DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Pending
Claims 1-20 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Species A1 and Species B1, Claims 1-2, 4-5, 10-12, 14-15, and 20, in the reply filed on 03/18/2026 is acknowledged.
Claims 3, 6-9, 13, and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/18/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-2, 4-5, 10-12, 14-15, and 20 are hereby under examination.
Claim Objections
Claim 11 objected to because of the following informalities:
In claim 11, “a memory stored with instructions and a processor” (line 2), should read -a processor with a memory stored with instructions- (Examiner's Note: Or a similar revision. The current presentation of the claim is in a manner such that it appears the memory itself is stored with both instructions and a processor).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “wherein the gas flow is delivered from the side of the monitoring device to a first user
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: a gas flow source. This element is necessary as part of the monitoring device as it is needed for “wherein the gas flow is delivered from the side of the monitoring device to a first user”. The applicant’s specification indicates the flow source as being present in the monitoring device “The monitoring device 101 can include a flow source 105 and at least one sensing device 106” (Par. 36 of applicant’s spec.) as well as Fig. 1 and Fig. 2 of the provided drawings (Gas flow source 105 schematically present in monitoring device 101). As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as there being a gas flow source present within the monitoring device.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: a gas flow source. This element is necessary as part of the monitoring device as it is needed for “wherein the gas flow is delivered from the side of the monitoring device to a first user”. The applicant’s specification indicates the flow source as being present in the monitoring device “The monitoring device 101 can include a flow source 105 and at least one sensing device 106” (Par. 36 of applicant’s spec.) as well as Fig. 1 and Fig. 2 of the provided drawings (Gas flow source 105 schematically present in monitoring device 101). As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as there being a gas flow source present within the monitoring device.
Claims 2, 4-5, and 10 are dependent on claim 1, and as such are also rejected.
Claims 12, 14-15, and 20 are dependent on claim 11, and as such are also rejected.
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 1-2, 4-5, 10-12, 14-15, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards a judicial exception without significantly more. These claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception or that are sufficient to amount to significantly more than the judicial exception.
Step 1 of the subject matter eligibility test
Claim 1 and 11 are directed towards a method and device, respectively, which describes one of the four statutory categories of patentable subject matter.
Step 2A of the subject matter eligibility test
Prong 1: Claims 1 and 11 recite the abstract idea of a mental process as follows: “obtaining sensing data measured…” “… the sensing data characterizes a physical parameter of a gas flow”, “determining a first physiological parameter of the first user based on the sensing data”.
The obtaining sensing data measured, the sensing data characterizes a physical parameter of a gas flow, and determining a first physiological parameter of the first user based on the sensing data can be practically performed by the human mind, with the aid of a pen and paper, but for performance on a generic processor, in a computer environment, or merely using the computer as a tool to perform the steps.
A person of ordinary skill in the art could reasonably obtain sensing data based on being handed a piece of paper with sensing data. A person of ordinary skill in the art could reasonably determine a first physiological parameter based on being handed a piece of paper with sensing data with a generic computer or with a pen and paper. There is currently nothing to suggest an undue level of complexity in the obtaining or determining steps. Therefore, a person would be able to practically be able to perform the obtaining and determining steps mentally or with the aid of pen and paper.
Prong Two: Claims 1 and 11 do not recite additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., a memory stored with instructions and a processor (Claim 11)) and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “at least one sensing device is provided within the monitoring device”, “gas flow is delivered from the side of the monitoring device to a first user”, a monitoring device).
