DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Examiner acknowledges the reply filed on 7/21/2026 in which claims 1, 26-28 and 30 have been amended. Claim 15 is cancelled. Currently claims 1-14, 16-30 are pending for examination in this application.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 8-12, 14, 16-17, 19, 20, 22, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Acker (US 20150273175 A1). The examiner notes Acker incorporates Bathe et al. (US 5,558,083) by reference in its entirety [0056].
Regarding claim 1, Acker teaches a system (Fig. 1) for delivering a nitric oxide to a subject, wherein the system comprises:
a) a nitric oxide injection line (Fig. 1, NO forward flow 137) configured to inject a first gas at an injection point (Fig. 1, injector module 107) into a breathing conduit (paragraph 0059 “With injector module 107 coupled to inspiratory limb 121 of the breathing circuit and/or in fluid communication with the breathing circuit”) comprising a breathing gas (ventilator 117 provides breathing gas into this circuit; paragraph 0059 “into inspiratory limb 121 of the patient breathing circuit affiliated ventilator 117 being used to delivery breathing gas to a patient 108”), wherein the first gas comprises a first amount of nitric oxide (paragraph 0065 teaches varying the amount of NO delivered on a breath-by-breath basis; A first amount of NO to be delivered based on the initial desired set dose);
b) a sampling line (Fig. 1, sample line 131) configured to sample a second gas comprising a second amount of nitric oxide and the breathing gas (Fig. 1, where the location of line 131 in the inspiratory limb would measure a mixture of NO from the injection point 107 and breathing gas from ventilator 117, and where this mixture has a different amount of NO based on being mixed with breathing gas) at a sampling location between the injection point of the first gas and a subject (Fig. 1, where the location of line 131 is between injection point 107 and patient 108) and
c) a feedback-loop controller (Fig. 1, system controller/CPU 111) that is in communication with:
i) a nitric oxide set-point controller configured to set a nitric oxide set-point amount (Fig. 1, user input/display 113; paragraph 0067 teaches that 113 can set the delivery concentration and patient dosing);
ii) the source (103) configured to provide a third gas having a third amount of nitric oxide (Fig. 1, NO source 103; paragraph 0065 teaches “varying the quantity” of NO delivered as a part of a feedback loop, therefore the source 103 would be configured to deliver a third gas with a third different amount of nitric oxide as a part of the iterative feedback to reach the target dosage);
iii) at least one sensor (Fig. 1, the sensors within gas sampling system 129) configured to measure the second amount of nitric oxide measured by the at least one sensor in the sampling line (Fig. 1, the sampling line 131 is directly connected to the sensors within 129; [0067]);
wherein the third amount of nitric oxide is determined by the feedback-loop controller based on the second amount of nitric oxide and the nitric oxide set-point amount (paragraph 0065 teaches a feedback system based on a “desired set dose”, which is a nitric oxide set-point amount, executed by processors, which is part of feedback-loop controller 111 in paragraph 0063, that varies the quantity of gas delivered, which could be a third amount of nitric oxide since the feedback is iterative until the desired dosage is reached; this third amount is based on monitoring inspiratory flow, which has the second amount of nitric oxide), wherein when the second amount of nitric oxide is different from the nitric oxide set-point amount, the feedback-loop controller is configured to communicate with the source to adjust the third amount of nitric oxide to match the nitric oxide set-point amount ([0065] suggests altering volume or mass of therapeutic gas delivered in a subsequent inspiratory flow; [0065] teaches monitoring the therapeutic gas flow in the inspiratory flow, which is a second amount of nitric oxide, and varying the quantity of delivered gas, which is a third amount of nitric oxide delivered after receiving feedback from the sensors; [0056] incorporates by reference Bathe: col. 2, lines 56-67; col. 6, line 54-col. 7, line 11).
Regarding claim 3, Acker teaches the system of claim 1.
Acker further teaches wherein the sampling line is operated by a pump (paragraph 0066 “actuating a sampling pump and/or opening a gas sampling valve (e.g., three way valve, etc.) to obtain a gas sample from the inspiratory limb of a patient breathing circuit”) and is configured to deliver a predetermined amount of the second gas to the at least one sensor (paragraph 0066 “the gas sample being of blended air and therapeutic gas (e.g., NO) being delivered to a patient; exposing the gas sample to gas sensors (e.g., catalytic type electrochemical gas sensors)”).
