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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/04/2025 is being considered by the examiner.
Response to Amendment
The amendment filed October 9th, 2025 has been entered. Claims 1, 4-11, and 14-20 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and 112(b) rejections previously set forth in the Non-final Office Action mailed June 11th, 2025.
Response to Arguments
Applicant’s arguments with respect to claims 1, 4-11 and 14-20 have been considered but are moot because the new grounds of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Applicant’s arguments regarding the rejection under 35 U.S.C. 101 have been considered but are not persuasive. The claims are still reciting merely an abstract idea and similarly to Electric Power Group, have extracting data, manipulating it and then outputting it which is seen by the courts as merely an abstract idea. As claimed the method and system are still separate from the actual ablation device. The claims as written do not provide the basis for patentability. See 35 U.S.C. 101 rejection for clarification and examiner suggestions.
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, 11 and 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite receiving data, generating a predicted success level, and outputting a location and defined ablation parameters.
The limitation of receiving data, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “by a processor”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “by a processor” language, “receiving” in the context of this claim encompasses the user manually gathering data.
Similarly, the limitation of determining, by a processor, an optimal ablation location and at least two ablation parameters, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “by a processor” language, “determining” in the context of this claim encompasses the user calculating using a mental process or math, an optimal ablation location based on the data and calculating ablation parameters to treat that location.
Similarly, the limitation of displaying, via a user interface, the optimal ablation location and the at least two ablation parameters as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “via a user interface” language, “displaying” in the context of this claim encompasses the user calculating using a mental process or math, a location and defined ablation parameters based on the data to produce a result of what they may be (i.e. showing them to the physician).
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” and “Math” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform the steps of receiving data, generating a predicted success level, and outputting a location and defined ablation parameters. The processor in all three steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of receiving data and generating an output based on a predicted level of success) such that it amount no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the receiving, generating, and outputting steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Further the examiner suggests referencing: Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). This case discloses that the mere collection, analysis and display of available information is found to be an abstract idea. In the present case, the focus of the claims is not on such an improvement in computers as tools, but on certain independently abstract ideas that use computers as tools. Merely receiving, analyzing, and outputting the ablation information does nothing significant to differentiate a process from ordinary mental processes. As a result, they do not require an arguably inventive set of components or methods, such as measurement devices or techniques, that would generate new data. The claims at issue do not require any nonconventional computer, network, or display components, or even a “non-conventional and non-generic arrangement of known, conventional pieces,” but merely call for performance of the claimed information collection, analysis, and display functions “on a set of generic computer components” and display devices. Bascom, 2016 WL 3514158, at *6–7. Nothing in the claims, understood in light of the specification, requires anything other than off-the-shelf, conventional computer, network, and display technology for gathering, sending, and presenting the desired information. Therefore claims 1, 4-11, 14-20 are not patent eligible.
Examiner suggests amending each independent claim whereby the final step results in a change to a device. For example, using the parameters to perform the ablation (Figure 16 shows the application of the ablation to the patient).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 8, 10, 11, 15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pappone et al. (U.S. PGPub. No. 2018/0206920) herein referred to as “Pappone” in view of Mangual-Soto et al. (U.S. PGPub. No. 2018/0318013) herein referred to as “Mangual-Soto” further in view of Edwards et al. (U.S. PGPub. No. US 2018/0261310) herein referred to as “Edwards”.
Regarding claim 1, Pappone discloses a method of aiding a physician in locating an area to perform an ablation on a patient with atrial fibrillation (AFIB) comprising: receiving data, via an input device, the data including a three-dimensional (3D) cardiac map including a plurality of locations and intracardiac electrogram (EGM) data associated with the plurality of locations during a period of time (measuring EGM signals; performing three dimensional mapping of the EGM signals, claim 1);
determining, by a processor, an optimal ablation location (automation of the process for detecting a potential target for ablation, Paragraphs [0028], [0051], detecting a location for ablation based on the mapping, claim 1)
outputting via a user interface, the optimal ablation location, wherein the determined optimal ablation location is indicated on the received 3D cardiac map (processing device 1004 may also generate and interpolate mapping information for displaying maps of the heart on display device 1006, Paragraph [0069], in step S1103, a 3D epicardial duration map is produced, in one embodiment this map is displayed on display 50, Paragraph [0074], wherein a duration map is used to identify targets, Paragraph [0022], Figure 7).
