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
Acknowledgement is made to Applicant's claim to priority to PCT/US2021/036269 filed 6/7/2021, U.S. Provisional App. No. 63/089,043 filed 10/8/2020, U.S. Provisional App. No. 63/035,451 filed 6/5/2020, U.S. Provisional App. No. 63/035,103 filed 6/5/2020, and U.S. Provisional App. No. 63/035,458 filed 6/5/2020.
Claim Objections
Claims 1-6, 9, 11-15, 18, and claims 7-8, 10, 16-17, 19 by dependency, are objected to because of the following informalities:
Every recitation of “the electrodes”, for instance lines 6-7, 10, 12, 15 of claim 1 and line 2 of claim 2, should read --the pair of electrodes-- to maintain consistent terminology throughout the claims.
Appropriate correction is required.
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.
Claims 10-11, 17, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10, which is dependent upon claim 9, recites the limitation "the pressure regulator" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of this Office Action, “the pressure regulator” will be interpreted as “a pressure regulator”.
Claim 11 recites the limitation "the pressure" in line 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of this Office Action, “the pressure” will be interpreted as “a pressure”.
Claim 17, which is dependent upon claim 9, recites the limitation "the methemoglobin level" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of this Office Action, “the methemoglobin level” will be interpreted as “a methemoglobin level”.
Claim 19, which is dependent upon claim 9, recites the limitation "the scavenger" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of this Office Action, “the scavenger” will be interpreted as “a scavenger”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zapol et al. (US 20180243527 A1), hereafter Zapol.
Regarding claim 1, Zapol discloses a nitric oxide generator (NO generation system of Fig. 1, par. 0184), comprising: an inlet (reactant gas intake 12; Fig. 1, par. 0184) arranged to receive a gas including nitrogen and oxygen (reactant gas can be atmospheric air/ambient air, par. 0015, 0183; atmospheric air has approximately 21% oxygen and 78% nitrogen by volume, par. 0381); an outlet (sample gas out near gas analysis sensor pack 54; Fig. 1); a pair of electrodes arranged downstream of the inlet (electrodes 24 downstream of reactant gas intake 12; Fig. 1) and configured to generate nitric oxide from the gas (electrodes 24 produce NO from the reactant gas; par. 0184); a pressure regulator (altitude compensator 34; Fig. 1, par. 0384-0385) configured to selectively adjust a pressure of the gas surrounding the electrodes (variable flow restriction of the altitude compensator 34 is used to control pressure within the plasma chamber 22 wherein the electrodes 24 are located; par. 0385, Fig. 1); an accumulator (reservoir 18; Fig. 1) in communication with the pressure regulator (Fig. 1 shows reservoir 18 and altitude compensator 34 are in the same gas flow path), wherein the accumulator is configured to add volume to a flow path between the inlet and the outlet (reservoir 18 holds a volume of gas in the flow path between inlet 12 and outlet, Fig. 1; air reservoir serves as an accumulator between the pump and plasma chamber, par. 0368) to store and maintain the pressure of the gas surrounding the electrodes (flow and pressure within the plasma chamber can be varied by flow control means in communication with the air reservoir, par. 0476); a nitric oxide sensor (gas analysis sensor pack 54, Fig. 1) arranged to measure a concentration of nitric oxide downstream of the electrodes (gas sensor chamber measures NO levels in the product gas, par. 0186); and a controller (treatment controller 30; Fig. 1) in communication with the pair of electrodes, the pressure regulator, and the nitric oxide sensor (Fig. 1 shows electrodes 24, altitude compensator 34, and nitric oxide sensor 54 are all in communication with the controller 30), wherein the controller is configured to selectively instruct the pressure regulator to adjust the pressure of the gas surrounding the electrodes in response to the concentration of nitric oxide measured at the outlet by the nitric oxide sensor (controller controls electrodes and pressure within chamber surrounding electrodes through altitude compensator to ensure accurate quantities of NO; par. 0385).
