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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 07/18/2023, 01/04/2024, 03/13/2024, 05/23/2024, 06/25/2024, 09/18/2024, 10/01/2024, 10/24/2024, 05/27/2025 and 12/02/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 25-28 are 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 25 recites “…wherein at least one gas supply system includes a therapeutic gas delivery system, wherein the one or more displays is configured to display the delivery of therapeutic gas through the therapeutic gas delivery system.” Claim 25 depends on claim 1, lines 1-2, which recites “A therapeutic gas delivery system comprising: at least one gas supply subsystem comprising…” Therefore, it is unclear how a therapeutic gas delivery system comprises of at least one gas supply subsystem (from claim 1) is to then comprise of a therapeutic gas delivery system (from claim 25). As best understood, for examination purposes, claim 25 will read as “…
Claim(s) 26-28 is/are rejected as they depend from and therefore incorporate the claimed subject matter rejected under this statute.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-8, 20, 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bathe (US 8573210 B2).
Regarding claim 1, Bathe teaches a therapeutic gas delivery system (gas delivery system 10, see Fig. 1) comprising:
at least one gas supply subsystem (gas source 50 and 60, see Fig. 1 and 7 and Col. 10, lines 49-61) comprising:
a gas source coupling (attachment portion 102, see Fig. 2) configured to receive a therapeutic gas source and form a fluid flow connection with the therapeutic gas source (Bathe teaches an attachment portion 102 for attaching the valve assembly 100 to the gas source 50 as seen in Fig. 2 and Col. 6, lines 26-29);
a therapeutic gas delivery system controller (control module 200, see Fig. 1); and
one or more display(s) (display 270, Fig. 10) configured to be in communication over a communication path with the therapeutic gas delivery system controller (Bathe teaches control module 200 to include a display 270 for providing visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Figs. 9-10 and Col. 11, lines 3-28),
wherein the one or more display(s) are configured to display a graphical, illustrative, or numerical indicator of at least one of a flow parameter and/or a system parameter (display 270 displays a visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Fig. 10 and Col. 11, lines 3-28. Bathe further teaches visual alarms may be displayed, as well as a main power indicator 272 as seen in Col. 11, lines 3-28).
Regarding claim 2, Bathe teaches the delivery system of claim 1, and further teaches wherein the one or more display(s) are further configured to display a visual alarm (display 270 displays a visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Fig. 10 and Col. 11, lines 3-28. Bathe further teaches visual alarms may be displayed as seen in Col. 11, lines 3-28).
Regarding claim 3, Bathe teaches the delivery system of claim 2, and further teaches
wherein the therapeutic gas delivery system controller is configured to produce an audible alarm (Bathe teaches the alarm to be audible and emitted through speaker 214 as seen in Figs. 1 and 13 and Col. 12, lines 15-33).
Regarding claim 4, Bathe teaches the delivery system of claim 1, and further teaches wherein the one or more display(s) are configured to display a bar graph, a chart, or a numerical display of a value of the at least one of the flow parameter and/or the system parameter (display 270 displays a visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Fig. 10 and Col. 11, lines 3-28 comprising of a numerical display of a value).
Regarding claim 7, Bathe teaches the delivery system of claim 1, and further teaches the therapeutic gas is nitric oxide (“…the gas used for treatment comprises nitric oxide.” see Col. 15, lines 47-48 and Col. 15, lines 47-60).
Regarding claim 8, Bathe teaches the delivery system of claim 7, and further teaches wherein the display is configured to present a concentration and/or flow rate of nitric oxide and breathing gas through the system (display 270 displays a visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Fig. 10 and Col. 11, lines 3-28 comprising a concentration and/or flow rate of nitric oxide and breathing gas through the system).
Regarding claim 20, Bathe teaches the delivery system of claim 1, and further teaches
wherein the one or more flow or system parameters includes at least one of a left cylinder status, right cylinder status, a patient line status, a sample gas sample line status, a delivery conduit status, an injector module status, a patient gas sample line status, and a breathing circuit expiratory limb status (display 270 displays a visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Fig. 10 and Col. 11, lines 3-28 which is a status of gas source 50 (taken as left cylinder status in Fig. 8).
Regarding claim 25, Bathe teaches the delivery system of claim 1, and further teaches wherein at least one gas supply system includes a therapeutic gas delivery system (see 112(b) rejection above; Bathe teaches a gas delivery system 10 for administering therapy gas comprising a gas source 50 as seen in Fig. 1 and Col. 5, line 60 to Col. 6, line 15), wherein the one or more displays is configured to display the delivery of therapeutic gas through the therapeutic gas delivery system (Bathe teaches control module 200 to include a display 270 for providing visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Figs. 1 and 9-10 and Col. 11, lines 3-28).
