DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application as originally filed on June 23, 2023.
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 § 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 1-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mault et al. (6,468,222) in view of Gloss et al. (2019/0011300).
As to Claims 1 and 14, Mault discloses 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 usage of “volume concentration of oxygen”, “volume concentration of carbon dioxide” and the “speed of sound”, Mault discloses a desire to provide consideration to both the “volume concentration of oxygen” and the “volume concentration of carbon dioxide” in a single device was known (“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). Further, Mault discloses consideration of using an assumed ratio to correlate the “volume concentration of oxygen” to the “volume concentration of carbon dioxide” and thus vice versa by flipping the assumed ratio (“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.” Column 17, Lines 30-50). Finally, Mault discloses the concept of “speed of sound” is a function of the carbon dioxide mole fraction (total amount of carbon dioxide moles within a mixture, e.g. composition of carbon dioxide within a solution – a concept that is intimately similar to the concentration of carbon dioxide) (“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 light of the aforementioned reasoning, it appears Mault is suitable to perform a determination of either volume concentration of oxygen or carbon dioxide based upon the speed of sound and the assumed ratio of the other of volume concentration of carbon dioxide or oxygen.
Regarding the concepts of “transit time” as related to the claimed “time of flight”, it noted “transit time” is a method of measuring the time difference between upstream and downstream ultrasonic signals, while “time of flight” is a method of measuring the time it takes for an ultrasonic signal to travel through a fluid and be received by the downstream receiver. Consequently, it clear these terms are intimately related to the manner, operation, and conveyance of the ultrasonic signals to/from the ultrasonic transducers. In this fact, the velocity of the fluid determines “transit time” or travel time of the ultrasonic signal, such that a shorter “transit time” means the fluid is flowing in the same direction and a larger “transit time” means the fluid is flowing in an opposite direction – thus making a determination of the flow and velocity of the fluid by comparing the ‘transit times” of both the upstream and downstream signals.
Although this correlation between “transit time” and the claimed “time of flight” considered, should Applicant respectfully disagree with Primary Examiner’s assessment of the correlation of “transit time” and the claimed “time of flight” is disclosed by Mault – stating Mault does not expressly disclose the language of “time of flight” as claimed, Primary Examiner presents the explicit teachings of Gloss to unequivocally confirm and affirm the claimed “time of flight” takes into account “transit time” in order to yield a determination of the flow and velocity of the fluid being conveyed.
Gloss teaches a system (best seen Figure 6A) having a flow element (2, “For flow quantity determination of the fluid, the clamp-on fluid meter 1 comprises a first measuring arrangement, which is formed as an ultrasound measuring arrangement having two ultrasound transducers 11, 12. The ultrasound transducers 11, 12 are fitted on the pipe 2, the measurement sound being introduced through the pipe wall with the pipe wall surfaces 2a and 2b.” Para 0052) configured to receive a direct gas flow, a temperature sensor (13/14, “As an alternative or in addition, as shown in FIG. 6A, two additional temperature sensors 13, 14 may be arranged on the pipe 2, which are provided in order to measure the temperature of the environment as well as the temperature of the tube, or of the pipe 2.” Para 0065) coupled to the flow element (2) a first ultrasonic transducer (one of 11/12, “The ultrasound transducers 11, 12 are fitted on the pipe 2, the measurement sound being introduced through the pipe wall with the pipe wall surfaces 2a and 2b.” Para 0052) and a second ultrasonic transducer (other of 11/12, “The ultrasound transducers 11, 12 are fitted on the pipe 2, the measurement sound being introduced through the pipe wall with the pipe wall surfaces 2a and 2b.” Para 0052) coupled to the flow element (2), whereby the first and second ultrasonic transducers (11/12) are configured to determine time of flight of the gas flow (“The time of flight of this ultrasound signal is determined, the path which the signal must travel and the corresponding time of flight being known, so that the temperature can be determined directly.” Para 0064).
Explicitly, regarding the concept of the determination of flow and velocity, Gloss teaches the explicit use of “a control and evaluation unit connected to said first and second measuring arrangements and configured to determine a time of flight of the ultrasound signal along the first measurement path and along the second measurement path … [and further] to determine a flow quantity of the fluid in the pipe, to determine a time of flight of the ultrasound signal along the second measurement path and determine changes due to operation in a flow cross section from the time of flight of the ultrasound signal along the second measurement path” (Paras 0034 and 0035) in order to monitor the flow and velocity along the flow path.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the first and second ultrasonic transducers of Mault operating with “transit time” to further operate in a manner to determine the claimed “time of flight” as taught by Gloss, to be a known methodology of monitoring the flow and velocity of gas/fluid along the flow path of the flow element.
