5, aDETAILED 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 20, 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed as November 20, 2025. As directed by the amendment: claims 1 and 7 have been amended, claim 6 and 26 have been canceled, and no claims have been added. Thus, claims 1-5, 7-25, and 27-32 are presently pending in the application.
Response to Arguments
Applicant argues on page 6 of the remarks that the objection made on claim 6 should be withdrawn. Applicant canceled the claim and the previous claim objections has been hereby withdrawn.
Applicant argues on page 6 of the of the remarks that the 112(d)-rejection made on Claims 26 should be withdrawn. Applicant has canceled the claim making the argument moot; the previous 112(d)-rejection has been hereby withdrawn.
Applicant argues on page 6 of the remarks that the 103-rejection of Gillerman in view of Ringwall is improper and should be withdrawn.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 “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”, 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7 of the remarks that the 103-rejection of Gillerman in view of Ringwall is improper for claims 21 and 32 and should be withdrawn.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 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 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 27 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 27, the phrase "the system of claim 26" renders the claim indefinite because it is unclear what claim is dependent from, the examiner is examining this claim as it is dependent off of claim 21.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillerman, (US 20200361773 A1), hereafter as Gillerman, in view of Ringwall et al. (US 3805590 A), hereafter has Ringwall, and Lindsay (US 20160213552 A1).
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 (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).
Gillerman does not specifically disclose a pressure sensor configured to measure a pressure in the scrubber (this limitation is functional; Gillerman does teach that sensors are used to monitor the effectiveness of the scrubber; para. 0159-0164).
However, Ringwall teaches a pressure sensor (Fig. 1; pressure sensor 30; Col. 3 lines 42-60) configured to measure a pressure and is mounted on the scrubber (The pressure sensor is configured to measure the pressure in the scrubber is a functional limitation).
Although, Ringwall does not specifically teach that the pressure sensor measures a pressure inside the scrubber, it would be obvious that although the sensor is mounted on the scrubber, it is taking measurements of the pressure inside of the scrubber because the solenoid valve is operated based on this reading to let oxygen from the supply into the scrubber.
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 sensors of Gillerman to include the pressure sensor as taught by Ringwall for the purpose of developing electrical control signals for the solenoid valve to control the amount of gas should be added to the scrubber (Col. 3 lines 42-60).
Modified Gillerman does not specifically discloses 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.
Ringwall further teaches wherein pressure measurements from the pressure sensor (Fig. 1; pressure sensor 30; Col. 3 lines 42-60) are communicated to a controller configured to control filling of the scrubber with product gas (examiner notes: Ringwall teaches that the sensors operate with electronic circuity to control signals to solenoid valve that is connected to the scrubber).
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 sensors of Modified Gillerman to communicated with the controller as taught by Ringwall to determine a flow rate of the product gas into the scrubber by controlling the pump for the purpose of adjusting different characteristics in response to the pressure (Col. 3 lines 42-60).
Modified Gillerman does not specifically disclose wherein the controller is configured to shut off the pump when the measured pressure reaches a target pressure.
However, Lindsay teaches wherein a controller (27) is configured to shut off the pump(26) when a measured pressure reaches a target pressure (para. 110; Examiner notes this limitation is functional; Lindsay teaches that when the pressure reaches a predetermined value the pump is turned off).
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 of Modified Gillerman to include the function of a controller shutting off the pump when the measured pressure reaches a target pressure as taught by Lindsay for the purpose of shutting off the pump when a threshold is reached because it can cause overpressure and no more fluid is pumped into the reservoir (para. 0110).
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; Ringwall 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, (US 20200361773 A1), hereafter as Gillerman, in view of Ringwall et al. (US 3805590 A), hereafter has Ringwall.
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.
However, Ringwall teaches a pressure sensor (Fig. 1; pressure sensor 30; Col. 3 lines 42-60) configured to measure a pressure mounted on the scrubber (The pressure sensor is configured to measure the pressure in the scrubber is a functional limitation).
Although, Ringwall does not specifically teach that the pressure sensor measures a pressure inside the scrubber, it would be obvious that although the sensor is mounted on the scrubber, it is taking measurements of the pressure inside of the scrubber because the solenoid valve is operated based on this reading to let oxygen from the supply into the scrubber.
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 sensors of Gillerman to include the pressure sensor as taught by Ringwall for the purpose of developing electrical control signals for the solenoid valve to control the amount of gas should be added to the scrubber (Col. 3 lines 42-60).
Modified Gillerman does not specifically teach a controller.
However, 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 Ringwall 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 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.
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 (30; Fig. 1; Ringwall 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.
However, Ringwall teaches a pressure sensor (Fig. 1; pressure sensor 30; Col. 3 lines 42-60) configured to measure a pressure mounted on the scrubber (The pressure sensor is configured to measure the pressure in the scrubber is a functional limitation).
Although, Ringwall does not specifically teach that the pressure sensor measures a pressure inside the scrubber, it would be obvious that although the sensor is mounted on the scrubber, it is taking measurements of the pressure inside of the scrubber because the solenoid valve is operated based on this reading to let oxygen from the supply into the scrubber.
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 sensors of Gillerman to include the pressure sensor as taught by Ringwall for the purpose of developing electrical control signals for the solenoid valve to control the amount of gas should be added to the scrubber (Col. 3 lines 42-60).
Modified Gillerman does not specifically teach a controller.
However, 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 Ringwall 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 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.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillerman, Ringwall, and Lindsay, 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, Ringwall, and Lindsay, 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, Ringwall, and Lindsay, 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).
Conclusion
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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785