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 .
Priority
Acknowledgment is made of Applicant's claim for priority to the following application(s):
* PCT/KR2023/006146 filed on 04 May 2023
* 10-2022-0079030 filed 28 June 2022
* 10-2023-0048239 filed 1 April 2023
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on the following date(s) is/are entered and considered by Examiner:
* 16 December 2024
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) 1-15 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:
a user terminal configured to generate electrocardiogram data for a user based on user input, to make an electrocardiogram reading request, and to view electrocardiogram reading result data for the electrocardiogram data;
a first server configured to receive the electrocardiogram data, to generate de-identification information by using a de-identification code value for user de-identification processing for the electrocardiogram data, and to provide collaboration request data including the generated de-identification information and the electrocardiogram data; and
a second server configured to receive the collaboration request data, and to generate electrocardiogram reading result data for the electrocardiogram data based on the collaboration request data by using a pre-trained neural network model;
wherein the first server receives the electrocardiogram reading result data from the second server, identifies the user by decrypting the de-identification information using the de-identification code value, and stores the identified user and the electrocardiogram reading result data in association with each other.
Claim interpretation:
While the claim recites various limitations “configured to” perform certain functions, the claims are not treated under Section 112(f) because the limitations provide adequate structure for performing the recited functionalities, e.g. a user terminal provides sufficient structure to process data in the manner recited.
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:
a user terminal configured to view electrocardiogram reading result data for the electrocardiogram data;
a first server configured to receive the electrocardiogram data; and
a second server configured to receive the collaboration request data, by using a pre-trained neural network model;
wherein the first server receives the electrocardiogram reading result data from the second server, identifies the user by decrypting the de-identification information using the de-identification code value, and stores the identified user and the electrocardiogram reading result data in association with each other.
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 (such as claim(s) 2 reciting a user interface, additional limitation(s) which add(s) insignificant extra-solution activity to the abstract idea).
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 (such as claim(s) 2 reciting a user interface, Belle discloses a display interface in a manner that would be WURC in the pertinent arts (column 6 line 9-18)). MPEP 2106.05(d)(II)(ii))
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 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 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) 1-15 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:
a user terminal (Figure 1 label 110 illustrating a biosignal detection device) configured to generate electrocardiogram data for a user based on user input (column 2 line 58-63 illustrating generating ECG data from a user’s input), to make an electrocardiogram reading request (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), and to view electrocardiogram reading result data for the electrocardiogram data (Figure 1 label 50 illustrating viewing the results of an ECG interpretation, considered to be part of the claimed user terminal as a single embodiment as illustrated by Figure 1);
a first server (column 2 line 58-63 illustrating an intermediary device) configured to receive the electrocardiogram data (Figure 1 label 130 illustrating the intermediary device capable of receiving ECG data from the biosignal detection device), to generate 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), and to provide collaboration request data including the generated de-identification information and the electrocardiogram data (column 5 line 21-25 illustrating providing de-identified ECG data for interpretation); and
a second server (Figure 1 label 120 illustrating a cloud server) configured to receive the collaboration request data (column 5 line 21-25 illustrating the cloud server receiving ECG data for interpretation), and to generate electrocardiogram reading result data for the electrocardiogram data based on the collaboration request data by using a pre-trained neural network model (column 18 line 23-25 illustrating processing ECG data using a trained neural network);
wherein the first server receives the electrocardiogram reading result data from the second server, identifies the user by decrypting the de-identification information using the de-identification code value, and stores the identified user and the electrocardiogram reading result data in association with each other (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).
Claim 2: Belle discloses:
The system of claim 1, as discussed above and incorporated herein.
Belle further discloses:
wherein:
the first server provides the electrocardiogram reading result data as a primary reading result to the user terminal, and, in response to a secondary reading request from the user terminal, obtains expert reading information from an expert terminal for expert in-depth reading through communication with the second server and provides a secondary reading result including the expert reading information 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”]); and
the second server provides a user interface for expert in-depth reading to the expert terminal, obtains expert reading information from the expert terminal, and provides the expert reading information to the first server (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”]).