Regarding claim 26, Bathe teaches the delivery system of claim 25, and further teaches further comprising a breathing circuit (breathing circuit 410, see Fig. 1), wherein the one or more displays is configured to display the delivery of therapeutic gas to the breathing circuit (Bathe teaches control module 200 to include a display 270 for providing visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Figs. 1 and 9-10 and Col. 11, lines 3-28. As such, Bathe teaches display 270 to display the delivery of gas through breathing circuit 410 as the gas travels from the gas source 50 to ventilator 400 as seen in Fig. 1).
Regarding claim 27, Bathe teaches the delivery system of claim 26, and further teaches wherein the breathing circuit is a conventional ventilator circuit, an anesthesia circuit, a spontaneous circuit, a nasal cannula circuit, a high frequency jet ventilation circuit, a high frequency oscillatory ventilator unfiltered circuit, a dual-limb transport ventilator circuit, or a single-limb transport ventilator circuit (Bathe teaches ventilator 400 with an associated breathing circuit 410 as seen in Fig. 1 and Col. 9, lines 1-2 and therefore teaches a conventional ventilator circuit).
Claim(s) 29-30 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lucas (US 7159608 B1).
Regarding claim 29, Lucas teaches a therapeutic gas delivery system (system 10, see Fig. 2; Lucas teaches system 10 include banks of compressed gas cylinders 72 which includes stored compressed gases such as medical air, nitrogen, nitrous oxide and oxygen as seen in Col. 3, lines 7-23) comprising:
a first gas supply subsystem (banks of compressed gas cylinders 72 (left), see Fig. 2) comprising a first compressed gas cylinder configured to supply therapeutic gas (Lucas teaches banks of compressed gas cylinders 72 (left)which includes stored compressed gases such as medical air, nitrogen, nitrous oxide and oxygen as seen in Fig. 2 and Col. 3, lines 7-23);
a second gas supply subsystem (banks of compressed gas cylinders 72 (right)), see Fig. 2) comprising a second compressed gas cylinder configured to supply therapeutic gas (Lucas teaches banks of compressed gas cylinders 72 (right) which includes stored compressed gases such as medical air, nitrogen, nitrous oxide and oxygen as seen in Fig. 2 and Col. 3, lines 7-23); and
a therapeutic gas delivery system controller (manifold logic board 40 and processor 42, see Fig. 2),
wherein the therapeutic gas delivery system receives therapeutic gas from the first compressed gas cylinder until the first compressed gas cylinder is depleted, wherein when the first compressed gas cylinder is depleted the therapeutic gas delivery system controller performs an automatic switchover such that the therapeutic gas delivery system receives therapeutic gas from the second compressed gas cylinder (Lucas teaches banks of compressed gas cylinders 72 (left and right) as seen in Fig. 2, and further teaches automatically switching between an “In-Use” supply of compressed gas to a “Reserve” supply of compressed gas as seen in Col. 2, lines 1-11 and Col. 3, lines 26-54. As such, Lucas teaches when the left bank of compressed gas cylinders 72 is depleted, the switch between the input line occurs such that system 10 receives gas from the right bank of the compressed gas cylinders 72).
Regarding claim 30, Lucas teaches the delivery system of claim 29, and further teaches wherein the automatic switchover provides continuous uninterrupted delivery of therapeutic gas to a patient (Lucas teaches manifold 20 detecting when the gas pressure for the In-Use supply lines falls below a threshold value, the manifold automatically switches the input supply lines to the Reserve supply to prevent any interruption of the supply of gas as seen in Col. 3, lines 26-44).
Regarding claim 34, Lucas teaches the delivery system of claim 29, and further teaches further comprising at least one display (display panel 54, see Fig. 3) in communication with the therapeutic gas delivery system controller (Lucas teaches display panel 54 to output statuses associated with each of the input supply lines as seen in Col. 3, lines 45-54 and further teaches processor 42 is operative responsive to the electrical signals from the transducers 32, 34, 36 to output corresponding pressure levels through the display panel 54 as seen in Col. 8, lines 7-19), wherein the at least one display is configured to display a visual alarm when the first compressed gas cylinder is depleted (Fig. 3 shows display panel 54 with LEDs 86 to be lighted up when the banks of compressed gas cylinders 72 (left) is empty as seen in Col. 4, lines 20-37).
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Harvie (US 20030189492 A1).
