DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to an amendment filed on 12/5/2025. As directed by the amendment, claim 14 is canceled, and no claims are amended, or added. Thus, claims 1-13 and 15-20 are pending for this application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-10, 12-13, and 15-20 are rejected under 35 U.S.C. 103 as obvious over Tolmie (2007/0181126) in view of Bathe (2013/0074838), Lott (5,664,733), Yee (US 2009/0260629) and Crump (US 7,021,313).
Regarding claim 1, Tolmie discloses a method of delivery nitric oxide (NO) to a patient (an apparatus delivers nitric oxide to a patient 14, see fig. 1, the abstract and para. [0001]), the method comprising:
combining a first gas stream comprising molecular oxygen (defined by a gas stream provided by O2 supply 18, see fig. 2 and para. [0029]) and a second gas stream comprising NO (defined by a gas stream provided by NO supply 38, see fig. 1 and para. [0020]) to provide a combined gas stream (the first gas stream and second gas stream are combined at an injection device 36, when the injection device 36 releases the second gas stream into an inspiratory limb 28, see fig. 1 and paras. [0001] and [0021]), and
delivering the combined gas stream to the patient (the combined gas stream is delivered to the patient 14 via an inspiratory limb 28 and patient limb 32, see fig. 1 and para. [0019]).
Tolmie discloses that the second gas stream is provided by an NO source (defined by NO supply 38, see fig. 1) having an NO concentration of 800 ppm (the NO source 38 supplies NO having a concentration of 800ppm, see fig. 1 and para. [0028]), but is silent with regard to the concentration being greater than 800ppm to about 10,000 ppm.
However, Bathe teaches that a system for delivering NO to a patient (see fig. 1 and the abstract) includes an NO source (defined by gas source 50, see fig. 1) having an NO concentration of 4,880 ppm, see para. [0067].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the concentration Tolmie’s NO source to be 4,880 ppm, as taught by Bathe, for the purpose of providing a higher concentration of NO for increasing the rate at which the NO relaxes vascular smooth muscle and when inhaled and the rate at which the NO dilates the pulmonary vasculature, see para. [0065] of Bathe.
The modified Tolmie method discloses everything as claimed including a central processing unit (CPU) (see element “52” in fig. 1 of Tolmie) for controlling a flow of gas from each of the first gas stream and second gas stream, see paras. [0022] and [0033] of Tolmie, so that diffusion of the first gas stream and second gas stream occurs so that 80 ppm of NO is delivered to the patient (the injection device 36 injects NO into the inspiratory limb 28, see paras. [0021] and [0028] of Tolmie, such that the first gas stream diffuses with the second gas stream at the intersection of the injection device 36 and the inspiratory limb 28, see fig. 1 of Tolmie), but is silent with regard to the combined gas stream has a nitrogen dioxide (NO2) concentration of less than 1 ppm of NO2 is delivered to the patient.
However, Lott teaches that a nozzle (see fig. 5) for combining a first fluid stream and a second fluid stream (see figs. 5-6 and the abstract) having a nozzle outlet orifice 40 (see fig. 5) delivering a first fluid stream (an accelerated first fluid stream enters the nozzle 10, see col. 5 lines 21-31) intersecting with second fluid stream (a second fluid stream is injected into the mixing area 80, see col. 5 lines 21-31) at a mixing chamber 80 (see fig. 5),
the combined gas stream diffusing within a diffuser 70 (see fig. 5) having a tapered cross section for rapidly diffusing the combined gas stream (the nozzle provides a chaotic turbulent flow, see fig. 5 and col. 5 lines 32-39, and the diffuser 70 includes an inlet end 72 which tapers to an outlet end 74, see fig. 5 and col. 5 lines 25-32, to improve the mixing of the combined gas stream, see col. 1 lines 5-15 and col. 5 lines 27-40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intersection between the modified Tolmie injection device and inspiratory limb with the addition of nozzle outlet orifice, mixing chamber and diffuser, as taught by Lott, for the purpose of improving the mixing of the combined gas stream, see col. 1 lines 5-15 of Lott.
