DETAILED ACTION
This Office Action is in response to the amendment, filed on July 24, 2026. Primary Examiner acknowledges Claims 1-20 are pending in this application, with Claims 1, 7-9, and 14 having been currently amended.
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 § 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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
(STEP 1): Four Categories of Statutory Subject Matter
The independent claim, Claim 1, and its dependent claims, Claims 2-6, recite a method that is one of the four statutory categories.
In particular, the subject matter of the independent claim, Claim 1, and further as incorporated into its dependents, Claims 2-6, explicitly recite the limitation:
A method, comprising:
determining time of flight of a gas flow with a first ultrasonic transducer and a second ultrasonic transducer, wherein the gas flow includes a volume concentration of oxygen;
responsive to determining the time of flight, determining a speed of sound in the gas flow; and
responsive to determining the speed of sound, determining a volume concentration of carbon dioxide in the gas flow based at least in part on the speed of sound and the volume concentration of oxygen.
(STEP 2A): Whether a Claim is Directed to a Judicial Exception
(STEP 2A, Prong One): Whether a Claim Recites An Abstract Idea, Law of Nature or Natural Phenomenon
Regarding “determining time of flight of a gas flow with a first ultrasonic transducer and a second ultrasonic transducer, wherein the gas flow includes a volume concentration of oxygen”, this claim limitations appears to be directed to mental processes that can be performed by a person simply observing the output of the claimed “ultrasonic transducers” to determine the “time of flight”. The term “time of flight” is a measure of the time it takes for an ultrasonic signal to travel through a fluid and is received by a downstream receiver; whilst, the term “transit time” is the time difference between upstream and downstream ultrasonic signal, calculated by measuring the difference in the time it takes for the signal to travel with and against the fluid flow. In this fact, “time of flight” related to the time it takes for an ultrasonic signal sent from a “first ultrasonic transducer” to be received by the “second ultrasonic transducer” in a singular direction – downstream; whilst, “transit time” is a consideration of the aforementioned ultrasonic signals from a “first ultrasonic transducer” to be received by the “second ultrasonic transducer” and vice versa in two directions – downstream and upstream.
Consequently, the concept of “determining time of flight of a gas flow with a first ultrasonic transducer and a second ultrasonic transducer, wherein the gas flow includes a volume concentration of oxygen” is an observation, evaluation, judgement, or opinion, which is grouped as a mental process under 2019 PEG. Additionally, it is noted the act of performing a mathematical formula or equation is a determination, which is also grouped as a mental process under 2019 PEG.
Regarding “responsive to determining the time of flight, determining a speed of sound in the gas flow”, this claim limitations appears to be directed to mathematical concepts performed by a person utilizing the “speed of sound” calculation.
Consequently, the concept of “responsive to determining the time of flight, determining a speed of sound in the gas flow” is a mathematical formula or equation, which is grouped as a mathematical concepts under 2019 PEG. Additionally, it is noted the act of performing a mathematical formula or equation is a determination, which is also grouped as a mental process under 2019 PEG.
Regarding “responsive to determining the speed of sound, determining a volume concentration of carbon dioxide in the gas flow based at least in part on the speed of sound and the volume concentration of oxygen”, this claim limitations appears to be directed to mathematical concepts performed by a person utilizing the correlation between “a volume concentration of carbon dioxide” as compared to “a volume concentration of oxygen”.
Consequently, the concept of “responsive to determining the speed of sound, determining a volume concentration of carbon dioxide in the gas flow based at least in part on the speed of sound and the volume concentration of oxygen” is a mathematical relationship, which is grouped as a mathematical concepts under 2019 PEG. Additionally, it is noted the act of performing a mathematical formula or equation is a determination, which is also grouped as a mental process under 2019 PEG.
Thus, the subject matter of the independent claim, Claim 1, and further as incorporated into its dependents, Claims 2-6, are directed to a judicial exception because they recite an abstract idea.
(STEP 2A, Prong Two): Whether a Claim Recites Additional Elements that Integrate the Judicial Exception into a Practical Application
Although the subject matter of Claim 1 and further as incorporated into its dependents, Claims 2-6, are directed to a judicial exception – abstract idea, this judicial exception is not integrated into a practical application as the additional elements of a “first ultrasonic transducer” and a “second ultrasonic transducer” are simply an element that is utilized to transmit and receive the ultrasonic signal to carry out the abstract idea of the method claim and amounts to being conventional practice in the field of use.
The recited abstract idea within the method does not improve the functioning of known ultrasonic signals and their associated ultrasonic transducers, nor does the recited abstract idea impart any other technology or technical field application. Nor does the use of the additional elements simply serve to apply the aforementioned abstract idea with, or by the use of, a particular machine, effect a transformation or apply or use the aforementioned abstract idea in some meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
As the additional elements of the “first ultrasonic transducer” and the “second ultrasonic transducer” are utilized to collect data to feed the abstract determination process, and further to modify calculated “time of flight” be introduced into the known mathematical relationships of the “speed of sound” calculation and the known correlation between the “volume concentration of oxygen” and the “volume concentration of carbon dioxide”, the use of the additional elements is merely extra-solution activity – as the act of evaluating information and performing mathematics can be performed in the human mind.
Moreover, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by the claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex., LLC v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
Thus, for these additional reasons, the aforementioned abstract idea of the independent claims, and further as incorporated into its dependents, Claims 2-6, is not integrated into a practical application under 2019 PEG.
(STEP 2B): Whether a Claim Amounts to Significantly More
Although the subject matter of Claim 1 and further as incorporated into its dependents, Claims 2-6, are directed to a judicial exception – abstract idea, this judicial exception does not amount significantly more as the additional elements of a “first ultrasonic transducer” and a “second ultrasonic transducer” are simply an element that is utilized to transmit and receive the ultrasonic signal to carry out the abstract idea of the method claim and amounts to being conventional practice in the field of use.
Regarding “determining time of flight of a gas flow with a first ultrasonic transducer and a second ultrasonic transducer, wherein the gas flow includes a volume concentration of oxygen”, Mault et al. (6,468,222) in Column 10, Lines 30-65, “The transit time is the time between the transmission of the pulse from transducer 80 and detection of the pulse by transducer 82. The roles of transmitter and detector are then reversed, in order to measure a transit time for a pulse traveling in the opposite direction. A series of transit time measurements of the form U1-D1-U2-D2-U3-D3 are hence obtained, where U and D refer to transit times for pulses traveling up or down the flow tube, respectively, and the numbers refer to the sequence of measurement. (The terms up and down are appropriate for the configuration shown in FIG. 10; however in other embodiments the flow orientation may be horizontal, oblique, etc.). By averaging U1 and U2, we obtain an estimated up-time at the time D1 was measured by linear interpolation. To obtain a transit time difference, and hence flow rate, at the time that D1 was measured, we compare D1 with the average of U1 and U2. Similarly, to obtain a flow rate at the time U2 was measured, we compare U2 with the average of D1 and D2. This is but one simple method of processing the measured data. Other approaches will be clear to those of skill in the art.”
Consequently, the concept of “determining time of flight of a gas flow with a first ultrasonic transducer and a second ultrasonic transducer, wherein the gas flow includes a volume concentration of oxygen” was a known practice.
Regarding “responsive to determining the time of flight, determining a speed of sound in the gas flow”, Mault et al. (6,468,222) in Column 19, Lines 55-70, “Because the ultrasonic flow meter preferably used with the present invention transmits ultrasonic pulses in both upstream and downstream directions, the transit time, independent of flow speed, in ambient air may be determined by averaging the upstream and downstream transit times during inhalation of ambient air. The speed of sound may then be calculated according to the following equation. c=L/2x(1/t.sub.u +1/t.sub.d), where c is the speed of sound, L is the distance between the transducers, tu is the transit time in the up direction, and td is the time in the down direction.”
Consequently, the concept of “responsive to determining the time of flight, determining a speed of sound in the gas flow” was a known practice.
Regarding “responsive to determining the speed of sound, determining a volume concentration of carbon dioxide in the gas flow based at least in part on the speed of sound and the volume concentration of oxygen”, Mault et al. (6,468,222) in Column 22, Line 35 thru Column 23, Line 10, “As known to those of skill in the art, resting metabolic rate (RMR) may be calculated in a variety of ways. One known and accepted approach is given by the de Weir formula, which takes the form: RMR=1.44(3.581.times.VO.sub.2 + 1.448.times.VCO.sub.2)-17.73 where VO.sub.2 is the volume of oxygen consumed in milliliters-per-minute, VCO.sub.2 is the amount of CO.sub.2 produced in milliliters-per-minute, and RMR is the resting metabolic rate in Kcal per day. As an alternative, certain assumptions may be made concerning the ratio between VO.sub.2 and VCO.sub.2. Specifically, the respiratory quotient is given by the following formula: RQ = VCO2/VO2, where RQ represents respiratory quotient. The respiratory quotient typically ranges between 0.7 and 1.1 depending on the type of stored energy source being metabolized by the user's body. RQ may be assumed to be 0.85 for typical users during the calculation of resting metabolic rate. Therefore, using this ratio and substituting for VCO.sub.2 gives the equation: RMR=6.929.times.VO.sub.2 -17.73 here RMR is resting metabolic rate in Kcal per day, and VO.sub.2 is the volume of oxygen consumed by the user in milliliters-per-minute. Preferably, the various parameters which are measured by the calorimeter are summed or averaged over multiple breaths, thereby giving improved accuracy.”
Consequently, the concept of “responsive to determining the speed of sound, determining a volume concentration of carbon dioxide in the gas flow based at least in part on the speed of sound and the volume concentration of oxygen” was a known practice.
Thus, for these additional reasons, the aforementioned abstract idea of the independent claims, and further as incorporated into its dependents, Claims 2-6, including the subject matter of the additional elements of a “first ultrasonic transducer” and a “second ultrasonic transducer” are simply an element that is utilized to transmit and receive the ultrasonic signal to carry out the abstract idea of the method claim and amounts to being conventional practice in the field of use.
Consideration of Additional Subject Matter of the Dependent Claims
Explicitly, regarding the additional subject matter added to the dependent claims, Claims 2-6, appears to incorporate additional limitations, these additional limitation do not appear to further define the abstract idea as significantly more.
With respect to Claim 2, the subject matter appears to be directed towards the mathematical manipulation temperature to correlate the volume calculation of carbon dioxide using the ideal gas law (PV = nRT) which correlates pressure, volume, and temperature.
With respect to Claim 3, the subject matter appears to be directed towards humidity calculation as outlined in Mault et al. (6,468,222) Column 20, Lines 1-70 – “This leaves essentially two variables, ambient temperature and water vapor content. Relative humidity and ambient temperature are interrelated by equation (a). …”.
With respect to Claim 4, the subject matter appears to be directed towards the flow rate calculation as outlined in Mault et al. (6,468,222) Column 9, Line 40 thru Column 10, Line 15 – “According to the first preferred embodiment of the present invention, inhalation and exhalation volume are measured by instantaneously measuring the flow velocity of gas through the flow tube 36. Because all inhalation and exhalation passes through this tube, and the internal diameter of the tube is known, measuring flow velocity in the tube allows calculation of flow volume. According to the present invention, flow velocity in the flow tube 36 is measured using two spaced apart ultrasonic transducers.” and pressure using the ideal gas law (PV = nRT) which correlates pressure, volume, and temperature.
With respect to Claim 5, the subject matter appears to be directed towards the mathematical manipulation of the speed of sound to calculate the length and radius of flow as a function of the flow rate.
With respect to Claim 6, the subject matter appears to be directed towards the mathematical manipulation of the speed of sound to separate the transit time for each direction of inhalation and exhalation.
Thus, the additional subject matter added to the dependent claims, Claims 2-6, retain the status of not being integrated into a practical application as the subject matter is not significantly more than the aforementioned abstract idea method.
Conclusion of the 35 U.S.C. 101 Analysis
In light of the aforementioned reasoning, Claims 1-6 are deemed rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-11, 13-18, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Burgess et al. (2023/0166065).
