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 in response to the amendment filed on 05/20/2026. As directed by the amendment, claims 1-2, 6, 9, 16, 18, 25, 29-31 and 35 have been amended, claims 3-4, 10, 12-13, and 32-33 have been cancelled and claims 38-44 have been added. As such, claims 1-2, 5-8, 11, 14-31 and 34-44 are pending in the instant application.
Applicant has amended claim 25 to address a 112(b) rejection; the 112(b) rejection to the claims 25-28 has been withdrawn.
Response to Arguments
Applicant's arguments, see pages 9-13 of Remarks, filed 05/20/2026, pertaining to the
newly amended limitations have been noted. However, a new ground(s) of rejection has been
provided below to address the newly added limitations.
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) 1-2, 7-8, 20, 22-23, 25-27 and 40-42 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 Figley (US 20050217668 A1).
Regarding claim 1, Bathe teaches a therapeutic gas delivery (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 first gas source coupling (valve assembly 100 and attachment portion 102, see Fig. 2) configured to receive a first therapeutic gas source and form a fluid flow connection with the first 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 second gas source coupling (second valve assembly 101, see Fig. 7) configured to receive a second therapeutic gas source and form a fluid flow connection with the second therapeutic gas source (Bathe teaches a second valve assembly 101 which also comprises of an attachment portion 102 for gas source 60 to attach to as seen in Fig. 7 and Col. 10, lines 49-61);
a therapeutic gas delivery system controller (control module 200, see Fig. 1);
determine at least one of an identity, concentration, expiration date, or wetted volume of a therapeutic gas source (Bathe teaches gas data that can be provided in the form of a bar code 610 which comprises of gas composition, concentration, expiration date and other information as seen in Fig. 5 and Col. 7, lines 1-25. The gas data is entered into the valve memory 134 and compared to patient information from the CPU memory 212 by CPU 210 as seen in Fig. 12-13 and Col. 11, line 58 to Col. 12, line 33. The gas is administered if the gas data and patient information matches, else, an alarm will sound. Therefore, Bathe teaches determining at least one of an identity, concentration or expiration date of a gas source)
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).
But does not teach the therapeutic gas delivery system controller configured to:
automatically switch delivery of therapeutic gas to a patient from the first therapeutic gas source to the second therapeutic gas source such that delivery of therapeutic gas to the patient is uninterrupted; and
determine at least one of an identity, concentration, expiration date, or wetted volume of a replacement therapeutic gas source received by the first gas source coupling after the automatic switch.
However, Lucas teaches the therapeutic gas delivery system controller (manifold logic board 40 and processor 42, see Fig. 2) configured to:
automatically switch delivery of therapeutic gas to a patient from the first therapeutic gas source to the second therapeutic gas source such that delivery of therapeutic gas to the patient is uninterrupted (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 to prevent any interruption of the supply of 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, there is an automatic switch between the input line that occurs such that system 10 receives gas from the right bank of the compressed gas cylinders 72).
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 controller as taught by Lucas to seamlessly switch between the gas sources to prevent interruption of gas delivery (Col. 3, lines 26-54).
However, Figley teaches replacing the 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 Bathe in view of 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]). Bathe in view of Lucas and Figley teaches determine at least one of an identity, concentration, expiration date, or wetted volume of a replacement therapeutic gas source received by the first gas source coupling after the automatic switch (Figley teaches replacing a gas cylinder after the automatic switch and Bathe teaches determining at least one of an identity, concentration and expiration date of a gas source before administering the gas).
Regarding claim 2, modified Bathe teaches the delivery system of claim 1, and Bathe further teaches wherein the one or more display(s) are further configured to display a visual alarm, amd/or wherein the therapeutic gas delivery system controller is configured to produce an audible 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 and to be audible and emitted through speaker 214 as seen in Figs. 1 and 13 and Col. 11, lines 3-28 and Col. 12, lines 15-33).
Regarding claim 7, modified Bathe teaches the delivery system of claim 1, and Bathe 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, modified Bathe teaches the delivery system of claim 7, and Bathe 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, modified Bathe teaches the delivery system of claim 1, and Bathe 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 22, modified 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 further 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 modified Bathe 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, modified 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).
Regarding claim 25, modified Bathe teaches the delivery system of claim 1, and Bathe further teaches 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, modified Bathe teaches the delivery system of claim 25, 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).
Regarding claim 27, modified Bathe teaches the delivery system of claim 26, and Bathe 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).