The modified Tolmie method discloses that the combined gas stream is diffused to have a nitrogen dioxide NO2 concentration of less than 1 ppm of NO2 when delivered to the patient (Tolmie discloses combining the first gas stream of O2 with the second gas stream of NO within the inspiratory limb, see fig. 1 and para. [0021] of Tolmie; Tolmie, as modified by Lott, further discloses the nozzle for having the first gas stream enter the mixer close to a point of injection of the second gas stream where the combined gas stream diffuses via the diffuser, see fig. 5, col. 1 lines 5-15 and col. 5 lines 27-40 of Lott; as the applicant’s specification discloses that “one approach for rapidly mixing the NO and FGF is the use of a mixing device placed immediately downstream or close to the point of NO injection to ensure that the combined gas stream has a homogenous NO concentration as soon as possible”, see lines 1-3 of para. [0090] of the applicant’s specification, the modified Tolmie method discloses the diffusing the combined gas stream sufficiently rapidly so that the less than 1 ppm of NO2 is delivered to the patient).
Modified Tolmie discloses the first and gas streams are combined, but is silent regarding how the combination occurs, and thus does not disclose wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port.
However, Yee teaches (Fig. 1-3) a method of combining a first gas stream (“first gas” flowing through conduit 12,14, paragraph [0035]) and a second gas stream (“second gas” flowing through conduit 20, paragraph [0035]), wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port (second gas injected into entry end 16 of conduit and then mixed with gas stream within conduit 12,14, paragraph [0036] and [0043]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Tolmie such that the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port, as taught by Yee, for the purpose of allowable for an easy way to attach/detach a second gas to the main conduit (paragraph [0043] Yee).
Modified Tolmie does not disclose mixing the combined gas stream with a mixing device downstream of the injection port.
However, Crump teaches (Fig. 5a-5c) a method of mixing fluids wherein the mixing occurs via a mixing device (helical grooves 450, which causes the flow to be turbulent and thus improve mixing, Col. 10 lines 9-14 and 24-34) located downstream of the injection port (port 480, Col. 10 lines 9-14 and 24-34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Tolmie such that mixing the combined gas stream with a mixing device downstream of the injection port, as taught by Crump, for the purpose of improving turbulence and thus mixing of the two fluids (Col. 10 lines 9-14 and 24-34 Yee) and thus improve therapeutic outcome of the patient.
Regarding claim 2, the modified Tolmie method discloses that the NO source has an NO concentration of about 4880 ppm (see para. [0067] of Bathe).
Regarding claim 3, the modified Tolmie method discloses that the combined gas stream has an NO concentration of about 1 ppm to about 80 ppm (the NO source 38 supplies NO having a concentration of 800 ppm so that a dosage of NO, in the combined gas stream, is 80ppm, see fig. 1 and para. [0028] of Tolmie).
Regarding claim 5, the modified Tolmie method discloses that the second gas stream initially enters the first gas stream at an angle in a range of about 90° (the second gas stream is shown to enter at an angle perpendicular to an axis formed by the longitudinal axis of the nozzle, see fig. 5 of Lott, such that the second gas stream enters the first gas stream at an angle of about 90°).
Regarding claim 6, the modified Tolmie method discloses that a volumetric flow rate of the second gas is linearly proportional to a volumetric flow rate of the first gas (a volumetric flow rate of the first gas stream and the second gas stream is set, by a user, and controlled, by the CPU 24 and CPU 52 to be at a ratio of 0.1, see para. [0028] of Tolmie, such that if ten liters per minute of the first gas stream is provided, then one liter per minute of the second gas stream is provided).
