DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 05/20/2026, has been entered. Claims 1-17 remain pending in the application. Applicant’s amendment to the claims have overcome the 112 rejections previously set forth in the Non-Final Office Action mailed 02/20/2026.
Response to Arguments
35 USC § 112:
Applicant amended claims and addressed all previous 112 rejections and the previous 112 rejections have been withdrawn.
35 USC § 103:
Applicant’s arguments, see pages 6-8, filed 05/20/2026, with respect to the rejection(s) of claim(s) 1-17 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Simon et al. (US 4577639).
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Independent claims 1, 8, and 14 recite systems for assisting in obtaining ECG waveforms from a patient. Thus, they are directed to statutory categories of invention.
Step 2A, prong 1:
Claims 1, 8, and 14 recite the following claim limitations:
generate an initial analysis based on the ECG waveform;
operate to carry out the recommended action on the patient;
analyze the recorded ECG waveform and the initial analysis;
determine the recommended action based on the recorded ECG waveform and the initial analysis;
determine a recommended action based on at least one of the initially sensed ECG waveform and the initial analysis (claim 8)
These limitations under their broadest reasonable interpretation, cover concepts that can be practically preformed in the human mind. A human, provided ECG data, could observe, evaluate, and analyze the ECG waveform data to determine and operate a recommended action on a patient. Thus, the claims recite limitations which fall within the 'mental processes' grouping of abstract ideas.
Step 2A, prong 2:
Claims 1, 8, and 14 recite the following additional elements:
an ECG recording device;
one or more electrodes configured to detect bioelectric impedance on a patient; (claims 1 and 14)
a measuring device configured to receive raw data from the electrodes and generate an ECG waveform; (claim 1)
a transceiver configured to transmit and receive data; (claims 1 and 14)
an analysis server configured to analyze processed ECG data; (claim 1)
sense an initial ECG waveform from the patient using the ECG recording device in a first lead configuration; (claims 1 and 14)
communicate the recorded ECG waveform and the initial analysis from the recording device to the analysis server; (claim 1)
receive a recommended action from the analysis server; (claim 1)
communicate the recommended action to the recording device (claim 1)
recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
one or more processors (claims 8 and 14)
one or more memory storing instructions (claims 8 and 14)
receive, from a recording device, an initial ECG waveform sensed form the patient using a first lead configuration and an initial analysis of the ECG waveform; (claim 8)
determine a recommended action based on at least one of the initially sensed ECG waveform and the initial analysis; (claim 8)
transmit the recommended action to the recording device; (claim 8)
receive a recommended action from the analysis server based on the initial ECG waveform and the initial analysis (claims 8 and 14)
transmit the initial ECG waveform and the initial analysis to a server (claim 14);
receive a recommended action from the server based on the initial ECG waveform and the initial analysis; (claim 14)
The additional elements of an “ECG recording device”, “electrodes”, “measuring device”, “transceiver” and an “analysis server” merely perform data gathering, transmission, and processing functions. The claims are merely using convention computer components as tools to collect ECG data, analyze, and communicate a recommended action.
The additional element of “sensing a second ECG waveform using a different lead configuration than the first lead configuration” merely performs additional data collection to determine a recommended action.
The recitation of “analysis server” fails to recite any additional element or combination of additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited the analysis server, which upon reference of the specification is a remote server with internal processors (para. 0023), is a conventional component that does not impose any meaningful structural limitations on the apparatus used to implement the judicial exception. Similarly, the recitation of "one or more processors" fails to recite any additional element or combination of additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited the processor, is a conventional component that does not impose any meaningful structural limitations on the apparatus used to implement the judicial exception. The recitation of a processor in the claim does not integrate the judicial exception into a practical application because the claim merely uses the processor as a tool to perform the abstract idea.
The additional elements of “one or more memory storing instructions”, amount to nothing more than functions performed by a generic computer. Merely storing instructions/data in a memory does not integrate a judicial exception into practical application.
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and mere instructions to apply the exception using generic computer components (the processors and analysis server). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to 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 Step 2A Prong 2, the additional elements in the claim amount to no more than insignificant extra solution activity and mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B and does not provide an inventive concept.
The recitation of an analysis server/processor is not sufficient to amount to significantly more than the judicial exception because they are recited at a high level of generality, there is no meaningful limitation, such as a particular or unconventional structure that distinguishes the elements from well-known, routine, and/or conventional elements. Recitation of a processor as a tool to perform the abstract idea does not add significantly more than what is well-known, routine, and/or conventional in view of Alice Corp. Pty. Ltd. V. CLS Bank Int'l, 573 U.S. 208, 223, 110 USPQ2d 1976, 1983 (2014).
