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 .
Notice to Applicant
Receipt of Applicant’s Amendment filed December 11, 2025 is acknowledged.
Response to Amendment
Claims 1, 3, 5, 9-11, 13, 15, and 17-19 have been amended. Claims 2, 4, 6-8, 12, 14, and 16 have not been modified. Claim 20 has been added. Claims 1-20 are pending and are provided to be examined upon their merits.
Response to Arguments
Applicant’s arguments filed December 11, 2025 have been fully considered but they are not persuasive. A response is provided below.
Applicant argues 35 U.S.C. §101 Rejections, pg. 10 of Remarks:
Regarding 1), Applicant draws parallels to Example 42 and argues that (1) the server is interworked with the user terminals to provide remote access to users, (2) processing of electrocardiogram (ECG) signals is a conversion of from non-standardized ECG signal data to standardized output data, (3) there is an automatic generation and transmission of messages regarding updated information, and (4) there is an additional element of regenerating the classification data for the ECG signal and updating the real-time display with the regenerated data. Thus (5), the additional elements of the independent claims, as a whole, recite a specific technical improvement by providing a method for efficiently anticipating the required analysis time, which enables more efficient management of analyst sources and accurate clinical analysis under time constraints.
Examiner notes that the fact patterns of Example 42 are non-analogous to the instant application, as the instant application has no relevance to the technical problem of ensuring complete record consolidation from records stored in separate locations. However, each point is addressed below.
(1): The server of the instant application is a generic processor device to perform the abstract idea of labeling data, determining sections of interest to be analyzed, determining an expected analysis time, and generating a request signal for an analyst to analyze an ECG signal ([0204] of Applicant specification, “the devices and components described in the embodiments may be implemented by using one or more general purpose or special purpose computers, such as a processor, a controller, an arithmetic logic unit (ALU), a digital signal processor, a microcomputer, a field programmable gate array (FPGA), a programmable logic unit (PLU), a microprocessor, or any other device capable of executing and responding to instructions.”). Neither Applicant specification nor the claims recite any technical improvements in server devices that may represent an improvement in computer functionality (MPEP 2106.06(b)).
(2): Applicant specification does not support conversion of non-standard data formats to a standardized data format. Example 42 specifically outlines wherein data format standardization specifically is to solve the issue of data that “cannot be consolidated due to format inconsistencies”. No such motivation or support is provided in Applicant specification. Instead, Applicant specification recites wherein received ECG data is labeled according to a classification criterion standard, which is dissimilar from Example 42 ([0190] of Applicant specification, “As shown in FIG. 14, classification data regarding an electrocardiogram signal may include labels generated in three stages. In a first stage, an electrocardiogram signal may be classified into category values (labels) including a normal beat N, supraventricular ectopy beat (SVEB) S and ventricular ectopy beat (VEB) V according to a certain classification criterion. Here, the classification criterion may include IEC 60601-2-47, which is an international standard, or KS C IEC 60601-2-47, which is a domestic standard, but is not limited thereto. Also, the classification criteria may be changed or inserted by a user.”).
The signal data appears to be generic waveform data that is labeled before undergoing further processing ([0093], “In another embodiment, the electrocardiogram receiving unit 141 may analyze signal waveforms of an electrocardiogram signal by using received data regarding the electrocardiogram signal and generate classification data regarding the electrocardiogram signal.”).
(3): The amended independent claims do not recite a notification. Even further, any claimed notification is not implemented in a way, supported by Applicant specification, that provides a specific benefit over other systems. Example 42 specifically outlines wherein the automatic notification is for the benefit of ensuring “that all users can quickly be notified of any changes without having to manually look up or consolidate all of the provider’s updates”. This is dissimilar to the transmitting information regarding the expected analysis time, which is more akin to submitting a work order with an expected estimate completion time (MPEP 2106.05(a)II: “Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”).
(4): The claimed re-generating step is simply re-generating data on a display on an analyst terminal. No specific, technical improvements are provided by simply reciting that data is re-generated/provided for display on an analyst terminal as it represents a generic implementation of a display.
