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 Amendment
This office action is responsive to the amendment filed on 07/21/2026. As directed by the amendment: claims 1, 8, and 15 have been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1, 3-9, and 11-20 are presently pending in the application.
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.
Claims 1, 4-6, 8-9, 11-12, 14-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Porges (US-8915249-B2) in view of Anderson (US-20180193583-A1) and Poon (WO-2021137124-A1).
Regarding claim 1, Porges discloses ventilation device (FIG. 1 Breathing assistance device 10 set forth in column 3 lines 32-47) for providing a gas mixture for a user, the ventilation device comprising: a compressed air source (FIG. 1 Pressurized air source 20, which may comprise any system or device suitable for generating and/or delivering pressurized gas as set forth in column 3 lines 32-47) configured to deliver compressed air via an outlet (Where the compressed air leave pressurized air source 20); an oxygen source configured to output oxygen gas via an outlet (FIG. 1 Supplemental oxygen source 36 set forth in column 3 lines 32-47; the outlet being where the oxygen is entering the system); a patient interface (FIG. 1 Patient interface 24 set forth in column 3 lines 32-47) configured to deliver the output gas flow; and a controller (FIG. 1 Control system 44 set forth in column 3 lines 32-47) configured to: determine an inspiratory period of the user (FIG. 1 Controller system 44 can determine the beginning and/or end of inhalation column 6 lines 42-67, and shown by Tinh in the graph of FIG. 4 as set forth in column 7 lines 44-54), and control the device to deliver substantially only the oxygen gas to the patient interface during a first portion of the inspiratory period (FIG. 4 The concentration of gas delivered during the period T1 is approximately 100% oxygen as set forth in column 7 line 44 – column 8 line 5) and deliver substantially only the compressed air to the patient interface during a second portion of the inspiratory period (FIG. 4 The concentration of gas delivered during the period T2 is zero, so only the air is being supplied as set forth in column 7 line 44 – column 8 line 5).
Porges does not explicitly disclose the compressed air source is a compressor configured to compress ambient air and output compressed air, wherein the compressed air retains the oxygen concentration of the ambient air, or that the oxygen source is an oxygen concentrator configured to receive the compressed air from the air compressor outlet and deliver concentrated oxygen gas.
However, Poon teaches a compressor configured to compress ambient air and deliver compressed air via a compressor outlet (Poon: FIG. 1B Compression system 200 may draw in air from the surroundings of the device and compress the air as set forth in [0052]; the outlet being where the compressed air leaves the compression system 200 before it is forced into the canisters as set forth in [0052], wherein the compression system 200 may include one or more compressors configured to compress air and produce pressurized air as set forth in [0053]), wherein the compressed air retains the oxygen concentration of the ambient air (Poon: Ambient air is output from compression system 200 with the same oxygen concentration and doesn’t increase in concentration until it is reaches the cannister as set forth in [0012]), and an oxygen concentrator configured to receive the compressed air and deliver concentrated oxygen gas (Poon: FIG. 1B The canisters 302 and 304 of oxygen concentrator 100 which contain a gas separation adsorbent and are therefore referred to as sieve beds, where gas separation adsorbents useful in an oxygen concentrator are capable of separating at least nitrogen from an air stream to produce oxygen enriched air as set forth in [0051]-[0054], receiving compressed air from compression system 200 as set forth in [0052]).