As to Claim 1, Burgess discloses a method, comprising: determining, by a processor (13, “a controller 13 … The controller 13 can include a hardware processor and can be configured or programmed to control the components of the apparatus, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient, operating the humidifier 12 (if present) to humidify and/or heat the gases flow, receiving user input from the user interface 14 for reconfiguration and/or user-defined operation of the apparatus 10, and outputting information (for example on the display) to the user.” Para 0051; also see Paras 0053, 0054, 0076, and 0079), time of flight (“time of flight”, “Ultrasonic sensors including ultrasonic transmitters and/or receivers can be used to measure a time of flight of acoustic signals to determine gas velocity and/or composition, which can be used in flow therapy apparatuses … In one ultrasonic sensor (including ultrasonic transmitters and/or receivers) topology, a driver causes a first sensor, such as an ultrasonic transducer, to produce an ultrasonic pulse in a first direction. A second sensor, such as a second ultrasonic transducer, receives this pulse and provides a measurement of the time of flight of the pulse between the first and second ultrasonic transducers. Using this time of flight measurement, the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a hardware processor or controller of the flow therapy apparatus. Characteristics of the gases flow, such as gases concentration, can then also be determined by the hardware processor using the time of flight measurement. The second sensor can transmit and the first sensor can receive a pulse in a second direction opposite the first direction to provide a second measurement of the time of flight, allowing additional characteristics of the gases flow, such as a flow rate or velocity, to be determined.” Para 0004; “A respiratory assistance system for providing a flow of gases to a patient can comprise an acoustic source configured to generate at least a first acoustic signal; and at least two acoustic receivers configured to each receive the first acoustic signal, the at least two acoustic receivers in electrical communication with a hardware processor configured to determine a time of flight of the acoustic signal by determining a difference of time between a receipt of the at least first acoustic signal by a first one of the at least two acoustic receivers and a receipt of the at least first acoustic signal by a second one of the at least two acoustic receivers. … The at least two acoustic receivers can be positioned between the first and second acoustic transducers. The hardware processor can be configured to cancel out errors in the time of flight determinations due to delay of the first and second acoustic transducers. … The hardware processor can be configured to use a time of flight measurement taken along the first distance to provide an estimate of a time of flight. The hardware processor can be configured to use a time of flight measurement taken along the second distance to provide a more accurate assessment of the time of flight. The first distance can be shorter than the second distance. The time of flight measurements can be generated from between the first one of the at least two acoustic receivers and the acoustic source, between the second one of the at least two acoustic receivers and the acoustic source, between the first and second ones of the at least two acoustic receivers, between the first and second acoustic transducers, or a combination thereof in both directions along an acoustic path. The hardware processor can be configured to compare two or more of the time of flight measurements to determine accuracy of the two or more of the time of flight measurements. The hardware processor can be configured to use acoustic signals received by the at least two acoustic receivers to perform cross-correlation of the received acoustic signals. The hardware processor can be configured to use acoustic signals received at the at least two acoustic receivers to determine waveform deformation. The hardware processor can be configured to use acoustic signals received at the at least two acoustic receivers to detect a flow rate by determining time delay for the time of flight measurements.” Para 0012; “The processor can be configured to determine at least one characteristic of the gases flow based on a difference between a time of flight measurement of the transmitted acoustic signal and a time of flight measurement of the echoed acoustic signal.” Para 0013; “From these measurements, the hardware processor can calculate time of flight t.sub.2 between the acoustic receivers b, c at step 830: … This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” Paras 0120 and 0121; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement…” Para 0123; also see: Paras 0014-0016, 0018, 0106, 0123, 0126, 0127, 0138, 0139) of a gas flow (402, best seen Figure 22B, “Turning to FIG. 21, the gases exiting the blower can enter a flow path 402 in the sensor chamber 400, which can be positioned within the motor and sensor module. The flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape with no sharp turns. The flow path 402 can have curved ends with a straighter section between the curved ends.” Para 0098; also see: “A sensing circuit board 404 with sensors, such as ultrasonic transmitters, receivers, humidity sensor, temperature sensor, flow rate sensor, and the like, can be positioned in the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed in the flow path 402. … After passing through the flow path 402 in the sensor chamber 400, the gases can exit to the humidification chamber.” Para 0099 and “With continued reference to FIG. 21, openings 406 of the sensor chamber 400 can hold acoustic transmitters (shown as 1502 in FIG. 22A), such as ultrasonic transducers which form an acoustic axis (shown as 1520 in FIG. 22B and 1620 in FIGS. 23A-23B) along at least a portion of the flow path 402 to measure properties or characteristics of the gases within the flow.” Para 0100) with a first ultrasonic transducer (one of 1502, best seen Figures 22A/B, “The one or more acoustic transmitters 1502 can be ultrasonic transmitters. … The acoustic transmitters 1502 in FIG. 22A can be first and second ultrasonic transducers. The first and second acoustic transducers can be a matched pair of ultrasonic transducers, for example, a matched pair of piezoelectric transducers. ” Para 0102) and a second ultrasonic transducer (other of 1502, best seen Figures 22A/B, “The one or more acoustic transmitters 1502 can be ultrasonic transmitters. … The acoustic transmitters 1502 in FIG. 22A can be first and second ultrasonic transducers. The first and second acoustic transducers can be a matched pair of ultrasonic transducers, for example, a matched pair of piezoelectric transducers. ” Para 0102), wherein the flow of gas (402) includes a volume concentration of oxygen (“oxygen”, “The acoustic transmitters 1502 and acoustic receivers 1504 can measure characteristics of the gases flow, such as gases concentration including but not limited to oxygen concentration and flow rate.” Para 0117); responsive to determining the time of flight (“time of flight”), determining by a processor (13), a speed of sound (“speed of sound”, “Using this time of flight measurement, the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a hardware processor or controller of the flow therapy apparatus.” Para 0004; “This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.”; “From these measurements, the hardware processor can calculate time of flight t.sub.2 between the acoustic receivers b, c at step 830: … This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” Paras 0120 and 0121; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement…” Para 0123; “Using this configuration, the hardware processor can calculate both speed of sound, and therefore gases concentration, and flow rate.” Para 0138; also see: Para 0112, 0113, 0122-0124, 0127, 0135-0137) in the gas flow (402); and responsive to determining the speed of sound (“speed of sound”), determining by a processor (13), a volume concentration of carbon dioxide (“a carbon dioxide concentration”, “The gases concentration can comprise an oxygen concentration, a carbon dioxide concentration, a heliox concentration, or a concentration of any other desired gases in the flow path.” Paras 0011-0016, 0018; “Further, time of flight measurements taken along the short distance can allow the system to operate under different operating conditions, such as with a wide range of gases, and can be particularly helpful for gases such as heliox or carbon dioxide, which have very different speeds of sound.” Para 0127) in the gas flow (402) based at least in part on the speed of sound (“speed of sound”) and the volume concentration of oxygen (“oxygen”).
Regarding the transition from concentration of “oxygen” to concentration of “carbon dioxide”, Burgess notes “The at least one characteristic of the gases flow can comprise one or more of a gases concentration or a flow rate. The gases concentration comprises an oxygen concentration, a carbon dioxide concentration, a heliox concentration, or a concentration of any other desired gases in the flow path.” (Paras 0013-0016, 0018), “the measurement of gases fraction concentration, including but not limited to oxygen concentration, over systems that position the sensors upstream of the blower and/or the mixer.” (Para 0097); “The acoustic transmitters 1502 and acoustic receivers 1504 can measure characteristics of the gases flow, such as gases concentration including but not limited to oxygen concentration and flow rate. To calculate the flow rate of gases moving through the sensing chamber, the transmitters can each emit a signal so that there is a signal in both directions along the axis 1620 of the acoustic path. Further, to determine a particular gas concentration, for example but not limited to oxygen concentration, only signals in a single direction are necessary.” (Para 0117); “As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” (Para 0121). Thus, Burgess considers the concentration of gases within the gas flow can be composed of “one or more of a gases concentration” in a “gases fraction concentration”, such that “oxygen concentration” is “including but not limited” to other known compositions to include “a carbon dioxide concentration, a heliox concentration, or a concentration of any other desired gases in the flow path”. Thus, both the gaseous concentration of “oxygen” and “carbon dioxide” are within the operational conventionality of Burgess. Hence, Burgess meets the limitations of the claims.
As to Claim 2, Burgess discloses determining the volume concentration of carbon dioxide (“a carbon dioxide concentration”) in the gas flow (402) based at least in part on temperature (“temperature”, “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054; “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “The control system 920 can receive sensor inputs including but not limited to temperature sensor(s) inputs 901, flow rate sensor(s) inputs 902, motor speed inputs 903, pressure sensor(s) inputs 904, gas(s) fraction sensor(s) inputs 905, humidity sensor(s) inputs 906, pulse oximeter (for example, SpO.sub.2) sensor(s) inputs 907, stored or user parameter(s) 908, duty cycle or pulse width modulation (PWM) inputs 909, voltage(s) inputs 910, current(s) inputs 911, acoustic sensor(s) inputs 912, power(s) inputs 913, resistance(s) inputs 914, CO.sub.2 sensor(s) inputs 915, and/or spirometer inputs 916. The control system 920 can receive inputs from the user or stored parameter values in a memory 624 (shown in FIG. 19B).” Para 0089; “Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “This way, the hardware processor can be configured to estimate a temperature of the acoustic receivers 1504 to be at the same temperature or at a similar temperature as a measured temperature of gases in the flow path 402. Additional sensors, such as a temperature sensor, a humidity sensor or a flow rate sensor, can be placed along the extended arms 1506 or at other locations on the sensing circuit board 1500.” Para 0105; “A temperature sensor 1508 can be located on the same sensing circuit board 1600 and also directly within the flow path. The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115; “ The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like.” Para 0117; “This correction method can be computationally less complex than having to create a known gas condition in order to compute t.sub.2 + t.sub.2’ which depends on the speed of sound, temperature, humidity, gas composition, and the like.” Para 0124; “The variations can further include a temperature sensor, combined humidity and temperature sensor, and the like as described herein for determining the characteristics of the gases flow.” Para 0132).
As to Claim 3, Burgess discloses determining the volume concentration of carbon dioxide (“a carbon dioxide concentration”) in the gas flow (402) based at least in part on humidity (“humidity”, “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054; “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “The control system 920 can receive sensor inputs including but not limited to temperature sensor(s) inputs 901, flow rate sensor(s) inputs 902, motor speed inputs 903, pressure sensor(s) inputs 904, gas(s) fraction sensor(s) inputs 905, humidity sensor(s) inputs 906, pulse oximeter (for example, SpO.sub.2) sensor(s) inputs 907, stored or user parameter(s) 908, duty cycle or pulse width modulation (PWM) inputs 909, voltage(s) inputs 910, current(s) inputs 911, acoustic sensor(s) inputs 912, power(s) inputs 913, resistance(s) inputs 914, CO.sub.2 sensor(s) inputs 915, and/or spirometer inputs 916. The control system 920 can receive inputs from the user or stored parameter values in a memory 624 (shown in FIG. 19B).” Para 0089; “Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “This way, the hardware processor can be configured to estimate a temperature of the acoustic receivers 1504 to be at the same temperature or at a similar temperature as a measured temperature of gases in the flow path 402. Additional sensors, such as a temperature sensor, a humidity sensor or a flow rate sensor, can be placed along the extended arms 1506 or at other locations on the sensing circuit board 1500.” Para 0105; “A temperature sensor 1508 can be located on the same sensing circuit board 1600 and also directly within the flow path. The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115; “ The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like.” Para 0117; “This correction method can be computationally less complex than having to create a known gas condition in order to compute t.sub.2 + t.sub.2’ which depends on the speed of sound, temperature, humidity, gas composition, and the like.” Para 0124; “The variations can further include a temperature sensor, combined humidity and temperature sensor, and the like as described herein for determining the characteristics of the gases flow.” Para 0132).