Regarding claim 4, Acker teaches the system of claim 1.
Acker further teaches wherein the breathing gas is delivered by a breathing-assisting device (paragraph 0059 “As shown, ventilator 117 can include an inspiratory outlet for delivering breathing gas” where a ventilator is a breathing-assisting device).
Regarding claim 5, Acker teaches the system of claim 1.
Acker further teaches wherein the breathing gas comprises air and/or oxygen-enriched air (paragraph 0066 “the gas sample being of blended air and therapeutic gas (e.g., NO) being delivered to a patient” where the mixture of gases in the inspiratory limb are air and NO; paragraph 0058 “nitric oxide delivery system 100 can be used to wild stream blend therapeutic gas (e.g., nitric oxide, NO, etc.) into patient breathing gas in a breathing circuit (affiliated with a ventilator) as a proportion of the patient breathing gas”; One skilled in the art would know the ventilator 117 is providing the air based on Fig. 1).
Regarding claim 8, Acker teaches the system of claim 1.
Acker further teaches wherein the at least one sensor is a NO-sensor (paragraph 0067 “Gas sampling system 129 can include numerous sensors such as, but not limited to, nitric oxide gas sensors, nitrogen dioxide gas sensors, and/or oxygen gas sensors, to name a few that can be used to display relevant information (e.g., gas concentrations, etc.) on user input/display 113”).
Regarding claim 9, Acker teaches the system of claim 1.
Acker further teaches wherein the feedback-loop controller is in further communication with additional one or more sensors (Fig. 1, the sensors are in 129, which is connected to controller 111 via the dashed lines).
Regarding claim 10, Acker teaches the system of claim 9.
Acker further teaches wherein the additional one or more sensors comprise an oxygen sensor and/or a nitrogen dioxide sensor (Fig. 1, where 129 has both NO2 sensor and oxygen sensor).
Regarding claim 11, Acker teaches the system of claim 10.
Acker further teaches wherein the oxygen sensor detects an amount of oxygen and/or the nitrogen dioxide sensor detects an amount of nitrogen dioxide in the second gas (paragraph 0066 “exposing the gas sample to gas sensors (e.g., catalytic type electrochemical gas sensors); obtaining information from the sensor indicative of the concentration of target gas (e.g., NO, nitrogen dioxide, oxygen) being delivered to the patient”).
Regarding claim 12, Acker teaches the system of claim 1.
Acker further teaches wherein the nitric oxide set-point amount is a therapeutical target amount (paragraph 0067 “User input/display 113 can receive desired settings from the user, such as the patient's prescription (in mg/kg ideal body weight, mg/kg/hr, mg/kg/breath, mL/breath, cylinder concentration, delivery concentration, duration, etc.)” where a prescription is a therapeutical amount and concentration).
Regarding claim 14, Acker teaches the system of claim 1.
Acker further teaches wherein the nitric oxide set-point is a concentration of nitric oxide that correlates to the first amount of nitric oxide (paragraph 0065 “the delivery system can perform a method to, for example, deliver a desired set dose of therapeutic gas (e.g., NO concentration, NO PPM, etc.) to a patient in need thereof comprising: receiving and/or determining a desired set dose of therapeutic gas to be delivered to a patient” where the first desired dose of gas delivered to a patient is before any feedback and would be the first amount of nitric oxide).
Regarding claim 16, Acker teaches the system of claim 1.
Acker further teaches wherein at least once during nitric oxide delivery to the subject, the first amount of nitric oxide is the same as the third amount of nitric oxide (paragraph 0065; the first and third amount flow in the same line with no other additives as shown in figure 1 for example and thus the amount of NO is the same).
Regarding claim 17, Acker teaches the system of claim 1.
Acker further teaches wherein the source is configured to form nitric oxide in-situ (paragraph 0058 “receive nitric oxide from a nitric oxide source 103 (e.g., cylinder storing NO, NO generator, etc.” where a NO generator would from nitric oxide in-situ).