Regarding claim 5, Bathe teaches the delivery system of claim 1, but does not teach wherein the one or more display(s) are configured to present a graphic of the therapeutic gas delivery system comprising indicators for flow of the therapeutic gas through the system.
However, Harvie teaches wherein the one or more display(s) (LCD display 33, see Fig. 4) are configured to present a graphic of the therapeutic gas delivery system comprising indicators for flow of the therapeutic gas through the system (Fig. 4 shows LCD display 33 of electronic control unit 1 which displays a digital and analog pressure or liquid oxygen level indicator 32 visually displaying the remaining levels of gas in the oxygen or compressed air supply cylinder or tank 5 as seen in [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to include an oxygen level indicator to visually display the remaining levels of gas in the compressed air supply cylinder as taught by Harvie to have a graphic display of oxygen levels (see [0099]) that will aid in visually alerting the personnel the oxygen levels.
Regarding claim 6, Bathe in view of Harvie teaches the delivery system of claim 5, and Harvie further teaches wherein the graphic of the therapeutic gas delivery system further comprises indicators for a status of the therapeutic gas source, a sample line, an injector module, expiratory tubing, an electronically controlled gas blending device, or combinations thereof (Harvie teaches LCD display 33 of electronic control unit 1 which displays a digital and analog pressure or liquid oxygen level indicator 32 (taken as indicator for a status of therapeutic gas source) visually displaying the remaining levels of gas in the oxygen or compressed air supply cylinder or tank 5 as seen in Fig. 4 and [0099]).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Setzer (US 20080072902 A1).
Regarding claim 9, Bathe teaches the delivery system of claim 1, but does not teach further comprising an electrical power supply connection, an internal battery, and a power button, wherein the power button includes a power indicator that visually indicates an electrical power supply status of the electrical power supply connection and a battery charge status of the internal battery
However, Setzer teaches comprising an electrical power supply connection, an internal battery, and a power button, wherein the power button includes a power indicator that visually indicates an electrical power supply status of the electrical power supply connection and a battery charge status of the internal battery (Sanchez teaches a user interface for breathing assistance systems as seen in [0026], wherein Fig. 3 shows a power button 82 on a side panel of housing 78 as seen in [0050]. Sanchez further teaches a battery status region 146 to display the status of one or more ventilator batteries as seen in Fig. 5 and [0066]. Not to mention, Sanchez teaches if the ventilator 24 is plugged into an AC power source, external power LED 94 lights up, whereas, battery power LED 96 is lit up when ventilator 24 is running on batteries as seen in Fig. 5 and [0054] (which teaches an electrical power supply status as it can be either an AC power source or batter powered). Furthermore, there is an electrical power supply connection to connect the power supply to the ventilator which allows the ventilator to be powered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to include an electrical power supply connection, an internal battery, and a power button, wherein the power button includes a power indicator that visually indicates an electrical power supply status of the electrical power supply connection and a battery charge status of the internal battery as taught by Setzer as batteries are a known power source for ventilators, a power button is a known structure to turn on a ventilator, and the power indicator and battery charge status allows a user to know what power source is being used and the current status of battery charge (see [0054] and [0066]) to know when batteries need to be replaced.
Regarding claim 10, Bathe in view of Setzer teaches the delivery system of claim 9, and Setzer further teaches wherein one or more system parameters includes an electrical power supply status and a battery charge status (Sanchez teaches a battery status region 146 to display the status of one or more ventilator batteries as seen in Fig. 5 and [0066]. Not to mention, Sanchez teaches if the ventilator 24 is plugged into an AC power source, external power LED 94 lights up, whereas, battery power LED 96 is lit up when ventilator 24 is running on batteries as seen in Fig. 5 and [0054] (which teaches an electrical power supply status as it can be either an AC power source or batter powered).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Gamard (US 20080150739 A1).
Regarding claim 11, Bathe teaches the delivery system of claim 1, but does not teach further comprising an alarm silence button, wherein the alarm silence button includes an alarm indicator that visually indicates a status of one or more alarms of the therapeutic gas delivery system.
However, Gamard teaches further comprising an alarm silence button (‘Timer/Alarm Off’ key 48, see Fig. 2), wherein the alarm silence button includes an alarm indicator that visually indicates a status of one or more alarms of the therapeutic gas delivery system (Gamard teaches an alarm message 66 that may be presented in a flashing sequence or using altnerating colors for the message and background as seen in [0019]. Gamard further teaches ‘Timer/Alarm Off’ key 48 to terminate, pause or temporarily suspend the timing and alarm functions of the processor as seen in [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to include the Timer/Alarm Off key as taught by Gamard to deactivate the alarm such that the user can edit the data, adjust the parameters or turn off the flow of medical gas (see [0014]).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Thomson (US 20090139522 A1).
