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 .
DETAILED ACTION
In the response filed 09 January 2026, the following has occurred: Claims 1, 14 and 20 have been amended.
Now claims 1-2, 4-9, 13-16, 18 and 20-21 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 January 2026 has been entered.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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, 4-9, 13-16, 18, 20 and 21 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.
Claims 1, 14 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite method, system and non-transitory computer readable medium (CRM) for assessing a representation of a physiological system of a subject for a disease state. The limitations of:
Claim 1, which is representative of claims 14 and 20
[… obtaining …], a plurality of biophysical signal data sets of a subject; wherein the plurality of biophysical signal data sets include wide-band phase gradient biopotential signal data; generating outputs of feature sets for use in a trained machine learning operation by: generating, […], a decomposed and reconstructed model from a […] analysis of the wide-band phase gradient biopotential signal data; subtracting, […], the decomposed and reconstructed model from the wide-band phase gradient biopotential signal data to generate a residue data set; generating, […] using only data from the residue data set, a residue model comprising a point-cloud residue; performing a […] analysis of the frequency components of the wideband phase gradient biopotential signal data by analyzing, […], only the residue model and not the decomposed and reconstructed model; generating, […], a three-dimensional volumetric object from only the point-cloud residue and without using the subtracted signal data or the decomposed and reconstructed model, wherein the point-cloud residue comprises a plurality of vertices defined in a three-dimensional phase space; and determining, […], values for machine extractable features associated with a geometric associated aspect of the three-dimensional volumetric object, […. organizing a model …] using (i) the values determined for the corresponding machine extractable features with (ii) labeled data for significant coronary artery disease; assessing, using at least one […] classifier […], the presence and/or non-presence of significant coronary artery disease, and outputting the values determined for the corresponding machine extractable features and a diagnosis of the presence and/or non-presence of significant coronary artery disease based on the assessment.
, as drafted, is a method, which under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions). That is, by a human user interacting with one or more processors (claim 1), a system comprising a processor and a memory (claim 14) and a non-transitory CRM with a processor (claim 20), the claimed invention amounts to managing personal behavior or interaction between people, the Examiner notes as stated in the “October 2019 Update: Subject Matter Eligibility” guidance at page 5, “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”.. For example, by a human user interacting with one or more processors (claim 1), a system comprising a processor and a memory (claim 14) and a non-transitory CRM with a processor (claim 20), the claim encompasses collection of data for organization of the collected data into models to be used to further organize the data into determinations about coronary artery disease that are provides to a human user via interaction with the generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of one or more processors (claim 1), a system comprising a processor and a memory (claim 14) and a non-transitory CRM with a processor (claim 20), which implements the abstract idea. The one or more processors (claim 1), a system comprising a processor and a memory (claim 14) and a non-transitory CRM with a processor (claim 20) are recited at a high level of generality (i.e., a general purpose computer; See Applicant’s specification Figure 17, paragraphs [0174]-[0184]) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim recites the additional elements of “equipment configured to measure electrical properties of a subject”, “obtaining, by one or more processors…”, “a Fast Fourier Transform analysis”, “a chaotic analysis” and “training a model including a plurality of classifiers”. The “equipment configured to measure electrical properties of a subject” steps are recited at a high-level of generality (i.e., an off the shelf lead for and ECG; See Applicant’s specification paragraphs [0068]-[0069]), and amounts to generally linking the abstract idea to a particular technological environment. The “obtaining, by one or more processors…” steps are recited at a high-level of generality (i.e., as a general means of receiving/transmitting data) and amounts to the mere transmission and/or receipt of data, which is a form of extra-solution activity. The “a Fast Fourier Transform analysis” is recited at a high level of generality (i.e., off the shelf FFT and inverse FFT) and amounts to generally linking the abstract idea to a particular technological environment. The “a chaotic analysis” is recited at a high level of generality (i.e., off the shelf algorithms for analysis of chaotic datasets) and amounts to generally linking the abstract idea to a particular technological environment. The “training a model including a plurality of classifiers” is recited at a high level of generality (i.e., off the shelf training of a model for use in making determinations) and amounts to generally linking the abstract idea to a particular technological environment. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient 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 elements of one or more processors (claim 1), a system comprising a processor and a memory (claim 14) and a non-transitory CRM with a processor (claim 20), to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using a generic hardware component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “equipment configured to measure electrical properties of a subject”, “obtaining, by one or more processors…”, “a Fast Fourier Transform analysis”, “a chaotic analysis” and “training a model including a plurality of classifiers” were considered extra-solution activity and/or generally linking to a particular technological environment. The “equipment configured to measure electrical properties of a subject” has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Burton: Figure 1, paragraphs [0047]-[0052]; Upton: Figure 1, paragraph [0098]; use of noninvasive equipment to collect biophysical signals is well-understood, routine, and conventional. The “obtaining, by one or more processors…” steps have been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.05(d)(II)(i) “Receiving or transmitting data over a network” is well-understood, routine, and conventional. The “a Fast Fourier Transform analysis” has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Burton: paragraphs [0058]; use of FFT is well-understood, routine and conventional. The “a chaotic analysis” has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Chen: page 3; Bukhman (20100274303): paragraph [0095]; Duan (20080183093): paragraph [0062]; use of chaotic analysis is well-understood, routine and conventional. The “training a model including a plurality of classifiers” has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Burton: paragraph [103]; Choi: Figure 1, paragraphs [0007]; training a machine learning model is well-understood, routine and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claims 2, 4-9, 13, 15-16, 18 and 21 are similarly rejected because either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible.
