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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on the following date(s) is/are entered and considered by Examiner:
* 21 July 2026
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Claim 1 recites:
A system for providing an electrocardiogram reading service, the system comprising:
at least one processor;
at least one memory operably coupled to the at least one processor; and
computer-executable instructions stored in the at least one memory, wherein the computer-executable instructions, when executed by the at least one processor, cause the system to perform operations comprising:
receiving from a user terminal at a first server, an electrocardiogram analysis request, wherein the electrocardiogram analysis request comprises electrocardiogram data for a user;
responsive to receiving, by the first server, the electrocardiogram data from the user terminal, generating de-identification information by using a de-identification code value for user de-identification processing for the electrocardiogram data;
generating, by the first server, collaboration request data including the de-identification information and the electrocardiogram data;
transmitting, to a second server, the collaboration request data from the first server, wherein the second server is configured to generate an electrocardiogram analysis result data by inputting the electrocardiogram data based on the collaboration request data into a pre-trained neural network model;
receiving, at the first server, the electrocardiogram analysis result data from the second server;
identifying, by the first server, the user by decrypting the de-identification information using the de-identification code value, and storing the identified user and the electrocardiogram analysis result data in association with each other, wherein the electrocardiogram analysis result data is viewed in the user terminal; and
responsive to determining, by the first server, whether the electrocardiogram analysis result data indicates an abnormality condition, transmitting a notification to the user terminal.
Step 1:
The claim as a whole falls within at least one statutory category, i.e. a process, machine, manufacture, or composition of matter.
Step 2A Prong One:
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Certain methods of organizing human activity” because the steps of processing a cardiogram for a patient and diagnosing the patient are traditionally performed by a physician when treating a patient, i.e. managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). MPEP 2106.04(a)(2)(II)
The highlighted portion, as drafted, is a process that, under its broadest reasonable interpretation, falls under “Mental processes”.
But for a generic computer invoked with a high level of generality in a post hoc manner to implement the abstract idea, the highlighted steps may be practically performed in the human mind either mentally or with pen and paper.
Accordingly, these limitations have been found to be directed towards concepts performed in the human mind (including an observation, evaluation, judgment, opinion). MPEP 2106.04(a)(2)(III)
The different categories of abstract ideas are being considered together as one single abstract idea. MPEP 2106.04(II)(B)
Dependent claim(s) recite(s) additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim(s) 2-14 reciting limitations further defining the abstract idea, which may be performed in the mind but for recitation of generic computer components, and/or may be a method of managing relationship or interactions between people).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites the following additional element(s), if any:
at least one processor;
at least one memory operably coupled to the at least one processor; and
computer-executable instructions stored in the at least one memory, wherein the computer-executable instructions, when executed by the at least one processor, cause the system to perform operations comprising:
receiving from a user terminal at a first server, an electrocardiogram analysis request, wherein the electrocardiogram analysis request comprises electrocardiogram data for a user;
transmitting, to a second server, the collaboration request data from the first server, wherein the second server is configured to generate an electrocardiogram analysis result data by inputting the electrocardiogram data based on the collaboration request data into a pre-trained neural network model;
receiving, at the first server, the electrocardiogram analysis result data from the second server;
identifying, by the first server, the user by decrypting the de-identification information using the de-identification code value, and storing the identified user and the electrocardiogram analysis result data in association with each other, wherein the electrocardiogram analysis result data is viewed in the user terminal; and
responsive to determining, by the first server, whether the electrocardiogram analysis result data indicates an abnormality condition, transmitting a notification to the user terminal.
The additional element(s) do(es) not integrate the abstract idea into a practical application, other than the abstract idea per se.
Regarding the terminal and servers, and the use of a neural network, when read in light of the Specification as originally filed the broadest reasonable interpretation of these limitations would include a generic/general-purpose computer (page 18 line 23 to page 19 line 9), and amount(s) to mere instructions to apply an exception (invoking computers as a tool to perform the abstract idea). Similar rationale applies to the generic computer functions of processing and storing data (since they are recited in a generic manner devoid of any technical details). MPEP 2106.05(f))
Regarding the steps of sending/receiving data, displaying data, and encrypting/decrypting data, these limitations merely add(s) insignificant extra-solution activity to the abstract idea (mere data gathering, insignificant application). MPEP 2106.05(g))
Dependent claim(s) recite(s) additional subject matter which amount to limitation(s) consistent with the additional element(s) in the independent claims.
