data” [0025]) related to a predetermined patient (“whole electrocardiogram data of a patient” [0036]; fig. 3); receiving a display time period being arrange of data to be displayed from among the time series data (“divided electrocardiogram” [0038]; fig. 3; “divided ECG ID 330” fig. 4); identifying a first state of the patient corresponding to the display time period by inputting, to a trained model ([0027]), a plurality of types of diagnosis/treatment information in the display time period and by identifying an output of the trained model as the first state, the trained model configured to receive an input of a plurality of types of diagnosis/treatment information and output a state ([0027], [0032-0034], [0039]); determining reference data corresponding to a second state (“normal” ([0050]); “accuracy of determining the presence or absence of abnormality” [0039]) different from the first state, based on one selected from relevant data that is of a same type (“electrocardiogram data” [0050], [0060]) as the time series data; and causing a display to display time series data corresponding to the display time period and the reference data, so as to be kept in correspondence with each other (“normal electrocardiogram data can be displayed along with the abnormal electrocardiogram data” [0050]; “displays waveform images of a plurality of consecutive pieces of divided electrocardiogram data including normal divided electrocardiogram data and abnormal divided electrocardiogram data which include a waveform portion suspected of indicating heart disease” [0060]). Tamura et al. does not expressly disclose the display time period being a range of data to be displayed from among the time series data is received by a user instruction. However Tamura et al. discloses an input processing part 341 dividing an acquired electrocardiogram data into a plurality of pieces of electrocardiogram data each having a predetermined time length (e.g., 30 seconds). Tamura et al. additionally states the portion of electrocardiogram data that is acquired is a predetermined time period of 24 hours ([0036]). This selection of a predetermined time length of 30 seconds is regarded as a received user instruction. One of ordinary skill in the art would understand or find it obvious that a user necessarily instructs and programs the input processing part 341 to divide the electrocardiogram data into the 30 second ranges of data. Alternatively, Malchano et al. (US 2017/0020395) further evidences this by teaching it is known in the art for a user to instruct or program a processor for data collection purposes ([0098]), and one of ordinary skill in the art before the effective filing date of the claimed invention would understand or find it obvious that a user would instruct or program the input processing part 341 to divide the electrocardiogram data into the 30 second ranges of data.
Regarding claim 12, Tamura et al. discloses a non-transitory computer-readable storage medium storing therein a medical information display program that causes a computer to realize: obtaining time series data (“electrocardiogram data” [0025]) related to a predetermined patient (“whole electrocardiogram data of a patient” [0036]; fig. 3); receiving a display time period being arrange of data to be displayed from among the time series data (“divided electrocardiogram” [0038]; fig. 3; “divided ECG ID 330” fig. 4); identifying a first state of the patient corresponding to the display time period by inputting, to a trained model ([0027]), a plurality of types of diagnosis/treatment information in the display time period and by identifying an output of the trained model as the first state, the trained model configured to receive an input of a plurality of types of diagnosis/treatment information and output a state ([0027], [0032-0034], [0039]); determining reference data corresponding to a second state (“normal” ([0050]); “accuracy of determining the presence or absence of abnormality” [0039]) different from the first state, based on one selected from relevant data that is of a same type (“electrocardiogram data” [0050], [0060]) as the time series data; and causing a display to display time series data corresponding to the display time period and the reference data, so as to be kept in correspondence with each other (“normal electrocardiogram data can be displayed along with the abnormal electrocardiogram data” [0050]; “displays waveform images of a plurality of consecutive pieces of divided electrocardiogram data including normal divided electrocardiogram data and abnormal divided electrocardiogram data which include a waveform portion suspected of indicating heart disease” [0060]). Tamura et al. does not expressly disclose the display time period being a range of data to be displayed from among the time series data is received by a user instruction. However Tamura et al. discloses an input processing part 341 dividing an acquired electrocardiogram data into a plurality of pieces of electrocardiogram data each having a predetermined time length (e.g., 30 seconds). Tamura et al. additionally states the portion of electrocardiogram data that is acquired is a predetermined time period of 24 hours ([0036]). This selection of a predetermined time length of 30 seconds is regarded as a received user instruction. One of ordinary skill in the art would understand or find it obvious that a user necessarily instructs and programs the input processing part 341 to divide the electrocardiogram data into the 30 second ranges of data. Alternatively, Malchano et al. (US 2017/0020395) further evidences this by teaching it is known in the art for a user to instruct or program a processor for data collection purposes ([0098]), and one of ordinary skill in the art before the effective filing date of the claimed invention would understand or find it obvious that a user would instruct or program the input processing part 341 to divide the electrocardiogram data into the 30 second ranges of data.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamura et al. (US 2022/0130548) in view of Rath (US 2015/0305688).
Regarding claim 4, Tamura et al. does not expressly disclose wherein the diagnosis/treatment event (“a plurality of pieces of abnormal electrocardiogram data to the doctor's device 2 in association with information indicating the time at which electrocardiogram data corresponding to each of the portions suspected of indicating disease was measured” [0028]; “marker M is information for identifying the waveform portion determined to be suspected of indicating heart disease” [0058]) is an event of being admitted into and/or discharged from a hospital related to the patient or said another patient. Rath teaches tracking a patient’s health after the event of the patient being discharged from a hospital ([0025]), suggesting it is an important diagnosis/treatment event to make note of for a patient to identify the first state. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tamura et al. to associate the diagnosis/treatment event of being admitted into a hospital as part of identifying the first state as taught by Rath to provide a complete history of the seriousness of the patient’s condition, including visits to the hospital.
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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