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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Notice to Applicant
In the amendment dated 9/3/2026, the following has occurred: Claims 1, 3 – 8, 10 – 15, and 17 – 20 have been amended.
Claims 1 – 20 are pending.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims, understood as a whole, recites subject matter within a statutory category as a process (claims 8 – 14), machine (claims 1 – 7), and manufacture (claims 15 – 20) which recite the abstract idea steps of
identify at least one ablation line treatment for a patient based on atrial fibrillation-related features associated with the patient;
estimate reconnection probabilities for ablation sites associated with the at least one ablation line treatment, based on the ablation sites and corresponding ablation characteristics;
identify patient atrial fibrillation predictors associated with the patient, based on demographics and heart component dimension parameters associated with the patient;
enable a healthcare provider to provide the at least one ablation line treatment for the patient, in response to a prediction that the patient would not respond to any treatment using pulmonary vein isolation only.
generate, a recommended ablation line treatment for the patient, the recommended ablation line treatment being selected from the one or more ablation line treatments based at least in part on the reconnection probabilities, the patient atrial fibrillation predictors, and the patient demographics.
The Examiner understands the claimed invention, as a whole, in light of the Specification. The Examiner is also aware of the recent In Ex Parte Desjardins decision and related MPEP updates. The instant invention differs from Desjardins because the instant invention is not disclosed as a technological improvement. Rather, the invention applies known technology to the abstract idea to obtain all the benefits of applying the known technology to the abstract idea.
These steps of claims 1 – 20, as drafted, under the broadest reasonable interpretation, includes mathematical concepts. MPEP 2106.04(a)(2) guides the Examiner
When determining whether a claim recites a mathematical concept (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations), examiners should consider whether the claim recites a mathematical concept or merely limitations that are based on or involve a mathematical concept. A claim does not recite a mathematical concept (i.e., the claim limitations do not fall within the mathematical concept grouping), if it is only based on or involves a mathematical concept. See, e.g., Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902-03 (Fed. Cir. 2017) (determining that the claims to a particular configuration of inertial sensors and a particular method of using the raw data from the sensors in order to more accurately calculate the position and orientation of an object on a moving platform did not merely recite “the abstract idea of using ‘mathematical equations for determining the relative position of a moving object to a moving reference frame’.”). For example, a limitation that is merely based on or involves a mathematical concept described in the specification may not be sufficient to fall into this grouping, provided the mathematical concept itself is not recited in the claim.
It is important to note that a mathematical concept need not be expressed in mathematical symbols, because “[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula.” In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea); and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a stable value protected life insurance policy by performing calculations and manipulating the results’’ as an abstract idea).
Note that the formulas do not need to be expressed. However, the claimed steps of training, identifying, estimating, and predicting are all mathematical operations.
These steps of 1 – 20, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The Specification itself describes that the invention is directed towards methods of organizing human activity. For example,
FIELD OF THE INVENTION
[0002] This disclosure relates to computer systems and computer implemented methods for the treatment of atrial fibrillation using pulmonary vein isolation.
DETAILED DESCRIPTION
[0019] Embodiments herein enable using deep-learning for identifying pulmonary vein isolation non-responders, as described. A system trains a set of machine-learning models to predict which atrial fibrillation patients would respond to which treatments using ablation lines. The models identify an ablation line treatment for a patient based on atrial fibrillation-related features associated with the patient. The models estimate reconnection probabilities for ablation sites associated with at least one ablation line treatment. The models identify patient atrial fibrillation predictors associated with the patient, based on demographics and heart component dimension parameters associated with the patient, and use the at least one ablation line treatment, reconnection probabilities, patient atrial fibrillation predictors, and patient demographics to predict whether the patient would not respond to pulmonary vein isolation only treatment. In response to a prediction that the patient would not respond to pulmonary vein isolation only treatment, the system enables a healthcare provider to provide the at least one ablation line treatment for the patient.
The invention uses mathematics to aid a healthcare provider. As stated in paragraph 20, “The system outputs these predictions to Pat's physician, which enables the changing of the treatment that Pat was going to receive.”
