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 .
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 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method of analyzing electromechanical characteristics of a heart of a subject using a model that analyzes ECG and measurements of movement caused by the heart.
To start off, step 1 is covered as the claims recite a method.
Moving on to step 2A, this is a two-prong analysis. Under prong one, examiner is required to show the abstract idea, law of nature, or natural phenomenon. In this case, examiner points out that the steps of “analyzing a time series of electrocardiogram (ECG) measurements of the heart and measured during a first period of time after stent-placement angioplasty of the subject”, “analyzing a time series of measurements of movement caused by the heart during a second period of time after the stent-placement angioplasty of the subject and at least overlapping with the first period of time”, and “extracting one or more features of the measurements of movement” (Claim 21) are the abstract idea directed to a mental process. These limitations, under broadest reasonable interpretation, can be done in the mind other than the recitation of the generic computer component. That is, other than reciting “a model” nothing in the claim precludes the step from practically being performed in the mind. The steps of analyzing can simply mean looking at the data and coming up with any result, as doctors do when they look at medical charts. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Under prong two, examiner is required to show that the judicial exception is not integrated into a practical application. In particular, the claim recites the additional element including: “producing the at least one inference”, “the at least one model is trained to map the time series of ECG measurements and the time series of measurements of movement to corresponding changes in electromechanical characteristics of the heart” (Claim 1), and “non-linear feature” (Claim 21) . In this case, the additional elements recited are being performed using a generic computer function such that they amount no more than mere instructions to apply the exception using a generic computer component. The producing is merely data calculation that a generic computer can perform, the model being used is also a generic computer model, examiner believes that a physician would be capable of mapping the measurements to corresponding changes in characteristics in the heart. In terms of the model, that is simply a generic computer implementation of an abstract idea, it is no more than an automation of a mental process. Accordingly, these additional element do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea (MPEP 2106.05F). The claim is directed to an abstract idea.
Lastly for step 2B, 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 producing data and a trained model amount 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. The claim is not patent eligible.
Examiner states that the claim recites a judicial exception, but is not integrated into a practical application (Step 2b of 2019 PEG). In particular the steps of the claim do not recite any additional element that is required for the claim to be performed, moreover the steps of the claim add insignificant extra-solution activity to the abstract idea. (See MPEP 2106.05 (g)). Therefore, the claim 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 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements recited. Dependent claims 2-4, 6-10, 16, and 18-20 do not integrate the abstract idea into a practical application.
Claims 2-4, 6-10, 16, and 18-20 are rejected based on their dependency to claim 1.
Allowable Subject Matter
Claims 1 and 21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
Claims 2-4, 6-10, 16, and 18-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Examiner was able to find broad references (US 2016/0220152 Mierheina and US 2015/0025335 Jain) that showed a model that analyzes ECG and movement measurements of the heart to produce an inference (See Paras 33, 36, and 52 of Mierheina and Paras 23, 29, and 37 of Jain). No references were found to teach the specific measurements being taken after a stent-placement angioplasty. This specific surgical procedure is important to the claims as the inference is being produced based on the results of the surgical procedure. Examiner did not find the motivation to combine references that taught the method for any other surgical procedure. For this reason claims 1-4, 6-10, 16, and 18-21 are objected to as allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 04/30/2026 have been fully considered but they are not persuasive.
Examiner first refers to the newly amended limitations. Applicant presents the argument “Claim 1 requires a trained computational model that performs a defined mapping between multi-modal physiological signals and corresponding electromechanical characteristics of the heart. Such processing involves analyzing synchronized time-series data and applying a trained model to generate inferences based on relationships between different physiological signal modalities. These actions are not practically performable in the human mind”. Examiner respectfully does not agree. Claim 1 does show a trained model, however, including a machine trained model in the claims does not overcome the 101 rejection. A trained model is merely a generic computer component. Examiner believes that a physician would be capable of mapping time series of ECG and movement measurements to corresponding changes in electromechanical characteristics of the heart. The mapping in its simplest form can mean nothing more than: "if the ECG says this, the movement says this, then it corresponds to this change in the heart". Examiner believes that these are steps that a user can do in their mind, utilizing a generic computer component.
Examiner does not believe that the newly recited trained model is not used for general analysis. While the examiner agrees that the model is being used in a particular post-procedural context, the computations the model is doing are steps can be performed using a generic computer, they are merely nothing more than data comparison. Examiner does not believe that the model used is curated specifically for the task at hand. Applicant argues “using a trained model to map the time series of ECG measurements and the time series of measurements of movement to corresponding changes in electromechanical characteristics of the heart after the stent-placement angioplasty can enable identification of relationships between electrical and mechanical cardiac activity that are not detectable using conventional analysis techniques” and examiner would agree with this remark if the model was doing any more than comparing and contrasting data to each other to determine an end result. A physician could do the entire method of claim 1 on a generic computer by simply looking at the data and comparing it to other data. The argument would stand, if the trained model was doing computational analysis that would be impossible for a user to do in a real-time application. Applicant points out “the time series of measurements of movement and the time series of ECG measurements may be synchronized "within about 5 ms of each other" so that the time periods are overlapping, which can allow for "increased opportunities for identifying time intervals or otherwise for analysis."” However, none of that is recited in the claims. No measurement of time is disclosed.
Claim 21 is rejected for the same reasons claim 1 is rejected, without the use of a trained model. A physician is more than capable of extracting non-linear features from the measurements of movement. For this reason, examiner holds the U.S.C 101 rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796
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