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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (63/264, 336) filed on the November 19, 2021.
Response to Amendment
This office action is responsive to the amendment filed as April 14, 2026. As directed by the amendment: claims 1 and 27 have been amended, claim 6 and 26 are still canceled, and claim 33 has been added. Thus, claims 1-5, 7-25, and 27-33 are presently pending in the application.
Response to Arguments
Applicant argues on page 7 of the of the remarks that the 112(d)-rejection made on Claims 27 should be withdrawn. Applicant has amended the claim making the argument moot; the previous 112(d)-rejection has been hereby withdrawn.
Applicant argues on page 7 of the remarks that the 103-rejection of Gillerman in view of Ringwall is improper and should be withdrawn. However, Applicant amended the claim to add new limitation of “a pressure sensor configured to measure a pressure of the pressurized product gas in the scrubber and wherein an amount of the pressurized product gas accumulates within the scrubber and is at least partially scrubbed of NO2 prior to passage from the scrubber through the flow controllers wherein the amount of the pressurized product gas is at least an amount of product gas for a single NO pulse”, that was not previously considered. Applicant has amended the claims and a new 103 rejection stated below addresses the new limitation of the claim.
Applicant argues on page 7-8 of the remarks that the 103-rejection of Gillerman in view of Ringwall is improper for claims 1, 21, and 32 and should be withdrawn. Examiner respectfully disagrees. Examiner agrees that Gillerman does not specifically teach the limitation of the controller utilizing the pressure measurements from the pressure sensor. However, due to an absence of the limitations of a controller configured to regulate an amount of NO in the product gas by the plasma chamber, the controller utilizing a pressure measurement from the pressure sensor of Ringwall in the scrubber to determine a mass flow rate of the product gas out of the scrubber, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that the controller would reasonably encompass the absent limitation of regulating the amount of NO in the product gas by the plasma chamber for the purpose of providing improved flow accuracy at high and low flow rates. One would be motivated to use controller to use the sensors to accurately regulating the nitric oxide.
Applicant’s arguments with respect to claim(s) 14, 15, 16, 19, and 21-32 have been considered but are moot because the new ground of rejection is given.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention
Claim(s) 1-5, 7-13, 17-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillerman, (US 20200361773 A1), hereafter as Gillerman, in view of Richey et al. (US 20140190348 A1), hereafter as Richey.
Regarding Claim 1, Gillerman discloses a nitric oxide generation system (abstract; para. 0004, 0079) comprising:
a plasma chamber (plasma chamber 300; Fig. 7; para. 0004-0005, 0079, 0097) configured to ionize a reactant gas including nitrogen and oxygen to form a product gas that includes nitric oxide (Examiner notes: the chamber is to ionize a reactant gas comprising ambient air for producing a product gas containing NO);
a scrubber downstream (scrubber 304; Fig. 7; para. 0004, 0079, 0097) from the plasma chamber and having a volume at least partially containing NO2 scrubbing material (para. 0097; Examiner notes: the plasma chamber 300 is followed by a first scrubber 304 for removing nitrogen dioxide);
a flow controller (valve 305; Fig. 7; para. 0097) downstream of the scrubber, the flow controller configured to control the flow of the product gas from the scrubber to a delivery device (para. 0097; Examiner notes: the valve controls and adjust the product gas delivery from the 304 to inspiratory stream 312);
a pump (pump 302; Fig. 7; para. 0097) configured to convey the product gas from the plasma chamber into the scrubber, the pump configured to pressurize the product gas in the scrubber when the flow controller is positioned to restrict the flow of product gas from the scrubber (Examiner notes: when the valve 305 is in closed position it is positioned to restrict the flow of product gas, when no delivery to the inspiratory stream 312 is initiated and the pump 302 is delivering the product gas to the scrubber 304); and
wherein the pressurized product gas accumulates within the scrubber and is at least partially scrubbed of NO2 prior to passage from the scrubber through the flow controller wherein the amount of the pressurized product gas is at least an amount of product gas for a single NO pulse. (Fig. 7; para. 0097, 0137; Examiner notes: the pressurization of the product gas occurs when the valve is in closed position prior to initiating a delivery and the pump 302 is delivering the product gas to accumulate in the scrubber 304 comprising the scavenger material for NO2 removal followed by opening the valve 305 to deliver the product gas to the inspiratory system 312; the product gas from the controller is at least an amount for single pulse; para. 0097, 0181, 0223; Examiner notes: the product gas in pulsatile treatment is directed as a patient dose).
