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
I. Claim Objections
The claim amendments filed May 15, 2026 have successfully overcome all previous claim objections. Those objections are now withdrawn.
II. Claim Rejection under 35 U.S.C. § 112
The claim amendments have successfully overcome the previous § 112 rejection. That rejection is now withdrawn.
III. Claim Rejections under 35 U.S.C. § 101
Applicant’s remarks concerning the § 101 rejections have been fully considered but are not persuasive.
Concerning Step 2A, Prong One, Applicant first argues that the human mind cannot predictably and reliably extract data for a phase of a specific number of cardiac cycles following an arousal, such as 5-25 cardiac cycles. The Examiner respectfully disagrees. Applicant provides no explanation for why a human mind cannot do this, particularly with the aid of pen and paper. Similarly, Applicant argues that the step of “determining … a deviation …” step is done “by signal-processing operations comparing the per-subject recovery curve to a reference. These are not mental tasks; they are quantitative signal-processing operations performed by a processing unit operating on real-time biosignal data.” The Examiner respectfully disagrees. Applicant again provides no explanation for why these steps cannot be done mentally. The human mind is fully capable of determining a deviation of one signal from another. The fact that the steps are claimed to be carried out by a generic processing unit is not relevant as to whether the claims are directed to a mental process.
Applicant next argues that, concerning whether the claims are directed to a natural phenomenon, “the claims do not seek to monopolize that phenomenon. Rather, they recite a specific technological way of using the phenomenon to produce a diagnostic likelihood output via concrete signal-processing steps and a hardware system.” The Examiner respectfully disagrees. It is initially noted that this does not appear to be an argument relevant to Step 2A, Prong One (rather, it seems to be addressed to Step 2A, Prong Two, and/or Step 2B). Nevertheless, the Examiner respectfully disagrees that such a “specific technical way” is recited. As noted in the rejections, other than the phenomenon itself, the claims merely recite a generic processor to identify the phenomenon, insignificant pre-solution activity of generic data collection components to collect the data necessary to evaluate the phenomenon, and insignificant post-solution activity of a generic output step to indicate the phenomenon occurred. None of these types of limitations bestow eligibility to an otherwise natural phenomenon.
Concerning Step 2A, Prong Two, Applicant first argues that the claims here recite a technical improvement to diagnosis. The Examiner respectfully disagrees. Applicant’s argument relies entirely on the alleged improvement in diagnosis that occurs solely as a result of the recited mental steps. Such an improvement would occur even if the steps were carried out mentally. The end result is not an improvement to any of the technology recited; e.g., none of the sensors, the processor or the output device have any improvements or changes in how they function as a result of carrying out the mental process. The fact that a mental process may yield useful or advantageous conclusions does not necessarily mean that carrying it out on a generic computer gives rise to a “technological” improvement of any kind.
Applicant next argues that the claims are tied to a particular machine because the claims transform two signals into a new signal that did not previously exist and cannot be generated by human observation. The Examiner respectfully disagrees. The human mind is fully capable of taking two signals and transforming them into a new one that did not previously exist. The claims here merely carry out that analysis using a generic processor. Carrying out a mental process using a generic processor does not equate to a “particular machine” in the § 101 analysis.
Applicant next argues that “the claim ends with a transformative output step: outputting an indication of the likelihood of OSA/COMISA to a user interface. This is not extra-solution activity; it is the actionable diagnostic deliverable that, per the specification, enables a healthcare professional to "decide on the best treatment for the subject," including the choice between PAP therapy alone and adjunctive cognitive behavioral therapy for insomnia (CBTi) - a clinically critical distinction since, as the specification explains, "A subject with COMISA who only uses PAP therapy will likely fail adherence criteria, and may even drop out of PAP therapy altogether." The Examiner respectfully disagrees. Applicant appears to be arguing that the claims allow for a particular treatment to occur. However, the claims recite no such treatment. The fact that such data could eventually be used to develop treatment is irrelevant in the § 101 analysis. For example, as noted in § 2106.04(d)(2), even making specific treatment recommendations or instructing/prescribing treatment does not arise to a particular treatment or prophylaxis because it does not require that the treatment actually be used or carried out on the patient. Here, there is nothing in the claims that requires any kind of use of the output information.
