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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 17, 2026 has been entered.
Response to Amendment
Claims 1-4, 6, 11-13, and 16 have been amended. Claims 7 and 14-15 have not been modified. Claims 5, 8-10, and 17-20 have been cancelled. Claims 1-4, 6, and 11-16 are pending and are provided to be examined upon their merits.
Response to Arguments
Applicant’s arguments filed April 17, 2026 have been fully considered but they are not persuasive. A response is provided below.
Applicant argues 35 U.S.C. §112 Rejections, pg. 12 of Remarks:
Examiner acknowledges Applicant amendment and withdraws the prior 112 rejection.
Applicant argues 35 U.S.C. §101 Rejections, pg. 13 of Remarks:
Applicant argues that the claims recite additional elements that integrate the judicial exception into a practical application by improving functioning of a computer or other technology or technological field by “calculat[ing] exactly how long a doctor or analyst will need to finish the review by finding every occurrence of a specific heart pattern and multiplying it by the time required to analyze each one.” Examiner notes that this function is abstract, as it is encompasses analyzing case workload, which solves an issue with workflow management.
Furthermore, efficiency is not enough to amount to a practical application via an improvement to computer or technology under Step 2A Prong 2 (see MPEP § 2106.05(a)(I) examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: ii. accelerating a process of analyzing audit log data when the increased speed comes solely from the capabilities of a general-purpose computer, FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016)) (also see MPEP § 2106.05(f)(2) stating “"claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not provide an inventive concept (Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367 (Fed. Cir. 2015)”), and, thus, the combination of the generic computer components do not provide a non-conventional and non-generic arrangement of known, conventional pieces; note this is applied to Step 2B as well as Step 2A Prong 2).
Applicant first argues that the invention improves the server’s ability to handle high-volume data by transforming raw waveforms into a more efficient, structured data format. Examiner respectfully disagrees.
As explained by Applicant, the transformation is data reduction and categorization, which is performed by determining sections of interest of an electrocardiogram signal ([0074], “Here, the section of interest may include a section of the electrocardiogram signal measured at a specified period and time. The section of interest may refer to a section designated by various conditions.”) and classifying/labelling sections of data using labels provided by a person ([0027], “When a first label and a second label are received as analysis conditions” [0067], “analysis conditions given by a medical staff”). Identifying sections of interest and labelling the data are human activities that is typically performed by a human analyst or a cardiologist who is analyzing an electrocardiogram signal. Here, the server is applied to perform the data pre-processing on behalf of a human. Furthermore, no specific, technical improvements are made to the server device itself, specifically in how a server handles data, as improvements are instead directed to the abstract idea of pre-processing data.
Examiner notes that if Applicant created a new type of data file that more efficiently packs electrocardiogram signal data into a smaller data packet size, which may be an improvement in electrocardiogram data structures, that may be a consideration under 35 U.S.C. 101.
Applicant secondly argues that the claimed feature of classifying the signal based on pattern information and symptom detection improves the computer’s search and retrieval functionality with its specific signal processing technique. Examiner respectfully disagrees.
There is nothing specific about Applicant’s signal processing technique that improves upon classification over other classification methods, as labelling is performed by any generic algorithmic process ([0070], “The electrocardiogram data processing server 10 may execute a classification process of adding labels corresponding to respective sections of an electrocardiogram signal. The classification process is based on a certain algorithm, and the corresponding algorithm may be generated through learning by various machine learning, reinforcement learning algorithms, and neural networks.”).
Regarding the search function, this is an abstract activity of retrieving relevant signal data based on a table indicating the relationship between patient and signal features, which is an activity that is typically performed by a human analyst or a cardiologist who is analyzing an electrocardiogram signal. Under the broadest reasonable interpretation, the outlined methodology may serve to provide instructions to a cardiologist to analyze data according to a data table and retrieving data corresponding to relevant labels ([0126], “The analysis condition processing unit 142 may determine one or more labels related to past medical history, the questionnaires, etc. of a target object by using a table indicating the relationship between medical history and labels and retrieve sections of an electrocardiogram signal for labels related to past medical history, questionnaires, etc., thereby generating output data regarding the sections of the electrocardiogram signal.”).
