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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 have been considered but are moot because the new ground 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.
Rejection under 35 USC 101
Applicant argues that the step of outputting the optimal location for performing the ablation by generating a three-dimensional electroanatomic map of the heart and displaying, on the three-dimensional electroanatomic map, an indication of the optimal location amounts to significantly more than providing results and reflects an improvement to electrophysiological mapping and ablation guidance. Examiner respectfully disagrees and maintains that the outputting step is still directed towards the extra-solution activity of providing results which fails to amount to significantly more. Examiner also maintains that the claims as a whole are directed to gathering and analyzing information using conventional techniques and displaying the result, which fails to show an improvement to the technology (MPEP 2106.05(a)(II)).
Step 2A, Prong One
Applicant further argues that the human mind cannot practically generate a three-dimensional map and therefore the claims do not recite a mental process. Examiner respectfully disagrees and notes that the human mind with paper and pencil is capable of generating a three-dimensional map based on analyzed data. Applicant further argues that three-dimensional mapping is a technical EP mapping operation in view of the specification, not a mental process. Examiner respectfully disagrees and notes that as currently written, the claims do not require a technical EP mapping operation and instead recite a generic processor generating the three-dimensional map which amounts to nothing more than providing instructions to implement the abstract idea on a generic computer component. Applicant further argues that claim 1 is analogous to claim 2 of Example 37 of the 2019 Subject Matter Eligibility Guidance. Examiner respectfully disagrees as claim 2 of Example 37 is directed towards determining the amount of use of each icon by tracking how much memory has been allocated to each application while the instant claims are directed towards determining an optimal location for an ablation based on gathered data. Examiner maintains that the human mind is capable of evaluating gathered data and generating a three-dimensional map based on the evaluation using a paper and pencil.
Step 2A, Prong Two
Applicant argues that the step of outputting the optimal location for performing the ablation on by generating a three-dimensional map integrates the abstract idea into a practical application by addressing the specific problem of predicting origins of arrhythmia. Examiner respectfully disagrees and maintains that generating the three-dimensional map is directed towards the insignificant extra-solution activity of providing results (MPEP 2106.05(g)). Also, the claim invokes a generic processor merely as a tool for generating the three-dimensional map rather than purporting to improve the technology or a computer. See MPEP 2106.05(f). Therefore, the limitation represents no more than mere instructions to apply the judicial exception on a computer. It can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of computers.
Applicant further argues that claim 1 is analogous to claims 2 and 3 of Example 48 because instant claim 1 carries the process through to a technical EP mapping result by generating the three-dimensional map and displaying on that map, an indication of the optimal ablation location. Examiner respectfully disagrees as claim 2 of Example 48 requires synthesizing speech waveforms from a cluster of numbers, while claim 3 of Example 48 requires converting a cluster of points in feature space into speech signals in the time domain and extracting spectral features from only one target source of the separated signals from the output step and generating a sequence of words from the spectral features to produce a transcript of the speech signal corresponding to the target source which are steps than cannot be practically performed in the human mind.
Applicant further argues that instant claim 1 is analogous to claim 2 of Example 45 since claim 2 requires sending control signals to an injection molding apparatus to open the mold and eject the molded polyurethane. Examiner respectfully disagrees and notes that the instant claims as a whole do not require sending a control signal in response to the analysis of gathered data, the generation of the map, or the training of the optimal location generation. The instant claims as a whole do not practically apply the abstract idea of locating an origin of arrhythmia and indicating an optimal ablation site. There is no technical implementation of the located origin of arrhythmia and indication of an optimal ablation.
Applicant further argues that instant claim 1 is analogous with Example 37 because the generation of the three-dimensional map is more than displaying a result and is instead a particular EP mapping display which provides an improvement to the technology. Examiner respectfully disagrees and maintains that the three-dimensional map with an indication of an optimal ablation site is a result and the claims as a whole are directed to gathering and analyzing information using conventional techniques and displaying the result, which fails to show an improvement to the technology (MPEP 2106.05(a)(II)).
