DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on October 30, 2025 were received and fully considered. Claims 31-35 are new. No claims were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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 1-5, 9-15, and 19-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a series of steps or acts for determining a sleep stage of a subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“...extracting one or more features from the thoracic RIP signal and from the abdomen RIP signal; determining the sleep stage of the subject based on the one or more features extracted from the thoracic RIP signal and from the abdomen RIP signal by performing a computer-based classification of the one or more features extracted from the thoracic RIP signal and from the abdomen RIP signal using a classifier, wherein the classifier is a neural network, decision tree or trees, forests of decision trees, clustering, and/or a support vector machine, wherein the one or more extracted features used in the computer-based classification include one or more of a respiratory rate or respiratory rate variability, a first harmonic or a DC component of a respiratory rate, a harmonic of the respiratory rate, a breath-by-breath characteristic, a breath amplitude, a breath length, a zero-flow ratio, RIP phase, skewness of breaths, max flow in, max flow out, a ratio of max flow in and max flow out, a time constant of inhalation and/or exhaustion, an abdomen respiratory volume signal, a thorax respiratory volume signal, a sum of the abdomen and thorax respiratory volume signal (RIPSum), a time derivative of a sum of the abdomen respiratory volume signal and the thorax respiratory volume signal (RIPflow), or a respiratory phase signal (Phase) indicating a phase difference between the abdomen respiratory volume signal and the thorax respiratory volume signal, or mean and standard deviations, or difference mean ratios thereof, and wherein the sleep stage of the subject is determined without using either cardio or heart-based features of a signal of the subject and without using a cardio or heart-based signal of the subject.”
These limitations describe a mathematical calculation. Furthermore, the limitations describe a mental process as the skilled artisan is capable of analyzing conventional RIP signals (e.g. from a computer readout) and making a mental assessment thereafter. Furthermore, nothing from the claims, as currently recited, suggest that the skilled artisan could not practically perform the identified judicial exception mentally, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“...obtaining by a processor one or more respiratory signals, the one or more respiratory signals being an indicator of a respiratory activity of the subject, the one or more respiratory signals including a thoracic respiratory inductance plethysmography (RIP) signal and an abdomen respiratory inductance plethysmography (RIP) signal...”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations amount to insignificant pre-solution activity, e.g., mere data gathering steps necessary to perform the mental process. Moreover, the recited processor does not integrate the claims into a practical application because “use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step . . . ) would not integrate a judicial exception.” See MPEP 2106.05(b)(III).
Furthermore, the additional limitations do not add significantly more to the identified judicial exception as they amount to obtaining widely known types of physiological signals and a generically recited processor. Moreover, the recited processor does not amount to significantly more because a general-purpose processor that merely executes the judicial exception is not a particular machine. See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 706-17 (Fed. Cir. 2014), cited in MPEP § 2106.05(b)(I).
Independent claims 11 and 20 are also not patent eligible for substantially similar reasons.
Dependent claims 2-5, 9, 10, 12-15, and 21-35 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-5, 9-15, and 19-35 are not patent eligible under 35 USC 101.
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they are not persuasive. Examiner maintains that the claims recite an abstract idea (mathematical calculations and/or mental process) that is (1) not integrated into a practical application; and (2) the additional limitations (generically recited processor) do not recite significantly more. Applicant’s argument that the claims cannot be practically performed by a skilled artisan is also not persuasive as nothing from the claims suggest that the skilled artisan would not be able to perform the recited steps mentally, or with simple pen/paper. In any case, Examiner maintains that the claims recite mathematical calculations. See also 2024 AI SME update, which establishes that a trained neural network, as is similarly and more generically recited in the instant claims, amounts to a series of mathematical calculations1. Applicant also appears to argue that the instant claims recite an improvement, i.e. solve the technical problem of determining sleep stages without using other signals (EEG). However, this is not persuasive as the purported improvement appears to lie within the judicial exception itself, which would not amount to significantly more2. Applicant goes onto argue that determining the sleep stage integrates the judicial exception into a practical application as it “changes the method from a simple calculation of values to an actual practical application” (remarks, pg. 18). Examiner respectfully disagrees as “wherein the sleep stage of the subject is determined…”, as recited in claim 1, is part of the judicial exception. In any case, and should applicant positively incorporate an outputting step (e.g. display), this would also not integrate the claims into a practical application3.
For at least these reasons, the 35 USC 101 rejections are maintained.
Conclusion
No claim is allowed.
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 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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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 See Claim 2 from Example 47, which held that a trained neural network amounts to mathematical calculations and/or a mental process.
https://www.uspto.gov/sites/default/files/documents/2024-AI-SMEUpdateExamples47-49.pdf
2 “the judicial exception alone cannot provide the improvement.” See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981).
3 MPEP 2106.05(g) Insignificant Extra-Solution Activity… data gathering and outputting
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