For claims 1 and 11. The additional elements merely serve to gather data to be used by the abstract idea. The memory and processor are merely used as a pre-solution step of necessary data gathering to be used by the abstract idea. The sensing device within the monitoring device and gas flow as additional types data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing that is performed remains in the abstract realm, i.e. the gathered data is not used for a treatment or meaningful purpose. Additionally, there is no overall improvement to existing technology present. The mental process merely functions on generic computer elements that do not change the functionality of the device itself. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test for Claims 1 and 11.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
a sensing device and gas flow generator inside of a monitoring device as disclosed by Robinson (US Pub. No. 20130032149) hereinafter Robinson “Thus, conventional ventilators, particularly controlled mechanical ventilation (CMV) systems, include inputs that allow operating clinicians to select and use several modes of ventilation, either individually and/or in various combinations, using different ventilator setting controls. These mechanical ventilators have become increasingly sophisticated and complex, due in part to enhanced understandings of lung pathophysiology. Accordingly, many conventional ventilators are microprocessor-based and equipped with sensors that monitor patient pressure, flow rates, and/or volumes of gases, and then drive automated responses in response…” (Par. 3) and Cewers (US Pub. No. 20080121232) hereinafter Cewers “The illustrated conventional ventilator includes a first flow sensor 44 adapted to measure a flow of the first gas and a second flow sensor 46 adapted to measure the flow of the second gas. A pressure sensor 48 measures the pressure of the gas in conduit 42 delivered to the patient via the patient circuit. In addition, and oxygen concentration monitor 49 measure the concentration of oxygen in the gas delivered to the patient. The outputs of flow sensors 44 and 46, pressure sensor 48, and oxygen monitor 49 are provided to a controller 50. The controller typically uses this information, at least in some ventilation modes, to control the flow, volume, and/or pressure of gas delivered to the patient, i.e., to control valves 34 and 30 and/or the actuation of the gas sources 30 and/or 32 so that the desired flow, pressure, or volume of gas is administered to the patient having the desired oxygen concentration.” (Par. 6).
A memory with instructions and a processor as disclosed by Chen (US Pub. No. 20100298663) hereinafter Chen “Processor 304 is used for standard computational tasks well known in the art, such as retrieving instructions from a memory, processing the instructions, receiving data from memory, performing calculations and analyses on the data in accordance with the previously indicated instructions, storing the results of calculations back to memory, programming other internal devices within ICD programmer 254, and transmitting data to and receiving data from various external devices such as ICD 100.” (Par. 63) and Wang (US Pub. No. 20130199299) hereinafter Wang “will be understood by those of skill in the art that information and signals may be represented using any of a variety of different technologies and techniques (e.g., data, instructions, commands, information, signals, bits, symbols, and chips may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof)…” (Par. 45).
are all well-understood, routine, and conventional.
Claims 2, 4-5, 10, 12, 14-15, and 20 do not include additional elements, alone or in combination that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) as all of the elements are directed to the further describing of the abstract idea, pre-solution activities, and computer implementation.
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely further describe the abstract idea:
determining the first physiological parameter of the first user based on peaks of the sensing data or changing rates derived from the sensing data in a time domain or a maximum frequency component of the sensing data in a frequency domain (Claims 4 and 14),
applying Fourier transform to the sensing data to obtain the maximum frequency component of the sensing data (Claims 5 and 15),
determining a frequency corresponding to the maximum frequency component as the first physiological parameter (Claims 5 and 15),
wherein the first physiological parameter is a breathing rate (Claims 10 and 20).
Further describe the pre-solution activity (or structure used for such activity):
A flow sensor (Claims 2 and 12)
A processor with a memory and instructions (Claims 14 and 15)
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example,
A flow sensor as indicated by Robinson and Cewers above,
A processor with a memory and instructions as indicated by Chen and Wang above.
are all well-understood, routine, and conventional.
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, data gathering, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements improves the functioning of a mobile device, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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.
The claims are generally directed towards a method comprising obtaining sensing data from a sensing device, wherein the sensing data characterizes a parameter of a gas flow, and determining a first physiological parameter of the user based on the sensing data.
Claim(s) 1-2, 4-5, 10-12, 14-15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams (US Pub. No. 20210113796) hereinafter Williams, and further in view of Gulley (US Pub. No. 20240082521) hereinafter Gulley.
