DETAILED ACTION
This Office Action is in response to the filing of a preliminary amendment to the claims on 2/13/2025. As per the preliminary amendment, claims 1-23 have been cancelled, and claims 24-45 have been added. Thus, claims 24-45 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 44 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 44 recites the limitation "the measured pressure" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “mixing element” in claims 24, 32, and 41.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 24-28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Barker et al. (US Pub. 2015/0059745) in view of Aylsworth (US Pat. 5,060,514) in view of Esnouf (US Pat. 6,508,250). The applied Barker reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the references, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 24, Barker discloses a gases delivery apparatus (the device connected to gases outlet 12 in Fig. 3 that leads to a patient interface), comprising: a controller (see [0101] lines 5-7, [0143] lines 9-11, and [0155] lines 1-18); a gas mixing chamber (mixing chamber being the blower unit casing 32 in Fig. 9 which receives gases from air inlet vents 22 and supplemental gas connection inlet 24 in Fig. 6; see also [0098] lines 3-13 and [0102] lines 2-7) comprising a gases flow path from a first end of the gas mixing chamber to a second end of the gas mixing chamber (flow path between the inlet port 37 of the blower unit and the outlet port 38 seen in Fig. 10A and 11; see also [0102] lines 2-7); an air inlet, via which air enters the first end of the gas mixing chamber from a gas source (air inlet vents 22 in Fig. 6); a supplementary gas inlet, via which a supplementary gas enters the first end of the gas mixing chamber to be mixed with the air in the gases flow path (see supplemental gas connection inlet 24 in Fig. 6; see also [0098]); and a gases measurement apparatus, comprising: a gas measuring chamber (see sensing passage 206 in Fig. 27B where air flow path axis 208 defines two ends of a sensing chamber, which is a representation of the sensor assembly 60 as seen in Fig. 17), comprising a gases flow path from a first end of the gas measuring chamber to a second end of the gas measuring chamber (see Fig. 27B air flow path axis 208), wherein a downstream direction is defined along the gases flow path from the first end to the second end (downstream shown in the direction that the arrow of air flow path axis 208 points in Fig. 27B) and an upstream direction is defined along the gases flow path from the second end to the first end (upstream shown opposite the direction that the arrow of air flow path 208 points in Fig. 27B); a first ultrasonic sensor positioned at the first end of the gas measuring chamber (transducer 272 in Fig. 27B), the first ultrasonic sensor configured to transmit a downstream acoustic pulse train in a first measurement phase (downstream pulse seen as the ultrasonic pulse 276 which travels downstream from transducer 272 to transducer 274 in Fig. 27B; see also [0170] lines 3-14), to detect an upstream acoustic pulse train in a second measurement phase (upstream pulse seen as the ultrasonic pulse 276 which travels upstream from the transducer 274 to transducer 272 in Fig. 27B, see also [0170] lines 3-14), and to send a signal to the controller (transducers send signal to the controller as seen in [0155] lines 1-18); and a second ultrasonic sensor positioned at the second end of the gas measuring chamber (transducer 274 in Fig. 27B), the second ultrasonic sensor configured to transmit the upstream acoustic pulse train in the second measurement phase (upstream pulse seen as the ultrasonic pulse 276 which travels upstream from the transducer 274 to transducer 272 in Fig. 27B, see also [0170] lines 3-14), to detect the downstream acoustic pulse train in the first measurement phase (downstream pulse seen as the ultrasonic pulse 276 which travels downstream from transducer 272 to transducer 274 in Fig. 27B, see also [0170] lines 3-14), and to send a signal to the controller (transducers send signal to the controller as seen in [0155] lines 1-18), wherein the controller is configured to determine a gas flow characteristic of the gases in the gas measuring chamber (see [0170] where the pair of transducers are used as the flow rate sensor; and see [0150]-[0155] and [0168] where the gas composition is determined based on the ultrasonic sensors and the monitored speed of sound, in order to measure respective ratios of known gases in the composition) based at least in part on a signal received from the first ultrasonic sensor and a signal received from the second ultrasonic sensor (see [0170] where the pair of transducers are used as the flow rate sensor; and see [0150]-[0155] and [0168] where the gas composition is determined based on the ultrasonic sensors and the monitored speed of sound, in order to measure respective ratios of known gases in the composition), and wherein determining the gas flow characteristic of the gases comprises determining a flow rate of the gases (see [0170] where the pair of transducers are used as the flow rate sensor).
