DETAILED ACTION
Applicant' s arguments, filed 06/09/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/22/2023, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are the current claims hereby under examination.
Examiner’s Note: all references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2024/0285187 A1.
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 .
Claim Objections
Claims 1-2, 4-7, 10-11, 13, and 17-20 are objected to because of the following informalities:
Claim 1 line 14 it appears that “each candidate sniff” should read “each of the candidate sniffs”
Claim 1 line 17 it appears that “the time intervals” should read “time intervals”
Claim 1 line 23 it appears that “accelerometer signal features” should read “the plurality of accelerometer signal features”
Claim 2 line 8 it appears that “quantifying the respiratory muscle effort comprises” should read “the quantifying the respiratory muscle effort further comprises” to make clear that the mean comparison of claim 2 is a further limitation of and not in place of the quantification of claim 1.
Claim 4 lines 1-2 it appears that “quantifying the respiratory muscle effort of the patient comprises” should read “the quantifying the respiratory muscle effort of the patient further comprises” to make clear that the ratio determination of claim 4 is a further limitation of and not in place of the mean comparison of claim 2.
Claim 5 lines 5 and 7 it appears that “each bump” should read “each of the bumps”
Claim 6 lines 2, 6, and 14 it appears that “of the bump” should read “for each of the bumps”
Claim 7 lines 9 and 12 it appears that “a first axis” should read “a first axis of the plurality of axes” and that “a second axis” should read “a second axis of the plurality of axes”
Claim 10 line 27 it appears that “accelerometer signal features” should read “the plurality of accelerometer signal features”
Claim 10 lines 20-21 it appears that “with time intervals of the candidate sniffs” should read “with the time intervals of the candidate sniffs”
Claim 11 line 8 it appears that “quantifying the respiratory muscle effort by comparing” should read “the quantifying the respiratory muscle effort further comprises comparing” to make clear that the mean comparison of claim 11 is a further limitation of and not in place of the quantification of claim 10.
Claim 13 lines 6, and 9 it appears that “each bump” should read “each of the bumps”
Claim 13 line 12 it appears that “the bump” should read “for each of the bumps”
Claim 17 lines 16 and 22 it appears that “each candidate sniff” should read “each of the candidate sniffs”
Claim 18 line 2 it appears that “each candidate sniff” should read “each of the candidate sniffs”
Claim 19 line 1 it appears that “wherein the plurality” should read “wherein determining the plurality” because the recited steps appear to be directed towards how the features are determined rather than only defining the features themselves.
Claim 19 line 10 it appears that “a first axis and a second axis” should read “a first axis and a second axis of the plurality of axes”
Claim 20 line 2 it appears that “each candidate sniff” should read “each of the candidate sniffs”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “portions of the number of preprocessed EMG signals as candidate sniffs”, “a bump in which values of a sniff EMG signal is equal to or greater than a predetermined threshold sniff value” and “a plurality of EMG-derived features from the number of preprocessed EMG signals associated with the time intervals of the candidate sniffs” It is unclear if “portions of the number of preprocessed EMG signals”, “a sniff EMG signal”, and “the number of preprocessed EMG signals associated with the time intervals of the candidate sniffs” are each referring to the same portion of the preprocessed EMG signal or different portions of the signal. It would seem that the relationship between each of these signal portion should be made clear or consistent terminology should be utilized. For the purposes of this examination, each limitation is interpreted as referring to the same portion of the preprocessed EMG signals.
Claim 1 recites “identifying, with the controller, portions of the number of preprocessed EMG signals as candidate sniffs, each candidate sniff comprising a bump in which values of a sniff EMG signal is equal to or greater than a predetermined threshold sniff value; determining with the controller a plurality of EMG-derived features from the number of preprocessed EMG signals associated with the time intervals of the candidate sniffs” but it is unclear if the “a bump in which values of a sniff EMG signal is equal to or greater than a predetermined threshold sniff value” is the metric used to identify the candidate sniffs or is merely a description of what the candidate sniffs comprise. If it is a description of what the candidate sniffs comprise, then it is unclear if the bump is related to, separate from, or a subset of the plurality of EMG derived features. For the purposes of this examination, the limitations are interpreted as the bump being used to identify the candidate sniffs and being separate from the plurality of EMG derived features. This rejection is further applied to the similar limitations of claim 17.