Regarding claim 40, modified Bathe teaches the system of claim 1, and further teaches further comprising a gas source identifier reader (bar code 610, see Fig. 5) associated with the first gas source coupling, wherein the therapeutic gas delivery system controller is configured to determine the at least one of the identity, concentration, expiration date, or wetted volume of the replacement therapeutic gas source based on information read from a gas source identifier associated with the replacement therapeutic gas source by the gas source identifier reader (Bathe teaches valve assembly 100 includes valve 107 (which includes attachment portion 102) and circuit 150 as seen in Figs. 2-4 and Col. 6, lines 16-25. An external scanning device scans bar code 610 which conveys information to valve memory 134 of circuit 150 as seen in Col. 7, lines 1-25 of Bathe. Bar code 610 comprises of gas composition, concentration, expiration date and other information relating to gas data as seen in Fig. 5 and Col. 7, lines 1-25 of Bathe. The gas data is entered into the valve memory 134 and compared to patient information from the CPU memory 212 by CPU 210 as seen in Fig. 12-13 and Col. 11, line 58 to Col. 12, line 33 of Bathe. The gas is administered if the gas data and patient information matches, else, an alarm will sound. Therefore, Bathe teaches determining at least one of an identity, concentration or expiration date of a gas source. Modified Bathe therefore teaches determining at least one of an identity, concentration and expiration date of a gas source before administering the gas (taught by Bathe) after replacing a gas cylinder after the automatic switch (taught by Figley)).
Regarding claim 41, modified Bathe teaches the system of claim 40, and Bathe further teaches wherein the gas source identifier comprises at least one of an RFID tag, a QR code, or a barcode, and wherein the gas source identifier reader comprises at least one of an RFID reader, an imaging device, a camera, or a barcode scanner (Bathe teaches an external scanning device scans bar code 610 which conveys information to valve memory 134 of circuit 150 as seen in Fig. 5 and Col. 7, lines 1-25).
Regarding claim 42, modified Bathe teaches the system of claim 40, and Bathe further teaches further comprising a gas source detector (CPU transceiver 220, not directly shown in figures but is part of control module 200 shown in Fig. 9) operatively associated with the first gas source coupling, wherein the gas source detector is configured to detect that the replacement therapeutic gas source is properly received by the first gas source coupling before the gas source identifier reader reads the gas source identifier (Bathe teaches valve assembly 100 includes valve 107 and circuit 150, wherein circuit 150 includes a valve transceiver 120 for establishing communication with the control module 200 as seen in Figs. 2-4 and Col. 6, lines 16-25. Bathe further teaches when valve assembly 100 is placed on cart 500 in proximity and in a line-of-sight path with the CPU transceiver 220, a communication is established between the valve receiver 120 and the CPU transceiver 220 as seen in Figs. 9 and 12 and Col. 10, lines 36-48).
Claim(s) 5-6 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 Figley (US 20050217668 A1), as applied to claim 1 above, and further in view of Harvie (US 20030189492 A1).
Regarding claim 5, modified 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 modified 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, modified Bathe in view of Harvie teaches the delivery system of claim 5, and further teaches wherein the graphic of the therapeutic gas delivery system further comprises indicators for a status of the first therapeutic gas source, a status of the second 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]. As such, modified Bathe in view of Harvie teaches indicators for a status of both the first gas source 50 and second gas source 60 of Bathe as Bathe teaches two gas sources).
Claim(s) 9 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 Figley (US 20050217668 A1), as applied to claim 1 above, and further in view of Setzer (US 20080072902 A1).
Regarding claim 9, modified 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, and wherein one or more system parameters includes an electrical power supply status and a battery charge status
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, and wherein one or more system parameters includes an electrical power supply status and a battery charge status (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 modified 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.
Claim(s) 11 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 Figley (US 20050217668 A1), as applied to claim 1 above, and further in view of Gamard (US 20080150739 A1).
Regarding claim 11, modified 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 modified 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) 14-15 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 Figley (US 20050217668 A1), as applied to claim 1 above, and further in view of Slaker (US 20110056489 A1).
Regarding claim 14, modified Bathe teaches the delivery system of claim 1, and Bathe 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 modified 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, modified Bathe teaches the delivery system of claim 1, and Bathe 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 modified 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 and 18 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 Figley (US 20050217668 A1), as applied to claim 1 above, and further in view of Allen (US 20160282165 A1).