Regarding claim 2, Zapol discloses the nitric oxide generator of claim 1 (shown above), further comprising a scavenger (filter-scavenger-filter 38; Fig. 1) arranged upstream of the outlet and downstream of the electrodes (filter-scavenger-filter 38 is upstream of sample gas outlet at 54 and downstream of electrodes 24; Fig. 1).
Regarding claim 3, Zapol discloses the nitric oxide generator of claim 1 (shown above), further comprising a filter arranged upstream of the outlet and downstream of the electrodes (filter 50 is upstream of sample gas out at 54 and downstream of electrodes 24; Fig. 1).
Regarding claim 4, Zapol discloses the nitric oxide generator of claim 1 (shown above), wherein the controller is configured to instruct the pressure regulator (altitude compensator 34) to increase the pressure of the gas surrounding the electrodes to increase the concentration of nitric oxide at the outlet (altitude compensation increases pressure at the plasma chamber to increase NO output, par. 0385; gas sensor data is used to automatically adjust NO production to match a target level, par. 0411).
Regarding claim 5, Zapol discloses the nitric oxide generator of claim 1 (shown above), wherein the controller is configured to instruct the pressure regulator to decrease the pressure of the gas surrounding the electrodes to decrease the concentration of nitric oxide at the outlet (gas sensor data is used to automatically adjust NO production to match a target level, par. 0411; lower pressure in the plasma chamber leads to less NO production, par. 0681; control algorithm input parameters include plasma chamber pressure which can be altered to adjust NO production rates, par. 0011, 0367, 0387).
Claim Rejections - 35 USC § 103
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 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) 6, 9-15, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zapol.
Regarding claim 6, Zapol discloses the nitric oxide generator of claim 1 (shown above), wherein the controller is configured to selectively adjust a signal sent to the electrodes (controller communicates with electrodes to control the concentration of NO in the product gas; par. 0184) to provide an inhaled concentration of nitric oxide between 50 ppm and 5000 ppm at the outlet (NO is present in concentration between 50-5000 ppm depending on the desired dose and inspiratory flow; par. 0484).
Zapol does not explicitly a nitric oxide concentration greater than or equal to about 150ppm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration of Zapol from between 50 ppm and 5000 ppm to greater than or equal to about 150 ppm, as claimed, since the ranges overlap between 150 ppm and 5000 ppm and it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 9, Zapol discloses a nitric oxide generator (NO generation system of Fig. 1, par. 0184), comprising: an inlet (reactant gas intake 12; Fig. 1, par. 0184) arranged to receive a gas including nitrogen and oxygen (reactant gas can be atmospheric air/ambient air, par. 0015, 0183; atmospheric air has approximately 21% oxygen and 78% nitrogen by volume, par. 0381); an outlet (sample gas out near gas analysis sensor pack 54; Fig. 1); a pair of electrodes arranged downstream of the inlet (electrodes 24 downstream of reactant gas intake 12; Fig. 1) and configured to generate nitric oxide from the gas (electrodes 24 produce NO from the reactant gas; par. 0184); a nitric oxide sensor (gas analysis sensor pack 54, Fig. 1) arranged to measure a concentration of nitric oxide downstream of the electrodes (gas sensor chamber measures NO levels in the product gas, par. 0186); and a controller (treatment controller 30; Fig. 1) in communication with the pair of electrodes and the nitric oxide sensor (Fig. 1 shows electrodes 24 and nitric oxide sensor 54 are in communication with the controller 30), wherein the controller is configured to selectively adjust a signal sent to the electrodes (controller communicates with electrodes to control the concentration of NO in the product gas; par. 0184) to provide an inhaled concentration of nitric oxide between 50 ppm and 5000 ppm at the outlet (NO is present in concentration between 50-5000 ppm depending on the desired dose and inspiratory flow; par. 0484).
Zapol does not explicitly disclose an inhaled concentration of nitric oxide greater than or equal to about 150 ppm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration of Zapol from between 50 ppm and 5000 ppm to greater than or equal to about 150 ppm, as claimed, since the ranges overlap between 150 ppm and 5000 ppm and it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 10, as best understood based on the 35 U.S.C. 112(b) issue identified above, Zapol discloses the nitric oxide generator of claim 9 (shown above), further comprising an accumulator (reservoir 18; Fig. 1) in communication with a pressure regulator (altitude compensator 34; Fig. 1, par. 0384-0385).