Regarding claim 1, Williams discloses A method, wherein the method is applied to a monitoring device (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein...”) (abstract (systems and methods)), and the method comprises:
obtaining sensing data measured by at least one sensing device (Par. 350, “A sensor output 2202 from a sensor configured for measuring a gases flow parameter can be fed into a signal processing algorithm 2204. The sensor can be located in, at least partially in, or outside of the gases flow path…”) (Par. 347, “…The flow rate can be at least partially measured by an acoustic flow sensor and/or a thermistor flow sensor, which are described above. The thermistor flow sensor can have lower noise than the acoustic flow sensor while having a high enough sampling rate and being fast enough to produce flow rate readings for the processes described herein”) (Fig. 22a, first sensor output -2202); and
determining a first physiological parameter of the first user based on the sensing data (Fig. 22A, respiratory rate- 2210)(Par. 366, “Returning to FIG. 22A, during the frequency analysis using the signal analysis algorithm 2208, the magnitudes of various frequencies are calculated from the data, which represents the strength of each frequency signal in the data. The dominant frequency, or the frequency that results in the largest magnitude, as determined by the algorithm 2208 is the respiratory rate 2210.”).
Williams fails to explicitly disclose wherein the at least one sensing device is provided within the monitoring device (Examiner's Note: Williams indicates that the above indicated method is usable with the different disclosed systems (Williams (Par. 341)), but fails to explicitly state that the sensing device is within the monitoring device).
However, Williams highly suggests wherein the at least one sensing device is provided within the monitoring device (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein…”) (Par. 345, “… The gases flow parameter can be measured in a flow passage after the outlet of the flow generator. Measuring the gases flow parameter inside the respiratory device, as opposed to in the patient interface, can allow the sensor to be closer to the controller and/or avoid the need to replace the sensor with the patient interface…”) (Par. 293, “The system 10 can use ultrasonic transducer(s), flow sensor(s) such as a thermistor flow sensor, pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors, in communication with the controller 13, to monitor characteristics of the gases flow and/or operate the system 10 in a manner that provides suitable therapy. The gases flow characteristics can include gases concentration, flow rate, pressure, temperature, humidity, or others…”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Williams with that of Williams to include wherein the at least one sensing device is provided within the monitoring device as varying sensor locations is a known variation (Williams (Par. 345)) and it would have yielded the predictable result of preventing a need for replacement of the sensor with the patient interface (Williams (Par. 345)).
Modified Williams fails to explicitly disclose the sensing data characterizes a physical parameter of a gas flow at a side of the monitoring device, wherein the gas flow is delivered from the side of the monitoring device to a first user.
However, Williams does disclose the sensing data characterizes a physical parameter at a side of the monitoring device (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein…”) (Par. 345, “… The gases flow parameter can be measured in a flow passage after the outlet of the flow generator. Measuring the gases flow parameter inside the respiratory device, as opposed to in the patient interface, can allow the sensor to be closer to the controller and/or avoid the need to replace the sensor with the patient interface…”) (Par. 350, “A sensor output 2202 from a sensor configured for measuring a gases flow parameter can be fed into a signal processing algorithm 2204. The sensor can be located in, at least partially in, or outside of the gases flow path…”) (Par. 347, “…The flow rate can be at least partially measured by an acoustic flow sensor and/or a thermistor flow sensor, which are described above. The thermistor flow sensor can have lower noise than the acoustic flow sensor while having a high enough sampling rate and being fast enough to produce flow rate readings for the processes described herein”) (Fig. 22a, first sensor output -2202) (Par. 293, “The system 10 can use ultrasonic transducer(s), flow sensor(s) such as a thermistor flow sensor, pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors, in communication with the controller 13, to monitor characteristics of the gases flow and/or operate the system 10 in a manner that provides suitable therapy. The gases flow characteristics can include gases concentration, flow rate, pressure, temperature, humidity, or others…”), wherein the gas flow is delivered from the side of the monitoring device to a first user (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein…”) (Par. 345, “The gases flow parameter used for determining the patient's respiratory rate can be calculated from any of the sensor signals described above. The gases flow parameter can be measured at any point along the gases flow path, anywhere from the entrance to the flow generator up to the patient interface.”)(Fig. 1, (flow generator – 11)) (Par. 290, “operating the flow generator 11 to create a flow of gases for delivery to a patient”).