Porges and Poon are both considered to be analogous to the claimed invention because they are in the same field of air delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the compressed air source and oxygen sources, as well as the configuration between the gas sources, of Porges to incorporate the teaching of Poon and include a compressor configured to compress ambient air and deliver compressed air via a compressor outlet (Poon: FIG. 1B Compression system 200 may draw in air from the surroundings of the device and compress the air as set forth in [0052]; the outlet being where the compressed air leaves the compression system 200 before it is forced into the canisters as set forth in [0052], wherein the compression system 200 may include one or more compressors configured to compress air and produce pressurized air as set forth in [0053]), wherein the compressed air retains the oxygen concentration of the ambient air (Poon: Ambient air is output from compression system 200 with the same oxygen concentration and doesn’t increase in concentration until it is reaches the cannister as set forth in [0012]), and an oxygen concentrator configured to receive the compressed air and deliver concentrated oxygen gas (Poon: FIG. 1B The canisters 302 and 304 of oxygen concentrator 100 which contain a gas separation adsorbent and are therefore referred to as sieve beds, where gas separation adsorbents useful in an oxygen concentrator are capable of separating at least nitrogen from an air stream to produce oxygen enriched air as set forth in [0051]-[0054], receiving compressed air from compression system 200 as set forth in [0052]). In the case of Porges as modified by Poon, the compressor providing the compressed air to the oxygen concentrator in addition to the airway leading to the rest of the system, which would mean that two parallel flow paths are created, one of which includes the oxygen concentrator and the other of which bypasses the oxygen concentrator. Doing so would enable the use of ambient air as an air source for the device and utilize the compressed air output from the compressor to produce an oxygen enriched air source by means of the oxygen concentrator (Poon: As set forth in [0052]).
Porges as modified does not explicitly disclose a gas source control valve fluidly coupled to the compressor outlet via two parallel flow paths, one of which includes the oxygen concentrator and the other of which bypasses the oxygen concentrator, configured to receive the compressed air from the compressor outlet and the concentrated oxygen gas from the oxygen outlet and selectively output a gas flow comprising at least one of the concentrated oxygen gas and the compressed air according to a controller.
However, Anderson teaches a gas source control valve fluidly coupled to both an air source and an oxygen gas source, configured to receive the air and the oxygen gas and selectively output a gas flow comprising at least one of the oxygen gas and the compressed air according to a controller (Anderson: FIG. 1 Reservoirs 14, containing air, and 15, containing oxygen, are connected to a valve 18 via conduits 16 and 17. Valve 18 is controlled via an actuator 40 by a central processing unit 33 to control the oxygen level of the air leaving valve 18 as set forth in [0006]-[0007]).
Porges and Anderson are both considered to be analogous to the claimed invention because they are in the same field of air delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porges to incorporate the teaching of Anderson and include a gas source control valve fluidly coupled to both an air source and an oxygen gas source, configured to receive the air and the oxygen gas and selectively output a gas flow comprising at least one of the oxygen gas and the compressed air according to a controller (Anderson: FIG. 1 Reservoirs 14, containing air, and 15, containing oxygen, are connected to a valve 18 via conduits 16 and 17. Valve 18 is controlled via an actuator 40 by a central processing unit 33 to control the oxygen level of the air leaving valve 18 as set forth in [0006]-[0007]). In the case of Porges as modified by Poon, the valve being coupled to the compressor outlet and oxygen outlet via the parallel flow paths. Doing so would provide a way to precisely control the amount of each gas being delivered to the patient as dictated by the algorithms stored in the CPU (Anderson: Set forth in [0006]-[0008]).
Regarding claim 4, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Porges as modified further discloses the ventilation device, wherein the controller is configured to determine a switching time (Ts) (FIG. 4 Between the times T1 and T2) in accordance with the determined inspiratory period of the user (FIG. 4 Between the times T1 and T2 make up Tinh, the inhalation period of the user as set forth in column 7 line 44 – column 8 line 10).
Regarding claim 5, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Porges as modified further discloses the ventilation device, wherein the switch of the output gasses occurs at the switching time (Ts) (FIG. 4 The concentration of gas delivered during the period T1 is approximately 100% oxygen and the concentration of gas delivered during the period T2 is zero, so only the air is being supplied as set forth in column 7 line 44 – column 8 line 5).
Regarding claim 6, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Porges as modified further discloses the ventilation device, wherein, at the patient interface, the flow rate of the concentrated oxygen gas is substantially equal to the flow rate of the compressed air (FIG. 4 Shows the Ftot, total flow, over Tinh, Inhalation time, which shows the total air flow into the patient airway during the inhalation portion is constant, indicating that the flow rate of oxygen gas is equal to the flow rate of the air).