Claim 1 recites “a number of attributes of the number of preprocessed EMG signals” and “a number of attributes of the confirmed sniffs” but it is unclear if these limitations are the same as, related to, a subset of, or different from “a plurality of EMG-derived features from the number of preprocessed EMG signals”. It is unclear if the attributes from the preprocessed EMG signals may be the same attributes as the confirmed sniffs since the sniffs are confirmed from the preprocessed EMG signals and thus the preprocessed EMG signals include the confirmed sniffs and their corresponding attributes. For the purposes of this examination, the number of attributes will be interpreted as being a subset of the EMG derived features. This rejection is further applied to the similar limitations of claim 10.
Claims 2-9 are rejected by virtue of their dependence on claim 1.
Claims 11-15 are rejected by virtue of their dependence on claim 10.
Claims 18-20 are rejected by virtue of their dependence on claim 17.
Claim 3 recites “a sniff EMG signal” in line 5 but it is unclear if this limitation is the same as, related to, or different from “a sniff EMG signal” of claim 1. In particular, it would seem that the sniff EMG signal of claim 1 is derived from the preprocessed EMG signal whereas the sniff EMG signal of claim 3 is generated from a separate preprocessing step to generate an EMG signal with accentuated sniff activity. It would seem these limitations refer to different EMG signals and are interpreted as such.
Claim 5 recites “identifying for each of the candidate sniffs, with the controller, a bump …” but it is unclear if this “bump” is the same as related to, or different from, the “bump” of claim 1. In particular, the bump of claim 1. For the purposes of this examination, the bumps will be interpreted as the same elements.
Claim 5 recites “a maximum sniff EMG value in the bump” but it is unclear if this limitation is the same as, related to, or different from “the maximum sniff value in the sniff EMG signal” of claim 3. For the purposes of this examination, the limitations will be interpreted as the same maximum value. This rejection is further applied to the similar limitations of claim 13.
Claim 5 recites “classifying the candidate sniff as an artifact if a number of predetermined amplitude conditions are indicative of artifact activity” but it is unclear how this step relates to the rest of the claimed method. It is unclear if the “number of predetermined amplitude conditions” are meant to refer to any of the midpoint, offset value, local minimums, amplitude, or difference values calculated in the preceding steps of the claim or if the classification is based on completely unrelated amplitude conditions. For the purposes of this examination, the limitation is interpreted as the classification using a combination of the determined values from the earlier steps of the claim. This rejection is further applied to the similar limitations of claim 13.
Claim 5 recites “classifying the candidate sniff as an artifact” but it is unclear if this limitation is the same as, related to, or different from “classifying, with the controller the candidate sniffs either as confirmed sniffs or as signal artifacts based on the comparing” of claim 1. In particular, the limitation indicates that the candidate sniff is classified as “an artifact of the signal artifacts” which appears to indicate that the classified artifact is a subset of the artifacts of claim 1 but it is unclear what the relationship between the classification step of claim 5 and the classification step of claim 1 is. It is unclear if the classification of claim 5 is intended to replace the step of claim 1, is a subset of the step of claim 1, or is entirely separate from the step of claim 1. For the purposes of this examination, the limitation of claim 5 will be interpreted as further limiting the classification of claim 1. This rejection is further applied to the similar limitations of claim 13.
Claim 6 recites “classifying the candidate sniff as an artifact if a number of predetermined asymmetry conditions are indicative of artifact activity” but it is unclear how this step relates to the rest of the claimed method. It is unclear if the “number of predetermined asymmetry conditions” are meant to refer to any of the symmetry features calculated in the preceding steps of the claim or if the classification is based on completely unrelated asymmetry conditions. it is unclear if this limitation is the same as, related to, or different from the classifying steps of claims 5 and/or 1. For the purposes of this examination, the limitation is interpreted as the classification using a combination of the determined values from the earlier steps of the claim.