Regarding claim 12, Bathe teaches the delivery system of claim 1, but does not teach further comprising a global status indicator, wherein the global status indicator visually indicates one or more global statuses of the therapeutic gas delivery system.
However, Thomson teaches comprising a global status indicator (plurality of light emitting diodes (LED's) 106, 108, and 110, see Fig. 5), wherein the global status indicator visually indicates one or more global statuses of the therapeutic gas delivery system (Thomson teaches a first LED 110 to emit a first color of to indicate the cycling of breathing, a second LED 108 having a second color to show that the overall system is on and has sufficient power to operate and a third LED 106 having a third color used to show an alarm condition, wherein if there is a power failure or the device stops cycling, the third LED 106 turns on as seen in [0051]-[0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to include the global status indicator as taught by Thomson to alert the user if the gas system is performing normally or if there is an error and further providing more details based on which LED(s) is lighted or not lighted (see [0051]-[0054]).
Regarding claim 13, Bathe in view of Thomson teaches the delivery system of claim 12, and Thomson further teaches wherein one or more of the global statuses include a delivery status and an alarm status (Thomson teaches a first LED 110 to emit a first color of to indicate the cycling of breathing, a second LED 108 having a second color to show that the overall system is on and has sufficient power to operate and a third LED 106 having a third color used to show an alarm condition, wherein if there is a power failure or the device stops cycling, the third LED 106 turns on as seen in [0051]-[0054]. Therefore, Thomson teaches a delivery status with first LED 110 and second LED 108 and an alarm status with third LED 106).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Slaker (US 20110056489 A1).
Regarding claim 14, Bathe teaches the delivery system of claim 1, and further teaches further comprising an injector module outlet (injection module tubing outlet 276, see Fig. 10)
But does not teach a corresponding port indicator, wherein the port indicator visually indicates a delivery status of the injector module outlet.
However, Slaker teaches a corresponding port indicator (one or more LEDs or other indicators 223, see Fig. 10a), wherein the port indicator visually indicates a delivery status of a port ([0304] of applicant’s specification recites ” The one or more port indicators 712 (e.g., 712(a), 712(b)) may include one or more visual indicators (e.g., LED light), which may indicate the status of one or more corresponding ports (e.g., port status of injector module outlet 722, port status of secondary delivery subsystem outlet 726) of the therapeutic gas delivery system 100.” Slaker teaches the gas delivery port 134 to disperse oxygen or other therapeutic gases out of the respiratory treatment system 100. Slaker further teaches operation of the gas delivery ports 134 or other system elements can be indicated by LEDs or other indicators 123 as seen in [0031] and the one or more LEDs or other indicators 223 to show function of gas delivery ports as seen in [0054]. As such, the one or more LEDs or other indicators 223 indicate a delivery status of a port (whether or not gas delivery port 134 is dispersing oxygen or other therapeutic gases)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to include one or more LEDs or other indicators and sensors as taught by Slaker to show the function of gas delivery ports (see [0031] and [0054]) to assure the port is working.
Regarding claim 15, Bathe teaches the delivery system of claim 1, and further teaches further comprising a secondary delivery subsystem outlet (Bathe teaches gas source 50 and 60 as seen in Fig. 7. Bathe further teaches gas source 50 with an outlet 106 as seen in Fig. 2. As such, gas source 60 should also have an outlet to establish fluidic communication with the second valve assembly of the gas delivery device as seen in Col. 10, lines 51-61).
But does not teach a corresponding port indicator, wherein the port indicator visually indicates a delivery status of the secondary delivery subsystem outlet.
However, Slaker teaches a corresponding port indicator (one or more LEDs or other indicators 223, see Fig. 10a), wherein the port indicator visually indicates a delivery status of a port ([0304] of applicant’s specification recites ” The one or more port indicators 712 (e.g., 712(a), 712(b)) may include one or more visual indicators (e.g., LED light), which may indicate the status of one or more corresponding ports (e.g., port status of injector module outlet 722, port status of secondary delivery subsystem outlet 726) of the therapeutic gas delivery system 100.” Slaker teaches the gas delivery port 134 to disperse oxygen or other therapeutic gases out of the respiratory treatment system 100. Slaker further teaches operation of the gas delivery ports 134 or other system elements can be indicated by LEDs or other indicators 123 as seen in [0031] and the one or more LEDs or other indicators 223 to show function of gas delivery ports as seen in [0054]. As such, the one or more LEDs or other indicators 223 indicate a delivery status of a port (whether or not gas delivery port 134 is dispersing oxygen or other therapeutic gases)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to include one or more LEDs or other indicators and sensors as taught by Slaker to show the function of gas delivery ports (see [0031] and [0054]) to assure the port is working. Furthermore, one of ordinary skill in the art would recognize to include one or more LEDs or indicators and sensors for both gas delivery ports of gas source 50 and 60 as both gas sources will be delivering gas to the system.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Allen (US 20160282165 A1).