As to Claim 15, the modified Mault, specifically Mault discloses the capability of the system (Figures 1 and 2) to be connected to an alternative respiratory device (10) than the modified Mault’s calorimeter, but rather a respiratory device in the form of a ventilator (“It should be understood that instead of ambient air, the calorimeter may be connected to a mechanical ventilator, or to a alternative gas supply.” Column 6, Line 65 thru Column 7, Line 10; and “A first end of the flow pathway is in fluid communication with the respiratory connector and a second end is in fluid communication with a source and sink for respiratory gases which may be either the ambient atmosphere, a mechanical ventilator, or other gas mixture source.” Column 1, Line 55 thru Column 2, Line 10).
As to Claims 2 and 17, the modified Mault, specifically Mault discloses the processor (96) is further configured to determine a concentration of carbon dioxide in the gas flow (“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) based at least in part on temperature (“Temperature stability is improved by heating, however the oxygen sensitivity is better at lower temperatures.” Column 14, Line 55 thru Column 15, Line 5; “The comparison of the two signals eliminates environmental effects (e.g. temperature, LED intensity), and is used to determine oxygen concentration by the CPU.” Column 16, Line 60 thru Column 17, Line 10; “As will be clear to those of skill in the art, there are a number of ways to determine metabolic parameters such as VO.sub.2 (volume of oxygen consumed) and RMR (resting metabolic rate). As mentioned previously, the presently preferred approach to determining metabolic parameters uses measurements of ambient temperature, pressure and humidity along with inhalation volume, exhalation volume, and oxygen concentration in the exhalation.” Column 17, Lines 20-30; also see: “Preferably, the production of CO.sub.2 should also be determined. In order to do this, additional calculations are required. First, certain assumptions may be made about the temperature and humidity of exhaled breath. The volume of water vapor in the exhaled breath may be determined from the assumed relative humidity and temperature, and the measured flow volume.” Column 22, Lines 5-25).
As previously addressed, in the independent claims, Mault discloses a desire to provide consideration to both the “volume concentration of oxygen” and the “volume concentration of carbon dioxide” in a single device was known (“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). Further, Mault discloses consideration of using an assumed ratio to correlate the “volume concentration of oxygen” to the “volume concentration of carbon dioxide” and thus vice versa by flipping the assumed ratio (“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.” Column 17, Lines 30-50).
In light of the modification of Mault, Mault discloses the claimed configuration whereby a determination of either of volume concentration of oxygen or carbon dioxide is based upon temperature. Thus, the limitations of the claims are met by the modified Mault.
As to Claim 3, the modified Mault, specifically Mault discloses the processor (96) is further configured to determine a concentration of carbon dioxide in the gas flow (“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) based at least in part on humidity (“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; “As will be clear to those of skill in the art, there are a number of ways to determine metabolic parameters such as VO.sub.2 (volume of oxygen consumed) and RMR (resting metabolic rate). As mentioned previously, the presently preferred approach to determining metabolic parameters uses measurements of ambient temperature, pressure and humidity along with inhalation volume, exhalation volume, and oxygen concentration in the exhalation.” Column 17, Lines 20-30; also see: “Preferably, the production of CO.sub.2 should also be determined. In order to do this, additional calculations are required. First, certain assumptions may be made about the temperature and humidity of exhaled breath. The volume of water vapor in the exhaled breath may be determined from the assumed relative humidity and temperature, and the measured flow volume.” Column 22, Lines 5-25).
As previously addressed, in the independent claims, Mault discloses a desire to provide consideration to both the “volume concentration of oxygen” and the “volume concentration of carbon dioxide” in a single device was known (“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). Further, Mault discloses consideration of using an assumed ratio to correlate the “volume concentration of oxygen” to the “volume concentration of carbon dioxide” and thus vice versa by flipping the assumed ratio (“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.” Column 17, Lines 30-50).
In light of the modification of Mault, Mault discloses the claimed configuration whereby a determination of either of volume concentration of oxygen or carbon dioxide is based upon humidity. Thus, the limitations of the claims are met by the modified Mault.
As to Claims 4 and 18, the modified Mault, specifically Mault discloses the processor (96) is configured to determine a flow rate (“the accuracy with which flow rates through the flow tube 36 may be measured using an ultrasonic flow measurement system increases as flow velocity increases.” Column 7, Line 55 thru Column 8, Line 15; “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. … 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. ” Column 10, Lines 20-50) of the gas flow with the first and second ultrasonic transducers (80/82); and 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 to Claims 5, 12 and 19, please see the rejection of Claim 18, which addresses 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.