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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, the additional elements do not integrate the judicial exception into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Accordingly, the claim recites an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use.
The additional elements, as discussed above and incorporated herein, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use, as discussed above and incorporated herein.
Mere instructions to apply an exception, insignificant extra-solution activity, and linking to a particular technological environment using a generic computer component cannot provide an inventive concept.
Regarding the step of sending and receiving data, these limitations amount(s) to element(s) that have been recognized as well-understood, routine, and conventional (WURC) activity in particular fields (e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)). MPEP 2106.05(d)(II)(ii))
Regarding the steps of displaying data, Belle (10485489) discloses a computer display in a manner that would be WURC in the pertinent arts (column 6 line 9-17).
Regarding the steps of encrypting and decrypting data, Belle discloses a variety of encryption techniques in a manner that would be WURC in the pertinent arts (column 7 line 23-28).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims.
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.
The claim is not patent eligible.
Claim(s) 15-20 recite(s) substantially similar limitations as those of claim(s) 1-14 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Belle.
Claim 1: Belle discloses:
A system (Title, Abstract illustrating a system) for providing an electrocardiogram reading service (column 4 line 14-16 illustrating interpretating an ECG), the system comprising:
at least one processor (Figure 1 illustrating a processor);
at least one memory operably coupled to the at least one processor (Figure 1 illustrating memory operatively connected to the processor); and
computer-executable instructions stored in the at least one memory, wherein the computer-executable instructions, when executed by the at least one processor (Figure 1 illustrating a signal processor with associated software code), cause the system to perform operations comprising:
receiving from a user terminal at a first server (column 5 line 39-48 illustrating a user device operatively connected to on-prem virtual machine comprising a plurality of suitable local and remote computing systems, including a cloud disclosed in Figure 11 [considered to be a form of “first server”]), an electrocardiogram analysis request, wherein the electrocardiogram analysis request comprises electrocardiogram data for a user (column 5 line 25-30 illustrating the biosignal detection signal sending data to an intermediary device to request ECG interpretation, e.g. hemodynamic stability scoring/classification);
responsive to receiving, by the first server, the electrocardiogram data from the user terminal, generating de-identification information by using a de-identification code value for user de-identification processing for the electrocardiogram data (column 5 line 21-25 illustrating de-identified ECG data);
generating, by the first server, collaboration request data including the de-identification information and the electrocardiogram data (column 5 line 21-25 illustrating providing de-identified ECG data for interpretation);
transmitting, to a second server (Figure 11 illustrating a cloud server [considered to be a form of “second server”]), the collaboration request data from the first server (from above and incorporated herein), wherein the second server is configured to generate an electrocardiogram analysis result data by inputting the electrocardiogram data based on the collaboration request data into a pre-trained neural network model (column 18 line 23-25 illustrating processing ECG data using a trained neural network);
receiving, at the first server, the electrocardiogram analysis result data from the second server (column 20 line 40-44 illustrating re-identifying the patient’s ECG data and storing the interpretation results together with the re-identified patient data for display, Figure 11 illustrating the on-prem server receiving the analyzed patient results));
identifying, by the first server, the user by decrypting the de-identification information using the de-identification code value, and storing the identified user and the electrocardiogram analysis result data in association with each other, wherein the electrocardiogram analysis result data is viewed in the user terminal (Figure 1 label 150, column 5 line 39-48 illustrating displaying the results to the user); and
responsive to determining, by the first server, whether the electrocardiogram analysis result data indicates an abnormality condition, transmitting a notification to the user terminal (Figure 12 illustrating displaying patient trajectory scores to the user).
Claim 2: Belle discloses:
wherein the operations further comprise:
transmitting, by the first server, the electrocardiogram analysis result data as a primary analysis result to the user terminal (column 5 line 12-19 illustrating providing results processed by a processing system operating on the biosignal detection device as well as additional interpretation functions provided by a cloud based system [considered to be “expert in-depth reading”]);
in response to a secondary reading request from the user terminal, obtaining, at the second server, expert analysis information from an expert terminal for an expert in-depth analysis, wherein the expert terminal includes a user interface for the expert in-depth analysis (column 20 line 61-63 illustrating an AWS cloud analytics engine [considered to be a form of “user interface for expert in-depth reading to the expert terminal” because the cloud abstracts the interpretation function from the user, and can include human or machine “experts”; the claim does not explicitly recite human “experts”]); and
transmitting a secondary analysis result including the expert analysis information to the user terminal (Figure 1 label 150 as discussed above, and incorporated herein).
