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 .
Response to Arguments
This office action is responsive to Request for Reconsideration files on 03/30/2026. As directed by the amendment: claims 1 – 23 are pending, no claims were cancelled, no claims have been added & 1, 4, 6 – 10, 16 – 18 & 22 have been amended.
Applicant’s arguments, see Page 10, filed 03/30/2026, with respect to the rejection(s) of claim 7 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amendments that were not considered prior being considered and finding new reference that reads on the limitations.
Applicant’s arguments, see Page 11, filed 03/30/2026, with respect to the rejection(s) of claim 1 – 6 & 8 – 13 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amendments that were not considered prior being considered and finding new reference that reads on the limitations.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. This is in reference to all the arguments of the combination of references presented in the 35 U.S.C. 103 rejections of claims 1 – 6 & 8 – 23.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 – 5 & 7 are rejected under 35 U.S.C. 103 as being unpatentable by Orr et al. (US 20160166797 A1) in view of Barker et al. (WO 2011136664 A1), Sanders et al. (US 5148802 A) & Lynn et al. (US 2008/0200775 A1).
Regarding claim 1, A system for determining total flow output from a Venturi flow generator, the system comprising:
a patient interface 17 (Paragraph 0103)
the patient interface 17 in communication with a patient interface pressure sensor 40 to measure a patient interface pressure at the patient interface 17 (Paragraph 0092).
Orr does not disclose the flow generator for connection to the patient interface.
Sanders discloses the flow generator 14 for connection to the patient interface 22. (Column 4, last paragraph – Column 5, First paragraph)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Orr to include a flow generator for connection to the patient interface as the flow generator is able to receive breathing gas from any suitable source such as a pressurized bottle or the ambient atmosphere and is able to pass said breathing gas through a delivery conduit to a breathing appliance such as a mask or any suitable known construction which is worn by a patient. (Column 4, last paragraph – Column 5, First paragraph)
Sanders does not disclose a venturi flow generator.
However, Barker discloses a venturi adapter. (Page 8, lines 24 – 29)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include a venturi adapter as is able to provide oxygen by having the central source to be oxygen or by blending atmospheric air with incoming oxygen from the central source being a venturi. (Page 8, lines 24 – 29)
Modified Orr discloses an oxygen input line (Paragraph 0088 discloses a tubing for connection) for conveying oxygen from a source of oxygen 22 to the flow generator (Barker) (Paragraph 0088),
Modified Orr does not expressly disclose the oxygen input line comprising an oxygen flow valve for controlling a flow of oxygen from an oxygen source to the venturi flow generator.
Lynn discloses the oxygen input line comprising an oxygen flow valve for controlling a flow of oxygen from an oxygen source to the flow generator. (Paragraph 0019)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include disclose the oxygen input line comprising an oxygen flow valve for controlling a flow of oxygen from an oxygen source to the flow generator. This would occur by having the flow generator be between the oxygen force and the valve as it would allow the valve to control the oxygen source to deliver a specific pattern and/or rate of oxygen to flow through the nasal cannula. (Paragraph 0027) This would also allow auto optimization of gas delivery for application during routine use. (Paragraph 0037)
Modified Orr discloses an oxygen input line sensor 30 for determining oxygen input line flow (Paragraph 0090); and
wherein the patient interface pressure sensor 40 and the oxygen input line sensor 30 are in communication with a controller 35 (Paragraph 0091), the controller 35 programmed to receive the patient interface pressure and the oxygen input line flow and determine the total flow output from the flow generator 14 based on the patient interface pressure at the patient interface and the oxygen input line flow (Paragraph 0099 & 0106 - 0107).
Regarding claim 2, Modified Orr discloses the system as claimed in claim 1.
