DETAILED ACTION
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 Rejections - 35 USC § 112
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 4 - 7 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.
In regard to claim 4, lines 1 - 2 recite, “the plurality of local maxima comprise two and five local maxima.” However, it is unclear how the plurality of local maxima can be both two and five local maxima. Examiner notes that paragraph [0205] of the Applicant’s specification states “the method can further comprise identifying between two and five local maxima” and recommends amending claim 4 to -- the plurality of local maxima comprise between two and five local maxima --, which is consistent with the specification. Claims 5 & 6 are rejected by virtue of dependence on claim 4.
In regard to claim 6, lines 1 - 2 recite, “the plurality of local maxima comprise three local maxima” while claim 5, from which claim 6 depends, includes the limitation, “the plurality of local maxima comprise two local maxima.” However, it is unclear how the plurality of local maxima can be both two and three local maxima.
In regard to claim 7, line 1 recites, “at each iteration” which lacks antecedent basis. Additionally, it is unclear if claim 7 requires that the controller introduced in claim 1 from which claim 7 depends perform multiple iterations of the steps of receiving a signal, performing a frequency analysis of the signal, identifying a plurality of local maxima of the signal, and outputting a frequency as claim 7 implies. Further clarification is required to define the metes and bounds of the claim. Claim 8 is rejected by virtue of dependence on claim 7.
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 - 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite details of a respiratory system that includes a respiratory device comprising a controller, which are all within a statutory category of invention, to “identify a plurality of local maxima of the signal resulting from the frequency analysis,” and “output a frequency… as an estimated respiratory rate” which falls into the category of a mental process. This judicial exception is not integrated into a practical application because with regard to Revised step 2A, prong 1, an exception is present as noted above and with regard to Revised step 2A, prong 2, the claim does not recite additional elements that integrate the judicial exception into a practical application. Further, with regard to Revised step 2B, the claim does not recite additional elements that integrate the judicial exception into practical application. In particular, the step of receiving “a signal of a parameter…” is directed towards a generalized data gathering step with no specific structure required to collect the data as there is no positively claimed step of measuring the “signal of a parameter”. Additionally, “performing a frequency analysis of the signal,” is directed towards a generic method of processing data and is not sufficient to integrate the abstract idea into practical application. While claim 1 does include the limitation of “a respiratory device,” the structure referred to are merely nominal or high level and do not provide specific structural details beyond those well known in the art, and thus provide no meaningful limitations or sufficient structure to integrate the judicial exception into practical application. The “controller” is similarly directed towards general structures that do not impose meaningful limitation onto the claim scope, as the limitations do not constitute use of the exception in the context of “a particular machine”. Claims 2 - 14 are directed towards details of data processing and are not sufficient to integrate the judicial exception into practical application. Claims 15 - 19 are directed towards general details of the respiratory system configured to deliver a respiratory therapy to a patient, but Examiner notes that the respiratory system in relation to delivering a respiratory therapy is exclusively discussed in the preamble of claim 1 from which claims 15 - 19 depend and is thus not positively claimed such that the details of claims 15 - 19 do not further integrate the judicial exception into practical application. Further, the limitation of sealed and non-sealed systems disclosed in claims 15 and 17 and the types of therapy that the system is “configured to” deliver in claims 16, 18, and 19 are nominal or high level and do not provide specific structural details beyond those well known in the art, and thus provide no meaningful limitations or sufficient structure to integrate the judicial exception into practical application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 - 6, 11, 12, & 14 - 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lellouche (WO 2017059530 A1 - Cited by Applicant as Universite Laval) in view of Sullivan (US 6984207 B1).
In regard to claim 1, Lellouche discloses a respiratory system configured to deliver breathing gas or respiratory therapy to a patient (paragraph [0010]) where the system is further configured to determine a respiratory rate of the patient (paragraph [0010]). The respiratory device comprises a controller (FIG. 1, component 22; paragraph [0091]) in communication with a signal processing module (FIG. 1, component 23; paragraph [0091]) where the signal processing module receives data signals from a respiratory rate sensor (FIG. 1, component 20), where the respiratory rate sensor can be a physical sensor, such as a strain gauge placed along the patient’s chest or other physical device allowing for the measurement of the respiratory rate of the patient (paragraph [0088]), or a soft sensor that estimates respiratory rate from other parameters (paragraph [0088]) such as oxygen flow sensors, pulse oximetry sensors, and CO2 sensors (paragraph [0097]). The signal (FIG. 4a, component 30), is filtered (FIG. 4b; paragraph [0096]) and then undergoes frequency analysis (FIG. 4c; paragraph [0096]) where the highest magnitude of frequency values is output as an estimated respiratory rate (paragraph [0096]).