For these reasons, there is no inventive concept. The claim is not patent eligible. Even when viewed as a whole, nothing in the claim adds significantly more to the abstract idea.
Dependent claims
Claims 2-3, 9-10, and 15-16 recite limitations that further define the second lead configuration, such as having a different number of leads than the first lead configuration.
Claims 4 and 11 adds the additional element of “machine learning” to compare initial waveforms to previous waveforms. As mentioned above, the recitation of a processor as a tool to perform the abstract idea does not add significantly more than what is well-known, routine, and/or conventional in view of Alice Corp. Pty. Ltd. V. CLS Bank Int'l, 573 U.S. 208, 223, 110 USPQ2d 1976, 1983 (2014).
Claims 5-7 and 12-13 recite limitations that further define the recommended action, such as determining or communicating the recommended action to the recording device or the patient.
Claim 17 adds the limitation of a “display” to display the recommended action, which merely acts as extra-solution activity. Merely displaying results on a display does not integrate a judicial exception into practical application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (US 20160135706 A1), hereinafter Sullivan '706, and in view of Bae et al. (US 20140142448 A1), hereinafter Bae, and in further view of Baumer et al. (US 20230200708 A1), hereinafter Baumer.
Regarding claim 1, Sullivan '706 discloses a system for assisting in obtaining ECG waveforms from a patient (abstract (a system and method for medical premonitory event estimation)) comprising:
an ECG recording device (Fig. 2, element 100) comprising:
one or more electrodes (Fig. 2, element 112) configured to detect bioelectric impedance on a patient;
a measuring device (Fig. 3, element 305) configured to receive raw data from the electrodes and generate an ECG waveform; and
a transceiver (Fig. 5, element 539) configured to transmit and receive data (para. 0260 (user interface pod 140 may communicate wirelessly with the control unit 120, for example, using a Bluetooth… or other type of communication interface));
an analysis server (Fig. 8G, element 8065) configured to analyze processed ECG data (para. 0506 (patient data may be streamed (e.g., in real-time) from the computing device to a server for processing)).
wherein the ECG recording device is programmed to: sense an initial ECG waveform from the patient using the ECG recording device (para. 0295 (medical device 100 can measure data, such as ECG data of the subject 104, and can use the data to estimate the risk of medical events occurring in various time periods)).
generate an initial analysis at the ECG recording device based on the ECG waveform obtained from the patient by the recording device (para. 0364 (single lead QRS morphology metrics can include side-to-side and front-to-back channel similarity scores. In implementations, similarity scores are obtained by comparing QRS complexes to a normal template)).
communicate the recorded ECG waveform from the recording device to the analysis server (para. 0381 (medical device to initiate real-time or substantially real-time streaming of the patient's ECG data 8005 (and/or other physiological data) to a remote server (e.g., arrow 8065) for additional monitoring and analysis)).
Sullivan ‘706 does not teach sensing an initial ECG waveform from the patient using the ECG recording device in a first lead configuration, communicating the initial analysis from the recording device to the analysis server; receive a recommended action from the analysis server; and operate to carry out the recommended action on the patient, wherein the analysis server is programmed to: analyze the recorded ECG waveform and the initial analysis; determine the recommended action, based on the record ECG waveform and the initial analysis, and communicate the recommended action to the recording device, wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
Bae teaches an ECG recording device (Fig. 4, element 410 – ECG sensor unit) comprising:
an analysis server configured to analyze processed ECG data (Fig. 4, element 430 – server);
wherein the ECG recording device (Fig. 4, element 410 – ECG sensor unit) is programmed to:
sense an initial ECG waveform from the patient using the ECG recording device (Fig. 1, element 411 – ECG measuring unit, para. 0047 (the ECG sensor unit 410 measures a normal waveform or an arrhythmia waveform using an ECG measuring unit 411));
generate an initial analysis at the ECG recording device based on the ECG waveform obtained from the patient by the recording device (para. 0048 (whether the measured signal is a normal signal or an abnormal signal may be determined by a primary determining unit 414));
communicate the recorded ECG waveform and the initial analysis from the recording device to the analysis server (para. 0049 (when the measured signal is determined to have an abnormal waveform by the primary determining unit 414, a predetermined interval of the signal may be transmitted to the gateway 420 through a transmitter 413), 0050 (the gateway 420 transmits the abnormal signal to the server 430));
wherein the analysis server is programmed to: analyze the recorded ECG waveform and the initial analysis (para. 0052 (the secondary determining unit 434 determines whether the input abnormal signal actually represents an arrhythmia waveform, based on a feature point and a rhythm of the input abnormal signal));
determine the recommended action based on the recorded ECG waveform and the initial analysis (para. 0054 (if only slight arrhythmia is diagnosed, the medical team 440 may alarm a patient to be careful. The medical team transmits analysis results as feedback by a receiver 423 of the gateway 420, through a receiver 436 and transmitter 437 of the server 430. Additionally, feedback is displayed on the display unit 424 so that the patient may perform the appropriate actions)).
