DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first
inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/1/2026 has been entered.
Status of Claims
Claims 1, 6, and 10 are currently amended.
Claims 2-4 and 7-9 are cancelled.
Response to Arguments
Applicant's arguments, page 5-7, filed 6/25/2026, have been fully considered but they are not
persuasive.
35 U.S.C. 101
Regarding claim 1, applicant argue that the amended claims cannot be performed in the mind
because the real-time processing constraint requires producing a second ECG signal within one second of receiving the first ECG signal. Support for this amendment is found in (page 6-7, lines 29-33 and 1-7) the applicant’s specification. The examiner will point out from the paragraph that “to produce a second ECG signal, in which the interference is suppressed relative to the first ECG signal.” The examiner argues that a physician or a medical device engineer may perform the noise suppression equation within a second. These equation may take the form of non-linear diffusion filters or adaptive noise cancellation techniques. Furthermore, examiner argues that if the neural network (NN) was amended into the claims to perform this process, the NN would recite computer implementation to perform the abstract idea.
The applicant further argues that the displaying limitation meaningfully ties the claimed output
to a specific medical procedure context, namely electrophysiological mapping, thus providing technological advancement in the relevant field. The examiner respectfully disagrees and argues that the “display screen” is recited as post-solution activity to perform a diagnostic step.
Regarding claim 10, the examiner has not provided a specific rejection because the claim does
not recite an abstract idea. However, claim 10 is dependent on independent claim 6, which is rejected under the 35 U.S.C. 101 rejection. Therefore, the rejection to claims 10 is maintained.
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 and 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 6 recite a method and device with instructions for performing operations comprising:
receiving, from one or more sources external to the heart, one or more external signals that concurrently sense the interference during acquisition of the first ECG signal;
training a Neural Network (NN), by a processor configured with an autoencoder neural network (NN) architecture having at least five layers, a Neural Network (NN) using (i) one or more training ECG signals that are not distorted by the interference, and (ii) one or more training interference signals each having one or more respective spectral lines and one or more respective harmonics;
producing a second ECG signal, within less than one second from receiving the first ECG signal, in which the interference is suppressed relative to the first ECG signal, by applying trained Neural Network (NN) to the first ECG signal and to the one or more external signals, and wherein training the NN comprises training an autoencoder artificial NN having at least five lavers.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is
evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to a method, claim 6 is directed to a system to perform the steps of the method, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claims 1 and 6 recite a method and device with instructions to perform the method
comprising:
receiving, from one or more sources external to the heart, one or more external signals that concurrently sense the interference during acquisition of the first ECG signal;
training a Neural Network (NN), by a processor configured with an autoencoder neural network (NN) architecture having at least five layers, a Neural Network (NN) using (i) one or more training ECG signals that are not distorted by the interference, and (ii) one or more training interference signals each having one or more respective spectral lines and one or more respective harmonics;
producing a second ECG signal, within less than one second from receiving the first ECG signal, in which the interference is suppressed relative to the first ECG signal, by applying trained Neural Network (NN) to the first ECG signal and to the one or more external signals, and wherein training the NN comprises training an autoencoder artificial NN having at least five lavers.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the
limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1 and 6 recite an abstract idea of a mental process.
Claims 1 and 6 recite the abstract idea of a mental process. The limitations as drafted in the claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic data gathering device (which is interpreted as a processer in a data gathering device) and memory, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example:
“Receiving, from one or more sources external to the heart, one or more external signals that concurrently sense the interference during acquisition of the first ECG signal.” A physician may receive ECG signal from a multitude of outside sources such as electrodes, heartbeat sensors, and wristwatches.
“Producing a second ECG signal, within less than one second from receiving the first ECG signal, in which the interference is suppressed relative to the first ECG signal, by applying a trained Neural Network (NN) to the first ECG signal and to the one or more external signals.” A physician may manually provide filtering for a second ECG signal by using filtering equations, such as non-linear diffusion filters or adaptive noise cancellation techniques, within a second.
“Training a Neural Network (NN), by a processor configured with an autoencoder neural network (NN) architecture having at least five layers, a Neural Network (NN) using (i) one or more training ECG signals that are not distorted by the interference, and (ii) one or more training interference signals each having one or more respective spectral lines and one or more respective harmonics;” A physician gather ECG signals with one or more spectral lines and perform math equation to acquire respective harmonics. The signals may by not distorted by interference by applying filtering equations to the frequency signals.
“Producing a second ECG signal, in which the interference is suppressed relative to the first ECG signal, by applying trained Neural Network (NN) to the first ECG signal and to the one or more external signals, and wherein training the NN comprises training an autoencoder artificial NN having at least five lavers.” A physician may obtain a second ECG signal by filtering/suppressing interference from a first ECG signal using a filtering equation through five layers of steps.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial
exception into a practical application?
Claims 1 and 6 recite the additional elements of a “one or more external source”, “display” and
a “processor” which are being interpreted as a processor of a generic data gathering device.
acquiring a first electrocardiogram (ECG) signal from one or more electrodes located on a catheter positioned inside the heart of the patient; The catheter and electrodes are recited as pre-solution activity to gather ECG data.
execute the NN using a trained model stored in non-transitory computer-readable memory; The generic computer components, NN and memory, are recited computer implementation to execute processing steps already indicated as an abstract idea.
Displaying the second ECG signal to a physician during an electrophysiological (EP) mapping procedure. The “display screen” is recited as post-solution activity to perform a diagnostic step.
However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical
application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the
judicial exception?
The additional elements when considered individually and in combination are not enough to
qualify as significantly more than the abstract idea.
acquiring a first electrocardiogram (ECG) signal from one or more electrodes located on a catheter positioned inside the heart of the patient; The catheter and electrodes are recited as pre-solution activity to gather ECG data.
execute the NN using a trained model stored in non-transitory computer-readable memory; The generic computer components, NN and memory, are recited computer implementation to execute processing steps already indicated as an abstract idea.
Displaying the second ECG signal to a physician during an electrophysiological (EP) mapping procedure. The “display screen” is recited as post-solution activity to perform a diagnostic step.
As discussed above with respect to integration of the abstract idea into a practical application, “one or more external source”, “display” and a “processor” which are being interpreted as a processor of a generic data gathering device, as recited to perform the steps of:
receiving, from one or more sources external to the heart, one or more external signals that concurrently sense the interference during acquisition of the first ECG signal;
training a Neural Network (NN), by a processor configured with an autoencoder neural network (NN) architecture having at least five layers, a Neural Network (NN) using (i) one or more training ECG signals that are not distorted by the interference, and (ii) one or more training interference signals each having one or more respective spectral lines and one or more respective harmonics;
producing a second ECG signal, within less than one second from receiving the first ECG signal, in which the interference is suppressed relative to the first ECG signal, by applying trained Neural Network (NN) to the first ECG signal and to the one or more external signals, and wherein training the NN comprises training an autoencoder artificial NN having at least five lavers.
amount to no more than mere instructions to apply the exception using generic computer
components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example FONTANARAVA et al (U.S. Patent Application Publication Number: US 2019/0298204 A1, hereinafter Fontanarava) teaches a data gathering device with a processor and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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