Regarding claim 16, modified Bathe teaches the delivery system of claim 1, and Bathe further teaches wherein the first 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 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 modified 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.
Regarding claim 18, modified Bathe teaches the delivery system of claim 16, and Bathe further teaches wherein second 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 further 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 modified Bathe 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 in view of Lucas 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) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable Bathe (US 8573210 B2) in view of Lucas (US 7159608 B1), Figley (US 20050217668 A1) and Allen (US 20160282165 A1), as applied to claim(s) 16/18 above, and further in view of Skidmore (US 20110138323 A1).
Regarding claim 17, modified Bathe 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 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]).
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 further 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 Bathe (US 8573210 B2) in view of Lucas (US 7159608 B1) and Figley (US 20050217668 A1), as applied to claim 1 above, and further in view of Tolmie (WO 2014159912 A1).
Regarding claim 21, modified Bathe teaches the delivery system of claim 1, and Bathe 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 further 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 modified 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). Modified 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 modified 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) 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) and Figley (US 20050217668 A1), as applied to claim 23 above, and further in view of Kemps (US 20130220326 A1).
Regarding claim 24, modified Bathe 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 modified Bathe 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 Lucas (US 7159608 B1) and Figley (US 20050217668 A1), as applied to claim 26 above, and further in view of Montgomery (US 20070190184 A1).
Regarding claim 28, modified 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 modified Bathe to use CPAP delivery system as taught by Montgomery as an alternative gas delivery system (see [0062]).
Claim(s) 29-31 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas (US 7159608 B1) in view of Bathe (US 8573210 B2) and Figley (US 20050217668 A1).
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) configured to:
automatically switch delivery of the therapeutic gas to a patient from the first compressed gas cylinder to the second compressed gas cylinder such that delivery of therapeutic gas to the patient is uninterrupted (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 to prevent any interruption of the supply of 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, there is an automatic switch between the input line that occurs such that system 10 receives gas from the right bank of the compressed gas cylinders 72).
but does not teach determine at least one of an identity, concentration, expiration date, or wetted volume of a replacement compressed gas cylinder received by the first gas supply subsystem after the automatic switch.
However, Bathe teaches determine at least one of an identity, concentration, expiration date, or wetted volume of a therapeutic gas source (Bathe teaches gas data that can be provided in the form of a bar code 610 which comprises of gas composition, concentration, expiration date and other information as seen in Fig. 5 and Col. 7, lines 1-25. The gas data is entered into the valve memory 134 and compared to patient information from the CPU memory 212 by CPU 210 as seen in Fig. 12-13 and Col. 11, line 58 to Col. 12, line 33. The gas is administered if the gas data and patient information matches, else, an alarm will sound. Therefore, Bathe teaches determining at least one of an identity, concentration or expiration date of a gas source)
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 include the CPU to determine at least one of an identity, concentration or expiration date of a therapeutic gas source as taught by Bathe to verify the gas data is correct for usage (see Col. 11, line 58 to Col. 12, line 33).
However, Figley teaches replacing the 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 in view of Bathe 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]). Lucas in view of Bathe and Figley teaches determine at least one of an identity, concentration, expiration date, or wetted volume of a replacement therapeutic gas source received by the first gas source coupling after the automatic switch (Figley teaches replacing a gas cylinder after the automatic switch and Bathe teaches determining at least one of an identity, concentration and expiration date of a gas source before administering the gas).
Regarding claim 30, modified Lucas teaches the delivery system of claim 29, and Lucas 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 31, modified Lucas teaches the delivery system of claim 29, and Figley further teaches 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 the 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]).
Regarding claim 34, modified Lucas teaches the delivery system of claim 29, and Lucas 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(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable Lucas (US 7159608 B1) in view of Bathe (US 8573210 B2) and Figley (US 20050217668 A1), as applied to claim 34 above, and further in view of Gamard (US 20080150739 A1).
Regarding claim 35, modified 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 the 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 modified 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 Bathe (US 8573210 B2) and Figley (US 20050217668 A1), as applied to claim 29 above, and further in view of Arp (US 5165397 A).
Regarding claim 36, modified 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 modified 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 Bathe (US 8573210 B2), Figley (US 20050217668 A1) and Arp (US 5165397 A), as applied to claim 36 above, and further in view of Gamard (US 20080150739 A1).
Regarding claim 37, modified 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 modified 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]).