Bae does not teach sensing an initial ECG waveform from the patient using the ECG recording device in a first lead configuration; receive a recommended action from the analysis server; and operate to carry out the recommended action on the patient; communicate the recommended action to the recording device, wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
Baumer teaches an ECG recording device (Fig. 1A, element 102 – portable device) comprising:
one or more electrodes configured to detect bioelectric impedance on a patient (Fig. 1B, element 108 – first electrode, Fig. 1B, element 114 – second electrode);
wherein the ECG recording device is programmed to: sense an initial ECG waveform from the patient using the ECG recording device in a first lead configuration (0025 (electronics subassemblies may further include a processor for analyzing sensed electrical activity of the heart));
receive a recommended action from the analysis server; and operate to carry out the recommended action on the patient (para. 055 (If it is determined that the quality of one or more of the test signal of ECG activity and the test signal of heart sounds activity is not acceptable, then the process proceeds to block 812 where instructions are received at the user device 210 from the server/processor 212 to the user device 210 regarding the positions of the electrodes 108, 114 and repositioning of the portable device 102));
communicate the recommended action to the recording device (para. 0055 (Visual feedback may be provided by the illumination ring 160 of the portable device. Tactile feedback may be provided by a vibration mechanism or haptic transducer 158 of the portable device 102)),
wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration (para. 0055 (If it is determined that the quality of one or more of the test signal of ECG activity and the test signal of heart sounds activity is not acceptable, then the process proceeds to block 812 where instructions are received at the user device 210 from the server/processor 212 to the user device 210 regarding the positions of the electrodes 108, 114 and repositioning of the portable device 102), 0056 (Returning to block 810, if it is determined that the quality of each of the ECG signal and the heart sounds signal is acceptable, then the process proceeds to block 814 where analysis signals of ECG activity and heart sounds activity are captured)).
Sullivan ‘706, Bae, and Baumer are all considered to be analogous to the claimed invention because they are in the same field of systems using leads for ECG analysis. Sullivan ‘706 teaches communicating the recorded ECG waveform from the recording device to the analysis server, but does not teach communicating the initial analysis to the analysis server (Sullivan ‘706, para. 0381). Bae teaches communicating the measured ECG signals and the initial analysis of determining whether the signals are normal or abnormal, and transmits the data to the server (Bae, para. 0047 – 0048). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the listing teachings of Bae, and provide communication of the initial analysis to the analysis server. Doing so would reduce the processing burden of the control unit within Sullivan’s device, by allowing the analysis server to store/analyze the initial analysis, thereby allowing the server to perform extensive analysis of the ECG data.
Similarly, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Bae, and program the analysis server to analyze the recorded ECG waveform and the initial analysis, and determine the recommended action based on the recorded ECG waveform and the initial analysis. Bae teaches an initial analysis of determining whether the measured signals are normal or abnormal, and sending the data to the server (Bae, para. 0047 – 0048). The server analyzes the data with a second determining unit to verify the initial analysis, before reaching the diagnosis (Bae, para. 0052-0054). After determining a recommended action, the medical team transmits analysis results as feedback to the server (Bae, para. 0054). Sullivan teaches determining a recommended action based on the initial analysis, but does so based on the control unit within the wearable medical device (Sullivan ‘706, para. 0514). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Bae listed above, to enable a more advanced analysis using the server. Such a modification would also reduce the processing burden of the control unit within the wearable device.