Regarding claim 16, Bathe teaches the delivery system of claim 1, and further teaches wherein the therapeutic gas source includes a first compressed gas cylinder (gas source 50, see Fig. 1), wherein the one or more flow or system parameters includes a first cylinder status, wherein the first cylinder status visually indicates whether the first compressed gas cylinder is delivering therapeutic gas or is idle (display 270 displays a visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Fig. 10 and Col. 11, lines 3-28 (which shows whether the gas cylinder is delivering therapeutic gas or idle),
But does not teach wherein the first cylinder status includes a percentage of available therapeutic gas in the first compressed gas cylinder.
However, Allen teaches wherein the first cylinder status includes a percentage of available therapeutic gas in the compressed gas cylinder (Allen teaches display 6 to provide information on the calculated time remaining for a patient to continue to draw gas from the cylinder at the current flow rate before the cylinder becomes fully depleted as well as a graphical scale of between 0 and 100% representing the amount of gas remaining in the cylinder as a percentage of the maximum amount of gas as seen in [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to include a percentage of available therapeutic gas in the compressed gas cylinder as taught by Allen to have a graphical representation of the percentage of available therapeutic gas in the compressed gas cylinder (see [0051]) to know when to change out the cylinder before/when the gas completely depletes.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Allen (US 20160282165 A1), as applied to claim 16 above, and further in view of Skidmore (US 20110138323 A1).
Regarding claim 17, Bathe in view of Allen teaches the delivery system of claim 16, and Bathe further teaches alarms/alerts but does not teach wherein the first cylinder status visually indicates if the first compressed gas cylinder is in a low priority alarm or a high priority alarm.
However, Skidmore teaches the icon display module 222 to communicate the seriousness or priority of an alarm message via exclamation marks, wherein the more exclamation marks communicate it is relatively serious as seen in Figs. 3-5 and [0028]. Skidmore further teaches if multiple alarm messages occur at a similar time, the clinicians can readily determine which alarm messages are of higher priority and should be addressed more quickly as seen in as seen in [0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe in view of Allen to indicate the seriousness or priority of an alarm message as taught by Skidmore to aid clinicians in determining which alarm messages are of high priority and should be addressed more quickly (see [0030]).
Regarding claim 18, Bathe in view of Allen teaches the delivery system of claim 16, and further teaches wherein the therapeutic gas source includes a second compressed gas cylinder (Bathe teaches a second gas source 60 as seen in Col. 10, lines 51-61).
But does not teach wherein the one or more flow or system parameters includes a second cylinder status, wherein the second cylinder status visually indicates whether the second compressed gas cylinder is delivering therapeutic gas or is idle, wherein the second cylinder status includes a percentage of available therapeutic gas in the second compressed gas cylinder.
However, Lucas teaches banks of compressed gas cylinders 72 (left) (taken as first compress gas cylinder) and banks of compressed gas cylinders 72 (right) (taken as second compress gas cylinder) as seen in Fig. 2 and further teaches display panel 54 outputting statuses associated with both the left bank and right bank as seen in Figs. 3-4 and Col. 4, lines 4-37 and lines 48-65.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe in view of Allen to have the display output parameters for both the first compressed gas cylinder and second compressed gas cylinder as taught by Lucas to output parameters/statuses associated with both cylinders on the display, to monitor each cylinder (see Col. 4, lines 4-37).
Modified Bathe teaches wherein the one or more flow or system parameters includes a second cylinder status, wherein the second cylinder status visually indicates whether the second compressed gas cylinder is delivering therapeutic gas or is idle, wherein the second cylinder status includes a percentage of available therapeutic gas in the second compressed gas cylinder (Modified Bathe teaches the display to output parameters for both the first compressed gas cylinder and second compressed gas cylinder (taught by Lucas), and therefore teaches the display 270 displays a visual indication to the user the components of the gas being delivered from the gas source 60 to the ventilator 400 (taught by Bathe) and a graphical representation of the percentage of available therapeutic gas in the second compressed gas cylinder (taught by Allen).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Allen (US 20160282165 A1) and Lucas (US 7159608 B1), as applied to claim 18 above, and further in view of Skidmore (US 20110138323 A1).