Step 2B
Applicant argues that the Office has failed to sow that the claimed ordered combination of registering data to a coordinate system, generating an optimal ablation location based on the registered data, generating a three-dimensional map, and displaying an indication of the optimal location on that map is well-understood, routine, or conventional and is merely insignificant extra-solution activity. Examiner respectfully disagrees and maintains that determining the optimal location for ablation is the result of the analysis required by the claims, therefore outputting the optimal location would amount to nothing more than providing results (MPEP 2106.05(g)).
Examiner also maintains that that even newly discovered or novel judicial exceptions are still exceptions (MPEP 2106.04(I)) and that the question of whether a particular claimed invention is novel or obvious is "fully apart" from the question of whether it is eligible (MPEP 2106.05(d)). Examiners should rely on what the courts have recognized, or those in the art would recognize, as elements that are well-understood, routine, conventional activity in the relevant field when making the required determination. In this case, Examiner maintains that it is well-understood, routine, and conventional in the art to use a CS catheter, ECG leads, CT, MRI, and ICEG to gather data. For examples, see:
CS catheter
Gillberg et al (US Publication 2012/0165811) [0018]
Pachon Mateos et al (US Publication 2007/0038251)
ECG
Gillberg et al (US Publication 2012/0165811) [0026]
Keidar (US Publication 2004/0078036) [0024]
CT
Federov et al (US Publication 2022/0346856) [0025]
Keidar (US Publication 2004/0078036) [0038]
MRI
Ciaccio (US Publication 2009/0099563) [0012]
Federov et al (US Publication 2022/0346856) [0025]
ICEG
Ciaccio (US Publication 2009/0099563) [0044]
Keidar (US Publication 2004/0078036) [0007]
For the reasons discussed above, Examiner maintains that the claims as a whole recite an abstract idea without significantly more.
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 11-20 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.
Regarding claim 11, the limitations of “the processor generating…”, “the processor further generating…”, “the input/output device outputting…”, “the processor verifying…”, “the processor via the input/output device receiving…” appear to recite functional language and thus render the claim unclear. Specifically, it is unclear if claim 11 is reciting a processor and an input/output device configured to execute the claimed steps or if claim 11 is reciting the functions performed by the processor and input/output devices. In order to further advance prosecution, Examiner is interpreting claim 11 as reciting a processor and an input/output device configured to execute the claimed steps. Dependent claims inherit the same deficiencies.
Examiner suggests amending the claim to recite:
A system of aiding a physician to perform an ablation to treat an arrythmia using a located origin of the arrythmia for patients with non-sustained tachycardia, the system comprising:
an input/output device [[for]] configured to receive [[receiving]] at least a first set of data prior to performing the ablation and collected using at least electrocardiogram (ECG) leads, and at least a second set of data measured after initiation of the ablation by at least one of an ECG, an intracardiac electrogram (ICEG), magnetic resonance imaging (MRI), computed tomography (CT) and a coronary sinus (CS) catheter; and
a processor [[for]] configured to:
[[registering]] register the first set of data to a coordinate system of the second set of data;
[[the processor generating]] generate, based on the registered first and second sets of data, an optimal location within a heart for performing an ablation to treat the arrythmia with non-sustained tachycardia;
[[the processor further generating]] generate a three-dimensional electroanatomic map of the heart [[and]], wherein the input/output device is further configured to output[[ting]] the optimal location for performing the ablation by displaying, on the three-dimensional electroanatomic map, an indication of the optimal location, the optimal location being based on a voxel determined to be the origin of the arrythmia;
[[the processor verifying]] verify a clinical outcome of the ablation performed at the optimal location both during and after the ablation; and
[[the processor]] receive via the input/output device feedback on the verified clinical outcome of the ablation, the feedback including the outcome of the ablation measured both during the ablation and after ablation associated with the received first set of data.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of locating an origin of arrhythmia and indicating an optimal ablation site) without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a method/system for locating an origin of arrhythmia and indicating an optimal ablation site.