Sullivan ‘706 does not teach receiving a recommended action from the analysis server and operate to carry out the recommended action on the patient. Baumer teaches receiving a recommended action from the analysis server, of repositioning the electrodes on a user, and carries it out the patient by providing visual or tactile feedback, to allow the user to reposition the electrodes. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Baumer and provide the ECG recording device receiving the recommended action from the analysis server. Doing so prevents the device itself from determining a recommended action, which could cause delay in the device in measuring signals, drain the battery, and cause burden within the control units of the devices.
Baumer teaches communicating the recommended action of repositioning the electrodes to the device, to receive a better signal. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Baumer and communicate the recommended action to the recording device, wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration. Doing so would ensure that the electrodes are able to measure quality signals that can be accurately analyzed.
Regarding claim 4, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 1 as discussed above.
Sullivan ‘706 teaches comparing the initially sensed ECG waveform to previous patient ECG waveforms using machine learning; and generating the recommended action based on machine learning analysis (para. 0300 (computing device may receive the ECG data of the subject, from the wearable medical device and use the data to estimate the risk of medical events occurring in various time periods… processing for determining event estimation of risk scores and/or actions in response thereto, such as operations performed by the machine learning classification system)).
Sullivan ‘706 does not teach wherein the analysis is programmed to determine the recommended action.
Bae teaches wherein the analysis server (Fig. 4, element 430) is programmed to determine the recommended action by: comparing the initially sensed ECG waveform to previous patient ECG waveforms using machine learning (para. 0075 (a secondary determining unit may perform learning of the artificial neural network, using ECG data received from an ECG-MIT-BIH database… of electrocardiography data used to diagnose arrhythmia)); and generating the recommended action based on machine learning analysis (para. 0062 (secondary determining unit of a server, determines whether an abnormal signal indicates arrhythmia using an artificial neural network. Also, a type of arrhythmia of the abnormal signal may be determined)).
Sullivan ‘706 teaches machine learning analysis within the control unit of the wearable device, as opposed to the analysis server. Although Sullivan teaches that the analysis server received real-time of the ECG data for additional monitoring and analysis, it does explicitly disclose what type of analysis is being conducted (Sullivan ‘706, para. 0381). Bae teaches a server that performs the machine learning to determine the recommended action. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Bae and provide machine learning to help the analysis of the recommended action, within the analysis server. Doing so would reduce the processing burden on the control unit within the wearable device, by having the server conduct machine learning analysis, as the analysis server receives ECG data for additional monitoring and analysis.
Regarding claim 5, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 1 as discussed above.
Sullivan ‘706 does not teach wherein the recommended action is communicated to the recording device while the patient is at the recording device.
Bae teaches wherein the recommended action is communicated to the recording device while the patient is at the recording device (para. 0040 (a sensor may measure data for 24 hours. During regular daily activity, generated ECG data may be transmitted in real time to a server 231 through a terminal 230 that uses wireless trans mission technology. The ECG data may be stored in the server 231. Additionally, the server 231 may automatically analyze a state of a patient using the ECG data, and notify a medical team 240 and the patient 210 of emergency information)).
Bae teaches that a sensor, that measures data for 24 hours, can transmit to the sensor real time measurements. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Bae and communicate to the recording device while the patient is at the recording device. Doing so would allow immediate feedback and recommended actions to the user, which improves patient monitoring effectiveness.
Regarding claims 6 and 7, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 1 as discussed above.
Sullivan ‘706 does not teach wherein the recommended action is determined based on previously determined recommended actions associated with the patient.
Baumer teaches wherein the recommended action is determined based on previously determined recommended actions associated with the patient (para. 0053 (At block 808, test signals corresponding to sensed ECG activity and sensed heart sounds activity are captured), 0054 (At block 810, a determination is made regarding proper locating of the second electrode 114 on the chest and the quality of the ECG activity signal and the heart sounds activity signal), 0055 (If it is determined that the quality of one or more of the test signal of ECG activity and the test signal of heart sounds activity is not acceptable, then the process proceeds to block 812 where instructions are received… the process then returns to block 808 where another set of test signals of ECG activity and heart sounds activity are captured after the position of the suspension structure 110 and the second electrode 114 are adjusted), 0056 (if it is determined that the quality of each of the ECG signal and the heart sounds signal is acceptable, then the process proceeds to block 814 where analysis signals of ECG activity and heart sounds activity are captured)).
Baumer teaches if the server determines that the quality of an ECG signal is not acceptable, then the recommended action is to reposition the electrodes, before measuring the signals again, to ensure that the signal quality is acceptable. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Baumer and determine a recommended action based on previously determined recommended actions associated with the patient. Doing so allows the system to ensure that the recommended action is accurate within the patient, and that the measured signals have good quality.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan ‘706 and in view of Bae and in further view of Baumer and Simon et al. (US 4577639), hereinafter Simon.