Claim 7 recites steps of filtering and determining to qualify a candidate sniff as an artifact. It is unclear if these recited steps are meant to further limit the steps of producing a number of preprocessed accelerometer signals, determining a plurality of accelerometer signal features, and comparing the accelerometer signal features to sniff detection thresholds to classify the candidate sniffs as artifacts of claim 1 or of they are intended to be separate and distinct steps from those set forth in claim 1. In particular, the limitation indicates that the candidate sniff is “qualified” as “an artifact of the signal artifacts” which appears to indicate that the qualified artifact is a subset of the artifacts of claim 1 but it is unclear what the relationship between the qualification step of claim 7 and the classification step of claim 1 is. It is unclear if the qualification of claim 7 is intended to replace the step of claim 1, is a subset of the step of claim 1, or is entirely separate from the step of claim 1 For the purposes of this examination, the limitations of claim 7 will be interpreted as further limiting each of these steps of claim 1. This rejection is further applied to the limitations of claims 8 and 9 which recite different steps of processing accelerometer signals to distinguish artifacts from sniffs and are interpreted in a similar manner. This rejection is further applied to the similar limitations of claims 14-15.
Claim 12 recites “identify local regular breathing EMG maxima in the regular breathing EMG signals” but it is unclear if this step is the same as related to, or different from “identify local regular breathing EMG maxima associated with regular breathing in the number of preprocessed EMG signals”. In particular, it is unclear if the “local regular breathing EMG maxima” of claim 12 is the same maxima as claim 11. It would seem that each maxima is determined from a different set of signals and thus are different maxima. The maxima of claim 11 is determined from “the number of preprocessed EMG signals” while the maxima of claim 12 is determined from “the regular breathing EMG signals” which are the result of preprocessing the raw EMG signals to produce “a regular breathing EMG signal” and “a sniff EMG signal” each of these signals are considered to be separate and distinct from the “number of preprocessed EMG signals” determined in claim 10 and used in claim 11 because no relationship between the various signals has been set forth nor have the identifying steps of claim 12 been set forth as further limiting the steps of claim 11. Thus it is unclear of the determined regular breathing maxima of claim 12 is different from the determined regular breathing maxima of claim 11. For the purposes of this examination, the maximas are interpreted as different maximas. This rejection and interpretation are similarly applied to “the maximum sniff value in the sniff EMG signal” of claim 12 which appears to refer to the “a maximum sniff value” of claim 11 but the maximum sniff value of claim 12 is produced from a different signal than the maximum sniff value of claim 11 and thus it is unclear if they are the same or different values and are being interpreted as different values.
Claim 12 recites “wherein comparing the mean of the local regular breathing EMG maxima to the maximum sniff value comprises finding the ratio of the mean of the local regular breathing EMG maxima to the maximum sniff value” but it is unclear if this comparing is the same as, related to, different from, or meant to further limit the comparing performed in order to quantify respiratory muscle effort of claim 11. In particular, the comparing of claim 12 appears to utilize different values than the comparing of claim 11 as described in the above 112b rejections of claim 12 and the language of the comparing step of claim 12 makes it unclear if it is intended to further limit the comparing of step 11 of is a separate comparing step. For the purposes of this examination, the comparing step of claim 12 is interpreted as a separate comparing step since it appears to utilize different values and is not recited as further limiting the step of claim 11.