While Lellouche discloses determining respiratory rate of a patient using a respiratory rate sensor such as a physical sensor, including a strain gauge placed along the patient’s chest and additionally disclose that multiple physiological parameter sensors (FIG. 1, components 18) are used to measure a plurality of physiological parameters of a patient (paragraph [0086]), they do not specify identifying a plurality of local maxima of the received signal used to determine respiratory rate after performing a frequency analysis of the signal.
However, Sullivan teaches a passive physiological monitoring system that comprises a physical sensor comprising a strain gauge placed on a patient that is used to detect respiratory motion and additional parameters, including heart rate (Column 6, line 59 - Column 7, line 6). Sullivan further teaches that the placement of the sensor on the chest causes the signal to include information indicative of respiration rate, heart rate, and other noise, such as extraneous movement and speech (Column 7, lines 7 - 20; Column 8, lines 41 - 53), and that respiration rate and heart rate are calculated using the energy spectrum from the time series data (Column 7, lines 50 - 51; Column 7, line 65 - Column 8, line 2) by filtering the signals and performing a fast Fourier transform (FFT) on the signal to identify primary signal frequencies (Column 8, lines 61 - 67) and identifying a plurality of peaks or local maxima in the signal resulting from frequency analysis (FIG. 4, components 37, 39, & 41; Column 9, lines 19 - 39) where each frequency is attributed to a specific parameter such as respiratory rate and heart rate. The local maxima with the highest magnitude is output as an estimated respiratory rate (Column 9, lines 25 - 30); FIG. 4, see “Respiration”).
It would have been obvious to one of ordinary skill in the art to have modified the respiratory system disclosed by Lellouche with the teaching of Sullivan that includes identifying a plurality of local maxima in the signal resulting from frequency analysis because Lellouche already discusses measuring a variety of parameters and isolating an estimated respiratory rate by performing a frequency analysis and identifying the highest magnitude of frequency values as the estimated respiratory rate (paragraph [0096]) such that modifying Lellouche with the teaching of Sullivan would improve the ability to measure different health parameters and isolate the respiratory rate from noise and other health parameters by identifying a plurality of local maxima associated with each parameter and outputting the frequency with the highest magnitude among the plurality of local maxima as the estimated respiratory rate.
In regard to claims 2 & 3, Lellouche as modified discloses the invention of claim 1 and Lellouche further discloses that the controlled is configured to filter a magnitude of each waveform (FIG. 3, component 40) where the filter is a band-pass filter in the frequency band from about 0.08 Hz to about 0.7 Hz, which corresponds to a respiratory rate of an adult patient (paragraph [0093]).
In regard to claims 4 - 6, Lellouche as modified discloses the invention of claim 1. Sullivan teaches that the plurality of local maxima comprise two to five local maxima (FIG. 4, components 37, 39, & 40). While FIG. 4 shows that the plurality of local maxima comprise three local maxima (FIG. 4, components 37, 39, & 40), it would be obvious to one of ordinary skill in the art prior to the effective filing date that the plurality of local maxima can vary based on routine experimentation to optimize the identification of health parameter information through the use of filtering and other signal-processing algorithms that remove noise such that only a local maxima with a primary frequency representing respiratory rate and a local maxima with the second highest frequency representing heart rate are identified (Column 8, line 54 - Column 9, line 5) such that the plurality of local maxima comprise two local maxima.
In regard to claim 11, Lellouche as modified discloses the invention of claim 1. Sullivan further teaches that the respiratory signal received by the controller is transformed to the frequency domain using Fast Fourier Transform (Column 7, lines 7 - 20). One of ordinary skill in the art would recognize that a Fast Fourier Transform is an algorithm for computing a Discrete Fourier Transform.
In regard to claim 12, Lellouche as modified discloses the invention of claim 11. Lellouche further discloses that the frequency analysis takes place in the range of 0.08 Hz to 0.7 Hz depending on patient data, which corresponds to the breathing frequency range of 4.8 breaths per minute to 42 breaths per minute (paragraph [0093]) and encompasses a typical breathing frequency range.
