DETAILED ACTION
Acknowledgements
This office action is in response to Applicant’s claims filed on February 06, 2026.
Claims 1-20 are pending
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 .
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/06/2026 has been entered.
Response to Amendments
Claims 1-20 remain pending.
Claim Rejection(s) – 35 U.S.C § 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 1-20 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter based on the grounds set out in detail below:
Independent Claims 1 and 13:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Independent Claim 1 falls within the statutory category of a process
Independent Claim 13 falls within the statutory category of a machine.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1 and 13 (Claim 1 being representative) claimed invention is directed to an abstract idea without significantly more.
The claim elements which set forth the abstract idea are:
receiving a plurality of electroanatomical points associated with one or more pairs of heart beats measured, the electroanatomical points including both location and value;
generating a model based on the received plurality of electroanatomical points associated with one or more pairs of heart beats;
determining via the generated model whether two of the received plurality of electroanatomical points for two given heart beats are part of an arrythmia to produce a similarity result for algorithmic input, the similarity result being assigned to the two of the received plurality of electroanatomical points for the pair of heart beats as a similarity percentage configured to indicate the pair of heart beats have similarities;
outputting the arrythmia including the received plurality of electroanatomical points including the location and value the determined two of the received plurality of electroanatomical points associated with the two given heart beats as part of the arrhythmia and an identification of the similarity percentage configured to indicate the pair of heart beats have similarities.
The aforementioned claim limitations recite an abstract idea as they merely claim managing a physician or users personal behavior to filter and analyze information to output the arrhythmia type therefore is still managing personal behavior within “certain methods of organizing human activity”. See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent Claims 1 and 13 this judicial exception is not integrated into a practical application.
The additional claim elements for claim 1 are:
one or more processors
electrophysiology (EP) mapping
body surface (BS) electrodes or one or more catheters
The additional claim elements for claim 13 not already recited in claim 1 are:
a memory executing instructions by the one or more processors
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim limitations.
The additional element, one or more processors with a memory storing executable instructions, is executing the abstract idea and is a generic computer product used as a tool to apply the abstract idea in the manner of reciting “by one or more processors” or other similar language and further disclosed in the instant applications specification as a general purpose computer, para. [0028].
The additional element, electrophysiology (EP) mapping, is merely invoked as a tangential environment and called on in the exact same manner as the above discussed computing products and therefore merely generally linking the abstract idea to the technology environment of EP studies.
The additional element, body surface (BS) electrodes or one or more catheters, is merely “apply-it” to gather data
Accordingly, the independent claims 1 and 13 as a whole do not integrate the recited abstract idea into a practical application (2106.05(f) and 2106.04(d)(1)).
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims 1 and 13 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2, the additional elements of a computer, whether viewed individually or as an ordered combination, amount to no more than merely using the elements as a tool to apply the abstract idea and the electrophysiology (EP) mapping as generally linking to the field of EP studies, The same analysis also applies here. Therefore, the claims do not amount to significantly more and the claims are ineligible.
Dependent Claims 2-12 and 14-20:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
The dependent claims 2-12 falls within the statutory category of a process
The dependent claims 14-20 falls within the statutory category of a machine
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2-12 and 14-20 claimed invention is directed to an abstract idea without significantly more. The claims further limit the abstract idea by (1) determining if the electroanatomical points of the two given heart beats are a part of the arrhythmia, (2) data within the two given heart beats of interest, and (3) usage of the similarity result of the two given heart beats and therefore is still managing personal behavior within “certain methods of organizing human activity”. See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): The additional claim elements in the dependent claims 2-12 and 14-20 not previously analyzed in the independent claims are:
A neural network
One or more Electrophysiology studies and EP maps
Signal imitations
A power line hum
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim limitations.
The additional element, neural network, is a tool used by the general computer (the processor) to apply the abstract idea and is therefore “apply-it”.
The additional element, One or more EP studies and EP maps, is merely invoked as a tangential environment and called on in the exact same manner as the above discussed computing products and therefore merely generally linking the abstract idea to the technology environment of electrophysiology.
The additional elements, signal imitations and a power line hum, are merely invoking a tangential environment and called on in the exact same manner as the discussed computing products and therefore generally linking the abstract idea to the technological environment of noise and artifacts.
Eligibility Step 2B (Does the claim amount to significantly more?): The additional elements considered in the dependent claims 2-12 and 14-20 both alone and in an ordered combination do not amount to more than the judicial exception for the same reasons to those discussed above for prong 2A-2 analysis as the additional elements are merely “apply-it” or generally linking respectively as outlined above. The claims are not patent eligible.
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claims for reasons argued in pages 1-6 of applicant’s remarks filed February 06, 2026.