Furthermore, as noted above, no specific, technical improvements are made to the server device itself, specifically in how a server handles data, as improvements are instead directed to the abstract idea of pre-processing data.
Applicant thirdly argues that the invention introduces a machine-controlled feedback loop that optimizes the computer’s operation. Examiner respectfully disagrees.
As noted by Applicant, when the expected analysis time is less than the pre-set target time, the electrocardiogram signal is transmitted to an analyst terminal for analysis. This is activity covers performance of an abstract idea of certain methods of organizing human activity by assigning a work order, which is task management.
When the expected analysis time is greater than or equal to the pre-set target time, a notification signal is sent. Applicant argues that this is a technical constraint, which forces modification of the analysis condition to prevent system inefficiency. However, the modification of the analysis condition is not positively recited as the claim recites wherein “a notification signal is transmitted to enable modification”. Even if the modification was positively recited, the modification is directed towards re-selecting a signal section of interest and condition within the signal to be analyzed by a human to reduce an expected analysis time. This is not directed towards improvements in the system’s efficiency, such as by improvements to the functioning of the computer; it is directed towards an improvement in an analysts workflow efficiency by suggesting the most relevant portions of an ECG signal, which is an improvement to the abstract idea of task management of an ECG analyst or a cardiologist.
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 1-4, 6-7, and 11-16 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 1-4, 6-7, and 11-16). Accordingly, claims 1-4, 6-7, and 11-16 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 an electrocardiogram data processing server, an electrocardiogram signal of a first target object, wherein the electrocardiogram signal is measured during a measurement period;
receiving, by the electrocardiogram data processing server, a first classification data regarding the electrocardiogram signal of the first target object, wherein the first classification data comprises labels classified according to pre-set category values with respect to the electrocardiogram signal of the first target object, and wherein the receiving the first classification data further comprises: dividing the electrocardiogram signal into a plurality of signal segments according to signal waveforms by extracting interval sections from the electrocardiogram signal and extracting labels corresponding to each section based on morphology within the interval sections including at least one of peak points, signal slopes, or signal widths, and setting each of the signal segments to one of the pre-set category values;
generating data and symptom detection information at a time of measurement of the first target object using the first classification data, wherein the data includes pattern information regarding the electrocardiogram signal of the first target object when the first target object feels pain, frequencies of patterns occurring in the electrocardiogram signal, an occurrence period of the patterns, and data regarding the patterns per a predetermined unit period of the electrocardiogram signal, and wherein the symptom detection information at the time of measurement includes symptom detection information that is input by the first target object, questionnaire data in communication with the first target object, and past medical history information of the first target object;
generating a second classification data regarding the electrocardiogram signal based on the data and the symptom detection information;
generating, by the electrocardiogram data processing server, output data that includes the electrocardiogram signal, the first and second classification data, and a result data of a questionnaire of the first target object, wherein first labels are generated by a classification algorithm that classifies the electrocardiogram signal based on morphological characteristics of signal segments, and second labels are labels modified by an analyst based on the first labels, wherein the first labels and the second labels are distinguishably indicated in the output data in conjunction with heart rate information, and wherein the questionnaire includes answers of the first target object to questions provided by a medical staff;
determining, by the electrocardiogram data processing server, priorities of a plurality of pieces of label information based on information related to the first target object;
arranging, by the electrocardiogram data processing server, the plurality of pieces of label information included in the output data according to the determined priorities;
transmitting, the output data to a medical staff terminal to display the electrocardiogram signal together with heart rate information, the first and second classification data, and a result data of a questionnaire of the first target object;
receiving, by the electrocardiogram data processing server, an analysis condition regarding the electrocardiogram signal from the medical staff terminal while a frequency of occurrence value of each label and the output data are displayed on the medical staff terminal, wherein the analysis condition includes one or more labels selected from among labels associated with the electrocardiogram signal;
determining as a first section, by the electrocardiogram data processing server, one or more sections of the electrocardiogram signal corresponding to all or a part of the analysis condition;
calculating, by the electrocardiogram data processing server, an expected analysis time for the first section of interest by: determining a number of occurrences of the one or more sections corresponding to the analysis condition within the measurement period based on an occurrence pattern of the one or more sections; and multiplying the determined number of occurrences by an analysis time required to analyze each occurrence of the one or more sections corresponding to the analysis condition;
transmitting, by the electrocardiogram data processing server, data regarding the expected analysis time to the medical staff terminal, wherein the data include a result indicating whether the expected analysis time is less than a pre-set target time, so that when the expected analysis time is less than the pre-set target time, the electrocardiogram signal is transmitted to an analyst terminal for analysis, and when the expected analysis time is greater than or equal to the pre-set target time, a notification signal is transmitted to enable modification of the analysis condition to reduce the expected analysis time; and
transmitting an analysis request signal according to the analysis condition to an 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 “receiving,…, an electrocardiogram signal of a first object”, “receiving,…, a first classification data”, “generating data and symptom detection information”, “generating a second classification data”, and “generating,…, output data that includes the electrocardiogram signal, the first and second classification data, and a result of a questionnaire of the first target object”. The Analyzing, classifying, and labeling electrocardiogram signals are human activities typically performed by analysts or cardiologists. Under the broadest reasonable interpretation, the claims may provide a set of instructions for a cardiologist to follow when analyzing and labelling an ECG signal.