Barker lacks a detailed description of at least one mixing element situated within the gases flow path.
However, Aylsworth teaches a similar ultrasonic measuring device with a mixing element placed in the gases flow path (disc 9a with apertures 11 in Figs. 1-3 which mix the gas as it passes through).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing chamber of Barker to include a mixing element as taught by Aylsworth, as it would reduce the turbulence of the flow which helps create a laminar flow for more accurate measurements (Aylsworth; see Col. 9 lines 58-62).
The modified Barker device lacks a detailed description of wherein an inner diameter of the supplementary gas inlet is substantially smaller than an inner diameter of the air inlet, allowing for a velocity of the supplementary gas entering the gas mixing chamber to be higher than the velocity of air entering the gas mixing chamber.
However, Esnouf teaches a respiratory device for mixing gases, wherein an inner diameter of the supplementary gas inlet is substantially smaller than an inner diameter of the air inlet (see Fig. 1 and Col. 3 lines 17-20, where an orifice 22 is 1.5 mm and openings 20 are each 5 mm), allowing for a velocity of the supplementary gas entering the gas mixing chamber to be higher than the velocity of air entering the gas mixing chamber (see Col. 3 lines 6-49 and Fig. 1, where the orifice 22 brings in supplementary oxygen from oxygen supply tube 8, its small bore size causing the oxygen to travel at a higher velocity than the air coming through larger openings 20).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supplemental oxygen inlet of the modified Barker device to be a smaller diameter than the air inlet as taught by Esnouf, as it would create a mechanical control over the mixed concentration of oxygen based on the size of the inlets, for additional adjustment over the desired ratio (Esnouf; see Col. 3 lines 6-20).
Regarding claim 25, the modified Barker device has wherein the supplementary gas comprises oxygen (Barker; see [0095] lines 5-11 and [0098] lines 3-13 where the central gases supply of supplemental gas is oxygen).
Regarding claim 26, the modified Barker device has wherein the downstream acoustic pulse train or the upstream acoustic pulse train comprises a plurality of acoustic pulses (Barker; pulses 276 in Fig. 27B, see also [0170] lines 3-14).
Regarding claim 27, the modified Barker device has wherein: the gas flow characteristic further comprises at least one of gases concentration (Barker; see [0150]-[0155] and [0168] where the gas composition is determined based on the ultrasonic sensors and the monitored speed of sound, in order to measure respective ratios of known gases in the composition).
Regarding claim 28, the modified Barker device has at least one temperature sensor configured to measure temperature of the gases flowing in the gases flow path (Barker; see [0027] lines 1-8 and [0155] lines 1-18).
Regarding claim 30, the modified Barker device has wherein the gas mixing chamber is a part of a blower assembly of the gases delivery apparatus (Barker; see blower 35 in Fig. 10, such that the respiratory device 10 is a blower assembly, which includes the mixing chamber).
Regarding claim 31, the modified Barker device has a breathing tube for receiving respiratory gases from the gas delivery apparatus (Barker; see [0096] outlet 12 of the device 10, analogous to user conduit 3 in Figs. 1-2); and a patient interface in fluid communication with the breathing tube for delivering the respiratory gases to a patient (Barker; see [0096] where the outlet 12 of the device 10 leads to a patient interface, analogous to user interface 5 in Figs. 1-2).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Barker in view of Aylsworth in view of Esnouf as applied to claim 24 above, and further in view of Sugawara et al. (US Pub. 2013/0008438).
Regarding claim 29, the modified Barker device has a gases measurement apparatus.
The modified Barker device lacks a detailed description of heat transfer features, that increase heat transfer from the gases flowing through the gases measurement apparatus to a housing of the gases measurement apparatus and reduce heat transfer from the gases to the environment, wherein optionally the heat transfer features are tracks formed on a conductive path assembled into the gases measurement apparatus.
