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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/10/26 has been entered.
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 1-2, 4-16, and 18 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 1, step f., the control unit “outputting a three-dimensional visualization of the activation map” is vague. It is unclear how a control unit/processor is outputting a 3D visualization, or if this is meant to be just that the control unit is outputting “data representing” a 3D visualization of the activation map.
Claims 15 and 16 use the same/similar language and are also vague.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-16, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter which was not described in the original specification is the control unit “outputting a three-dimensional visualization of the activation map”, in combination with the other elements/steps in the claims.
The original disclosure did not discuss any display or GUI to display a visualization of the map or use the term “visualization”. The disclosure discussed a general CPU/microprocessor (e.g. page 5, first full paragraph, etc.) as being used for the claimed control unit. It is unclear how a CPU outputs a 3D “visualization”, or if this just means that only “data” is output from the microprocessor that can then be used to provide a 3D visualization map.
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 1-2, 4-16, and 18 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 of acquiring ECG data, generating a random ECG using white noise and a generator of a GAN, and comparing the ECG to the random ECG using a discriminator of the GAN to generate and output an activation map if there is correspondence between the two. This judicial exception is not integrated into a practical application because the combination of additional elements fails to integrate the judicial exception into a practical application. The generically recited computer elements (e.g. control unit having a discriminator and generator of a GAN, etc.) or addition elements (in claims 16 and 18 a sensing module having electrodes for acquiring the ECG), do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. In addition, the sensing module having electrodes does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the apparatus to a particular technological environment and/or just meant to collect the data for the processing/mental concept. 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 compute/generate more data and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.05. As set forth in the applicant’s specification on page 5, lines 8-16, page 12, first full paragraph, page 7, first full paragraph, and page 15, second full paragraph, the control unit has a GAN and are standard, conventional, and/or well-known elements.
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 acquiring ECG data, generating a random ECG using white noise and a generator of a GAN, and comparing the ECG to the random ECG using a discriminator of the GAN to generate and output an activation map if there is correspondence between the two, 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. control unit having a GAN generator and discriminator; sensing module having electrodes in claims 16 and 18, 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 15 having a control unit, and corresponding method claim 1) is a system having control unit/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 ECG 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 control unit/processor is recited so generically (no details whatsoever are provided other than that it is a control unit/processor) that it represents 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 control unit/processor. No element has been set forth to sense the ECG signal, and the only additional element is the sensing module having electrodes (in claims 16/18), where the control unit/processor performs the necessary software tasks so that the result of the abstract mental process is just data/generating an activation map if there is correspondence between the random ECG and measured ECG. In addition, the sensing module having electrodes does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the apparatus to a particular technological environment and/or just meant to collect the data for the processing/mental concept. The sensing module having electrodes limitation represents token 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 acquiring ECG data, generating a random ECG using white noise and a generator of a GAN, and comparing the ECG to the random ECG using a discriminator of the GAN to generate and output an activation map if there is correspondence between the two, etc.), 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 as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
Response to Arguments
Applicant's arguments filed 2/10/26 have been fully considered but they are not persuasive. The applicant’s argument that the invention improves a problem in the art is not persuasive as the abstract idea by itself cannot provide the improvement/invention. Additional elements that practically integrate the abstract idea/mental concept into a complete system or method must be provided, which the claims do not provide. While the applicant argues that the claimed invention uses ECG signals and provides a visualization, the claims only receive/acquire data and manipulate the data for data to be output, and/or use a general control unit/processor to manipulate the data, and/or use a conventional GAN or neural network as part of the control unit in the system and method. The claims do not include additional elements directed to actually sensing the ECG, such as electrodes, in addition to a GUI/display to provide the 3D visualization to a user that could diagnose the patient’s condition, and therefore are lacking these additional elements that would practically integrate the abstract idea/mental concept into a complete system or method.
The argument that the 101 rejection should be withdrawn since the claims are “restricted in scope to a particular type of machine learning algorithm (GAN) the use of which is recited with particularity in the claim” is not persuasive. As set forth in the disclosure, the use of GAN is a machine learning limitation that as described in the disclosure is a well-known technique and is broadly and functionally described (e.g. page 7, first full paragraph, page 12, first full paragraph, page 15, second full paragraph, etc.). In addition, the control unit which implements the GAN is a generic computing machine or processor (e.g. page 5, lines 8-16, etc.). Therefore the additional limitations of the control unit having a generator and discriminator of a GAN fails to practically integrate the mental concept into a complete system or method. The additional limitations 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. While the applicant argues that the use of the GAN improves computer functionality, this is not what the claims and disclosure are directed to, but are directed to a cardiac activation map for diagnosing a patient’s heart condition (e.g. page 1 of the specification under Background). 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 idea, and thus this claim cannot improve computer functionality or other technology. Finally, it is noted that the claims do not impose any limitation on how the ECG information/data is measured (until claims 16 and 18), and therefore the system and method are only acting on, manipulating, and computing data. While claims 16 and 18 do contain a sensing module with electrodes, this post solution activity does not practically integrate the mental concept into a complete system as it appears to be tangentially or generically linked/used to get the data for the mental concept.
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.
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 on 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 3/7/26