Gillerman does not specifically disclose a pressure sensor configured to measure a pressure of the pressurized product gas in the scrubber, the pressure sensor configured to communicate the measured pressure to a controller, the controller being configured to determine a flow rate of the product gas into the scrubber by controlling the pump, wherein the controller is configured to shut off the pump when the measured pressure reaches a target pressure (this limitation is functional; Gillerman does teach that sensors are used to monitor the effectiveness of the scrubber; para. 0159-0164).
However, Richey teaches a pressure sensor (Fig. 5A-5B; 534; para. 0070) configured to measure a pressure of the pressurized product gas in the scrubber (Fig. 5A-5B; 532), the pressure sensor configured to communicate the measured pressure to a controller (para. 0070; this limitation is functional however, the pressure sensor communicates with the controller), the controller being configured to determine a flow rate of the product gas into the scrubber by controlling the pump (Fig. 5A-5B; 530), wherein the controller is configured to shut off the pump when the measured pressure reaches a target pressure (para. 0070).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller, scrubber, and system of Modified Gillerman to include a pressure sensor configured to measure a pressure of the pressurized product gas in the scrubber, the pressure sensor configured to communicate the measured pressure to a controller, the controller being configured to determine a flow rate of the product gas into the scrubber by controlling the pump, wherein the controller is configured to shut off the pump when the measured pressure reaches a target pressure as taught by Richey for the purpose of shutting off the pump when a threshold is reached reduce energy usage of the pump or maintain a safe pressure at the accumulator (para. 0070).
Regarding Claim 2, Modified Gillerman discloses the system of claim 1, wherein a reactant gas flow rate through the plasma chamber (plasma chamber 300; Fig. 7; para. 0004, 0079, 0097) is continuous (para. 0095, 0097, 0117, 0246; Examiner notes: a reactant gas flow through the plasma chamber is performed continuously).
Regarding Claim 3, Modified Gillerman discloses the system of claim 2, wherein the reactant gas flow rate through the plasma chamber (plasma chamber 300; Fig. 7; para. 0004, 0079, 0097) is a constant value (para. 0095, 0097, 0117, 0246; Examiner notes: a reactant gas flow through the plasma chamber performed at a constant rate).
Regarding Claim 4, Modified Gillerman discloses the system of claim 1, wherein a reactant gas flow rate through the plasma chamber (plasma chamber 300; Fig. 7; para. 0004, 0079, 0097) is intermittent (para. 0095, 0097, 0107, 0190, 0246; Examiner notes: a reactant gas flow through the plasma chamber is modulated utilizing on/off valve control making it “intermittent”; with valve 310).
Regarding Claim 5, Modified Gillerman discloses the system of claim 1, wherein a pressure within the plasma chamber (plasma chamber 300; Fig. 7; para. 0004, 0079, 0097) is at or below atmospheric pressure (para. 0012, 0097: the plasma chamber is operated at atmospheric).
Regarding Claim 7, Modified Gillerman discloses the system of claim 6, further comprising a controller configured to regulate an amount of NO in the product gas by modulating a plasma in the plasma chamber (para. 0097, 0159; NO generation is maintained at a desired level by controlling (a controller) plasma chamber activity based on feedback from various sensors), the controller utilizing a pressure measurement in the scrubber to determine a flow rate of the product gas out of the scrubber (pressure sensor; Richey and sensors in Gillerman (para. 0159-0160, 0163-0164) is gas sensor measuring pressure located after the scrubber to measure released conditions of the scrubber, i.e., a pressure measurement in the scrubber, used as a feedback to deliver desired dose of the scrubbed NO gas).
Regarding Claim 8, Modified Gillerman discloses the system of claim 1, wherein the product gas is delivered intermittently (para. 0097, 0181, 0223; examiner notes: the produced NO gas is used for pulsatile treatment).