The most remarkable prior art of record is as follows:
• Nemati, et al (hereinafter Nemati) (US20190328243A1)
o The systems and methods can accurately and efficiently determine abnormal cardiac activity from motion data and/or cardiac data using techniques that can be used for long-term monitoring of a patient. In some embodiments, the method for using machine learning to determine abnormal cardiac activity may include receiving one or more may include applying a trained deep learning architecture to each tensor of the one or more periods of time to classify each window and/or each period into one or more classes using at least the one or more signal quality indices for the cardiac data and the motion data and cardiovascular features. The deep learning architecture may include a convolutional neural network, a bidirectional recurrent neural network, and an attention network. The one or more classes may include abnormal cardiac activity and normal cardiac activity.
• Chang et. al (hereinafter Chang) (US10117595B2)
o A method and an apparatus for detecting cardiac arrhythmia and a recording medium using the method are provided. In the method, physiological signals of a human comprising a sequence of heart pulses are acquired, and an average of heartbeat intervals between pairs of consecutive heart pulses in the sequence of heart pulses is calculated. Each pair of consecutive heartbeat intervals is examined to identify premature ventricular contraction (PVC) candidates or atrial premature contraction (APC) candidates based on whether a difference between the pair of consecutive heartbeat intervals is larger than a product of a factor and the average of heartbeat intervals and whether an average of the pair of consecutive heartbeat intervals is within a predetermined range.
Iyun et. al (hereinafter Iyun) (US10376221B2)
o Cardiac electrograms are recorded in a plurality of channels. Beats are classified automatically into respective classifications according to a resemblance of the morphologic characteristics of the beats to members of a set of templates. Respective electroanatomic maps of the heart are generated from the classified beats.
Haeusser, et al. (hereinafter Haeusser) (US11389102B2)
Disclosed are various examples and embodiments of systems, devices, components and methods configured to detect a location of a source of at least one cardiac rhythm disorder in a patient's heart. In some embodiments, electrogram signals are acquired from a patient's body surface, and subsequently normalized, adjusted and/or filtered, followed by generating a two-dimensional spatial map, grid or representation of the electrode positions, processing the amplitude-adjusted and filtered electrogram signals to generate a plurality of three-dimensional electrogram surfaces corresponding at least partially to the 2D map, one surface being generated for each or selected discrete times, and processing the plurality of three-dimensional electrogram surfaces through time to generate a velocity vector map corresponding at least partially to the 2D map. The resulting velocity vector map maybe employed to classify a patient as one of an A-type patient, a B-type patient, and a C-type patient, and to guide therapy subsequently delivered to the patient. Trained atrial discriminative machine learning models that facilitate the foregoing systems and methods, and that provide predictions or results concerning a patient's condition, are also disclosed.
White (US20040019287A1)
A cardiac rhythm management system adapted to administer therapy based on identification and analysis of a trend in a series of similarity metrics based on a comparison of a cardiac complex and a template at a time following an electrical stimulation. Where the trend indicates a monotonically increasing correlation, therapy is inhibited and otherwise, therapy is delivered. In one embodiment, analysis of the trend includes discarding spurious data, executing a smoothing function, and calculating a moving average.
US20230149089A1 – TRAYANOVA et. al
A method for guiding ablation of atrial or ventricular arrhythmia in a patient's heart is provided. A digital representation of the electrical functioning of atria or ventricles of the patient's heart is generated based on imaging data of the patient's heart that reveals the presence of adipose tissue. The arrhythmias arising in the presence of the adipose tissue in the digital representation of the patients atria or ventricles are determined. The method further includes identifying, in the digital representation, ablation targets that need to be ablated to terminate determined arrhythmias; executing, in the digital representation, a mock-up of a clinical ablation procedure of the patient to determine the electrical response of the patients heart to ablating the ablation targets, and to determine whether the heart continues to generate new arrhythmias post-procedure; and generating a final set of ablation targets based on the mock-up of the clinical ablation procedure.
Response to Arguments Regarding 35 U.S.C 101 Rejection
Applicant's arguments on pages 6-9 of the remarks have been fully considered but they are not persuasive.
