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 .
Status of Claims
The amendments and remarks filed on 04DEC2025 have been entered and considered.
Claims 13-15, 17- & 19-23 are currently pending.
Claims 13 & 15 have been amended.
No claims have been added, canceled, or withdrawn.
No new matter has been added.
Claims 13-15, 17, & 19-23 are under examination.
Response to Arguments
Applicant's arguments filed 04DEC2025 regarding the rejections under 35 USC 101 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 10 of the Remarks):
“Applicant's claims do not recite a mental process that can be practically performed in the human mind. For example, independent claim 1 recites calculating respective mutual information metrics between multiple pairs of electrodes from signals acquired from a plurality of electrodes (such as the forty eight electrodes depicted in Fig. 4), generating a graph with electrodes as nodes and edges based on exceeding a threshold, calculating local efficiency metrics for each node based on shortest path lengths in subgraphs, averaging these to a resultant local efficiency, and analyzing across incremented thresholds. See Specification at 11 [0065], [0066]-[0068], [0070]-[0072].”
The examiner is not persuaded. The claim amounts to no more than a mental process since it doesn’t involve tasks which cannot be performed by a human who may have the time and ability to process data such as is claimed; i.e. the claims do not restrict the time the invention takes for processing nor does it provide tasks incapable of a clinician to arrive at the same result. Additionally, the features argued do not amount to more than mental process. Feature , “calculating respective mutual information metrics between multiple pairs of electrodes from signals acquired from a plurality of electrodes” can be performed by hand by a physician using tools such as excel, or even on pen and paper when given enough time to do so. The action does not require more than analyzing data that is acquired as currently written. Feature “generating a graph with electrodes as nodes and edges based on exceeding a threshold” , amounts to no more than a clinician watching data to see what falls below a threshold so that they can plot it to form a graph, marking where the electrodes lie. This feature only requires to graphing of data, and therefore represents a mental process. It does not include anything that may prevent a clinician from graphing it by hand or using tools already available to generate said graph. Feature “calculating local efficiency metrics for each node based on shortest path lengths in subgraphs” contains “shortest”, which the examiner notes is not supported in the specification. “Calculating local efficiency metrics for each node based on path lengths in subgraphs” is merely creating graphs for each electrode and performing calculations to arrive at a local efficiency metric, accounting for path lengths per each subgraph. This is just the plotting of data followed by using mathematical equations to arrive at a result. This is an example of an abstract idea, namely extra-solution activity for the graphing and a mathematical process for the calculations. Feature “averaging these to a resultant local efficiency” can be performed by a clinician by hand as it is merely performing a calculation based on the graphed data. Finally, feature “analyzing across incremented thresholds.” Is merely data analysis with a threshold, which a clinician skilled in the art would understand how to perform. Data analysis with restricting thresholds for data amounts to no more than an abstract idea when presented with no limiting factors.
“These steps involve extensive mathematical computations on large datasets-such as estimating mutual information using histograms of local activation times from thousands of data points (e.g., over approximately 150 heartbeats per electrode), determining shortest paths in potentially complex graphs, and iterating the process to produce and analyze ordered pairs-which cannot practically be performed mentally or with pen and paper due to the volume of data, the complexity of pairwise comparisons (potentially hundreds or thousands), and the precision required for graph- theoretic operations like path length calculations. See, e.g., id. at 11 [0054]-[0056], [0057]-[0062. Such processes are far beyond what a human could reliably perform mentally, as a human cannot feasibly track and compute such interdependent metrics across numerous nodes and thresholds in the mind.”
The examiner is not persuaded. The claims recites tasks that a clinician of skill in the art would be able to perform without the invention, such as by using a program like excel or other programs to perform calculations, graphing, and analysis of large data sets. The use of large data sets or complex calculations does not mean a clinician wouldn’t be able to perform the limitations as they are written since the use of programs for data analysis is already known to the art, and there are forulas available such as with multivariable calculus or other high level math which accounts for multiple parameters, which one can use to perform data analysis by hand or with the above stated programs. The claims do not recite any limitations which a clinician couldn’t perform when given the tools to do so. Therefore the claims are abstract.
