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 .
Response to Amendment
This action is in response to the remarks filed on 5/01/2026. The amendments filed on 5/01/2026 are entered.
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, 4-14 and 16-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas of “mental processes” or “concepts relating to data comparisons that can be performed mentally or are analogous to human mental work” without significantly more.
Analyses of the subject matter eligibility tests are performed for each of the independent claims and associated dependent claims below.
Regarding independent claim 1, the claim recites:
The limitation of “extracting, via the processing circuitry, first frames corresponding to at least one echocardiogram view from the echocardiogram data” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about the frames that correspond to a particular echocardiogram view. The limitation of “extracting, via the processing circuitry, second frames corresponding to ventricular systole from the first frames corresponding to the at least one echocardiogram view” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about the frames that correspond to ventricular systole from the first frames. The limitation of “determining, via at least one machine learning model executed by the processing circuitry, an RHD risk score based on the second frames corresponding to ventricular systole such that the second frames are given greater weight in the determining than any other frames” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about an RHD risk score based upon the second frames observed. A human may also mentally give more weight to the second frames than other frames when generating a mentally determined RHD risk score. Therefore, the claim is directed to an abstract idea and a judicial exception.
Step 2A Prong 2 Analysis (Claim 1): This judicial exception is not integrated into a practical application because it does not recite any elements that integrate the abstract idea into a practical application such as improving the operation of the diagnostic device, or effecting a particular treatment or prophylaxis for a disease or medical condition. The claims do not recite any features of components that integrates the judicial exception into a practical application because the additional recited elements of “receiving, via processing circuitry, echocardiogram data” form extra-solution activity of mere data gathering that is executed on a generic computer of processing circuitry. Therefore, all of these claimed elements are not sufficient to improve the functioning of a diagnostic device or form of technology. Furthermore, while directed to activity for medical diagnostics, the claimed steps do not effect a particular treatment or prophylaxis for a disease or medical condition as it is only claiming diagnostic measurement steps and not altering a particular treatment in any way.
Step 2B Analysis (Claim 1): The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional recited elements of “receiving, via processing circuitry, echocardiogram data” form extra-solution activity of mere data gathering that is executed on a generic computer of processing circuitry. The limitations do not include improvements to the functioning of a computer or to any other technology or technical field, and the elements of the claim further do not effect a particular treatment or prophylaxis for a disease or medical condition. Furthermore, there are no claimed features that provide elements to identify improvements to general computing technologies based on the claimed features. As discussed above, limitations form insignificantly extra-solution activity, and link the judicial exception to generic medical diagnostics. Therefore the additional elements do not amount to significantly more.
Independent claims 13 and 20 include similar features to claim 1 and are similarly rejected.
Dependent claims 2 and 14 includes limitations that are directed to narrowing the form of acquired data in the extra solution activity of data gathering and therefore it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 4 includes limitations that are directed to adjusting the weight associated with various input data, which is directed to narrowing the mental processing abstract idea of the independent claim as a user may think within the mind about the second frames weighing a larger amount in the mental calculation of a risk score. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claims 5 and 16 includes limitations that are directed to particular identifying and characterizing of features within the observed images which is directed to narrowing the mental processing abstract idea of the independent claim as a user may think within the mind about features within the images. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claims 6 and 17 includes limitations that are directed to identifying and characterizing of features within the observed images which is directed to narrowing the mental processing abstract idea of the independent claim as a user may think within the mind about features within the images. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claims 7 and 18 includes limitations that are directed to identifying and characterizing of features within the observed images which is directed to narrowing the mental processing abstract idea of the independent claim as a user may think within the mind about features within the images. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 8 includes limitations that are directed to factors to be considered when providing a risk score which is directed to narrowing the mental processing abstract idea of the independent claim as a user may think within the mind about what elements of the gathered data to include in the mental analysis. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claims 9 and 19 includes limitations that are directed to identifying and characterizing of features within the observed images which is directed to narrowing the mental processing abstract idea of the independent claim as a user may think within the mind about features within the images. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 10 includes limitations that are directed to adjusting the weight associated with various input data, which is directed to narrowing the mental processing abstract idea of the independent claim as a user may think within the mind about the second frames weighing a larger amount in the mental calculation of a risk score. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 11 includes limitations that are directed to narrowing the type of model used in the analysis. It does not integrate into a practical application or amount to significantly more because it does not differentiate the mental processing steps of the claimed invention in such a way that precludes a human from performing the steps within the mind. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 12 includes limitations that are directed to narrowing the output of the mental processing abstract idea of the independent claim as a user may determine the type of RHD from observed input data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 21 includes limitations that are directed to narrowing the output of the mental processing abstract idea of the independent claim as a user may determine the type of RHD from observed input data. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 22 includes limitations that are directed to extra solution activity of data outputting as the determination is provided to a health care provider as an output. The “allow directed treatment” doesn’t form a positively recited particular treatment and therefore does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Response to Arguments
Applicant's arguments filed 5/01/2026 have been fully considered but they are not persuasive. Responses to each of the applicant’s arguments are detailed below.