Regarding claim 8, Porges discloses a ventilation device (FIG. 1 Breathing assistance device 10 set forth in column 3 lines 32-47) for providing a gas mixture for a user, the ventilation device comprising: a compressed air source configured to deliver compressed air via a compressor outlet (FIG. 1 Pressurized air source 20 set forth in column 3 lines 32-47; the outlet being where the compressed air enters the system); an oxygen gas source configured to deliver oxygen gas via an oxygen outlet (FIG. 1 Supplemental oxygen source 36 set forth in column 3 lines 32-47; the outlet being where the oxygen enters the system); a patient interface (FIG. 1 Patient interface 24 set forth in column 3 lines 32-47) for delivering the output gas flow; and a controller (FIG. 1 Control system 44 set forth in column 3 lines 32-47) configured to: determine an inspiratory period of a user (FIG. 1 Controller system 44 can determine the beginning and/or end of inhalation column 6 lines 42-67, and shown by Tinh in the graph of FIG. 4 as set forth in column 7 lines 44-54), and control the device to deliver a first pulse of a first output gas flow (FIG. 4 The concentration of gas delivered during the period T1 is approximately 100% oxygen as set forth in column 7 line 44 – column 8 line 5) and thereafter switch to deliver a second pulse of a second output gas flow during the inspiratory period (FIG. 4 The concentration of gas delivered during the period T2 is zero, so only the air is being supplied as set forth in column 7 line 44 – column 8 line 5).
Porges does not explicitly disclose the compressed air source is a compressor configured to compress ambient air and output compressed air, wherein the compressed air retains the oxygen concentration of the ambient air, or that the oxygen source is an oxygen concentrator configured to receive the compressed air from the air compressor outlet and deliver concentrated oxygen gas.
However, Poon teaches a compressor configured to compress ambient air and deliver compressed air via a compressor outlet (Poon: FIG. 1B Compression system 200 may draw in air from the surroundings of the device and compress the air as set forth in [0052]; the outlet being where the compressed air leaves the compression system 200 before it is forced into the canisters as set forth in [0052], wherein the compression system 200 may include one or more compressors configured to compress air and produce pressurized air as set forth in [0053]), wherein the compressed air retains the oxygen concentration of the ambient air (Poon: Ambient air is output from compression system 200 with the same oxygen concentration and doesn’t increase in concentration until it is reaches the cannister as set forth in [0012]), and an oxygen concentrator configured to receive the compressed air and deliver concentrated oxygen gas (Poon: FIG. 1B The canisters 302 and 304 of oxygen concentrator 100 which contain a gas separation adsorbent and are therefore referred to as sieve beds, where gas separation adsorbents useful in an oxygen concentrator are capable of separating at least nitrogen from an air stream to produce oxygen enriched air as set forth in [0051]-[0054], receiving compressed air from compression system 200 as set forth in [0052]).
Porges and Poon are both considered to be analogous to the claimed invention because they are in the same field of air delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the compressed air source and oxygen sources, as well as the configuration between the gas sources, of Porges to incorporate the teaching of Poon and include a compressor configured to compress ambient air and deliver compressed air via a compressor outlet (Poon: FIG. 1B Compression system 200 may draw in air from the surroundings of the device and compress the air as set forth in [0052]; the outlet being where the compressed air leaves the compression system 200 before it is forced into the canisters as set forth in [0052], wherein the compression system 200 may include one or more compressors configured to compress air and produce pressurized air as set forth in [0053]), wherein the compressed air retains the oxygen concentration of the ambient air (Poon: Ambient air is output from compression system 200 with the same oxygen concentration and doesn’t increase in concentration until it is reaches the cannister as set forth in [0012]), and an oxygen concentrator configured to receive the compressed air and deliver concentrated oxygen gas (Poon: FIG. 1B The canisters 302 and 304 of oxygen concentrator 100 which contain a gas separation adsorbent and are therefore referred to as sieve beds, where gas separation adsorbents useful in an oxygen concentrator are capable of separating at least nitrogen from an air stream to produce oxygen enriched air as set forth in [0051]-[0054], receiving compressed air from compression system 200 as set forth in [0052]). In the case of Porges as modified by Poon, the compressor providing the compressed air to the oxygen concentrator in addition to the airway leading to the rest of the system, which would mean that two parallel flow paths are created, one of which includes the oxygen concentrator and the other of which bypasses the oxygen concentrator. Doing so would enable the use of ambient air as an air source for the device and utilize the compressed air output from the compressor to produce an oxygen enriched air source by means of the oxygen concentrator (Poon: As set forth in [0052]).