Claim(s) 38-39 and 43-44 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 Figley (US 20050217668 A1), as applied to claim 1 above, and further in view of Acker (US 20150320953 A1).
Regarding claim 38, modified Bathe teaches the system of claim 1, but does not teach wherein the therapeutic gas delivery system controller is configured to automatically switch delivery of therapeutic gas to the patient from the first therapeutic gas source to the second therapeutic gas source when a run-time-to-empty value or pressure value of the first therapeutic gas source reaches a threshold value.
However, Acker teaches wherein the therapeutic gas delivery system controller (“…therapeutic gas delivery system 100 can include a system controller (not shown) and/or subsystems can include subsystem controllers such as, but not limited to, gas supply subsystem controller 129(a), gas supply subsystem controller 129(b), primary gas delivery subsystem controller 144, a secondary gas delivery subsystem controller 164, and/or a gas analyzing subsystem(s) controller 184.” See [0111]) is configured to automatically switch delivery of therapeutic gas to the patient from the first therapeutic gas source to the second therapeutic gas source when a run-time-to-empty value or pressure value of the first therapeutic gas source reaches a threshold value (Acker teaches a gas delivery system comprising two or more therapeutic gas sources in which when the run-time-to-empty value for the first therapeutic gas source is below a minimum threshold, there is a seamless transition from a first therapeutic gas source to a second therapeutic gas source as seen in [0096]. Acker further teaches the run-time-to-empty value is based off gas pressure values from a gas pressure sensor and a wetted volume of the therapeutic gas source as seen in [0189] and [0096]).
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 include the controller and pressure sensor taught by Acker to include a run-time-to-empty value for a seamless transition between gas sources when one gas source is below a threshold (see [0096]).
Regarding claim 39, modified Bathe in view of Acker teaches the system of claim 38, and Acker further teaches wherein the therapeutic gas delivery system controller is configured to calculate the run-time-to-empty value based on at least a gas pressure value, a wetted volume of the first therapeutic gas source, and an average therapeutic gas consumption rate (Acker teaches the run-time-to-empty value is based off gas pressure values from a gas pressure sensor and a wetted volume of the therapeutic gas source as seen in [0189] and [0096]).
Regarding claim 43, modified Bathe teaches the system of claim 40, but does not teach wherein the therapeutic gas delivery system controller is configured to maintain a shutoff valve downstream from the first gas source coupling in a closed state until verification analysis of the information read from the gas source identifier is complete.
However, Acker teaches wherein the therapeutic gas delivery system controller (“…therapeutic gas delivery system 100 can include a system controller (not shown) and/or subsystems can include subsystem controllers such as, but not limited to, gas supply subsystem controller 129(a), gas supply subsystem controller 129(b), primary gas delivery subsystem controller 144, a secondary gas delivery subsystem controller 164, and/or a gas analyzing subsystem(s) controller 184.” See [0111]) is configured to maintain a shutoff valve (shut off valve 126(a), see Fig. 2) downstream from the first gas source coupling (gas source connection valve 118(a), see Fig. 2) (see Fig. 2) in a closed state until verification analysis of the information read from the gas source identifier is complete (Acker teaches the gas delivery system controller may maintain shut off valve 126(a) in a closed state until completion of verification analysis of the therapeutic gas source data and keep the therapeutic gas source closed off from the gas delivery subsystems downstream from shut off valve 126(a), 126(b) if incorrect information is detected (e.g. expired gas source, concentration out of range, wetted volume out of range, wrong therapeutic gas, etc.) as seen in [0247]).
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 include the shut off valve and controller as taught by Acker to prevent an incorrect gas source from being connected/delivered (see [0164] and [0247]).
Regarding claim 44, modified Bathe in view of Acker teaches the system of claim 43, and Acker further teaches wherein the therapeutic gas delivery system controller is configured to maintain the shutoff valve in the closed state when the verification analysis indicates that the replacement therapeutic gas source is expired, has a concentration out of range, has a wetted volume out of range, or contains a wrong therapeutic gas (Acker teaches the gas delivery system controller may maintain shut off valve 126(a) in a closed state until completion of verification analysis of the therapeutic gas source data and keep the therapeutic gas source closed off from the gas delivery subsystems downstream from shut off valve 126(a), 126(b) if incorrect information is detected (e.g. expired gas source, concentration out of range, wetted volume out of range, wrong therapeutic gas, etc.) as seen in [0247]).
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.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785