Modified Orr discloses wherein the oxygen input line sensor 30 comprises a pressure sensor (Paragraph 0090 discloses the sensor may be a simple pressure system) for measuring oxygen input line pressure and wherein the oxygen input line flow is determined by the oxygen input line pressure. (Paragraph 0090)
Regarding claim 3, Modified Orr discloses the system as claimed in claim 1.
Modified Orr discloses wherein the oxygen input line sensor 30 comprises an oxygen flowmeter for measuring an oxygen input line flow. (Paragraph 0090 / Note: the examiner considers Orr teaches the device that measures the flow rate of gas using the pressure)
Regarding claim 4, Modified Orr discloses the system as claimed in claim 1.
Modified Orr discloses wherein the controller 35 is programmed to determine the total flow output from the Venturi flow generator (Baker) based on the patient interface pressure at the patient interface and the oxygen input line flow. (Paragraph 0099 & 0106 - 0107).
Regarding claim 5, Modified Orr discloses the system as claimed in claim 4.
Modified Orr discloses wherein the controller 35 is programmed with at least one algorithm to calculate total flow output based on known patient pressure at the patient interface and known oxygen input line flow. (Paragraph 0114)
Regarding claim 7, A method for determining total flow generator flow output, the method comprising:
obtaining, by a processor 35, information relating to a patient interface pressure (Paragraph 0093 discloses the processor gathers information on the patients breathing pressure by the patient interface and is able to send the processor 35 the information) and an oxygen input line flow (Paragraph 0091 discloses the oxygen flow analyzer processor 34 sends the oxygen flow rate value to the processor 35); and
determining, by the processor 35, a total flow generator Barker flow output based on the patient interface pressure and the oxygen input line flow. (Paragraph 0099 & 0106 - 0107).
Orr does not disclose a Venturi adapter.
However, Barker discloses a venturi adapter. (Page 8, lines 24 – 29)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include a venturi adapter as is able to provide oxygen by having the central source to be oxygen or by blending atmospheric air with incoming oxygen from the central source being a venturi. (Page 8, lines 24 – 29)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable by Orr et al. (US 20160166797 A1) in view of Barker et al. (WO 2011136664 A1), Sanders et al. (US 5148802 A) & Lynn et al. (US 2008/0200775 A1) as claimed in claim 1, in further view of Burk et al (US 10737049 B1).
Regarding claim 6, Modified Orr discloses the system as claimed in claim 1.
Modified Orr discloses wherein the system further comprises a housing 80, the controller 35, the oxygen flow valve 25, and the patient interface pressure sensor 40 located within the housing 80 (Figure 5 / Paragraph 0103), the housing 80 having a coupler 92 to couple to the oxygen source to the housing 80. (Figure 5)
Orr does not disclose the housing having a receptacle.
Burk discloses the housing 49 have a receptacle 48. (Column 8, Paragraph 2)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include wherein the housing has a receptacle as it is a known way of being able to receive the housing of any connector. (Column 8, Paragraph 2)
Modified Orr discloses wherein the Venturi flow generator (Baker) is coupled to a proximal end of the oxygen input line.
Modified Orr does not disclose wherein a distal end of the oxygen input line comprises a connector to connect to the receptacle of the housing, the connector comprising a type-identifier, and the receptacle comprising a reader in communication with the controller, the reader to read the type-identifier and convey the type-identifier to the controller.
Burk discloses wherein a distal end of the oxygen input line 20 comprises a connector 10 to connect to the receptacle 48 of the housing 49 (Column 7, Paragraph 1 / Column 8, Paragraph 2), the connector 10 comprising a type-identifier 30 (Column 8, last paragraph), and the receptacle 48 comprising a reader in communication with the controller (Column 9, Paragraph 1 discloses the readers to be optical sensors), the reader to read the type-identifier (Column 10, Paragraph 4) and convey the type-identifier to the controller (Column 10, Paragraph 4).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing day to further modify Orr to include wherein a distal end of the oxygen input line comprises a connector to connect to the receptacle of the housing, the connector comprising a type-identifier, and the receptacle comprising a reader in communication with the controller, the reader to read the type-identifier and convey the type-identifier to the controller as it would allow the device to receive a signal relating to the patient interface that allows the change of parameters appropriate for the patient interface. (Column 10, Paragraph 4)
Claim(s) 8 – 9 are rejected under 35 U.S.C. 103 as being unpatentable by Orr et al. (US 20160166797 A1) in view of Barker et al. (WO 2011136664 A1), Sanders et al. (US 5148802 A) & Lynn et al. (US 2008/0200775 A1) as claimed in claim 7, in further view of Hudson et al (US 2020/0121873 A1).
