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 Arguments
Applicant's arguments and amendments regarding the 101 rejection, filed 11/11/2025 have been fully considered but they are not persuasive. The Applicant as argued that the training learning algorithm is the improvement to the functioning of a computer. The Examiner respectfully disagrees. Genetic Technologies Limited v. Merial LLC (Fed Cir., 2016) tells us that the inventive concept of step 2 of the Alice/Mayo analysis cannot be supplied by the abstract idea. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered law of nature (or natural phenomenon or abstract idea) cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity.” Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. The determination of the values involves mathematics using equations based on the waveform (eg. see Specification Para. 56-58). The values of healthy and sick patients are then fed into a generic neural network to train it for further calculations. With regards to the Desjardins decision, each case has its own merits. In this case, this training is something a trained physician can do in the mind or with pen and paper, eg. The trained physician can observe and analyze data on a waveforms belonging to healthy and sick patients and then calculate the intrinsic frequencies and angles using given equations. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). The Examiner recommends adding more language for non-generic physical elements or transformative steps towards the data that is rooted in the hardware. The 101 rejection is maintained below.
Applicant’s arguments and amendments regarding the 103 rejection, see page 15, filed 11/11/2025, with respect to claims 1-12 and 14-21 have been fully considered and are persuasive. The 103 rejection of claims 1-12 and 14-21 has been withdrawn.
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 1-12, 14-21 are rejected under 35 U.S.C. 101 because of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, claims 1-4 and 5-14 recite apparatuses, claim 15 recites a method.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites computing a first intrinsic frequency of a systolic phase of a cardiac cycle of the patient, a second intrinsic frequency of a diastolic phase of the cardiac cycle of the patient, a systolic intrinsic phase angle describing the systolic phase of the cardiac cycle of the patient, and a diastolic intrinsic phase angle describing the diastolic phase of the cardiac cycle of the patient (analysis/mathematical calculation), providing the first intrinsic frequency, the second intrinsic frequency, the systolic intrinsic phase angle, and the diastolic intrinsic phase angle to a trained artificial neural network (ANN) (observation/analysis/mathematical calculation) configured generate a classification score representing a likelihood that the patient has experienced a myocardial infarction (determination), determining, based on the classification score, whether the patient has suffered a myocardial infarction (determination).
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims recite a wearable device comprising at least once sensor, and a computing system. The wearable sensor and computing system are generic in view of the Applicant’s specification (eg. Para. 35-38). These are recited at a high level of generality and is recited as performing generic computer functions. i.e., data processing and mere data gathering. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Additionally, the sensors are recited at a high level of generality and amount to an insignificant extrasolution activity of mere data gathering (see MPEP 2106.05(g)). The alerts are insignificant extrasolution activity of outputting data. Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception? The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
The dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process).
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.
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/MICHAEL J LAU/Examiner, Art Unit 3796