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 .
Status of Claims
This office action for the 18/670154 application is in response to the communications filed July 12, 2026.
Claims 1 and 12 were amended July 12, 2026.
Claims 10 and 19 were cancelled July 12, 2026.
Claims 23 and 24 were added as new July 12, 2026.
Claims 1, 3, 5, 6, 9, 12, 14, 15, 17, and 21-24 are currently pending and considered below.
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, 5, 6, 9, 12, 14, 15, 17, and 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
As per claim 1,
Step 1: The claim recites subject matter within a statutory category as a process.
Step 2A is a two-prong inquiry, in which Prong 1 determines whether a claim recites a judicial exception. Prong 2 determines if the additional limitations of the claim integrates the recited judicial exception into a practical application. If the additional elements of the claim fail to integrate the judicial exception into a practical application, claim is directed to the recited judicial exception, see MPEP 2106.04(II)(A).
Step 2A Prong 1: The claim contains subject matter that recites an abstract idea, with the steps of a method for detecting respiratory events in a subject, the method comprising: acquiring a full-night time sequence of physiological signals having an overall recording duration, wherein at least one of peripheral oxygen saturation, instantaneous heart rate, and a PPG envelope is obtained from the full-night time sequence; using a preliminary evaluation model to analyze the full-night time sequence over the overall recording duration, classify the full-night time sequence into a risk category for respiratory event detection, and select, based on the risk category, a model threshold and a vote threshold for detecting respiratory events in the full-night time sequence; segmenting the full-night time sequence into overlapping input segments of a predetermined duration shorter than the overall recording duration; for each input segment, selecting a localized analysis window within the input segment that is shorter than the predetermined duration, and analyzing the localized analysis window with a model to generate a prediction score for a respiratory event; comparing the prediction score with the selected model threshold and labeling the input segment as positive when the prediction score exceeds the selected model threshold; for each evaluation time within the full-night time sequence, computing a vote count equal to a number of positive input segments whose time spans cover the evaluation time; identifying respiratory-event intervals as contiguous ranges of evaluation times for which the vote count meets or exceeds the selected vote threshold; and outputting a final event count as a count of the respiratory-event intervals, together with start and end times of the respiratory-event intervals; wherein the model comprises an ensemble including a first model with a first input-segment duration and a second model with a second, shorter input-segment duration, and the prediction score is obtained as a weighted average of outputs of the first and second models. These steps, as drafted, under the broadest reasonable interpretation recite:
certain methods of organizing human activity (e.g., fundamental economic principles or practices including: hedging; insurance; mitigating risk; etc., commercial or legal interactions including: agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations; etc., managing personal behavior or relationships or interactions between people including: social activities; teaching; following rules or instructions; etc.) but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from being directed to certain methods of organizing human activity. The identified abstract idea, law of nature, or natural phenomenon identified above, in the context of this claim, encompasses a certain method of organizing human activity, namely managing personal behavior or relationships or interactions between people. This is because each of the limitations of the abstract idea recites a list of rules or instructions that a human person can follow in the course of their personal behavior. If a claim limitation, under its broadest reasonable interpretation, covers at least the recited methods of organizing human activity above, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See MPEP 2106.04(a).
Step 2A Prong 2: The claim does not recite additional elements that integrate the judicial exception into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception, see MPEP 2106.05(f), such as:
“by a photoplethysmogram sensor” which corresponds to merely reciting the words “apply it” (or an equivalent) with the judicial exception. This is because the function of the photoplethysmogram sensor is merely defining the sensing source of where the physiological signals are being acquired in this step of the claim. Without providing any sort of technical detail beyond this recitation, this limitation is merely applying the judicial exception portion of “acquiring…a time sequence of physiological sensors” to the technology of the photoplethysmogram sensor.
“trained machine learning” which corresponds to merely using a computer as a tool to perform an abstract idea. Page 5 Lines 26-31 describes that the hardware that implements the steps of the abstract idea amount to nothing more than a generic computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
Accordingly, this claim is directed to an abstract idea.