The claim further recites “determining,…, priorities of pieces of label information”, “receiving,…, an analysis condition”, “determining as a first section,…, one or more sections”, “calculating,…, an expected analysis time for the first section of interest”, and “transmitting an analysis request signal according to the analyst condition to an analyst terminal”, which encompasses workflow analysis and task assignment by determining the time that a task will take and creating instructions/request for an analyst to follow.
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:
electrocardiogram data processing server (1-4,11-16); classification algorithm (1,11); medical staff terminal (1-4,11-12,14); analyst terminal (1-4,11-14); processor (11) computer readable memory (11); communication unit (11)
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.
Classification algorithms are also taught at a high level of generality. [0070] recites: “The classification process is based on a certain algorithm, and the corresponding algorithm may be generated through learning by various machine learning, reinforcement learning algorithms, and neural networks.” No specific, technical improvements are being made to the technology of machine learning as generic machine learning algorithms are applied to perform the abstract idea of labelling and classifying electrocardiograms.
Computer-readable mediums are also taught at a high level of generality. [0206] 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] 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 other than the first section of interest to be analyzed in response to the analysis request signal regarding the electrocardiogram signal, receiving, by the electrocardiogram data processing server, data regarding the input for inserting the second section of interest to be analyzed; and transmitting. by the electrocardiogram data processing server, 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 the server at a high level of generality such that it is only applied to perform the insignificant extra-solution activities of receiving and transmitting data.
Claims 3 and 13: These claims recite the method further comprising: controlling, by the electrocardiogram data processing server, the analyst terminal to display the electrocardiogram signal and the classification data regarding the electrocardiogram signal included in the analysis request signal, and upon detecting an input from the medical staff terminal for inputting a priority value in the first section, re-generating the electrocardiogram signal and the first and second classification data regarding the electrocardiogram signal based on the priority value and controlling the analyst terminal to display the first and second classification data; which teaches outputting data onto the analyst terminal by priority requests from medical staff 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, by the electrocardiogram data processing server, data regarding an input priority value inserted or modified from the analyst terminal; transmitting, by the electrocardiogram data processing server, 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 the server at a high level of generality such that it is only applied to perform the insignificant extra-solution activities of receiving and transmitting data.
Claims 6 and 16: These claims recite wherein determining the first section further comprises determining the first section on a daily basis; which only serves to limit the determination of sections using a time constraint.
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 serves to further limit the abstract idea of setting of the analysis condition.
Claim 15: This claim recites 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 teaches an abstract idea of determining patterns and sections of interest to be analyzed by a human analyst, which is a typical activity performed by ECG analysts or cardiologists.
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 2-4, 6-7, and 12-16 additional limitations which amount to elements that have been recognized as activities in particular fields, claims 2-4, 6-7, and 12-16 e.g., performing repetitive calculations, Flook, MPEP §2106.05(d)(II)(ii); claims 2-4, 6-7, and 12-16, 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 1-4, 6-7, and 11-16 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Conclusion
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/D.C./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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