However Pappone does not explicitly disclose determining, by a processor, at least two ablation parameters associated with the optimal ablation location, the two ablation parameters associated with the optimal ablation location, the two ablation parameters among an ablation index, an ablation power, and a time of application, wherein the at least two ablation parameters are associated with an expected success level exceeding a threshold level; and displaying via a user interface, the at least two ablation parameters.
Mangual-Soto discloses systems, apparatuses, and methods for determining ablation parameters (Paragraph [0002]). Mangual-Soto further discloses determining, by a processor, at least two ablation parameters associated with the optimal ablation location, the two ablation parameters associated with the optimal ablation location, the two ablation parameters among an ablation index, an ablation power, and a time of ablation application (method of determining ablation parameters, Paragraph [0079], in block 608, one or more ablation parameters (e.g., ablation energy level, ablation time, and ablation contact force) are determined using the index map, Paragraph [0083]), and outputting via a user interface, the at least two ablation parameters (the method can include graphically outputting the one or more of ablation energy level, ablation time, and ablation contact force such as by displaying a numerical value for the one or more of ablation energy level, ablation time, and ablation contact force, Paragraph [0016], the ablation parameters can be superimposed upon a three-dimensional cardiac model, Paragraph [0086], Figure 10).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone to incorporate the teachings of Mangual-Soto by including determining, by a processor, at least two ablation parameters associated with the optimal ablation location, the two ablation parameters associated with the optimal ablation location, the two ablation parameters among an ablation index, an ablation power, and a time of ablation application, wherein the at least two ablation parameters are associated with an expected success level exceeding a threshold level; and displaying via a user interface, the at least two ablation parameters. The motivation to do so being to being to determine one or more ablation parameters that will likely result in the creation of a transmural lesion at that location (Mangual-Soto, Paragraph [0083]).
However Pappone in view of Mangual-Soto does not explicitly disclose wherein the at least two ablation parameters are associated with an expected success level percent.
Edwards discloses predicting the success outcomes for a plurality of patients (Paragraph [0232]), wherein the at least two ablation parameters are associated with an expected success level percent (the rules module can compare patient information to patient information to generate a predicted outcome for the patient, based on a planned surgery the predicted outcome may be expressed as a percent chance of achieving a successful surgery, Paragraph [0234], rules are associated with catheter ablation, Paragraph [0235]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Mangual-Soto to incorporate the teachings of Edwards by including wherein the at least two ablation parameters are associated with an expected success level percent. The motivation to do so being to predict the outcome of using the parameters to determine a successful surgery (Edwards, Paragraph [0234]).
Regarding claim 5, Pappone in view of Pappone in view of Mangual-Soto discloses the method of claim 1.
Pappone further discloses wherein the receiving includes at least one 3D cardiac map and at least one electrogram (EGM) data for the patient and further includes a potential location for the ablation (measuring EGM signals, performing three dimensional mapping of the EGM signals, and detecting a location for ablation based on the mapping, claim 1, Paragraph [0073-0074]). However Pappone does not explicitly disclose wherein the received data includes defined ablation parameters associated with the potential location. Mangual-Soto further discloses wherein the received data includes defined ablation parameters associated with the potential location (method of determining ablation parameters, Paragraph [0079], in block 608, one or more ablation parameters (e.g., ablation energy level, ablation time, and ablation contact force) are determined using the index map, Paragraph [0083]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone to incorporate the teachings of Mangual-Soto by including wherein the received data includes defined ablation parameters associated with the potential location. The motivation to do so being to being to determine one or more ablation parameters that will likely result in the creation of a transmural lesion at that location (Mangual-Soto, Paragraph [0083]).
Regarding claim 8, Pappone in view of Mangual-Soto and Edwards discloses the method of claim 1.
Pappone further discloses wherein the received data includes any of the following: ripple frequency maps with ripple percentage and peaks, fragmentation index, cycle length maps, complex fractionated atrial electrograms (CFAE), finder, fractionation map, complexity map, clinical ablation parameters including site, and index, clinical outcome including acute, after a blanking period of several days and after long-term follow-up (a signal processor, e.g., a computer 40, using CFAE module of CART03 may be used for mapping, Paragraph [0073], processing device 1004 may include one or more processors each configured to process the ECG signals, record ECG signals over time, filter ECG signals, fractionate ECG signals into signal components, Paragraph [0069]).