Porges as modified does not explicitly disclose a gas source control valve fluidly coupled to the compressor outlet via two parallel flow paths, one of which includes the oxygen concentrator and the other of which bypasses the oxygen concentrator, configured to receive the compressed air from the compressor outlet and the concentrated oxygen gas from the oxygen outlet and selectively output a gas flow comprising at least one of the concentrated oxygen gas and the compressed air according to a controller.
However, Anderson teaches a gas source control valve fluidly coupled to both an air source and an oxygen gas source, configured to receive the air and the oxygen gas and selectively output a gas flow comprising at least one of the oxygen gas and the compressed air according to a controller (Anderson: FIG. 1 Reservoirs 14, containing air, and 15, containing oxygen, are connected to a valve 18 via conduits 16 and 17. Valve 18 is controlled via an actuator 40 by a central processing unit 33 to control the oxygen level of the air leaving valve 18 as set forth in [0006]-[0007]).
Porges and Anderson are both considered to be analogous to the claimed invention because they are in the same field of air delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porges to incorporate the teaching of Anderson and include a gas source control valve fluidly coupled to both an air source and an oxygen gas source, configured to receive the air and the oxygen gas and selectively output a gas flow comprising at least one of the oxygen gas and the compressed air according to a controller (Anderson: FIG. 1 Reservoirs 14, containing air, and 15, containing oxygen, are connected to a valve 18 via conduits 16 and 17. Valve 18 is controlled via an actuator 40 by a central processing unit 33 to control the oxygen level of the air leaving valve 18 as set forth in [0006]-[0007]). In the case of Porges as modified by Poon, the valve being coupled to the compressor outlet and oxygen outlet via the parallel flow paths. Doing so would provide a way to precisely control the amount of each gas being delivered to the patient as dictated by the algorithms stored in the CPU (Anderson: Set forth in [0006]-[0008]).
Regarding claim 9, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 8 above.
Porges as modified further discloses the ventilation device, wherein the first pulse comprises compressed oxygen gas (compressed as modified above by Poon) and the second pulse comprises the compressed air (FIG. 4 The concentration of gas delivered during the period T1 is approximately 100% oxygen and the concentration of gas delivered during the period T2 is zero, so only the air is being supplied as set forth in column 7 line 44 – column 8 line 5).
Regarding claim 11, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 8 above.
Porges as modified further discloses the ventilation device, wherein the controller is configured to determine a switching time (Ts) (FIG. 4 Between the times T1 and T2) in accordance with the determined inspiratory period of the user (FIG. 4 Between the times T1 and T2 make up Tinh, the inhalation period of the user as set forth in column 7 line 44 – column 8 line 10).
Regarding claim 12, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Porges as modified further discloses the ventilation device, wherein the controller is configured to control the gas source control valve to terminate the first pulse and begin the second pulse at the determined switching time (Ts) (FIG. 1 Controller system 44 controls the device to deliver gas as shown in FIG. 4 as a first pulse, the period T1 which is approximately 100% oxygen, which is then terminated in order to deliver a second pulse, T2 where the oxygen concentration is zero and air is being delivered as set forth in in column 7 line 44 – column 8 line 5, where the switching time is the time between T1 and T2).
Regarding claim 14, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 8 above.
Porges as modified further discloses the ventilation device, wherein the flow rate of the first pulse is substantially equal to the flow rate of the second pulse (FIG. 4 Shows the Ftot, total flow, over Tinh, Inhalation time, which shows the total air flow into the patient airway during the inhalation portion is constant, indicating that the flow rate of oxygen gas is equal to the flow rate of the air) and wherein the first and second pulse flows are only output during the inspiration period and are different in duration from each other (FIG. 4 T1 and T2 may be selected such that T1=2/3Tinh and T2=1/3Tinh as set forth in column 8 lines 6-7).