Claim 3: Belle discloses:
The system of claim 1, as discussed above and incorporated herein.
Belle further discloses:
wherein:
the electrocardiogram reading result data primarily provided to the user terminal includes at least one of whether there is a disease and disease likelihood score related to the disease that are obtained by the 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 reading result data provided by the expert in-depth reading includes expert reading 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:
The system of claim 1, as discussed above and incorporated herein.
Belle further discloses:
wherein the second server obtains the electrocardiogram reading result data generated by the neural network model as a primary reading result, provides a user interface for expert in-depth reading to the expert terminal, obtains expert reading information as a secondary reading result from the expert terminal, and then generates final electrocardiogram reading result data based on the primary reading result and the secondary reading result (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:
The system of claim 1, as discussed above and incorporated herein.
Belle further discloses:
wherein the second server determines whether the electrocardiogram data included in the collaboration request data is readable by the neural network model, provides a user interface for expert in-depth reading to the expert terminal depending on whether the electrocardiogram data is readable (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:
The system of claim 5, as discussed above and incorporated herein.
Belle further discloses:
wherein the second server, when the electrocardiogram data included in the collaboration request data is not readable by the neural network model (column 11 line 42-43 illustrating determining that the ECG contains noise [considered to be “not readable”]), transmits the collaboration request data to the expert terminal and receives electrocardiogram reading 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:
The system of claim 1, as discussed above and incorporated herein.
Belle further discloses:
wherein the second server, when the electrocardiogram reading result data includes information indicating that the user is in an emergency state, provides a user interface for expert in-depth reading to the expert terminal and then receives expert reading information from the expert terminal (column 2 line 65 to column 3 line 3 illustrating providing emergency interpretation to patients located in an emergency department).
Claim 8: Belle discloses:
The system of claim 1, as discussed above and incorporated herein.
Belle further discloses:
wherein the second server compares a prediction value for a likelihood of a disease included in the electrocardiogram reading result data with a preset threshold (column 19 line 8-18 illustrating comparing the ECG data to a threshold), provides a user interface for expert in-depth reading to the expert terminal depending on a result of the comparison, and obtains expert reading 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:
The system of claim 8, as discussed above and incorporated herein.
Belle further discloses:
wherein the second server, when the prediction value is equal to or larger than the preset threshold value (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), transmits the collaboration request data to the expert terminal and receives the electrocardiogram reading result data generated by the expert terminal (as discussed above with respect to claim 8, and incorporated here).
Claim 10: Belle discloses:
The system of claim 8, as discussed above and incorporated herein.
Belle further discloses:
wherein the first server:
assigns 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 random identifier to the patient [considered to be a form of “user authentication”]); and
generates the de-identification information by de-identifying user identification information in such a manner as to apply a different de-identification code value for each user or each user group (as discussed above with respect to claim 1, and incorporated herein, Belle disclosing randomizing the patient’s identifier).
Claim 11: Belle discloses:
The system of claim 1, as discussed above and incorporated herein.
Belle further discloses:
wherein the second server, when the electrocardiogram reading result data includes a prediction result for a preset electrocardiogram abnormality diagnosis condition, adds warning flag data adapted to provide notification of an electrocardiogram abnormality state to the electrocardiogram reading 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:
The system of claim 11, as discussed above and incorporated herein.
Belle further discloses:
wherein the electrocardiogram abnormality diagnosis condition means that there is obtained 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:
The system of claim 11, as discussed above and incorporated herein.
Belle further discloses:
wherein the first server, when the electrocardiogram reading result data with the warning flag data added thereto is received, provides a notification service for the electrocardiogram reading result data to the user terminal (column 16 line 28-45 illustrating providing the flagged data to the user for display and review),
Claim 14: Belle discloses:
The system of claim 1, as discussed above and incorporated herein.
Belle further 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 reading result data includes the de-identification information and the electrocardiogram reading 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.
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.
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/T.N.N./ Examiner, Art Unit 3685 /KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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