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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/5/2025 has been entered.
Status of Claims
Claims 1, 3, 7, 31, and 39 are amended.
Claims 2, 6, 8-9, 16-30, 33, 37-38, 40-41, 44-46, and 51-97 are cancelled.
Response to Arguments
Applicant's arguments, see page 10-11, filed 11/5/2025, have been fully considered but they are
not persuasive.
35 U.S.C. 101:
Regarding claim 1 and 31, the applicant argues that the amended claims render the rejection
moot. The examiner respectfully disagrees and argues that the additional elements of the amended claims do not integrate the judicial exception into a practical application. Specifically, the “one or more sensing electrodes configured to sense electrical signals that are indicative of cardiac activity of the patient in combination with one or more accelerometers configured to generate a plurality of motion signals representative of movement of the patient,” are used as pre-solution activity to the step of data gathering. Furthermore, the use of electrical sensing electrodes and accelerometers working together in a wearable device is well known and conventional in the art. The amended step “receive the electrical signals from the one or more sensing electrodes, determine electrocardiogram (ECG) data for the patient based upon the electrical signals” and “generate a plurality of motion signals representative of movement of the patient,” describes the method of using said electrodes and accelerometers to gather data. Therefore, this recites nothing more than pre-solution activity to the step of data gathering.
The applicant amended the claim to recite “analyzing motion signals of the one or more accelerometers to determine initiation of a high-noise activity.” This limitation recites computer implementation to the mental process of analyzing motion signals. The additional element of one or more accelerometers is well-known and conventional in the art, even in combination with the ECG electrodes and processors.
Furthermore, the applicant amended the claim to recite “extracting, from the plurality of motion signals, a plurality of features relating to a current state or activity of the patient based on the plurality of motion signals, applying the motion classifier to a feature vector comprising the plurality of features to generate a respective classification of the plurality of motion classifications, and storing, to the at least one memory, the respective classification.” The motion classifier is recited as part of a generic processor to perform the mental step of classifying motion signals relating to current state or activity of a patient. This mental step may be observed by a physician to identify specific features of a patient relating to motion. This information may be stored in a notebook or retained in memory.
Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of claims 1 and 31 are merely generically recited computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity.
Applicant’s arguments, see pages 10-11, filed 11/5/2025, with respect to the rejection(s) of
claim(s) 1, 3-5, 7, 10-15, 31-32, 34-36, 39, 42-43, and 47-50 under 35 U.S.C. 103 rejection have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
The closest prior art: US 20170087371 A1 teaches wherein the AIN robust mode comprises analyzing a second plurality of ECG metrics based on the ECG data to detect the arrhythmia, wherein the second plurality of ECG metrics comprises a subset of the first plurality of ECG metrics, determine a termination of the high-noise activity based on one or more of a predetermined time out condition occurring after a predetermined time period, the patient input, or the plurality of motion signals, and cause, in response to determining the termination of the high-noise activity, the arrhythmia detection process to execute in the AIN sensitive mode (paragraph 252 and 280). However, no prior was found to teach every limitation of independent claims 1 and 31, specifically, “extracting, from the plurality of motion signals, a plurality of features relatinq to a current state or activity of the patient based on the plurality of motion signals, applying the motion classifier to a feature vector comprising the plurality of features to generate a respective classification of the plurality of motion classifications, “ in combination with all limitations in the claims.
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, 3-5, 7, 10-15, 31-32, 34-36, 39, 42-43, and 47-50 are rejected under 35 U.S.C. 101
because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 31 recite two apparatuses with instructions for performing operations of the device comprising:
analyzing a first plurality of ECG metrics based on the ECG data to detect an arrhythmia;
analyzing motion signals of the one or more accelerometers to determine initiation of a high-noise activity;
extracting, from the plurality of motion signals, a plurality of features relating to a current state or activity of the patient based on the plurality of motion signals;
generate a respective classification of the plurality of motion classifications;
storing the respective classification;
analyzing a second plurality of ECG metrics based on the ECG data to detect the arrhythmia, wherein the second plurality of ECG metrics comprises a subset of the first plurality of ECG metrics;
determine a termination of the high-noise activity based on one or more of a predetermined time out condition occurring after a predetermined time period, the patient input, or the plurality of motion signals;
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 an apparatus and claim 31 is directed to an apparatus 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 31 recite two apparatuses with instructions for performing operations of the
device comprising:
analyzing a first plurality of ECG metrics based on the ECG data to detect an arrhythmia;
analyzing motion signals of the one or more accelerometers to determine initiation of a high-noise activity;
extracting, from the plurality of motion signals, a plurality of features relating to a current state or activity of the patient based on the plurality of motion signals;
generate a respective classification of the plurality of motion classifications;
storing the respective classification;
analyzing a second plurality of ECG metrics based on the ECG data to detect the arrhythmia, wherein the second plurality of ECG metrics comprises a subset of the first plurality of ECG metrics;
determine a termination of the high-noise activity based on one or more of a predetermined time out condition occurring after a predetermined time period, the patient input, or the plurality of motion signals;
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 31 recite an abstract idea of a mental process.