As to Claims 6 and 20, the modified Mault, specifically Mault discloses the concept of “transit time” as related to “speed of sound”, whereby “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; “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), (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). Still further, the modified Mault, specifically Gloss teaches the concept of “time of flight” as related to the “speed of sound”. Explicitly, Gloss teaches the operation by which the dimensions of the flow element (2) correlate to “time of flight” and “speed of sound” – “the pipe may be determined with the aid of the speed of sound of the fluid and the time of flight of the ultrasound signal along the second measurement path.” (Para 0016; also see: “For example, in that the known quantities of external circumference of the pipe and speed of sound in the material of the pipe and the time of flight of the ultrasound signal which has been determined are used for calculating the wall thickness.” Para 0027).
In light of the aforementioned reasoning, it is clear the modified Mault is able to determine the speed of sound based upon the “time of flight” of the gas flow, whereby consideration is given to both “the transit time in the up direction” and “the time in the down direction”.
As to Claim 7, Mault discloses a system (Figures 1 and 2), comprising: 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) configured to direct a gas flow, 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; and 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 gas (“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; “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; 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 of the time of flight and the temperature of the gas flow.
Regarding the concepts of “transit time” as related to the claimed “time of flight”, it noted “transit time” is a method of measuring the time difference between upstream and downstream ultrasonic signals, while “time of flight” is a method of measuring the time it takes for an ultrasonic signal to travel through a fluid and be received by the downstream receiver. Consequently, it clear these terms are intimately related to the manner, operation, and conveyance of the ultrasonic signals to/from the ultrasonic transducers. In this fact, the velocity of the fluid determines “transit time” or travel time of the ultrasonic signal, such that a shorter “transit time” means the fluid is flowing in the same direction and a larger “transit time” means the fluid is flowing in an opposite direction – thus making a determination of the flow and velocity of the fluid by comparing the ‘transit times” of both the upstream and downstream signals.
Although this correlation between “transit time” and the claimed “time of flight” has been considered, should Applicant respectfully disagree with Primary Examiner’s assessment of the correlation of “transit time” and the claimed “time of flight” is disclosed by Mault – stating Mault does not expressly disclose the language of “time of flight” as claimed, Primary Examiner presents the explicit teachings of Gloss to unequivocally confirm and affirm the claimed “time of flight” takes into account “transit time” in order to yield a determination of the flow and velocity of the fluid being conveyed.
Gloss teaches a system (best seen Figure 6A) having a flow element (2, “For flow quantity determination of the fluid, the clamp-on fluid meter 1 comprises a first measuring arrangement, which is formed as an ultrasound measuring arrangement having two ultrasound transducers 11, 12. The ultrasound transducers 11, 12 are fitted on the pipe 2, the measurement sound being introduced through the pipe wall with the pipe wall surfaces 2a and 2b.” Para 0052) configured to receive a direct gas flow, a temperature sensor (13/14, “As an alternative or in addition, as shown in FIG. 6A, two additional temperature sensors 13, 14 may be arranged on the pipe 2, which are provided in order to measure the temperature of the environment as well as the temperature of the tube, or of the pipe 2.” Para 0065) coupled to the flow element (2) a first ultrasonic transducer (one of 11/12, “The ultrasound transducers 11, 12 are fitted on the pipe 2, the measurement sound being introduced through the pipe wall with the pipe wall surfaces 2a and 2b.” Para 0052) and a second ultrasonic transducer (other of 11/12, “The ultrasound transducers 11, 12 are fitted on the pipe 2, the measurement sound being introduced through the pipe wall with the pipe wall surfaces 2a and 2b.” Para 0052) coupled to the flow element (2), whereby the first and second ultrasonic transducers (11/12) are configured to determine time of flight of the gas flow (“The time of flight of this ultrasound signal is determined, the path which the signal must travel and the corresponding time of flight being known, so that the temperature can be determined directly.” Para 0064).
Explicitly, regarding the concept of the determination of flow and velocity, Gloss teaches the explicit use of “a control and evaluation unit connected to said first and second measuring arrangements and configured to determine a time of flight of the ultrasound signal along the first measurement path and along the second measurement path … [and further] to determine a flow quantity of the fluid in the pipe, to determine a time of flight of the ultrasound signal along the second measurement path and determine changes due to operation in a flow cross section from the time of flight of the ultrasound signal along the second measurement path” (Paras 0034 and 0035) in order to monitor the flow and velocity along the flow path.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the first and second ultrasonic transducers of Mault operating with “transit time” to further operate in a manner to determine the claimed “time of flight” as taught by Gloss, to be a known methodology of monitoring the flow and velocity of gas/fluid along the flow path of the flow element.