Step 2A, Prong One
Regarding claims 1-20, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claims 1 and 11, the limitations of “registering the first set of data…”, “generating, based on the registered first and second data, an optimal location…”, “outputting the optimal location by generating a three-dimensional map…”, and “training the optimal location generation using feedback…” are a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) with paper and pencil under the broadest reasonable interpretation but for the recitation of generic computer components.
Step 2A, Prong Two
For claims 1-20, the judicial exception is not integrated into a practical application. For claims 1 and 11, the additional limitation of an “Input/Output device” and a “processor” are recited at a high level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
The limitation of “receiving at least a first set of data…and a second set of data…” amounts to nothing more than the pre-solution activity of data gathering while the limitation of “outputting the optimal location” amounts to nothing more than the post-solution activity of providing results (MPEP 2106.05(g)).
Step 2B
The claims do not include additional elements that are sufficient enough 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 limitations of “receiving at least a first set of data…and a second set of data…” and “outputting the optimal location” amount to nothing more than extra-solution activities and fail to integrate the abstract idea into a practical application. In addition, the ECG leads, ICEG, MRI, CT and CS Catheter are recited at a high level of generality and using them to gather data is considered to be well known, routine, and conventional in the art.
Examples:
CS catheter
Gillberg et al (US Publication 2012/0165811) [0018]
Pachon Mateos et al (US Publication 2007/0038251)
ECG
Gillberg et al (US Publication 2012/0165811) [0026]
Keidar (US Publication 2004/0078036) [0024]
CT
Federov et al (US Publication 2022/0346856) [0025]
Keidar (US Publication 2004/0078036) [0038]
MRI
Ciaccio (US Publication 2009/0099563) [0012]
Federov et al (US Publication 2022/0346856) [0025]
ICEG
Ciaccio (US Publication 2009/0099563) [0044]
Keidar (US Publication 2004/0078036) [0007]
Dependent claims 2-6, 10, 12-16, and 20 are further directed to the abstract idea and do not introduce any additional elements that amount to significantly more under the Step 2A and Step 2B analyses.
Dependent claims 7-9 and 17-19 are directed towards extra-solution activities (MPEP 2106.05(g)) and do not introduce any additional elements that amount to significantly more under the Step 2A and Step 2B analyses.
Examiner suggests amending claims 1 and 11 to positively recite the step of performing the ablation based on the determined optimal location in order to help overcome the 101 rejection.
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.
Claim(s) 1-5, 7-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Passerini et al (US 2015/0294082) et al in view of Federov et al (US 2022/0346856) hereinafter Federov.
Regarding claim 1, Passerini discloses a method for aiding in performing an ablation to treat an arrythmia using a located origin of the arrythmia for patients with non-sustained tachycardia, the method comprising:
receiving at least a first set of data measured prior to performing the ablation and collected using at least electrocardiogram (ECG} leads (Fig. 1: step 106; [0025] EP data can include ECG measurements of the patient using ECG leads on a patient's torso), and at least a second set of data measured after initiation of the ablation by at least one of an ECG, an intracardiac electrogram (ICEG), magnetic resonance imaging (MRI), computed tomography (CT)and a coronary sinus (CS) catheter (Fig. 1: step 116; [0054] the ablated region can be automatically segmented from an interventional image (e.g., interventional MRI) acquired during the intervention after the ablation session);
registering the first set of data to a coordinate system of the second set of data (Fig. 1: step 118; [0056] the patient-specific anatomical heart model and the patient-specific computational cardiac EP model are updated based on the ablated region);
generating, based on the registered first and second sets of data, an optimal location within a heart for performing an ablation to treat the arrythmia with non-sustained tachycardia (Fig. 1: Step 112; [0052] pacing targets and ablation targets based on the virtual electrophysiology interventions are output);
outputting the optimal location for performing the ablation by generating a three-dimensional electroanatomic map of the heart (Fig. 2; [0024] image 210 shows a patient-specific anatomical model of the LV and RV mapped with myocardial fibers) and
displaying, on the three-dimensional electroanatomic map, an indication of the optimal location ([0052] pacing targets and ablation targets can be output by displaying the pacing targets and ablation targets on a visualization of the patient-specific anatomical heart model); and
training the optimal location generation using feedback based on a verified clinical outcome of the ablation performed at the output optimal location ([0057] Once the patient-specific anatomical heart model and the patient-specific computational EP model are updated, the method of FIG. 1 returns to step 110 and additional virtual EP interventions are performed using the updated patient-specific computational cardiac EP model),
the feedback including the outcome of the ablation measured both during the ablation and after ablation associated with the received first set of data ([0056] the patient-specific anatomical heart model and the patient-specific computational cardiac EP model are updated based on the ablated region).