However, Sugawara teaches an oxygen concentrator that has conductive heat transfer features (coupler socket 71 and oxygen outlet 100 in Fig. 9, see also [0065] lines 1-8) which are placed around a measurement sensor (temperature sensor 400 in Fig. 9) to promote rapid heat transfer from the gas to the coupler socket to reduce heat transfer from the gas to the environment and increase temperature sensing speed/ heat transfer to the sensor (see [0065] lines 1-8), and which are on a conductive path (conductive path formed by the thermally conductive metallic material of oxygen outlet 100 in [0065]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensor assembly of the modified Barker device to be surrounded by a conductive path for heat transfer coupling as taught by Sugawara as it would be using a known technique in the art of heat transfer to speed up temperature sensing results (Sugawara; see [0065]).
Claims 32-34, 36, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Barker in view of Aylsworth in view of Esnouf in view of Sugiura (US Pub. 2011/0209558).
Regarding claim 32, Barker discloses a gases delivery apparatus (the device connected to gases outlet 12 in Fig. 3 that leads to a patient interface), comprising: a controller (see [0101] lines 5-7, [0143] lines 9-11, and [0155] lines 1-18), a gas mixing chamber configured to receive gases from a gases source (mixing chamber being the blower unit casing 32 in Fig. 9 which receives gases from air inlet vents 22 and supplemental gas connection inlet 24 in Fig. 6; see also [0098] lines 3-13 and [0102] lines 2-7), the gas mixing chamber comprising a gases flow path from a first end of the gas mixing chamber to a second end of the gas mixing chamber (flow path between the inlet port 37 of the blower unit and the outlet port 38 seen in Fig. 10A and 11; see also [0102] lines 2-7), an air inlet, via which air enters the first end of the gas mixing chamber from a gas source (air inlet vents 22 in Fig. 6); a supplementary gas inlet, via which another supplementary gas enters the first end of the gas mixing chamber to be mixed with the air in the gases flow path (see supplemental gas connection inlet 24 in Fig. 6; see also [0098]); a gas measuring chamber configured to receive gases from the gas mixing chamber (see sensing passage 206 in Fig. 27B where air flow path axis 208 defines two ends of a sensing chamber, which is a representation of the sensor assembly 60 as seen in Fig. 17, which is downstream of the mixing chamber as it measures the mixed gas composition, such as described in [0154]), the gas measuring chamber comprising a gases flow path from a first end of the gas measuring chamber to a second end of the gas measuring chamber (see Fig. 27B air flow path axis 208), wherein a downstream direction is defined along the gases flow path from the first end to the second end (downstream shown in the direction that the arrow of air flow path axis 208 points in Fig. 27B) and an upstream direction is defined along the gases flow path from the second end to the first end (upstream shown opposite the direction that the arrow of air flow path 208 points in Fig. 27B), a first ultrasonic sensor positioned at the first end of the gas measuring chamber (transducer 272 in Fig. 27B), the first ultrasonic sensor configured to transmit a downstream acoustic pulse train in a first measurement phase (downstream pulse seen as the ultrasonic pulse 276 which travels downstream from transducer 272 to transducer 274 in Fig. 27B; see also [0170] lines 3-14), to detect an upstream acoustic pulse train in a second measurement phase (upstream pulse seen as the ultrasonic pulse 276 which travels upstream from the transducer 274 to transducer 272 in Fig. 27B, see also [0170] lines 3-14), and to send a signal to the controller (transducers send signal to the controller as seen in [0155] lines 1-18); a second ultrasonic sensor positioned at the second end of the gas measuring chamber (transducer 274 in Fig. 27B), the second ultrasonic sensor configured to transmit the upstream acoustic pulse train in the second measurement phase (upstream pulse seen as the ultrasonic pulse 276 which travels upstream from the transducer 274 to transducer 272 in Fig. 27B, see also [0170] lines 3-14), to detect the downstream acoustic pulse train in the first measurement phase (downstream pulse seen as the ultrasonic pulse 276 which travels downstream from transducer 272 to transducer 274 in Fig. 27B, see also [0170] lines 3-14), and to send a signal to the controller (transducers send signal to the controller as seen in [0155] lines 1-18); and a temperature sensor configured to measure temperature of the gases flowing in the gases flow path of the gas measuring chamber (see [0027] lines 1-8 and [0155] lines 1-18); wherein the controller is configured to determine a flow rate of the gases (see [0170] where the pair of transducers are used as the flow rate sensor) by: identifying peaks in the upstream acoustic pulse train and the downstream acoustic pulse train created by the first ultrasonic sensor and the second ultrasonic sensor (see [0170] where flow rate is determined by the acoustic pulses upstream and downstream, where peaks of the pulses are what is received by the transducers); determining the flow rate of the gases based at least in part on the time of flight and the measured temperature (see [0170] where flow rate is determined by the acoustic pulses upstream and downstream, and the speed of sound signal, where [0152] shows the speed of sound is dependent on temperature, and thus the flow rate depends in part on the temperature).