Regarding claim 15, Porges discloses ventilation device (FIG. 1 Breathing assistance device 10 set forth in column 3 lines 32-47) for providing a gas mixture for a user, the ventilation device comprising: a compressed air source configured to deliver compressed air via an outlet (FIG. 1 Pressurized air source 20 set forth in column 3 lines 32-47; the outlet being where the pressurized air enters the system); an oxygen source configured to deliver oxygen gas via an oxygen outlet (FIG. 1 Supplemental oxygen source 36 set forth in column 3 lines 32-47; the outlet being where the oxygen enters the system); a patient interface (FIG. 1 Patient interface 24 set forth in column 3 lines 32-47) configured to receive the first and second gas pulses delivered, and to deliver the first and second gas pulses (FIG. 4 The first pulse, the period T1 which is approximately 100% oxygen, which is then terminated in order to deliver a second pulse, T2 where the oxygen concentration is zero and air is being delivered as set forth in in column 7 line 44 – column 8 line 5); and a controller (FIG. 1 Control system 44 set forth in column 3 lines 32-47) configured to: determine a switching time (Ts) that occurs during an inspiratory period of a user, and control the device to terminate the delivery of the first pulse and begin the delivery of the second pulse at the switching time (Ts) (FIG. 1 Controller system 44 controls the device to deliver gas as shown in FIG. 4 as a first pulse, the period T1 which is approximately 100% oxygen, which is then terminated in order to deliver a second pulse, T2 where the oxygen concentration is zero and air is being delivered as set forth in in column 7 line 44 – column 8 line 5, where the switching time is the time between T1 and T2, the controller able to determine the beginning and/or end of inhalation column 6 lines 42-67, and shown by Tinh in the graph of FIG. 4 as set forth in column 7 lines 44-54).
Porges does not explicitly disclose the compressed air source is a compressor configured to compress ambient air and output compressed air, wherein the compressed air retains the oxygen concentration of the ambient air, or that the oxygen source is an oxygen concentrator configured to receive the compressed air from the air compressor outlet and deliver concentrated oxygen gas.
However, Poon teaches a compressor configured to compress ambient air and deliver compressed air via a compressor outlet (Poon: FIG. 1B Compression system 200 may draw in air from the surroundings of the device and compress the air as set forth in [0052]; the outlet being where the compressed air leaves the compression system 200 before it is forced into the canisters as set forth in [0052], wherein the compression system 200 may include one or more compressors configured to compress air and produce pressurized air as set forth in [0053]), wherein the compressed air retains the oxygen concentration of the ambient air (Poon: Ambient air is output from compression system 200 with the same oxygen concentration and doesn’t increase in concentration until it is reaches the cannister as set forth in [0012]), and an oxygen concentrator configured to receive the compressed air and deliver concentrated oxygen gas (Poon: FIG. 1B The canisters 302 and 304 of oxygen concentrator 100 which contain a gas separation adsorbent and are therefore referred to as sieve beds, where gas separation adsorbents useful in an oxygen concentrator are capable of separating at least nitrogen from an air stream to produce oxygen enriched air as set forth in [0051]-[0054], receiving compressed air from compression system 200 as set forth in [0052]).