Claims 2 and 15 further recite performance of a triangulation operation on the residue, however performance of a triangulation operation is not an additional element, and therefore cannot provide a practical application and/or significantly more.
Claims 4 and 16 further recite what the extractable features are but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claim 5 further recites generation of contour data but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claims 6 recite the additional element of noninvasive equipment. However, this additional element was already considered above and the same motivation is incorporated herein.
Claim 7 further recites the removal of a baseline wandering trend but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claim 8 recites the additional elements of “wherein the three-dimensional object is rendered and displayed at a display… and/or presented in a report” and a computing device. The computing device is recited at a high level of generality (i.e., a general purpose computer; See Applicant’s specification Figure 17, paragraphs [0174]-[0184]) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The “wherein the three-dimensional object is rendered and displayed at a display… and/or presented in a report” is recited at a high level of generality (i.e., as a generic display interface for presentation of information to a user) and amounts to generally linking the abstract idea to a particular technological environment. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient 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 elements of a computing device to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “wherein the three-dimensional object is rendered and displayed at a display… and/or presented in a report” was considered generally linking the abstract idea to a particular technological environment. This has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Burton: Figure 12-14, paragraph [0053]; Upton: Figure 5, paragraph [0150]; display of generated data objects is well-understood, routine, and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claim 9, further recites use of a sampling rate in collection of data but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claims 13, further recite analysis of biophysical signal but does not recite any additional elements, and therefore cannot provide a practical application and/or significantly more.
Claim 21 recites the additional element of using a neural network, however this is recited at a high level of generality (i.e., neural network machine learning algorithm) and amounts to generally linking the abstract idea to a particular technological environment. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a neural network were considered generally linking the abstract idea to a particular technological environment. This has been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Burton: paragraph [0020]; Choi: paragraph [0007]; use of neural networks is well-understood, routine, and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Response to Arguments
Applicant's arguments filed on 09 January 2026 have been fully considered but they are not persuasive. Applicant's arguments will be addressed below in the order in which they appear in the response filed on 09 January 2026.
Rejections under 35 U.S.C. § 101
Regarding the rejection of claims 1-2, 4-9, 13-16, 18 and 21, the Examiner has considered the Applicant’s arguments but does not find them persuasive. The Examiner has attempted to address all of the arguments presented by the Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
Applicant argues:
Applicant has amended independent claim 1 to include the feature of assessing the presence and/or non-presence of significant coronary artery disease and outputting the values determined for the corresponding machine extractable features and a diagnosis of the presence and/or non-presence of significant coronary artery disease based on the assessment. Applicant respectfully submits that these newly added features clearly are not directed to an abstract idea, and in the alternative, are additional elements that integrate the judicial exception into a practical application. Accordingly, claim 1 is therefore eligible subject matter under 35 U.S.C. § 101..
The Examiner respectfully disagrees.
It is respectfully submitted, the amended limitations do not introduce any additional elements, assessing and outputting the presence of CAD is not an additional element, the assessment at best, is merely generally linking use of the trained classifier to a particular technological environment to organize data to provide an output for a human user to use. The amended limitations further do not provide a technical solution to a technical problem recited in Applicant’s specification and/or an improvement in the functionality of the computer, no portions of Applicant’s specification is argued for any recitations of any technical problems rooted in computer hardware technology. The claims may improve upon the organization of data for analysis and use by a physician in interacting with their patients (i.e., the abstract idea), however an improved abstract idea is still an abstract idea. The claims as drafted do not recite improvements to the performance of the computer or a technical solution to a technical problem recited in Applicant’s specification and therefore cannot provide a practical application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew E Lee whose telephone number is (571)272-8323. The examiner can normally be reached M-Th 9-5:00 PM.
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/A.E.L./ Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684