Gulley teaches the sensing data characterizes a physical parameter of a gas flow at a side of the monitoring device (Par. 196, “Referring to FIG. 22, a summary flow diagram of an embodiment of the breathing parameter process or algorithm 700 in a first configuration is shown. The algorithm 700 operates or executes during operation of the respiratory apparatus 10, i.e. when it is delivering high flow therapy to a patient.”) (Par. 197, “At step 701, the algorithm 700 receives or retrieves flow parameter data such as, but not limited to, a ‘raw’ flow rate signal or flow rate data e.g. from one or more flow rate sensors of the respiratory apparatus, representing or indicative of the flow rate of the flow of gases or gases stream delivered to the patient.”)(Fig. 1, (flow source – 50))(Par. 123, “The flow source could be an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gas and/or a high flow apparatus with a flow generator 50B. FIG. 1 shows a flow source 50 with a flow generator 50B, with an optional air inlet 50C and optional connection to an O2 source (such as tank or O2 generator)…” “…The flow source provides a (preferably high) flow of gas that can be delivered to a patient via a delivery conduit 16, and patient interface 51.”)(Par. 125, “One or more sensors 53A, 53B, 53C, 53D such as flow, oxygen fraction, pressure, humidity, temperature or other sensors can be placed throughout the system and/or at, on or near the patient 56.”), wherein the gas flow is delivered from the side of the monitoring device to a first user (Par. 196, “Referring to FIG. 22, a summary flow diagram of an embodiment of the breathing parameter process or algorithm 700 in a first configuration is shown. The algorithm 700 operates or executes during operation of the respiratory apparatus 10, i.e. when it is delivering high flow therapy to a patient.”) (Par. 197, “At step 701, the algorithm 700 receives or retrieves flow parameter data such as, but not limited to, a ‘raw’ flow rate signal or flow rate data e.g. from one or more flow rate sensors of the respiratory apparatus, representing or indicative of the flow rate of the flow of gases or gases stream delivered to the patient.”) (Fig. 1, (flow source – 50))(Par. 123, “The flow source could be an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gas and/or a high flow apparatus with a flow generator 50B. FIG. 1 shows a flow source 50 with a flow generator 50B, with an optional air inlet 50C and optional connection to an O2 source (such as tank or O2 generator)…” “…The flow source provides a (preferably high) flow of gas that can be delivered to a patient via a delivery conduit 16, and patient interface 51.”)(Par. 125, “One or more sensors 53A, 53B, 53C, 53D such as flow, oxygen fraction, pressure, humidity, temperature or other sensors can be placed throughout the system and/or at, on or near the patient 56.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Williams with that of Gulley to include the sensing data characterizes a physical parameter of a gas flow at a side of the monitoring device, wherein the gas flow is delivered from the side of the monitoring device to a first user through the combination of references as the use of differing flow parameters is known (Gulley (Par. 197)) and it would have yielded the same or similar result of allowing for the calculation of respiratory parameters (Gulley (Par. 200)).
Regarding claim 11, Williams discloses A monitoring device (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein...”)(Abstract (device)), comprising:
obtaining sensing data measured by at least one sensing device (Par. 350, “A sensor output 2202 from a sensor configured for measuring a gases flow parameter can be fed into a signal processing algorithm 2204. The sensor can be located in, at least partially in, or outside of the gases flow path…”) (Par. 347, “…The flow rate can be at least partially measured by an acoustic flow sensor and/or a thermistor flow sensor, which are described above. The thermistor flow sensor can have lower noise than the acoustic flow sensor while having a high enough sampling rate and being fast enough to produce flow rate readings for the processes described herein”) (Fig. 22a, first sensor output -2202); and
determining a first physiological parameter of the first user based on the sensing data (Fig. 22A, respiratory rate- 2210)(Par. 366, “Returning to FIG. 22A, during the frequency analysis using the signal analysis algorithm 2208, the magnitudes of various frequencies are calculated from the data, which represents the strength of each frequency signal in the data. The dominant frequency, or the frequency that results in the largest magnitude, as determined by the algorithm 2208 is the respiratory rate 2210.”).