Claim 18 recites “wherein identifying portions of the sniff EMG signal as candidate sniffs comprises … identifying a midpoint … calculating, at the midpoint … and determining an amplitude” but it is unclear how these determined metrics are then used to identify the portions of the sniff EMG signal as candidate sniffs. It would seem that the claim recites a number of processing steps for the bump of the candidate sniffs but then fails to tie in these processing steps to the identifying step they are supposed to be limiting. It is unclear how or if the recited features from the determinations of claim 18 are used in the identification step of claim 17. It is further unclear if the features of the bump determined in claim 18 are a subset of or otherwise related to “a plurality of EMG derived features from the sniff EMG signal” of claim 17. For the purposes of this examination, the limitation will be interpreted as the recited parameters being used in some form to identify the candidate sniffs and being part of the plurality of derived sniff EMG features.
Claim 19 recites “qualifying as a signal artifact any of the candidate sniffs for which the ratio for the first axis and the ratio for the second axis exceeds a predetermined frequency band ratio” but it is unclear if this qualifying step is the same as, related to, or different from the classifying step of claim 17 since it would appear both result in the determination of a candidate sniff as either a confirmed sniff or a signal artifact. For the purposes of this examination, the limitation will be interpreted as further limiting the classification of claim 17.
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 1-20 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. Claims 1-20 are directed to a method of processing EMG and accelerometer signals using a computational algorithm, which is an abstract idea. Claims 1-20 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] receiving, a raw EMG signal and raw accelerometer signals
[B1] producing a number of preprocessed EMG signals by preprocessing the raw EMG signal with the controller
[C1] producing a number of preprocessed accelerometer signals by preprocessing the raw accelerometer signals with the controller
[D1] identifying, with the controller, portions of the number of preprocessed EMG signals as candidate sniffs
[E1] determining, a plurality of EMG-derived features from the number of preprocessed EMG signals associated with the time intervals of the candidate sniffs
[F1] determining, a plurality of accelerometer signal features from the number of preprocessed accelerometer signals associated with the time intervals of the candidate sniffs
[G1] comparing, the plurality of EMG-derived features and accelerometer signal features to a plurality of sniff detection threshold values
[H1] classifying, with the controller the candidate sniffs either as confirmed sniffs or as signal artifacts based on the comparing
[I1] quantifying a respiratory muscle effort of the patient by comparing a number of attributes of the number of preprocessed EMG signals to a number of attributes of the confirmed sniffs.
These elements [A1]-[I1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] measuring, with a number of electromyography (EMG) electrodes, respiratory muscle activity of the patient
[B2] measuring, with an accelerometer, acceleration in a plurality of axes of a thorax of the patient
[C2] a controller
These elements [A2]-[C2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[B2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [C2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations “measuring, with a number of electromyography (EMG) electrodes, respiratory muscle activity of the patient” and “measuring, with an accelerometer, acceleration in a plurality of axes of a thorax of the patient” are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than a conventional EMG sensor detecting electrical impulses from muscles and an accelerometer detecting motion of the thorax. Such sensors are conventional as evidenced by Applicant’s lack of a particular description drawn towards their structure and method of operation.
Further, the element [C2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-9 and 16 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim 10 recites the same abstract idea as claim 1 and is thus rejected on the same basis as claim 1 as presented above. Additionally, each of the and additional elements as claim 10 have already been addressed in the above rejection of claim 1 and thus do not amount to significantly more than the abstract idea.
Claims 11-15 recite only limitations that further limit the abstract idea and are thus rejected on the same grounds as claims 2-9.