While Passerini discloses using voxels to determine border zones and scar tissue of a 3D model of a heart, Passerini fails to expressly disclose the optimal location being based on a voxel determined to be the origin of the arrythmia. However, Federov discloses the optimal location being based on a voxel determined to the origin of the arrhythmia (Figs. 5, 11 and [0062], [0078]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Passerini with the optimal location being based on a voxel determined to be the origin of the arrythmia as taught by Federov. Such a modification would provide the predictable results of determining a location of a source of arrhythmia in a patient’s heart (Federov, Abstract).
Regarding claims 2 and 12, the modified Passerini discloses the method and system of claims 1and 11 as discussed above, but fails to disclose outputting a certainty score for the origin of the arrythmia. However, Federov discloses outputting a certainty score for the origin of the arrythmia (Figure 11 and [0025] the display will feature a 2D or 3D rendition of the patient's heart with each region color-coded or marked in some way based on the predicted probability of each region to be a cardiac arrhythmia source). It would have been obvious to before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as taught by Passerini with outputting a certainty score for the origin of the arrythmia, as taught by Federov. Such a modification would provide the predictable results of providing the location of at least one source of arrhythmia (Federov, Abstract).
Regarding claims 3 and 13, the modified Passerini discloses the method and systems of claims 1 and 11, as discussed above, but fails to disclose wherein the certainty score ranges from 0 to 1. However, Federov discloses wherein the certainty score ranges from 0 to 1 (Figure 11, Fedorov teaches locating a source of arrhythmia using a certainty score from 0 to 1). It would have been obvious to before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as taught by Passerini with the certainty score ranging from 0 to 1, as taught by Federov. Such a modification would provide the predictable results of providing the location of at least one source of arrhythmia (Federov, Abstract).
Regarding claims 4 and 14, the modified Passerini discloses the method and systems of claims 1 and 11, as discussed above, but fails to disclose wherein the certainty score is assigned per voxel in the output associated with the optimal location. However, Federov discloses wherein the certainty score is assigned per voxel in the output associated with the optimal location (Figure 11, Fedorov teaches locating a source of arrhythmia using a score from 0 to 1, wherein a score is assigned to each voxel of the image; [0061] Fedorov further discloses how the classification algorithms used to develop the certainty score were trained). It would have been obvious to before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method as taught by Passerini with the certainty score being assigned per voxel in the output associated with the optimal location as taught by Federov. Such a modification would provide the predictable results of providing the location of at least one source of arrhythmia (Federov, Abstract).
Regarding claims 5 and 15, Passerini discloses wherein the feedback is associated with the outcome of a performed ablation ([0056] the patient-specific anatomical heart model and the patient-specific computational cardiac EP model are updated based on the quantified ablated region).
Regarding claims 7 and 17, Passerini discloses wherein the first set of data includes patient data ([0025] EP data can include ECG measurements of the patient using ECG leads on a patient's torso).
Regarding claims 8 and 18, Passerini discloses wherein the first set of data includes additional data ([0016] At step 102, medical image data of the patient is received).
Regarding claims 9 and 19, Passerini discloses wherein the second set of data includes at least one of an ECG, MRI/CT, and 3D mapping ([0054] the ablated region can be automatically segmented from an interventional image (e.g., interventional MRI) acquired during the intervention after the ablation session).
