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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 ("RCE"), 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 11, 2026, has been entered.
Status of Claims
Claims 26, 27, and 29-44 were previously pending and subject to a Final Office Action having a notification date of November 21, 2025 (“Final Office Action”). Following the Final Office Action, Applicant filed the RCE and an amendment on February 11, 2026 (“Amendment”), amending claims 26, 41, and 44 and canceling claim 42.
The present non-final Office Action addresses pending claims 26, 27, and 29-41, 43, and 44 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
These rejections are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
On page 7 of the Amendment in relation to Step 2A of the Alice/Mayo test, Applicant first takes the position that "measuring, via sensors comprising at least one CO2 sensor and at least one pressure sensor and excluding at least one of: (i) oxygen sensor and (ii) flow sensor [time-dependent measurements…]" as recited in claim 26 "is a concrete, physical constraint on the data acquisition hardware, defining a specific, simplified sensor configuration. This configuration represents a technical improvement by enabling respiratory monitoring with reduced hardware complexity and cost, as well as potentially enabling portability and ease of use not achievable with systems requiring oxygen or flow sensors (as discussed in the specification, e.g., [0051, 0066]). This is not generic data gathering; it's data gathering with a specific, unconventional technical limitation that fundamentally alters the nature of the measurement system." The Examiner disagrees.
However, that the measurement of the time-dependent measurements includes a CO2 and pressure sensor but excludes an O2 and/or a flow sensor still just amounts to using a CO2 and pressure sensor to measure time-dependent measurements of training subjects while they perform single-breath maneuvers which just amounts to using machinery as tools performing their typical functionality (MPEP 2106.05(f)). In response to Applicant's assertion that such exclusion of an O2 and/or a flow sensor "[defines] a specific, simplified hardware configuration" that "[enables] respiratory monitoring with reduced hardware complexity and cost…portability and ease of use not achievable with systems requiring oxygen or flow sensors," the Examiner submits that such limitation amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Similar to how nothing in the claims indicated what specific steps were undertaken other than merely using the abstract idea in the context of XML documents in Intellectual Ventures I v. Capital One Fin. Corp., 850 F.3d 1332 (Fed. Cir. 2017)(MPEP 2106.05(f)), there are no specific details in the present claims regarding how a solution to a problem is accomplished other than using the abstract idea (i.e., determining the various phase using the measurements, normalizing the measurements, generating input records, creating a training set, mapping between input-records and ventilation states, estimating a ventilation state for a current subject, and presenting the estimated state) in the context of measuring time-dependent measurements during single breath maneuvers of training subjects generically using CO2 and pressure sensors in their ordinary capacity without using O2 and/or flow sensors. Furthermore, as the claim is directed to analyzing CO2 and pressure signals to determine inhalation/holding/exhalation phases, normalizing the measurements and creating input-records, creating a training set, and using the training set to estimate a ventilation state for a current subject, then the Examiner fails to understand how not obtaining measurements from an O2 and/or a flow sensor (where such measurements are not even used in the mental process steps in the first place) provides the asserted technological advantage.
Applicant next asserts that "determining the inhalation phase, the holding phase, and the exhalation phase of the single breath maneuver by analyzing the time-dependent measurements of at least one of (i) a CO2 sensor signal and (ii) a pressure sensor signal" as recited in claim 26 "is a concrete signal processing step that identifies specific physiological events within the raw sensor data. This transforms raw, continuous sensor signals into structured, phase-segmented information, which is a technical operation on sensor data, not a mental process. This enables the system to precisely contextualize subsequent measurements within the dynamic phases of a breath." The Examiner disagrees that the above limitation does not recite an abstract idea (e.g., a mental process) because a medical professional (e.g., pulmonologist, respiratory therapist, etc.) could readily determine the inhalation/holding/exhalation phases of each training subject via reviewing the time-dependent measurements and observing certain breath pressure drops and/or certain changes in CO2 concentration as set forth at 20:16-17 of the present specification. As the above limitation thus recites part of the abstract idea, it cannot provide a practical application (e.g., technological improvement) of itself.