In regard to claim 14, Lellouche as modified discloses the invention of claim 1 and further discloses that the parameter is breathing gas flow signal or flow rate. Lellouche additionally discloses that respiratory rate can be estimated using data obtained from carbon dioxide data, nasal temperature, respiratory noise, and electromyographic signals of nasal muscles, or the like (paragraph [0097]).
In regard to claims 15 - 16, Lellouche as modified discloses the invention of claim 1 and further discloses that the system dispenses the respiratory therapy to a patient using a gas administration device such as a nasal cannula (paragraph [0083]). Examiner notes that in paragraph [0011] of the Applicant’s specification, a “non-sealed device” is described as “a nasal cannula”. The system is further configured to administer nasal high flow therapy (paragraph [0083]).
In regard to claim 17, Lellouche as modified discloses the invention of claim 1 and further discloses that the system dispenses the respiratory therapy to a patient using a gas administration device such as a facial mask (paragraph [0083]). Examiner notes that in paragraph [0340] of the Applicant’s specification, a “sealed system” is described as using “a face mask”.
Claims 7 - 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lellouche (WO 2017059530 A1 - Cited by Applicant as Universite Laval) in view of Sullivan (US 6984207 B1) as applied to claim 1 above, and further in view of Baker (US 5853364 A).
In regard to claim 7 - 8 Lellouche as modified discloses the invention of claim 1. While Lellouche discusses iteratively adjusting filtering parameters during the application of a frequency analysis algorithm (FIG. 3, component 42; paragraph [0096]) to improve the extraction of physiological parameters such as respiratory rate (FIG. 3, see “feedback”; paragraph [0095]), they do not specify that at each iteration of the frequency analysis algorithm, each of the plurality of local maxima is estimated to be caused by a same waveform as a previous local maximum if its frequency is within a certain distance of the previous local maximum.
However, Baker teaches a method and apparatus for estimating physiological parameters using model-based adaptive filtering using a Kalman filter where when the value of the parameter measured has little to no variation from the previous value, the measured signal is considered to be from the same waveform versus measurement noise and the value is filtered very little (Column 10, lines 41 - 49) by averaging the calculated value with previous values. In contrast, if the measured signal deviates from the previous signal by a certain amount, then the measured signal is considered measurement noise and the Kalman filter averages the calculated saturation more with previous values to bring the change more in line with an expected physiological value (Column 10, lines 41 - 49) or the value is rejected if the value is determined to be an outlier (FIG. 1A, component 21; Column 6, lines 34 - 37).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system disclosed by Lellouche as modified with the teaching of Baker that includes estimating if a local maxima is caused by a same waveform as a previous waveform and determining a filtered value for a magnitude of the one of the plurality of local maxima because Baker teaches that doing so reduces noise effects in a system for measuring physiological parameters (Column 3, lines 43 - 60).
Claims 9 - 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lellouche (WO 2017059530 A1 - Cited by Applicant as Universite Laval) in view of Sullivan (US 6984207 B1) as applied to claim 1 above, and further in view of Sentelle (US 20150301167 A1).
In regard to claims 9 - 10, Lellouche as modified discloses the invention of claim 1. While Lellouche discusses iteratively adjusting filtering parameters during the application of a frequency analysis algorithm (FIG. 3, component 42; paragraph [0096]) to improve the extraction of physiological parameters such as respiratory rate (FIG. 3, see “feedback”; paragraph [0095]), they do not specify that if a frequency of one of the plurality of local maxima is not within a certain distance of a frequency of any previous local maximum and considered to be caused by a new waveform, a filtered value for a magnitude of the one of the plurality of local maxima begins from zero, the filtered value for the magnitude of the one of the plurality of local maxima being determined using the magnitude of the one of the plurality of local maxima and an assumed previous magnitude of zero.
