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 Amendment
This Office Action is responsive to the amendment filed on 07/27/2026. As directed by the amendment: claims 1, 12-14, 16, 18, 20, 31-33, 35, and 37-39 have been amended, claims 2, 5, 21, and 24 have been cancelled, and no claims have been added. Claims 3-4, 6-11,19, 22-23 and 25-30 were previously withdrawn due to a Restriction Requirement. Thus, claims 1, 12-18, 20, and 31-39 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 13-17, filed 07/27/2026, regarding 35 U.S.C. 112(a) and 112(b) have been fully considered but they are not persuasive. Applicant, on page 14, submits paragraphs from the instant specification that supports the “computing CPC data” and the way CPC coupling is described in different patents and asserts in the declaration that CPC technology is neither emerging/unpredictable nor conventional/well known. Applicant further asserts on page 15 that “computing CPC is closer to the end where it need not be described in detail, as it was patented in 2008, had been FDA cleared by the time the present application was effectively filed, and had been studied.” Applicant further argues on pages 15 and 16 that “Because CPC technology was patented in 2008, had been FDA cleared by the time the present application was effectively filed, and had been studied, Applicant submits there is no "express findings of fact" in the Office Action which would support the lack of written description rejection of independent claims 1 and 20.”
Examiner agrees because [0052] incorporates by reference the patents related to CPC and describes that way in which CPC technology is computed. Therefore, the rejection is withdrawn.
Applicant's arguments, see pages 17-20, filed 07/27/2026, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues on pages 17-18 and 20 that the claim “is patent-eligible under Prong Two of Step 2A by integrating any such abstract idea into a practical application because Applicant's claims provide an improvement to sleep health technology and to the sleep health technical field by "evaluating sleep health of the person based on the cardiopulmonary coupling events for the sleep disordered breathing events."”
Examiner disagrees because the argument made is regarding the ability of a human to be able to determine SDB/DBE from observing and evaluating a physiological signal (oxygen saturation) and the ability to correlate CPC events for each SDB/DBE, which requires observation and evaluation of data. Further, Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity.
Applicant argues on page 19 that “"the solutions provided by the Application involve an intersection of determining disordered breathing events (using oxygen saturation data) and determining a type of CPC event for each disordered breathing event (using CPC data)," it is incorrect to say that nothing else in the claims is part of the solutions provided by this Application. (See id., 1 15.)
For example, the element in independent claims 1 and 20 of "evaluate sleep health of the
person based on the types of cardiopulmonary coupling events for the sleep disordered breathing events" is not extra-solution activity.”
Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
Applicant then argues on page 19 that “dependent claims 3, 4, 6, 8-10, 20, 22, 23, 25, and 27-29 utilize oxygen saturation to determined disordered breathing events, and the features of such dependent claims are not extra-solution activity. (See id., 1 17.) Since the Office Action recognizes in page 5 that "determining disordered breathing events" is not extra-solution activity, it is inconsistent to say that dependent claims which further expand on "determining disordered breathing events" would be extra-solution activity.” Applicant further argues “dependent claims 12-18 and 31-39 are not extra-solution activity. The "technology of this Application utilizes CPC data with oxygen saturation data to analyze sleep disordered breathing and evaluate a person's sleep health." (Id., 1 14.). Because dependent claims 12-18 and 31-39 utilize types of CPC events and/or oxygen saturation data during sleep disordered breathing events to evaluate a person's sleep health, the features of such dependent claims are not extra-solution activity.”
Examiner disagrees because the extra-solution activity is found in the dependent claim along with the additional mental process since the claims require determining of events, which is indicated as a mental process. Further, Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. Therefore, the rejection of the claims is maintained.
The Affidavit under 37 CFR 1.132 filed on 07/27/2026 is not sufficient to overcome the rejection of claims 1, 12-18, 20, and 31-39. Applicant’s declaration asserts the following arguments:
The Cardiopulmonary Coupling (CPC) technology was unpredictable and not well-known or conventional by citing a patent and an NPL showing it was not known in September 2018 (time of which the provisional of this case was filed) (bullets 4-6).
Examiner disagrees because the technology not being conventional is not relevant because the claim is generally all mental process which does not have to be shown to be routine and conventional. The additional elements in the claim are the two data accessing steps, which appear to be routine data gathering, no specific hardware required.
It would not be practical to calculate CPC computations (of bullets 9 and 10) because computational complexity, time constraints, quality of computations, and risk of human error (bullet 11).