Regarding Claim 9, Modified Gillerman discloses the system of claim 8, wherein a product gas delivery flow rate varies pulse to pulse (para. 0097, 0181, 0223; examiner notes: the produced NO gas is used to deliver the produced NO gas with a suitable flow for pulsatile treatment in which pulse dose are varied).
Regarding Claim 10, Modified Gillerman discloses the system of claim 8, wherein a product gas delivery flow rate varies within a pulse (para. 0097, 0181, 0223; examiner notes: the produced NO gas is used for pulsatile treatment in which concentration of NO varies within the NO pulse).
Regarding Claim 11, Modified Gillerman discloses the system of claim 1, wherein a mass of the product gas in the scrubber (scrubber 304; Fig. 7; para. 0004, 0079, 0097) is at least a mass of a single NO pulse (para. 0095, 0097, 0102; Examiner notes: the product gas in pulsatile treatment is directed as a patient dose, i.e., a mass of the product gas, as a pulse of the patient dose directly from the scrubber meeting the needed dosing amount, i.e., at least a mass of a single NO pulse).
Regarding Claim 12, Modified Gillerman discloses the system of claim 1, wherein the volume between the scrubber (scrubber 304; Fig. 7; para. 0004, 0079, 0097) and the flow controller (valve 305; Fig. 7; para. 0097) is less than 5 ml (para. 0097; Examiner notes: when eliminating dead volume = no dead volume by placing the flow controller at the end of the scrubber).
Regarding Claim 13, Modified Gillerman discloses the system of claim 1, wherein the volume between the scrubber (scrubber 304; Fig. 7; para. 0004, 0079, 0097) and the flow controller (valve 305; Fig. 7; para. 0097) is less than 10 ml (para. 0097; Examiner notes: when eliminating dead volume = no dead volume by placing the flow controller at the end of the scrubber).
Regarding Claim 17, Modified Gillerman discloses the system of claim 1, further comprising a controller configured to calculate an estimated amount of NO loss within the system due to at least one of oxidation of NO and interaction between the product gas and components of the system (para. 0097, 0142, 0154; Examiner notes: NO loss is quantified, for example the calculate an estimated amount of NO loss within the system, by utilizing a controller in the system in which loss occurs as well as NO loss due to NO oxidation).
Regarding Claim 18, Modified Gillerman discloses the system of claim 17, wherein the controller is configured to control the plasma chamber (plasma chamber 300; Fig. 7; para. 0004-0005, 0079, 0097) to overproduce NO in anticipation of the estimated amount of NO loss calculated by the controller (para. 0097, 0142, 0154; Examiner notes: the NO loss is quantified by utilizing the controller and the system is controlled to make up losses in NO production, i.e. overproduce NO).
Regarding Claim 20, Modified Gillerman discloses the system of claim 1, wherein a mass of gas between the pump (pump 302; Fig. 7; para. 0097) and the flow controller (valve 305; Fig. 7; para. 0097), including the scrubber (scrubber 304; Fig. 7; para. 0004, 0079, 0097), is greater than a mass of a pulse of gas to be delivered to a delivery device (para. 0094, 0097: Examiner notes: the produced amount of the product gas from input air to the valve 305 after the scrubber is in excess, i.e., greater, than the NO pulse to be delivered to a patient via a delivery device).
Claim(s) 21-25, 27-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillerman in view of Richey.