Regarding claim 10, Pappone in view of Mangual-Soto and Edwards discloses the method of claim 1.
Pappone further discloses wherein the received data includes at least one cardiac mapping that includes at least one of ripple frequency maps with ripple percentage and peaks, fragmentation index, cycle length maps, complex fractionated atrial electrograms (CFAE), finder, fractionation map, complexity map, anatomical mapping including computed tomography (CT), magnetic resonance imaging (MRI), ultrasonography, clinical ablation parameters including site, and index, and clinical outcome including acute, after a blanking period of several days and after long-term follow-up (a signal processor, e.g., a computer 40, using CFAE module of CART03 may be used for mapping, Paragraph [0073], processing device 1004 may include one or more processors each configured to process the ECG signals, record ECG signals over time, filter ECG signals, fractionate ECG signals into signal components, Paragraph [0069]).
Regarding claim 11, Pappone discloses a system for aiding a physician in locating an area to perform an ablation on a patient with atrial fibrillation (AFIB) (Paragraph [0028]),
the system comprising: a processor operatively coupled to a memory (signal processor 40, Paragraph [0063], the signal processor may store data representing the information 52 in a memory 58, Paragraph [0065]), cooperatively operating to:
receive data from at least one device, the data including a three-dimensional (3D) cardiac map including a plurality of locations and intracardiac electrogram (EGM) data associated with the plurality of locations during a period of time (measuring EGM signals; performing three dimensional mapping of the EGM signals, claim 1);
determine an optimal ablation location (automation of the process for detecting a potential target for ablation, Paragraphs [0028], [0051], detecting a location for ablation based on the mapping, claim 1) output via a user interface the optimal ablation location, wherein the determined optimal ablation location is indicated on the received 3D cardiac map (processing device 1004 may also generate and interpolate mapping information for displaying maps of the heart on display device 1006, Paragraph [0069], in step S1103, a 3D epicardial duration map is produced, in one embodiment this map is displayed on display 50, Paragraph [0074], wherein a duration map is used to identify targets, Paragraph [0022], Figure 7).
However Pappone does not explicitly disclose wherein the system is configured to determine at least two ablation parameters associated with the optimal ablation location, the two ablation parameters among an ablation index, an ablation power, and a time of ablation application, wherein the at least two ablation parameters are associated with an expected success level percent; and output via a user interface, the at least two ablation parameters.
Mangual-Soto discloses systems, apparatuses, and methods for determining ablation parameters (Paragraph [0002]). Mangual-Soto further discloses determining, by a processor, at least two ablation parameters associated with the optimal ablation location, the two ablation parameters associated with the optimal ablation location, the two ablation parameters among an ablation index, an ablation power, and a time of ablation application (method of determining ablation parameters, Paragraph [0079], in block 608, one or more ablation parameters (e.g., ablation energy level, ablation time, and ablation contact force) are determined using the index map, Paragraph [0083]), and outputting via a user interface, the at least two ablation parameters (the method can include graphically outputting the one or more of ablation energy level, ablation time, and ablation contact force such as by displaying a numerical value for the one or more of ablation energy level, ablation time, and ablation contact force, Paragraph [0016], the ablation parameters can be superimposed upon a three-dimensional cardiac model, Paragraph [0086], Figure 10).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone to incorporate the teachings of Mangual-Soto by including determining, by a processor, at least two ablation parameters associated with the optimal ablation location, the two ablation parameters associated with the optimal ablation location, the two ablation parameters among an ablation index, an ablation power, and a time of ablation application, wherein the at least two ablation parameters are associated with an expected success level exceeding a threshold level; and displaying via a user interface, the at least two ablation parameters. The motivation to do so being to being to determine one or more ablation parameters that will likely result in the creation of a transmural lesion at that location (Mangual-Soto, Paragraph [0083]).
However Pappone in view of Mangual-Soto does not explicitly disclose wherein the at least two ablation parameters are associated with an expected success level percent.
Edwards discloses predicting the success outcomes for a plurality of patients (Paragraph [0232]), wherein the at least two ablation parameters are associated with an expected success level percent (the rules module can compare patient information to patient information to generate a predicted outcome for the patient, based on a planned surgery the predicted outcome may be expressed as a percent chance of achieving a successful surgery, Paragraph [0234], rules are associated with catheter ablation, Paragraph [0235]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Mangual-Soto to incorporate the teachings of Edwards by including wherein the at least two ablation parameters are associated with an expected success level percent. The motivation to do so being to predict the outcome of using the parameters to determine a successful surgery (Edwards, Paragraph [0234])
Regarding claim 15, Pappone in view of Rodriguez discloses the system of claim 11.