Examiner disagrees because the claim fails to recite any time constraint, computational complexity (the claim doesn’t set forth any particular steps or type of analysis), and “risk of human error” which is not a consideration as to whether or not a person could do this mentally or with aid of pen and paper. Examiner notes that impractical does not mean a person couldn’t do it.
The technology of the invention uses CPC data and oxygen saturation requires less sensors that the prior use of polysomnographic sensor which is an improvement in the diagnostic art (bullets 13-14), which shows that the oxygen saturation and CPC data cannot be extra-solution activity (bullets 15-18).
Examiner notes that no sensors are claimed and that the CPC and oxygen saturation data are extra-solution activity as they are data collected. The claims fail to integrate the judicial exception into practical application because most of the limitations of the claim are directed to a mental process that can be done by a human.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 12-18, 20, and 31-39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the types of CPC events" in line 14. There is insufficient antecedent basis for this limitation in the claim. Line 11 requires the determination of a single type of CPC event.
Claim 20 recites the limitation "the types of CPC events" in line 17. There is insufficient antecedent basis for this limitation in the claim. Line 14 requires the determination of a single type of CPC event.
Regarding claim 38, it is unclear if the “type of CPC event” of claim 38 of line 2 is the same or different than the “type of CPC event” of claim 20.
Regarding claim 38, it is unclear if the “types of CPC event” of claim 38 line 3 is the same or different than the “type of CPC event” of claim 20.
Regarding claim 39, it is unclear if the “type of CPC event” of claim 39 of line 2 is the same or different than the “type of CPC event” of claim 20.
Regarding claim 39, it is unclear if the “types of CPC event” of claim 39 line 3 is the same or different than the “type of CPC event” of claim 20.
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, 12-18, 20, and 31-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 20 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 1 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 20, the following step is an abstract idea:
“determining sleep disordered breathing events for the person over the sleep time period based on the oxygen saturation data,
computing cardiopulmonary coupling data for the person for the sleep time period based on the physiological measurements,
correlating the cardiopulmonary coupling data in time with the oxygen saturation data over the sleep time period,
determining a type of cardiopulmonary coupling event for each of the sleep disordered breathing events based on the cardiopulmonary coupling data corresponding in time to the sleep disordered breathing events,
evaluating sleep health of the person based on the types of cardiopulmonary coupling events for the sleep disordered breathing events”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could evaluate a SDB based on SpO2 data, compute CPC data based on physiological measurements, correlate cardiopulmonary coupling data with oxygen saturation data, determine a type of cardiopulmonary coupling event for each disordered breathing event, and evaluating sleep health, in the human mind or by pen and paper.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claim 1, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “oxygen saturation data”, “sleep health”, “sleep time period”, “physiological measurements”, “types of SDB events”, and “cardiopulmonary coupling data” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Regarding claim 20, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a memory”, and “a processor” are recited at a high level of generality and are generic computer components amounting to insignificant extra-solution activity in that they are merely objects on which the functional limitations operate [MPEP 2106.05(b)].
- “oxygen saturation data”, “sleep health”, “sleep time period”, “physiological measurements”, “types of SDB events”, and “cardiopulmonary coupling data” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
Regarding claim 1, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “oxygen saturation data”, “sleep health”, “sleep time period”, “physiological measurements”, “types of SDB events”, and “cardiopulmonary coupling data” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Regarding claim 20, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a memory”, and “a processor” are recited at a high level of generality and are generic computer components amounting to insignificant extra-solution activity in that they are merely objects on which the functional limitations operate [MPEP 2106.05(b)].
- “oxygen saturation data”, “sleep health”, “sleep time period”, “physiological measurements”, “types of SDB events”, and “cardiopulmonary coupling data” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1 and 20, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the processor, and memory, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The “accessing oxygen saturation data” and “accessing cardiopulmonary coupling data” are data selected for manipulation and are therefore well-understood, routine and conventional.
Dependent claims 12-18, and 31-39 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to data gathering sleep disordered breathing (claims 2 and 21 [sleep disordered breathing ], 13-15 and 31-34 [type of [CPC-CVHR]) or further defining the abstract idea with further data gathering of (claims 12 and 31 [combining cyclic variation with CPC] 16-18 and 35-39 [measuring sleep apnea, desaturation]), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional. Furthermore, claims 12-18 and 31-39 recite additional mental processes that are implemented on a generic computing system and simply amount to implementing the abstract idea on a computer.
In summary, claims 1, 12-18, 20, and 31-39 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
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