Barker lacks a detailed description of at least one mixing element situated within the gases flow path.
However, Aylsworth teaches a similar ultrasonic measuring device with a mixing element placed in the gases flow path (disc 9a with apertures 11 in Figs. 1-3 which mix the gas as it passes through).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing chamber of Barker to include a mixing element as taught by Aylsworth, as it would reduce the turbulence of the flow which helps create a laminar flow for more accurate measurements (Aylsworth; see Col. 9 lines 58-62).
The modified Barker device lacks a detailed description of wherein an inner diameter of the supplementary gas inlet is substantially smaller than an inner diameter of the air inlet, allowing for a velocity of the supplementary gas entering the gas mixing chamber to be higher than the velocity of air entering the gas mixing chamber.
However, Esnouf teaches a respiratory device for mixing gases, wherein an inner diameter of the supplementary gas inlet is substantially smaller than an inner diameter of the air inlet and offset therefrom (see Fig. 1 and Col. 3 lines 17-20, where an orifice 22 is 1.5 mm and openings 20 are each 5 mm, with orifice 22 offset relative openings 20), allowing for a velocity of the supplementary gas entering the gas mixing chamber to be higher than the velocity of air entering the gas mixing chamber (see Col. 3 lines 6-49 and Fig. 1, where the orifice 22 brings in supplementary oxygen from oxygen supply tube 8, its small bore size causing the oxygen to travel at a higher velocity than the air coming through larger openings 20).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supplemental oxygen inlet of the modified Barker device to be a smaller diameter than the air inlet and offset therefrom as taught by Esnouf, as it would create a mechanical control over the mixed concentration of oxygen based on the size of the inlets, for additional adjustment over the desired ratio (Esnouf; see Col. 3 lines 6-20).
The modified Barker device lacks a detailed description of the determination of the downstream and upstream time of flights being based on an average of their respective direction acoustic pulses.
However, Sugiura teaches a ultrasonic flow sensing device where average propagation time of ultrasonic waves transmitted and received by a pair of sensors are averaged to improve the measuring accuracy (see [0064]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasonic pulses of Barker to be averaged over time as taught by Sugiura, as it would account for differences between individual waves in order to reduce error and improve accuracy of the detected pulses. It is understood that in the modified Barker device, the peak signals of Barker are the averaged values.
Regarding claim 33, the modified Barker device has wherein the gases comprise two gases (Barker; see [0095] lines 5-11, atmospheric air and central gases supply of supplemental gas which combine in the blower assembly).
Regarding claim 34, the modified Barker device has wherein the two gases comprise oxygen and air (Barker; see [0095] lines 5-11, atmospheric air and central gases supply of supplemental gas which combine in the blower assembly).
Regarding claim 36, the modified Barker device has wherein the downstream acoustic pulse train or the upstream acoustic pulse train comprises a plurality of acoustic pulses (Barker; pulses 276 in Fig. 27B, see also [0170] lines 3-14).
Regarding claim 39, the modified Barker device has wherein the gas mixing chamber is a part of a blower assembly of the gases delivery apparatus (Barker; see blower 35 in Fig. 10, such that the respiratory device 10 is a blower assembly, which includes the mixing chamber).
Regarding claim 40, the modified Barker device has wherein the supplementary gas inlet is configured to be offset relative to the air inlet (Esnouf; see Fig. 1 where orifice 22 is offset from openings 20).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Barker in view of Aylsworth in view of Esnouf in view of Sugiura as applied to claim 32 above, and further in view of Huddart (US Pub. 2006/0113690).