Regarding claim 11, as best understood based on the 35 U.S.C. 112(b) issue identified above, Zapol discloses the nitric oxide generator of claim 10 (shown above), wherein the accumulator is configured to add volume to a flow path between the inlet and the outlet (reservoir 18 holds a volume of gas in the flow path between inlet 12 and outlet, Fig. 1; air reservoir serves as an accumulator between the pump and plasma chamber, par. 0368) to store and maintain the pressure of the gas surrounding the electrodes (flow and pressure within the plasma chamber can be varied by flow control means in communication with the air reservoir, par. 0476).
Regarding claim 12, Zapol discloses the nitric oxide generator of claim 9 (shown above), further comprising a pressure regulator (altitude compensator 34; Fig. 1, par. 0384-0385) configured to selectively adjust a pressure of the gas surrounding the electrodes (variable flow restriction of the altitude compensator 34 is used to control pressure within the plasma chamber 22 wherein the electrodes 24 are located; par. 0385, Fig. 1).
Regarding claim 13, Zapol discloses the nitric oxide generator of claim 12 (shown above), wherein the controller is in communication with the pressure regulator (Fig. 1 shows altitude compensator 34 in communication with controller 30) and the controller is configured to selectively instruct the pressure regulator to adjust the pressure of the gas surrounding the electrodes in response to the concentration of nitric oxide measured at the nitric oxide sensor (controller controls electrodes and pressure within chamber surrounding electrodes through altitude compensator to ensure accurate quantities of NO; par. 0385).
Regarding claim 14, Zapol discloses the nitric oxide generator of claim 13 (shown above), wherein the controller is configured to instruct the pressure regulator (altitude compensator 34) to increase the pressure of the gas surrounding the electrodes to increase the concentration of nitric oxide at the outlet (altitude compensation increases pressure at the plasma chamber to increase NO output, par. 0385; gas sensor data is used to automatically adjust NO production to match a target level, par. 0411).
Regarding claim 15, Zapol discloses the nitric oxide generator of claim 13 (shown above), wherein the controller is configured to instruct the pressure regulator to decrease the pressure of the gas surrounding the electrodes to decrease the concentration of nitric oxide at the outlet (gas sensor data is used to automatically adjust NO production to match a target level, par. 0411; lower pressure in the plasma chamber leads to less NO production, par. 0681; control algorithm input parameters include plasma chamber pressure which can be altered to adjust NO production rates, par. 0011, 0367, 0387).
Regarding claim 18, Zapol discloses the nitric oxide generator of claim 9 (shown above), further comprising a scavenger (filter-scavenger-filter 38; Fig. 1) arranged upstream of the outlet and downstream of the electrodes (filter-scavenger-filter 38 is upstream of sample gas outlet at 54 and downstream of electrodes 24; Fig. 1).
Regarding claim 19, as best understood based on the 35 U.S.C. 112(b) issue identified above, Zapol discloses the nitric oxide generator of claim 9 (shown above), further comprising a filter arranged upstream of the outlet and downstream of a scavenger (filter 50 is upstream of sample gas out at 54 and downstream of scavenger 38; Fig. 1).
Claim(s) 7-8 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zapol in view of Crosbie (US 20150090261 A1).
Regarding claim 7, Zapol discloses the nitric oxide generator of claim 1 (shown above).
Zapol does not disclose further comprising a methemoglobin sensor adapted to sense a methemoglobin level in a patient.
Crosbie teaches a nitric oxide generator (abstract) comprising a methemoglobin sensor adapted to sense a methemoglobin level in a patient (controller receives information from a methemoglobin sensor, par. 0034-0035; methemoglobin levels of a patient can be measured to find a correlation between administered NO and methemoglobin level, par. 0086) for the purpose of monitoring effectiveness of NO treatment (high oxyhemoglobin and low methemoglobin indicates treatment success; par. 0087).