Pappone further discloses wherein the receiving includes a potential location for the ablation (measuring EGM signals, performing three dimensional mapping of the EGM signals, and detecting a location for ablation based on the mapping, claim 1, Paragraph [0073-0074]). However Pappone does not explicitly disclose wherein the receiving includes defined ablation parameters associated with the potential location. Mangual-Soto further discloses wherein the receiving includes defined ablation parameters associated with the potential location (method of determining ablation parameters, Paragraph [0079], in block 608, one or more ablation parameters (e.g., ablation energy level, ablation time, and ablation contact force) are determined using the index map, Paragraph [0083]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone to incorporate the teachings of Mangual-Soto by including wherein the receiving includes defined ablation parameters associated with the potential location. The motivation to do so being to being to determine one or more ablation parameters that will likely result in the creation of a transmural lesion at that location (Mangual-Soto, Paragraph [0083]).
Regarding claim 18, Pappone in view of Mangual-Soto and Edwards discloses the system of claim 11.
Pappone further discloses wherein the received data includes any of the following: ripple frequency maps with ripple percentage and peaks, fragmentation index, cycle length maps, complex fractionated atrial electrograms (CFAE), finder, fractionation map, complexity map, clinical ablation parameters including site, and index, clinical outcome including acute, after a blanking period of several days and after long-term follow-up (a signal processor, e.g., a computer 40, using CFAE module of CART03 may be used for mapping, Paragraph [0073], processing device 1004 may include one or more processors each configured to process the ECG signals, record ECG signals over time, filter ECG signals, fractionate ECG signals into signal components, Paragraph [0069]).
Regarding claim 20, Pappone in view of Mangual-Soto and Edwards discloses the system of claim 11.
Pappone further discloses wherein the received data includes at least one cardiac mapping including at least one of ripple frequency maps with ripple percentage and peaks, fragmentation index, cycle length maps, complex fractionated atrial electrograms (CFAE), finder, fractionation map, complexity map, anatomical mapping including computed tomography (CT), magnetic resonance imaging (MRI), ultrasonography, clinical ablation parameters including site, and index, and clinical outcome including acute, after a blanking period of several days and after long-term follow-up (a signal processor, e.g., a computer 40, using CFAE module of CART03 may be used for mapping, Paragraph [0073], processing device 1004 may include one or more processors each configured to process the ECG signals, record ECG signals over time, filter ECG signals, fractionate ECG signals into signal components, Paragraph [0069]).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pappone in view of Mangual-Soto and Edwards further in view of Alhusseini et al. (WO 2019212833) herein referred to as “Alhusseini”.
Regarding claim 4, Pappone in view of Rodriguez discloses the method of claim 1.
Pappone discloses wherein the received data includes at least one 3D cardiac map (performing three dimensional mapping of the EGM signals, claim 1, Paragraphs [0073-0074]). However Pappone does not explicitly disclose wherein the received data includes at least one electrogram (EGM) data for individuals other than the patient.
Alhusseini discloses a system and method for identifying and treating a disease in a patient by collecting data from one or more data streams including treatment of heart rhythm disorders including atrial fibrillation (Paragraph [0011]). Alhusseini further discloses receiving time-series data (intracardiac electrograms (seen as EGM signals)) which are processed to distinguish AF ablation targets (Paragraph [00164] and [00169]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Rodriguez to incorporate the teachings of Alhusseini by receiving electrogram (EGM) signals for individuals other than the patient. The motivation to do so being to generate maps of AF which may point to regions of organized rotational or focal activation, combine them with clinical data to create personal electrogram phenotypes, and provide therapy options based on the personalized electrogram-based phenotype (Alhusseini, Paragraphs [00164]-[00173]).
Regarding claim 14, Pappone in view of Rodriguez discloses the system of claim 11.
Pappone discloses wherein the received data includes at least one 3D cardiac map (performing three dimensional mapping of the EGM signals, claim 1, Paragraphs [0073-0074]). However Pappone does not explicitly disclose wherein the received data includes at least one electrogram (EGM) data for individuals other than the patient.