Regarding claim 35, the modified Barker device has a gas measurement apparatus, and the controller is further configured to determine the flow rate of the gases based at least in part on the average time of flights, and the measured temperature.
The modified Barker device lacks a detailed description of at least one pressure sensor, the at least one pressure sensor configured to measure pressure of the gases flowing in the gases flow path, wherein the at least one pressure sensor is configured to provide pressure measurement data to the controller, the pressure measurement data being used for a flow rate measurement.
However, Huddart teaches a similar gases measuring system in a humidifier circuit, having at least one pressure sensor (see orifice plate 7 in Figs. 1-2, which is used as a pressure sensor; see [0070]), the at least one pressure sensor configured to measure pressure of the gases flowing in the gases flow path (see [0070] and [0072]), wherein the at least one pressure sensor is configured to provide pressure measurement data to the controller (see Fig. 2 where pressure sensor 7 communicates with the control unit), the pressure measurement data being used for a flow rate measurement (see [0070] and [0072]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the measuring chamber of the modified Barker device to include a pressure sensor that communicates with the controller as taught by Huddart, as it would provide additional measurement of the air in the system, for better control over the gases flowing in the system (Huddart; see [0072]). It is understood that in the modified Barker device, the controller receives data from the ultrasonic sensors, temperature sensors, and pressure sensor, to determine a flow rate.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Barker in view of Aylsworth in view of Esnouf in view of Sugiura as applied to claim 32 above, and further in view of Austerlitz et al. (US Pub. 2007/0245802).
Regarding claim 37, the modified Barker device has the first and second ultrasonic sensors.
The modified Barker device lacks a detailed description of the ultrasonic sensors being excited at their natural resonant frequency.
However, Austerlitz teaches an ultrasonic oxygen sensor that is used at its natural resonant frequency to alleviate a reduction in signal amplitude (see [0045] lines 5-8).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the signal frequency of the transducers of the modified Barker device to operate at their natural resonant frequency as taught by Austerlitz as it is a known method for receiving signals with a higher amplitude as would be known in the art.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Barker in view of Aylsworth in view of Esnouf in view of Sugiura in view of Huddart as applied to claim 35 above, and further in view of Sugawara.
Regarding claim 38, the modified Barker device has a gases measurement apparatus.
The modified Barker device lacks a detailed description of heat transfer features, that increase heat transfer from the gases flowing through the gases measurement apparatus to a housing of the gases measurement apparatus and reduce heat transfer from the gases to the environment, wherein optionally the heat transfer features are tracks formed on a conductive path assembled into the gases measurement apparatus.
However, Sugawara teaches an oxygen concentrator that has conductive heat transfer features (coupler socket 71 and oxygen outlet 100 in Fig. 9, see also [0065] lines 1-8) which are placed around a measurement sensor (temperature sensor 400 in Fig. 9) to promote rapid heat transfer from the gas to the coupler socket to reduce heat transfer from the gas to the environment and increase temperature sensing speed/ heat transfer to the sensor (see [0065] lines 1-8), and which are on a conductive path (conductive path formed by the thermally conductive metallic material of oxygen outlet 100 in [0065]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensor assembly of the modified Barker device to be surrounded by a conductive path for heat transfer coupling as taught by Sugawara as it would be using a known technique in the art of heat transfer to speed up temperature sensing results (Sugawara; see [0065]).
Claims 41, 43, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Barker in view of Aylsworth in view of Esnouf in view of Sugiura.