Regarding claims 7-8, the modified Tolmie method discloses the first gas stream has a first velocity and the second gas stream has a second velocity and that a ratio of the first velocity to the second velocity is less than about 1:1 (a CPU 24 controls the first gas stream to be provided at ten liters per minute and a CPU 52 controls the second gas stream to be provided at one liter per minute such that the ratio of the first velocity to the second velocity is 1:0.1, see para. [0028] of Tolmie).
Regarding claim 9, the modified Tolmie method discloses everything as claimed including the ratio being less than 1:1, see para. [0028] of Tolmie, and further discloses that the volumetric flow rate of the first gas stream is able to two liters per minute (the volumetric flow rate of the first gas stream is varied to be between ten to two liters per minute, see para. [0027] of Tolmie, and the ratio of the first velocity and second velocity is controlled to be at the ratio of 1:0.1, see para. [0028] of Tolmie).
The modified Tolmie method does not explicitly disclose that the volumetric flow rate of the first gas stream is less than 2SLPM, when being provided at the ratio of less than 1:1 with the second gas stream. However, Tolmie discloses that “Typical instantaneous flow rates will vary from 10 to 2 liters/min” and that the clinician is able to set the flow rate of the first gas stream, see paras. [0025] and [0028] of Tolmie, where the CPU 24 controls the volumetric flow rate of the first gas stream, based on the clinician input settings, to be variable when being provided to assist the patient’s inspiratory cycle at the ratio of less than 1:1 with the second gas stream, see paras. [0027]-[0028] of Tolmie,
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the volumetric flow rate of the modified Tolmie first gas stream to be able to vary between ten liters per minute and less than two standard liters per minute, for the purpose of allowing volumetric flow rate of the first gas stream to accommodate different patients, see para. [0027] of Tolmie, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 10, the modified Tolmie method discloses the second gas stream enters the first gas stream near a central midpoint of a highest velocity of the first gas stream (the first gas stream passes through an outlet orifice 40 so that the first gas stream includes the central midpoint along the outlet orifice 40, where the first gas stream is at its highest velocity, see fig. 5 and col. 4 lines 42-46 of Lott; the second gas stream enters, perpendicular to the outlet orifice 40, so that the second gas stream enters the first gas stream near the central midpoint and highest velocity of the first gas stream, see fig. 5 of Lott).
Regarding claim 12, modified Tolmie discloses the first gas stream and the second gas stream are combined in a device comprising an injection port (port 16,20 of Yee), but does not disclose the device comprising: a body comprising a wall having a thickness, an outer surface, and an inner surface surrounding a hollow internal region; a projection extending from the inner surface of the body and into the hollow internal region; and an injection channel passing through the wall and projection to the injection port such that the injection port injects the second gas stream into the first gas stream at a distance from the inner surface of the body.
However, Yee further teaches (Fig. 7, 8-1 and 8-2) a system for delivering a first gas and a second gas to a patient (the system includes a PAP device 230, see fig. 7, for delivering a first gas and second gas to a patient, see the abstract and para. [0035]) includes a body (defined by connector 310, see fig. 8-1) having a gas conduit (see element 320 in fig. 8-1) for directing the second gas (the gas conduit 320 receives the second gas from a second source, see para. [0035]) into a transverse first gas stream (the body 310 includes a hollow interior region, see annotated fig. 8-2 of Yee below, for directing the first gas stream, in a transverse direction along the body 310, to the patient, see para. [0035] and [0054]), and a projection (defined by fin 325, see figs. 8-1 to 8-2) extending from an inner surface (see annotated fig. 8-2 of Yee) of the body 310 and into the hollow internal region (the projection 325 is shown to extend from the inner surface into the hollow internal region, see figs. 8-1 to 8-2); and an injection channel (defined by a hollow interior, best shown in fig. 6-10, of the projection 325, see figs. 8-1 to 8-2) passing through a wall (see annotated fig. 8-2 of Yee) of the body 310 and the projection 325 to an injection port (defined by an opening of second end 318, see annotated fig. 8-2 of Yee, where a second gas flows, see para. [0035]) such that the injection port injects the second gas stream into the first gas stream at a distance from the inner surface of the body 310 (the injection port 310 being shown to extend a distance from the inner surface of the body 310 via the projection 325, see annotated fig. 8-2 of Yee, so that the second gas stream is injected into the transverse first gas stream, see figs. 8-1 to 8-2).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Tolmie method to include providing a device comprising: a body comprising a wall having a thickness, an outer surface, and an inner surface surrounding a hollow internal region; a projection extending from the inner surface of the body and into the hollow internal region; and an injection channel passing through the wall and projection to the injection port such that the injection port injects the second gas stream into the first gas stream at a distance from the inner surface of the body, as taught by Yee, for the purpose of improving the safety of the system by preventing the second gas stream from flowing backwards, toward the nozzle outlet end, of the body, see para. [0041] of Yee.