Williams fails to explicitly disclose a memory stored with instructions and a processor, wherein the processor is configured to call and run the instructions stored in the memory to execute operations (Examiner's Note: Williams fails to explicitly state a memory stored with instructions and a processor).
However, Williams highly suggests a memory stored with instructions and a processor (Par. 350, “The controller or processor(s) can run the signal processing algorithm 2204 to process the signal output 2202 and measure the gases flow parameter. A gases flow parameter signal 2206 can be fed into a signal analysis algorithm 2008.”), wherein the processor is configured to call and run the instructions stored in the memory to execute operations (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein…”)(Par. 346, “the controller or one or more processors can obtain a signal indicative of the flow rate from the flow rate sensor.”)(Par. 323, “FIG. 19B illustrates a block diagram of an embodiment of a controller 600. The controller 600 can include programming instructions for detection of input conditions and control of output conditions. The programming instructions can be stored in the memory 624 of the controller 600. The programming instructions can correspond to the methods, processes and functions described herein. The programming instructions can be executed by one or more hardware processors 622 of the controller 600. The programming instructions can be implemented in C, C++, JAVA, or any other suitable programming languages. Some or all of the portions of the programming instructions can be implemented in application specific circuitry 628 such as ASICs and FPGAs.”) (Par. 290, “controller 13 can include one or more hardware and/or software processors and can be configured or programmed to control the components of the apparatus”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Williams with that of Williams to include a memory stored with instructions and a processor, wherein the processor is configured to call and run the instructions stored in the memory to execute operations through the combination of embodiments as it would have yielded the predictable result of providing the exact computational structures needed to execute the method.
Modified Williams fails to explicitly disclose wherein the at least one sensing device is provided within the monitoring device (Examiner's Note: Williams indicates that the above indicated method is usable with the different disclosed systems (Williams (Par. 341)), but fails to explicitly state that the sensing device is within the monitoring device).
However, Williams highly suggests wherein the at least one sensing device is provided within the monitoring device (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein…”) (Par. 345, “… The gases flow parameter can be measured in a flow passage after the outlet of the flow generator. Measuring the gases flow parameter inside the respiratory device, as opposed to in the patient interface, can allow the sensor to be closer to the controller and/or avoid the need to replace the sensor with the patient interface…”) (Par. 293, “The system 10 can use ultrasonic transducer(s), flow sensor(s) such as a thermistor flow sensor, pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors, in communication with the controller 13, to monitor characteristics of the gases flow and/or operate the system 10 in a manner that provides suitable therapy. The gases flow characteristics can include gases concentration, flow rate, pressure, temperature, humidity, or others…”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Williams with that of Williams to include wherein the at least one sensing device is provided within the monitoring device as varying sensor locations is a known variation (Williams (Par. 345)) and it would have yielded the predictable result of preventing a need for replacement of the sensor with the patient interface (Williams (Par. 345)).
Modified Williams fails to explicitly disclose the sensing data characterizes a physical parameter of a gas flow at a side of the monitoring device, wherein the gas flow is delivered from the side of the monitoring device to a first user.