Regarding claim 8, Modified Orr discloses the method as claimed in claim 7.
Modified Orr does not disclose wherein the method further comprises the step of obtaining, by a processor, information relating to a Venturi flow generator type; and wherein the step of determining, by the processor, a total Venturi flow generator flow output comprises determining, by the processor, the total Venturi flow generator flow output based on the patient interface pressure, the oxygen input line flow, and the Venturi flow generator type.
Hudson discloses wherein the method further comprises the step of obtaining, by a processor, information relating to a flow generator type (Claim 2)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include wherein the method further comprises the step of obtaining, by a processor, information relating to a flow generator type as it would allow selecting a troubleshooting option when something occurs to the device (Claim 5)
Based on this modification, modified Orr discloses wherein the step of determining, by the processor 35, a total Venturi flow generator flow output comprises determining, by the processor 35, the total Venturi flow generator flow output based on the patient interface pressure, the oxygen input line flow, and the Venturi flow generator type. (as claimed in claim 7)
Regarding claim 9, Modified Orr discloses the method as claimed in claim 8.
Modified Orr wherein the processor 35 is programmed with at least one algorithm to calculate total flow output based on known patient pressure at the patient interface and known oxygen input line flow. (Paragraph 0114)
Claim(s) 10 & 13 - 14 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Sanders et al. (US 5148802 A), Lynn et al. (US 2008/0200775 A1) & Zilberg et al. (WO 2004/066804 A2).
Regarding claim 10, A system for determining an amount of gas inhaled by a patient, the system comprising:
a patient interface 17 (Paragraph 0103)
the patient interface 17 in communication with a patient interface pressure sensor 40 to measure a patient interface pressure at the patient interface 17 (Paragraph 0092).
Orr does not disclose the air entrainment flow generator for connection to the patient interface.
Sanders discloses the flow generator 14 for connection to the patient interface 22. (Column 4, last paragraph – Column 5, First paragraph)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Orr to include a flow generator for connection to the patient interface as the flow generator is able to receive breathing gas from any suitable source such as a pressurized bottle or the ambient atmosphere and is able to pass said breathing gas through a delivery conduit to a breathing appliance such as a mask or any suitable known construction which is worn by a patient. (Column 4, last paragraph – Column 5, First paragraph)
Modified Orr an oxygen input line (Paragraph 0088 discloses a tubing for connection) for conveying oxygen from a source of oxygen to the flow generator 14,
Modified Orr does not disclose the oxygen input line comprising an oxygen flow valve for controlling a flow of oxygen from an oxygen source to the air entrainment flow generator.
