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 .
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Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim.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.
Claim 13 is 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 13, “an estimated confidence level” is vague and inferentially included. It is unclear if this estimated confidence level is the same as “a confidence level” used in claim 10 or different. If it is different, it is unclear what element is providing the estimated confidence level. In line 3, “a plurality of voxels”, “an anatomy surface” and “a highest mean confidence level” are vague and inferentially included. No element has been set forth to produce or receive these elements and it is unclear whether they are meant as positive structural limitations or are meant as functional/intended use recitations.
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 10-11 and 13-24 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 a source vector and confidence level of the vector to identify a next region for acquiring additional cardiac input. 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 a source vector and confidence level of the vector to identify a next region for acquiring additional cardiac input, 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 next region for acquiring additional cardiac data/inputs. 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 a source vector and confidence level of the vector to identify a next region for acquiring additional cardiac input), 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.
Response to Arguments
Applicant's arguments filed 6/8/26 have been fully considered but they are not persuasive. The arguments that “claim 10 recites a specific arrangement of trained networks” and that the output neural network operates on “anatomy” are not persuasive and are not commensurate in scope to the claimed limitations, as claim 10 does not contain these limitations.
The argument that claim 10 recites a particular arrangement of a first device, a second device, and an output neural network that produces a source vector and confidence level to guide acquisition of additional cardiac input, which is the specific improvement, is not persuasive as the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements, or by additional elements in combination with the recited judicial exception to incorporate the abstract idea/mental concept into a complete system.
The argument that the claims are analogous to different USPTO subject matter eligibility guidance such as example 37 claim 2, example 47 claim 3, or example 40 claim 1 is not persuasive as those claims were found eligible as they were directed to improvements in the computer networking technology or computer functionality themselves, not to computers just outputting data from calculations as the current claims are directed to.
All the claims are doing are just providing additional data without disrupting the initial set of data. The Federal Circuit concluded that "[s]tanding alone, the act of providing someone an additional set of information without disrupting the ongoing provision of an initial set of information is an abstract idea," 896 F.3d at 1344-45, 127 USPQ2d at 1559.
In additions, 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.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/George R Evanisko/Primary Examiner, Art Unit 3792 8/25/26
Prosecution Insights