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 .
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 234-253 are rejected under 35 U.S.C. 101 because of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, claims 234-253 recite apparatuses.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites at least one neural network, wherein the at least one neural network is trained based on a historical collection of a plurality of ECG signal portions with annotation data (observing and analyzing data), wherein the at least one neural network is further trained based on weight data for the annotation data of the plurality of ECG signal portions (observing and analyzing data), and monitor the at least one ECG signal to detect at least one arrhythmia event based on the arrhythmia classifier (making determinations/evaluations/judgments). These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims recite an ECG device with leads, a non-transitory computer, and a processor. These elements are recited at a high level of generality and is recited as performing generic computer functions. i.e., data processing and display. The neural network amounts to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. The collection of data using a generic ECG device and communication of the arrhythmia event are merely insignificant extrasolution activities of necessary data gathering and outputting (see MPEP 2106.05(g)).
The dependent claims do not add any significant elements to integrate the abstract idea into a practical application. Therefore, they are also rejected.
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception? NO, The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 234-253 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 234-253, it is unclear what is meant by “atypical”. The specification does not provide enough explanation as to what makes all the elements “atypical”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 234, 238-244 and 246-253 is/are rejected under 35 U.S.C. 103 as being unpatentable over Szabados (US 11,083,371 B1) in view of Weinstein (US 2021/0121090 A1).
Regarding claims 234 and 244, Szabados discloses a wearable electrocardiogram (ECG) lead arrhythmia monitoring system for identifying arrhythmias experienced by a patient (eg. Col. 1, Ln. 44-61, Col. 17, Ln. 42-Col. 18, Ln. 2, Fig. 12-14), comprising: an external wearable heart monitoring device configured for continuous and long-term monitoring (eg. Fig. 1, 9, Col. 11, Ln. 35-52) of the patient comprising: a plurality of ECG electrodes and associated circuitry configured to sense surface ECG activity of the patient, wherein the plurality of ECG electrodes and associated circuitry are configured to provide at least one ECG channel producing at least one ECG signal for the patient (eg. Col. 12, Ln. 65- Col. 13, Ln. 16, Col. 14, Ln. 10-18, claim 1); and a non-transitory computer-readable medium comprising an arrhythmia classifier comprising at least one neural network (Eg. Col. 2, Ln. 20-25), wherein the at least one neural network is trained based on a historical collection of a plurality of ECG signal portions with annotation data (eg. Col. 6, Ln. 35- Col. 10, Ln. 5, Col. 23, Ln. 23-Col. 29, Ln. 28 trained data from different periods), the annotation data comprising at least one respective annotation for each respective ECG signal portion of the plurality of ECG signal portions (eg. Col. 23, Ln. 23 – Col. 24, Ln. 45, Col. 31 Ln. 31) and wherein the at least one neural network is further trained based on weight data for the annotation data of the plurality of ECG signal portions (eg. Col. 6, Ln. 35- Col. 10, Ln. 5, Col. 23, Ln. 23-Col. 29, Ln. 28), the weight data comprising a respective weight for each respective annotation based on a respective annotator of the respective annotation; and at least one processor operatively connected to the at least one ECG channel and the non-transitory computer-readable medium (eg. Col. 6, Ln. 35- Col. 10, Ln. 5, Col. 23, Ln. 23-Col. 29, Ln. 28), the at least one processor configured to: receive the at least one ECG signal of the at least one ECG channel (eg. Col. 37, Ln. 20-49); monitor the at least one ECG signal to detect at least one arrhythmia event based on the arrhythmia classifier (eg. Col. 22, Ln. 59-Col. 26, Ln. 34, Col. 30, Ln. 62-Col. 31, Ln. 24); and transmit at least one communication based on the at least one arrhythmia event to a remote computer system (eg. Col. 20, Ln. 25-Col. 22, Ln. 2, Col. 25, Ln. 15-46, Col. 37, Ln. 9-21, Col. 38, Ln. 66-Col. 43, Ln. 14). Szabados does not specifically teach training weights on each respective annotation.