Lynn discloses the oxygen input line comprising an oxygen flow valve for controlling a flow of oxygen from an oxygen source to the flow generator. (Paragraph 0019)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include disclose the oxygen input line comprising an oxygen flow valve for controlling a flow of oxygen from an oxygen source to the flow generator. This would occur by having the flow generator be between the oxygen force and the valve as it would allow the valve to control the oxygen source to deliver a specific pattern and/or rate of oxygen to flow through the nasal cannula. (Paragraph 0027) This would also allow auto optimization of gas delivery for application during routine use. (Paragraph 0037)
Modified Orr discloses an oxygen input line sensor 30 for determining oxygen input line flow (Paragraph 0090); and
wherein the patient interface pressure sensor 40 and the oxygen input line sensor 30 are in communication with a processor 35 (Paragraph 0091), and wherein the processor 35 is programmed to receive, during a pause between a patient exhalation and a patient inhalation, the patient pressure at the patient interface and the oxygen input line flow (Paragraph 0097) and determine a leak flow (Note: the examiner considers the oxygen leak flow as the flow received in the pause between the inhalation and the exhalation) output from the flow generator based on the patient pressure at the patient interface and the oxygen input line flow during the pause between the patient exhalation and the patient inhalation (Paragraph 0097 discloses calculating the pressure values to determine the baseline pressure of the pause based on the flow of oxygen);
wherein the processor 35 is further programmed to receive, during the patient inhalation, the patient pressure at the patient interface and the oxygen input line flow (Paragraph 0019 – 0023) and determine a total flow output from the flow generator 14 based on the patient pressure at the patient interface and the oxygen input line flow during a patient inhalation (Paragraph 0019 – 0023) ; and
Modified Orr discloses the processor 35.
Modified Orr does not disclose further programmed to calculate a patient flow by subtracting the leak flow output from the total flow output.
Zilberg discloses further programmed to calculate a patient flow (Note: the examiner considers this to be inhalation and exhalation) by subtracting the leak flow output (Note: this is considered to be leak around the patient interface such as a leak around a mask seal) from the total flow output (Note: this is considered the flow that leaves the flow generator). (Claim 4)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to be programmed to calculate a patient flow by subtracting the leak flow output from the total flow output as it would allow the device to determine when inspiration and expiration begins and determine the flow rates of air to the patient. (Zilberg: Page 2, Paragraph 4)
Regarding claim 13, Orr discloses the system as claimed in claim 10.
Orr discloses wherein the oxygen input line sensor 30 comprises an oxygen flowmeter for measuring an oxygen input line flow. (Paragraph 0090 / Note: the examiner considers Orr teaches the device that measures the flow rate of gas using the pressure)
Regarding claim 14, Orr discloses the system as claimed in claim 10.
Orr disclosed wherein the processor 35 is programmed with at least one algorithm to calculate total flow output based on known patient pressure at the patient interface and known oxygen input line flow. (Paragraph 0114)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Sanders et al. (US 5148802 A), Zilberg et al. (WO 2004/066804 A2) & Lynn et al. (US 2008/0200775 A1) as claimed in claim 10, in view of Sackner et al. (WO 9841146 A1).
Regarding claim 11, Modified Orr discloses the system as claimed in claim 10.
Modified Orr does not disclose wherein the processor is further programmed to calculate a tidal volume of gas by integrating the patient flow over a single breath.
Sackner discloses wherein the processor is further programmed to calculate a tidal volume of gas by integrating the patient flow over a single breath. (Claim 3)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Orr wherein the processor is further programmed to calculate a tidal volume of gas by integrating the patient flow over a single breath as the measurement of breath by breath peak inspiratory flow and acceleration, and breath by breath ventilation as the product of respiratory rate and tidal volume of the breath as herein described, also permit simultaneous computation of the ratio of respiratory drive to ventilation on either a breath by breath or a time average basis. (Column 10, Paragraph 2)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Sanders et al. (US 5148802 A), Zilberg et al. (WO 2004/066804 A2) & Lynn et al. (US 2008/0200775 A1) as claimed in claim 10, in view of Jaffe et al. (US 8166971 B2).
Regarding claim 12, Modified Orr discloses the system as claimed in claim 10.
Modified Orr discloses wherein the oxygen input line sensor for measuring oxygen input line flow. (as claimed in claim 10)
Modified Orr does not disclose a flow sensor.