The analysis of claim 17 is as follows:
Step 1: Claim 17 is drawn to a process
Step 2A – Prong One: Claim 17 recites an abstract idea. In particular, claim 17 recites the following limitations:
[A1] receiving, a raw EMG signal measured by the EMG electrodes and raw accelerometer signals measured by the accelerometer
[B1] producing a regular breathing EMG signal and a sniff EMG signal by preprocessing the raw EMG signal the regular breathing EMG signal accentuating regular breathing activity and the sniff EMG signal accentuating sniff activity
[C1] producing a number of preprocessed accelerometer signals by preprocessing the raw accelerometer signals
[D1] identifying, portions of the sniff EMG signal as candidate sniffs, each candidate sniff comprising a bump in which all values of the sniff EMG signal are greater than or equal to a predetermined threshold sniff value
[E1] determining, a plurality of EMG-derived features from the sniff EMG signal associated with the candidate sniffs and a plurality of accelerometer signal features from the number of preprocessed accelerometer signals associated with the candidate sniffs
[F1] classifying, each candidate sniff as a confirmed sniff or as a signal artifact based on comparing the plurality of EMG-derived features and accelerometer signal features to a plurality of sniff detection threshold values
[G1] identifying, local regular breathing EMG maxima in the regular breathing EMG signal and a maximum sniff value in the sniff EMG signal associated with the confirmed sniffs
[H1] quantifying, a respiratory muscle effort of the patient by determining a ratio of a mean of the local regular breathing EMG maxima to the maximum sniff value
These elements [A1]-[H1] of claim 17 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 17 recites the following limitations that are beyond the judicial exception:
[A2] measuring, with a number of electromyography (EMG) electrodes, respiratory muscle activity of the patient
[B2] measuring, with an accelerometer, acceleration in a plurality of axes of a thorax of the patient
[C2] a controller
These elements [A2]-[C2] of claim 17 do not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[B2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [C2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 17 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations “measuring, with a number of electromyography (EMG) electrodes, respiratory muscle activity of the patient” and “measuring, with an accelerometer, acceleration in a plurality of axes of a thorax of the patient” are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than a conventional EMG sensor detecting electrical impulses from muscles and an accelerometer detecting motion of the thorax. Such sensors are conventional as evidenced by Applicant’s lack of a particular description drawn towards their structure and method of operation.
Further, the element [C2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 18-20 depend from claim 17, and recite the same abstract idea as claim 17. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Prior Art
Examiner’s Note: Applicant’s specification define a sniff as a much sharper, stronger, and shorter breath than regular breathing in paragraphs 0039 and 0061. Thus Applicant’s specification sets forth that a sniff is separate and distinct from a regular breath. The claims are interpreted in accordance with this distinction set forth in the specification that a regular breath may not be considered a sniff.
US Patent Application Publication Number US 2018/0235503 A1 hereinafter Derkx teaches systems and methods for determining a respiratory activity in patients with chronic obstructive pulmonary disease (COPD) based on surface electromyography measurements taken from the intercostal muscles on the chest of a subject. A processing apparatus for processing an electromyography signal indicative of an activity of a target muscle in a human or animal body that relates to the measurement of respiratory effort amid an activity of at least one further muscle is presented. The processing apparatus comprises a first interface for receiving a first electromyography signal obtained from the target muscle and the further muscle at a first location on the body; a second interface for receiving a second electromyography signal obtained from the further muscle at a second location on the body; and an analysis unit for determining a similarity signal based on the first electromyography signal and the second electromyography signal, wherein the analysis unit is further configured to determine a respiratory phase as an inspiratory phase if the similarity signal obtained from the first and the second electromyography signal is below a first predetermined threshold and/or determine a respiratory phase as an expiratory phase if the similarity signal obtained from the first and the second electromyography signal exceeds a second predetermined threshold (Abstract). Derkx teaches a method for determining respiratory effort by receiving EMG signals, preprocessing them, and using the amplitude of the receiving signals to determine a respiratory effort metric (Paragraphs 0081, 0086, 0089, 0110, and 0114). Derkx further teaches that accelerometers may be used to identify motion artifacts and use such artifacts to exclude certain breaths from measurement (Paragraphs 0055 and 0089). Derkx further teaches that sniff maneuvers may be performed to calibrate the EMG measurements (Paragraph 0087).