Regarding claim 19, modified Bathe teaches the delivery system of claim 18, but does not teach wherein the second cylinder status visually indicates if the second compressed gas cylinder is in a low priority alarm or a high priority alarm.
However, Skidmore teaches the icon display module 222 to communicate the seriousness or priority of an alarm message via exclamation marks, wherein the more exclamation marks communicate it is relatively serious as seen in Figs. 3-5 and [0028]. Skidmore further teaches if multiple alarm messages occur at a similar time, the clinicians can readily determine which alarm messages are of higher priority and should be addressed more quickly as seen in as seen in [0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Bathe to indicate the seriousness or priority of an alarm message as taught by Skidmore to aid clinicians in determining which alarm messages are of high priority and should be addressed more quickly (see [0030]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Lucas (US 7159608 B1) and Tolmie (WO 2014159912 A1).
Regarding claim 21, Bathe teaches the delivery system of claim 1, and further teaches a second gas source 60 as seen in Col. 10, lines 51-61
but does not teach wherein the one or more flow or system parameters includes at least one of a secondary delivery subsystem status and dose.
However, Lucas teaches banks of compressed gas cylinders 72 (left) (taken as first delivery subsystem) and banks of compressed gas cylinders 72 (right) (taken as second delivery subsystem) as seen in Fig. 2 and further teaches display panel 54 outputting statuses associated with both the left bank and right bank as seen in Figs. 3-4 and Col. 4, lines 4-37 and lines 48-65.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to have the display output parameters for both the first delivery subsystem and second delivery subsystem as taught by Lucas to output parameters/statuses associated with both cylinders on the display, to monitor each cylinder (see Col. 4, lines 4-37). Bathe in view of Lucas teaches the display to output parameters for both the first delivery subsystem and second delivery subsystem (taught by Lucas), and therefore teaches the display 270 displays a visual indication to the user the components of the gas being delivered from the gas source 60 to the ventilator 400 (taught by Bathe).
However, Tolmie teaches wherein the one or more flow or system parameters include a dose (“The apparatus can also include a display that provides a visual and/or numeric indication of the volumetric flow of breathing gas and/or the calculated dose. This visual and/or numeric indication can include any means of displaying the flow of breathing gas and/or calculated dose, including numerals, graphics, images or the like.” See [0046], [0044] and [0034]).
Bathe teaches the control module 200 may be configured to alert a user when the desired dose has been delivered as seen in Col. 14, lines 8-33. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe in view of Lucas to have the display provide a visual and/or numeric indication of the calculated dose and include the CPU as taught by Tolmie to inform the user when the dose rises above or falls below a predetermined level (see [0044]).
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Lucas (US 7159608 B1).
Regarding claim 22, Bathe teaches the delivery system of claim 1, and further teaches wherein at least one gas supply system includes a secondary delivery subsystem (Bathe teaches a second gas source 60 as seen in Col. 10, lines 51-61)
But does not teach wherein the one or more displays is configured to display the delivery of therapeutic gas through the secondary delivery subsystem.
However, Lucas teaches banks of compressed gas cylinders 72 (left) (taken as first delivery subsystem) and banks of compressed gas cylinders 72 (right) (taken as second delivery subsystem) as seen in Fig. 2 and further teaches display panel 54 outputting statuses associated with both the left bank and right bank as seen in Figs. 3-4 and Col. 4, lines 4-37 and lines 48-65.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe in view of Allen to have the display output parameters for both the first delivery subsystem and delivery subsystem as taught by Lucas to output parameters/statuses associated with both cylinders on the display, to monitor each cylinder (see Col. 4, lines 4-37).
Regarding claim 23, Bathe in view of Lucas teaches the delivery system of claim 22, and Bathe further teaches further comprising a breathing circuit (breathing circuit 410, see Fig. 1), wherein the one or more displays is configured to display the delivery of therapeutic gas to the breathing circuit (Bathe teaches control module 200 to include a display 270 for providing visual indication to the user the components of the gas being delivered from the gas source 50 to the ventilator 400 as seen in Figs. 1 and 9-10 and Col. 11, lines 3-28. As such, Bathe teaches display 270 to display the delivery of gas through breathing circuit 410 as the gas travels from the gas source 50 to ventilator 400 as seen in Fig. 1).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Lucas (US 7159608 B1), as applied to claim 23 above, and further in view of Kemps (US 20130220326 A1).