Regarding claim 19, Acker teaches the system of claim 1.
Acker further teaches wherein the system comprises an auxiliary sensor positioned adjacent to an injection point and configured to measure a flow rate of the breathing gas (Fig. 1, flow sensor 119; paragraph 0061 “one or more breathing circuit gas (BCG) flow sensors 119 that can measure the flow of at least patient breathing gas (e.g., forward flow 133) through injector module 107”), and wherein the auxiliary sensor is in communication with the feedback-loop controller (paragraph 0062 “For example, nitric oxide delivery system 100 can confirm that the desired concentration of NO is in the combined breathing gas and therapeutic gas by using the known NO concentration of NO source 103; the amount of breathing gas flow in the patient circuit using information from BCG flow sensor 119” where it is implicit that the system 100 uses information from sensor 119 by communicating with controller 111 in the system 100).
Regarding claim 20, Acker teaches the system of claim 19.
Acker further teaches wherein when the flow rate of the breathing gas is different than a flow rate correlated to the nitric oxide set-point amount, the feedback-loop controller corrects a flow of the third gas (paragraph 0062 “For example, nitric oxide delivery system 100 can confirm that the desired concentration of NO is in the combined breathing gas and therapeutic gas by using the known NO concentration of NO source 103; the amount of breathing gas flow in the patient circuit using information from BCG flow sensor 119; and the amount of therapeutic gas flow in conduit 105 to injector module 107 (and in turn to patient 108) using information from NO flow sensor 115”; Fig. 1, NO flow sensor 115 and flow sensor 119 are connected to controller 111; Based on the feedback loop discussed in paragraph 0065, the controller would correct flow through sensor 115 after receiving feedback that the desired concentration is not achieved using information from flow sensor 119 and NO flow sensor 115; [0056] incorporates by reference Bathe: col. 2, lines 56-67; col. 6, line 54-col. 7, line 11).
Regarding claim 22, Acker teaches the system of claim 1.
Acker further teaches wherein an exhaling conduit comprises a fourth gas exhaled by the subject (Fig. 1, expiratory limb 127; paragraph 0059 “an expiratory inlet for receiving patient expiration via an expiratory limb 127 and “Y” piece 125 of the patient breathing circuit”) and wherein the fourth gas is vented to the ambient environment (paragraph 0087 “Further, in at least some instances, BiPAP ventilator 117 can include a bias flow rate that can be substantially high (e.g., more than 10 liters per minute, 10-20 liters per minute, etc.) that may be used to expel expiratory flow (e.g., from the patient) out of exhaust port 604”; the ventilator 117 can vent the expiratory fourth gas).
Regarding claim 30, Acker teaches the system of claim 1.
Acker further teaches a setup comprising the system of claim 1 (Fig. 1) integrated with a ventilator (Fig. 1, ventilator 117), an anesthesia gas delivery system (paragraph 0113 “based on at least user input and/or algorithm(s) associated with the delivery system when use with an anesthesia machine is input and/or detected”), a bidirectional flow system (paragraph 0007 “In one or more embodiments, the injector module includes and/or is in communication with a bi-directional breathing circuit gas (BCG) flow sensor capable of measuring forward flowing breathing gas and reverse flowing breathing gas”), an intrapulmonary percussion ventilator system, a high-flow oxygen delivery system or any combination thereof.
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.
Claims 2 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150273175 A1) which incorporates Bathe et al. (US 5,558,083)
Regarding claim 2, Acker teaches the system of claim 1.
Acker does not specifically teach wherein the sampling location is at a distance of about 6 to about 12 inches from a connecting point of the breathing conduit and an exhaling conduit with a face mask or a breathing tube.
However, one skilled in the art could arrive at disposing the sampling location at a distance of about 6 to about 12 inches from a connecting point of the breathing conduit and an exhaling conduit with a face mask or a breathing tube through routine optimization. Fig. 1 of Acker shows the sample line 131 being close to the connecting point of breathing and exhaling conduit, but does not disclose the specific distance of this location. One would be motivated to optimize these distances to determine which distance would provide the most accurate sample taking from the breathing conduit. See also MPEP § 2144.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Acker to have the sampling location is at a distance of about 6 to about 12 inches from a connecting point of the breathing conduit and an exhaling conduit with a face mask or a breathing tube since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Acker would not operate differently with the claimed distances and since the sampling line would still be located within the inspiratory limb with the claimed distances the device would function appropriately having the claimed distances.