Applicant next asserts that "normalizing the time-dependent measurements of the exhalation phase, using measurements obtained during at least one of: (i) the inhalation phase and (ii) the holding phase, of the same single breath maneuver" as recited in claim 26 "is a highly specific and unconventional signal processing technique. It uses data from earlier phases of the same single breath maneuver to correct or standardize measurements from a later phase. This is a technical improvement in signal processing that enhances data quality and comparability, particularly for dynamic physiological signals, and is not a generalized mathematical concept. This technical step directly addresses issues like sensor drift, baseline variations, or subject-specific physiological differences within a single breath cycle." Notwithstanding that present specification does mention concepts such as "sensor drift" or "baseline variations" in the first place, but generically/broadly normalizing the CO2 and pressure readings in the exhalation phase based on those in the inhalation and/or holding phase is well within the capability of the human mind with pen and paper at the high level of generality as claimed and thus cannot provide a practical application (e.g., technological improvement) of itself.
Applicant next asserts that the machine learning model is trained and applied to "input-records at least from the normalized measurements" which "means the ML is operating on data that has undergone specific, unconventional technical transformations (phase determination and intra-maneuver normalization) derived from a novel, constrained sensor set. This is not merely applying ML to generic data; it's applying it to technically prepared data from a novel sensor configuration and processing pipeline, thereby improving the accuracy and utility of the respiratory monitoring system." Respectfully, Applicant's assertions that the ML is being applied to "technically prepared data from a novel sensor configuration and processing pipeline" is embellishing what claim 26 actually encompasses: a medical professional (e.g., pulmonologist, etc.) mentally reviewing time-dependent measurements (e.g., CO2 and breath pressure readings) over time during single breath maneuvers of training subjects to determine inhalation/holding/exhalation phases for each training subject (e.g., based on breath pressure drops and/or certain changes in CO2 concentration as set forth at 20:16-17 of the present specification); normalizing the time-dependent measurements of the exhalation phase based on those of the inhalation and/or holding phase (e.g., using any appropriate normalization method); etc.
Furthermore, there are no details in the claims that anything other than generic/established ML techniques are being used in the context of mentally-performable steps of estimating a subject's ventilation state based on mentally-performable analyses of time-dependent measurements of single breath maneuvers of training subjects. Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Requirements that the machine learning model be “iteratively trained” or dynamically adjusted do not represent a technological improvement because iterative training using selected training material and dynamic adjustments based on real-time changes are incident to the very nature of machine learning. Id., p. 12. Claims that do not delineate steps through which the machine learning technology achieves an alleged improvement do not render the claims patent eligible. Id., p. 13. Allowing a claim that functionally describes a mere concept without disclosing how to implement that concept risks defeating the very purpose of the patent system. Id.
At page 9 of the Amendment in relation to Step 2B of the Alice/Mayo test, Applicant takes the position that "[simplified] hardware," "[enhanced] signal processing," and "[leveraged] ML for novel data collectively "[provide] a technical solution to the technical problem of non-invasively and cost-effectively monitoring respiratory states with improved accuracy and reduced hardware complexity."