Claim 3: Belle discloses:
wherein:
the electrocardiogram analysis result data includes at least one of a presence of a disease and a disease likelihood score based on the pre-trained neural network model (column 5 line 21-25 illustrating using the neural network to determine a classification [considered to be “whether there is a disease”] or score [considered to be “disease likelihood score”]); and
the electrocardiogram analysis result data provided by the expert in-depth analysis includes expert analysis information regarding the disease (column 20 line 61-63 illustrating an AWS cloud analytics engine [considered to be a form of “expert in-depth reading”]).
Claim 4: Belle discloses:
wherein the operations further comprise:
generating, by the second server, a user interface for expert in-depth analysis to an expert terminal (as discussed above and incorporated herein, Belle discloses a plurality of characteristics for the ECG (column 9-20);
receiving, by the second server, expert analysis information from the expert terminal (as discussed above and incorporated herein, Belle discloses a plurality of characteristics for the ECG (column 9-20), and
generating final electrocardiogram analysis result data based on the electrocardiogram analysis result data and the expert analysis information (as discussed above and incorporated herein, Belle discloses a plurality of characteristics for the ECG (column 9-20) and are considered to be forms of “primary” and “secondary” results from an AWS cloud server [considered to be a form of “expert terminal”]).
Claim 5: Belle discloses:
wherein the second server is configured to determine whether the electrocardiogram data included in the collaboration request data is readable by the pre-trained neural network model, generate a user interface for expert in-depth analysis to an expert terminal depending on whether the electrocardiogram data is readable, and receive expert analysis information from the expert terminal (Figure 5 illustrating determining if the ECG contains missing data or if the ECG may be interpreted, and providing the ECG to the AWS cloud expert system), and obtains expert reading information from the expert terminal (as discussed above and incorporated herein)).
Claim 6: Belle discloses:
wherein the second server, when the electrocardiogram data included in the collaboration request data is not readable by the pre-trained neural network model (column 11 line 42-43 illustrating determining that the ECG contains noise [considered to be “not readable”]), is configured to transmit the collaboration request data to the expert terminal and receive electrocardiogram analysis result data generated by the expert terminal (column 12 line 43-48 illustrating providing a portion of the AWS cloud server capable of providing a band-pass filter to remove noise from the ECG [considered to be a form of “expert terminal”]).
Claim 7: Belle discloses:
further comprising:
generating, by the second server, a user interface for expert in-depth analysis at an expert terminal, when the electrocardiogram analysis result data includes information indicating that the user is in an emergency state (column 2 line 65 to column 3 line 3 illustrating providing emergency interpretation to patients located in an emergency department); and
receiving, by the second server, expert analysis information from the expert terminal (Figure 11 illustrating the cloud server receiving data).
Claim 8: Belle discloses:
wherein the second server is configured to compare a prediction value for a likelihood of a disease included in the electrocardiogram analysis result data with a preset threshold (column 19 line 8-18 illustrating comparing the ECG data to a threshold), provide a user interface for expert in-depth analysis to an expert terminal depending on a result of comparing, and obtain expert analysis information (column 19 line 12-18 illustrating providing the threshold results to a classifier for further interpretation [considered to be a form of “expert reading” by the AWS cloud server).
Claim 9: Belle discloses:
wherein the second server, when the prediction value is equal to or larger than the preset threshold (column 4 line 43-53 illustrating comparing the hemodynamic parameter to a threshold to determine stable or unstable condition when the parameter is equal or greater than a stable threshold), is configured to transmit the collaboration request data to the expert terminal and receive the electrocardiogram analysis result data generated by the expert terminal (as discussed above with respect to claim 8, and incorporated here).
Claim 10: Belle discloses:
further comprising:
assigning a user identification information through user authentication during an initial connection process of the user terminal (column 5 line 35-36 illustrating the biosignal detection device assigning a secondary identifier to the patient [considered to be a form of “user authentication”]); and
generating the de-identification information by de-identifying the user identification information in such a manner as to apply a different de-identification code value for each user or each user group (column 7 line 22-30 illustrating mapping patient identifier to a second identifier in manner that the patient would be re-identifiable by mapping back to the original identifier).
