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 May 13, 2026 were received and fully considered. Claims 1, 11, and 20 were amended. Claim 36 is new. Please see corresponding rejection headings and response to arguments section below for more detail.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on May 13, 2026 has been 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 1-5, 9-15, and 19-36 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 indication of 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...performing on the processor or another computing system”
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 21-36 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 19-36 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. Applicant appears to raise the following main arguments, which Examiner will address in turn:
The claims were amended to recite “by performing on the processor or another computing system”, which “expressly precludes the limitations describing merely a mental process or something performed by a person using simply pen/paper” (remarks, pg. 15);
Examiner respectfully disagrees. As set forth in the previous and current office action, the claims, even as amended, recite an abstract idea (mathematical calculation and/or mental process). Examiner also maintains that nothing from the claims suggest that the skilled artisan would not be capable of practically performing the identified abstract idea mentally, or using simple pen/paper. Furthermore, merely reciting a processor or another computing system fails to integrate the claims into a practical application1.
The claims recite a significant advancement and improvement from what was known at the time of filing of the present application, i.e. solves the technical problem of determining a patient’s sleep stages without using other signals or data generally required by other sleep study systems, such as an EEG (remarks, pgs. 15-16);
Examiner respectfully disagrees. Similar to what was argued before, Examiner maintains that the purported improvement appears to lie within the judicial exception itself, which would not amount to significantly more2.
The determining and outputting of the sleep stages to the sleep physician or medical provider changes the method from a simple calculation of values to an actual practical application (remarks, pg. 17);
Examiner respectfully disagrees. The determining step has been identified as being part of the judicial exception and does not integrate the claims into a practical application. Furthermore, there is no outputting/displaying step recited in the claims. 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.
Examiner fails to consider the claims as a whole (remarks, pg. 19);
Examiner respectfully disagrees. When considering the claims as a whole, Examiner maintains that the claims recite an abstract idea that is not integrated into a practical application. See corresponding rejection heading above for more detailed analysis.
The pending claims, as a whole, are not conventional, well-understood, and routine, as they are not disclosed or suggested by the prior art of record (remarks, pg. 19);
Examiner respectfully disagrees. The absence of a prior art rejection does not equate to patent eligibility as 35 USC 101 is a different statute than 35 USC 102/103. Moreover, the “conventional, well-understood, and routine” (ala Berkheimer analysis) applies to additional (e.g. structural) limitations, i.e. does not apply to limitations that have been identified to the abstract idea.
For at least these reasons, the 35 USC 101 rejections are maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 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).
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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