Regarding claim 29, Acker teaches the system of claim 1.
Acker does not specifically teach wherein the system is configured to deliver 0.1 L/min - 200 L/min of breathing gas.
However, one skilled in the art could arrive at these flow levels through routine optimization. Acker teaches the ventilator 117 having various flow rates (paragraph 0087 “e.g., more than 10 liters per minute, 10-20 liters per minute, etc.”) that supply the breathing gas. Therefore, it would been obvious to modify and optimize the exact breathing gas delivery rates to align with a user’s inhalation and exhalation rates. See also MPEP § 2144.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150273175 A1), incorporates Bathe et al. (US 5,558,083), in view of Acker (US 20140261415 A1).
Regarding claim 6, Acker (US 20150273175 A1) teaches the system of claim 1.
Acker (US 20150273175 A1) is silent wherein the first gas further comprises a carrier gas.
However, Acker (US 20140261415 A1) teaches a nitric oxide source with a carrier gas (paragraph 0040 “A source of therapeutic gas containing nitric oxide may include gas storage cylinder 103. Exemplary cylinders may contain NO in a carrier gas such as nitrogen”) that injects nitric oxide into a nitric oxide delivery system (paragraph 0042 “Gas storage cylinder 103 is in fluid communication with conduit 105, which carries the therapeutic gas from gas storage cylinder 103 to the nitric oxide delivery device” wherein the gas injected into the system is the first gas and would contain carrier gas) in a manner analogous to the instant application.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Acker (US 20150273175 A1) to include a first gas comprising carrier gas injected from a nitric oxide injection line. The carrier gas can help modulate the concentration of NO injected and generate the most appropriate concentration for a user (paragraph 0040 “Exemplary cylinders may contain NO in a carrier gas such as nitrogen, with a NO concentration ranging from 1 ppm to 20,000 ppm, such as from 5 ppm to 10,000 ppm, or from 10 ppm to 5,000 ppm. In one or more embodiments, the cylinder has a high nitric oxide concentration, such as about 2440 ppm or about 4880 ppm. In other embodiments, the cylinder concentration is about 800 ppm”).
Regarding claim 7, modified Acker (US 20150273175 A1) teaches the system of claim 6.
Modified Acker (US 20150273175 A1) does not specifically teach wherein the second gas further comprises the carrier gas. However, when the NO source of Acker (US 20150273175 A1) is modified with the NO source of Acker (US 20140261415 A1), then the first gas with carrier gas injected at 107 of Fig. 1 would continue to have the same carrier gas when the second gas is sampled by sampling line 131 of Fig. 1. Therefore, the second gas further comprises the carrier gas.
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150273175 A1), incorporates Bathe et al. (US 5,558,083), in view of Acker (US 20150314101 A1).
Regarding claim 13, Acker teaches the system of claim 1.
Acker (US 20150273175 A1) does not specifically teach wherein the nitric oxide set-point is a flow rate of nitric oxide that correlates to the first amount of nitric oxide.
However, Acker (US 20150314101 A1) teaches wherein the nitric set-point is a flow rate of nitric oxide (paragraph 0057 “exemplary expected information from the NO flow sensor for a desired flow rate of 10 ml/min”) that correlates to the first amount of nitric oxide (paragraph 0061 “as the NO delivery system attempts to adjust the flow of gas to the breathing circuit to attempt to deliver at the desired flow rate” wherein the delivery system would deliver a first amount that correlates to a flow rate set-point to reach the desired rate).
Thus, it would have been obvious to substitute the concentration set point to a flow rate set point for the predictable result of the nitric oxide system working to deliver a desired flow rate dose. Acker (US 20150273175 A1) suggests other possible set-points that would be considered a desired dose(paragraph 0065 “the delivery system can perform a method to, for example, deliver a desired set dose of therapeutic gas (e.g., NO concentration, NO PPM, etc.) to a patient in need thereof comprising: receiving and/or determining a desired set dose of therapeutic gas to be delivered to a patient”) and it would therefore be reasonable to substitute for a flow rate set-point.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150273175 A1), incorporates Bathe et al. (US 5,558,083), in view of Fine (US 20140127081 A1).