Regarding claim 2, Sullivan ‘706 (in view of Bae and Baumer) teaches the system comprising the features of claim 1 as discussed above.
Sullivan ‘706 does not teach wherein the different lead configuration comprises a configuration having different leads than the first lead configuration.
Simon teaches wherein the different lead configuration comprises a configuration having different leads than the first lead configuration (col. 1, lines 59-63 (In response to the detection and identification of the lead failure processor means coupled to the switch controlled ECG signal preprocessor automatically changes the lead configuration to continue ECG monitoring when possible)).
Sullivan ‘706, Bae, Baumer, and Simon are all considered to be analogous to the claimed invention because they are in the same field of systems using leads for ECG analysis. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan ‘706 to incorporate the teachings of Simon and provide a different lead configuration having different leads than the first lead configuration. Doing so would provide continuous heart activity monitoring despite possible lead failures by using different lead configurations.
Regarding claim 3, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 1 as discussed above.
Sullivan ‘706 does not teach wherein the different lead configuration comprises a configuration having a different amount of leads than the first lead configuration.
Simon teaches wherein the different lead configuration comprises a configuration having a different amount of leads than the first lead configuration (col. 1, lines 59-63 (In response to the detection and identification of the lead failure processor means coupled to the switch controlled ECG signal preprocessor automatically changes the lead configuration to continue ECG monitoring when possible), col. 2, lines 31-34 (The number of leads 102 can vary depending on the configuration selected with typical configurations employing three, five and sometimes twelve leads)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan ‘706 to incorporate the teachings of Simon and provide a different amount of leads than the first lead configuration. Simon teaches a different amount of possible lead configurations so it would have been obvious to incorporate it within Sullivan’s system to allow a more thorough analysis of the heart (col. 2, lines 27-34). Selection from a different amount of possible leads would have been a predictable modification to ensure that system is able to maintain continuous monitoring when a lead become unavailable.
Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan '706, and in view of Simon.
Regarding claim 8, Sullivan ‘706 teaches a system for assisting in obtaining ECG waveforms from a patient (abstract (a system and method for medical premonitory event estimation)), comprising:
one or more processors (para. 0261 (control unit includes at least one processor));
one or more memory storing instructions (para. 0267 (memory unit may be coupled to the control unit));
wherein the one or more processors are configured to execute the instructions to:
receive, from a recording device, an initial ECG waveform sensed from the patient using an initial analysis of the ECG waveform (para. 0295 (medical device 100 can measure data, such as ECG data of the subject 104, and can use the data to estimate the risk of medical events occurring in various time periods));
determine a recommended action based on at least one of the initially sensed ECG waveform and the initial analysis (para. 0513 (control unit 120 compares the event estimation of risk scores for each of the calculated time-until-event periods to stored event estimation of risk thresholds. The comparison provides information which is used by the control unit 120 to determine a recommended treatment plan or course of action)); and
transmit the recommended action to the recording device (para. 0514 (If an action or alarm is recommended, the wearable medical device initiates the appropriate action and/or alarm at stage 1710 and processing returns to stage 1702 for the wearable medical device 100 to monitor the subject));
Sullivan ‘706 does not teach a first lead configuration waveform and wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
Simon teaches a system (Fig. 1, element 100) for assisting in obtaining ECG waveforms from a patient, comprising:
one or more processors (col. 2, lines 63-64 (CPU may comprise one or more microprocessors));
receive, from a recording device, an initial ECG waveform sensed from the patient using a first lead configuration and an initial analysis of the ECG waveform (Fig. 1, element 102, col. 2, lines 27-34 (leads from the electrodes placed on a patient are coupled to a lead fail detector means… number of leads can vary depending on the configuration selected with typical configurations employing three, five and sometimes twelve leads), col. 6, lines 15-16 (existing lead configuration selected));
determine a recommended action based on at least one of the initially sensed ECG waveforms and the initial analysis (abstract (CPU automatically selects an ECG lead configuration in which all electrodes are attached to the patient and are below an impedance threshold), col. 4, lines 59-61 (detector circuit 104 provides a means for determining the status of each of the ECG leads and a means for identifying those leads which fail)); and
transmit the recommended action to the recording device (col. 5, lines 3-5 (CPU periodically checks the lead fail flags from circuit 104), col. 5, lines 7-8 (if only one lead has failed the CPU performs an ALS (automatic lead switching) evaluation), col. 6, lines 15-24 (based on the existing lead configuration selected and the identity of the bad lead detected the CPU takes the action… to switch to another lead configuration the CPU commands the switch circuit 202 to switch the necessary lead inputs to the analog circuit 204));
wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration (col. 1, lines 59-63 (In response to the detection and identification of the lead failure processor means coupled to the switch controlled ECG signal preprocessor automatically changes the lead configuration to continue ECG monitoring when possible)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s system to incorporate the teachings of Simon and provide a first and second lead configuration in response to a recommended action. Simon teaches identifying lead failures and changing lead configurations when a lead failure is detected. Applying Simon’s teaching to Sullivan’s system would improve the system by allowing the system to continue monitoring the ECG waveforms even if a lead fails. The switching mechanism taught by Simon, allows the system to switch to a second configuration in response to a recommended action by the CPU, allowing for continuous monitoring.
