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, 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 04, 2026 has been entered.
Status of Claims
This office action for the 18/670154 application is in response to the communications filed May 04, 2026.
Claims 1 and 12 were amended May 04, 2026.
Claims 1, 3, 5, 6, 9, 10, 12, 14, 15, 17, 19, 21 and 22 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, 10, 12, 14, 15, 17, 19, 21 and 22 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 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 time sequence; segmenting the 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 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; identifying respiratory-event intervals as contiguous ranges of evaluation times for which the vote count meets or exceeds a 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 10,
Claim 10 depends from claim 1 and inherits all the limitations of the claim from which it depends. Claim 10 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 using a preliminary evaluation model to classify a patient's full night's signal into risk categories for determining the model threshold and the vote threshold for respiratory event detection.” 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.
Subject Matter Free of Prior Art
Claims 1, 3, 5, 6, 9, 10, 12, 14, 15, 17, 19, 21 and 22 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, 10, 12, 14, 15, 17, 19, 21 and 22 contain subject matter free of prior art.
Response to Arguments
Applicant's arguments filed May 04, 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 are not directed to certain methods of organizing human activity. Rather, they are directed to physiological signal-processing techniques for detecting respiratory event intervals in a subject.
The Examiner respectfully disagrees. The Applicant’s position fails to address the Examiner’s position which stipulates that the steps of this physiological signal processing technique amount to “Certain Methods of Organizing Human Activity”. Physiological signals, at least in the manner claimed, amount to nothing more than information able to be manipulated and analyzed. The Applicant has provided no other reason as to why the pending claims are not directed to an abstract idea aside from citing elements of the claim and arguing a differing direction. There is no underlying reasoning to the Applicant’s arguments and they fundamentally do not redress the detailed rejection above.
The Applicant further argues that they disagree with the assertion that the pending claims can be performed by a human and the pending claims should not be treated as being directed to a mental process.
The Examiner respectfully disagrees. The Examiner has never taken the position that the pending claims can be performed by a human. Rather, the position is more nuanced in that the elements of the abstract idea recited by the claim are capable of being performed by a human. Further, the Examiner has not taken the position that the abstract idea amounts to a mental process. The Applicant has argued against a position that the Examiner has not based the rejection on. Accordingly, this argument is not relevant to the current discussion.
The Applicant further argues that the pending claims provide a practical application of any alleged abstract idea recited by the pending claims because the claimed framework imposes a particular temporal structure on the physiological signal-processing operation. Specifically, this temporal structure includes 1) requirement that the time sequence of physiological signals having an overall recording duration being analyzed in segments allowing localized portions of physiological recording to be evaluated while preserving temporal coverage of the whole recording, 2) the trained machine learning model does not merely classify the entire segment in an undifferentiated manner, but rather selects a localized analysis window that is shorter than the predetermined duration, 3) the ensemble arrangement of machine learning uses its models to analyze input-segment durations to generate a prediction score for respiratory detection, and 4) the evaluation time within in the time sequence allows the computation of a vote count equal to a number of positive input segments whose time spans cover the evaluation time. These outputs provide a specific technical solution for localizing and counting respiratory events within a physiological time sequence.
The Examiner respectfully disagrees. The arguments pertaining to points 1-4 largely, if not entirely, relate to elements contained within the abstract idea. The only elements with points 1-4 that are not included in the abstract idea are the machine learning elements. Limitations that are included in the abstract idea cannot provide for a practical application of the abstract idea. Only elements outside of the abstract idea ,i.e. additional elements to the abstract idea, can provide for a practical application of the abstract idea. The Applicant argues that the machine learning models used in the pending claims are not generic in nature, but fails to provide any technical detail that would differentiate the claimed models from generic models. Finally, the Applicant has failed to identify what technical problem exists that the pending claims provide a technical solution to. Without a clear technical problem being addressed, there is no basis to conclude that technology is being improved. The vague assertion of problems with localizing and counting respiratory events within a physiological time sequence is not sufficient in establishing a technical problem and really amounts to nothing more than a bare assertion of improvement.
The Applicant further argues that the pending claims are similar to CardioNet wherein the pending claims provide a specific improvement in respiratory-event detection technology using physiological signals. The argued technical problem is stated as a single global determination of event over the entire recording would not provide localized event intervals and may fail to accurately define event timing.
The Examiner respectfully disagrees. A failure to properly identify a localized event does not appear to pertain to technology, but rather with how existing technology is used. In both instances, global and local, the respiratory events are present and detected. It is the analysis difference that results in the lack of accuracy or event timing determination. In CardioNet, the technical improvement dealt with how physiological signals were being acquired, not merely with how they were analyzed. The pending claims merely relate to how already acquired physiological signals were being analyzed. Specifically, the sensors in CardioNet required the claimed T wave filtering steps in the data acquisition to differentiate a T wave from being aliased with an R wave. This improved the data gathering step. There is no analog in the pending claims here because all of the data has already been collected by the PPG sensor and there has been no discussion about how the PPG sensor collects data. Merely segmenting existing data to pull information from it is merely data analysis. There is no convincing evidence that technology is being improved here at least with regard to CardioNet.
The Applicant further argues that the pending claims do not simply instruct a generic computer to receive data, analyze the data and output the result. The claimed order of combination of elements place meaningful limitations on the claims and define the specific technical implementation.
The Examiner respectfully disagrees. Placing meaningful limitations on claims and defining a specific technical implementation does not preclude the claim from implementing the steps of the abstract idea on a generic computer. The Applicant has failed to address the specific arguments made by the Examiner in the rejection above. The Applicant’s arguments here simply ignore the technical reality of what is being claimed. It is manifestly apparent that the steps of the abstract idea are merely being applied to a computer being used as a tool for the reasoning indicated above.
The Applicant further argues that the PPG sensor should not be considered as insignificant extra-solution activity.
The Applicant’s argument here is moot in light of the updated rejection above.
The Applicant further argues that the pending claims provide something significantly more than the abstract idea because of the ordered combination of elements of the claim. This combination is not well-understood, routine, or conventional and therefore amounts to something significantly more.
The Examiner respectfully disagrees. For an additional element to provide something significantly more than the abstract idea, it must be separate from the abstract idea. An element in a claim cannot both serve as part of the abstract idea and an additional element to the abstract idea. An abstract idea that is not well-understood, routine or conventional is still at the end of the day an abstract idea. The pending claims have no additional elements to consider as something significantly more than the abstract idea. Accordingly, the Applicant’s argument here is not persuasive.
The Applicant further argues that dependent claims provide additional elements for patent eligibility.
The Examiner respectfully disagrees. The Applicant merely list features of the dependent claims and do not actually provide any reasoning as to how these features would relate to patent eligibility. Accordingly, there is no actual argument being made here. In contrast, the Examiner has provided a detailed rejection that clearly articulates why the limitations of the dependent claims fail to provide patent eligibility.
Conclusion
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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