(5): Examiner notes that providing a method for efficiently anticipating the required analysis time, which enables more efficient management of analyst sources and accurate clinical analysis under time constraints is an improvement to the abstract idea rather than a technology or technical field. Anticipating required analysis time is simply an estimation of how long it would take a human analyst to perform the task of analyzing an ECG signal, which is an improvement to the business process of task completion. Management of analyst sources and ensuring accurate clinical analysis under time constraints follow the same business process of managing analysts and their activities.
Regarding 2), Applicant argues that the amended claims are patent eligible according to McRO, Inc. v. Bandai Namco Games America Inc., as the present claims recite a “specific sequence of steps to automate the task of determining and updating the expected analysis time for ECG signals in a more accurate and convenient manner”. Examiner notes that automating the task is simply automation of manual processes, which is insufficient to show an improvement under 35 U.S.C. 101 (MPEP 2106.05(a)I: “Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017)”).
Applicant argues 35 U.S.C. §103 Rejections, pg. 9 of Remarks:
Applicant amendments have overcome the prior art. Please see an explanation below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 11 recite “calculating, by the processor, based on the determined priorities, an expected analysis time by multiplying a first section occurring period by an analysis time of the first section”. It is indefinite as to what value the “first section occurring period” refers to. For the purpose of Examination, the Examiner interprets the first section occurring period to be equal to the value of “1”, as multiplying the analysis time of the section by “1” will result in the expected analysis time for a section to be equal to the analysis time for the first section. This is consistent with new claim 20, which refers to re-calculating expected analysis time for “a section to be analyzed”.
Claims 2-10 and 12-20 are rejection by virtue of their dependency on their respective independent claims.
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.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process and a machine
(claims 1-20). Accordingly, claims 1-20 are all within at least one of the four statutory
categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP §2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and /or c) mathematical concepts. MPEP §2106.04(a).
The Examiner has identified method claim 1 as the claim that represents the claimed invention for analysis; device claim 11 being similar to method claim 1.
Claim 1:
A method of processing analysis tasks for signal sections corresponding to an analysis condition, the method comprising:
receiving, by a processor, an electrocardiogram signal of a first target object;
receiving, by the processor, classification data regarding the electrocardiogram signal of the first target object;
generating, by the processor, output data that includes a plurality of pieces of label information regarding sections of the electrocardiogram signal in conjunction with one another;
determining, by the processor, priorities of the plurality of pieces of label information based on information related to the first target object;
arranging, by the processor, the plurality of pieces of label information included in the output data according to the determined priorities;
transmitting, by the processor, the output data to a medical staff terminal to display the plurality of pieces of label information in an order corresponding to the priorities and displaying pre-stored past medical history information regarding the first target object, by using the output data regarding the electrocardiogram signal and the classification data regarding the electrocardiogram signal;
receiving, by the processor, an analysis condition regarding the electrocardiogram signal from the medical staff terminal;
determining as a first section of interest to be analyzed, by the processor, one or more sections of the electrocardiogram signal corresponding to all or a part of the analysis condition;
calculating, by the processor, based on the determined priorities, an expected analysis time by multiplying a first section occurring period by an analysis time of the first section;
transmitting, by the processor, information regarding the expected analysis time to the medical staff terminal;
generating, by the processor, an analysis request signal regarding the electrocardiogram signal;
transmitting, by the processor, the analysis request signal to an analyst terminal; and
upon detecting an input from the medical staff terminal of a priority value with respect to the first section of interest to be analyzed, re-generating, by the processor, the electrocardiogram signal and the classification data regarding the electrocardiogram signal based on the priority value and displaying the re-generated classification data on the analyst terminal.
These above limitations, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity under managing personal behaviors of people. The claim elements are directed towards “determining,…, priorities of the plurality of pieces of label information”, “receiving,…, an analysis condition”, “determining one or more sections of the electrocardiogram signal… as a first section of interest to be analyzed”, “calculating,…, an expected analysis time”, and “generating an analysis request”, which encompasses workflow analysis by determining the time that a task will take and creating instructions/request for an analyst to follow. The claim further recites “upon detecting an input from the medical staff terminal of a priority value…”, which is managing the interaction between a user (medical staff) and a computer; see MPEP 2106.04(a)(2)II which recites wherein “certain activity between a person and a computer (…) may fall within the "certain methods of organizing human activity" grouping”
Accordingly, the claim recites at least one abstract idea.