Regarding claim 9, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 8 as discussed above.
Sullivan ‘706 does not teach wherein the different lead configuration comprises a configuration having different leads than the first lead configuration.
Simon teaches wherein the different lead configuration comprises a configuration having different leads than the first lead configuration (col. 1, lines 59-63 (In response to the detection and identification of the lead failure processor means coupled to the switch controlled ECG signal preprocessor automatically changes the lead configuration to continue ECG monitoring when possible)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan ‘706 to incorporate the teachings of Simon and provide a different lead configuration having different leads than the first lead configuration. Doing so would provide continuous heart activity monitoring despite possible lead failures by using different lead configurations.
Regarding claim 10, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 8 as discussed above.
Sullivan ‘706 does not teach wherein the different lead configuration comprises a configuration having a different amount of leads than the first lead configuration.
Simon teaches wherein the different lead configuration comprises a configuration having a different amount of leads than the first lead configuration (col. 1, lines 59-63 (In response to the detection and identification of the lead failure processor means coupled to the switch controlled ECG signal preprocessor automatically changes the lead configuration to continue ECG monitoring when possible), col. 2, lines 31-34 (The number of leads 102 can vary depending on the configuration selected with typical configurations employing three, five and sometimes twelve leads)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan ‘706 to incorporate the teachings of Simon and provide a different amount of leads than the first lead configuration. Simon teaches a different amount of possible lead configurations so it would have been obvious to incorporate it within Sullivan’s system to allow a more thorough analysis of the heart (col. 2, lines 27-34). Selection from a different amount of possible leads would have been a predictable modification to ensure that system is able to maintain continuous monitoring when a lead become unavailable.
Regarding claim 11, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 8 as discussed above.
Sullivan ‘706 further discloses wherein the one or more processors are configured to execute the instructions to determine the recommended action by:
utilizing machine learning to compare the initially sensed ECG waveform to previous patient ECG waveforms; and generating the recommended action based on machine learning analysis (para. 0300 (computing device may receive the ECG data of the subject, from the wearable medical device and use the data to estimate the risk of medical events occurring in various time periods… processing for determining event estimation of risk scores and/or actions in response thereto, such as operations performed by the machine learning classification system)).
Regarding claim 12, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 8 as discussed above.
Sullivan ‘706 further discloses wherein the recommended action is communicated to the recording device while the patient is at the recording device (para. 0513 (control unit compares the event estimation of risk scores for each of the calculated time-until-event periods to stored event estimation of risk thresholds… to determine a recommended treatment plan or course of action)).
Regarding claim 13, Sullivan ‘706 (in view of Simon) teaches the system comprising the features of claim 8 as discussed above.
Sullivan ‘706 further discloses wherein the recommended action is determined based on previously determined recommended actions (para. 0513 (control unit compares the event estimation of risk scores for each of the calculated time-until-event periods to stored event estimation of risk thresholds… to determine a recommended treatment plan or course of action)).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan ‘706 and in view of Bae and in further view of Simon.