Regarding the applicant’s arguments on pages 10-13 of the remarks, the applicant argues that the claims should not be rejected under 35 U.S.C. 101. The applicant argues on page 10 of the remarks that it is not reasonable to assert that the claimed features can be done in the human mind when considering the claim as a whole. The applicant argues that as a whole, the claim cannot be considered an abstract idea mental process because it could not be reasonably performed within the human mind. In the current rejections, it is the examiner’s position that the limitations of the independent claim do not meaningfully limit the steps considered to be mental processing abstract ideas in such a way that would preclude the limitations as being performed within the human mind. The echocardiogram data, while not capable of being directly acquired by a human mind, is considered to be extra solution activity of mere data gathering and therefore once produced to a human mind, the human would be capable of performing the subsequent processing steps. While a machine learning model is claimed in relation to generic computer processing circuitry, the interpretation in the rejections above is that it is merely an algorithm in which a computer is being used as a tool to perform the abstract idea. Humans readily observe medical image data, including individual frames of echocardiogram data, and make diagnostic inferences based upon the observed data. These inferences can provide greater weights towards particular diagnostic views of target regions of interest, and provide an analogous risk score determination as the claimed invention above. The claims do not positively recite processing steps or features that would be outside of the mental processing a human would perform to obtain an analogous risk score and therefore does not provide any additional processing in which the claim as a whole could be considered beyond the abstract idea of mental processing. Examiner suggests claiming more particular processing steps (if present in the applicant’s originally filed specification) that would not be capable of being performed within a human mind as one way to potentially overcome the current interpretation in the rejections above. For instance, additional limitations such as those defining training of a machine learning model or layers of a convolutional neural network would not be capable of being performed within a human mind. Including such features could form a combined set of features that are beyond the abstract idea interpretation. Reiterating as currently stated above, the limitations directed to the abstract idea mental processing steps are claimed in a broad manner in which analogous mental determinations and visual image analysis could be performed by a human within the mind. Therefore, the claims remain directed to an abstract idea.
The applicant further argues on pages 11-12 of the remarks that the claims include a practical application of improving the technology of rheumatic heart disease detection based upon machine learning and sets of frames that are given greater weight over other frames. The examiner does not find this argument persuasive because the machine learning model serves as a generic computing means in which a broad image analysis determination is made. The model does not reduce noise in the acquired echocardiograms or otherwise improve image quality, nor does it improve the speed or efficiency of image acquisition or improve how machine learning models are designed in order to improve their accuracy or efficiency. It merely forms an applying of the judicial exception on a computer, using the machine learning model as instructions to perform the human mental processing steps on the computer device. As discussed above, the same recommended recitation of additional processing steps such as those defining training of a machine learning model or defining layers of a convolutional neural network could also incorporate any recited abstract idea into the improvement of a machine learning algorithm (improvement to a technology) and integrate the abstract idea into a practical application. Currently, the broad recitation of weighting second frames remains interpretable as mental processing abstract idea limitations and therefore does not integrate the abstract idea into a practical application.
The applicant further argues on pages 12-13 of the remarks that the claims recite additional limitations that amount to significantly more as the claimed features do not represent a well-understood, routine, and conventional technique. In the current rejections, the structural recitation of processing circuitry forms a generic computer device in which the abstract idea is applied. In the current rejections, no specific limitations beyond the abstract idea recitation or extra-solution activity of data gathering were identified that would be interpreted as beyond well-understood, routine, and conventional techniques. The extraction of image data and determination of medical diagnostic analyses from that data are all capable of being performed within the human mind as currently claimed and therefore are directed to the judicial exception. No additional limitations or combinations of limitations in the claim amount to significantly more. As suggested above, further narrowing of the machine learning model techniques to particular steps that would not be capable of being performed within the human mind could also provide “significantly more” via an improvement to technology and could also render the claim subject matter eligible at step 2B.
As discussed above, examiner suggests further narrowing of the independent claim processing steps, likely including further limitations of the machine learning model, that would differentiate from an interpretation in which a human mind could reasonably perform those additional processing steps. If sufficiently differentiated, such a limitation could potentially render the claims subject matter eligible.
For these reasons, the applicant’s arguments have been considered but are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Min et al. (U.S. Pub. No. 20220392065) teaches to a medical image analysis, risk, diagnosis, and decision-making system and method that utilizes machine learning and artificial intelligence-based processing to determine algorithm outputs.
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 SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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, Keith Raymond can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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