Porges and Poon are both considered to be analogous to the claimed invention because they are in the same field of air delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the compressed air source and oxygen sources, as well as the configuration between the gas sources, of Porges to incorporate the teaching of Poon and include a compressor configured to compress ambient air and deliver compressed air via a compressor outlet (Poon: FIG. 1B Compression system 200 may draw in air from the surroundings of the device and compress the air as set forth in [0052]; the outlet being where the compressed air leaves the compression system 200 before it is forced into the canisters as set forth in [0052], wherein the compression system 200 may include one or more compressors configured to compress air and produce pressurized air as set forth in [0053]), wherein the compressed air retains the oxygen concentration of the ambient air (Poon: Ambient air is output from compression system 200 with the same oxygen concentration and doesn’t increase in concentration until it is reaches the cannister as set forth in [0012]), and an oxygen concentrator configured to receive the compressed air and deliver concentrated oxygen gas (Poon: FIG. 1B The canisters 302 and 304 of oxygen concentrator 100 which contain a gas separation adsorbent and are therefore referred to as sieve beds, where gas separation adsorbents useful in an oxygen concentrator are capable of separating at least nitrogen from an air stream to produce oxygen enriched air as set forth in [0051]-[0054], receiving compressed air from compression system 200 as set forth in [0052]). In the case of Porges as modified by Poon, the compressor providing the compressed air to the oxygen concentrator in addition to the airway leading to the rest of the system, which would mean that two parallel flow paths are created, one of which includes the oxygen concentrator and the other of which bypasses the oxygen concentrator. Doing so would enable the use of ambient air as an air source for the device and utilize the compressed air output from the compressor to produce an oxygen enriched air source by means of the oxygen concentrator (Poon: As set forth in [0052]).
Porges as modified does not explicitly disclose a gas source control valve fluidly coupled to the compressor outlet via two parallel flow paths, one of which includes the oxygen concentrator and the other of which bypasses the oxygen concentrator, configured to receive the compressed air from the compressor outlet and the concentrated oxygen gas from the oxygen outlet and selectively output a gas flow comprising at least one of the concentrated oxygen gas and the compressed air according to a controller.
However, Anderson teaches a gas source control valve fluidly coupled to both an air source and an oxygen gas source, configured to receive the air and the oxygen gas and selectively output a gas flow comprising at least one of the oxygen gas and the compressed air according to a controller (Anderson: FIG. 1 Reservoirs 14, containing air, and 15, containing oxygen, are connected to a valve 18 via conduits 16 and 17. Valve 18 is controlled via an actuator 40 by a central processing unit 33 to control the oxygen level of the air leaving valve 18 as set forth in [0006]-[0007]).
Porges and Anderson are both considered to be analogous to the claimed invention because they are in the same field of air delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porges to incorporate the teaching of Anderson and include a gas source control valve fluidly coupled to both an air source and an oxygen gas source, configured to receive the air and the oxygen gas and selectively output a gas flow comprising at least one of the oxygen gas and the compressed air according to a controller (Anderson: FIG. 1 Reservoirs 14, containing air, and 15, containing oxygen, are connected to a valve 18 via conduits 16 and 17. Valve 18 is controlled via an actuator 40 by a central processing unit 33 to control the oxygen level of the air leaving valve 18 as set forth in [0006]-[0007]). In the case of Porges as modified by Poon, the valve being coupled to the compressor outlet and oxygen outlet via the parallel flow paths. Doing so would provide a way to precisely control the amount of each gas being delivered to the patient as dictated by the algorithms stored in the CPU (Anderson: Set forth in [0006]-[0008]).
Regarding claim 16, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Porges as modified further discloses the ventilation device, wherein the controller is configured to terminate the second pulse prior to the start of an expiratory period of the user (FIG. 1 Controller system 44 controls the device to deliver gas as shown in FIG. 4 as a first pulse, the period T1 which is approximately 100% oxygen, which is then terminated in order to deliver a second pulse, T2 where the oxygen concentration is zero and air is being delivered as set forth in in column 7 line 44 – column 8 line 5, T1 and T2 occurring during the inspiratory period of the user prior to the expiratory period).
Regarding claim 18, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Porges as modified further discloses the ventilation device, wherein the controller is configured to determine the inspiratory period of the user (FIG. 1 Controller system 44 able to determine the beginning and/or end of inhalation column 6 lines 42-67, and shown by Tinh in the graph of FIG. 4 as set forth in column 7 lines 44-54).
Regarding claim 19, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Porges as modified further discloses the ventilation device, wherein the controller is configured to control the flow rate of the first gas pulse to be substantially equal to the flow rate of the second gas pulse (FIG. 4 Shows the Ftot, total flow, over Tinh, Inhalation time, which shows the total air flow into the patient airway during the inhalation portion is constant, indicating that the flow rate of oxygen gas is equal to the flow rate of the air).