Regarding Claim 21, Gillerman discloses a nitric oxide generation system (abstract; para. 0004, 0079), comprising:
a plasma chamber (plasma chamber 300; Fig. 7; para. 0004, 0079, 0097) configured to ionize a reactant gas including nitrogen and oxygen to form a product gas that includes nitric oxide (NO) (Examiner notes: the chamber is to ionize a reactant gas comprising ambient air for producing a product gas containing NO);
a scrubber (scrubber 304; Fig. 7; para. 0004, 0079, 0084, 0097) positioned downstream of the plasma chamber, the scrubber having a volume at least partially containing NO2 scrubbing material (Examiner notes: the plasma chamber 300 is followed by a first scrubber 304 for removing nitrogen dioxide);
a flow controller (valve 305; Fig. 7; para. 0097) downstream of the scrubber, the flow controller configured to control the flow of product gas from the scrubber to a delivery device (para. 0097; Examiner notes: the valve controls and adjust the product gas delivery from the 304 to inspiratory stream 312);
a pump (pump 302; Fig. 7; para. 0097) configured to push the product gas from the plasma chamber into the scrubber (para. 0097), the pump configured to pressurize the product gas in the scrubber when the flow controller is positioned to restrict the flow of product gas from the scrubber (Examiner notes: when the valve 305 is in closed position it is positioned to restrict the flow of product gas, when no delivery to the inspiratory stream 312 is initiated and the pump 302 is delivering the product gas to the scrubber 304);
wherein the pressurized product gas accumulates within the scrubber and is at least partially scrubbed of NO2 prior to passage from the scrubber through the flow controller (Fig. 7; para. 0097, 0137; Examiner notes: the pressurization of the product gas occurs when the valve is in closed position prior to initiating a delivery and the pump 302 is delivering the product gas to accumulate un the scrubber 304 comprising the scavenger material for NO2 removal followed by opening the valve 305 to deliver the product gas to the inspiratory system 312),
and wherein a mass of gas in the scrubber and pneumatic connections between the pump and the flow controller is greater than a mass of a pulse of gas to be delivered to a delivery device (para. 0094, 0097; Examiner notes: a produced amount of the product gas from input air to the valve 305 after the scrubber is in excess, for example: greater, than the NO pulse to be delivered to a patient via a delivery device).
Gillerman does not disclose a pressure sensor configured to measure a pressure in the scrubber a pressure sensor configured to measure a pressure in the scrubber; and a controller configured to regulate an amount of NO in the product gas by the plasma chamber, the controller utilizing the pressure measurement from the pressure sensor to determine a mass flow rate of the product gas out of the scrubber.
However, Richey teaches a pressure sensor (Fig. 5A-5B; 534; para. 0070) configured to measure a pressure of the pressurized product gas in the scrubber (Fig. 5A-5B; 532), and a controller configured to regulate an amount of gas in the product gas by the chamber (para. 0070; this limitation is functional however, the pressure sensor communicates with the controller), the controller utilizing the pressure measurement from the pressure sensor to determine a mass flow rate of the product gas out of the scrubber (para. 0070).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller, scrubber, and system of Modified Gillerman to include a pressure sensor configured to measure a pressure in the scrubber a pressure sensor configured to measure a pressure in the scrubber; and a controller configured to regulate an amount of NO in the product gas by the plasma chamber, the controller utilizing the pressure measurement from the pressure sensor to determine a mass flow rate of the product gas out of the scrubber as taught by Richey for the purpose of shutting off the pump when a threshold is reached reduce energy usage of the pump or maintain a safe pressure at the accumulator (para. 0070).
Also, Modified Gillerman teaches a control system configured to regulate an amount of NO in the product gas by the plasma chamber because the NO generation is maintained at a desired level by controlling (a controller) plasma chamber activity based on feedback from various sensors (para. 0097, 0159). Also, the controller is then utilizing a pressure measurement from the pressure sensor of Richey to determine a mass flow rate of the product gas out of the scrubber because the sensor is gas sensor measuring pressure located after the scrubber to measure released conditions of the scrubber (para. 0123, 0159-0160, 0163-0164; a pressure measurement in the scrubber, used as a feedback to deliver desired dose of the scrubbed NO gas).
Therefore, Gillerman is considered to be in field of production of nitric oxide. Due to an absence of the limitations of and a controller configured to regulate an amount of NO in the product gas by the plasma chamber, the controller utilizing a pressure measurement from the pressure sensor of Richey in the scrubber to determine a mass flow rate of the product gas out of the scrubber, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that the controller would reasonably encompass the absent limitation of regulating the amount of NO in the product gas by the plasma chamber for the purpose of providing improved flow accuracy at high and low flow rates. One would be motivated to use controller to use the sensors to accurately regulating the nitric oxide.