However, Williams does disclose the sensing data characterizes a physical parameter at a side of the monitoring device (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein…”) (Par. 345, “… The gases flow parameter can be measured in a flow passage after the outlet of the flow generator. Measuring the gases flow parameter inside the respiratory device, as opposed to in the patient interface, can allow the sensor to be closer to the controller and/or avoid the need to replace the sensor with the patient interface…”) (Par. 350, “A sensor output 2202 from a sensor configured for measuring a gases flow parameter can be fed into a signal processing algorithm 2204. The sensor can be located in, at least partially in, or outside of the gases flow path…”) (Par. 347, “…The flow rate can be at least partially measured by an acoustic flow sensor and/or a thermistor flow sensor, which are described above. The thermistor flow sensor can have lower noise than the acoustic flow sensor while having a high enough sampling rate and being fast enough to produce flow rate readings for the processes described herein”) (Fig. 22a, first sensor output -2202) (Par. 293, “The system 10 can use ultrasonic transducer(s), flow sensor(s) such as a thermistor flow sensor, pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors, in communication with the controller 13, to monitor characteristics of the gases flow and/or operate the system 10 in a manner that provides suitable therapy. The gases flow characteristics can include gases concentration, flow rate, pressure, temperature, humidity, or others…”), wherein the gas flow is delivered from the side of the monitoring device to a first user (Par. 341, “The present disclosure discloses processes for determining respiratory rates of a patient using a respiratory system, such as the ones described herein…”) (Par. 345, “The gases flow parameter used for determining the patient's respiratory rate can be calculated from any of the sensor signals described above. The gases flow parameter can be measured at any point along the gases flow path, anywhere from the entrance to the flow generator up to the patient interface.”)(Fig. 1, (flow generator – 11)) (Par. 290, “operating the flow generator 11 to create a flow of gases for delivery to a patient”).
Gulley teaches the sensing data characterizes a physical parameter of a gas flow at a side of the monitoring device (Par. 196, “Referring to FIG. 22, a summary flow diagram of an embodiment of the breathing parameter process or algorithm 700 in a first configuration is shown. The algorithm 700 operates or executes during operation of the respiratory apparatus 10, i.e. when it is delivering high flow therapy to a patient.”) (Par. 197, “At step 701, the algorithm 700 receives or retrieves flow parameter data such as, but not limited to, a ‘raw’ flow rate signal or flow rate data e.g. from one or more flow rate sensors of the respiratory apparatus, representing or indicative of the flow rate of the flow of gases or gases stream delivered to the patient.”)(Fig. 1, (flow source – 50))(Par. 123, “The flow source could be an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gas and/or a high flow apparatus with a flow generator 50B. FIG. 1 shows a flow source 50 with a flow generator 50B, with an optional air inlet 50C and optional connection to an O2 source (such as tank or O2 generator)…” “…The flow source provides a (preferably high) flow of gas that can be delivered to a patient via a delivery conduit 16, and patient interface 51.”)(Par. 125, “One or more sensors 53A, 53B, 53C, 53D such as flow, oxygen fraction, pressure, humidity, temperature or other sensors can be placed throughout the system and/or at, on or near the patient 56.”), wherein the gas flow is delivered from the side of the monitoring device to a first user (Par. 196, “Referring to FIG. 22, a summary flow diagram of an embodiment of the breathing parameter process or algorithm 700 in a first configuration is shown. The algorithm 700 operates or executes during operation of the respiratory apparatus 10, i.e. when it is delivering high flow therapy to a patient.”) (Par. 197, “At step 701, the algorithm 700 receives or retrieves flow parameter data such as, but not limited to, a ‘raw’ flow rate signal or flow rate data e.g. from one or more flow rate sensors of the respiratory apparatus, representing or indicative of the flow rate of the flow of gases or gases stream delivered to the patient.”) (Fig. 1, (flow source – 50))(Par. 123, “The flow source could be an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gas and/or a high flow apparatus with a flow generator 50B. FIG. 1 shows a flow source 50 with a flow generator 50B, with an optional air inlet 50C and optional connection to an O2 source (such as tank or O2 generator)…” “…The flow source provides a (preferably high) flow of gas that can be delivered to a patient via a delivery conduit 16, and patient interface 51.”)(Par. 125, “One or more sensors 53A, 53B, 53C, 53D such as flow, oxygen fraction, pressure, humidity, temperature or other sensors can be placed throughout the system and/or at, on or near the patient 56.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Williams with that of Gulley to include the sensing data characterizes a physical parameter of a gas flow at a side of the monitoring device, wherein the gas flow is delivered from the side of the monitoring device to a first user through the combination of references as the use of differing flow parameters is known (Gulley (Par. 197)) and it would have yielded the same or similar result of allowing for the calculation of respiratory parameters (Gulley (Par. 200)).