Regarding claim 41, Barker discloses a method for determining a flow rate of gases (see [0170] where flow rate is determined) flowing through a gas measurement apparatus for a respiratory gases delivery apparatus (the device connected to gases outlet 12 in Fig. 3 that leads to a patient interface), along a gases flow path from a first end of the gas measurement apparatus to a second end of the gas measurement apparatus (see Fig. 27B air flow path axis 208), wherein the gas measurement apparatus is configured to receive gases from a gas mixing chamber (see sensing passage 206 in Fig. 27B where air flow path axis 208 defines two ends of a sensing chamber, which is a representation of the sensor assembly 60 as seen in Fig. 17, which is downstream of the mixing chamber as it measures the mixed gas composition, such as described in [0154]) which is configured to receive gases from a gases source (mixing chamber being the blower unit casing 32 in Fig. 9 which receives gases from air inlet vents 22 and supplemental gas connection inlet 24 in Fig. 6; see also [0098] lines 3-13 and [0102] lines 2-7), the gas mixing chamber comprising a gases flow path from a first end of the gas mixing chamber to a second end of the gas mixing chamber (flow path between the inlet port 37 of the blower unit and the outlet port 38 seen in Fig. 10A and 11; see also [0102] lines 2-7); an air inlet, via which air enters the first end of the gas mixing chamber from a gas source (air inlet vents 22 in Fig. 6); and a supplementary gas inlet, via which another supplementary gas enters the first end of the gas mixing chamber to be mixed with the air in the gases flow path of the gas mixing chamber (see supplemental gas connection inlet 24 in Fig. 6; see also [0098]); and wherein the gas measurement apparatus comprises: a first ultrasonic sensor positioned at the first end (transducer 272 in Fig. 27B), a second ultrasonic sensor positioned at the second end (transducer 274 in Fig. 27B), and a temperature sensor configured to measure temperature of the gases flowing in the gases flow path of the gas measurement apparatus (see [0027] lines 1-8 and [0155] lines 1-18), a downstream direction defined along the gases flow path of the gas measurement apparatus from the first end to the second end (downstream shown in the direction that the arrow of air flow path axis 208 points in Fig. 27B) and an upstream direction defined along the gases flow path of the gas measurement apparatus from the second end to the first end (upstream shown opposite the direction that the arrow of air flow path 208 points in Fig. 27B), the method comprising: transmitting a downstream acoustic pulse train from the first ultrasonic sensor and detecting the downstream acoustic pulse train at the second ultrasonic sensor (downstream pulse seen as the ultrasonic pulse 276 which travels downstream from transducer 272 to transducer 274 in Fig. 27B; see also [0170] lines 3-14); determining a downstream time of flight based at least in part on the downstream acoustic pulse train (see [0155] lines 1-18); transmitting an upstream acoustic pulse train from the second ultrasonic sensor and detecting the upstream acoustic pulse train at the first ultrasonic sensor (upstream pulse seen as the ultrasonic pulse 276 which travels upstream from the transducer 274 to transducer 272 in Fig. 27B, see also [0170] lines 3-14); determining an upstream time of flight based at least in part on the upstream acoustic pulse train (see [0155] lines 1-18); identifying peaks in the upstream acoustic pulse train and the downstream acoustic pulse train (see [0170] where flow rate is determined by the acoustic pulses upstream and downstream, where peaks of the pulses are what is received by the transducers); measuring temperature of the gases flowing in the gases flow path of the gas measurement apparatus using the temperature sensor (see [0027] lines 1-8 and [0155] lines 1-18); and determining a flow rate of the gases based at least in part on the time of flight and the measured temperature (see [0170] where flow rate is determined by the acoustic pulses upstream and downstream, and the speed of sound signal, where [0152] shows the speed of sound is dependent on temperature, and thus the flow rate depends in part on the temperature).
Barker lacks a detailed description of at least one mixing element situated within the gases flow path.
However, Aylsworth teaches a similar ultrasonic measuring device with a mixing element placed in the gases flow path (disc 9a with apertures 11 in Figs. 1-3 which mix the gas as it passes through).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing chamber of Barker to include a mixing element as taught by Aylsworth, as it would reduce the turbulence of the flow which helps create a laminar flow for more accurate measurements (Aylsworth; see Col. 9 lines 58-62).
The modified Barker device lacks a detailed description of wherein an inner diameter of the supplementary gas inlet is substantially smaller than an inner diameter of the air inlet, allowing for a velocity of the supplementary gas entering the gas mixing chamber to be higher than the velocity of air entering the gas mixing chamber.