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Porges (US-8915249-B2) in view of Anderson (US-20180193583-A1) and Poon (WO-2021137124-A1) as applied to claims 1 and 6, in further view of Truschel (US-20190201647-A1).
Regarding claim 3, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Porges as modified does not explicitly disclose a ventilation device, further comprising a proportional delivery valve configured to throttle the output gas flow of the gas source control valve that is delivered by the patient interface.
However, Truschel teaches a ventilation device, further comprising a proportional delivery valve (Truschel: FIG. 1A and 1C Flow controller 150) configured to throttle the output gas flow of the gas source control valve that is delivered by the patient interface (Truschel: FIG. 1C Flow controller 150 is a throttle valve configured to modify an amount of gas flow/flow rate delivered to the patient via the patient interface as set forth in [0036]).
Porges and Truschel are both considered to be analogous to the claimed invention because they are in the same field of breathing therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porges to incorporate the teaching of Truschel and include a ventilation device further comprising a proportional delivery valve (Truschel: FIG. 1A and 1C Flow controller 150) configured to throttle the output gas flow of the gas source control valve that is delivered by the patient interface (Truschel: FIG. 1C Flow controller 150 is a throttle valve configured to modify an amount of gas flow capable of exiting a gas outlet of nasal interface as set forth in [0036]). Doing so would ensure the flow rate of the gas flow output to patient via patient interface is adjustable (Truschel: As set forth in [0036]).
Regarding claim 7, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 6 above.
Porges as modified does not explicitly disclose a ventilation device, wherein the flow rate of the oxygen gas and the compressed air is controlled by a proportional delivery valve.
However, Truschel teaches a ventilation device, further comprising a proportional delivery valve (Truschel: FIG. 1A and 1C Flow controller 150) configured to throttle the output gas flow of the gas source control valve that is delivered by the patient interface (Truschel: FIG. 1C Flow controller 150 is a throttle valve configured to modify an amount of gas flow/flow rate delivered to the patient via the patient interface as set forth in [0036]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porges to incorporate the teaching of Truschel and include a proportional delivery valve (Truschel: FIG. 1A and 1C Flow controller 150) configured to throttle the output gas flow of the gas source control valve that is delivered by the patient interface (Truschel: FIG. 1C Flow controller 150 is a throttle valve configured to modify an amount of gas flow capable of exiting a gas outlet of nasal interface as set forth in [0036]) to control the flow rate of the oxygen gas and the compressed air. Doing so would ensure the flow rate of the gas flow output to patient via patient interface is adjustable (Truschel: As set forth in [0036]).
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Porges (US-8915249-B2) in view of Anderson (US-20180193583-A1) and Poon (WO-2021137124-A1) as applied to claims 9 and 16, in further view of Christopher (US-20140238398-A1).
Regarding claim 13, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Porges as modified does not explicitly disclose a ventilation device, wherein the controller is configured to control the gas source control valve to output a third pulse of the compressed air during an expiratory period that follows the first and second pulses, wherein the controller is configured to control the delivery of the third pulse at a lower flow rate than the first and second pulses.
However, Christopher teaches supplying air during an expiratory period that follows the inspiratory period at a lower flow rate than in the inspiratory period (Christopher: FIG. 32 A flow of 15 L/min is selected to be administered throughout the inspiratory phase and a flow of 7 L/min is selected to be administered throughout the expiratory phase. Thus, flow-targeted ventilation is synchronized with the respiratory cycle and results in a flow pattern that is not the same constant flow throughout the entire respiratory cycle as set forth in [0132]).
Porges and Christopher are both considered to be analogous to the claimed invention because they are in the same field of air delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porges to incorporate the teaching of Christopher and output a third pulse of the compressed air at a lower flow rate than the first and second pulses during an expiratory period that follows the first and second pulses (Christopher: FIG. 32 A flow of 15 L/min is selected to be administered throughout the inspiratory phase and a flow of 7 L/min is selected to be administered throughout the expiratory phase. Thus, flow-targeted ventilation is synchronized with the respiratory cycle and results in a flow pattern that is not the same constant flow throughout the entire respiratory cycle as set forth in [0132]). Doing so would facilitate speech and glottic functioning and to prevent airway collapse and wash out dead space without providing excessive expiratory flows for the patient (Christopher: As set forth in [0132]).