Regarding claim 13, the modified Tolmie method discloses the hollow internal region has a diameter (the body 310 is shown to have a hollow interior region diameter, where the projection 325 is located, having a diameter of 21.6 mm, see para. [0057] of Yee).
The modified Tolmie method does not explicitly disclose that a length of the projection from the inner surface to an outlet of the injection port is in a range of about 30% to about 45% of the diameter of the hollow internal region.
However, Tolmie teaches that a length, of the projection from the inner surface to the outlet of the injection port, is shown to have a dimension that is less than the diameter of the hollow internal region, see annotated fig. 8-2 of Yee, where the hollow interior region diameter is 21.6 mm and the projection includes a 2.8 mm diameter at the second end 318, where the outlet of the injection port is located, see para. [0056] of Yee.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length, of projection from the inner surface to the outlet of the injection port, of the modified Tolmie method to be 45% of the diameter of the hollow internal region, to allow the outlet of the injection port to provide sufficient gas flow and minimize noise, see para. [0056] of Yee, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 15, the modified Tolmie method discloses the first gas stream and the second gas stream are combined in a device (defined by injection device 36, valve 37 and flow sensor 39, see fig. 1 and para. [0021] of Tolmie) that is integral to an injector module comprising a flow sensor (see element 39 in fig. 1 and para. [0021] of Tolmie).
Regarding claim 16, the modified Tolmie method discloses everything as claimed including the NO source having an NO concentration of greater than 4,880 ppm, and the steps of combining the first gas stream and second gas stream, delivering the combined gas stream to the patient and the combined gas stream has the nitrogen dioxide concentration of less than 1 ppm of NO2 when delivered to the patient, as recited in the rejection of claim 1 above.
The modified Tolmie method discloses that the combined gas stream has a set dose of NO (a user inputs parameters for setting a dosage of NO to be receiving by the patient, see para. [0025] of Tolmie).
Regarding claim 16, Tolmie discloses a method of delivery nitric oxide (NO) to a patient (an apparatus delivers nitric oxide to a patient 14, see fig. 1, the abstract and para. [0001]), the method comprising:
combining a first gas stream comprising molecular oxygen (defined by a gas stream provided by O2 supply 18, see fig. 2 and para. [0029]) and a second gas stream comprising NO (defined by a gas stream provided by NO supply 38, see fig. 1 and para. [0020]) to provide a combined gas stream having a set dose of NO (the first gas stream and second gas stream are combined at an injection device 36, when the injection device 36 releases the second gas stream into an inspiratory limb 28, see fig. 1 and paras. [0001] and [0021]).
Tolmie discloses that the second gas stream is provided by an NO source (defined by NO supply 38, see fig. 1) having an NO concentration of 800 ppm (the NO source 38 supplies NO having a concentration of 800ppm, see fig. 1 and para. [0028]), but is silent with regard to the concentration being greater than 800ppm to about 10,000 ppm.