Step 2B: The claim does not recite additional elements that amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 3,
Claim 3 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 3 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising: establishing the model threshold based on a training set of physiological signals wherein the presence and absence of respiratory events have been validated; and adjusting the vote threshold based on a selected specificity and sensitivity for the detection of respiratory events.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 5,
Claim 5 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 5 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein at least one of the first model and the second model is selected from the group consisting of is a one-dimensional convolutional neural network, a two-dimensional convolutional neural network, a recurrent neural network, a model with a self-attention mechanism, and a decision-tree-based model.” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 6,
Claim 6 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 6 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the predetermined duration of the input segments ranges from 10 seconds to 30 minutes.” further defines an additional element that was insufficient to provide a practical application and/or significantly more. The claim with this further defining limitation still corresponds to merely using a computer as a tool to perform an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 9,
Claim 9 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 9 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the respiratory events are selected from the group consisting of apneas and hypopneas.” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 12,
Claim 12 is substantially similar to claim 1. Accordingly, claim 12 is rejected for the same reasons as claim 1.
As per claim 14,
Claim 14 is substantially similar to claim 3. Accordingly, claim 14 is rejected for the same reasons as claim 3.
As per claim 15,
Claim 15 is substantially similar to claim 5. Accordingly, claim 15 is rejected for the same reasons as claim 5.
As per claim 17,
Claim 17 depends from claim 12 and inherits all the limitations of the claim from which it depends. Claim 17 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“further comprising a user interface configured to display the final event count along with the time sequence of physiological signals and indications of detected respiratory events.” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“further comprising a user interface configured to display the final event count along with the time sequence of physiological signals and indications of detected respiratory events.” which corresponds to mere data gathering and/or output.
Step 2B: As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, see MPEP 2106.05(d)(II), such as:
“further comprising a user interface configured to display the final event count along with the time sequence of physiological signals and indications of detected respiratory events.” which corresponds to receiving or transmitting data over a network.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 19,
Claim 19 is substantially similar to claim 10. Accordingly, claim 19 is rejected for the same reasons as claim 10.
As per claim 21,
Claim 21 depends from claim 12 and inherits all the limitations of the claim from which it depends. Claim 21 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the localized window has a duration between 1 and 60 seconds” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 22,
Claim 22 depends from claim 12 and inherits all the limitations of the claim from which it depends. Claim 22 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the weighted average uses determined weights stored in the memory” introduces additional elements that is insufficient to provide a practical application or significantly more:
Step 2A Prong 2: In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g), such as:
“wherein the weighted average uses determined weights stored in the memory” which corresponds to mere data gathering and/or output.
Step 2B: As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and/or generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, identified as insignificant extra-solution activity to the abstract idea, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as:
computer functions that have been identified by the courts as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, see MPEP 2106.05(d)(II), such as:
“wherein the weighted average uses determined weights stored in the memory” which corresponds to storing and retrieving information in memory.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 23,
Claim 23 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 23 merely further defines the abstract idea and/or introduces additional elements that are insufficient to provide a practical application or something significantly more:
“wherein the risk category is selected from low-risk, medium-risk, and high-risk categories, and wherein the selected model threshold and the selected vote threshold correspond to a selected sensitivity and specificity for detecting respiratory events for the risk category” further describes the abstract idea. This claim limitation is still directed to “Certain Methods of Organizing Human Activity” and therefore continues to recite an abstract idea.
Looking at the limitations of the claim as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely recite an abstract idea and/or provide conventional computer implementation which does not impose a meaningful limit to integrate the abstract idea into a practical application and/or amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As per claim 24,
Claim 24 is substantially similar to claim 23. Accordingly, claim 24 is rejected for the same reasons as claim 23.
Subject Matter Free of Prior Art
Claims 1, 3, 5, 6, 9, 12, 14, 15, 17, and 21-24 contain subject matter free of prior art.