Regarding claim 17, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 16 above.
Porges as modified does not explicitly disclose a ventilation device, wherein the controller is configured to control the gas source control valve to deliver to the patient interface a third gas pulse of the compressed air during an expiratory period that follows the first and second gas pulses, wherein the controller is configured to control the delivery of the third pulse at a lower flow rate than the first and second pulses.
However, Christopher teaches supplying air during an expiratory period that follows the inspiratory period at a lower flow rate than in the inspiratory period (Christopher: FIG. 32 A flow of 15 L/min is selected to be administered throughout the inspiratory phase and a flow of 7 L/min is selected to be administered throughout the expiratory phase. Thus, flow-targeted ventilation is synchronized with the respiratory cycle and results in a flow pattern that is not the same constant flow throughout the entire respiratory cycle as set forth in [0132]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porges to incorporate the teaching of Christopher and output a third pulse of the compressed air at a lower flow rate than the first and second pulses during an expiratory period that follows the first and second pulses (Christopher: FIG. 32 A flow of 15 L/min is selected to be administered throughout the inspiratory phase and a flow of 7 L/min is selected to be administered throughout the expiratory phase. Thus, flow-targeted ventilation is synchronized with the respiratory cycle and results in a flow pattern that is not the same constant flow throughout the entire respiratory cycle as set forth in [0132]). Doing so would facilitate speech and glottic functioning and to prevent airway collapse and wash out dead space without providing excessive expiratory flows for the patient (Christopher: As set forth in [0132]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Porges (US-8915249-B2) in view of Anderson (US-20180193583-A1) and Poon (WO-2021137124-A1) as applied to claim 15, in further view of Bambrilla (US-20150068519-A1).
Regarding claim 20, Porges as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Porges as modified fails to explicitly disclose the ventilation device, wherein the patient interface includes an air entrainment interface.
However, Bambrilla teaches wherein a patient interface includes an air entrainment interface (Bambrilla: As set forth in [0010]).
Porges and Bambrilla are both considered to be analogous to the claimed invention because they are in the same field of ventilation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Porges to incorporate the teaching of Bambrilla and include wherein the patient interface includes an air entrainment interface (Bambrilla: As set forth in [0010]). Doing so allows the device to deliver proper mixtures of air and oxygen (Bambrilla: As set forth in [0010]).
Response to Arguments
Applicant's arguments filed 07/21/2026 have been fully considered but they are not persuasive.
Applicant argues that the Porges-Poon-Anderson combination relied on in the Office Action does not teach or suggest the claimed architecture, wherein the same compressor outlet feeds the gas source control valve through two parallel routes: a concentrator route that produces concentrated oxygen gas, and a bypass route that delivers ambient-composition compressed air to the valve without passing through the oxygen concentrator, and that specifically, Porges does not disclose a single compressor outlet feeding both an oxygen-concentrator path and a compressor-bypass path to a common gas source control valve, and that Poon or Anderson do not cure this deficiency. Applicant also argues that the combination set forth in the previous office action is a hindsight reconstruction.
However, Examiner would like to note that Porges teaches delivering compressed air directly to the patient with supplemental oxygen added to the airflow, while Poon is relied upon for teaching a compressor that compresses ambient air and supplies the compress air to an oxygen cannister. As explained in the Office Action, the modification replaces the air source of Porges with the compressor taught by Poon. Since Porges already includes a compressed air pathway directly to a pathway being delivered to the patient, the substitute compressor supplies the compress air for that pathway while also supplying the oxygen concentrator. Thus, the proposed modification is based on maintaining the operation of Porges using the compressed air source taught by Poon, not on importing every aspect of Poon’s specific gas flow arrangement. Further, Poon even teaches two possible distinct pathways at the outlet of the compressor. Accordingly, the rejection is not a hindsight reconstruction, and is predictable substitution to one of ordinary skill in the art for the compressed air sources to enable the system to utilize ambient air as the air source while also being used to produce a concentrated oxygen gas. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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 KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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