Alhusseini discloses a system and method for identifying and treating a disease in a patient by collecting data from one or more data streams including treatment of heart rhythm disorders including atrial fibrillation (Paragraph [0011]). Alhusseini further discloses receiving time-series data (intracardiac electrograms (seen as EGM signals)) which are processed to distinguish AF ablation targets (Paragraph [00164] and [00169]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Rodriguez to incorporate the teachings of Alhusseini by receiving electrogram (EGM) signals for individuals other than the patient. The motivation to do so being to generate maps of AF which may point to regions of organized rotational or focal activation, combine them with clinical data to create personal electrogram phenotypes, and provide therapy options based on the personalized electrogram-based phenotype (Alhusseini, Paragraphs [00164]-[00173]).
Claims 6, 7, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Pappone in view of Mangual-Soto and Edwards further in view of Rodriguez et al. (U.S. PGPub. No. 2020/0022649) herein referred to as “Rodriguez”.
Regarding claim 6, Pappone in view of Mangual-Soto and Edwards discloses the method of claim 1.
However Pappone does not explicitly disclose wherein the received data includes data configured from training data with acute outcomes of retrospective cases fed to a machine learning model.
Rodriguez discloses wherein the received data includes data configured from training data with acute outcomes of retrospective cases fed to a machine learning model (training set data including collections of ablation segment effectiveness parameters 2100 may include examples of positive and negative outcomes, positive outcome (in other words: effective ablation), Paragraph [0382], the estimator is created using machine learning to discover correlations between input parameters and observed outcomes, Paragraph [0119]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Mangual-Soto and Edwards to incorporate the teachings of Rodriguez by including wherein the received data includes data configured from training data with acute outcomes of retrospective cases fed to a machine learning model. The motivation to do so being to being discover correlations between input parameters and observed outcomes (Rodriguez, Paragraph [0119]).
Regarding claim 7, Pappone in view of Mangual-Soto, Edwards, and Rodriguez discloses the method of claim 6.
However Pappone does not explicitly disclose wherein the training data includes any of the following: the maps that are created during an ablation, the ablation data collected during the procedure, ablation catheter type, three-dimensional (3D) location of ablation points, power used for ablation, time of point ablation duration, irrigation, catheter stability, parameters related to the area of the ablation to verify transmural ablation based on a 'predicted' tissue width, and/or the outcome of the procedure.
Rodriguez discloses wherein the training data includes any of the following: the maps that are created during an ablation, the ablation data collected during the procedure, ablation catheter type, three-dimensional (3D) location of ablation points, power used for ablation, time of point ablation duration, irrigation, catheter stability, parameters related to the area of the ablation to verify transmural ablation based on a 'predicted' tissue width, and/or the outcome of the procedure (training set data including collections of ablation segment effectiveness parameters 2100 with observed lesion effectiveness 1602, Paragraph [0381], training set data including collections of ablation segment effectiveness parameters 2100 include examples of positive and negative outcomes, Paragraph [0382]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pappone in view of Mangual-Soto, Edwards, and Rodriguez discloses the method of claim 6.
to incorporate the teachings of Rodriguez by including wherein the training data includes any of the following: the maps that are created during an ablation procedure, the ablation data collected during the procedure, ablation catheter type, three-dimensional (3D) location of ablation points, power used for ablation, time of point ablation duration, irrigation, catheter stability, parameters related to the area of the ablation to verify transmural ablation based on a 'predicted' tissue width, and/or the outcome of the procedure. The motivation to do so being to being discover correlations between input parameters and observed outcomes (Rodriguez, Paragraph [0119]).
Regarding claim 16, Pappone in view of Mangual-Soto and Edwards discloses the system of claim 11.
However Pappone does not explicitly disclose wherein the received data includes data configured from training data with acute outcomes of retrospective cases fed to a machine learning model.
Rodriguez discloses wherein the received data includes data configured from training data with acute outcomes of retrospective cases fed to a machine learning model (training set data including collections of ablation segment effectiveness parameters 2100 may include examples of positive and negative outcomes, positive outcome (in other words: effective ablation), Paragraph [0382], the estimator is created using machine learning to discover correlations between input parameters and observed outcomes, Paragraph [0119]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Mangual-Soto and Edwards to incorporate the teachings of Rodriguez by including wherein the received data includes data configured from training data with acute outcomes of retrospective cases fed to a machine learning model. The motivation to do so being to being discover correlations between input parameters and observed outcomes (Rodriguez, Paragraph [0119]).
