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 09/03/2025. As directed by the amendment: No claims have been amended, claims 5 and 24 have been cancelled, and no claims have been added. Claims 2-4,6-11,19,22-23 and 25-30 were previously withdrawn due to a Restriction Requirement. Thus, claims 1-2,12-18,20-21 and 31-39 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 14-16, filed 10/16/2025, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues on pages 14-15 that “This statement in the Office Action fails to address Applicant’s argument, which is that “computing” cardiopulmonary coupling data cannot practically be performed in the human mind. Applicant continues to assert that “computing cardiopulmonary coupling data” cannot practically be performed in the human mind, and therefore, independent claim 1 does not recite a mental process.” 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.
Applicant then argues on page 15 that “The Office Action dated September 19, 2025 took the same approach and the present Office Action still takes the same approach and fails to meet its burden to properly reject dependent claims 2, 12-18, 21, and 31-39 by addressing their particular recitations.” Examiner disagrees because the extra-solution activity is explained and therefore provided the burden of proof. Therefore, the rejection of the claims is maintained.
Applicant’s arguments , see pages 16-20, filed 10/16/2025, with respect to 35 U.S.C. 103 have been considered but are moot because of the Declaration under 37 CFR 1.130(a) filed on 12/07/2025.
The declaration under 37 CFR 1.130(a) filed on 12/07/2025 is sufficient to overcome the rejection of claims 1-2, 12-18, 20-21, and 31-39 based on Hilmisson et al., “Sleep apnea detection: accuracy of using automated ECG analysis compared to manual scored polysomnography (apnea hypopnea index),” Sleep and Breathing, vol. 23, pp.125-133 (2019) (hereinafter “Hilmisson reference’). Applicant’s declaration provides evidence for the reliance on the exception under 35 U.S.C. 102(b)(1), showing that Hilmisson is the sole inventor of the invention (bullet point 3 of affidavit filed 12/07/2025), and the other names did not contribute to the invention (bullet point 7 of affidavit filed 12/07/2025).
Claim Rejections - 35 USC § 112
Claims 1-2,12-18,20-21 and 31-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Merely recite a description of the problem to be solved while claiming all solutions to it, leaving the industry to “complete an unfinished invention.” See Ariad, 598 F.3d at 1353
Disclosure of function alone is little more than a wish possession. See MPEP 2163(II)(A)(3)(a).
The written description requirement is not satisfied by merely outlining the goals or results one hopes to achieve with the invention. See MPEP 2163(II)(A)(3)(a).
Claims 1 and 20 fail to sufficiently describe the interpretations from the ECG signal in enough detail for one skilled in the art to have written description. The mere statement and recitation of the computing CPC data claims 1 and 20 and in [0055] of the instant specification fails to provide sufficient detail as to how the computing is done and the calculation required to be done on the CPC. Therefore, claims 1-2,12-18,20-21 and 31-39 do not provide sufficient detail for one to replicate and understand the intended function that’s being performed. Examiner suggests amending the phrase to recite “accessing CPC data”, as seen in Fig. 2, [0024], and originally claimed.
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 1-2,12-18,20-21 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.
Regarding claims 1 and 20, although the phrase “computing CPC data” is claimed and is mentioned in [0055] of the instant specification, CPC data is not explicitly computed. Nevertheless, Examiner suggests amending the phrase to recite “accessing CPC data”, as seen in Fig. 2, [0024], and originally claimed.
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 1-2, 12-18, 20-21, and 31-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claims 1 and 20 recites a step determining a type of cardiopulmonary coupling event for each of the disordered breathing events, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. a memory, a processor), determining values, and determining a type of cardiopulmonary coupling do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and determining a type of cardiopulmonary coupling, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
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 disordered breathing events…and determining a type of cardiopulmonary coupling event for each of the 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 correlate cardiopulmonary coupling data with oxygen saturation data and determine a type of cardiopulmonary coupling event for each disordered breathing event.
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:
- “accessing oxygen saturation data”, “health”, and “accessing 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)].
- “accessing oxygen saturation data”, “health”, and “accessing 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:
- “accessing oxygen saturation data”, “determining disordered breathing events”, and “accessing 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)].
- “accessing oxygen saturation data” and “accessing 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 2, 12-18, 21, 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.
In summary, claims 1-2, 12-18, 20-21, 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