Regarding claims 10 and 20, Passerini discloses wherein the at least one of an ECG, MRI/CT, and 3D mapping are combined to produce a composite map ([0056] At step 118, the patient-specific anatomical heart model and the patient-specific computational cardiac EP model are updated based on the ablated region).
Regarding claim 11, Passerini discloses a system of aiding a physician to perform an ablation to treat an arrythmia using a located origin of the arrythmia for patients with non-sustained tachycardia, the system comprising:
an input/output device (input/output devices 508) configured to receive at least a first set of data prior to performing the ablation and collected using at least electrocardiogram (ECG) leads, and at least a second set of data measured after initiation of the ablation by at least one of an ECG, an intracardiac electrogram (ICEG), magnetic resonance imaging (MRI), computed tomography (CT) and a coronary sinus (CS) catheter ([0060] input/output devices 508 may be used in conjunction with a set of computer programs as an annotation tool to annotate volumes received from the image acquisition device 520; Examiner notes that the input/output device is configured to receive acquired data); and
a processor ([0060] processor 504, which controls the overall operation of the computer 502 by executing computer program instructions which define such operation) configured to:
register the first set of data to a coordinate system of the second set of data (Fig. 1: step 118; [0056] the patient-specific anatomical heart model and the patient-specific computational cardiac EP model are updated based on the ablated region);
generate, based on the registered first and second sets of data, an optimal location within a heart for performing an ablation to treat the arrythmia with non-sustained tachycardia (Fig. 1: Step 112; [0052] pacing targets and ablation targets based on the virtual electrophysiology interventions are output);
generate a three-dimensional electroanatomic map of the heart (Fig. 2; [0024] image 210 shows a patient-specific anatomical model of the LV and RV mapped with myocardial fibers),
wherein the input/output device is further configured to output the optimal location for performing the ablation by displaying, on the three-dimensional electroanatomic map, an indication of the optimal location ([0052] pacing targets and ablation targets can be output by displaying the pacing targets and ablation targets on a visualization of the patient-specific anatomical heart model);
verify a clinical outcome of the ablation performed at the optimal location both during and after the ablation ([0056] quantifying the ablated region); and
receive via the input/output device feedback on the verified clinical outcome of the ablation, the feedback including the outcome of the ablation measured both during the ablation and after ablation associated with the received first set of data ([0056] the patient-specific anatomical heart model and the patient-specific computational cardiac EP model are updated based on the ablated region).
While Passerini discloses using voxels to determine border zones and scar tissue of a 3D model of a heart, Passerini fails to expressly disclose the optimal location being based on a voxel determined to be the origin of the arrythmia. However, Federov discloses the optimal location being based on a voxel determined to the origin of the arrhythmia (Figs. 5, 11 and [0062], [0078]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Passerini with the optimal location being based on a voxel determined to be the origin of the arrythmia as taught by Federov. Such a modification would provide the predictable results of determining a location of a source of arrhythmia in a patient’s heart (Federov, Abstract).
Claim(s) 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Passerini (US 2015/0294082) in view of Federov (US 2022/0346856) and further in view of Susil et al (US Patent No. 7844319) hereinafter Susil.
Regarding claims 6 and 16, the modified Passerini discloses the method and system of claims 1 and 11 as discussed above, but fails to disclose outputting an option to obtain new origins during the ablation. However, Susil discloses outputting an option to obtain new origins during the ablation (Col. 9, lines 4-13, By using MRI, endocardial landmarks can be visualized (on an output device) throughout the procedure and this information facilitates the identification of multiple ablation sites for arrhythmias (multiple origins), which provides options for different optimal locations during the procedure).
It would have been obvious to before the effective filing date of the claimed invention to one of ordinary skill in the art to further modify the method as taught by Passerini, with outputting an option to obtain new origins during the ablation as taught by Susil. Such a modification would provide the predictable results of ablating every origin of arrhythmia during the procedure in order to prevent the patient from having to undergo multiple procedures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kilray et al (US 2017/0027649) discloses mapping the heart prior to the ablation based on gathered data, performing an ablation, and verifying an outcome of an ablation procedure [0035].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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