Jaffe discloses a flow sensor (Column 5, Paragraph 2)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include a flow sensor as it is considered a known flow measurement device can be utilized. (Column 5, Paragraph 2)
Claim(s) 15 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Sanders et al. (US 5148802 A), Zilberg et al. (WO 2004/066804 A2) & Lynn et al. (US 2008/0200775 A1) as claimed in claim 14, in further view of Vicario et al. US 2021/0236757 A1).
Regarding claim 15, Modified Orr discloses the system as claimed in claim 14.
Modified Orr discloses the processor 35.
Modified Orr does not disclose further programmed to calculate a concentration of oxygen in the patient flow to determine a fraction of inhaled oxygen.
Vicario discloses further programmed to calculate a concentration of oxygen in the patient flow to determine a fraction of inhaled oxygen. (Paragraph 0032)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modified Orr to have the controller be able to calculate a concentration of oxygen \in the patient flow to determine a fraction of inhaled oxygen as it would allow the determination of a subject’s oxygen consumption based on the inhalation and it is able to improve the accuracy of O2 measurements of inhalation gas. (Paragraph 0035 / Abstract)
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Sanders et al. (US 5148802 A), Zilberg et al. (WO 2004/066804 A2) & Lynn et al. (US 2008/0200775 A1) as claimed in claim 10, in further view of Burk et al (US 10737049 B1).
Regarding claim 16, Orr discloses the system as claimed in claim 10.
Orr discloses wherein the system further comprises a housing 80, the processor 35, the oxygen flow valve 25, and the patient interface pressure sensor 40 located within the housing 80 (Figure 5 / Paragraph 0103), the housing 80 having a coupler 92 to couple to the oxygen source to the housing 80. (Figure 5)
Orr does not disclose the housing have a receptacle.
Burk discloses the housing 49 having a receptacle 48. (Column 8, Paragraph 2)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include wherein the housing has a receptacle as it is a known way of being able to receive the housing of any connector. (Column 8, Paragraph 2)
Modified Orr discloses wherein the air entrainment flow generator (Baker) is coupled to a proximal end of the oxygen input line.
Modified Orr does not disclose wherein a distal end of the oxygen input line comprises a connector to connect to the receptacle of the housing, the connector comprising a type-identifier, and the receptacle comprising a reader in communication with the controller, the reader to read the type-identifier and convey the type-identifier to the controller.
Burk discloses wherein a distal end of the oxygen input line 20 comprises a connector 10 to connect to the receptacle 48 of the housing 49 (Column 7, Paragraph 1 / Column 8, Paragraph 2), the connector 10 comprising a type-identifier 30 (Column 8, last paragraph), and the receptacle 48 comprising a reader in communication with the processor (Column 9, Paragraph 1 discloses the readers to be optical sensors), the reader to read the type-identifier (Column 10, Paragraph 4) and convey the type-identifier to the processor (Column 10, Paragraph 4).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing day to further modify Orr to include wherein a distal end of the oxygen input line comprises a connector to connect to the receptacle of the housing, the connector comprising a type-identifier, and the receptacle comprising a reader in communication with the processor, the reader to read the type-identifier and convey the type-identifier to the processor as it would allow the device to receive a signal relating to the patient interface that allows the change of parameters appropriate for the patient interface. (Column 10, Paragraph 4)
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Sanders et al. (US 5148802 A), Zilberg et al. (WO 2004/066804 A2) & Lynn et al. (US 2008/0200775 A1) as claimed in claim 10, in view of Hudson et al (US 2020/0121873 A1).
Regarding claim 17, Modified Orr discloses the system as claimed in claim 10.
Modified Orr does not disclose wherein the flow generator comprises a type-identifier and wherein the processor is programmed to receive data relating to the type-identifier of the air entrainment flow generator (Barker).