Regarding claim 18, Acker teaches the system of claim 17.
Acker is silent wherein the third amount is controlled by a temperature and pressure supplied to the source.
However, Fine teaches wherein a nitric oxide amount is controlled by a temperature (paragraph 0123 “The reservoir 200 can operate at a temperature above room temperature. To get the temperature of the reservoir up to the operating temperature, a heating device 204 can be utilized” wherein a heating device supplies temperature and controls the amount of nitric oxide as taught in paragraph 0123) and pressure supplied to the source (paragraph 0016 teaches the nitric oxide source including a pressurized bottle, which would supply pressure to a nitric oxide source).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified Acker to include a third amount controlled by a temperature and pressure supplied to the source. Supplying pressure can dispense the amount of a source faster (paragraph 0176 “For example, it can be quicker to provide nitric oxide from a gas bottle than to provide nitrogen dioxide from a reservoir. Therefore, it may be beneficial to include a gas bottle as part of a first platform that is acting as a backup to a second platform”). Using temperature to control a nitric oxide amount can provide a way of controlling the amount of nitric oxide released (paragraph 0201 “The simplest control for a liquid source can be temperature, which can in turn control the pressure of the nitric oxide-releasing compound in the reservoir, and therefore, the concentration of nitric oxide-releasing compound released from the reservoir”) and increase the total amount of nitric oxide released from a source (paragraph 0064 “In some embodiments, heating the first reservoir can increase a total amount of the first nitric oxide-releasing compound released from the first reservoir”).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150273175 A1), incorporates Bathe et al. (US 5,558,083), in view of Miller (US 20170095634 A1).
Regarding claim 21, Acker teaches the system of claim 1.
Acker is silent wherein the breathing gas further comprises a first amount of a pharmaceutically active ingredient.
However, Miller teaches an analogous nitric oxide deliver system (Fig. 1) with breathing gas (Fig. 1, the gas supplied by air source 120, see paragraph 0048), wherein the breathing gas further comprises a first amount of a pharmaceutically active ingredient (paragraph 0048 “The one or more inert and/or non-reactive gases can include one or more of nitrogen, helium, neon, argon, krypton, nitrous oxide, anesthesia gas and/or any another suitable gas” where anesthesia gas is a pharmaceutically active ingredient).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the breathing gas of Acker to include a first amount of a pharmaceutically active ingredient to provide additional therapeutic effects to a user when they inhale the gas, wherein the active ingredient would have a different therapeutic impact than the nitric oxide.
Claims 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150273175 A1), incorporates Bathe et al. (US 5,558,083), in view of Jafri (US 20180304038 A1).
Regarding claim 23, Acker teaches the system of claim 1.
Acker further teaches wherein an exhaling conduit comprises a fourth gas exhaled by the subject (Fig. 1, expiratory limb 127; paragraph 0059 “an expiratory inlet for receiving patient expiration via an expiratory limb 127 and “Y” piece 125 of the patient breathing circuit”).
Acker is silent wherein the system is configured to recirculate at least a portion of the fourth gas into the breathing conduit, wherein the at least a portion of the fourth gas is substantially free of carbon dioxide.
However, Jafri teaches a nitric oxide delivery device (Fig. 1, device 1) configured to recirculate at least a portion of the fourth gas into the breathing conduit (paragraph 0092 “From the patient interface 3 a filter 31 for the exhaled breathing gas is furthermore provided. The filter 31 may selectively filter out a component of the exhaled breathing gas. This filtered out gas may then be redistributed to the arrangement for onsite production of nitric oxide 210 (shown) and/or another gas to the arrangement for onsite enrichment of oxygen 220 (not shown)” wherein the redistributed gas goes from 210 or 220 to the breathing conduit 3 according to Fig. 1 ), wherein the at least a portion of the fourth gas is substantially free of carbon dioxide (paragraph 0039 “The device may further comprise a filter and/or a reservoir for exhaled breathing gases. A filter may filter, collect, and/or transfer exhaled breathing gases to prevent dissipation of the gaseous mixture or of e.g. carbon dioxide or nitric oxide into ambient air”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Acker to recirculate a fourth gas into the breathing conduit, wherein at least a portion of the fourth gas is substantially free of carbon dioxide. It would be obvious to recirculate to minimize any wasted NO or breathing gas. It would be obvious to make a portion of the fourth gas substantially free of carbon dioxide since this gas is reintroduced to the patient and excess carbon dioxide in this gas would be harmful for the patient.
