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 December 15, 2025 were received and fully considered. Claims 1, 4, 8, 31, and 32 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 6, 2026 has been entered.
Claim Objections
Claims 1, 31, and 32 are objected to because of the following informalities:
“normalised” as recited in the current amendment (in multiple instances) should be changed to --normalized--. The same applies to independent claims 31 and 32.
Appropriate correction is required.
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, 3-15, 17-22, 25-27, and 29-32 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 computer-implemented method for predicting a presence of a cardiorespiratory disease in a user, 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:
“...a machine learning model… obtaining a single breath waveform from the capnogram, wherein obtaining the single breath waveform comprises: identifying at least one anomalous breath waveform of plurality of breath waveforms; excluding the at least one anomalous breath waveform from the plurality of breath waveforms; normalizing a duration of the plurality of breath waveforms to produce a plurality of normalised breath waveforms; and selecting the single breath waveform from the plurality of normalised breath waveforms; determining one or more transition points of the single breath waveform, wherein the one or more transition points comprise: a delta transition point between an expiratory baseline and an expiratory upstroke, a gamma transition point between an inspiratory downstroke and an inspiratory baseline, and an alpha transition point between the expiratory upstroke and an expiratory plateau; extracting features of the single breath waveform using the one or more transition points; and wherein determining the one or more transition points comprises: identifying a hump artefact in the single breath waveform and, when there is a hump artefact, accounting for the hump artefact during the determining of the one or more transition points; inputting the extracted features of the single breath waveform to the machine learning model; determining by the machine learning model from the extracted features of the single breath waveform a classification of the capnogram…”
These limitations describe a mathematical calculation. When given their broadest reasonable interpretation in light of the specification, the limitations identified above including the recited machine learning algorithm are mathematical calculations. Moreover, the plain meaning a machine learning algorithm is a series of mathematical calculations. See also 2024 AI SME Update, which held a similar claim construction was not patent eligible (see claim 2 of example 47, using a trained artificial neural network to analyze anomalies on input data was not patent eligible). The 2024 AI SME Update also sets forth that a trained machine learning model/engine amounts to a mental process (claim 2 of example 47). As such, 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 (using the simplest form of machine learning), 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 a capnogram from a user, wherein the capnogram comprises a plurality of breath waveforms…the classification indicating whether the user has a cardiorespiratory disease.”
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, i.e., mere data gathering steps necessary to perform the identified judicial exception do not integrate 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 obtaining data from conventional sensor (capnogram).
Independent claims 31 and 32 are also not patent eligible for substantially similar reasons.
Dependent claims 3-15, 17-27, 29, and 30 also fail to integrate the claims into a practical application and do not recite significantly 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, 3-15, 17-27, and 29-32 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.
Regarding patent eligibility, Applicant raises the following main arguments:
“[Examiner] impermissibly failed to consider dependent [claims] 3-15, 17-27, 29, and 30 independently under its subject matter eligibility analysis” (remarks, pg. 14);
Examiner respectfully disagrees. As set forth in the previous and current office actions Dependent claims 3-15, 17-27, 29, and 30 fail to integrate the claims into a practical application and do not recite significantly 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 in the rejection of independent claim 1, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
“Claim 1 as amended does not recite a mathematical concept” (remarks, pgs. 14-17);
Examiner respectfully disagrees. Examiner maintains that claim 1, as amended, recites a mathematical concept and/or mental process. It is important to note that a mathematical concept need not be expressed in mathematical symbols, because words used in a claim operating on data to solve a problem can serve the same purpose as a formula.1 Here, Examiner argues that the identified abstract idea recites limitations that ultimately serve the same purpose as a mathematical concept, formula, etc. Moreover, nothing from the claims, as currently amended, suggest that the skilled artisan would not be able to practically perform these limitations mentally (or using simple pen/paper), having first obtained data via conventional means2.
“Claim 1 as amended does not recite a mental process” (remarks, pg. 18);
Again, Examiner respectfully disagrees and maintains that nothing from the claims, as currently amended, suggest that the skilled artisan would not be able to practically perform these limitations mentally (or using simple pen/paper).
“Claim 1 as amended recites additional elements that integrate any allegedly abstract ideas into the practical application of improving detection of cardiorespiratory diseases using capnometry” (remarks, pgs. 18-20);
Examiner respectfully disagrees. It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.3 Here, the purported improvement (alleged greater accuracy) appears to lie within the judicial exception itself. However, an alleged improved mathematical calculation is still a calculation nonetheless and would not be patent eligible. Moreover, there is no improvement to the additional/structural limitations, i.e. highly generalized capnogram. As such, any improvement that lies within the mathematical concept and/or mental process fails to integrate the claimed invention into a practical application.
“Claim 1… recites additional elements that amount to significantly more than any alleged abstract idea” (remarks, pgs. 20-21).
Applicant contends that determining the one or more transition points via identifying a hump artefact, as set forth in the current amendment, amounts to significantly more than the abstract idea. Examiner respectfully disagrees. This limitation is considered to be part of the abstract idea, i.e. not an additional/structural limitation. Examiner maintains the only additional limitations are “obtaining a capnogram from a user, wherein the capnogram comprises a plurality of breath waveforms…the classification indicating whether the user has a cardiorespiratory disease”, which are highly generalized and amount to extra-solution activity. Therefore, this argument is moot and is not persuasive.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were persuasive in view of amendment. Therefore, these rejections are withdrawn.
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 See MPEP 2106.04(a)(2)(I)
2 Claim 1 recites “obtaining a capnogram from the user, wherein the capnogram comprises a plurality of breath waveforms”, which is highly generalized. Moreover, utilizing a capnogram in order to provide cardiorespiratory diagnosis is widely known, routine, and conventional.
3 See MPEP 2106.05(a) Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field