Specifically, Applicant asserts that explicitly excluding oxygen and flow sensors, which are typically found in respiratory monitoring systems, simplifies hardware which is a technical improvement in device design. However, that the measurement of the time-dependent measurements includes a CO2 and pressure sensor but excludes an O2 and/or a flow sensor still just amounts to using a CO2 and pressure sensor to measure time-dependent measurements of training subjects while they perform single-breath maneuvers which just amounts to using machinery as tools performing their typical functionality (MPEP 2106.05(f)). In response to Applicant's assertion that such exclusion of an O2 and/or a flow sensor is a "technical improvement in device design," the Examiner submits that such limitation amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Similar to how nothing in the claims indicated what specific steps were undertaken other than merely using the abstract idea in the context of XML documents in Intellectual Ventures I v. Capital One Fin. Corp., 850 F.3d 1332 (Fed. Cir. 2017)(MPEP 2106.05(f)), there are no specific details in the present claims regarding how a solution to a problem is accomplished other than using the abstract idea (i.e., determining the various phase using the measurements, normalizing the measurements, generating input records, creating a training set, mapping between input-records and ventilation states, estimating a ventilation state for a current subject, and presenting the estimated state) in the context of measuring time-dependent measurements during single breath maneuvers of training subjects generically using CO2 and pressure sensors in their ordinary capacity without using O2 and/or flow sensors. Furthermore, as the claim is directed to analyzing CO2 and pressure signals to determine inhalation/holding/exhalation phases, normalizing the measurements and creating input-records, creating a training set, and using the training set to estimate a ventilation state for a current subject, then the Examiner fails to understand how not obtaining measurements from an O2 and/or a flow sensor (where such measurements are not even used in the mental process steps in the first place) provides the asserted technological advantage.
Applicant also asserts that precise phase determination and intra-maneuver normalization of CO2 and pressure signals improves the quality and interpretability of the physiological data. However, the recited phase determination and intra-maneuver normalization steps are practically mentally performable as already noted herein and thus cannot provide the asserted technological improvement.
In relation to Applicant's assertion that applying ML to "this uniquely prepared and technically constrained data" derives meaningful physiological parameters, the training and execution of the generic ML model is recited at such a high level of generality as to amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Requirements that the machine learning model be “iteratively trained” or dynamically adjusted do not represent a technological improvement because iterative training using selected training material and dynamic adjustments based on real-time changes are incident to the very nature of machine learning. Id., p. 12. Claims that do not delineate steps through which the machine learning technology achieves an alleged improvement do not render the claims patent eligible. Id., p. 13. Allowing a claim that functionally describes a mere concept without disclosing how to implement that concept risks defeating the very purpose of the patent system. Id.
At the bottom of page 9 of the Amendment, Applicant asserts the above-discussed limitations provide an "unconventional and inventive combination of elements." However, while any novelty in the implementation of an idea may be considered under step 2B of the Alice analysis, it does not necessarily turn an abstraction into something concrete. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014). Furthermore, while the Examiner has not necessarily asserted that the above limitations are conventional, the Examiner has nevertheless determined that they do not provide "significantly more" than the abstract idea(s) for the reasons discussed herein.
Finally, on page 10 of the Amendment, Applicant asserts "Transformation of a Particular Machine: The method transforms a generic respiratory monitoring system into a specialized, more efficient, and more accurate non-invasive respiratory monitoring device. The specific sensor configuration and signal processing steps are integral to this transformation, enabling the device to function effectively with reduced hardware complexity and improved data quality. This goes beyond merely using a computer as a tool; it defines a novel architecture and operational method for a technical system." However, any alleged transformation of an article is not a stand-alone test for patent eligibility. Bilski v. Kappos, 561 US 593, 658 (2010). Furthermore, a claim is ineligible even if it passes the machine or transformation test if it fails the Alice/Mayo test at steps 2A and 2B. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014). As set forth here, the present claims fail the Alice/Mayo test at steps 2A and 2B.
The 35 USC 101 rejection is maintained.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
These rejections are withdrawn in view of the Amendment.