Regarding claim 24, Bathe in view of Lucas teaches the delivery system of claim 23, but does not teach wherein the breathing circuit is a t-piece resuscitator circuit, an infant resuscitator circuit, or an infant t-piece resuscitator circuit.
However, Kemps teaches a T-piece resuscitator apparatus 3 as a patient interface as seen in Figs. 1 and 7-9 and [0024] and [0192], wherein T-piece resuscitator apparatus 3 is connected to conduit 5 as seen in Fig. 1 and [0126]. Kemps further apparatus 3 to include a breath indicator 14 which switches between two visual indicator states to see the breath by breath indication of an infant as seen in Fig. 3 and [0136]-[0137] and [0166].
Bathe teaches the patient can be a near-term neonate as seen in Col. 15, lines 39-46. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe in view of Lucas to use the t-piece resuscitator apparatus as a patient interface and include the resuscitator as taught by Kemps to aid ventilating a neonate or infant as the indicators allow a medical professional to determine if an infant is breathing correctly (see [0126] and [0168]).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bathe (US 8573210 B2) in view of Montgomery (US 20070190184 A1).
Regarding claim 28, Bathe teaches the delivery system of claim 26, but does not teach
wherein the breathing circuit is a high frequency oscillatory ventilator filtered circuit, an infant flow circuit, a precision flow circuit, a continuous positive airway pressure system circuit, a high flow breathing circuit, a high flow infant circuit nasal cannula circuit, or a high flow nasal cannula oxygen therapy circuit.
However, Montgomery teaches wherein the breathing circuit is a high frequency oscillatory ventilator filtered circuit, an infant flow circuit, a precision flow circuit, a continuous positive airway pressure system circuit, a high flow breathing circuit, a high flow infant circuit nasal cannula circuit, or a high flow nasal cannula oxygen therapy circuit (Montgomery teaches a NO delivery system for when the patient is being mechanically ventilated in Fig. 8 and further teaches other gas delivery systems can be used in place of a ventilator, such as a constant positive airway pressure (CPAP) where the gas flow is from a blower as seen in [0062]).
Bathe teaches a nitric oxide delivery device as seen in Col. 15, lines 47-60. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Bathe to use CPAP delivery system as taught by Montgomery as an alternative gas delivery system (see [0062]).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas (US 7159608 B1) in view of Figley (US 20050217668 A1).
Regarding claim 31, Lucas teaches the delivery system of claim 29, and further teaches wherein the therapeutic gas delivery system receiving therapeutic gas from the second compressed gas cylinder (Lucas teaches system 10 include banks of compressed gas cylinders 72 (right) which includes stored compressed gases such as medical air, nitrogen, nitrous oxide and oxygen as seen in Col. 3, lines 7-23, wherein the right gas cylinder 72 delivers gas to system 10 as seen in Figs. 2-3)
But does not teach wherein the therapeutic gas delivery system receiving therapeutic gas from the second compressed gas cylinder provides time to disconnect the first compressed gas cylinder and connect a replacement compressed gas cylinder to the first gas supply subsystem.
However, Figley teaches wherein the therapeutic gas delivery system (system 10, see Fig. 1; Figley teaches a system 10 for administering therapeutic gas to a spontaneously breathing, non-ventilated patient as seen in [0128]) receiving therapeutic gas from the second source of gas provides time to disconnect the first compressed gas cylinder and connect a replacement compressed gas cylinder to the first gas supply subsystem (“…system 10 includes an internal reservoir for uninterrupted service. The reservoir contains a quantity of gas so the system can continue to deliver gas to the patient while the source gas cylinder is being replaced. The reservoir is recharged when a new source cylinder is connected. Uninterrupted gas delivery is important for certain applications such as inhaled nitric oxide therapy.” See [0144]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Lucas to have the second compressed gas cylinder to contain enough gas to provide time to disconnect the first compressed gas cylinder and connect a replacement compressed gas cylinder to the first gas supply subsystem as taught by Figley to have uninterrupted gas delivery while a new/replacement gas cylinder is being connected (see [0144]).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas (US 7159608 B1) in view of Figley (US 20050217668 A1), as applied to claim 31 above, and further in view of Drzewiecki (US 6076392 A).
Regarding claim 32, Lucas in view of Figley teaches the delivery system of claim 31, but does not teach wherein the replacement compressed gas cylinder includes a cylinder concentration such that the cylinder concentration can be verified before the replacement compressed gas cylinder is connected.