As to Claim 4, Burgess discloses determining a flow rate (“flow rate”, “A respiratory flow therapy apparatus including a sensor module can measure a flow rate of gases or gases concentration provided to a patient. The sensor module can be located after a blower and/or mixer. The sensor module can include at least an ultrasonic transmitter, a receiver, a temperature sensor, a pressure sensor, a humidity sensor and/or a flow rate sensor.” Abstract; “Characteristics of the gases flow, such as gases concentration, can then also be determined by the hardware processor using the time of flight measurement. The second sensor can transmit and the first sensor can receive a pulse in a second direction opposite the first direction to provide a second measurement of the time of flight, allowing additional characteristics of the gases flow, such as a flow rate or velocity, to be determined.” Para 0004; “The one or more characteristics of the gases flow can comprise a gases flow rate. … The system can further comprise one or more of a temperature sensor, a pressure sensor, a humidity sensor, and/or a flow rate sensor. The flow rate sensor can be a heated temperature sensing element. The hardware processor can be configured to be in communication with the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor and to use outputs of the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor to determine the one or more characteristics of the gases flow. … The processor can be configured to compute or adjust a calibration parameter of the acoustic transmitters and/or the one or more acoustic receivers based on a flow rate measured by the flow rate sensor.” Para 0011-0013, 0015, 0016, 0018; also see: “The acoustic transmitters 1502 and acoustic receivers 1504 can measure characteristics of the gases flow, such as gases concentration including but not limited to oxygen concentration and flow rate. To calculate the flow rate of gases moving through the sensing chamber, the transmitters can each emit a signal so that there is a signal in both directions along the axis 1620 of the acoustic path. Further, to determine a particular gas concentration, for example but not limited to oxygen concentration, only signals in a single direction are necessary. To determine flow rate, signals in both directions may be necessary. The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like. … The hardware processor can also be configured to use outputs of the one or more of the additional sensors to provide corrections to calculation of a characteristic of the gases flow, such as flow rate. For example, flow readings taken from a different flow rate sensor other than the ultrasonic sensors can be used to compute or adjust a calibration parameter of the ultrasonic sensors including ultrasonic transmitters and/or receivers, thereby continuously correcting any error or drift in the ultrasonic transmitters’ and/or receivers’ reading. The different flow rate sensor can comprise a heated temperature sensing element configured to measure flow rate.” Para 0117; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement …” Para 0123; “Once an appropriate sampling of the relevant signals within the determined window is established, the system can determine gases concentration and/or flow rate for the particular gas using the methods described herein.” Para 0127; “Using this configuration, the hardware processor can calculate both speed of sound, and therefore gases concentration, and flow rate.” Para 0138) of the gas flow (402) with the first ultrasonic transducer (one of 1502) and the second ultrasonic transducer (other of 1502); and determining a pressure (“pressure”, “The sensor module can include at least an ultrasonic transmitter, a receiver, a temperature sensor, a pressure sensor, a humidity sensor and/or a flow rate sensor.” Abstract; “The system can further comprise one or more of a temperature sensor, a pressure sensor, a humidity sensor, and/or a flow rate sensor. The flow rate sensor can be a heated temperature sensing element. The hardware processor can be configured to be in communication with the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor and to use outputs of the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor to determine the one or more characteristics of the gases flow.” Para 0011-0016, 0018; also see: “The apparatus 10 can include additional sensors that can be in communication with the hardware processor. These sensors can include a flow rate sensor, a temperature sensor, a humidity sensor, a pressure sensor, or the like. Output of the additional sensors can be used for determining the characteristics of the gases flow, such as temperature, pressure, humidity, and the like.” Para 0053; “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054; “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “Immersing at least part of the sensing circuit board and sensors in the flow path can increase the accuracy of measurements because the sensors immersed in the flow are more likely to be subject to the same conditions, such as temperature and pressure, as the gases flow, and therefore provide a better representation of the characteristics of the gases flow.” Para 0099; “The sensing circuit board 1500 can include one or more acoustic transmitters 1502, one or more acoustic receivers 1504, and one or more of additional sensors, such as sensor 1508. The one or more acoustic transmitters 1502 can be ultrasonic transmitters. Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115; “To calculate the flow rate of gases moving through the sensing chamber, the transmitters can each emit a signal so that there is a signal in both directions along the axis 1620 of the acoustic path. Further, to determine a particular gas concentration, for example but not limited to oxygen concentration, only signals in a single direction are necessary. To determine flow rate, signals in both directions may be necessary. The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like.” Para 0117) of the gas flow (402) based at least in part on the flow rate (“flow rate”).
As to Claim 7, Burgess discloses a system, comprising: a flow element (11, “A schematic representation of a respiratory system or flow therapy apparatus 10 is provided in FIG. 1. The apparatus 10 can include a main housing 100. The main housing 100 can contain a flow generator 11 that can be in the form of a motor/impeller arrangement, an optional humidifier or humidification chamber 12, a controller 13, and a user interface 14. The user interface 14 can include a display and input device(s) such as button(s), a touch screen, a combination of a touch screen and button(s), or the like. The controller 13 can include a hardware processor and can be configured or programmed to control the components of the apparatus, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient, operating the humidifier 12 (if present) to humidify and/or heat the gases flow, receiving user input from the user interface 14 for reconfiguration and/or user-defined operation of the apparatus 10, and outputting information (for example on the display) to the user. The user can be a patient, healthcare professional, or anyone else interested in using the apparatus.” Para 0051; “The controller 13 can control the flow generator 11 to generate a gases flow of a desired flow rate, one or more valves to control mixing of air and oxygen or other breathable gas, and/or the humidifier 12, if present, to humidify the gases flow to an appropriate temperature and/or humidity.” Para 0053) configured to direct a gas flow (402, best seen Figure 22B, “Turning to FIG. 21, the gases exiting the blower can enter a flow path 402 in the sensor chamber 400, which can be positioned within the motor and sensor module. The flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape with no sharp turns. The flow path 402 can have curved ends with a straighter section between the curved ends.” Para 0098; also see: “A sensing circuit board 404 with sensors, such as ultrasonic transmitters, receivers, humidity sensor, temperature sensor, flow rate sensor, and the like, can be positioned in the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed in the flow path 402. … After passing through the flow path 402 in the sensor chamber 400, the gases can exit to the humidification chamber.” Para 0099 and “With continued reference to FIG. 21, openings 406 of the sensor chamber 400 can hold acoustic transmitters (shown as 1502 in FIG. 22A), such as ultrasonic transducers which form an acoustic axis (shown as 1520 in FIG. 22B and 1620 in FIGS. 23A-23B) along at least a portion of the flow path 402 to measure properties or characteristics of the gases within the flow.” Para 0100); a temperature sensor (“temperature”, “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054, “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “The control system 920 can receive sensor inputs including but not limited to temperature sensor(s) inputs 901, flow rate sensor(s) inputs 902, motor speed inputs 903, pressure sensor(s) inputs 904, gas(s) fraction sensor(s) inputs 905, humidity sensor(s) inputs 906, pulse oximeter (for example, SpO.sub.2) sensor(s) inputs 907, stored or user parameter(s) 908, duty cycle or pulse width modulation (PWM) inputs 909, voltage(s) inputs 910, current(s) inputs 911, acoustic sensor(s) inputs 912, power(s) inputs 913, resistance(s) inputs 914, CO.sub.2 sensor(s) inputs 915, and/or spirometer inputs 916.” Para 0089; “The sensing circuit board 1500 can include one or more acoustic transmitters 1502, one or more acoustic receivers 1504, and one or more of additional sensors, such as sensor 1508. The one or more acoustic transmitters 1502 can be ultrasonic transmitters. Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “A temperature sensor 1508 can be located on the same sensing circuit board 1600 and also directly within the flow path. The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115) coupled to the flow element (11), the temperature sensor (“temperature”) configured to determine a temperature of the gas flow (402); a first ultrasonic transducer (one of 1502, best seen Figures 22A/B, “The one or more acoustic transmitters 1502 can be ultrasonic transmitters. … The acoustic transmitters 1502 in FIG. 22A can be first and second ultrasonic transducers. The first and second acoustic transducers can be a matched pair of ultrasonic transducers, for example, a matched pair of piezoelectric transducers. ” Para 0102) and a second ultrasonic transducer (other of 1502, best seen Figures 22A/B, “The one or more acoustic transmitters 1502 can be ultrasonic transmitters. … The acoustic transmitters 1502 in FIG. 22A can be first and second ultrasonic transducers. The first and second acoustic transducers can be a matched pair of ultrasonic transducers, for example, a matched pair of piezoelectric transducers. ” Para 0102) coupled to the flow element (11), wherein the first ultrasonic transducer (one of 1502) and the second ultrasonic transducer (other of 1502) are configured to determine time of flight (“time of flight”, “Ultrasonic sensors including ultrasonic transmitters and/or receivers can be used to measure a time of flight of acoustic signals to determine gas velocity and/or composition, which can be used in flow therapy apparatuses … In one ultrasonic sensor (including ultrasonic transmitters and/or receivers) topology, a driver causes a first sensor, such as an ultrasonic transducer, to produce an ultrasonic pulse in a first direction. A second sensor, such as a second ultrasonic transducer, receives this pulse and provides a measurement of the time of flight of the pulse between the first and second ultrasonic transducers. Using this time of flight measurement, the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a hardware processor or controller of the flow therapy apparatus. Characteristics of the gases flow, such as gases concentration, can then also be determined by the hardware processor using the time of flight measurement. The second sensor can transmit and the first sensor can receive a pulse in a second direction opposite the first direction to provide a second measurement of the time of flight, allowing additional characteristics of the gases flow, such as a flow rate or velocity, to be determined.” Para 0004; “A respiratory assistance system for providing a flow of gases to a patient can comprise an acoustic source configured to generate at least a first acoustic signal; and at least two acoustic receivers configured to each receive the first acoustic signal, the at least two acoustic receivers in electrical communication with a hardware processor configured to determine a time of flight of the acoustic signal by determining a difference of time between a receipt of the at least first acoustic signal by a first one of the at least two acoustic receivers and a receipt of the at least first acoustic signal by a second one of the at least two acoustic receivers. … The at least two acoustic receivers can be positioned between the first and second acoustic transducers. The hardware processor can be configured to cancel out errors in the time of flight determinations due to delay of the first and second acoustic transducers. … The hardware processor can be configured to use a time of flight measurement taken along the first distance to provide an estimate of a time of flight. The hardware processor can be configured to use a time of flight measurement taken along the second distance to provide a more accurate assessment of the time of flight. The first distance can be shorter than the second distance. The time of flight measurements can be generated from between the first one of the at least two acoustic receivers and the acoustic source, between the second one of the at least two acoustic receivers and the acoustic source, between the first and second ones of the at least two acoustic receivers, between the first and second acoustic transducers, or a combination thereof in both directions along an acoustic path. The hardware processor can be configured to compare two or more of the time of flight measurements to determine accuracy of the two or more of the time of flight measurements. The hardware processor can be configured to use acoustic signals received by the at least two acoustic receivers to perform cross-correlation of the received acoustic signals. The hardware processor can be configured to use acoustic signals received at the at least two acoustic receivers to determine waveform deformation. The hardware processor can be configured to use acoustic signals received at the at least two acoustic receivers to detect a flow rate by determining time delay for the time of flight measurements.” Para 0012; “The processor can be configured to determine at least one characteristic of the gases flow based on a difference between a time of flight measurement of the transmitted acoustic signal and a time of flight measurement of the echoed acoustic signal.” Para 0013; “From these measurements, the hardware processor can calculate time of flight t.sub.2 between the acoustic receivers b, c at step 830: … This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” Paras 0120 and 0121; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement…” Para 0123; also see: Paras 0014-0016, 0018, 0106, 0123, 0126, 0127, 0138, 0139) of the gas flow (402); and a processor (13, “a controller 13 … The controller 13 can include a hardware processor and can be configured or programmed to control the components of the apparatus, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient, operating the humidifier 12 (if present) to humidify and/or heat the gases flow, receiving user input from the user interface 14 for reconfiguration and/or user-defined operation of the apparatus 10, and outputting information (for example on the display) to the user.” Para 0051; also see Paras 0053, 0054, 0076, and 0079) configured to determine a volume concentration of a component of gas (“oxygen” OR “carbon dioxide” - “The gases concentration can comprise an oxygen concentration, a carbon dioxide concentration, a heliox concentration, or a concentration of any other desired gases in the flow path.” Paras 0011-0016, 0018; “Further, time of flight measurements taken along the short distance can allow the system to operate under different operating conditions, such as with a wide range of gases, and can be particularly helpful for gases such as heliox or carbon dioxide, which have very different speeds of sound.” Para 0127; also see: “The acoustic transmitters 1502 and acoustic receivers 1504 can measure characteristics of the gases flow, such as gases concentration including but not limited to oxygen concentration and flow rate.” Para 0117) in the gas flow (402) based at least in part on the time of flight (“time of flight”) and the temperature (“temperature”) of the gas flow (402).