Hudson discloses wherein the flow generator comprises a type-identifier and wherein the processor is programmed to receive data relating to the type-identifier of the air entrainment flow generator. (Claim 2 / Paragraph 0012)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include wherein the method further comprises the step of obtaining, by a processor, information relating to a flow generator type as it would allow selecting a troubleshooting option when something occurs to the device (Claim 5 / Paragraph 0012 – 0013)
Claims 18 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Lynn et al. (US 2008/0200775 A1), Sackner et al. (WO 9841146 A1) & Zilberg et al. (WO 2004/066804 A2).
Regarding claim 18, A method for calculating patient tidal volume of gas inhaled, the method comprising:
obtaining, by a processor 35, information relating to a patient interface pressure and an oxygen input line flow (Paragraph 0099 & 0106 - 0107), determining, by the processor 35, a total flow generator flow output based on the patient interface pressure and the oxygen input line flow (Paragraph 0099 & 0106 - 0107),
wherein oxygen flows from the source of oxygen to the oxygen input line (Paragraph 0088), and from the flow generator to the patient interface. (Paragraph 0099 & 0106 - 0107)
Or does not disclose through the oxygen flow valve directly to the flow generator.
Lynn discloses the oxygen input line comprising an oxygen flow valve for controlling a flow of oxygen from an oxygen source to the flow generator. (Paragraph 0019)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include disclose the oxygen input line comprising an oxygen flow valve for controlling a flow of oxygen from an oxygen source to the flow generator. This would occur by having the flow generator be between the oxygen force and the valve as it would allow the valve to control the oxygen source to deliver a specific pattern and/or rate of oxygen to flow through the nasal cannula. (Paragraph 0027) This would also allow auto optimization of gas delivery for application during routine use. (Paragraph 0037)
Modified Orr does not disclose a leak flow, calculating, by the processor, patient flow by subtracting the leak flow from the total flow generator flow output.
Zilberg discloses a leak flow (Note: this is considered to be leak around the patient interface such as a leak around a mask seal), calculating, by the processor, patient flow (Note: the examiner considers this to be inhalation and exhalation) by subtracting the leak flow (Note: this is considered to be leak around the patient interface such as a leak around a mask seal) from the total flow generator flow output (Note: this is considered the flow that leaves the flow generator). (Claim 4)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to be programmed to calculate a patient flow by subtracting the leak flow output from the total flow output as it would allow the device to determine when inspiration and expiration begins and determine the flow rates of air to the patient. (Zilberg: Page 2, Paragraph 4)
Orr does not disclose calculating, by the processor, patient tidal volume of gas inhaled by integrating the patient flow over a single breath.
Sackner discloses calculating, by the processor, patient tidal volume of gas inhaled by integrating the patient flow over a single breath. (Claim 3)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Orr to include calculating, by the processor, patient tidal volume of gas inhaled by integrating the patient flow over a single breath as the measurement of breath by breath peak inspiratory flow and acceleration, and breath by breath ventilation as the product of respiratory rate and tidal volume of the breath as herein described, also permit simultaneous computation of the ratio of respiratory drive to ventilation on either a breath by breath or a time average basis. (Page 15, Paragraph 2)
Regarding claim 19, Modified Orr discloses the method as claimed in claim 18.
Modified Orr discloses wherein the step of determining, by the processor 35, a flow generator total flow output based on the patient interface pressure and the oxygen input line flow (Paragraph 0099 & 0106 – 0107), comprises the processor 35 determining the flow generator total flow output based on at least one of:
a pre-defined mathematical function stored in a memory accessible by the processor 35, a lookup table stored in a memory accessible by the processor, and a trained artificial neural network stored in a memory accessible by the processor (Paragraph 0107 – 0109).
Regarding claim 20, Modified Orr discloses the method as claimed in claim 19.
Modified Orr discloses wherein the step of obtaining, by the processor 35, a leak flow (as claimed in claim 18 / Zilbreg, Claim 4) comprises determining, by the processor 35, a pause period between a patient exhalation and a patient inhalation (Paragraph 0107), and wherein the method further comprises the steps of: obtaining, by a processor, information relating to a patient interface pressure and an oxygen input line flow during the pause period, determining, by the processor, a flow generator leak flow based on the patient interface pressure and the oxygen input line flow during the pause period (Orr, Paragraph 0107 – 0109 / Zilbreg, Claim 4, Page 2, Paragraph 4).