As to Claims 8 and 9, the modified Mault, specifically Mault considers the volume concentration of both “oxygen” and “carbon dioxide”. Explicitly, Mault discloses a desire to provide consideration to both the “volume concentration of oxygen” and the “volume concentration of carbon dioxide” in a single device was known (“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). Further, Mault discloses consideration of using an assumed ratio to correlate the “volume concentration of oxygen” to the “volume concentration of carbon dioxide” and thus vice versa by flipping the assumed ratio (“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.” Column 17, Lines 30-50).
As to Claim 10, the modified Mault, specifically Mault discloses the use of a humidity sensor (94, “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; “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. … If the relative humidity sensor 94 were actually positioned in ambient air, instead of inside the case, its output would reflect the relative humidity in the ambient air. Since the relative humidity sensor 94 may be at an elevated temperature, its output indicates the relative humidity at this elevated temperature, rather than at true ambient conditions.” Column 17, Line 50 thru Column 18, Line 30; “At this point, the partial pressure of water, ppH2O is known based on the output of the humidity sensor 94 and the assumption that the partial pressure is the same inside and outside the case.” Column 20, Line 1-40).
As to Claim 11, the modified Mault, specifically Mault discloses the concept of “transit time” as related to the determination of pressure, whereby 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, and to determine a flow rate (“the accuracy with which flow rates through the flow tube 36 may be measured using an ultrasonic flow measurement system increases as flow velocity increases.” Column 7, Line 55 thru Column 8, Line 15; “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. … 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. ” Column 10, Lines 20-50) of the gas flow with the first and second ultrasonic transducers (80/82). Consequently, the operation of the ultrasonic transducers as measuring the ”transit time” and thus “time of flight” are correlated with the ability to determine pressure as a function of the detected flow profile.
As to Claim 13, the modified Mault, specifically Mault discloses the concept of “transit time” as related to “speed of sound”, whereby “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; “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), (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). Still further, the modified Mault, specifically Gloss teaches the concept of “time of flight” as related to the “speed of sound”. Explicitly, Gloss teaches the operation by which the dimensions of the flow element (2) correlate to “time of flight” and “speed of sound” – “the pipe may be determined with the aid of the speed of sound of the fluid and the time of flight of the ultrasound signal along the second measurement path.” (Para 0016; also see: “For example, in that the known quantities of external circumference of the pipe and speed of sound in the material of the pipe and the time of flight of the ultrasound signal which has been determined are used for calculating the wall thickness.” Para 0027).
In light of the aforementioned reasoning, it is clear the modified Mault is able to determine the speed of sound based upon the “time of flight” of the gas flow, whereby consideration is given to both “the transit time in the up direction” and “the time in the down direction”.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mault et al. (6,468,222) in view of Gloss et al. (2019/0011300), as applied to Claim 14, and further in view of Esposito Jr. (2008/0283062).
As to Claim 16, the modified Mault, specifically Mault discloses the capability to connect the system (Figures 1 and 2) to an alternative respiratory device, in the form of a mechanical ventilator (“It should be understood that instead of ambient air, the calorimeter may be connected to a mechanical ventilator, or to a alternative gas supply.” Column 6, Line 65 thru Column 7, Line 10; and “A first end of the flow pathway is in fluid communication with the respiratory connector and a second end is in fluid communication with a source and sink for respiratory gases which may be either the ambient atmosphere, a mechanical ventilator, or other gas mixture source.” Column 1, Line 55 thru Column 2, Line 10); yet, does not expressly disclose the use of an alternative respiratory device in the form of a “continuous positive airway pressure (CPAP) machine”.
Esposito teaches the system of utilizing ultrasonic transducers for flow measurement was known (“For ultrasonic flow measurement approaches, two windows are placed in the airway adapter, so that the ultrasonics beam interrogate the flow in an acute angle as possible with the direction of flow.” Para 0017) whereby the flow measurement device may be imparted to various respiratory devices including ventilators and CPAP machines (“Respiratory component sensors, which include, but are not limited to, gas constituent sensors and gas flow sensors, are widely used and may be found in monitoring devices and therapeutic devices, such as ventilators and pressure support systems, such as CPAP machines.” Para 0005) to monitor the flow within the respiratory device.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the respiratory device of the modified Mault to operate with a CPAP machine, as taught by Esposito to be a known functionally equivalent source to provide gas flow to a patient in need of respiratory therapy support.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cewers et al. (2002/0144681) and Cardelius et al. (2004/0211244) each disclose a respiratory device utilizing at least a pair of ultrasonic transducers and a temperature sensor whereby the transit time of the ultrasonic transducers is utilized to determine a flow profile through the flow element.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785