However, Drzewiecki teaches determining or verification of the identity and purity of a gas flowing from a source, as it is possible for an incorrect gas or a contaminated gas to be supplied as seen in Col. 6, line 50 to Col. 7, line 7. Drzewiecki further teaches using fluidic sensors and the memory of processor 130 to verify the identity of the gas as seen in Fig. 11B and Col. 28, lines 56-64 and Col. 30, lines 15-35.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Lucas in view of Figley to include the fluidic sensors and processor (and memory of the processor) as taught by Drzewiecki to verify the identity of the gas from a source to prevent an incorrect or contaminated gas from being supplied (see Col. 6, line 50 to Col. 7, line 7).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas (US 7159608 B1) in view of Figley (US 20050217668 A1), as applied to claim 31 above, and further in view of Bathe (US 20120240927 A1).
Regarding claim 33, Lucas in view of Figley teaches the delivery system of claim 31, but does not teach wherein the replacement compressed gas cylinder includes an expiration date such that the expiration date can be verified before the replacement compressed gas cylinder is connected.
However, Bathe teaches gas data to be provided in the form of a bar code 610 disposed on a label that is affixed to the side of the gas source, wherein the gas data may include information such as expiration date as seen in Fig. 5 and [0037].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Lucas in view of Figley to have a bar code with expiration date on the side of the gas source as taught by Bathe to prevent the drug from being delivered if the expiration date is assed the current date (see [0012] and [0060]).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas (US 7159608 B1) in view of Gamard (US 20080150739 A1).
Regarding claim 35, Lucas teaches the delivery system of claim 34, but does not teach wherein the at least one display is configured to display a visual alarm if a replacement compressed gas cylinder is not full with therapeutic gas.
However, Gamard teaches wherein the at least one display is configured to display a visual alarm if a replacement compressed gas cylinder is not full with therapeutic gas (Gamard teaches the main display 16B to present a visual alarm 66 or indicator to notify the user that the gas content within the cylinder is low as seen in Fig. 2 and [0019]. As such, main display 16B displays a visual alarm when a compressed gas cylinder (including the replacements) is not full with therapeutic gas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Lucas to have the display show a visual alarm when the gas content within the cylinder is low as taught by Gamard to be alerted when the gas cylinder is to be replaced (see [0019]).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas (US 7159608 B1) in view of Arp (US 5165397 A).
Regarding claim 36, Lucas teaches the delivery system of claim 29, and further teaches a bottom LED 86 to indicate when the input supply line has a sufficiently low pressure to be associated with an "Empty" status as seen in Fig. 3 and Col. 4, lines 20-37.
But does not teach wherein the therapeutic gas delivery system controller produces an audible alarm when the first compressed gas cylinder is depleted.
However, Arp teaches wherein the therapeutic gas delivery system controller (microprocessor 275, see Fig. 3) produces an audible alarm when the gas source is depleted (Arp teaches microprocessor 275 to output signals to alarm 75’ which can be audible, visible or a combination of both as seen in Fig. 3 and Col. 17, lines 35-58. Arp further teaches when oxygen source 10 is interrupted or depleted, the audible and visible alarms 75 will be activated as seen in Col. 8, line 46 to Col. 9, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Lucas to have an audible alarm for when a gas source is depleted as taught by Arp to alert the patient/personnel of an abnormal operating condition (see Col. 8, line 46 to Col. 9, line 2), especially as Lucas already teaches a visual alarm for when the banks of compressed gas cylinders 72 (left) is emptied.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas (US 7159608 B1) in view of Arp (US 5165397 A), as applied to claim 36 above, and further in view of Gamard (US 20080150739 A1).
Regarding claim 37, Lucas teaches the delivery system of claim 36, but does not teach wherein the therapeutic gas delivery system controller produces an audible alarm if a replacement compressed gas cylinder is not full of therapeutic gas.
However, Gamard teaches wherein the therapeutic gas delivery system controller produces an audible alarm if a replacement compressed gas cylinder is not full of therapeutic gas (Gamard teaches when the gas cylinder reaches an prescribed alarm threshold before it is emptied, the processor within the monitoring device 10 activates the alarm status 70 as well as the audible alarm as seen in [0018]-[0019]. As such, an audible alarm is produced when a compressed gas cylinder (including the replacements) is not full with therapeutic gas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Lucas to have the controller produce an audible alarm when the gas content within the cylinder reaches a prescribed alarm threshold as taught by Gamard to be alerted when the gas cylinder is to be replaced (see [0018]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sanchez (US 20110132369 A1) teaches a ventilation system with a system status display.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785