Applicant next argues that the claims are similar to the USPTO eligibility examples 39 and/or 43, which Applicant alleges constitutes examples “in which sensor-based diagnostic methods producing clinically meaningful outputs were treated as integrating any exception into a practical application.” The Examiner respectfully disagrees. Example 39 is for training a neural network for facial detection, and thus shares little to no similarity to the claims here. It was also not based on a conclusion of integration into a practical application; rather, example 39 was considered eligible in Step 2A, Prong One because “the steps are not practically performed in the human mind.” Example 43 was a treatment method, and even there, claim 1 was found ineligible because the treatment step was too generic (“Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal.”). The claims here contain no treatment step at all, and thus share no relevant similarity to the claims found eligible in Example 43.
Concerning Step 2B, Applicant argues that the claims recite “significantly more” under Step 2B because “the specific combination of receiving an arousal signal and a heartrate signal, processing the heartrate signal to extract a recovery response phase signal (a feature not conventionally extracted in routine cardiac monitoring), comparing it to a reference signal to compute a deviation, and outputting a likelihood of OSA versus COMISA based on that deviation, is not well-understood, routine, or conventional in the medical diagnostic arts as of the effective filing date.” The Examiner respectfully disagrees. The official notice did not assert these limitations in combination were well-known. The “well-understood, routine and conventional” analysis in Step 2B is only concerned with the “additional elements” other than the judicial exception (i.e. other than the mental process, or other than the natural phenomenon). Step 2B does not require showing that the entire claim (i.e., including the mental steps or natural phenomenon) constitutes well-understood, routine and conventional activity, and the previous rejection did not make such an assertion. As such, Applicant has not adequately challenged the facts that were actually under official notice in the § 101 rejections; therefore, the facts under official notice are now taken to be admitted prior art. See MPEP § 2144.03(C).
IV. Claim Rejections under 35 U.S.C. §§ 102 and 103
Applicant’s remarks concerning the previous prior art rejections have been considered and are persuasive. All previous rejections under 35 U.S.C. §§ 102 and 103 have 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 1-8, 10-14 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process and/or a natural phenomenon without significantly more.
Step 1: All of claims 1-8, 10-14 and 16 are directed either to a method/process or to a system/machine.
Step 2A, Prong One: The claims recite a mental process including steps such as the three “determining …” steps in claim 1 which could be performed by the human mind and/or by a human with a physical aid such as pen and paper. A person is capable of mentally analyzing a heartrate signal to determine a recovery response phase signal, mentally analyzing that signal to determine a deviation from a reference signal, and mentally determining, based on the deviation, a likelihood that the subject has at least one of obstructive sleep apnea (OSA) or Comorbid Insomnia and Sleep Apnea (COMISA). Additionally/alternatively, the claims are also directed to the natural phenomenon of a human having natural variations in how their heart rate responds to arousals based on whether or not they have a certain condition such as obstructive sleep apnea (OSA) or Comorbid Insomnia and Sleep Apnea (COMISA); the claims here merely observe and identify when this natural phenomenon occurs, using generic technology (described more below).
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process and/or natural phenomenon using generic processing technology and add insignificant extra-solution activity. Specifically: the step of “receiving …” the data from the arousal and/or cardiac sensor(s) is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process. The step of “outputting an indication of the likelihood to a user interface” is considered insignificant post-solution activity of merely outputting the results of the judicial exception. Furthermore, merely carrying out mental steps using generic computing technology such as “a processing unit” or a “computer” is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components (“a processing unit” and/or “computer”), generic data collection components (“arousal sensor” and “cardiac sensor”) and a generic “user interface” for output. The Examiner previously took official notice that the processing and data collection components are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. Applicant’s subsequent reply dated May 15, 2026 did not adequately traverse the Examiner's assertion of official notice because it did not challenge the actual specific noticed facts (rather, Applicant challenged that the entire claimed combination including the judicial exception was not well-understood, routine and conventional – an argument which is moot because that was not asserted in the official notice); therefore, the facts under official notice are now taken to be admitted prior art. See MPEP § 2144.03(C) The Examiner further takes official notice that it is incredibly well-understood, routine and conventional to output medical diagnostic indications to a user interface via wired and/or wireless communication links. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
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 JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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