Regarding claim 14, Sullivan ‘706 teaches a ECG recording system for assisting in obtaining ECG waveforms from a patient (abstract (a system and method for medical premonitory event estimation)), comprising:
one or more processors (para. 0261 (control unit includes at least one processor));
one or more memory storing instructions (para. 0267 (memory unit may be coupled to the control unit));
one or more electrodes configured to detect bioelectric impedance (Fig. 2, element 112);
a transceiver configured to receive and transmit data (Fig. 5, element 539, para. 0260 (user interface pod 140 may communicate wirelessly with the control unit 120, for example, using a Bluetooth… or other type of communication interface));
wherein the one or more processors are configured to execute the instructions to:
sense an initial ECG waveform from the patient using the one or more electrodes (para. 0295 (medical device 100 can measure data, such as ECG data of the subject 104, and can use the data to estimate the risk of medical events occurring in various time periods));
generate an initial analysis based on the initial ECG waveform (para. 0364 (single lead QRS morphology metrics can include side-to-side and front-to-back channel similarity scores. In implementations, similarity scores are obtained by comparing QRS complexes to a normal template));
transmit the initial ECG waveform to a server (para. 0381 (medical device to initiate real-time or substantially real-time streaming of the patient's ECG data 8005 (and/or other physiological data) to a remote server (e.g., arrow 8065) for additional monitoring and analysis)); and
Sullivan ‘706 does not teach sensing an initial ECG waveform from the patient using the one or more electrodes in a first lead configuration; transmitting the initial analysis to a server; receive a recommended action from the server based on the initial ECG waveform and the initial analysis, wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
Bae teaches transmitting the initial analysis to a server (para. 0048 (whether the measured signal is a normal signal or an abnormal signal may be determined by a primary determining unit 414), 0049 (when the measured signal is determined to have an abnormal waveform by the primary determining unit 414, a predetermined interval of the signal may be transmitted to the gateway 420 through a transmitter 413), 0050 (the gateway 420 transmits the abnormal signal to the server 430));
receive a recommended action from the server based on the initial ECG waveform and the initial analysis wherein the analysis server is programmed to: analyze the recorded ECG waveform and the initial analysis (para. 0052 (the secondary determining unit 434 determines whether the input abnormal signal actually represents an arrhythmia waveform, based on a feature point and a rhythm of the input abnormal signal), 0054 (if only slight arrhythmia is diagnosed, the medical team 440 may alarm a patient to be careful. The medical team transmits analysis results as feedback by a receiver 423 of the gateway 420, through a receiver 436 and transmitter 437 of the server 430. Additionally, feedback is displayed on the display unit 424 so that the patient may perform the appropriate actions)).
Bae does not teach sensing an initial ECG waveform from the patient using the one or more electrodes in a first lead configuration and wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration.
Simon teaches an ECG recording system (Fig. 1, element 100) for assisting in obtaining ECG waveforms from a patient, comprising:
one or more processors (col. 2, lines 63-64 (CPU may comprise one or more microprocessors));
one or more electrodes (Fig. 1, element 102) configured to detect bioelectric impedance;
wherein the one or more processors sense an initial ECG waveform from the patient using the one or more electrodes in a first lead configuration (Fig. 1, element 102, col. 2, lines 27-34 (leads from the electrodes placed on a patient are coupled to a lead fail detector means… number of leads can vary depending on the configuration selected with typical configurations employing three, five and sometimes twelve leads), col. 6, lines 15-16 (existing lead configuration selected));
generate an initial analysis based on the initial ECG waveform (abstract (CPU automatically selects an ECG lead configuration in which all electrodes are attached to the patient and are below an impedance threshold), col. 4, lines 59-61 (detector circuit 104 provides a means for determining the status of each of the ECG leads and a means for identifying those leads which fail));
transmit the initial ECG waveform and the initial analysis to a server (col. 5, lines 3-5 (CPU periodically checks the lead fail flags from circuit 104)); and
receive a recommended action from the server based on the initial ECG waveform and the initial analysis (col. 5, lines 7-8 (if only one lead has failed the CPU performs an ALS (automatic lead switching) evaluation), col. 6, lines 15-24 (based on the existing lead configuration selected and the identity of the bad lead detected the CPU takes the action… to switch to another lead configuration the CPU commands the switch circuit 202 to switch the necessary lead inputs to the analog circuit 204));
wherein the recommended action comprises sensing a second ECG waveform using a different lead configuration than the first lead configuration (col. 1, lines 59-63 (In response to the detection and identification of the lead failure processor means coupled to the switch controlled ECG signal preprocessor automatically changes the lead configuration to continue ECG monitoring when possible)).