Regarding claim 24, modified Acker teaches the system of claim 23.
Acker further teaches wherein the fourth gas comprises a fourth amount of nitric oxide (paragraph 0102 “the later part of expiration where minimal iNO may be detected” where minimal NO is a fourth amount of NO).
Regarding claim 25, modified Acker teaches the system of claim 23.
Modified Acker further teaches wherein the second gas comprises at least a portion of the fourth gas. The second gas comprises at least a portion of the fourth gas when Acker is modified with the teachings of Jafri. When the fourth gas is recirculated into the breathing conduit as taught above, then the second gas, which is sampled by sampling line 131, would also collect at least a portion of the fourth gas within the second gas that it samples.
Regarding claim 26, modified Acker teaches the system of claim 24.
Modified Acker further teaches wherein the second amount of nitric oxide comprises at least the first amount and the fourth amount of the nitric oxide. The second amount of nitric oxide comprises the first amount and the fourth amount when Acker is modified with the teachings of Jafri. When the fourth gas is recirculated into the breathing conduit as taught above, then the second gas with the second amount of nitric oxide, which is sampled by sampling line 131, would also collect at least a portion of the first and fourth amounts of nitric oxides since the first gas and fourth gas are continuously looped within the system.
Claim 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150273175 A1), incorporates Bathe et al. (US 5,558,083), in view of Jafri (US 20180304038 A1) as applied above and in further view of Miller (US 20170095634 A1).
Regarding claim 27, modified Acker teaches the system of claim 23.
Modified Acker is silent wherein the breathing gas further comprises a pharmaceutically active ingredient.
However, Miller teaches an analogous nitric oxide deliver system (Fig. 1) with breathing gas (Fig. 1, the gas supplied by air source 120, see paragraph 0048), wherein the breathing gas further comprises a first amount of a pharmaceutically active ingredient (paragraph 0048 “The one or more inert and/or non-reactive gases can include one or more of nitrogen, helium, neon, argon, krypton, nitrous oxide, anesthesia gas and/or any another suitable gas” where anesthesia gas is a pharmaceutically active ingredient).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the breathing gas of Acker to include a pharmaceutically active ingredient to provide additional therapeutic effects to a user when they inhale the gas, wherein the active ingredient would have a different therapeutic impact than the nitric oxide.
Acker, as modified by Jafri and Miller as described above, teaches wherein the fourth gas comprises a second amount of the pharmaceutically active ingredient, wherein the second amount of the pharmaceutically active ingredient is less than the first amount of pharmaceutically active ingredient. The fourth gas, which is exhaled from a user, would have a second amount of active ingredient that is less than the first amount since the first amount enters the patient and the patient would absorb the active ingredient before exhaling any excess or waste ingredient. This excess or waste amount would be less than the first amount that initially enters a user’s body.
Regarding claim 28, modified Acker teaches the system of claim 27.
Miller further teaches wherein the pharmaceutically active ingredient comprises an anesthetic (paragraph 0048 “In other embodiments, the air source 120 comprises a mixture of oxygen and one or more inert and/or non-reactive gases. The one or more inert and/or non-reactive gases can include one or more of nitrogen, helium, neon, argon, krypton, nitrous oxide, anesthesia gas and/or any another suitable gas. In some embodiments, the air source 120 comprises oxygen at any suitable concentration”).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are not persuasive. [0065] was relied upon previously to reject claim 15 and is still relied upon. Bathe which is incorporated by reference in its entirety in [0056] of Acker further explains how the feedback loop works.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bathe et al. (US 8,776,794 B2)
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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