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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/20/26 has been entered.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification does not use the term “converge” and it is unclear what this is related to in the disclosure.
Election/Restrictions
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/11/25.
Applicant's election with traverse of the restriction in the reply filed on 4/11/25 is acknowledged. The traversal is on the ground(s) that both groups are searched in the same overall area of A61B5. This is not found persuasive because A61B5 encompasses over a million documents to search through. In addition, as seen by the different classification for each group set forth in the restriction, they are searched in different areas and therefore there is a search burden.
The requirement was deemed proper and was therefore made FINAL.
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 10-24 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.
In claim 10, the next to last line, “to produce outputs that combine to converge on the focal point location” is vague as it is unclear what is actually being done by the system/output neural network. Does the system combine the outputs? Or does the system only provide the outputs that someone else or some other element must combine? Does the combining alone force, or result in, a convergence on the focal point location? Or is this convergence just another “indication” of the focal point location? In addition, the term “converge” is unclear as to what are the metes and bounds of this term.
As claim 10 has not positively recited any structure that actually combines the outputs, or converge the outputs, the examiner has interpreted claim 10 as an output NN that produces a plurality of outputs that some other element or user can use to combine to converge on the focal point location.
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 10-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the mental concept, or mathematical equation, of receiving a plurality of inputs to convert into spatial ECG feature vectors and spatial shape representations to be operated on by a neural network to produce outputs that combine to converge on focal point locations. This judicial exception is not integrated into a practical application because the combination of additional elements (inputs, devices, neural networks, etc.) fails to integrate the judicial exception into a practical application. The generically recited computer elements (e.g. inputs, devices, neural networks) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered separately and in combination do not add significantly more to the exception. The additional limitations only receive and calculate data and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.05.
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of receiving a plurality of inputs to convert into spatial ECG feature vectors and spatial shape representations to be operated on by a neural network to produce outputs that combine to converge on focal point locations, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. inputs, devices, a neural network; i.e. a computer or processor-- As described in the present disclosure, the system and method uses a general computer/processor programmed to perform the functions of the claims (e.g. paras. 133-134, etc.)) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claim 10 having inputs, devices, and a neural network, which is described in the disclosure as a general processor/computer in paragraphs 133-134, etc.) is a system having a computer or processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claims do not impose any limits on how the plurality of inputs or information is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. The claim also does not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The output neural network/processor is recited so generically (no details whatsoever are provided other than that they are a neural network/processor) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the processor. No element has been set forth to sense the plurality of input signals, such as the LAT points, ECG signals, etc., and the only additional elements are the inputs and devices, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/an output of a plurality of signals. The inputs and devices limitations represent extra-solution activity because it is a mere nominal or tangential addition to the claim. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of receiving a plurality of inputs to convert into spatial ECG feature vectors and spatial shape representations to be operated on by a neural network to produce outputs that combine to converge on focal point locations), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim(s) as a whole does not integrate the recited judicial exception into a practical application and the claim(s) is directed to the judicial exception.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 10, 11, 14, 16, and 21-24 are rejected under 35 U.S.C. 102a1 as being anticipated by Tuysuzoglu et al (2017/0330075). Tuysuzoglu discloses the following claimed limitations:
--a plurality of inputs (e.g. figure 5, elements 502, 504, 506; figure 6, element 602, etc.) that are a plurality of ECG signals and associated locations (e.g. element 502 showing ECGs of different/associated locations, paras. 34-35, etc.) and anatomy surface information, such as from CT (e.g. elements 504, 506, paras. 34-35, 38-39, etc.)
--inputted into two different devices to convert the data (e.g. figure 5, first device is the three blocks after element 502, second device is the 2 blocks after element 504; figure 6, first device is block 606, second device is block 604, etc.) where the first device provides spatial ECG vectors (e.g. conduction velocities, paras. 35, 37, 45, etc.) and is a first device neural network (e.g. paras. 35, convolution layers), and second device provides spatial shape representations and is a second device neural network (e.g. paras. 34, 35, 39, etc.)
As to the newly claimed limitation in claim 10, Tuysuzoglu meets the claim limitations as follows:
--the two device outputs are then used in an output neural network to provide outputs (e.g. figure 5, para. 35, output of conduction velocities on the anatomical cardiac model which are indicative of areas for ablation/focal points; figure 6, elements 610, 612, 614, 616, and/or 608, paras. 50, 53, 47-49, output of conduction, diffusivity, and/or action potential duration on the anatomical cardiac model which are “indicative” of areas for ablation/focal points, etc.). These outputs may be used by a person or other element to combine to converge on a focal point location as they represent areas and are indications of areas for ablation/focal points.
Claim Rejections - 35 USC § 103
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.
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.
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 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tuysuzoglu et al. Tuysuzoglu discloses the claimed invention and using neural networks to process the data as first and second devices, but does not specifically disclose a transformer NN and Vnet NN for the first and second devices. It would have been obvious to one having ordinary skill in the art at the time the invention was made (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Tuysuzoglu, with using a transformer NN and Vnet NN, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of providing specific kinds of NNs that can operate on ECG data and 3D image data that requires less training time and gets high resolution image data.
Response to Arguments
Applicant's arguments filed 2/20/26 have been fully considered but they are not persuasive. The arguments that “the claims are directed to a method and apparatus of mapping efficiency by suggesting map point locations” and “the data including a plurality of signals received during the performance of a triangulation to locate a focal tachycardia” are not persuasive and are not commensurate in scope to the claimed limitations, as claims 10-24 do not contain these limitations. The claims are not to a method and they do not mention mapping efficiency, triangulation, and/or focal tachycardia. In addition, the applicant’s arguments that the claims overcome the limitations of the prior art systems may be correct (for some claims), however that argument is directed to anticipation and obviousness, not 101 and abstract ideas. As set forth in the recent court decision, Recentive Analytics, Inc. v. Fox Corp., patents “that do no more than claim the application of generic machine learning to new data environments, without disclosing improvements to the machine learning models to be applied, are patent ineligible under 101”. As described in the present disclosure, the system and method uses a general computer/processor programmed to perform the functions of the claims (e.g. paras. 133-134, etc.) and the claims are directed to general “neural networks”, and to conventional transformer networks or Vnet networks.
The argument regarding the 102 rejection in view of Tuysuzoglu is not persuasive as set forth above in the 102 rejection addressing the new claim limitation of outputs “that combine to converge on” the focal point location. Tuysuzoglu discloses that conduction velocity, action potential duration, ablation location, etc. are output and these outputs are produced and may be used by another person or element to combine and converge to be indicative of focal point location as they represent areas that may be arrhythmic or require ablation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 3/17/26