US Patent Application Publication Number US 2013/0310699 A1 hereinafter Hart teaches a method of monitoring a patient including measuring neural respiratory drive using a monitoring device, repeating the measurement either continuously or at regular time intervals, and comparing the measurements obtained in order to predict treatment failure and/clinical deterioration and/or re-admission. The neural respiratory drive is measured by obtaining a measure of the second intercostal space parasternal electromyogram. A monitoring device includes a signal input, a processing unit, and an output unit, and is arranged to measure the neural respiratory drive, store the measured value and compare it to a previously measured value for the neural respiratory drive (Abstract). Hart teaches that respiratory effort may be measured using EMG electrodes which measure the respiratory effort during normal breathing and during maximal effort sniff maneuvers. The sniff maneuvers are used to normalize the regular breathing data (Paragraphs 0111-0112). The measured EMG signal is preprocessed and the peak magnitude is identified (Paragraphs 0115-0116). The average peak magnitude of normal respiratory signals is determined and the maximum amplitude for the sniff maneuvers is determined (Paragraphs 0117-0119). The respiratory effort is then determined by a ratio of the mean maximum amplitude of the normal respiratory signal as compared to the maximum amplitude of the sniff maneuvers (Paragraphs 0120-0124).
US Patent Application Publication Number US 2020/0100697 A1 hereinafter Philips teaches a method for generating a filtered EMG signal includes obtaining a combined signal, wherein the combined signal comprises an ECG signal and an EMG signal. A first high pass filter is applied to the combined signal and an ECG model signal is generated, based on the high pass filtered combined signal. The method further includes, generating a partially filtered EMG signal by subtracting the ECG model from the high pass filtered combined signal. A second high pass filter is then applied to the partially filtered EMG signal to generate a second EMG signal and to the ECG model signal to generate a second ECG model signal. A filtered EMG signal is generated based on the second EMG signal and the second ECG model by way of a gating technique (Abstract). Philips teaches methods of extracting an ECG signal from an EMG signal of the intercostal space. (Paragraphs 0071-0098). Philips teaches that the filtered EMG signal may be used to determine parameters such as respiratory effort or neural respiratory drive (Paragraphs 0099). Philips further recites that the filtered EMG signal may have sniffs marked by a clinician or an automatic algorithm (Paragraphs 0119-0120).
None of Derkx, Hart, and/or Philips teach or reasonably suggest the method comprising “identifying, with the controller, portions of the number of preprocessed EMG signals as candidate sniffs; determining, with the controller, a plurality of EMG-derived features from the number of preprocessed EMG signals associated with time intervals of the candidate sniffs; determining, with the controller, a plurality of accelerometer signal features from the number of preprocessed accelerometer signals associated with time intervals of the candidate sniffs; comparing, with the controller the plurality of EMG-derived features and accelerometer signal features to a plurality of sniff detection threshold values, classifying, with the controller the candidate sniffs either as confirmed sniffs or as signal artifacts based on the comparing” in combination with the other claimed steps.
In particular, none of the prior art of record teaches a method of differentiating regular breaths from sniffs in EMG signals. While Philips paragraph 0120 recites that Figs. 8B and 8C depict graphs where sniffs are automatically detected by an algorithm, the specification does not actually describe an algorithm for detecting these points. At most, the specification recites a peak detection unit in paragraph 0108 which is what appears to be used to denote the “sniffs” in Figs. 8B and 8C as there is no differentiation between regular breathing and sniffs. Philips teaches that the first two breaths of Figs. 8A-C are regular breaths and the remaining eleven are sniffs. These sniffs are annotated by the physician in Fig. 8A and paragraphs 0118-0119. The graphs of Figs, 8B-C also include the annotations of the hollow circles seemingly performed by an automatic sniff detection algorithm as described in paragraph 0120 but these annotations also include the first two normal breaths being marked as sniffs. The first two breaths are regular breathing as described in paragraphs 0118-0119 and as can be seen in the pressure chart below each of the EMG charts in Figs. 8A-C. Thus the marking of these breaths as “sniffs” and the lack of an actual algorithm for performing the sniff detection seems to indicate that Philips merely detects the peaks of the filtered EMG signal. There is no differentiation between sniffs and regular breathing and Philips provides no criteria or method to perform sniff detection and thus Philips cannot reasonably teach the identification and classification of sniffs, which are different from regular breaths as set forth by Applicant’s specification, from EMG data as no identification method or thresholds to differentiate the breath types are disclosed.
