DETAILED ACTION
Claims 1-15 are hereby the present claims under consideration.
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 5-9 and 13-15 are objected to because of the following informalities:
Claim 1 lines 19-20 it appears that “time intervals of the candidate sniffs” should read “the time intervals of the candidate sniffs”
Claim 5 line 2 it appears that “each candidate sniff” should read “each of the candidate sniffs”
Claim 6 line 4 it appears that “the amplitude” should read “the amplitude of the bump”
Claims 5-9 and 13-15, it appears that “an artifact” should read “an artifact of the signal artifacts” to clarify that each of the signals qualified as an artifact are part of the classification of artifacts of claims 1 and 10.
Claim 13 line 3 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 1-15 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 “identifying, with the controller, portions of the number of preprocessed EMG signals as candidate sniffs” but it is unclear what metric, determination, comparison, or other processing is performed in order to carry out the recited identification. It is unclear what a “candidate sniff” entails and how it is identified from the preprocessed EMG signals. It is unclear what attributes of a signal are indicative of a candidate sniff. For the purposes of this examination, any portion of a preprocessed EMG signal may be considered a candidate sniff. This rejection is further applied to the similar limitations of claim 10.
Claim 1 recites “determining, with the controller, a plurality of EMG-derived features from the number of preprocessed EMG signal associated with time intervals of the candidate sniffs” and “determining, with the controller, a plurality of accelerometer signal features from the number of preprocessed accelerometer signals associated with time intervals of candidate sniffs” but it is unclear what the “time intervals associated with the candidate sniffs” comprise and how they are determined since it is unclear what process is used to identify the candidate sniffs. It is further unclear what features are being derived from the EMG and accelerometer signals. For the purposes of this examination, the limitation will be interpreted as any feature derived from any time in the pre-processed signals since it is unclear what the time intervals of the candidate sniffs entail. This rejection is further applied to the similar limitations of claim 10.
Claim 1 recites “comparing, with the controller, the plurality of EMG-derived features and accelerometer signal features to a plurality of sniff detection threshold values” but it is unclear what the sniff detection threshold values entail and how such values which differentiate candidate sniffs from noise are determined. It is unclear what comparison takes place between the features of the EMG and accelerometer and the sniff detection threshold values. For the purposes of this examination, the limitation will be interpreted as any comparison of the extracted features to threshold values. This rejection is further applied to the similar limitations of claim 10.
Claim 1 recites “classifying, with the controller, the candidate sniffs either as confirmed sniffs of as signal artifacts based on the comparing” but it is unclear what criteria are used to classify the candidate sniffs into confirmed sniffs or signal artifacts. It is unclear the number or degree of difference/similarity required between the EMG and accelerometer features and the sniff detection threshold values that qualify a candidate sniff as either a confirmed sniff or signal artifact. It is unclear what the classification entails and how the results of the comparison are transformed into the output of the classification. For the purposes of this examination, the limitation will be interpreted as any classification between sniffs and noise. This rejection is further applied to the similar limitations of claim 10.
Claim 1 recites “quantifying with the controller 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” but it is unclear what “number of attributes” from the pre-processed EMG signals entail and it is unclear what the “number of attributes” from the confirmed sniffs entail. It is unclear how this comparison results in a quantification of respiratory muscle effort or what the quantification itself entails. For the purposes of this examination, the limitation will be interpreted as any quantification of any type of metric relating to RME from the EMG signals of regular breathing and sniffs. This rejection is further applied to the similar limitations of claim 10.
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.
The following claim limitations lack proper antecedent basis; Claims 2 and 11 lines 4-5 “the mean of the local regular breathing maxima”; Claim 3 lines 8-13:“the local regular breathing EMG maxima in the regular breathing EMG signal”, “the maximum sniff value in the sniff EMG signal”; Claim 4 lines 2-3: “the mean of the local EMG maxima” and “the maximum sniff value”; Claim 5 lines 9-12: “the local sniff EMG minimum immediately preceding the bump”, “the local sniff EMG minimum immediately following the bump”, “the difference”; Claim 6 line 3 “the ratio”, “the mean of the local sniff EMG minimum immediately preceding the bump and the local sniff EMG minimum immediately following the bump”; Claim 12 line 9 “the mean of the local EMG maxima”; Claim 13 lines 10-12 “the local sniff EMG minimum immediately preceding the bump”, “the local sniff EMG minimum immediately following the bump”, “the difference”
Claim 2 recites limitations of identifying, determining, and quantifying drawn towards the EMG signals but it is unclear if these limitations are meant to further limit the steps of producing preprocessed EMG signals, determining EMG features, comparing the EMG features, classifying the candidate sniffs, and quantifying RME of claim 1. In particular it is unclear which if the limitations of claim 2 are meant to further limit which of the steps of claim 1 or if they are intended to be separate and distinct steps from those carried out in claim 1. For the purposes of this examination, the steps of claim 2 will be interpreted as further limiting their respective steps from claim 1. This rejection is further applied to the various steps of claims 3-6 which are also interpreted as further limiting their respective steps of claim 1. This rejection is further applied to the similar limitations of claims 11-13.
Claim 2 recites “wherein quantifying the respiratory muscle effort comprises comparing the mean of the local breathing EMG maxima to the maximum sniff value” but it is unclear how this comparison results in the recited quantification. In particular it is unclear what the outcome of the comparison is and how it relates to a quantified RME value. For purposes of this examination, the limitation will be interpreted as any type of quantification related to a comparison of the recited values. This rejection is further applied to the similar limitations of claim 11.
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. 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. 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. 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 Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “quantifying with the controller 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” but paragraph 0067 and Fig. 3 appear to indicate that the quantification of RME is performed by generating a specific ratio between amplitudes of regular breathing signals and confirmed sniff signals. The specification does not appear to contemplate additional metrics to quantify RME. Thus it appears that the genus of claimed quantification by a comparison of “a number of attributes” from regular breathing and sniff EMG signals is not supported by the disclosed species of quantifying RME through a ratio of the mean maximum average of regular breathing signals to the maximum value of detected sniff activity. This rejection is further applied to the similar limitations of claim 10.
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 1-15 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 1-15 are directed to a method of processing EMG and accelerometer signals using a computational algorithm, which is an abstract idea. Claims 1-15 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 time intervals of the candidate sniffs
[F1] determining, a plurality of accelerometer signal features from the number of preprocessed accelerometer signals associated with 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 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.
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.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791