However, Esnouf teaches a respiratory device for mixing gases, wherein an inner diameter of the supplementary gas inlet is substantially smaller than an inner diameter of the air inlet and offset therefrom (see Fig. 1 and Col. 3 lines 17-20, where an orifice 22 is 1.5 mm and openings 20 are each 5 mm, with orifice 22 offset relative openings 20), allowing for a velocity of the supplementary gas entering the gas mixing chamber to be higher than the velocity of air entering the gas mixing chamber (see Col. 3 lines 6-49 and Fig. 1, where the orifice 22 brings in supplementary oxygen from oxygen supply tube 8, its small bore size causing the oxygen to travel at a higher velocity than the air coming through larger openings 20).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supplemental oxygen inlet of the modified Barker device to be a smaller diameter than the air inlet and offset therefrom as taught by Esnouf, as it would create a mechanical control over the mixed concentration of oxygen based on the size of the inlets, for additional adjustment over the desired ratio (Esnouf; see Col. 3 lines 6-20).
The modified Barker device lacks a detailed description of the determination of the downstream and upstream time of flights being based on an average of their respective direction acoustic pulses.
However, Sugiura teaches a ultrasonic flow sensing device where average propagation time of ultrasonic waves transmitted and received by a pair of sensors are averaged to improve the measuring accuracy (see [0064]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasonic pulses of Barker to be averaged over time as taught by Sugiura, as it would account for differences between individual waves in order to reduce error and improve accuracy of the detected pulses. It is understood that in the modified Barker device, the peak signals of Barker are the averaged values.
Regarding claim 43, the modified Barker device has wherein the method further comprises calculating an oxygen concentration in the gases using a downstream average time of flight and upstream average time of flight respectively for the gases, for air and for 100% oxygen (Barker; see [0150]-[0155] and [0168] where the gas composition is determined based on the ultrasonic sensors and the monitored speed of sound, in order to measure respective ratios of known gases in the composition, thus relying on an average time of flight for the pulses (as taught by Sugiura) and where the mixes gases are air and pure oxygen (Barker; see [0042])).
Regarding claim 45, the modified Barker device has wherein the supplementary gas inlet is configured to be offset relative to the air inlet (Esnouf; see Fig. 1 where orifice 22 is offset from openings 20).
Claims 42 and 44 is rejected under 35 U.S.C. 103 as being unpatentable over Barker in view of Aylsworth in view of Esnouf in view of Sugiura as applied to claims 41 and 43 above, respectively and further in view of Huddart.
Regarding claim 42, the modified Barker device has a gas measurement apparatus, and the controller is further configured to determine the flow rate of the gases based at least in part on the average time of flights, and the measured temperature.
The modified Barker device lacks a detailed description of at least one pressure sensor, the at least one pressure sensor configured to measure pressure of the gases flowing in the gases flow path, wherein the at least one pressure sensor is configured to provide pressure measurement data to the controller, the pressure measurement data being used for a flow rate measurement.
However, Huddart teaches a similar gases measuring system in a humidifier circuit, having at least one pressure sensor (see orifice plate 7 in Figs. 1-2, which is used as a pressure sensor; see [0070]), the at least one pressure sensor configured to measure pressure of the gases flowing in the gases flow path (see [0070] and [0072]), wherein the at least one pressure sensor is configured to provide pressure measurement data to the controller (see Fig. 2 where pressure sensor 7 communicates with the control unit), the pressure measurement data being used for a flow rate measurement (see [0070] and [0072]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the measuring chamber of the modified Barker device to include a pressure sensor that communicates with the controller as taught by Huddart, as it would provide additional measurement of the air in the system, for better control over the gases flowing in the system (Huddart; see [0072]). It is understood that in the modified Barker device, the controller receives data from the ultrasonic sensors, temperature sensors, and pressure sensor, to determine a flow rate.
Regarding claim 44, the modified Barker device as modified in claim 42 has wherein the method further comprises calculating an oxygen concentration in the gases using a downstream average time of flight and upstream average time of flight respectively for the gases, for air and for 100% oxygen (Barker; see [0150]-[0155] and [0168] where the gas composition is determined based on the ultrasonic sensors and the monitored speed of sound, in order to measure respective ratios of known gases in the composition, thus relying on an average time of flight for the pulses (as taught by Sugiura) and where the mixes gases are air and pure oxygen (Barker; see [0042])), as well as the measured pressure (Huddart; see [0070] and [0072]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Muz et al. (US Pub. 2004/0097822) and Van Kesteren (US Pub. 2012/0271188) are cited to show measurement devices for the fractions of mixed air in a respiratory setting.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Thurs 9:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785