As to Claim 8, Burgess discloses the component of gas is oxygen (“The gases concentration can comprise an oxygen concentration, a carbon dioxide concentration, a heliox concentration, or a concentration of any other desired gases in the flow path.” Paras 0011-0016, 0018; “Further, time of flight measurements taken along the short distance can allow the system to operate under different operating conditions, such as with a wide range of gases, and can be particularly helpful for gases such as heliox or carbon dioxide, which have very different speeds of sound.” Para 0127; also see: “The acoustic transmitters 1502 and acoustic receivers 1504 can measure characteristics of the gases flow, such as gases concentration including but not limited to oxygen concentration and flow rate.” Para 0117).
As to Claim 9, Burgess discloses the component of gas is carbon dioxide (“The gases concentration can comprise an oxygen concentration, a carbon dioxide concentration, a heliox concentration, or a concentration of any other desired gases in the flow path.” Paras 0011-0016, 0018; “Further, time of flight measurements taken along the short distance can allow the system to operate under different operating conditions, such as with a wide range of gases, and can be particularly helpful for gases such as heliox or carbon dioxide, which have very different speeds of sound.” Para 0127).
As to Claim 10, Burgess discloses a humidity sensor (“humidity”, “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054; “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “The control system 920 can receive sensor inputs including but not limited to temperature sensor(s) inputs 901, flow rate sensor(s) inputs 902, motor speed inputs 903, pressure sensor(s) inputs 904, gas(s) fraction sensor(s) inputs 905, humidity sensor(s) inputs 906, pulse oximeter (for example, SpO.sub.2) sensor(s) inputs 907, stored or user parameter(s) 908, duty cycle or pulse width modulation (PWM) inputs 909, voltage(s) inputs 910, current(s) inputs 911, acoustic sensor(s) inputs 912, power(s) inputs 913, resistance(s) inputs 914, CO.sub.2 sensor(s) inputs 915, and/or spirometer inputs 916. The control system 920 can receive inputs from the user or stored parameter values in a memory 624 (shown in FIG. 19B).” Para 0089; “Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “This way, the hardware processor can be configured to estimate a temperature of the acoustic receivers 1504 to be at the same temperature or at a similar temperature as a measured temperature of gases in the flow path 402. Additional sensors, such as a temperature sensor, a humidity sensor or a flow rate sensor, can be placed along the extended arms 1506 or at other locations on the sensing circuit board 1500.” Para 0105; “A temperature sensor 1508 can be located on the same sensing circuit board 1600 and also directly within the flow path. The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115; “ The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like.” Para 0117; “This correction method can be computationally less complex than having to create a known gas condition in order to compute t.sub.2 + t.sub.2’ which depends on the speed of sound, temperature, humidity, gas composition, and the like.” Para 0124; “The variations can further include a temperature sensor, combined humidity and temperature sensor, and the like as described herein for determining the characteristics of the gases flow.” Para 0132) configured to determine a humidity of the gas flow (402).
As to Claim 11, Burgess discloses the processor (13) is configured to determine a pressure (“pressure”, “The sensor module can include at least an ultrasonic transmitter, a receiver, a temperature sensor, a pressure sensor, a humidity sensor and/or a flow rate sensor.” Abstract; “The system can further comprise one or more of a temperature sensor, a pressure sensor, a humidity sensor, and/or a flow rate sensor. The flow rate sensor can be a heated temperature sensing element. The hardware processor can be configured to be in communication with the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor and to use outputs of the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor to determine the one or more characteristics of the gases flow.” Para 0011-0016, 0018; also see: “The apparatus 10 can include additional sensors that can be in communication with the hardware processor. These sensors can include a flow rate sensor, a temperature sensor, a humidity sensor, a pressure sensor, or the like. Output of the additional sensors can be used for determining the characteristics of the gases flow, such as temperature, pressure, humidity, and the like.” Para 0053; “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054; “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “Immersing at least part of the sensing circuit board and sensors in the flow path can increase the accuracy of measurements because the sensors immersed in the flow are more likely to be subject to the same conditions, such as temperature and pressure, as the gases flow, and therefore provide a better representation of the characteristics of the gases flow.” Para 0099; “The sensing circuit board 1500 can include one or more acoustic transmitters 1502, one or more acoustic receivers 1504, and one or more of additional sensors, such as sensor 1508. The one or more acoustic transmitters 1502 can be ultrasonic transmitters. Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115; “To calculate the flow rate of gases moving through the sensing chamber, the transmitters can each emit a signal so that there is a signal in both directions along the axis 1620 of the acoustic path. Further, to determine a particular gas concentration, for example but not limited to oxygen concentration, only signals in a single direction are necessary. To determine flow rate, signals in both directions may be necessary. The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like.” Para 0117) of the gas flow (402) based at least in part on the time of flight (“time of flight”) of the gas flow (402).
As to Claim 13, Burgess discloses the processor (13) is further configured to determine a speed of sound (“speed of sound”, “Using this time of flight measurement, the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a hardware processor or controller of the flow therapy apparatus.” Para 0004; “This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.”; “From these measurements, the hardware processor can calculate time of flight t.sub.2 between the acoustic receivers b, c at step 830: … This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” Paras 0120 and 0121; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement…” Para 0123; “Using this configuration, the hardware processor can calculate both speed of sound, and therefore gases concentration, and flow rate.” Para 0138; also see: Para 0112, 0113, 0122-0124, 0127, 0135-0137) of the gas flow (402) based at least in part on the time of flight (“time of flight”) of the gas flow (402).
As to Claim 14, Burgess discloses a system, comprising: a respiratory device (10, “A schematic representation of a respiratory system or flow therapy apparatus 10 is provided in FIG. 1. The apparatus 10 can include a main housing 100. … The controller 13 can include a hardware processor and can be configured or programmed to control the components of the apparatus, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient, operating the humidifier 12 (if present) to humidify and/or heat the gases flow, receiving user input from the user interface 14 for reconfiguration and/or user-defined operation of the apparatus 10, and outputting information (for example on the display) to the user.” Para 0051; “With continued reference to FIG. 1, a patient breathing conduit 16 can be coupled to a gases flow outlet 21 in the housing 100 of the flow therapy apparatus 10, and be coupled to a patient interface 17, such as a non-sealing interface like a nasal cannula with a manifold 19 and nasal prongs 18. Additionally, or alternatively, the patient breathing conduit 16 can be coupled to a face mask, or a tracheostomy interface. The gases flow that is generated by the flow therapy apparatus 10, and which may be humidified, is delivered to the patient via the patient conduit 16 through the cannula 17. The patient conduit 16 can have a heater wire 16a to heat gases flow passing through to the patient. The heater wire 16a can be under the control of the controller 13. The patient conduit 16 and/or patient interface 17 can be considered part of the flow therapy apparatus 10, or alternatively peripheral to it. The flow therapy apparatus 10, breathing conduit 16, and patient interface 17 together can form a flow therapy system.” Para 0052; “General operation of a flow therapy breathing apparatus 10 will now be described. The controller 13 can control the flow generator 11 to generate a gases flow of a desired flow rate, one or more valves to control mixing of air and oxygen or other breathable gas, and/or the humidifier 12, if present, to humidify the gases flow to an appropriate temperature and/or humidity. As will be described in greater detail below, the apparatus 10 can use ultrasonic sensing to monitor characteristics of the gases in the flow. For example, the characteristics of the gases flow can include gases concentration, flow rate, or the like. The apparatus 10 can include additional sensors that can be in communication with the hardware processor.” Para 0053; “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17. The controller 13 can receive output from the sensors to assist it in operating the flow therapy apparatus 10 in a manner that provides suitable therapy. Providing suitable therapy can include meeting a patient’s inspiratory demand. The apparatus 10 can include a wireless data transmitter and/or receiver, or a transceiver 15 to enable the controller 13 to receive data signals 8 in a wireless manner from the operation sensors and/or to control the various components of the flow therapy apparatus 10. Additionally, or alternatively, the data transmitter and/or receiver 15 may deliver data to a remote server or enable remote control of the apparatus 10. The apparatus 10 can include a wired connection, for example, using cables or wires, to enable the controller 13 to receive data signals 8 from the operation sensors and/or to control the various components of the flow therapy apparatus 10.” Para 0054; “For example, the flow therapy apparatus 10 can also be used as a continuous positive airway pressure (CPAP) device.” Para 0060); a tubing (16/17, “With continued reference to FIG. 1, a patient breathing conduit 16 can be coupled to a gases flow outlet 21 in the housing 100 of the flow therapy apparatus 10, and be coupled to a patient interface 17, such as a non-sealing interface like a nasal cannula with a manifold 19 and nasal prongs 18. Additionally, or alternatively, the patient breathing conduit 16 can be coupled to a face mask, or a tracheostomy interface. The gases flow that is generated by the flow therapy apparatus 10, and which may be humidified, is delivered to the patient via the patient conduit 16 through the cannula 17. The patient conduit 16 can have a heater wire 16a to heat gases flow passing through to the patient. The heater wire 16a can be under the control of the controller 13. The patient conduit 16 and/or patient interface 17 can be considered part of the flow therapy apparatus 10, or alternatively peripheral to it. The flow therapy apparatus 10, breathing conduit 16, and patient interface 17 together can form a flow therapy system.” Para 0052; “The gases flow can be directed out through the patient conduit 16 and cannula 17 to the patient. The cannula 17 may instead be any other patient interface, such as a full face mask, nasal mask, nasal pillows mask, tracheostomy interface, or endotracheal tube. The controller 13 can also control a heating element in the humidifier 12 and/or the heating element 16a in the patient conduit 16 to heat the gas to a desired temperature that achieves a desired level of therapy and/or level of comfort for the patient.” Para 0053; “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054) coupled to the respiratory device (10); a flow element (11, “A schematic representation of a respiratory system or flow therapy apparatus 10 is provided in FIG. 1. The apparatus 10 can include a main housing 100. The main housing 100 can contain a flow generator 11 that can be in the form of a motor/impeller arrangement, an optional humidifier or humidification chamber 12, a controller 13, and a user interface 14. The user interface 14 can include a display and input device(s) such as button(s), a touch screen, a combination of a touch screen and button(s), or the like. The controller 13 can include a hardware processor and can be configured or programmed to control the components of the apparatus, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient, operating the humidifier 12 (if present) to humidify and/or heat the gases flow, receiving user input from the user interface 14 for reconfiguration and/or user-defined operation of the apparatus 10, and outputting information (for example on the display) to the user. The user can be a patient, healthcare professional, or anyone else interested in using the apparatus.” Para 0051; “The controller 13 can control the flow generator 11 to generate a gases flow of a desired flow rate, one or more valves to control mixing of air and oxygen or other breathable gas, and/or the humidifier 12, if present, to humidify the gases flow to an appropriate temperature and/or humidity.” Para 0053) coupled to the tubing (16/17) and configured to direct a gas flow (402, best seen Figure 22B, “Turning to FIG. 21, the gases exiting the blower can enter a flow path 402 in the sensor chamber 400, which can be positioned within the motor and sensor module. The flow path 402 can have a curved shape. The flow path 402 can be configured to have a curved shape with no sharp turns. The flow path 402 can have curved ends with a straighter section between the curved ends.” Para 0098; also see: “A sensing circuit board 404 with sensors, such as ultrasonic transmitters, receivers, humidity sensor, temperature sensor, flow rate sensor, and the like, can be positioned in the sensor chamber 400 such that the sensing circuit board 404 is at least partially immersed in the flow path 402. … After passing through the flow path 402 in the sensor chamber 400, the gases can exit to the humidification chamber.” Para 0099 and “With continued reference to FIG. 21, openings 406 of the sensor chamber 400 can hold acoustic transmitters (shown as 1502 in FIG. 22A), such as ultrasonic transducers which form an acoustic axis (shown as 1520 in FIG. 22B and 1620 in FIGS. 23A-23B) along at least a portion of the flow path 402 to measure properties or characteristics of the gases within the flow.” Para 0100), wherein the gas flow (402) includes volume concentration of oxygen (“oxygen”, “The acoustic transmitters 1502 and acoustic receivers 1504 can measure characteristics of the gases flow, such as gases concentration including but not limited to oxygen concentration and flow rate.” Para 0117; also see: “The gases concentration can comprise an oxygen concentration, a carbon dioxide concentration, a heliox concentration, or a concentration of any other desired gases in the flow path.” Paras 0011-0016, 0018); a temperature sensor (“temperature”, “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054, “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “The control system 920 can receive sensor inputs including but not limited to temperature sensor(s) inputs 901, flow rate sensor(s) inputs 902, motor speed inputs 903, pressure sensor(s) inputs 904, gas(s) fraction sensor(s) inputs 905, humidity sensor(s) inputs 906, pulse oximeter (for example, SpO.sub.2) sensor(s) inputs 907, stored or user parameter(s) 908, duty cycle or pulse width modulation (PWM) inputs 909, voltage(s) inputs 910, current(s) inputs 911, acoustic sensor(s) inputs 912, power(s) inputs 913, resistance(s) inputs 914, CO.sub.2 sensor(s) inputs 915, and/or spirometer inputs 916.” Para 0089; “The sensing circuit board 1500 can include one or more acoustic transmitters 1502, one or more acoustic receivers 1504, and one or more of additional sensors, such as sensor 1508. The one or more acoustic transmitters 1502 can be ultrasonic transmitters. Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “A temperature sensor 1508 can be located on the same sensing circuit board 1600 and also directly within the flow path. The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115) coupled to the flow element (11), the temperature sensor (“temperature”) configured to determine a temperature of the gas flow (402); a first ultrasonic transducer (one of 1502, best seen Figures 22A/B, “The one or more acoustic transmitters 1502 can be ultrasonic transmitters. … The acoustic transmitters 1502 in FIG. 22A can be first and second ultrasonic transducers. The first and second acoustic transducers can be a matched pair of ultrasonic transducers, for example, a matched pair of piezoelectric transducers. ” Para 0102) and a second ultrasonic transducer (other of 1502, best seen Figures 22A/B, “The one or more acoustic transmitters 1502 can be ultrasonic transmitters. … The acoustic transmitters 1502 in FIG. 22A can be first and second ultrasonic transducers. The first and second acoustic transducers can be a matched pair of ultrasonic transducers, for example, a matched pair of piezoelectric transducers. ” Para 0102) coupled to the flow element (11), wherein the first ultrasonic transducer (one of 1502) and the second ultrasonic transducer (other of 1502) are configured to determine time of flight (“time of flight”, “Ultrasonic sensors including ultrasonic transmitters and/or receivers can be used to measure a time of flight of acoustic signals to determine gas velocity and/or composition, which can be used in flow therapy apparatuses … In one ultrasonic sensor (including ultrasonic transmitters and/or receivers) topology, a driver causes a first sensor, such as an ultrasonic transducer, to produce an ultrasonic pulse in a first direction. A second sensor, such as a second ultrasonic transducer, receives this pulse and provides a measurement of the time of flight of the pulse between the first and second ultrasonic transducers. Using this time of flight measurement, the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a hardware processor or controller of the flow therapy apparatus. Characteristics of the gases flow, such as gases concentration, can then also be determined by the hardware processor using the time of flight measurement. The second sensor can transmit and the first sensor can receive a pulse in a second direction opposite the first direction to provide a second measurement of the time of flight, allowing additional characteristics of the gases flow, such as a flow rate or velocity, to be determined.” Para 0004; “A respiratory assistance system for providing a flow of gases to a patient can comprise an acoustic source configured to generate at least a first acoustic signal; and at least two acoustic receivers configured to each receive the first acoustic signal, the at least two acoustic receivers in electrical communication with a hardware processor configured to determine a time of flight of the acoustic signal by determining a difference of time between a receipt of the at least first acoustic signal by a first one of the at least two acoustic receivers and a receipt of the at least first acoustic signal by a second one of the at least two acoustic receivers. … The at least two acoustic receivers can be positioned between the first and second acoustic transducers. The hardware processor can be configured to cancel out errors in the time of flight determinations due to delay of the first and second acoustic transducers. … The hardware processor can be configured to use a time of flight measurement taken along the first distance to provide an estimate of a time of flight. The hardware processor can be configured to use a time of flight measurement taken along the second distance to provide a more accurate assessment of the time of flight. The first distance can be shorter than the second distance. The time of flight measurements can be generated from between the first one of the at least two acoustic receivers and the acoustic source, between the second one of the at least two acoustic receivers and the acoustic source, between the first and second ones of the at least two acoustic receivers, between the first and second acoustic transducers, or a combination thereof in both directions along an acoustic path. The hardware processor can be configured to compare two or more of the time of flight measurements to determine accuracy of the two or more of the time of flight measurements. The hardware processor can be configured to use acoustic signals received by the at least two acoustic receivers to perform cross-correlation of the received acoustic signals. The hardware processor can be configured to use acoustic signals received at the at least two acoustic receivers to determine waveform deformation. The hardware processor can be configured to use acoustic signals received at the at least two acoustic receivers to detect a flow rate by determining time delay for the time of flight measurements.” Para 0012; “The processor can be configured to determine at least one characteristic of the gases flow based on a difference between a time of flight measurement of the transmitted acoustic signal and a time of flight measurement of the echoed acoustic signal.” Para 0013; “From these measurements, the hardware processor can calculate time of flight t.sub.2 between the acoustic receivers b, c at step 830: … This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” Paras 0120 and 0121; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement…” Para 0123; also see: Paras 0014-0016, 0018, 0106, 0123, 0126, 0127, 0138, 0139) of the gas flow (402); and a processor (13, “a controller 13 … The controller 13 can include a hardware processor and can be configured or programmed to control the components of the apparatus, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient, operating the humidifier 12 (if present) to humidify and/or heat the gases flow, receiving user input from the user interface 14 for reconfiguration and/or user-defined operation of the apparatus 10, and outputting information (for example on the display) to the user.” Para 0051; also see Paras 0053, 0054, 0076, and 0079) configured to determine a speed of sound (“speed of sound”, “Using this time of flight measurement, the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a hardware processor or controller of the flow therapy apparatus.” Para 0004; “This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.”; “From these measurements, the hardware processor can calculate time of flight t.sub.2 between the acoustic receivers b, c at step 830: … This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” Paras 0120 and 0121; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement…” Para 0123; “Using this configuration, the hardware processor can calculate both speed of sound, and therefore gases concentration, and flow rate.” Para 0138; also see: Para 0112, 0113, 0122-0124, 0127, 0135-0137) in the gas flow (402); and wherein, responsive to determining the speed of sound (“speed of sound”), the processor (13) is further configured to determine a volume concentration of a carbon dioxide (“carbon dioxide”, “The gases concentration can comprise an oxygen concentration, a carbon dioxide concentration, a heliox concentration, or a concentration of any other desired gases in the flow path.” Paras 0011-0016, 0018; “Further, time of flight measurements taken along the short distance can allow the system to operate under different operating conditions, such as with a wide range of gases, and can be particularly helpful for gases such as heliox or carbon dioxide, which have very different speeds of sound.” Para 0127) in the gas flow (402) based at least in part on the speed of sound (“speed of sound”) and the volume concentration of oxygen (“oxygen”).
As to Claims 15 and 16, Burgess discloses the respiratory device (10) is a ventilator in the form of a CPAP device (“CPAP”, “For example, the flow therapy apparatus 10 can also be used as a continuous positive airway pressure (CPAP) device.” Para 0060) to provide ventilation therapy to the patient.
As to Claim 17, Burgess discloses determining the volume concentration of carbon dioxide (“a carbon dioxide concentration”) in the gas flow (402) based at least in part on temperature (“temperature”, “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054; “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “The control system 920 can receive sensor inputs including but not limited to temperature sensor(s) inputs 901, flow rate sensor(s) inputs 902, motor speed inputs 903, pressure sensor(s) inputs 904, gas(s) fraction sensor(s) inputs 905, humidity sensor(s) inputs 906, pulse oximeter (for example, SpO.sub.2) sensor(s) inputs 907, stored or user parameter(s) 908, duty cycle or pulse width modulation (PWM) inputs 909, voltage(s) inputs 910, current(s) inputs 911, acoustic sensor(s) inputs 912, power(s) inputs 913, resistance(s) inputs 914, CO.sub.2 sensor(s) inputs 915, and/or spirometer inputs 916. The control system 920 can receive inputs from the user or stored parameter values in a memory 624 (shown in FIG. 19B).” Para 0089; “Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “This way, the hardware processor can be configured to estimate a temperature of the acoustic receivers 1504 to be at the same temperature or at a similar temperature as a measured temperature of gases in the flow path 402. Additional sensors, such as a temperature sensor, a humidity sensor or a flow rate sensor, can be placed along the extended arms 1506 or at other locations on the sensing circuit board 1500.” Para 0105; “A temperature sensor 1508 can be located on the same sensing circuit board 1600 and also directly within the flow path. The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115; “ The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like.” Para 0117; “This correction method can be computationally less complex than having to create a known gas condition in order to compute t.sub.2 + t.sub.2’ which depends on the speed of sound, temperature, humidity, gas composition, and the like.” Para 0124; “The variations can further include a temperature sensor, combined humidity and temperature sensor, and the like as described herein for determining the characteristics of the gases flow.” Para 0132).
As to Claim 18, Burgess discloses determining a flow rate (“flow rate”, “A respiratory flow therapy apparatus including a sensor module can measure a flow rate of gases or gases concentration provided to a patient. The sensor module can be located after a blower and/or mixer. The sensor module can include at least an ultrasonic transmitter, a receiver, a temperature sensor, a pressure sensor, a humidity sensor and/or a flow rate sensor.” Abstract; “Characteristics of the gases flow, such as gases concentration, can then also be determined by the hardware processor using the time of flight measurement. The second sensor can transmit and the first sensor can receive a pulse in a second direction opposite the first direction to provide a second measurement of the time of flight, allowing additional characteristics of the gases flow, such as a flow rate or velocity, to be determined.” Para 0004; “The one or more characteristics of the gases flow can comprise a gases flow rate. … The system can further comprise one or more of a temperature sensor, a pressure sensor, a humidity sensor, and/or a flow rate sensor. The flow rate sensor can be a heated temperature sensing element. The hardware processor can be configured to be in communication with the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor and to use outputs of the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor to determine the one or more characteristics of the gases flow. … The processor can be configured to compute or adjust a calibration parameter of the acoustic transmitters and/or the one or more acoustic receivers based on a flow rate measured by the flow rate sensor.” Para 0011-0013, 0015, 0016, 0018; also see: “The acoustic transmitters 1502 and acoustic receivers 1504 can measure characteristics of the gases flow, such as gases concentration including but not limited to oxygen concentration and flow rate. To calculate the flow rate of gases moving through the sensing chamber, the transmitters can each emit a signal so that there is a signal in both directions along the axis 1620 of the acoustic path. Further, to determine a particular gas concentration, for example but not limited to oxygen concentration, only signals in a single direction are necessary. To determine flow rate, signals in both directions may be necessary. The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like. … The hardware processor can also be configured to use outputs of the one or more of the additional sensors to provide corrections to calculation of a characteristic of the gases flow, such as flow rate. For example, flow readings taken from a different flow rate sensor other than the ultrasonic sensors can be used to compute or adjust a calibration parameter of the ultrasonic sensors including ultrasonic transmitters and/or receivers, thereby continuously correcting any error or drift in the ultrasonic transmitters’ and/or receivers’ reading. The different flow rate sensor can comprise a heated temperature sensing element configured to measure flow rate.” Para 0117; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement …” Para 0123; “Once an appropriate sampling of the relevant signals within the determined window is established, the system can determine gases concentration and/or flow rate for the particular gas using the methods described herein.” Para 0127; “Using this configuration, the hardware processor can calculate both speed of sound, and therefore gases concentration, and flow rate.” Para 0138) of the gas flow (402) with the first ultrasonic transducer (one of 1502) and the second ultrasonic transducer (other of 1502); and determining a pressure (“pressure”, “The sensor module can include at least an ultrasonic transmitter, a receiver, a temperature sensor, a pressure sensor, a humidity sensor and/or a flow rate sensor.” Abstract; “The system can further comprise one or more of a temperature sensor, a pressure sensor, a humidity sensor, and/or a flow rate sensor. The flow rate sensor can be a heated temperature sensing element. The hardware processor can be configured to be in communication with the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor and to use outputs of the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor to determine the one or more characteristics of the gases flow.” Para 0011-0016, 0018; also see: “The apparatus 10 can include additional sensors that can be in communication with the hardware processor. These sensors can include a flow rate sensor, a temperature sensor, a humidity sensor, a pressure sensor, or the like. Output of the additional sensors can be used for determining the characteristics of the gases flow, such as temperature, pressure, humidity, and the like.” Para 0053; “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054; “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “Immersing at least part of the sensing circuit board and sensors in the flow path can increase the accuracy of measurements because the sensors immersed in the flow are more likely to be subject to the same conditions, such as temperature and pressure, as the gases flow, and therefore provide a better representation of the characteristics of the gases flow.” Para 0099; “The sensing circuit board 1500 can include one or more acoustic transmitters 1502, one or more acoustic receivers 1504, and one or more of additional sensors, such as sensor 1508. The one or more acoustic transmitters 1502 can be ultrasonic transmitters. Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115; “To calculate the flow rate of gases moving through the sensing chamber, the transmitters can each emit a signal so that there is a signal in both directions along the axis 1620 of the acoustic path. Further, to determine a particular gas concentration, for example but not limited to oxygen concentration, only signals in a single direction are necessary. To determine flow rate, signals in both directions may be necessary. The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like.” Para 0117) of the gas flow (402) based at least in part on the flow rate (“flow rate”).