Sullivan ‘706 teaches communicating the recorded ECG waveform from the recording device to the analysis server, but does not teach communicating the initial analysis to the analysis server (Sullivan ‘706, para. 0381). Bae teaches communicating the measured ECG signals and the initial analysis of determining whether the signals are normal or abnormal, and transmits the data to the server (Bae, para. 0047 – 0048). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Bae, and provide communication of the initial analysis to the analysis server. Doing so would reduce the resource usage of Sullivan’s device, by allowing the analysis server to store/analyze the initial analysis, as opposed to the control unit within the wearable device.
Similarly, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Bae, and program the analysis server to analyze the recorded ECG waveform and the initial analysis, and determine the recommended action based on the recorded ECG waveform and the initial analysis. Bae teaches an initial analysis of determining whether the measured signals are normal or abnormal, and sending the data to the server (Bae, para. 0047 – 0048). The server analyzes the data with a second determining unit to verify the initial analysis, before reaching the diagnosis (Bae, para. 0052-0054). After determining a recommended action, the medical team transmits analysis results as feedback to the server (Bae, para. 0054). Sullivan teaches determining a recommended action based on the initial analysis, but does so based on the control unit within the wearable medical device (Sullivan ‘706, para. 0514). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s device to incorporate the teachings of Bae listed above, to enable a more advanced analysis using the server. Such a modification would also reduce the processing burden of the control unit within the wearable device.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s system to incorporate the teachings of Simon and provide a first and second lead configuration in respond to a recommended action. Doing so would improve Sullivan’s system by allowing continuous monitoring of the ECG waveforms even if a lead fails. The switching mechanism taught by Simon, allows the system to switch to a second configuration in response to a recommended action by the CPU, allowing for continuous monitoring.
Regarding claim 15, Sullivan ‘706 (in view of Bae and Simon) teaches the system comprising the features of claim 14 as discussed above.
Sullivan ‘706 does not teach wherein the different lead configuration comprises a configuration having different leads than the first lead configuration.
Simon teaches wherein the different lead configuration comprises a configuration having different leads than the first lead configuration (col. 1, lines 59-63 (In response to the detection and identification of the lead failure processor means coupled to the switch controlled ECG signal preprocessor automatically changes the lead configuration to continue ECG monitoring when possible)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan ‘706 to incorporate the teachings of Simon and provide a different lead configuration having different leads than the first lead configuration. Doing so would provides continuous heart activity monitoring despite possible lead failures by using different lead configurations.
Regarding claim 16, Sullivan ‘706 (in view of Bae and Simon) teaches the system comprising the features of claim 14 as discussed above.
Sullivan ‘706 does not teach wherein the different lead configuration comprises a configuration having a different amount of leads than the first lead configuration.
Simon teaches wherein the different lead configuration comprises a configuration having a different amount of leads than the first lead configuration (col. 1, lines 59-63 (In response to the detection and identification of the lead failure processor means coupled to the switch controlled ECG signal preprocessor automatically changes the lead configuration to continue ECG monitoring when possible), col. 2, lines 31-34 (The number of leads 102 can vary depending on the configuration selected with typical configurations employing three, five and sometimes twelve leads)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan ‘706 to incorporate the teachings of Simon and provide a different amount of leads than the first lead configuration. Simon teaches a different amount of possible lead configurations so it would have been obvious to incorporate it within Sullivan’s system to allow a more thorough analysis of the heart (col. 2, lines 27-34). Selection from a different amount of possible leads would have been a predictable modification to ensure that system is able to maintain continuous monitoring when a lead become unavailable.
Regarding claim 17, Sullivan ‘706 (in view of Bae and Simon) teaches the system comprising the features of claim 14 as discussed above.
Sullivan ‘706 further discloses wherein the one or more processors are configured to execute the instructions to control a display to display information corresponding to the recommended action (para. 0266 (medical support device may include a pacing unit or a monitoring device that records health related information from a subject, such as information about the subject's respiration rate or heart activity), 0267 (medical support device includes at least one control unit including one or more processors that controls operation of the medical support device)).
Sullivan ‘706 does not teach a display to display information corresponding to the recommended action.
Bae teaches a display to display information corresponding to the recommended action (para. 0050 (gateway 420 displays a waveform on a display unit 424 to notify a user of the occurrence of an abnormality), 0054 (feedback is displayed on the display unit 424 so that the patient may perform the appropriate actions)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sullivan’s monitoring device to incorporate the teachings of Bae and display information relating to the recommended action. Doing so would immediately inform the user of a possible arrhythmia status, and inform them of what to do next in a visual method.
Conclusion
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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