The Examiner has conducted a thorough search of the prior art and could not find a single reference, or combination of references with adequate rationale to combine, to teach the limitation of “for each input segment, selecting a localized analysis window within the input segment that is shorter than the predetermined duration, and analyzing the localized analysis window with a trained machine learning model to generate a prediction score for a respiratory event comparing the prediction score with a model threshold and labeling the input segment as positive when the prediction score exceeds the model threshold; for each evaluation time within the time sequence, computing a vote count equal to a number of positive input segments whose time spans cover the evaluation time”. The closest prior art that the Examiner was able to find was:
Garcia Molina et al. (US 2022/0386947) which teaches a bed controller 1904 which may have access to a plurality of classifiers that each function differently and/or use different training data to generate classifications. In such cases, classifier decisions can be treated as a vote and vote aggregation can be used to determine sleep state. If only one classifier is used, the vote of that classifier is the only vote and the vote is used as the sleep state. If there are multiple classifiers, the different classifiers can produce conflicting votes, and the bed controller can select a vote-winning sleep state. Various vote-counting schemes are possible. In some cases, the bed controller 1094 can count the votes for each sleep state and the sleep state with the most votes is the determined sleep state. In some cases, the bed controller 1904 can use other vote-counting schemes. For example, votes from different classifiers may be weighed based on the classifiers historical accuracy. In such a scheme, classifiers that have been historically shown to be more accurate can be given greater weight while classifiers with lesser historical accuracy can be given less weight. This accuracy may be tracked on a population level or on a particular user level. In some instances, votes may be cast by systems other than a machine-learning system, and those votes may be incorporated into the vote totals to impact the outcomes of the voting decision. For example, non-machine-learning pressure categorizing algorithms may cast votes based on, for example, comparisons with threshold values. However, this reference is deficient in teaching the input segments as claimed.
Previously applied Menon et al. (US 2019/0192085) is also deficient in teaching this limitation due to the lack of voting functionality with its machine learning model and lack of specificity in time segmentation.
It can be seen that the prior art does not teach this limitation. Accordingly, claims 1, 3, 5, 6, 9, 12, 14, 15, 17, and 21-24 contain subject matter free of prior art.
Response to Arguments
Applicant's arguments filed July 12, 2026 have been fully considered.
Applicant’s arguments pertaining to rejections made under 35 U.S.C. 101 are not persuasive.
The Applicant argues that the pending claims do not recite or require any activity described by the examples of “Certain Methods of Organizing Human Activity” as defined by the MPEP.
The Examiner respectfully disagrees. The pending claims, as is shown in the rejection above, recites a list of rules or instructions that a human person can follow in the course of their personal behavior. Following rules or instructions falls under managing personal behavior of a person, relationships or interactions. Managing personal behavior a person, relationships or interactions explicitly falls under “Certain Methods of Organizing Human Activity”. See MPEP 2106.04(a).
The Applicant further argues that the organization of time intervals does not organize personal behavior. The amended claims are directed to physiological signal-processing technology.
The Examiner respectfully disagrees. Management of physiological data, time and time segments are human behaviors. These items are merely data that a human can manipulate. The Applicant has merely outsourced this management to a device.
The Applicant further argues that the pending claims address a technical problem pertaining to fixed or otherwise non-adaptive thresholds in physiological monitoring. Such rigid thresholds may produce unstable respiratory event detection when applied to a diverse subject pool. Such variability directly affects the reliability of the collected data. The solution of the pending claims solves this technical problem with a technical solution. When considered as a whole, the pending claims provide a practical application in physiological monitoring and respiration-event detection technology.
The Examiner respectfully disagrees. Configurations of thresholds are not technical in nature. A threshold is an abstract line that segments conditions in data content. Improving on a threshold does not necessarily improve upon technology. If the technical problem to be solved is a fixed threshold, then the technical problem is abstract. However, if an improvement to this abstract idea of thresholds leads to an actual technical improvement, then this is something to explore. However, there is nothing in the pending claims that would require an improvement to technology. The thresholds are merely selected without any specificity.
The Applicant further argues that the additional claim elements are not recited as disconnected post-solution activity.
The Examiner respectfully disagrees. The additional elements merely apply the abstract idea to the specific sensor and computer environment.
The Applicant further argues that the Office Actions’ own prior-art discussion confirms that the claimed invention should not be dismissed at a high level of generality as merely routine or conventional computer implementation.
The Examiner respectfully disagrees. Novelty and conventionality are completely separate. A novel abstract idea is still an abstract idea. Without improving technology, that abstract idea will remain ineligible. The pending claims merely take this abstract idea and apply it to a generic computer with a PPG sensor as a means for collecting the data that the abstract idea manipulates. This does not satisfy the requirements of something significantly more than the abstract idea.
The Applicant further argues that the dependent claims provide further support for patent eligibility.
The Examiner respectfully disagrees. The contents of the argued dependent claims, 3, 14, 23 and 24, merely further define the abstract idea. There is no indication that technology would have been improved by these functions. Accordingly, they are not sufficient for patent eligibility.
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 CHAD A NEWTON whose telephone number is (313)446-6604. The examiner can normally be reached M-F 8:00AM-4:00PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H. CHOI can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAD A NEWTON/Primary Examiner, Art Unit 3681
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