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 July 13, 2026 were received and fully considered. No claims were amended. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 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 14-20 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 14 follows.
Regarding claim 14, the claim recites central and mixed apnea detection process. Thus, the claim is directed to a method/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:
“…calculating an event window based the desaturation event; determining, for the event window: one or more SpO2 features based on the SpO2 signal; one or more respiratory features based on a respiration signal derived from the one or more sensors; presence or absence of a snore signal; classifying the event window as a central and/or mixed apnea event based on: the one or more SpO2 features or the one or more respiratory features; and the absence of the snore signal during the event window; classifying the event window as asleep; and determining a central apnea hypopnea index by summing the event window and a plurality of event windows, wherein each of the plurality of event windows are classified as both the central and/or mixed apnea event and asleep.”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, aided with 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:
“…detecting a desaturation event based on an oxygen saturation (SpO2) signal derived from one or more sensors on a chest of a patient…”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception fail to integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they pertain to well-understood, conventional, and routine techniques for obtaining data from generically recited sensors.
Claim 15 recites “wherein the snore signal is derived from a microphone”, which amounts to extra-solution activity (data gathering from a conventional microphone) and does not integrate the claims into a practical application. Examiner takes official notice that it is widely-understood, routine, and conventional to utilize a microphone in order to obtain snore/sound data in a sleep apnea setting.
Claim 16 recites “wherein the snore signal is derived from an accelerometer”, which amounts to extra-solution activity (data gathering from a conventional accelerometer) and does not integrate the claims into a practical application. Examiner takes official notice that it is widely-understood, routine, and conventional to utilize an accelerometer in order to obtain snore/sound data in a sleep apnea setting.
Claim 17 recites “wherein the accelerometer is on the chest of the patient”, which amounts to extra-solution activity (data gathering from a conventional accelerometer) and does not integrate the claims into a practical application. Examiner takes official notice that it is widely-understood, routine, and conventional to utilize a chest-worn accelerometer in order to obtain snore/sound data in a sleep apnea setting.
Claim 18 recites “wherein the accelerometer and the one or more sensors are components of a patch worn on the chest of the patient”, which amounts to extra-solution activity (data gathering from a conventional accelerometer) and does not integrate the claims into a practical application. Examiner takes official notice that it is widely-understood, routine, and conventional to utilize a chest-worn accelerometer via patch/pad in order to obtain snore/sound data in a sleep apnea setting.
Claim 19 recites “wherein the one or more sensors comprise a photoplethysmography (PPG) sensor”, which amounts to extra-solution activity (data gathering from a conventional PPG sensor) and does not integrate the claims into a practical application. Examiner takes official notice that it is widely-understood, routine, and conventional to utilize a PPG in order to obtain data in a sleep apnea setting.
Claim 20 recites “wherein classifying the event window as asleep comprises determining movement of the patient based on the accelerometer or heart rate based on an electrocardiogram (ECG) sensor”, which merely further limits the abstract idea and as such, fails to integrate the claims into a practical application.
Therefore, claims 14-20 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. Specifically, applicant raises the following arguments (which Examiner addresses each in turn below):
“Claim 14 recites a specific use of sensor-derived signals… the SpO2 signal, the respiration signal, and the snore signal… therefore reflects and applies it steps to ‘particular data’ derived from a ‘particular machine’ to produce a particular result” (remarks, pg. 6);
Examiner respectfully disagrees. While the claims recite obtaining specific types of data, this does not integrate the claims into a practical application for several reasons. First, obtaining data, of any sort, merely amounts to extra-solution activity. See MPEP 2106.05(g), which establishes that mere data-gathering fails to integrate claims into a practical application. Applicant’s argument that the claims recite a particular machine is also not persuasive as the instant claims merely recite “one or more sensors on a chest of a patient”, which is highly generic and accordingly, does not amount to a particular machine. See also MPEP 2106.05(b), which sets forth examples constituting a particular machine1, all of which have added structural particularity. As the instant claims lack any structural particularity, applicant’s “particular machine” argument is not persuasive.
“the claim produces a concrete, real-world output: a central apnea hypopnea index quantifying a patient’s central and mixed apnea burden… therefore effects a transformation of patient physiological data into a specific, actionable clinical metric” (remarks, pg. 6);
Examiner respectfully disagrees. From MPEP 2106.05(c), “It is noted that while the transformation of an article is an important clue, it is not a stand-alone test for eligibility... Transformation of a physical or tangible object or substance is more likely to provide significantly more (or integrate a judicial exception into a practical application) than the transformation of an intangible concept such as a contractual obligation or mental judgment”. Here, the purported “transformation” is part of the abstract idea (mental process, judgment) and accordingly, does not integrate the claims into a practical application.
“the claims improve upon the art by solving a specific technical problem that persisted in the field and is novel over the prior art… improves the accuracy and reliability of automated apnea classification” (remarks, pgs. 6-7);
Examiner respectfully disagrees. Here, the purported improvement (alleged improvement an accuracy and reliability in apnea classification) lies within the judicial exception itself. However, Examiner maintains an alleged more accurate calculation is still a calculation nonetheless, and would not be patent eligible2.
“the claimed steps involve multi-channel signal acquisition, feature extraction, and multi-factor classification across a dynamically calculated event window, which cannot practically be performed in the human mind… processing of continuous, time-varying physiological signals across event windows in a manner that is plainly beyond unaided human cognition” (remarks, pg. 7);
Examiner respectfully disagrees for the following reasons. First, the 35 USC 101 rejections identifies that the instant claims recite mathematical calculations and/or mental process. As such, the inquiry as to whether limitations can or cannot be practically performed by a skilled artisan does not apply to limitations that correspond to mathematical calculations (simple or complex). Notwithstanding the above, Examiner maintains that the instant claims also recite a mental process as nothing from the instant claims suggest the skilled artisan would not be able to practically perform these steps mentally, aided with simple pen/paper.
“claim 14 cannot possibly pre-empt use of any abstract idea underlying the claimed process” (remarks, pg. 8);
Examiner respectfully disagrees. MPEP 2106.04 “While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility… Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B)… It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.”
For at least these reasons, the 35 USC 101 rejections are maintained. Please see above for more detailed analysis.
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 Examples from MPEP 2106.05(b) amounting to a particular machine:
-particular type of antenna and included details as to the shape of the antenna and the conductors, particularly the length and angle at which they were arranged.
- a Fourdrinier machine (which was understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web.
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).
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