However, Sentelle teaches a device for analyzing waveform frequency signals that includes analyzing multi-frequency data that includes an identified target where range bins of a range bin profile associated with a target or known value. When a frequency is detected outside of the range bin profile or is determined not to be the same waveform generated by a target based on the distance between the two values, the range profile is updated such that the portions of the range profile that do not include the target are zeroed out (paragraph [0302]; FIG. 28, component 2850). While Sentelle is specific to a radar system versus health monitoring systems, the teaching of Sentelle is directed towards analyzing frequency domain signals to identify a specific frequency caused by a target of interest which would apply to the processing of the frequency domain signals discussed by Lellouche.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system disclosed by Lellouche as modified with the teaching of Sentelle that signals outside of a range profile are zeroed because Lellouche already discusses improving the extraction of physiological parameters such as respiratory rate (FIG. 3, see “feedback”; paragraph [0095]) through iteratively updating filtering techniques and Sentelle teaches a filtering technique for isolating a target by zeroing out values outside of the range associated with the target such that modifying Lellouche with the teaching of Sentelle would be considered combining prior art elements according to known methods to yield the predictable result of identifying a target signal from multiple frequencies.
Claim 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lellouche (WO 2017059530 A1 - Cited by Applicant as Universite Laval) in view of Sullivan (US 6984207 B1) as applied to claim 1 above, and further in view of Strachan (US 20150150515 A1).
In regard to claim 13, Lellouche as modified discloses the invention of claim 1. While Lellouche discloses assessing the quality of pulse oximetry signals, they do not specify that the signal quality of the estimated respiratory rate is determined by the controller.
However, Strachan teaches a system for extraction of respiratory rate from signals processed using frequency analysis (paragraph [0046]) where a measure of confidence in the estimated respiratory rate is determined by determining the proportion of the total area under the frequency curve which represents the strength of the identified local maxima or peak (paragraph [0050]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system disclosed by Lellouche with the teachings of Strachan, which includes determining signal quality of the estimated respiratory rate, because Lellouche already discloses assessing the quality of other signals measured by their system such that modifying Lellouche with the teachings of Strachan would be considered combining prior art elements according to known methods to yield the predictable result of assessing the quality of a measured parameter.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lellouche (WO 2017059530 A1 - Cited by Applicant as Universite Laval) in view of Sullivan (US 6984207 B1) as applied to claim 1 above, and further in view of Klap (US 20110046498 A1).
In regard to claim 18, Lellouche as modified discloses the invention of claim 17. While Lellouche discloses administering respiratory therapy to a patient using a gas administration device (paragraph [0083]) and using a measured respiratory rate to automatically adjust the breathing gas flowrate to a patient (Abstract), they do not specify that the system is used to deliver CPAP therapy.
However, Klap teaches that CPAP systems can be used to deliver respiratory therapy to patients with sleep apnea where the system senses respiration rate in order to optimize the use of CPAP devices (paragraph [0330]).
It would have been obvious to one of ordinary skill in the art to have modified the system disclosed by Lellouche as modified with the teachings of Klap that include the delivering CPAP therapy to a user because Lellouche is already interested in delivering respiratory therapy to a patient where the respiratory therapy is adjusted based on respiration rate of the patient such that modifying Lellouche as modified with the teachings of Klap would be considered use of simple substitution of one known element, in this case the gas administration device disclosed by Lellouche, with the gas administration device configured to deliver CPAP therapy to a user taught by Klap, to obtain the predictable results of delivering respiratory therapy to a user.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lellouche (WO 2017059530 A1 - Cited by Applicant as Universite Laval) in view of Sullivan (US 6984207 B1) as applied to claim 1 above, and further in view of Gradon (US 20060027234 A1).
In regard to claim 19, Lellouche as modified discloses the invention of claim 17. While Lellouche discloses administering respiratory therapy to a patient using a gas administration device (paragraph [0083]), they do not specify that the system is used to deliver bilevel therapy.
However, Gradon teaches that Bi-level Positive Airway Pressure (BiPAP) systems can be used to deliver respiratory therapy to patients (paragraph [0024]).
It would have been obvious to one of ordinary skill in the art to have modified the system disclosed by Lellouche as modified with the teachings of Gradon that include the delivering BiPAP therapy to a user because Lellouche is already interested in delivering respiratory therapy to a patient such that modifying Lellouche as modified with the teachings of Gradon would be considered use of simple substitution of one known element, in this case the gas administration device disclosed by Lellouche, with the gas administration device configured to deliver BiPAP therapy to a user taught by Gradon, to obtain the predictable results of delivering respiratory therapy to a user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Perez De Alejo Fortun (US 20160242675 A1) discloses an apparatus comprising a respiratory therapy device that includes a processor configured to determine a respiratory rate of a patient based on flow rate or pressure of gas in the pipe (FIG. 1; Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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