Weinstein teaches an ECG device that trains arrhythmia type classifiers with weighted annotations for respective ECG signal portions (eg. Para. 101, 145, 185, 189, 209, 252, 297, 301, 375, 379).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Szabados with the training of weighted annotated ECG signal portions as taught by Weinstein to provide the predictable result of improving the neural network to reduce error rates.
Regarding claims 238 and 246, the combined invention of Szabado and Weinstein discloses each ECG electrode is configured to be anatomically located on the patient's thorax superior to the patient's xiphoid process and lateral to the patient's sternum, in an uninhibiting manner so as to allow for the patient to be ambulatory, wherein the at least one ECG channel comprises at least one atypical ECG channel and the at least one ECG signal comprises at least one atypical ECG signal (eg. Szabado, Fig. 9 and Weinstein Fig, 9E and associated paragraphs).
Regarding claim 239, the combined invention of Szabado and Weinstein discloses the external wearable heart monitoring device comprises a single adhesive patch (eg. Szabado, Fig. 9 and Weinstein Fig, 9E and associated paragraphs).
Regarding claims 240 and 247, the combined invention of Szabado and Weinstein discloses the respective weight for each respective annotator is based on a respective skill level of the respective annotator (eg. Weinstein, Para. 101, 145, 185, 189, 209, 252, 297, 301, 375, 379).
Regarding claims 241 and 248, the combined invention of Szabado and Weinstein discloses, the respective skill level for each respective annotator comprises a skill score, wherein the skill score comprises one of: an integer value from one to four; an integer value from one to five; an integer value from one to ten; an integer value from one to 100; one of 25, 50, 75, or 100; or a value from zero to one (eg. Weinstein, Para. 101, 145, 185, 189, 209, 252, 297, 301, 375, 379).
Regarding claim 242 and 249, the combined invention of Szabado and Weinstein discloses the remote computer system is configured to: receive a plurality of skill scores comprising a respective skill score for each respective annotator, wherein a plurality of annotators comprises each respective annotator; determine the respective weight for each respective annotator based on the plurality of skill scores; receive the historical collection of the plurality of ECG signal portions with the annotation data; and train the arrhythmia classifier based on the historical collection of the plurality of ECG signal portions with the annotation data and based on the weight data (eg. Weinstein, Para. 96, 101, 145, 151, 185, 189, 206, 209, 252, 260, 297, 301, 344, 375, 379).
Regarding claim 243 and 250-251, the combined invention of Szabado and Weinstein discloses the at least one communication comprises at least one further ECG signal portion associated with the at least one arrhythmia event; wherein the remote computer system is further configured to: receive the at least one communication comprising the at least one further ECG signal portion; receive further annotation data associated with the at least one further ECG signal portion from at least one annotator of the plurality of annotators; compare the further annotation data to the at least one arrhythmia event detected based on the arrhythmia classifier; determine an updated weight for each respective annotator of the at least one annotator based on comparing the further annotation data to the at least one arrhythmia event; and retrain the arrhythmia classifier based on the at least one further ECG signal portion, the further annotation data, and the updated weight data (eg. Weinstein, Para. 78 test performance of classifiers, 96, 101, 145, 151, 185, 189, 206, 209, 252, 260, 297, 301, 344, 375, 379).
Regarding claim 252, the combined invention of Szabado and Weinstein discloses training the arrhythmia classifier comprises: adjusting the respective weight for each of at least one annotator of the plurality of annotators based on a hyperparameter tuning process, wherein the respective skill score for each respective annotator of the plurality of annotators comprises an initial skill score, wherein the respective weight for each respective annotator comprises an initial weight, wherein the historical collection of the plurality of atypical ECG signal portions with the annotation data comprises a training subset of the plurality of atypical ECG signal portions and a validation subset of the plurality of atypical ECG signal portions, wherein the respective weight for each of the at least one annotator comprises a hyperparameter and an initial value of the hyperparameter comprises the initial weight, and wherein the hyperparameter tuning process comprises: training the arrhythmia classifier based on the training subset and the initial value of the hyperparameter; determining a metric associated with the initial value of the hyperparameter based on the validation subset; adjusting a value of the hyperparameter to provide an adjusted value of the hyperparameter; retraining the arrhythmia classifier based on the training subset and the adjusted value of the hyperparameter; and determining the metric associated with the adjusted value of the hyperparameter based on the validation subset (eg. Weinstein, Para. 78, 96-103. 118, 137, 140, 145, 151-153, 185, 189, 206-213, 246-247, 252, 260-262, 297, 301, 315, 344-346, 375).