Applicant states (see Pages 11-2 of the Remarks):
“Further, the claims integrate any such steps into a practical application by providing a new and specific technique that enables accurate, non-invasive classification of atrial fibrillation and estimation of the percentage of atrial remodeling using only intra-cardiac signals acquired from a multi-electrode catheter during ongoing fibrillation. See id. at " [0038]-[0039], [0044]. This technique improves the technical field of cardiac electrophysiology by supplying the physician with an objective, quantitative measure of remodeling that was not previously available from standard signal analysis, thereby directly informing and optimizing the choice and strategy of radiofrequency or pulsed-field ablation. See id. at " [0003], [0038], [0044]. The claimed process involves the construction of a regional information graph from mutual information thresholds, the iterative calculation of local efficiency across thresholds, and the detection of characteristic plateaus or minima in the resultant efficiency curve that collectively produce a clinically meaningful output to guide ablation strategies in a manner not achievable with prior mapping methods. See id. at " [0078]-[0088]. Because the claimed systems and methods improve the accuracy and utility of intra-cardiac mapping technology for atrial fibrillation and directly affects downstream treatment decisions, they integrate any alleged judicial exception into a practical application under Step 2A, Prong Two of the Alice framework.”
The examiner disagrees since the claims only require that the signals are acquired during atrial fibrillation and not the full data analysis. The data analysis steps as claimed amount to tasks which can be performed by a clinician, and these tasks do not require atomization to be achieved. The calculations that are argued to provide a more accurate analysis are not claimed in a manner that shows the significance of the analysis, nor details about the calculations that provide an improvement in the field. As claimed the limitations amount to tasks which can be performed by a clinician to achieve the same results. Therefore, the practical application has not been shown.
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 13-15, 17, & 19-23 are rejected under 35 U.S.C. 101. MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject matter. The stepwise analysis for the instant claim is provided here.
Step 1: Statutory Categories
Claim 13 is directed to an apparatus (i.e. machine) and thus meets the step 1 requirements.
Step 2A: Prong 1; Judicial Exception
Regarding claim 13 the following claim limitation is an abstract idea: “estimating how much remodeling is present in a fibrillating atrium”, “determine a plurality of local activation times (LATs) for each signal received from the plurality of electrodes in contact with the heart tissue of the patient during atrial fibrillation”; “determine, in response to the signals received from multiple electrode pairs from the plurality of electrodes of the catheter, mutual information metrics between the multiple pairs of electrodes”, “analyze each of the ordered pairs of resultant local efficiency and the corresponding selected mutual information metric threshold to estimate a percentage amount of remodeling of the atrium”, “generate, a graph with the electrode pairs as nodes, and edges as connections therebetween for which the respective mutual information metrics exceed a selected mutual information metric threshold”, “determine, a resultant local efficiency for the selected mutual information metric threshold, wherein the determination comprises averaging the respective local efficiency metrics of the nodes” and “determine, a respective local efficiency metric for each node, indicatin g an efficiency of information exchange between the node and other nodes connected to the node, based on path lengths between the connected nodes”, “repeat, iteratively by the processor” which are mental processes when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could analyze (i.e. evaluate) a local efficiency on the electrical measurement.
Step 2A: Prong 2; Additional Elements to Integrate J.E. Into A Practical Application
Regarding claim 13, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea: “plurality of electrodes”, a “non-transitory computer readable medium storing a plurality of instructions”, “catheter having a plurality of spines, each spine comprising a plurality of electrodes configured to contact heart tissue undergoing atrial fibrillation wherein each electrode is separated from a nearest-neighbor electrode by three millimeters or less”, “display”, and “a processor” are recited at a high level of generality and are generic cardiac ablation components amounting to insignificant extra-solution activity in that they are merely objects on which the functional limitations operate [MPEP 2106.05(b)]. “mutual information metric” is data that is necessary to implement the abstract idea on a computer [MPEP 2106.05(g)].
Step 2B: Significantly More/Inventive Concept
The additional elements of claim 13, when considered separately and in combination, do not add significantly more (i.e. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the recited, plurality of electrodes, non-transitory computer readable medium, catheter, and a processor, along with their associated estimations and related calculations are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements of “cause sets of signals to be acquired from each of the plurality of electrodes of the catheter over a period of time when in contact with the heart tissue of a patient during atrial fibrillation”, “incrementing the selected mutual information metric threshold until a maximum value is reached and storing each resultant local efficiency and corresponding selected mutual information threshold as an ordered pair in a memory of a computing system”, and “cause, an indication of the estimated amount of remodeling of the atrium based upon the analysis, to be outputted to a display coupled to the computing system” are insignificant extra-solution activity and do not amount to more than what is well- understood, routine, and conventional.
Dependent claims 14-15, 17, & 19-23 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 13. The dependent claim limitations are
directed to calculating from the signal’s respective mutual information metrics between all pairs of the electrodes (claims 15, 20-21), signal analysis/plotting (Claim 14), plotting (Claim 17), structure (Claim 19), and to analyzing the set of ordered pairs generated from the mutual information metric threshold (claims 22-23), which are insignificant extra-solution activity and do not amount to more than what is well understood, routine, and conventional.
In summary, claims 13-15, 17, & 19-23 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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