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 26, 27, 29-41, 43, and 44 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 26, 27, 29-41 and 43 are directed to a method (i.e., a process) and claim 44 is directed to a device (i.e., a machine). Accordingly, claims 26, 27, 29-41, 43, and 44 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Independent claim 26 includes limitations that recite at least one abstract idea. Specifically, independent claim 26 recites:
A computer-implemented method for respiratory monitoring of a subject, the method comprising:
measuring, via sensors comprising at least one CO2 sensor and at least one pressure sensor and excluding at least one of: (i) oxygen sensor and (ii) flow sensor, time-dependent measurements during single-breath maneuvers including inhale, hold and exhale phases, each single-breath maneuver of a different training-subject of a plurality of training-subjects;
determining the inhalation phase, the holding phase, and the exhalation phase of the single breath maneuver by analyzing the time-dependent measurements of at least one of (i) a CO2 sensor signal and (ii) a pressure sensor signal;
normalizing the time-dependent measurements of the exhalation phase, using measurements obtained during at least one of (i) the inhalation phase and (ii) the holding phase, of the same single breath maneuver;
generating an input-record at least from the normalized measurements for each of the training-subjects;
creating a training dataset comprising:
the plurality of input-records, each associated with a respective training- subject; and
associated plurality of ground truth labels, each indicating a parameter for a ventilation state of its associated training-subject;
training a machine learning model (MLM), using the training dataset, to map between input-records and the parameters indicating ventilations states;
applying said trained MLM to an input-record of the subject, to obtain an estimated parameter, indicating a ventilation state of the subject;
wherein the monitoring comprises presenting the estimated parameter indicating the ventilation state of the subject.
The Examiner submits that the foregoing underlined limitations constitute “mental processes” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). As an example, a medical professional could practically in their mind with pen and paper
review time-dependent measurements (e.g., CO2 and breath pressure readings) over time during single breath maneuvers of training subjects;
determine, for each training subject, inhalation/holding/exhalation phases using the time-dependent measurements (e.g., based on breath pressure drops and/or certain changes in CO2 concentration as set forth at 20:16-17 of the present specification);
normalize the time-dependent measurements of the exhalation phase based on those of the inhalation and/or holding phase (e.g., using any appropriate normalization method);
generate input-records from the normalized measurements for each of the training subjects (e.g., writing them down);
create a training dataset (e.g., again, via writing it down) including i) the input-records and ii) corresponding ventilation state ground truth parameter labels for each subject (e.g., ventilation/perfusion ratio, other indication of ventilation inhomogeneity of the subject, etc.);
map/link/associate the input-records and ventilation state parameters (e.g., including input-records and their corresponding ventilation state parameters in the same row of a table);
compare an input record of a current subject (e.g., including data extracted/derived from a single breath maneuver of the subject measured by CO2 and pressure sensors) to the training dataset to obtain an estimated parameter indicating a ventilation state of the current subject (e.g., identifying an input-record in the training dataset that is "closest" to the input record of the current subject and using the ventilation state of the closest training subject as the estimated ventilation state for the current subject); and
presenting the estimated ventilation state parameter of the current subject (e.g., writing it down).
These recitations, under their broadest reasonable interpretation, are similar to the "mental processes" concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Furthermore, the foregoing underlined limitations constitute “certain methods of organizing human activity” because they relate to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions). These recitations, under their broadest reasonable interpretation, are similar to the concept of a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 27, 29, 31-41, 43, and 44 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claim 27 recites how the parameter is a value indicating a metabolic property selected from Rest Metabolic rate (RMR), Respiratory Energy Expenditure (REE), Respiratory Quotient (RQ) and Oxygen consumption which just further defines the above-discussed abstract ideas and also relates to mathematical relationships ("mathematical concepts").
-Claim 29 recites how the estimated parameter comprises a value indicating a Ventilation-Perfusion ratio (V'/Q') which just further defines the above-discussed abstract ideas and also relates to mathematical relationships ("mathematical concepts").
-Claim 31 recites how the generated input record includes raw data of the measurements which just further defines the above-discussed abstract ideas.
-Claim 32 recites how the generated input record includes dead space to tidal volume ratio (VD/VT), extracted from the raw data of the measurements, which just further defines the above-discussed abstract ideas and also relates to mathematical relationships ("mathematical concepts").
-Claim 33 recites how the generated input record includes a slope of exhaled CO2 vs. flow, extracted from the raw data of the measurements which just further defines the above-discussed abstract ideas.