Regarding Claim 22, Modified Gillerman discloses the system of claim 21, wherein a reactant gas flow rate through the plasma chamber is continuous (para. 0095, 0097, 0117; Examiner notes: a reactant gas flow through the plasma chamber is performed at a constant rate).
Regarding Claim 23, Modified Gillerman discloses the system of claim 22, wherein the reactant gas flow rate through the plasma chamber is a constant value (para. 0095, 0097, 0107; Examiner notes: a reactant gas flow through the plasma chamber performed continuously).
Regarding Claim 24, Modified Gillerman discloses the system of claim 21, wherein a reactant gas flow rate through the plasma chamber is intermittent (para. 0095, 0097, 0107, 0190; Examiner notes: a reactant gas flow through the plasma chamber is modulated utilizing on/off valve control making it “intermittent”).
Regarding Claim 25, Modified Gillerman discloses the system of claim 1, wherein a pressure within the plasma chamber (plasma chamber 300; Fig. 7; para. 0004, 0079, 0097) is at or below atmospheric pressure (para. 0021, 0097: the plasma chamber is operated at atmospheric pressure).
Regarding Claim 27, Modified Gillerman discloses the system of claim 21 (see rejection above), further comprising a controller configured to regulate an amount of NO in the product gas by modulating a plasma in the plasma chamber (para. 0097, 0159; NO generation is maintained at a desired level by controlling (a controller) plasma chamber activity based on feedback from various sensors), the controller utilizing a pressure measurement in the scrubber to determine a flow rate of the product gas out of the scrubber ( Fig. 5A-5B; 534; Richey and sensors in Gillerman (para. 0159-0160, 0163-0164) is gas sensor measuring pressure located after the scrubber to measure released conditions of the scrubber, i.e., a pressure measurement in the scrubber, used as a feedback to deliver desired dose of the scrubbed NO gas).
Regarding Claim 28, Modified Gillerman discloses the system of claim 21, wherein the product gas is delivered intermittently (para. 0097, 0181, 0223; examiner notes: the produced NO gas is used for pulsatile treatment).
Regarding Claim 29, Modified Gillerman discloses the system of claim 28, wherein a product gas delivery flow rate varies pulse to pulse (para. 0097, 0181, 0223; examiner notes: the produced NO gas is used to deliver the produced NO gas with a suitable flow for pulsatile treatment in which pulse dose are varied).
Regarding Claim 30, Modified Gillerman discloses the system of claim 28, wherein a product gas delivery flow rate varies within a pulse (para. 0097, 0181, 0223; examiner notes: the produced NO gas is used for pulsatile treatment in which concentration of NO varies within the NO pulse).
Regarding Claim 31, Modified Gillerman discloses the system of claim 21, wherein a mass of the product gas in the scrubber is at least a mass of a single NO pulse (para. 0095, 0097, 0102; Examiner notes: the product gas in pulsatile treatment is directed as a patient dose, i.e., a mass of the product gas, as a pulse of the patient dose directly from the scrubber meeting the needed dosing amount, i.e., at least a mass of a single NO pulse).
Regarding Claim 32, Gillerman discloses nitric oxide generation system abstract; para. 0004, 0079), comprising: a plasma chamber (plasma chamber 300; Fig. 7; para. 0004, 0079, 0097) configured to ionize a reactant gas including nitrogen and oxygen to form a product gas that includes nitric oxide (NO) (Examiner notes: the chamber is to ionize a reactant gas comprising ambient air for producing a product gas containing NO);
a scrubber (scrubber 304; Fig. 7; para. 0004, 0079, 0084, 0097) positioned downstream of the plasma chamber (Fig. 7), the scrubber having a volume at least partially containing NO2 scrubbing material (Examiner notes: the plasma chamber 300 is followed by a first scrubber 304 for removing nitrogen dioxide);
a flow controller (valve 305; Fig. 7; para. 0097) downstream of the scrubber, the flow controller configured to control the flow of product gas from the scrubber to a delivery device (para. 0097; Examiner notes: the valve controls and adjust the product gas delivery from the 304 to inspiratory stream 312; this limitation is functional);
a pump (pump 302; Fig. 7; para. 0097) configured to push the product gas from the plasma chamber into the scrubber (para. 0097), the pump configured to pressurize the product gas in the scrubber when the flow controller is positioned to restrict the flow of product gas from the scrubber (Examiner notes: when the valve 305 is in closed position it is positioned to restrict the flow of product gas, when no delivery to the inspiratory stream 312 is initiated and the pump 302 is delivering the product gas to the scrubber 304);
Gillerman does not disclose a pressure sensor configured to measure a pressure in the scrubber; and a controller configured to regulate an amount of NO in the product gas by the plasma chamber, the controller utilizing the pressure measurement from the pressure sensor to determine a mass flow rate of the product gas out of the scrubber.