The invention is not directed towards treating a patient. Rather, the invention is directed towards providing a physician advice. The end of the invention is not a specific step performed but rather a potential step that may be performed later.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 7, 9 – 14, and 16 – 20, reciting particular aspects of how predicting patient responses may be performed but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of when executed, cause the one or more processors amounts to invoking computers as a tool to perform the abstract idea,, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of enable a healthcare provider to provide amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 7, 9 – 14, and 16 – 20, additional limitations which amount to invoking computers as a tool to perform the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 20; training, identifying, estimating, identifying, and predicting, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii))
Additional Elements
Computer – including one or more processors, non-transitory computer readable medium – figure 12 and paragraphs 105 – 108
instructions, which when executed – paragraph 109
a set of machine-learning models – paragraph 45, 92, 98 “without limitation, this may include the set of trained machine-learning models”
network – paragraph 113
training is not explained explicitly, however the Specification states in paragraph 18, “In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.”
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 7, 9 – 14, and 16 – 20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields; training and predicting, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Response to Arguments
Applicant’s arguments, see Section 112 Rejection, filed 9/3/2026, with respect to claims 1 – 20 have been fully considered and are persuasive. The 35 USC 112 rejection of claims 1 – 20 has been withdrawn.
Applicant's arguments filed 9/3/2026 have been fully considered but they are not persuasive.
Section 101 Rejection
The Applicant states, “The memorandum further explains that a claim may be eligible when it reflects an improvement to another technology or technical field rather than merely using a computer as a tool.” The Examiner notes that the MPEP and the Court describes understanding the claims as a whole in light of the Specification. The Specification describes the claimed invention and what the Applicant believes that they have invented.
Step 2A, Prong One
The Applicant states, “The Office Action's mathematical-concept rationale does not comport with USPTO Guidance Examples 38, 39, and 46 or the August 4, 2025 USPTO memorandum.” The first question that the Examiner has is what does the Applicant believe that they have invented. Paragraph 2 is, “This disclosure relates to computer systems and computer implemented methods for the treatment of atrial fibrillation using pulmonary vein isolation.” Paragraph 21 begins with, “The techniques of this disclosure relate to a system which uses machine-learning models that predict whether atrial fibrillation patients would not be responders to treatments using pulmonary vein isolation alone. This prediction is crucial for optimizing patient outcomes and tailoring treatment strategies.” The Specification and as claimed describes how this occurs.
However, the Specification does not describe the one feature that the cited Examples describe. That feature is a technical or a technological improvement. The Specification describes the invention as applying technology to the abstract idea to obtain all the benefits of applying that technology to the abstract idea. The invention uses technology as quoted from paragraph 21 above. The invention does not improve technology. Therefore, all arguments directed to Examples is considered moot.
Step 2A, Prong Two
The Applicant states, “Instead, the claimed model outputs are combined to generate a patient-specific ablation line treatment selected from one or more treatments identified for that patient based at least in part on the claimed reconnection probabilities, AF predictors, and patient demographics.” The claim ends with a recommendation. A recommendation represents a potential application and not an actual application. Therefore, no practical application occurs.
Further arguments directed towards a practical application are considered moot.
The Applicant states, “They recite a specific machine-learning process that generates a recommended ablation line treatment from identified candidate treatments using recited patient- and ablation-related information.” However, unlike Desjardins and Core Wireless, there is no technical or technological improvement.
Step 2B
The Applicant states, “Even if the Office Action were to maintain that the amended claims are directed to an abstract idea, the claim elements, considered as an ordered combination, provide significantly more than the alleged exception.” The Applicant knows that the idea of an “ordered combination” relates to whether the claimed invention, as a whole, represents a technical or technological improvement. However, since is none claimed or disclosed, this argument is also moot.
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.
Marrouche et al Pub. No.: US 2010/0298 Certain embodiments provide a method of assessing a risk of thromboembolic stroke in a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571)272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
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