-Claim 34 recites how the slope is generated at phase III which just further defines the above-discussed abstract ideas.
-Claim 35 recites how the generated input record includes a slope of exhaled CO2 vs. volume, generated from the raw data of the measurements which just further defines the above-discussed abstract ideas.
-Claim 36 recites how the slope is generated at phase III which just further defines the above-discussed abstract ideas.
-Claim 37 recites how the generated input record includes a slope of exhaled minute ventilation/CO2 production, generated from the raw data of the measurements which just further defines the above-discussed abstract ideas.
-Claim 38 recites how the slope is generated at phase III which just further defines the above-discussed abstract ideas.
-Claim 39 recites how the generated input record includes exhaled CO2 percentage, at end of phase III, vs. time and/or vs. volume, generated from the raw data of the measurements which just further defines the above-discussed abstract ideas.
-Claim 40 calls for correlating between the parameter and a medical indication for at least one selected from: congestive heart failure (CHF), circulatory failure, diffusion impairment, gas exchange efficiency, right to left shunt, pulmonary hypertension, metabolic syndrome, type 2 diabetes, obesity, cardiovascular disease, stress, recovery, poor sleep condition, acute respiratory distress syndrome (ARDS), which can be practically performed in the human mind ("mental processes") and relates to "certain methods of organizing human activity."
-Claim 41 calls for generating instructions for the subject to perform the single breath maneuver including an inhalation phase, instructing the subject to inhale for a predetermined inhale-time and profile; a holding phase, instructing to the subject to hold the inhaled air for a predetermined hold-time; and an exhalation phase, instructing the subject to exhale the held air for a predetermined exhale-time and profile, which can be practically performed in the human mind with pen and paper ("mental processes") and relates to "certain methods of organizing human activity."
-Claim 43 calls for analyzing the estimated parameter, comparing it to a threshold, and generating an instruction to present recommendations for treating the subject based on the analysis which can be practically performed in the human mind with pen and paper ("mental processes").
-Claim 44 calls for performing the method of claim 26 including respiratory monitoring of the subject which just amounts to "mental processes" and "certain methods of organizing human activity" similar to as discussed above.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A computer-implemented (using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f)) method for respiratory monitoring of a subject, the method comprising:
measuring, via sensors comprising at least one CO2 sensor and at least one pressure sensor and excluding at least one of: (i) oxygen sensor and (ii) flow sensor, time-dependent measurements during single-breath maneuvers including inhale, hold and exhale phases, each single-breath maneuver of a different training-subject of a plurality of training-subjects (adding extra-solution activity (data gathering) to the abstract idea as noted below, see MPEP § 2106.05(g); using computers or machinery as mere tools to perform the abstract idea as noted below, see MPEP § 2106.05(f));
determining the inhalation phase, the holding phase, and the exhalation phase of the single breath maneuver by analyzing the time-dependent measurements of at least one of (i) a CO2 sensor signal and (ii) a pressure sensor signal;
normalizing the time-dependent measurements of the exhalation phase, using measurements obtained during at least one of (i) the inhalation phase and (ii) the holding phase, of the same single breath maneuver;
generating an input-record at least from the normalized measurements for each of the training-subjects;
creating a training dataset comprising:
the plurality of input-records, each associated with a respective training- subject; and
associated plurality of ground truth labels, each indicating a parameter for a ventilation state of its associated training-subject;
training a machine learning model (MLM), using the training dataset, to (merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished, see MPEP § 2106.05(f)) map between input-records and the parameters indicating ventilations states;
applying said trained MLM (merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished, see MPEP § 2106.05(f)) to an input-record of the subject, to obtain an estimated parameter, indicating a ventilation state of the subject;
wherein the monitoring comprises presenting the estimated parameter indicating the ventilation state of the subject.