Richey teaches a pressure sensor (Fig. 5A-5B; 534; para. 0070) configured to measure a pressure in the scrubber (Fig. 5A-5B; 532), and a controller configured to regulate an amount of gas in the product gas by the chamber (para. 0070; this limitation is functional however, the pressure sensor communicates with the controller), the controller utilizing the pressure measurement from the pressure sensor to determine a mass flow rate of the product gas out of the scrubber (para. 0070).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller, scrubber, and system of Modified Gillerman to include a pressure sensor configured to measure a pressure in the scrubber; and a controller configured to regulate an amount of NO in the product gas by the plasma chamber, the controller utilizing the pressure measurement from the pressure sensor to determine a mass flow rate of the product gas out of the scrubber as taught by Richey for the purpose of shutting off the pump when a threshold is reached reduce energy usage of the pump or maintain a safe pressure at the accumulator (para. 0070).
Also, Modified Gillerman teaches a control system configured to regulate an amount of NO in the product gas by the plasma chamber because the NO generation is maintained at a desired level by controlling (a controller) plasma chamber activity based on feedback from various sensors (para. 0097, 0159). Also, the controller is then utilizing a pressure measurement from the pressure sensor of Richey to determine a mass flow rate of the product gas out of the scrubber because the sensor is gas sensor measuring pressure located after the scrubber to measure released conditions of the scrubber (para. 0123, 0159-0160, 0163-0164; a pressure measurement in the scrubber, used as a feedback to deliver desired dose of the scrubbed NO gas).
Therefore, Gillerman is considered to be in field of production of nitric oxide. Due to an absence of the limitations of and a controller configured to regulate an amount of NO in the product gas by the plasma chamber, the controller utilizing a pressure measurement from the pressure sensor of Richey in the scrubber to determine a mass flow rate of the product gas out of the scrubber, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that the controller would reasonably encompass the absent limitation of regulating the amount of NO in the product gas by the plasma chamber for the purpose of providing improved flow accuracy at high and low flow rates. One would be motivated to use controller to use the sensors to accurately regulating the nitric oxide.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillerman and Richey, as applied to claim 1, in view of Zapol et al. (US 20200139072 A1), hereafter has Zapol.
Regarding Claim 14, Modified Gillerman discloses the system of claim 1,
Modified Gillerman does not disclose the system further comprising a parallel flow path that includes a pressurized non-NOx containing gas.
However, Zapol teaches a parallel flow path that includes a pressurized non-NOx containing gas (146a, 148a; an oxygen gas flow delivery path parallel to a NO flow delivery path; Fig. 10; para. 0108, 0109).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the paths of Gillerman to include a parallel flow path that includes a pressurized non-NOx containing gas as taught by Zapol for the purpose of generating and delivering nitric oxide (Gillerman) in parallel with an other non-NOx gas such as oxygen to deliver multiple medical gases to a patient and minimizing the flow path length and having the flow restriction (para. 0108-0109).
Regarding Claim 15, Modified Gillerman discloses the system of claim 14,
Modified Gillerman does not disclose the system wherein the pressurized reactant gas is utilized to push an NO pulse to a patient and purge at least a portion of at least one of a pneumatic pathway within the system and the delivery device of NO and NO2.