Regarding claim 2, modified Williams further discloses wherein the at least one sensing device comprises at least one flow sensor (Williams ((Par. 350, “A sensor output 2202 from a sensor configured for measuring a gases flow parameter can be fed into a signal processing algorithm 2204. The sensor can be located in, at least partially in, or outside of the gases flow path…”) (Par. 347, “…The flow rate can be at least partially measured by an acoustic flow sensor and/or a thermistor flow sensor, which are described above. The thermistor flow sensor can have lower noise than the acoustic flow sensor while having a high enough sampling rate and being fast enough to produce flow rate readings for the processes described herein”) (Fig. 22a, first sensor output -2202)).
Modified Williams fails to explicitly disclose the physical parameter comprises a flow rate of the gas flow at the side of the monitoring device.
However, Williams does disclose the physical parameter comprises a flow rate at the side of the monitoring device (Williams (Par. 350, “A sensor output 2202 from a sensor configured for measuring a gases flow parameter can be fed into a signal processing algorithm 2204. The sensor can be located in, at least partially in, or outside of the gases flow path…”) (Par. 347, “…The flow rate can be at least partially measured by an acoustic flow sensor and/or a thermistor flow sensor, which are described above. The thermistor flow sensor can have lower noise than the acoustic flow sensor while having a high enough sampling rate and being fast enough to produce flow rate readings for the processes described herein”) (Fig. 22a, first sensor output -2202) (Par. 293, “The system 10 can use ultrasonic transducer(s), flow sensor(s) such as a thermistor flow sensor, pressure sensor(s), temperature sensor(s), humidity sensor(s), or other sensors, in communication with the controller 13, to monitor characteristics of the gases flow and/or operate the system 10 in a manner that provides suitable therapy. The gases flow characteristics can include gases concentration, flow rate, pressure, temperature, humidity, or others…”)).
Gulley further teaches the physical parameter comprises a flow rate of the gas flow at the side of the monitoring device (Gulley (Par. 196, “Referring to FIG. 22, a summary flow diagram of an embodiment of the breathing parameter process or algorithm 700 in a first configuration is shown. The algorithm 700 operates or executes during operation of the respiratory apparatus 10, i.e. when it is delivering high flow therapy to a patient.”) (Par. 197, “At step 701, the algorithm 700 receives or retrieves flow parameter data such as, but not limited to, a ‘raw’ flow rate signal or flow rate data e.g. from one or more flow rate sensors of the respiratory apparatus, representing or indicative of the flow rate of the flow of gases or gases stream delivered to the patient.”)(Par. 123, “The flow source could be an in-wall supply of oxygen, a tank of oxygen 50A, a tank of other gas and/or a high flow apparatus with a flow generator 50B. FIG. 1 shows a flow source 50 with a flow generator 50B, with an optional air inlet 50C and optional connection to an O2 source (such as tank or O2 generator)…” “…The flow source provides a (preferably high) flow of gas that can be delivered to a patient via a delivery conduit 16, and patient interface 51.”)(Par. 125, “One or more sensors 53A, 53B, 53C, 53D such as flow, oxygen fraction, pressure, humidity, temperature or other sensors can be placed throughout the system and/or at, on or near the patient 56.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Williams and Gulley with that of Gulley to include the physical parameter comprises a flow rate of the gas flow at the side of the monitoring device for the reasoning as indicated in claim 1 above.
Regarding claim 12, modified Williams discloses the method of claim 2, which comprises the device of claim 12. As the claims are similar, claim 12 is rejected in the same manner as claim 2.