Regarding claim 17, Pappone in view of Mangual-Soto and Edwards discloses the system of claim 11.
However Pappone does not explicitly disclose wherein the training data includes any of the following: the maps that are created during the ablation procedure, the ablation data collected during the procedure, ablation catheter type, three-dimensional (3D) location of ablation points, power used for ablation, time of point ablation duration, irrigation, catheter stability, parameters related to the area of the ablation to verify transmural ablation based on a 'predicted' tissue width, and/or the outcome of the procedure.
Rodriguez discloses wherein the training data includes any of the following: the maps that are created during an ablation procedure, the ablation data collected during the procedure, ablation catheter type, three-dimensional (3D) location of ablation points, power used for ablation, time of point ablation duration, irrigation, catheter stability, parameters related to the area of the ablation to verify transmural ablation based on a 'predicted' tissue width, and/or the outcome of the procedure (training set data including collections of ablation segment effectiveness parameters 2100 with observed lesion effectiveness 1602, Paragraph [0381], training set data including collections of ablation segment effectiveness parameters 2100 include examples of positive and negative outcomes, Paragraph [0382]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Mangual-Soto and Edwards to incorporate the teachings of Rodriguez by including wherein the training data includes any of the following: the maps that are created during an ablation, the ablation data collected during the procedure, ablation catheter type, three-dimensional (3D) location of ablation points, power used for ablation, time of point ablation duration, irrigation, catheter stability, parameters related to the area of the ablation to verify transmural ablation based on a 'predicted' tissue width, and/or the outcome of the procedure. The motivation to do so being to being discover correlations between input parameters and observed outcomes (Rodriguez, Paragraph [0119]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pappone in view of Mangual-Soto and Edwards further in view of Mahapatra et al. (U.S. PGPub. No. 2018/0228536) herein referred to as “Mahapatra”.
Regarding claim 9, Pappone in view of Mangual-Soto and Edwards discloses the method of claim 1.
However Pappone does not explicitly disclose wherein the received data includes patient parameters including at least one of age, gender, medications, medical history
Mahapatra discloses a method of determining a candidate ablation location (Abstract) wherein the method further discloses wherein the received data includes patient parameters including at least one of age, gender, medications, medical history (processing apparatus 16 employs the above-described probabilistic analysis to identify and output candidate ablation locations on display device 40, input device 44 is used to input patient- and case-specific data associated with the candidate ablation procedure, including a patient age, a patient gender, one or more known patient conditions (i.e., medical history), Paragraph [0030]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Mangual-Soto and Edwards to incorporate the teachings of Mahapatra by including wherein the received data includes patient parameters including at least one of age, gender, medications, medical history. The motivation to do so being to use patient specific data to identify and display one or more candidate ablation locations that are most likely to provided successful patient outcomes if ablation is performed at those ablation locations (Mahapatra, Paragraph [0031]).
Regarding claim 19, Pappone in view of Mangual-Soto and Edwards discloses the system of claim 11.
However Pappone does not explicitly disclose wherein the received data includes patient parameters including at least one of age, gender, medications, medical history
Mahapatra discloses a method of determining a candidate ablation location (Abstract) wherein the method further discloses wherein the received data includes patient parameters including at least one of age, gender, medications, medical history (processing apparatus 16 employs the above-described probabilistic analysis to identify and output candidate ablation locations on display device 40, input device 44 is used to input patient- and case-specific data associated with the candidate ablation procedure, including a patient age, a patient gender, one or more known patient conditions (i.e., medical history), Paragraph [0030]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Pappone in view of Mangual-Soto and Edwards to incorporate the teachings of Mahapatra by including wherein the received data includes patient parameters including at least one of age, gender, medications, medical history. The motivation to do so being to use patient specific data to identify and display one or more candidate ablation locations that are most likely to provided successful patient outcomes if ablation is performed at those ablation locations (Mahapatra, Paragraph [0031]).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Trayanova (U.S. Pat. No. 10,842,401), Rodriguez (U.S. Pat. No. 11,744,515), and Dalal (U.S. PGPub. No.2011/0015628) all disclose ablation planning methods and systems.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794