As to Claim 20, Burgess discloses the processor (13) is further configured to determine a speed of sound (“speed of sound”, “Using this time of flight measurement, the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a hardware processor or controller of the flow therapy apparatus.” Para 0004; “This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.”; “From these measurements, the hardware processor can calculate time of flight t.sub.2 between the acoustic receivers b, c at step 830: … This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” Paras 0120 and 0121; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement…” Para 0123; “Using this configuration, the hardware processor can calculate both speed of sound, and therefore gases concentration, and flow rate.” Para 0138; also see: Para 0112, 0113, 0122-0124, 0127, 0135-0137) of the gas flow (402) based at least in part on the time of flight (“time of flight”) of the gas flow (402).
Claim Rejections - 35 USC § 103
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.
Claims 5, 6, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (2023/0166065) in view of Mault et al. (6,468,222).
As to Claims 5, 12, and 19, Burgess discloses determining the determining the pressure (“pressure”, “The sensor module can include at least an ultrasonic transmitter, a receiver, a temperature sensor, a pressure sensor, a humidity sensor and/or a flow rate sensor.” Abstract; “The system can further comprise one or more of a temperature sensor, a pressure sensor, a humidity sensor, and/or a flow rate sensor. The flow rate sensor can be a heated temperature sensing element. The hardware processor can be configured to be in communication with the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor and to use outputs of the one or more of the temperature sensor, the pressure sensor, the humidity sensor, and/or the flow rate sensor to determine the one or more characteristics of the gases flow.” Para 0011-0016, 0018; also see: “The apparatus 10 can include additional sensors that can be in communication with the hardware processor. These sensors can include a flow rate sensor, a temperature sensor, a humidity sensor, a pressure sensor, or the like. Output of the additional sensors can be used for determining the characteristics of the gases flow, such as temperature, pressure, humidity, and the like.” Para 0053; “Additional sensors 3a, 3b, 3c, 20, 25, such as flow, temperature, humidity, and/or pressure sensors, can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0054; “As mentioned above, operation sensors, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the flow therapy apparatus 10 and/or the patient conduit 16 and/or cannula 17.” Para 0079; “Immersing at least part of the sensing circuit board and sensors in the flow path can increase the accuracy of measurements because the sensors immersed in the flow are more likely to be subject to the same conditions, such as temperature and pressure, as the gases flow, and therefore provide a better representation of the characteristics of the gases flow.” Para 0099; “The sensing circuit board 1500 can include one or more acoustic transmitters 1502, one or more acoustic receivers 1504, and one or more of additional sensors, such as sensor 1508. The one or more acoustic transmitters 1502 can be ultrasonic transmitters. Examples of the additional sensors can include a flow rate sensor, a humidity sensor, including a humidity sensor to be used with a separate temperature sensor and a combined humidity and temperature sensor, a sensor for measuring barometric pressure, a sensor for measuring differential pressure, and/or a sensor for measuring gauge pressure.” Para 0102; “The temperature sensor 1508 may also be a humidity sensor, pressure sensor, or the like. There may be a humidity or pressure sensor located elsewhere in the apparatus. The gases flow can travel through the sensing region 1630.” Para 0115; “To calculate the flow rate of gases moving through the sensing chamber, the transmitters can each emit a signal so that there is a signal in both directions along the axis 1620 of the acoustic path. Further, to determine a particular gas concentration, for example but not limited to oxygen concentration, only signals in a single direction are necessary. To determine flow rate, signals in both directions may be necessary. The additional sensors can also be used for determining the characteristics of the gases flow, such as temperature, pressure, flow rate, humidity, and the like.” Para 0117) of the gas flow (402) based at least in part on the flow rate (“flow rate”) of a flow element (11, “A schematic representation of a respiratory system or flow therapy apparatus 10 is provided in FIG. 1. The apparatus 10 can include a main housing 100. The main housing 100 can contain a flow generator 11 that can be in the form of a motor/impeller arrangement, an optional humidifier or humidification chamber 12, a controller 13, and a user interface 14. The user interface 14 can include a display and input device(s) such as button(s), a touch screen, a combination of a touch screen and button(s), or the like. The controller 13 can include a hardware processor and can be configured or programmed to control the components of the apparatus, including but not limited to operating the flow generator 11 to create a flow of gases for delivery to a patient, operating the humidifier 12 (if present) to humidify and/or heat the gases flow, receiving user input from the user interface 14 for reconfiguration and/or user-defined operation of the apparatus 10, and outputting information (for example on the display) to the user. The user can be a patient, healthcare professional, or anyone else interested in using the apparatus.” Para 0051; “The controller 13 can control the flow generator 11 to generate a gases flow of a desired flow rate, one or more valves to control mixing of air and oxygen or other breathable gas, and/or the humidifier 12, if present, to humidify the gases flow to an appropriate temperature and/or humidity.” Para 0053).
Yet, Burgess does not expressly disclose the pressure is “based at least in part on a length and a radius of the flow element”.
Mault teaches a method and system (Figures 1 and 2), comprising: a respiratory device (10, “Referring to FIGS. 1 and 2, a respiratory calorimeter according to the present invention is generally shown at 10. The calorimeter 10 includes a body 12 and a respiratory connector, such as mask 14, extending from the body 12.” Column 3, Lines 45-60), a flow element (36 via 34, best seen Figure 4, “The disposable portion 22 generally consists of an outer shell 34 with generally vertical side walls and a vertical flow tube 36 within the shell 34. The flow tube 36 is preferably cylindrical with open upper and lower ends. In the preferred embodiment, the flow tube has a length of about 63 mm and an internal diameter of about 12 mm. For definitional purposes, the flow tube 36 may be said to have an inner surface 38 on the inside of the tube 36 and an outer surface 40 on the outside of the tube 36. Likewise, the outer shell 34 may be said to have an inner surface 42 inside the shell and an outer surface 44 outside the shell. As best shown in FIG. 4, the outer surface 40 of the flow tube 36 is spaced from the inner surface 42 of the outer shell 34 so as to define a concentric gap between these two components of the disposable portion 22.” Column 4, Line 60 thru Column 5, Line 15) coupled (via insertion of 34 of 22 into 26, as shown in Figure 3, whereby “Referring again to FIG. 3, the upper end of the outer shell 34 of the disposable 22 has a pair of sidewardly projecting, generally horizontal, engagement rails 50. The recess 26 in the reusable portion 24 of the calorimeter has a pair of corresponding engagement slots 52, only one of which is shown. When the disposable portion 22 docks into the recess 26 of the reusable portion 24, the engagement rails 50 slide into the engagement slots 52 to securely interconnect the disposable portion and the remainder of the calorimeter 10.” Column 5, Lines 30-45) to the respiratory device (10) and configured to direct a gas flow, wherein the gas flow includes a volume concentration of oxygen (“The calorimeter 10 measures a variety of factors and calculates one or more respiratory parameters, such as oxygen consumption and metabolic rate.” Column 3, Line 55 thru Column 4, Line 5; also see: “According to a first preferred embodiment of the present invention, ambient temperature, relative humidity and pressure are measured as well as inhalation volume and exhalation volume and oxygen concentration.” Column 9, Lines 30-45); a temperature sensor (90, “A temperature sensor 90, an ambient pressure sensor 92, and a relative humidity sensor 94 are all mounted to the circuit board 88 in the positions shown.” Column 8, Lines 15-45) coupled (via 24 as connected to 26 and 34, “ As mentioned previously, a temperature sensor 90, a relative humidity sensor 94, and an ambient pressure sensor 92 are all mounted on the circuit board 88 inside the case of the reusable main portion 24 of the calorimeter 10.” Column 17, Line 50 thru Column 18, Line 30) to the flow element (36 via 34), the temperature sensor (90) configured to determine the temperature of the gas flow; a first ultrasonic transducer (one of 80/82, “An upper ultrasonic transducer 80 is disposed in the upper wall of the recess 26 in the reusable main portion 24 of the calorimeter 10. It is connected to the circuit board 88 by wires, not shown. A lower ultrasonic transducer 82 is disposed in the bottom ledge 58 and is also connected to the circuit board 88 by wires, not shown. The ultrasonic transducers 80 and 82 form part of the ultrasonic flow sensing system and will be described in more detail hereinbelow.” Column 8, Lines 45-55; also see: “Referring again to FIG. 4, the upper ultrasonic transducer 80 is supported in the upper wall 56 of the recess 26. The lower ultrasonic transducer 82 is supported in the bottom ledge 58 at the bottom of the recess 26. As shown, these transducers are positioned such that ultrasonic pulses traveling between the transducers 80 and 82 travel parallel to the flow in the flow tube 36 as shown by arrow E. As will be clear to those of skill in the art, transmitting ultrasonic pulses in a direction parallel to fluid flow provides advantages in measurement accuracy.” Column 9, Lines 50-65; and “FIG. 10 is a simplified illustration of the general configuration used in the present embodiment. Flow rates are measured using the pair of ultrasonic transducers, 80 and 82, mounted at opposite ends of a flow path, formed largely by flow tube 36. To send an ultrasonic pulse, a high voltage (approximately 200 V) is applied to one transducer, say 80, and the voltage is then quickly removed. This causes transducer 80 to resonate at its natural frequency and to function as an acoustic transmitter. … The transit time is the time between the transmission of the pulse from transducer 80 and detection of the pulse by transducer 82. The roles of transmitter and detector are then reversed, in order to measure a transit time for a pulse traveling in the opposite direction.” Column 10, Lines 30-50) and a second ultrasonic transducer (other of 80/82, “An upper ultrasonic transducer 80 is disposed in the upper wall of the recess 26 in the reusable main portion 24 of the calorimeter 10. It is connected to the circuit board 88 by wires, not shown. A lower ultrasonic transducer 82 is disposed in the bottom ledge 58 and is also connected to the circuit board 88 by wires, not shown. The ultrasonic transducers 80 and 82 form part of the ultrasonic flow sensing system and will be described in more detail hereinbelow.” Column 8, Lines 45-55; also see: “Referring again to FIG. 4, the upper ultrasonic transducer 80 is supported in the upper wall 56 of the recess 26. The lower ultrasonic transducer 82 is supported in the bottom ledge 58 at the bottom of the recess 26. As shown, these transducers are positioned such that ultrasonic pulses traveling between the transducers 80 and 82 travel parallel to the flow in the flow tube 36 as shown by arrow E. As will be clear to those of skill in the art, transmitting ultrasonic pulses in a direction parallel to fluid flow provides advantages in measurement accuracy.” Column 9, Lines 50-65; and “FIG. 10 is a simplified illustration of the general configuration used in the present embodiment. Flow rates are measured using the pair of ultrasonic transducers, 80 and 82, mounted at opposite ends of a flow path, formed largely by flow tube 36. To send an ultrasonic pulse, a high voltage (approximately 200 V) is applied to one transducer, say 80, and the voltage is then quickly removed. This causes transducer 80 to resonate at its natural frequency and to function as an acoustic transmitter. … The transit time is the time between the transmission of the pulse from transducer 80 and detection of the pulse by transducer 82. The roles of transmitter and detector are then reversed, in order to measure a transit time for a pulse traveling in the opposite direction.” Column 10, Lines 30-50) coupled to the flow element (36 via 34), wherein the first ultrasonic transducer (one of 80/82) and the second ultrasonic transducer (other of 80/82) are configured to determine time of flight (“The transit