Regarding claim 253, the combined invention of Szabado and Weinstein discloses the hyperparameter tuning process further comprises repeating adjusting of the value of the hyperparameter, retraining of the arrhythmia classifier, and determining of the metric associated with the adjusted value of the hyperparameter until a termination condition is satisfied, wherein repeating adjusting of the value of the hyperparameter, retraining of the arrhythmia classifier, and determining of the metric associated with the adjusted value of the hyperparameter until the termination condition is satisfied comprises repeating adjusting of the value of the hyperparameter, retraining of the arrhythmia classifier, and determining of the metric associated with the adjusted value of the hyperparameter until at least one of: a value of the hyperparameter that optimizes the metric is found; a maximum number of iterations is reached; or any combination thereof. (eg. Weinstein, Para. 78, 96-103. 118, 137, 140, 145, 151-153, 185, 189, 206-213, 246-247, 252, 260-262, 297, 301, 315, 344-346, 375).
Claim(s) 235-236 and 245 is/are rejected under 35 U.S.C. 103 as being unpatentable over Szabados (US 11,083,371 B1) in view of Weinstein (US 2021/0121090 A1), further in view of Bort (US 2022/0344025 A1).
Regarding claim 235-236 and 245, the combined invention of Szabados and Weinstein discloses the invention of claim 234, but does not disclose the plurality of ECG electrodes comprises at least three ECG electrodes, wherein the at least three ECG electrodes comprise a right arm (RA) EGG electrode, a left arm (LA) ECG electrode, and a left leg (LL) ECG electrode, wherein the at least one ECG channel comprises a lead I channel between the RA ECG electrode and the LA ECG electrode, a lead II channel between the RCA ECG electrode and the LL ECG electrode, and a lead III channel between the LA ECG electrode and the LL ECG electrode.
Bort teaches a wearable ECG patch system that uses a right arm, left arm, and left leg (eg. Fig. 3A-B, Para. 119-121).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Szabados and Weinstein with the ECG lead configuration as taught by Bort as a three lead electrode system using the arms and left leg are a common configuration used in the art for ECG monitoring.
Regarding claim 236, the combined invention of Szabados, Weinstein, and Bort discloses each ECG electrode is configured to be anatomically located within a circumferential atypical zone of the patient's torso in an uninhibiting manner so as to allow for the patient to be ambulatory, wherein the at least one ECG channel comprises at least one atypical ECG channel and the at least one ECG signal comprises at least one atypical ECG signal (Szabado eg. Col. 12, Ln. 65- Col. 13, Ln. 16, Col. 14, Ln. 10-18, claim 1 and Bort, Fig. 3A-3B 119-121, wireless patches).
Claim(s) 237 is/are rejected under 35 U.S.C. 103 as being unpatentable over Szabados (US 11,083,371 B1) in view of Weinstein (US 2021/0121090 A1), further in view of Kranz (US 2020/0375493 A1).
Regarding claim 237, the combined invention of Szabados and Weinstein discloses the invention of claim 234, but does not disclose plurality of ECG electrodes comprises at least four ECG electrodes, wherein the at least one atypical ECG channel comprises at least two atypical ECG channels, each atypical ECG channel associated with two respective ECG electrodes of the at least four ECG electrodes, wherein the at least two atypical ECG channels comprise a first atypical ECG channel and a second atypical ECG channel substantially orthogonal to the first atypical ECG channel.
Kranz teaches a wearable 4 lead electrode system (eg. Para. 59, 318, 349).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Szabados and Weinstein with the 4 lead ECG electrode system as taught by Kranz because a 4 lead electrode ECG configuration is well-known in the art.
Conclusion
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/MICHAEL J LAU/ Examiner, Art Unit 3796