DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/16/2026 has been entered.
Response to Arguments
Applicant's arguments filed on 01/16/2026 have been fully considered but they are not persuasive.
35 USC 101
Applicant argues that the claims are not directed to an abstract idea and are instead directed to a method of predicting the location of ablation using data from before the procedure and during the procedure. Examiner respectfully disagrees and maintains that the claims are directed to the abstract idea of locating an origin of arrhythmia and indicating an optimal ablation site. Specifically, Applicant argues that the feedback recited in the claims is not performed by a human and therefore cannot be performed in the human mind. Examiner respectfully disagrees and notes that as currently written, the claims require a generic computer component (processor) to verify an outcome and receive feedback regarding that outcome. Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675 (MPEP 2106.04(a)(2)(III)). Merely providing instructions to perform an abstract idea on a generic computer components fails to amount to significantly more.
Applicant further argues that the claims are also directed to a method to perform an ablation to treat an arrhythmia. Examiner respectfully disagrees and notes that as currently written, the claims do not positively recite the step of performing an ablation or any structure capable of performing an ablation. The claims only require gathering data prior to and after initiation of an ablation. Examiner suggests amending the claims to recite the particular treatment of performing an ablation in order to help overcome the pending 101 rejection.
Applicant’s arguments, see pages 7-13, filed on 01/16/2026, with respect to claims 1 and 11 have been fully considered and are persuasive. The prior art rejection of claims 1 and 11 has been withdrawn.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: Claims 1 and 11 both recite acronyms (ECG, MRI, ICEG, etc.) without first reciting the full term. Examiner suggests amending the claims to first recite the full term and then the acronym. Appropriate correction is respectfully requested.
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 of 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 to a coordinate system of the second set of data”, “generating, based on the registered first and second sets of data, an optimal location…”, “outputting the optimal location…”, 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) but for the recitation of generic computing components under the broadest reasonable interpretation.
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.
Further, 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 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’s Note Regarding Prior Art
Examiner notes that claims 1-20 are rejected under 35 USC 101, however no prior art rejections have been made. The following is a statement of reasons for the indication of allowable subject matter: Examiner has not found prior art that teaches or suggests in combination the limitations recited in claims 1 and 11. Ciaccio discloses indicating origins for non-sustained tachycardia [0013], but fails to teach:
receiving at least a first set of data measured prior to performing the ablation and collected using at least ECG leads, and at least a second set of data measured after initiation of the ablation by at least one of an ECG, an ICEG, MRI, CT and CS catheter;
registering the first set of data to a coordinate system of the second set of data;
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, the optimal location being based on a voxel determined to be the origin of the arrythmia;
outputting the optimal location for performing the ablation by displaying the heart with an indication of the optimal location; and
training the optimal location generation using feedback based on a verified clinical outcome of the ablation performed at the output optimal location, the feedback including the outcome of the ablation measured both during the ablation and after ablation associated with the received first set of data.
Trayanova et al (US 2023/0363689) discloses:
receiving at least a first set of data measured prior to performing the pacing and collected using at least ECG leads [0033], and at least a second set of data measured after initiation of the pacing by at least one of an ECG, an ICEG, MRI, CT and CS catheter [0034];
registering the first set of data to a coordinate system of the second set of data [0039];
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 [0040];
outputting the optimal location for performing the ablation by displaying the heart with an indication of the optimal location (Fig. 4).
Trayanova fails to disclose:
receiving at least a first set of data measured prior to performing the ablation and collected using at least ECG leads, and at least a second set of data measured after initiation of the ablation by at least one of an ECG, an ICEG, MRI, CT and CS catheter;
registering the first set of data to a coordinate system of the second set of data;
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, the optimal location being based on a voxel determined to be the origin of the arrythmia;
outputting the optimal location for performing the ablation by displaying the heart with an indication of the optimal location; and
training the optimal location generation using feedback based on a verified clinical outcome of the ablation performed at the output optimal location, the feedback including the outcome of the ablation measured both during the ablation and after ablation associated with the received first set of data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Trayanova et al (US 2023/0363689) is directed towards pacing the heart at an origin of idiopathic ventricular arrhythmia.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792