However, Bathe teaches that a system for delivering NO to a patient (see fig. 1 and the abstract) includes an NO source (defined by gas source 50, see fig. 1) having an NO concentration of 4,880 ppm, see para. [0067].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the concentration Tolmie’s NO source to be 4,880 ppm, as taught by Bathe, for the purpose of providing a higher concentration of NO for increasing the rate at which the NO relaxes vascular smooth muscle and when inhaled and the rate at which the NO dilates the pulmonary vasculature, see para. [0065] of Bathe.
The modified Tolmie method discloses everything as claimed including a central processing unit (CPU) (see element “52” in fig. 1 of Tolmie) for controlling a flow of gas from each of the first gas stream and second gas stream, see paras. [0022] and [0033] of Tolmie, so that diffusion of the first gas stream and second gas stream occurs so that 80 ppm of NO is delivered to the patient (the injection device 36 injects NO into the inspiratory limb 28, see paras. [0021] and [0028] of Tolmie, such that the first gas stream diffuses with the second gas stream at the intersection of the injection device 36 and the inspiratory limb 28, see fig. 1 of Tolmie), but is silent with regard to the combined gas stream has a nitrogen dioxide (NO2) concentration of less than 1 ppm of NO2 is delivered to the patient.
However, Lott teaches that a nozzle (see fig. 5) for combining a first fluid stream and a second fluid stream (see figs. 5-6 and the abstract) having a nozzle outlet orifice 40 (see fig. 5) delivering a first fluid stream (an accelerated first fluid stream enters the nozzle 10, see col. 5 lines 21-31) intersecting with second fluid stream (a second fluid stream is injected into the mixing area 80, see col. 5 lines 21-31) at a mixing chamber 80 (see fig. 5), the combined gas stream diffusing within a diffuser 70 (see fig. 5) having a tapered cross section for rapidly diffusing the combined gas stream (the nozzle provides a chaotic turbulent flow, see fig. 5 and col. 5 lines 32-39, and the diffuser 70 includes an inlet end 72 which tapers to an outlet end 74, see fig. 5 and col. 5 lines 25-32, to improve the mixing of the combined gas stream, see col. 1 lines 5-15 and col. 5 lines 27-40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intersection between the modified Tolmie injection device and inspiratory limb with the addition of nozzle outlet orifice, mixing chamber and diffuser, as taught by Lott, for the purpose of improving the mixing of the combined gas stream, see col. 1 lines 5-15 of Lott.
The modified Tolmie method discloses that the combined gas stream is diffused to have a nitrogen dioxide NO2 concentration of less than 1 ppm of NO2 when delivered to the patient (Tolmie discloses combining the first gas stream of O2 with the second gas stream of NO within the inspiratory limb, see fig. 1 and para. [0021] of Tolmie; Tolmie, as modified by Lott, further discloses the nozzle for having the first gas stream enter the mixer close to a point of injection of the second gas stream where the combined gas stream diffuses via the diffuser, see fig. 5, col. 1 lines 5-15 and col. 5 lines 27-40 of Lott; as the applicant’s specification discloses that “one approach for rapidly mixing the NO and FGF is the use of a mixing device placed immediately downstream or close to the point of NO injection to ensure that the combined gas stream has a homogenous NO concentration as soon as possible”, see lines 1-3 of para. [0090] of the applicant’s specification, the modified Tolmie method discloses the diffusing the combined gas stream sufficiently rapidly so that the less than 1 ppm of NO2 is delivered to the patient).
Modified Tolmie discloses the first and gas streams are combined, but is silent regarding how the combination occurs, and thus does not disclose wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port.
However, Yee teaches (Fig. 1-3) a method of combining a first gas stream (“first gas” flowing through conduit 12,14, paragraph [0035]) and a second gas stream (“second gas” flowing through conduit 20, paragraph [0035]), wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port (second gas injected into entry end 16 of conduit and then mixed with gas stream within conduit 12,14, paragraph [0036] and [0043]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Tolmie such that the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port, as taught by Yee, for the purpose of allowable for an easy way to attach/detach a second gas to the main conduit (paragraph [0043] Yee).