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the method being computer-implemented, the Examiner submits that this limitation amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of measuring, via sensors comprising at least one CO2 sensor and at least one pressure sensor and excluding at least one of: (i) oxygen sensor and (ii) flow sensor, time-dependent measurements during single-breath maneuvers including inhale, hold and exhale phases, each single-breath maneuver of a different training-subject of plurality of training-subjects, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of training the ML model with the training dataset and applying the trained ML model to the input-record of the subject, the Examiner submits that these limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Requirements that the machine learning model be “iteratively trained” or dynamically adjusted do not represent a technological improvement because iterative training using selected training material and dynamic adjustments based on real-time changes are incident to the very nature of machine learning. Id., p. 12. Claims that do not delineate steps through which the machine learning technology achieves an alleged improvement do not render the claims patent eligible. Id., p. 13. Allowing a claim that functionally describes a mere concept without disclosing how to implement that concept risks defeating the very purpose of the patent system. Id.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, independent claim 26 does not recite additional elements that integrate the judicial exception into a practical application. Accordingly, independent claim 26 is directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claim 30 recites how the ground truth labels are obtained via at least one selected from: MIGET, radionuclide imaging, MRI with intravenous contrast, and CO2 capnography which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 41 calls for presenting the instructions via a display and/or audible device which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 43 calls for presenting the generated instructions via a display and/or audible device which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Claim 44 calls for use of a device including a processor, input-device for receiving part of the input record, and output device for presenting the estimated parameter which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, independent claim 26 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the method being computer-implemented, the Examiner submits that this limitation amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of training the ML model with the training dataset and applying the trained ML model to the input-record of the subject, the Examiner submits that these limitations amount to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)). Claims that do no more than apply established methods of machine learning to a new data environment are not patent eligible. Recentive Analytics, Inc. v. Fox Corp., Fox Broadcasting Company, LLC, Fox Sports Productions, LLC, Case No. 23-2437, (Fed. Cir. 2025), pp. 10, 14. An abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment. Id. Requirements that the machine learning model be “iteratively trained” or dynamically adjusted do not represent a technological improvement because iterative training using selected training material and dynamic adjustments based on real-time changes are incident to the very nature of machine learning. Id., p. 12. Claims that do not delineate steps through which the machine learning technology achieves an alleged improvement do not render the claims patent eligible. Id., p. 13. Allowing a claim that functionally describes a mere concept without disclosing how to implement that concept risks defeating the very purpose of the patent system. Id.
Regarding the additional limitations directed to measuring, via sensors comprising at least one CO2 sensor and at least one pressure sensor and excluding at least one of: (i) oxygen sensor and (ii) flow sensor, time-dependent measurements during single-breath maneuvers including inhale, hold and exhale phases, each single-breath maneuver of a different training-subject of plurality of training-subjects which the Examiner submits merely amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)) and merely adds insignificant extra-solution activity to the abstract idea (see MPEP § 2106.05(g)) as discussed above, the Examiner has reevaluated such limitations and determined such limitations to not be unconventional as they merely consist of determining the level of a biomarker in blood by any means. Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 79, 101 (2012).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claim 30 recites how the ground truth labels are obtained via at least one selected from: MIGET, radionuclide imaging, MRI with intravenous contrast, and CO2 capnography which does no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the abstract idea (see MPEP § 2106.05(h)).
-Claim 41 calls for presenting the instructions via a display and/or audible device which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
-Claim 43 calls for presenting the generated instructions via a display and/or audible device which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Claim 44 calls for use of a device including a processor, input-device for receiving part of the input record, and output device for presenting the estimated parameter which amounts to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Therefore, claims 26, 27, 29-41, 43, and 44 are ineligible under 35 USC §101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892. For instance, U.S. Patent App. Pub. No. 2005/0288602 to Hoppe et al. discloses determining oxygen to carbon dioxide ratio in expired breath without volumetric/flow measurements for an improved economical device and U.S. Patent App. Pub. No. 2021/0405008 to Gerder et al. discloses determining inhalation and exhalation phase/timing information based on measured values from a carbon dioxide sensor.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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