Claims 1 and 31 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 processing system 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:
“Analyzing a first plurality of ECG metrics based on the ECG data to detect an arrhythmia.” A physician may analyze a first plurality of ECG metrics to detect an arrhythmia using equations and observational analysis.
“Analyzing motion signals of the one or more accelerometers to determine initiation of a high-noise activity.” A physician may determine high-noise activity based on motion signals obtained by accelerometers.
“Extracting, from the plurality of motion signals, a plurality of features relating to a current state or activity of the patient based on the plurality of motion signals;” A physician may observe a plurality of features and identify specific features of a patient relating to motion.
“Generate a respective classification of the plurality of motion classifications;” A physician may classify a plurality of motions based on collected features.
“Storing the respective classification;” This information may be stored in a notebook or retained in memory.
“Analyzing a second plurality of ECG metrics based on the ECG data to detect the arrhythmia, wherein the second plurality of ECG metrics comprises a subset of the first plurality of ECG metrics.” A physician may analyze a second plurality of ECG metrics to detect an arrhythmia using equations and observational analysis.
“Determine a termination of the high-noise activity based on one or more of a predetermined time out condition occurring after a predetermined time period, the patient input, or the plurality of motion signals.” A physician may determine a time out condition and determine a termination of the high-noise activity based on that condition.
Furthermore claims 10 and 42 recite additional steps that can be manually performed by the
clinician.
“Determine a portion of the ECG data that is noisy ECG data caused by patient activity; and determine the patient activity is the high-noise activity if the portion of ECG data that is noisy ECG data exceeds a predetermined noise threshold.” A physician may determine a noisy signal based on observation. A physician may determine a time out condition and determine a termination of the high-noise activity based on that condition.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial
exception into a practical application?
Claims 1 and 31 recite the additional elements of a “defibrillator”, “a processor”, “a
memory” and “one or more sensing electrodes,” “one or more accelerometers,” and “motion classifier” which are being interpreted as a processor of a data gathering device.
“receive the electrical signals from the one or more sensing electrodes, determine electrocardiogram (ECG) data for the patient based upon the electrical signals,” describes the method of using said electrodes to gather data.
The amended step of “one or more accelerometers configured to generate a plurality of motion signals representative of movement of the patient,” are used as pre-solution activity to the step of data gathering motion data.
The motion classifier is recited as part of a generic processor to perform the mental step of classifying motion signals relating to current state or activity of a patient.
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.
“receive the electrical signals from the one or more sensing electrodes, determine electrocardiogram (ECG) data for the patient based upon the electrical signals,” describes the method of using said electrodes to gather data.
The amended step of “one or more accelerometers configured to generate a plurality of motion signals representative of movement of the patient,” are used as pre-solution activity to the step of data gathering motion data.
The motion classifier is recited as part of a generic processor to perform the mental step of classifying motion signals relating to current state or activity of a patient.
As discussed above with respect to integration of the abstract idea into a practical application, “defibrillator”, “a processor”, “a memory”, and “one or more sensing electrodes,” “one or more accelerometers,” and “motion classifier” which are being interpreted as a processor of a data gathering device. as recited to perform the steps of:
analyzing a first plurality of ECG metrics based on the ECG data to detect an arrhythmia;
analyzing motion signals of the one or more accelerometers to determine initiation of a high-noise activity;
extracting, from the plurality of motion signals, a plurality of features relating to a current state or activity of the patient based on the plurality of motion signals;
generate a respective classification of the plurality of motion classifications;
storing the respective classification;
analyzing a second plurality of ECG metrics based on the ECG data to detect the arrhythmia, wherein the second plurality of ECG metrics comprises a subset of the first plurality of ECG metrics;
determine a termination of the high-noise activity based on one or more of a predetermined time out condition occurring after a predetermined time period, the patient input, or the plurality of motion signals;
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 Freeman et al. US Pub.: US 20170087371 A1, hereinafter Freeman) teaches a data gathering device with a processor and memory, 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-5, 7, 10, 13-15, 31, 32, 34-36, 39, 42, and 48-50 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
For “at least one memory configured to store an arrhythmia detection process configurable to execute in one of an activity-induced noise (AIN) sensitive mode and an AIN robust mode. The limitation is reciting that the arrhythmia detection process may or may not be programmed to execute one of the modes rather than have it be required. For clear prosecution of the claimed subject matter, the limitation should recite “an arrhythmia detection process configured to execute…”
Although there is no prior art rejection, the subject matter cannot be allowable due to the 35
U.S.C. 101 rejection disclosed above.
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