Claim 11 is found to be abstract for the same reasons.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the idea into a practical application. As noted at MPEP §2106.04 (ID)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
Additional elements cited in the claims:
A processor (1,11-15,17-20); a medical staff terminal (1-4,11-12,14,20); an analyst terminal (1-4,11-14); an electrocardiogram data processing server (11-19); a computer readable memory (11); a communication unit (11)
The independent claim recites an insignificant extra-solution activities of receiving and transmitting data. See also MPEP 2106.05(g).
Any computing devices that would be able to perform the method (terminals, server, processor) are taught at a high level of generality such that the claim elements amounts to no more than mere instructions to apply the exception using any generic component capable of performing the claim limitations. [0204] of Applicant specification recites: “The apparatus described above may be implemented as a hardware component, a software component, and/or a combination of hardware components and software components. For example, the devices and components described in the embodiments may be implemented by using one or more general purpose or special purpose computers, such as a processor, a controller, an arithmetic logic unit (ALU), a digital signal processor, a microcomputer, a field programmable gate array (FPGA), a programmable logic unit (PLU), a microprocessor, or any other device capable of executing and responding to instructions.” No specific, technical improvements are being made to computing devices as generic devices with software modules are simply being used to perform the abstract idea.
Computer-readable mediums are also taught at a high level of generality. [0206] of Applicant specification recites: “The methods according to embodiments may be embodied in the form of program instructions that can be executed by various computer means and recorded on a computer readable medium... Examples of the computer-readable recording medium include a hardware device specially configured to store and perform program instructions, for example, a magnetic medium, such as a hard disk, a floppy disk, and a magnetic tape, an optical recording medium, such as a CD-ROM, a DVD, and the like, a magneto-optical medium, such as a floptical disc, ROM, RAM, a flash memory, and the like.” No specific, technical improvements are being made to computer readable mediums as any generic storage medium is simply applied to perform the insignificant extra-solution activity of storing data.
The communication unit are also taught at a high level of generality. [0062] of Applicant specification recites: “All communication methods may include all communications through predetermined communication standards, predetermined frequency bands, predetermined protocols, or predetermined channels. For example, all communication methods may include Bluetooth, BLE, Wi-Fi, Zigbee, 3G,LTE, an ultrasound communication method, etc., and may include all short-distance communication, long- distance communication, wireless communication, and wired communication. Of course, it is not limited to the above examples.” No specific, technical improvements are being made to communication networks as a variety of known mechanisms are simply applied to perform the insignificant extra-solution activity of transmitting and receiving data.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional elements as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception 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, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID)(A)(2).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 2 and 12: These claims recite the method further comprising, applying, at the analyst terminal, an input for inserting a second section of interest to be analyzed other than the first section of interest to be analyzed in response to the analysis request signal regarding the electrocardiogram signal, receiving data regarding the input for inserting the second section of interest to be analyzed; and transmitting the data regarding the input to the medical staff terminal; which teaches an abstract idea of certain methods of organizing human activity under the managing personal behaviors sub-grouping, as receiving input from an analyst about a section that is to be analyzed by the analyst. This claim further teaches an insignificant extra-solution activity of transmitting data.
Claims 3 and 13: These claims recite the method further comprising: controlling the analyst terminal to display the electrocardiogram signal and the classification data regarding the electrocardiogram signal included in the analysis request signal; which teaches controlling the display of the analyst terminal at a high level of generality such that there are no specific, technical improvements to computer displays.
Claims 4 and 14: These claims recite the method further comprising: receiving data regarding an input priority value inserted or modified from the analyst terminal; transmitting the data regarding the input priority value to the medical staff terminal; and requesting a reply on whether to authorize the input priority value; which teaches an abstract idea of certain methods of organizing human activity under the managing personal behaviors sub-grouping, as requesting a reply for authorization. This claim further teaches insignificant extra-solution activities of receiving and transmitting data.