Claims 21 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Lynn et al. (US 2008/0200775 A1), Sackner et al. (WO 9841146 A1) & Zilberg et al. (WO 2004/066804 A2).as claimed in claim 18, in further view of Vicario et al. US 2021/0236757 A1).
Regarding claim 21, Modified Orr discloses the method as claimed in claim 18.
Modified Orr wherein the method further comprises the step of calculating a concentration of oxygen in the patient flow to determine a fraction of inhaled oxygen
Vicario discloses the method further comprises the step of calculating a concentration of oxygen in the patient flow to determine a fraction of inhaled oxygen. (Paragraph 0032)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modified Orr to have the controller be able to calculate a concentration of oxygen \in the patient flow to determine a fraction of inhaled oxygen as it would allow the determination of a subject’s oxygen consumption based on the inhalation and it is able to improve the accuracy of O2 measurements of inhalation gas. (Paragraph 0035 / Abstract)
Claims 22 - 23 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 20160166797 A1) in view of Lynn et al. (US 2008/0200775 A1), Zilberg et al. (WO 2004/066804 A2), Emerson et al. (US 6546930 B1), ORR et al. (US 10786645 B2), Kennedy et al. (US 20220020488 A1) & Slessareb et al. (JP 2009502265 A)
Regarding claim 22, A method for calculating a percentage of oxygen in a volume of gas inhaled during an inhalation, the method comprising:
Orr discloses a processor 35,
However, it does not disclose a flow generator.
Lynn discloses a flow generator 115. (Paragraph 0019)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Orr to include a flow generator in order to deliver an airflow to the patient and in combination with the oxygen flow valve allow auto optimization of gas delivery for application during routine use. (Paragraph 0037)
Modified Orr discloses obtaining information relating to a flow generator input (Paragraph 0085 discloses the processor controls the oxygen flow meaning the processor contains the input information of the flow generator);
obtaining, by a processor 35, information relating to a flow generator output (Paragraph 0090 discloses the oxygen flow analyzer that gathers the output of the flow);
Modified Orr discloses the processor 35.
Modified Orr does not disclose determining an oxygen leak flow, calculating.
Zilberg discloses determining an oxygen leak flow by calculating. (Claim 4)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to be programmed to calculate a patient flow by subtracting the leak flow output from the total flow output as it would allow the device to determine when inspiration and expiration begins and determine the flow rates of air to the patient. (Page 2, Paragraph 4)
Orr does not disclose adding 21% of a difference between a total oxygen flow generator flow output (Note: this is considered to be the mix of the pure oxygen from the source and the entrained ambient air) and a total oxygen flow generator flow input over a time of the inhalation to the total oxygen flow generator flow input over the time of the inhalation.
However, ORR discloses the concentration of typical air is approximately 21%. Column 11, lines 1 – 10)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Orr to add 21% as it would allow the determination of how much supplemental oxygen is actually being provided to the patient that does rely on the oxygen concentration of typical air in a time period that is considered to be exhalation. (Column 11, lines 1 – 22)
Modified Orr does not disclose the difference between a total oxygen flow generator flow output and a total oxygen flow generator flow input over a time of the inhalation to the total oxygen flow generator flow input over the time of the inhalation
Kennedy discloses the difference between a total oxygen flow generator flow output and a total oxygen flow generator flow input over a time of the inhalation to the total oxygen flow generator flow input over the time of the inhalation. (Paragraph 0103)
It would be obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include the difference between a total oxygen flow generator flow output and a total oxygen flow generator flow input over a time of the inhalation to the total oxygen flow generator flow input over the time of the inhalation as it would allow the calculation of the leak flow rate using several breathing cycles which include inhalation. (Paragraph 0103)
Modified Orr does not disclose a percentage of oxygen in a volume of gas inhaled by: subtracting the oxygen leak flow over the time of the inhalation to determine a volume of oxygen inhaled; and
dividing the volume of oxygen inhaled by a total volume of gas inhaled.