Regarding claim 4, modified Williams further discloses wherein determining the first physiological parameter of the first user based on the sensing data comprises (As indicated in claim 1 above):
determining the first physiological parameter of the first user based on peaks of the sensing data or changing rates derived from the sensing data in a time domain or a maximum frequency component of the sensing data in a frequency domain (Williams (Par. 350, “A gases flow parameter signal 2206 can be fed into a signal analysis algorithm 2008.”)(Par. 351, “The signal analysis algorithm 2008 can comprise a frequency analysis for a discrete time series. The frequency analysis can include the discrete Fourier transform (DFT)…”) (Par. 357, “The maximum frequency determines what frequencies are determined by the Goertzel algorithm. The patient's respiratory rate can fall within a defined range of possible frequencies…”) (Par. 366, “Returning to FIG. 22A, during the frequency analysis using the signal analysis algorithm 2208, the magnitudes of various frequencies are calculated from the data, which represents the strength of each frequency signal in the data. The dominant frequency, or the frequency that results in the largest magnitude, as determined by the algorithm 2208 is the respiratory rate 2210.”) (Fig. 22A, respiratory rate- 2210)).
Regarding claim 14, modified Williams discloses the method of claim 4, which comprises the device of claim 14. As the claims are similar, claim 14 is rejected in the same manner as claim 4.
Regarding claim 5, modified Williams further discloses wherein determining the first physiological parameter of the first user based on the maximum frequency component of the sensing data in the frequency domain comprises (as indicated in claim 4 above):
applying Fourier transform to the sensing data to obtain the maximum frequency component of the sensing data (Williams (Par. 350, “A gases flow parameter signal 2206 can be fed into a signal analysis algorithm 2008.”)(Par. 351, “The signal analysis algorithm 2008 can comprise a frequency analysis for a discrete time series. The frequency analysis can include the discrete Fourier transform (DFT)…”) (Par. 355, “A dominant frequency as determined by the signal analysis algorithm 2208 can be the respiratory rate from the output series. The dominant frequency is the frequency that results in the largest magnitude. As the patient breathing can result in the largest variation in the gases flow parameter than other factors that can affect the gases flow parameter, the dominant frequency can be assumed to be the respiratory rate “)(Par. 357, “The maximum frequency determines what frequencies are determined by the Goertzel algorithm. The patient's respiratory rate can fall within a defined range of possible frequencies…”)).; and
determining a frequency corresponding to the maximum frequency component as the first physiological parameter (Williams (Par. 350, “A gases flow parameter signal 2206 can be fed into a signal analysis algorithm 2008.”)(Par. 351, “The signal analysis algorithm 2008 can comprise a frequency analysis for a discrete time series. The frequency analysis can include the discrete Fourier transform (DFT)…”) (Par. 357, “The maximum frequency determines what frequencies are determined by the Goertzel algorithm. The patient's respiratory rate can fall within a defined range of possible frequencies…”) (Par. 366, “Returning to FIG. 22A, during the frequency analysis using the signal analysis algorithm 2208, the magnitudes of various frequencies are calculated from the data, which represents the strength of each frequency signal in the data. The dominant frequency, or the frequency that results in the largest magnitude, as determined by the algorithm 2208 is the respiratory rate 2210.”) (Fig. 22A, respiratory rate- 2210)).
Regarding claim 15, modified Williams discloses the method of claim 5, which comprises the device of claim 15. As the claims are similar, claim 15 is rejected in the same manner as claim 5.
Regarding claim 10, modified Williams further discloses wherein the first physiological parameter is a breathing rate (Williams (Par. 350, “A gases flow parameter signal 2206 can be fed into a signal analysis algorithm 2008.”)(Par. 351, “The signal analysis algorithm 2008 can comprise a frequency analysis for a discrete time series. The frequency analysis can include the discrete Fourier transform (DFT)…”) (Par. 357, “The maximum frequency determines what frequencies are determined by the Goertzel algorithm. The patient's respiratory rate can fall within a defined range of possible frequencies…”) (Par. 366, “Returning to FIG. 22A, during the frequency analysis using the signal analysis algorithm 2208, the magnitudes of various frequencies are calculated from the data, which represents the strength of each frequency signal in the data. The dominant frequency, or the frequency that results in the largest magnitude, as determined by the algorithm 2208 is the respiratory rate 2210.”) (Fig. 22A, respiratory rate- 2210)).
Regarding claim 20, modified Williams discloses the method of claim 10, which comprises the device of claim 20. As the claims are similar, claim 20 is rejected in the same manner as claim 10.
Conclusion
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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