Claims 1-15 are not rejected over the prior art as both claim 1 and 10 include the limitations not taught by the prior art as described above.
Response to Arguments
In regards to the rejections previously issued under 35 USC 112:
Applicant’s amendment and arguments have overcome some of the previously presented rejections but also necessitated new grounds of rejection. In particular, the majority of the rejections are directed towards the unclear relationship between the limitations of the dependent claims and the methods of the independent claims. New claims 18-20 are generally more clear since they recite what step is being limited in the preamble but then fail to tie the listed steps into the result at the end of the claim result in confusion as to how the recited steps are used. For example, claim 18 is directed towards limiting the step of identifying portions of the sniff EMG signal as candidate sniffs and lists several steps related to such an identification. The steps are left open-ended however as there is no ending limitation tying the results of the step back into the identifying limitation. It would seem that an added limitation of “wherein the candidate sniffs are identified based on the amplitude of the bump” or the like would serve to indicate how the recited steps limit the identification step while simultaneously making clear that the characteristics used in claim 18 are not part of “a plurality of EMG-derived features” of claim 17 by showing that the characteristics of claim 18 are tied to only the identification step rather than the subsequent determination step. Such a template for the dependent claims of identifying which independent claim step, if any, is being further limited in the preamble, and a general limitation at the end tying the results of the further limited step back into the general outcome of the independent claim step would resolve many of the above presented clarity issues.
Applicant’s argument that the claims are definite in view of the specification are not found to be persuasive because while the claims are read in light of the specification, the limitations of the specification are not read into the claims. Therefore what relationships are present between the variously claimed elements, such as the “number of preprocessed EMG signals” of claim 1, and the “regular breathing EMG signals” and “sniff EMG signals” of claim 3 must be made explicit if the limitations are meant to be related to each other.
In regards to the rejections previously issued under 35 USC 101:
Applicant argues that the claims recite operations on continuously sampled physiological signals that cannot be practically be performed in the human mind.
Applicant’s arguments are not commensurate in scope with the claimed invention. The claims do not require any continuous monitoring of the signals nor do they require real-time determination. Furthermore, each of the recited steps of the abstract idea are capable of being performed in the human mind using nothing more than pen and paper. The claimed pre-processing of signals is not particularly limited. Additionally, each of the steps of claim 1 are recited with a high level of generality and the particular techniques used to carry out those steps are not so complex as to be impossible to be performed in the human mind. The filtering of the received signals, identification of bumps based on amplitude metrics, determination of the recited EMG and accelerometer characteristics, classification of candidate sniffs from signal artifacts, and quantification of respiratory effort all involve basic mathematical principles readily carried out in the human mind. No time constraints or particular quantities of data are required by the claims. Even if particular speed requirements were in the claims, claiming the improved speed or efficiency inherent with applying the abstract idea on a computer does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures | LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). MPEP 2106.05(f)(2).
Applicant further argues that the claims represent an improvement to the field of non-invasive respiratory monitoring because the present invention is more comfortable than prior art techniques.
Applicant’s arguments are not found to be persuasive because the prior art of record, and as acknowledged by Applicant and evidenced in the prior art analysis above, performs sniff detection either manually of through the use of other sensors. Applicant does not provide sufficient evidence of improved sniff detection accuracy or speed over manual and/or prior art methods to be considered an improvement in the field of sniff detection. Additionally, the comfort of the patient is subjective and is not considered to amount to an improvement in the technology over other non-invasive sniff detection techniques such as clinician annotation or indication by the user when they perform a sniff. Furthermore, while the claimed method is considered novel, the novelty is based in the abstract idea and thus cannot amount to significantly more than the abstract idea itself. As per MPEP 2106.04(I) newly discovered or novel judicial exceptions are still exceptions.
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.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791
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