Claim 11: Belle discloses:
wherein the second server is configured to, when the electrocardiogram analysis result data includes a prediction result for the abnormality condition, add warning flag data to the electrocardiogram analysis result data (column 16 line 28-45 illustrating flagging the ECG when any number of criteria are not met [considered to be a form of “abnormality diagnosis condition”]).
Claim 12: Belle discloses:
wherein the abnormality condition indicates that the electrocardiogram data includes an abnormal electrocardiogram that deviates from a preset normal reference based on an electrocardiogram characteristic (column 16 line 28-45 illustrating comparing the ECG data to predetermined threshold [considered to be a form of “preset normal reference”]).
Claim 13: Belle discloses:
wherein the first server, when the electrocardiogram analysis result data including the warning flag data is received, is configured to provide a notification service for the electrocardiogram analysis result (column 16 line 28-45 illustrating providing the flagged data to the user for display and review).
Claim 14: Belle discloses:
wherein:
the collaboration request data further includes at least one of biological information (Figure 1 label 110 illustrating a biosignal) and electrocardiogram measurement time (Figure 4 illustrating ECG data plotted over an axis of time measured); and
the electrocardiogram analysis result data includes the de-identification information column 5 line 21-25 illustrating de-identified ECG data).
Claim(s) 15 recite(s) substantially similar limitations as those of claim(s) 1 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Claim 16: Belle discloses:
wherein the electrocardiogram data is obtained by measuring electrocardiograms with a single-lead of a wearable device (column 7 line 6-8 illustrating a lead of an ECG monitor providing ECG data).
Claim(s) 17, 18, 19, 20 recite(s) substantially similar limitations as those of claim(s) 10, 5/6, 9, 14 above, and are therefore rejected for substantially similar rationale as applied above, and incorporated herein.
Response to Arguments
In the Remarks filed on 20 July 2026, Applicant makes numerous arguments. Examiner will address these arguments in the order presented.
On page 11-12 Applicant argues that certain limitations are not practically performed in the human mind.
Examiner submits that some of the argued limitations are part of the additional elements. See above for highlighted abstract idea.
While Applicant’s arguments have been carefully considered, as discussed above and incorporated herein, the highlighted portions may be practically performed in the human mind.
On page 12-13 Applicant argues that the claims provide technical improvement by using neural network to process ECGs.
The argued limitations are directed to the de-identification of patient data, and merely using a generic neural network to identify abnormalities in an ECG without specific technical limitations regarding how the ECG would be processed to determine abnormality.
While Applicant’s arguments have been carefully considered, Applicant’s arguments are not found persuasive because the de-identification of data does not provide any technical improvement to the field of ECG processing (i.e. the claims lack nexus with the argued improvement because the claim merely recites a result of identifying ECG abnormality without any technical processing of the ECG to make the abnormality identification).
On page 14 Applicant argues that the claims provide specific technical component.
While Applicant’s arguments have been carefully considered, see the section above for discussion of the broadest reasonable interpretation of the computer structure as recited. At best, they represent generic computers (i.e. “apply it”) and/or insignificant data transmission, display, and de-identification, as discussed above and incorporated herein.
On page 15-17 Applicant argues that the ordered combination has not been properly considered under Step 2B.
As discussed in the section above, the additional elements have been considered both individually and as ordered combinations, and have not been found to provide significantly more.
On page 18-19 Applicant heavily argues the structure of the claims. It is noted that Applicant does not dispute that the functions are provided by the applied; Applicant merely argues that different structure provides the functions of Belle.
Examiner submits that the structure of Belle is flexible (see at least Figure 11 and accompanying description, Figure 1, column 5 line 12-20, column 39-49).
Accordingly, a user terminal is disclosed by Belle (column 19 line 46-63). Accordingly, Belle discloses that a user can be a health care provider or a patient, and that the terminal can display all the disclosed data to any of the aforementioned user.
While Applicant’s arguments have been carefully considered, they are not found persuasive because the argued structure is fully disclosed by the myriad embodiments of Belle.
Based on the evidence presented above, Applicant’s arguments are not found persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Juhn (20220367044) discloses an ECG interpretation/reading system (Abstract) in a manner similar to those disclosed in the instant pending Specification as originally filed.
Fornwalt (20210151191) discloses processing patient data to generate a diagnosis (Abstract) in a manner similar to those disclosed in the instant pending Specification as originally filed.
THIS ACTION IS MADE FINAL. 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 extension fee 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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/T.N.N./ Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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