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 nitric oxide generator of Zapol to comprise a methemoglobin sensor as taught by Crosbie for the purpose of monitoring effectiveness of NO treatment (Crosbie par. 0087).
Regarding claim 8, the modified Zapol discloses the nitric oxide generator of claim 7 (shown above).
The modified Zapol does not disclose wherein the controller is configured to monitor the methemoglobin level and instruct the pair of electrodes to decrease nitric oxide generation when the methemoglobin level reaches a predetermined threshold value.
Crosbie teaches a nitric oxide generator wherein the controller is configured to monitor the methemoglobin level (controller receives data from methemoglobin sensor; par. 0034) and instruct a pair of electrodes (pair of electrodes forms a spark gap 225; Fig. 3, par. 0054) to decrease nitric oxide generation when the methemoglobin level reaches a predetermined threshold value (NO level is reduced when methemoglobin level meets certain criteria, Crosbie par. 0087; amount of NO may be reduced in response to sensed parameters, par. 0032; NO production is adjusted by controlling spark intensity and/or duration, NO production is adjusted based on patient’s methemoglobin levels, par. 0018) for the purpose of adjusting production of NO responsive to a patient’s blood chemistry (par. 0018, 0035).
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 nitric oxide generator of Zapol to decrease nitric oxide generation when methemoglobin level reaches a predetermined threshold value as taught by Crosbie for the purpose of adjusting production of NO responsive to a patient’s blood chemistry (par. 0018, 0035). This modification would also provide the benefit of avoiding methemoglobinemia which is a known toxicity of inhaled NO therapy (see par. 0005 of Flanagan et al. reference listed below).
Regarding claim 16, Zapol discloses the nitric oxide generator of claim 9 (shown above).
Zapol does not disclose a methemoglobin sensor adapted to sense a methemoglobin level in a patient.
Crosbie teaches a nitric oxide generator (abstract) comprising a methemoglobin sensor adapted to sense a methemoglobin level in a patient (controller receives information from a methemoglobin sensor, par. 0034-0035; methemoglobin levels of a patient can be measured to find a correlation between administered NO and methemoglobin level, par. 0086) for the purpose of monitoring effectiveness of NO treatment (high oxyhemoglobin and low methemoglobin indicates treatment success; par. 0087).
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 nitric oxide generator of Zapol to comprise a methemoglobin sensor as taught by Crosbie for the purpose of monitoring effectiveness of NO treatment (Crosbie par. 0087).
Regarding claim 17, as best understood based on the 35 U.S.C. 112(b) issue identified above, Zapol discloses the nitric oxide generator of claim 9 (shown above).
Zapol does not disclose wherein the controller is configured to monitor the methemoglobin level and instruct the pair of electrodes to decrease nitric oxide generation when the methemoglobin level reaches a predetermined threshold value.
Crosbie teaches a nitric oxide generator wherein the controller is configured to monitor the methemoglobin level (controller receives data from methemoglobin sensor; par. 0034) and instruct a pair of electrodes (pair of electrodes forms a spark gap 225; Fig. 3, par. 0054) to decrease nitric oxide generation when the methemoglobin level reaches a predetermined threshold value (NO level is reduced when methemoglobin level meets certain criteria, Crosbie par. 0087; amount of NO may be reduced in response to sensed parameters, par. 0032; NO production is adjusted by controlling spark intensity and/or duration, NO production is adjusted based on patient’s methemoglobin levels, par. 0018) for the purpose of adjusting production of NO responsive to a patient’s blood chemistry (par. 0018, 0035).
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 nitric oxide generator of Zapol to decrease nitric oxide generation when methemoglobin level reaches a predetermined threshold value as taught by Crosbie for the purpose of adjusting production of NO responsive to a patient’s blood chemistry (par. 0018, 0035). This modification would also provide the benefit of avoiding methemoglobinemia which is a known toxicity of inhaled NO therapy (see par. 0005 of Flanagan et al. reference listed below).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Flanagan et al. (US 20140275901 A1) discloses monitoring methemoglobin during nitric oxide treatment.
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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785