Emerson discloses subtracting the oxygen leak flow over the time of the inhalation to determine a volume of oxygen inhaled. (Column 5, lines 5 – 15)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Orr to include subtracting the oxygen leak flow over the time of the inhalation to determine a volume of oxygen inhaled as it would allow clear information of what the maximum flow is needed to be provided to the patient. (Column 5, lines 5 – 15)
Slessareb discloses dividing the volume of oxygen inhaled by a total volume of gas inhaled. (Page 10, Last paragraph)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify Orr to include dividing the volume of oxygen inhaled by a total volume of gas inhaled as it would allow the knowledge of the concentration of oxygen inhaled by the patient. (Page 11, First paragraph)
Modified Orr does not disclose comprising oxygen from a source of compressed oxygen delivered through an oxygen input line.
However, modified Orr discloses it can receive information from the input of the oxygen flow. (Paragraph 0085 discloses the processor controls the oxygen flow meaning the processor contains the input information of the flow generator)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include input information comprising oxygen from a source of compressed oxygen delivered through an oxygen input line as it would be based on the oxygen information that the processor is able to acquire. This is something that is already proved can be detected (Paragraph 0085)
Modified Orr does not expressly disclose output comprising oxygen from the source of compressed oxygen blended with ambient air entrained through air input ports of the flow generator
However, Modified Orr discloses it is able to obtain information of the flow generator output. (Paragraph 0090 discloses the oxygen flow analyzer that gathers the output of the flow);
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr to include output information comprising oxygen from the source of compressed oxygen blended with ambient air entrained through air input ports of the flow generator as it would be based on the oxygen information that the processor is able to acquire. This is something that is already proved can be detected (Paragraph 0090)
Modified Orr discloses determining, by the processor, the total flow generator flow output based on a patient interface pressure and the flow generator input (Paragraph 0093 discloses the processor gathers information on the patients breathing pressure by the patient interface and is able to send the processor 35 the information), wherein the processor determines the total flow generator flow output (Paragraph 0099 & 0106 – 0107).
Modified Orr does not disclose using a polynomial function fitted to a plurality of pre-measured data points collected at multiple combinations of patient interface pressures and oxygen input line flow rates.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Orr by using a polynomial function fitted to a plurality of pre-measured data points collected at multiple combinations of patient interface pressures and oxygen input line flow rates as polynomial functions are known in the art to take pre-measured data points form a plurality of combinations of information. This would be an obvious function to use based on the results wanted.
Regarding claim 23, Modified Orr discloses the method for calculating the percentage of oxygen in a volume of gas inhaled during an inhalation as claimed in claim 22.
Modified Orr wherein the step of determining, by the processor 35, the oxygen leak flow, comprises determining, by the processor 35, a pause period between a patient exhalation and a patient inhalation (Paragraph 0107), and wherein the method further comprises the steps of:
obtaining, by a processor 35, the flow generator output during the pause period between the patient exhalation and the patient inhalation (Paragraph 0107); and
determining, by the processor, a flow generator leak flow based on the flow generator output during the pause period ((Paragraph 0050 discloses the action of subtracting the total amount of oxygen to be delivered, which is considered the total flow, to the calculated volume of oxygen delivered / Paragraph 0097 discloses determination of the flow found on the pause between the inhalation and the exhalation).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACIELA NATALIA LEBRON DE JESUS whose telephone number is (571)270-3892. The examiner can normally be reached Mon - Fri 8:00-5:00 CST.
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/GRACIELA NATALIA LEBRON DE JESUS/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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