Claims 5 and 15: These claims recite wherein determining the first section of interest to be analyzed further comprises: calculating, an occurrence pattern in which all or a part of the analysis condition are generated, from electrocardiogram signals, and determining the first section of interest to be analyzed based on the occurrence pattern; which further limits the determination of sections of interest to be analyzed by a human analyst.
Claims 6 and 16: These claims recite wherein determining the first section of interest to be analyzed further comprises determining the first section of interest to be analyzed on a daily basis; which further limits the determination of sections of interest to be analyzed by a human analyst.
Claim 7: This claim recites the method further comprising setting the analysis condition based on labels generated from the electrocardiogram signal or as an analysis time for a part of a measured period; which teaches an insignificant extra-solution activity of selecting a data source or type for manipulation.
Claim 8: This claim recites the method further comprising modifying the analysis condition by a questionnaire result of the first target object and as a part of a period during which the electrocardiogram signal is measured; which teaches an insignificant extra-solution activity of selecting a data source or type for manipulation and an abstract idea of certain methods of organizing human activity as receiving questionnaire results from a patient.
Claims 9 and 18: These claims recite wherein calculating the expected analysis time further comprises: when a first label and a second label are received as the analysis condition, determining a frequency of occurrence of the first label and a frequency of occurrence of the second label by using the classification data regarding the electrocardiogram signal; and calculating an expected analysis time of an electrocardiogram according to the analysis condition in consideration of the frequency of occurrence of the first label and the frequency of occurrence of the second label and an analysis time regarding the first label and an analysis time regarding the second label; which further limits the abstract idea of the determination of an analysis time.
Claims 10 and 19: These claims recite wherein calculating the expected analysis time further comprises: when a first disease is received as the analysis condition, determining one or more labels regarding the first disease by using a pre-stored table of labels for respective diseases; and, for the one or more labels, calculating an expected analysis time of the electrocardiogram according to the analysis condition in consideration of a frequency of occurrence and an analysis time of each of the one or more labels; which further limits the abstract idea of the determination of an analysis time.
Claim 17: This claim is rejected for the same reasons as claims 7 and 8, above.
Claim 20: This claim recites the method further comprising: when the calculated expected analysis time is greater than or equal to a pre-set target time, transmitting, by the processor, a notification signal to the medical staff terminal; and upon receiving a modification input regarding the analysis condition or a section to be analyzed from the medical staff terminal, re-calculating the expected analysis time based on the modification input; which teaches an abstract idea of adjusting the analysis time based on user input.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
These claims 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 use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
Amount to elements that have been recognized as activities in particular fields (such as Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), MPEP §2106.05(d)(II)(i);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 additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-10 and 12-20 additional limitations which amount to elements that have been recognized as activities in particular fields, claims 2-10 and 12-20 e.g., performing repetitive calculations, Flook, MPEP §2106.05(d)(II)(ii); claims 2-10 and 12-20, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv). 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.
Therefore, whether taken individually or as an ordered combination, claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Regarding prior art
Based on prior art search results, the prior art deemed closest to the instant claims are:
Lyman (US 20200160980) teaches a system for labeling received electrocardiogram signals, displaying said labelled signals, determining priorities for said signals, and assigning signals to analysts who provide input and determine analysis conditions. However, Lyman fails to teach or render obvious the specific combination of claimed elements, such as determining one or more sections corresponding to all or a part of the analysis condition, calculating an expected analysis time by multiplying a first section occurring period by an analysis time of the first section, transmitting information regarding the expected analysis time, and generating and transmitting an analysis request signal.
Li (US 20220031223) teaches a system for determining one or more sections of the electrocardiogram signal corresponding to all or a part of the analysis condition and generating and transmitting an analysis request signal. However, Li fails to teach or render obvious the specific combination of claimed elements, such as calculating an expected analysis time by multiplying a first section occurring period by an analysis time of the first section.
Sadeghi (US 20240105313) teaches a system for calculating an expected analysis time, transmitting the expected analysis time, and re-generating labelled electrocardiogram signals based on priority on an analyst terminal. However, Sadeghi fails to teach or render obvious the specific combination of claimed elements, such as calculating an expected analysis time by multiplying a first section occurring period by an analysis time of the first section.
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.
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/D.C./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684