I. ACKNOWLEDGEMENTS
This Office Action addresses U.S. Application No. 18/291164 (“’164 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is January 22, 2024.
This action is being issued following Applicant’s response of 2/9/2026 which included: 1) claim amendments 2) arguments and 3) a new declaration.
II. STATUS OF CLAIMS
Claims 1-11 were filed with the application. The amendment of 2/9/2026 amends claims 1, 4-6, and 10-11, and cancels claims 2-3. Therefore, as of the date of this Office Action, the status of the claims is:
a. Claim 1 and 4-11 (“Pending Claims”).
b. Claim 1 and 4-11 are examined (“Examined Claims”)
III. PRIORITY AND CONTINUING DATA
The ‘164 application is a national stage entry of PCT/KR2022/011904, filed 8/10//2022, which claims priority to Korean application 10-2021-0126071, filed 9/24/2021. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. REJECTIONS UNDER 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 1-11 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more (See MPEP 2106.04(a)).
Claim 1 recites the limitations:
Acquiring first biosignal data …
Outputting one or more heart rate variability features … by inputting the first biosignal into pre-trained neural network model., wherein the pretrained neural network model is a model generated based on a plurality of segments acquired by …
wherein the outputting …. includes
outputting the one or more heart rate variability feature values based on heart rate variability features corresponding to the plurality of segments
wherein a time period of each of the plurality of segments is longer than the first time period
The first step in the 101 analysis, step 1 in MPEP 2106, is whether the claimed invention is in one of the 4 statutory classes of invention. Here, the claim is drawn to a method for extracting heart rate variability features, which are each is one of the 4 statutory classes of invention. Hence, step 1 is satisfied.
The next step in the analysis, step 2A prong one, is whether the claim is directed to judicial exception, i.e. a law of nature, a natural phenomenon, or an abstract idea. Here, the outputting step a mental process that can be performed using a pencil and paper. Mental processes are recognized as judicial exceptions that recite an abstract idea. See MPEP 2164
In Step 2A, prong two of the analysis, the claim is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application.
The claim has only the additional element of the acquiring step, step is merely a data gathering step, which is pre-solution activity. In addition, the neural network model is also recited at a high level of generality. More specifically, this appears to be a generic neural network, or machine learning model, applied to a new environment, as discussed in Recentive Analytics, Inc. v Fox Corp., 134 F4th 1205 (Fed Cir 2025) Therefore, the additional elements and steps do not integrate the claim into a practical application. As such, the answer to step 2A, prong 2, is no.
The final step of the analysis, step 2B, where the claim is evaluated to determine whether the recited additional elements amount to significantly more than the judicial exception. Here, the additional steps and structure are simply well-understood, routine, and conventional processing steps and structure. Hence, the step does not recite an inventive concept.
As such, claim 1 is directed to an abstract idea and is not patent eligible.
As to claims 4, 5, 7-9, the claims do not add anything that changes the analysis and hence, are also drawn to an abstract idea.
The analysis of claim 6 follows that of claim 1.
Claims 10 and 11 recite a program and device for performing the method, and only recite structure at a high level of generality. Hence, the analysis of claim 1 applies to claims 10 and 11.
V. ALLOWABLE SUBJECT MATTER
Claims 1 and 4-11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
Claims 1, 4, 5, and 7-11 defines over the art of record in that none of the art specifies that each of the segments is longer than the first time period, as claimed.
Claim 6 defines over the art in that none of the art teaches measuring biosignals over longer time period then when arrhythmia is not present.
VI. ANSWER TO ARGUMENTS
With respect to the 101 rejection, Applicant has asserted that the claims include a series of processes corresponding to concrete computer-implemented steps rather than mere mental processes or mathematical steps. It is the Examiner’s opinion that the claim is simply applying a generic machine learning model to a new processing environment, which was held to not make a claim statutory in in Recentive Analytics, Inc. v Fox Corp., 134 F4th 1205 (Fed Cir 2025).
Applicant has asserted that the steps required to process a signal in a neural network cannot be performed mentally. However, the Fed Circuit has repeatedly held that applying a generic computer to an otherwise non-statutory claim does not save the claim. Specifically, the court noted in Recentive that the inquiry is whether the claims focus on specific asserted improvements in computer capabilities or simply uses the computer as a tool. a computer is used as a tool. If a computer is used as a tool, then the,use of a computer cannot make a mental process statutory. The fact that it is a neural network and not a computer does not change the analysis.
It is the Examiner’s position that the neural network model recited here is merely a generic neural network model. Nothing in the disclosure establishes that the neural network model is improved. Further, while the claim recites a specific type of training data, the use of the training data does not represent a technological improvement. As found in Recentive, using training data is incident to the operation of neural networks. Further, the current specification does not allege that the use of the training data based on segments in the second biosignal somehow results in an improvement to the functioning of the neural networks.
Hence, it is the Examiner’s position that the current claims merely apply a generic neural network model to the field of measuring heart rate variability parameters. As such, the claims still recite a mental process that can be performed mentally, i.e. using paper and pencil. For example, the broadest reasonable interpretation of the claims is that one gathers a short amount of data, and assumes it remains constant for a longer period and extrapolates the results over a longer period. The use of a generic neural network does not change the analysis.
Applicant’s argument that the specific dataset allows the model to learn the correlation between short term and long term inputs falls under the rational that this type of behavior is incident to neural networks in general. The training data inherently allows the model to perform whichever task it is being assigned, but does not implement and improvement to the functioning of the neural network.
As to claim 6, Applicant has asserted that the final step, varying the measurement period depending on whether an arrhythmia is present or up to a time point when a signal of a predefined pattern is measured provides a technological improvement. The Examiner disagrees, noting that the claim feature merely imparts a functional distinction. It does not improve the functioning of a neural network or otherwise improve the technology.
As such, the 101 rejections stand.
VII. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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/ROBERT L NASSER/ Primary Examiner, Art Unit 3992