Applicant notes Claim Rejections - 35 U.S.C. §101 Claims 1-20 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter. Applicant respectfully submits that the present claims are directed to an improvement in conventional electrophysiology and are therefore not directed to an abstract idea. The outputting an electrophysiology (EP) mapping of the arrythmia including the received plurality of electroanatomical points of the determined two of the received plurality of electroanatomical points associated with the two given heart beats as part of the arrhythmia from a received plurality of electroanatomical points associated with one or more pairs of heart beats measured using a plurality of body surface (BS) electrodes or one or more catheters provides the improvement in conventional electrophysiology and BS electrodes and catheters performing measurements are themselves not abstract. As such, the claimed invention is not an abstract idea. For example, as identified by the Federal Circuit Court of Appeals in SRIInt'l,Inc. v. Cisco Sys. improvements to computer networks, a technological improvement similar to the technological improvement in the present claims, are not abstract ideas. In SRI Intl, Inc., the case was on appeal for the Federal Circuit to consider a summary judgment motion for patent-ineligible subject matter with regard to two computer network patents. The appellant, Cisco Systems, argued the patents were not subject matter eligible under 35 U.S.C. § 101 because they were merely directed for analyzing data from multiple sources to detect suspicious activity. However, the Federal Circuit disagreed, finding that "the representative claim improves the technical functioning of the computer and computer networks by reciting a specific technique for improving computer network security." (SRI Int'l, Inc. v. Cisco Sys., 918 F.3d 1368, 1376 (Fed. Cir. 2019)). Thus, the court found that the patents at issue were not directed to an abstract idea under Alice step 1 and, therefore, were patent-eligible under 35 U.S.C. §101. In reaching its conclusion, the court observed that "[t]he specification bolsters our conclusion that the claims are directed to a technological solution to a technological problem" and identified that "[t]he specification explains that the claimed -13-9223909.1 invention is directed to solving [identified] weaknesses in conventional networks." (SRI Int'l, Inc. v. Cisco Sys., 918 F.3d 1368, 1375 (Fed. Cir. 2019)) (internal markings omitted). Therefore, under SRI Int'l,Inc, a patent recites patent-eligible subject matter when the specification describes the weakness in conventional computer networks, and the claimed invention solves the identified weakness. Like in SRI Int'l, Inc., the present specification that the claimed invention is directed to solving identified weaknesses of conventional EP mappings. For example, the present application expressly states that "Conventional correlation algorithms fail to account for deflection noise, ventricular far field, respiration interference, ringing artifacts of analog or digital filters, and the like, that may imitate a correlation between the two heart beats. Conventional correlation algorithms lack the desired accuracy and consistency. A method and system to reliably measure a strength of an association between two heart beats for any EP procedure would be beneficial." (Present Application, Par. [0004]). The specification teaches that "[a]ccording to an embodiment, the machine learning algorithm includes a determination engine that receives EP studies (each of which includes at least two heart beats) and determines for each of the EP studies whether the two heart beats are part of the same arrythmia. The processor produces corresponding diagnoses that are further used to generate a model. The model is configured to learn to ignore signal imitations (e.g., deflection noise, ventricular far field, respiration interference, ringing artifacts of analog or digital filters, and the like) when evaluating a pair of heart beats." (Present Application, Par. [0018]). Further, the outputting an electrophysiology (EP) mapping of the arrythmia including the received plurality of electroanatomical points including the location and value of the determined two of the received plurality of electroanatomical points associated with the two given heart beats as part of the arrhythmia and an identification of the similarity percentage configured to indicate the pair of heart beats have similarities. provides an improvement in conventional electrophysiology and, as such, the claimed invention is not an abstract idea. As a result, like in SRI, the present claims are patent-eligible under 35 U.S.C. §101 because the specification describes the shortcomings in conventional EP studies that the present invention solves.
In response to this argument presented previously, the present Office Action sets forth that based on MPEP 2106.04(d)(1) the claims must be evaluated to determine if they include the disclosed improvement. The Examiner set forth that the disclosed improvement is not included in the claims. (Office Action pages 35-36) In response thereto, Applicant has amended the claims as set forth above to include the improvement. As such, Applicant, for the reasons above, respectfully submits that the claims include the improvement described in the specification and are therefore patent eligible. That is, the present claims are patent-eligible under 35 U.S.C. §101 because the specification describes the shortcomings in conventional EP studies that the present invention solves.
Applicants arguments have been considered but are not found persuasive by examiner.
In response to applicant arguments that the instant applications claimed invention is not an abstract idea because the specification describes the shortcomings in conventional EP studies that the present invention solves integrates into an improvement to computer technology such as alleged to be similar to SRI Int'l, Inc. v. Cisco Sys., 918 F.3d 1368, 1375 (Fed. Cir. 2019). Examiner notes that there is no nexus between the SRI Int'l, Inc. v. Cisco Sys., 918 F.3d 1368, 1375 (Fed. Cir. 2019) claims and the claims examined for the instant application as the instant application does not improve a computer technology such as computer networks. Rather the instant application claims are confined to a general purpose computer (see para. Instant application 0028) to apply the abstract idea and do not positively recite an improvement to the shortcomings in conventional EP studies as an improvement to technology. The entire field of electrophysiology mapping using conventional correlations is not reasonably understood to be a problem arising in computer technology but rather a problem arising in mathematical analysis and identification of electrophysiologic arrythmias based on known data. The claimed invention is applying the computer as an intermediary tool to present the data to convey whether an arrhythmia is present and any improvement is an improvement to the abstract idea as now and previously identification of an arrythmia is a certain method of organizing human activity completed by a human to diagnose a patient. Furthermore, there is no reflection in the claims of technological improvements to the machine learning algorithms and the applicant notes the machine learning is used or in another word applied to learn to ignore signal imitations (e.g., deflection noise, ventricular far field, respiration interference, ringing artifacts of analog or digital filters, and the like). Finally, if applicants line of reasoning were correct the invention in Alice Corp. would have been subject matter eligible because it was an improvement to the technology of settlement risk mitigation.
Examiner maintains the rejection of claims 1-20 under 35 U.S.C 101.
Response to Arguments Regarding 35 U.S.C 103 Rejection
Applicant has overcome the 35 U.S.C 103 rejections atleast because of amendments and arguments made in pages 1-6 of remarks.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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