time is the time between the transmission of the pulse from transducer 80 and detection of the pulse by transducer 82. The roles of transmitter and detector are then reversed, in order to measure a transit time for a pulse traveling in the opposite direction.” Column 10, Lines 30-50) of the gas flow; a processor (96, “ A central processing unit 96 and a speaker for the calorimeter are also mounted to the circuit board, along with an application specific integrated circuit (ASIC) 98 that forms part of the ultrasonic flow sensing system.” Column 8, Lines 15-45; “The ASIC 98 is used to control the transmission and detection of ultrasonic pulses, and communicates with the CPU (central processing unit) 96 of the calorimeter using a serial UART (universal asynchronous receiver transmitter) operating at 19.2 Kbaud.” Column 10, Line 65 thru Column 11, Line 15; “A command is sent from the CPU 96 to the ASIC 98 to start the flow measurements.” Column 11, Lines 10-30; “FIG. 14 shows a simplified schematic of the calorimeter, in terms of its electrical configuration. The calorimeter has a central processing unit (CPU) 96 which controls the overall operation of the device.” Column 16, Lines 20-40) configured to determine a speed of sound (“Ultrasonic pulses are transmitted with and against the direction of flow, resulting in measurement of upstream and downstream transit times. If the gas flow rate is zero, the transit times in either direction through the gas are the same, being related to the speed of sound and distance traveled. However, with gas flow present, the upstream transit times differ from the downstream transit times. For constant flow, the difference between sequential upstream and downstream transit times is directly related to the gas flow speed.” Column 10, Lines 20-30; “As known to those of skill in the art, the speed of sound is a function of ambient temperature, the water vapor mole fraction, ambient pressure, and CO.sub.2 mole fraction. … where c is the speed of sound, t is the ambient temperature, x.sub.w is the water vapor mole fraction, p is ambient pressure and x.sub.c is the CO.sub.2 mole fraction. … Also, the speed of sound may be measured by the flow meter during inhalation.” Column 19, Lines 15-55; “The speed of sound may then be calculated according to the following equation. c=L/2x(1/t.sub.u +1/t.sub.d), (d) where c is the speed of sound, L is the distance between the transducers, tu is the transit time in the up direction, and td is the time in the down direction.” Column 19, Lines 55 thru 70; “Once recording begins, the calorimeter makes measurements of flow, oxygen concentration, and speed of sound. Oxygen partial pressure is measured every tenth of a second, and flow velocity and speed of sound are measured 200 times per second. Flow velocity and speed of sound measurements are averaged so as to obtain a value every tenth of a second for computation of volumes.” Column 23, Line 25 thru Column 24, Line 5) in the gas flow; and wherein, responsive to the determined speed of sound, the processor (96) is further configured to determine a volume concentration of carbon dioxide (“VO.sub.2, the amount of oxygen consumed, is the difference between the amount of oxygen inhaled and the amount of oxygen exhaled. It is also desirable to determine VCO.sub.2. VCO.sub.2 is the volume of the carbon dioxide produced by the body and is the difference between the amount of carbon dioxide exhaled and the amount of carbon dioxide inhaled. RMR may be calculated once VO.sub.2 and VCO.sub.2 are known. … Alternatively, certain assumptions may be made concerning the ratio between VO.sub.2 and VCO.sub.2 allowing RMR to be calculated from VO.sub.2 alone. Therefore, a primary purpose of the present invention is to determine VO.sub.2. This requires determination of both the amount of the oxygen inhaled and the amount of oxygen exhaled. It is preferred to also determine VCO.sub.2 as this allows other metabolic parameters to be determined. To determine VCO.sub.2 requires measurement or calculation of both the amount of carbon dioxide inhaled and the amount of carbon dioxide exhaled. The method and calculations used in the first preferred embodiment of the present invention are represented schematically in FIGS. 15 and 16.” Column 17, Lines 30-50; also see: “the preferred oxygen sensing capability of the present invention may be supplemented by the addition of a carbon dioxide sensor. Other gases may be sensed as well. Generically, oxygen sensors, carbon dioxide sensors, as well as other gas sensors are referred to herein as component gas concentration sensors. … Carbon dioxide and oxygen sensors may be combined into the same package for a combined fluorescent quenching sensor, for example, using selectively permeable membranes or different fluorescent compounds.” Column 30, Lines 10-40; “As known to those of skill in the art, the speed of sound is a function of ambient temperature, the water vapor mole fraction, ambient pressure, and CO.sub.2 mole fraction. … where c is the speed of sound, t is the ambient temperature, x.sub.w is the water vapor mole fraction, p is ambient pressure and x.sub.c is the CO.sub.2 mole fraction. … Also, the speed of sound may be measured by the flow meter during inhalation.” Column 19, Lines 15-55) in the gas flow based at least in part on the speed of sound and the volume concentration of oxygen.
Regarding the remaining limitations, Mault teaches the consideration to determine a pressure (“flow rates may be determined using tiny impellers in the flow path, hot wire based mass flow meters, and pressure differential type flow meters.” Column 12, Lines 35-45) of the gas flow based at least in part on the flow rate. As previously addressed the determined flow rate is a function of the ultrasonic flow measurement system (Column 7, Line 55 thru Column 8, Line 15), whereby the length and radius of the flow element (36 via 34) is known. Explicitly, the modified Mault states “In the preferred embodiment, the flow tube has a length of about 63 mm and an internal diameter of about 12 mm.” (Column 4, Line 60 thru Column 5, Line 15). Thus the standard length of the flow element (36 via 34) is 63 mm and the standard radius of the flow element (36 via 34) is 6 mm. Hence, the pressure is extrapolated from the length and radius – volume (Pv=nRT) of the flow element.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the determination of pressure of Burgess to include consideration of the flow element’s length and radius, as taught by Mault to be a known consideration suitable for determining the pressures experienced by the flow element.
As to Claim 6, the Burgess discloses determining the determining speed of sound (“speed of sound”, “Using this time of flight measurement, the speed of sound of the gases flow between the ultrasonic transducers can be calculated by a hardware processor or controller of the flow therapy apparatus.” Para 0004; “This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.”; “From these measurements, the hardware processor can calculate time of flight t.sub.2 between the acoustic receivers b, c at step 830: … This time of flight measurement t.sub.2 is a unidirectional measure of the speed of sound that depends only on the matching of the acoustic receivers’ delays. As described above, the hardware processor can optionally calculate gases concentration including but not limited to oxygen concentration from the unidirectional measure of the speed of sound at step 840.” Paras 0120 and 0121; “The speed of sound and flow rate measurements can be obtained from a time of flight measurement…” Para 0123; “Using this configuration, the hardware processor can calculate both speed of sound, and therefore gases concentration, and flow rate.” Para 0138; also see: Para 0112, 0113, 0122-0124, 0127, 0135-0137) of the gas flow (402) based at least in part on the time of flight (“time of flight”) of the gas flow (402).
Yet, does not expressly disclose consideration of both “an inhalation speed of sound and an exhalation seed of sound”.
Mault teaches a method and system (Figures 1 and 2), comprising: a respiratory device (10, “Referring to FIGS. 1 and 2, a respiratory calorimeter according to the present invention is generally shown at 10. The calorimeter 10 includes a body 12 and a respiratory connector, such as mask 14, extending from the body 12.” Column 3, Lines 45-60), a flow element (36 via 34, best seen Figure 4, “The disposable portion 22 generally consists of an outer shell 34 with generally vertical side walls and a vertical flow tube 36 within the shell 34. The flow tube 36 is preferably cylindrical with open upper and lower ends. In the preferred embodiment, the flow tube has a length of about 63 mm and an internal diameter of about 12 mm. For definitional purposes, the flow tube 36 may be said to have an inner surface 38 on the inside of the tube 36 and an outer surface 40 on the outside of the tube 36. Likewise, the outer shell 34 may be said to have an inner surface 42 inside the shell and an outer surface 44 outside the shell. As best shown in FIG. 4, the outer surface 40 of the flow tube 36 is spaced from the inner surface 42 of the outer shell 34 so as to define a concentric gap between these two components of the disposable portion 22.” Column 4, Line 60 thru Column 5, Line 15) coupled (via insertion of 34 of 22 into 26, as shown in Figure 3, whereby “Referring again to FIG. 3, the upper end of the outer shell 34 of the disposable 22 has a pair of sidewardly projecting, generally horizontal, engagement rails 50. The recess 26 in the reusable portion 24 of the calorimeter has a pair of corresponding engagement slots 52, only one of which is shown. When the disposable portion 22 docks into the recess 26 of the reusable portion 24, the engagement rails 50 slide into the engagement slots 52 to securely interconnect the disposable portion and the remainder of the calorimeter 10.” Column 5, Lines 30-45) to the respiratory device (10) and configured to direct a gas flow, wherein the gas flow includes a volume concentration of oxygen (“The calorimeter 10 measures a variety of factors and calculates one or more respiratory parameters, such as oxygen consumption and metabolic rate.” Column 3, Line 55 thru Column 4, Line 5; also see: “According to a first preferred embodiment of the present invention, ambient temperature, relative humidity and pressure are measured as well as inhalation volume and exhalation volume and oxygen concentration.” Column 9, Lines 30-45); a temperature sensor (90, “A temperature sensor 90, an ambient pressure sensor 92, and a relative humidity sensor 94 are all mounted to the circuit board 88 in the positions shown.” Column 8, Lines 15-45) coupled (via 24 as connected to 26 and 34, “ As mentioned previously, a temperature sensor 90, a relative humidity sensor 94, and an ambient pressure sensor 92 are all mounted on the circuit board 88 inside the case of the reusable main portion 24 of the calorimeter 10.” Column 17, Line 50 thru Column 18, Line 30) to the flow element (36 via 34), the temperature sensor (90) configured to determine the temperature of the gas flow; a first ultrasonic transducer (one of 80/82, “An upper ultrasonic transducer 80 is disposed in the upper wall of the recess 26 in the reusable main portion 24 of the calorimeter 10. It is connected to the circuit board 88 by wires, not shown. A lower ultrasonic transducer 82 is disposed in the bottom ledge 58 and is also connected to the circuit board 88 by wires, not shown. The ultrasonic transducers 80 and 82 form part of the ultrasonic flow sensing system and will be described in more detail hereinbelow.” Column 8, Lines 45-55; also see: “Referring again to FIG. 4, the upper ultrasonic transducer 80 is supported in the upper wall 56 of the recess 26. The lower ultrasonic transducer 82 is supported in the bottom ledge 58 at the bottom of the recess 26. As shown, these transducers are positioned such that ultrasonic pulses traveling between the transducers 80 and 82 travel parallel to the flow in the flow tube 36 as shown by arrow E. As will be clear to those of skill in the art, transmitting ultrasonic pulses in a direction parallel to fluid flow provides advantages in measurement accuracy.” Column 9, Lines 50-65; and “FIG. 10 is a simplified illustration of the general configuration used in the present embodiment. Flow rates are measured using the pair of ultrasonic transducers, 80 and 82, mounted at opposite ends of a flow path, formed largely by flow tube 36. To send an ultrasonic pulse, a high voltage (approximately 200 V) is applied to one transducer, say 80, and the voltage is then quickly removed. This causes transducer 80 to resonate at its natural frequency and to function as an acoustic transmitter. … The transit time is the time between the transmission of the pulse from transducer 80 and detection of the pulse by transducer 82. The roles of transmitter and detector are then reversed, in order to measure a transit time for a pulse traveling in the opposite direction.” Column 10, Lines 30-50) and a second ultrasonic transducer (other of 80/82, “An upper ultrasonic transducer 80 is disposed in the upper wall of the recess 26 in the reusable main portion 24 of the calorimeter 10. It is connected to the circuit board 88 by wires, not shown. A lower ultrasonic transducer 82 is disposed