However, Zapol teaches wherein the pressurized reactant gas is utilized to push an NO pulse to a patient and purge at least a portion of at least one of a pneumatic pathway within the system and the delivery device of NO and NO2 (using an air flow, i.e., a pressurized reactant gas, to purge a system including a cannula of No and NO2; para. 0244).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the paths of Gillerman to include a pressurized reactant gas is utilized to push an NO pulse to a patient and purge at least a portion of at least one of a pneumatic pathway within a system and a delivery device of NO and NO2 as taught by Zapol for the purpose of generating and delivering nitric oxide (Gillerman) utilizing a purging to improve a safety of NO generation and delivery device (para. 0243-0244).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillerman and Richey, as applied to claim 1, in view of Hall et al. (US 20200361772 A1), hereafter has Hall.
Regarding Claim 16, Modified Gillerman discloses the system of claim 1.
Modified Gillerman does not disclose the system wherein the product gas is configured to accumulate such that an increase in an oxidation due to the pressure in the scrubber is more than offset by an improvement in scrubbing due to one or more of an increase in a residence time and the pressure in the scrubber.
However, Hall teaches wherein a product gas is configured to accumulate such that an increase in an oxidation due to the pressure in the scrubber is more than offset by an improvement in scrubbing due to one or more of an increase in a residence time and the pressure in the scrubber (para. 0097, 0238-0239; formation of NO2 in the scrubber is prevented by utilizing a tortuous path that is created for the product gas; for example, an increase in a residence time).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Gillerman to include a product gas being configured to accumulate such that an increase in an oxidation due to the pressure in the scrubber is more than offset by an improvement in scrubbing due to one or more of an increase in a residence time and the pressure in the scrubber as taught by Hall, for the purpose of generating nitric oxide from which NO2 is scrubbed utilizing tortuous path to minimize NO2 levels (para. 0239).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillerman and Richey, as applied to claim 1, in view of Zapol et al. (US 20180296790 A1), hereafter has Zapol II.
Regarding Claim 19, Modified Gillerman discloses the system of claim 1, wherein a product gas flow rate entering the scrubber and product gas flow rate exiting the scrubber (para 0097; Examiner notes: the scrubber receiving the product gas flow and a scrubbed gas flow exiting the scrubber).
Modified Gillerman does not disclose wherein a product gas flow rate entering the scrubber is different than from product gas flow rate exiting the scrubber.
However, Zapol II teaches wherein a product gas flow rate entering the scrubber is different than from product gas flow rate exiting the scrubber (para. 0124; a gas flow from a NO generator entering a scrubber to perform scrubbing after with a scrubbed gas flow exits the scrubber wherein the removal along scrubber with a gas flow resistance, thus exit flow is reduced).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Gillerman to include a product gas flow rate entering the scrubber is different than from product gas flow rate exiting the scrubber as taught by Zapol II for the purpose of generating nitric oxide which is scrubbed efficiently to remove 95% of NO2 in the scrubber without reducing NO concentration (para. 0124).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillerman and Richey, as applied to claim 1, in view of Zapol et al. (US 20180243527 A1), here after as Zapol.
Regarding Claim 33, Modified Gillerman discloses the system of claim 1,
Modified Gillerman does not disclose further comprising a controller configured to regulate an amount of NO in the product gas formed by the plasma chamber, and an NO sensor configured to measure an amount of NO in the product gas, the controller configured to receive the measured NO amount to regulate the amount of NO in the product gas.
However, Zapol teaches a controller configured to regulate an amount of NO in the product gas formed by the plasma chamber (para. 0016; Examiner notes: this limitation is functional), and an NO sensor configured to measure an amount of NO in the product gas (para. 0016; this limitation is functional, Zapol teaches sensors to sensor NO concentration), the controller configured to receive the measured NO amount to regulate the amount of NO in the product gas (para. 0016-0018, 0032).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Modified Gillerman to include the a controller configured to regulate an amount of NO in the product gas formed by the plasma chamber, and an NO sensor configured to measure an amount of NO in the product gas, the controller configured to receive the measured NO amount to regulate the amount of NO in the product gas as taught by Zapol for the purpose of controlling and regulate the production of nitric oxide (para. 0014, 0020).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Other prior art of particular note include:
Acker et al. (US 20190184116 A1) teaches a controller that controls a flow of gas and delivering inhaled therapeutic nitric oxide gas.
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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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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