in the bottom ledge 58 and is also connected to the circuit board 88 by wires, not shown. The ultrasonic transducers 80 and 82 form part of the ultrasonic flow sensing system and will be described in more detail hereinbelow.” Column 8, Lines 45-55; also see: “Referring again to FIG. 4, the upper ultrasonic transducer 80 is supported in the upper wall 56 of the recess 26. The lower ultrasonic transducer 82 is supported in the bottom ledge 58 at the bottom of the recess 26. As shown, these transducers are positioned such that ultrasonic pulses traveling between the transducers 80 and 82 travel parallel to the flow in the flow tube 36 as shown by arrow E. As will be clear to those of skill in the art, transmitting ultrasonic pulses in a direction parallel to fluid flow provides advantages in measurement accuracy.” Column 9, Lines 50-65; and “FIG. 10 is a simplified illustration of the general configuration used in the present embodiment. Flow rates are measured using the pair of ultrasonic transducers, 80 and 82, mounted at opposite ends of a flow path, formed largely by flow tube 36. To send an ultrasonic pulse, a high voltage (approximately 200 V) is applied to one transducer, say 80, and the voltage is then quickly removed. This causes transducer 80 to resonate at its natural frequency and to function as an acoustic transmitter. … The transit time is the time between the transmission of the pulse from transducer 80 and detection of the pulse by transducer 82. The roles of transmitter and detector are then reversed, in order to measure a transit time for a pulse traveling in the opposite direction.” Column 10, Lines 30-50) coupled to the flow element (36 via 34), wherein the first ultrasonic transducer (one of 80/82) and the second ultrasonic transducer (other of 80/82) are configured to determine time of flight (“The transit time is the time between the transmission of the pulse from transducer 80 and detection of the pulse by transducer 82. The roles of transmitter and detector are then reversed, in order to measure a transit time for a pulse traveling in the opposite direction.” Column 10, Lines 30-50) of the gas flow; a processor (96, “ A central processing unit 96 and a speaker for the calorimeter are also mounted to the circuit board, along with an application specific integrated circuit (ASIC) 98 that forms part of the ultrasonic flow sensing system.” Column 8, Lines 15-45; “The ASIC 98 is used to control the transmission and detection of ultrasonic pulses, and communicates with the CPU (central processing unit) 96 of the calorimeter using a serial UART (universal asynchronous receiver transmitter) operating at 19.2 Kbaud.” Column 10, Line 65 thru Column 11, Line 15; “A command is sent from the CPU 96 to the ASIC 98 to start the flow measurements.” Column 11, Lines 10-30; “FIG. 14 shows a simplified schematic of the calorimeter, in terms of its electrical configuration. The calorimeter has a central processing unit (CPU) 96 which controls the overall operation of the device.” Column 16, Lines 20-40) configured to determine a speed of sound (“Ultrasonic pulses are transmitted with and against the direction of flow, resulting in measurement of upstream and downstream transit times. If the gas flow rate is zero, the transit times in either direction through the gas are the same, being related to the speed of sound and distance traveled. However, with gas flow present, the upstream transit times differ from the downstream transit times. For constant flow, the difference between sequential upstream and downstream transit times is directly related to the gas flow speed.” Column 10, Lines 20-30; “As known to those of skill in the art, the speed of sound is a function of ambient temperature, the water vapor mole fraction, ambient pressure, and CO.sub.2 mole fraction. … where c is the speed of sound, t is the ambient temperature, x.sub.w is the water vapor mole fraction, p is ambient pressure and x.sub.c is the CO.sub.2 mole fraction. … Also, the speed of sound may be measured by the flow meter during inhalation.” Column 19, Lines 15-55; “The speed of sound may then be calculated according to the following equation. c=L/2x(1/t.sub.u +1/t.sub.d), (d) where c is the speed of sound, L is the distance between the transducers, tu is the transit time in the up direction, and td is the time in the down direction.” Column 19, Lines 55 thru 70; “Once recording begins, the calorimeter makes measurements of flow, oxygen concentration, and speed of sound. Oxygen partial pressure is measured every tenth of a second, and flow velocity and speed of sound are measured 200 times per second. Flow velocity and speed of sound measurements are averaged so as to obtain a value every tenth of a second for computation of volumes.” Column 23, Line 25 thru Column 24, Line 5) in the gas flow; and wherein, responsive to the determined speed of sound, the processor (96) is further configured to determine a volume concentration of carbon dioxide (“VO.sub.2, the amount of oxygen consumed, is the difference between the amount of oxygen inhaled and the amount of oxygen exhaled. It is also desirable to determine VCO.sub.2. VCO.sub.2 is the volume of the carbon dioxide produced by the body and is the difference between the amount of carbon dioxide exhaled and the amount of carbon dioxide inhaled. RMR may be calculated once VO.sub.2 and VCO.sub.2 are known. … Alternatively, certain assumptions may be made concerning the ratio between VO.sub.2 and VCO.sub.2 allowing RMR to be calculated from VO.sub.2 alone. Therefore, a primary purpose of the present invention is to determine VO.sub.2. This requires determination of both the amount of the oxygen inhaled and the amount of oxygen exhaled. It is preferred to also determine VCO.sub.2 as this allows other metabolic parameters to be determined. To determine VCO.sub.2 requires measurement or calculation of both the amount of carbon dioxide inhaled and the amount of carbon dioxide exhaled. The method and calculations used in the first preferred embodiment of the present invention are represented schematically in FIGS. 15 and 16.” Column 17, Lines 30-50; also see: “the preferred oxygen sensing capability of the present invention may be supplemented by the addition of a carbon dioxide sensor. Other gases may be sensed as well. Generically, oxygen sensors, carbon dioxide sensors, as well as other gas sensors are referred to herein as component gas concentration sensors. … Carbon dioxide and oxygen sensors may be combined into the same package for a combined fluorescent quenching sensor, for example, using selectively permeable membranes or different fluorescent compounds.” Column 30, Lines 10-40; “As known to those of skill in the art, the speed of sound is a function of ambient temperature, the water vapor mole fraction, ambient pressure, and CO.sub.2 mole fraction. … where c is the speed of sound, t is the ambient temperature, x.sub.w is the water vapor mole fraction, p is ambient pressure and x.sub.c is the CO.sub.2 mole fraction. … Also, the speed of sound may be measured by the flow meter during inhalation.” Column 19, Lines 15-55) in the gas flow based at least in part on the speed of sound and the volume concentration of oxygen.
Regarding the remaining limitations, Mault teaches consideration of the inhalation speed of sound (“Also, the speed of sound may be measured by the flow meter during inhalation.” Column 19, Lines 15-55) and hints at the capability of also considering the exhalation speed of sound as a function of the exhalation volume – “According to a first preferred embodiment of the present invention, ambient temperature, relative humidity and pressure are measured as well as inhalation volume and exhalation volume and oxygen concentration.” Column 9, Lines 30-45); also see: “VO.sub.2, the amount of oxygen consumed, is the difference between the amount of oxygen inhaled and the amount of oxygen exhaled. It is also desirable to determine VCO.sub.2. VCO.sub.2 is the volume of the carbon dioxide produced by the body and is the difference between the amount of carbon dioxide exhaled and the amount of carbon dioxide inhaled. RMR may be calculated once VO.sub.2 and VCO.sub.2 are known. … Alternatively, certain assumptions may be made concerning the ratio between VO.sub.2 and VCO.sub.2 allowing RMR to be calculated from VO.sub.2 alone. Therefore, a primary purpose of the present invention is to determine VO.sub.2. This requires determination of both the amount of the oxygen inhaled and the amount of oxygen exhaled. It is preferred to also determine VCO.sub.2 as this allows other metabolic parameters to be determined. To determine VCO.sub.2 requires measurement or calculation of both the amount of carbon dioxide inhaled and the amount of carbon dioxide exhaled. The method and calculations used in the first preferred embodiment of the present invention are represented schematically in FIGS. 15 and 16.” Column 17, Lines 30-50).
In light of the configuration of the flow meter capable of measuring both inhalation and exhalation, and the ability of the flow meter to determine the speed of sound during inhalation, it appears the use of the exhalation speed of sound would be obvious to try choosing from a finite number of identified predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to compare the inhalation and exhalation volumes and in turn flow, pressure, and speed of sound based on the composition of the gas characteristics.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the determination of speed of sound of Burgess to include consideration both the inhalation and exhalation speed of sound, as taught by Mault to be a known consideration suitable for determining the composition of gases during each breathing cycle.
Response to Arguments
Applicant’s arguments, with respect to the prior art rejection of claim(s), have been considered but are moot.
Newly located Burgess et al. (2023/0166065) appears to better represent the method and systems as claimed whereby a processor it utilized to make the calculations of “time of flight”, “speed of sound” and “volume concentrations” of various gases therewith, such that the processor is expressly oriented to operate with a respiratory device and tubing to output a gas flow via a flow element.
In light of the aforementioned reasoning, the non-final rejection of the claims has been maintained and made FINAL.
Applicant’s arguments, with respect to the 101 rejection of claim(s), have been fully considered but they are not persuasive.
Applicant asserts “The human mind cannot observe a flow of gas and determine the concentration of carbon dioxide in the gas” (Pages 9 and 10 of Remarks); however, it should be noted the claim listing does not rely solely on the “concentration” but rather the “volume concentration”. In this fact, a human mind can determine “volume concentration” whereby high flow volumes move faster than lower flow volumes.
Additionally, the human mind can determine the expected naturally occurring phenomenon whereby a patient inhales oxygen and exhaled carbon dioxide. Consequently, the expected results of a patient breathing would result in the expectation that there are higher “volume concentrations” of oxygen and lower “volume concentrations” of carbon dioxide when the gas is being provided for inhalation by the patient and higher “volume concentrations” of carbon dioxide and lower “volume concentrations” of oxygen when the gas is being delivered for exhalation from the patient.
Still further, it should be noted Mault teaches the combination of elements including the pair of ultrasonic transducers is well-understood, routine, conventional to arrive at “transit time” a function of “time of flight”, a calculation of the speed of sound, and a volumetric concentration of gases. Consequently, Claims 1-6 do not positively recite an extra-solution activity elements that would preclude, prevent, or hinder the application of the claims under 101 – abstract idea.
Should Applicant respectfully disagree, it should be noted also that Burgess et al. (2023/0166065) expressly states the concepts of a processor it utilized to make the calculations of “time of flight”, “speed of sound” and “volume concentrations” of various gases therewith, such that the processor is expressly oriented to operate with a respiratory device and tubing to output a gas flow via a flow element were well-understood, routine, conventional as referenced in the Summary (Para 0004-0019). Consequently, Burgess further affirms and confirms that both Mault and Burgess were mental processes formulated by the act of performing the mathematical formula or equation to determine an observation, evaluation, or judgement as to the functionality of the pair of ultrasonic transducers to achieve “time of flight”, “speed of sound” and a “volume concentration” of gas.
In light of the aforementioned reasoning, the non-final rejection of the claims has been maintained and made FINAL.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Barker et al. (2015/0059745) and Holley et al. (2022/0339383) disclose additional methods and systems utilizing a pair of ultrasonic transducers whereby “time of flight” (Barker – “transit time” Para 0155), “speed of sound” and “volume concentrations” of various gases therewith are calculated.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
Prosecution Insights