Modified Tolmie does not disclose mixing the combined gas stream with a mixing device downstream of the injection port.
However, Crump teaches (Fig. 5a-5c) a method of mixing fluids wherein the mixing occurs via a mixing device (helical grooves 450, which causes the flow to be turbulent and thus improve mixing, Col. 10 lines 9-14 and 24-34) located downstream of the injection port (port 480, Col. 10 lines 9-14 and 24-34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Tolmie such that mixing the combined gas stream with a mixing device downstream of the injection port, as taught by Crump, for the purpose of improving turbulence and thus mixing of the two fluids (Col. 10 lines 9-14 and 24-34 Yee) and thus improve therapeutic outcome of the patient.
Regarding claim 17, the modified Tolmie method discloses that the set dose of NO is at a concentration of about 1 ppm to about 80 ppm, as recited in the rejection of claim 3 above.
Regarding claim 18, the modified Tolmie method discloses a volumetric flow rate of the second gas is linearly proportional to a volumetric flow rate of the first gas, as recited in the rejection of claim 6 above.
Regarding claim 19, the modified Tolmie method discloses the first gas stream has a first velocity and the second gas stream has a second velocity, and a ratio of the first velocity to the second velocity is less than 2:1, as recited in the rejection of claim 7 above.
Regarding claim 20, the modified Tolmie method discloses the second gas stream enters the first gas stream at or near a central midpoint of a highest velocity of the first gas stream, see the rejection of claim 10 above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tolmie (2007/0181126) in view of Bathe (2013/0074838), Lott (5,664,733), Yee (US 2009/0260629) and Crump (US 7,021,313), as applied to claim 1 above, and further in view of Zapol (2010/0051025).
Regarding claim 4, the modified Tolmie method discloses everything as claimed including that the first gas is a breathable gas comprising molecular O2 (the first gas provided by an O2 supply 18, see fig. 1 and para. [0029] of Tolmie), and the second gas comprises molecular NO (the second gas provided by the NO supply 28, see fig. 1 and para. [0029] of Tolmie), but does not explicitly disclose that the first gas comprises molecular N2 and molecular O2, and that the second gas comprises molecular NO and molecular N2.
However, Zapol teaches that a system for delivering NO to a patient (see fig. 1 and the abstract) includes a first gas comprising molecular N2 and molecular O2 (the first gas is provided by an O2 cylinder comprising molecular N2 and molecular O2, see para. [0082]), and
includes a second gas comprising molecular NO and molecular N2 (the second gas is provided by a NO cylinder comprising molecular NO and molecular N2, see para. [0082]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the O2 supply of the modified Tolmie method to comprise molecular N2 and molecular O2 and to have modified the NO supply of the modified Tolmie method to comprise molecular NO and molecular N2, as taught by Zapol, for the purpose of providing a low cost carrier gas for delivering the first gas and the second gas to the first gas stream and second gas stream.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tolmie (2007/0181126) in view of Bathe (2013/0074838), Lott (5,664,733), Yee (US 2009/0260629) and Crump (US 7,021,313), as applied to claim 1 above, and further in view of Psaros (5,845,633).
Regarding claim 11, the modified Tolmie method discloses that the second gas stream is injected into the first gas stream (the second gas stream is provided by the injection device 36 when a valve 37 is controlled to open or close as determined by CPU 52, see fig. 1 and paras. [0021] and [0028] of Tolmie), but is silent with regard to the second gas stream being injected into the first gas stream as a plurality of pulses.
However, Psaros teaches that a system for delivering NO to a patient (see fig. 1 and the abstract) includes a control device 150 (see fig. 7) for opening or closing a valve 148 (see fig. 7) to provide a second gas stream of NO in brief pulses 156A-156F (see fig. 8; the control devic3 150 actuates the valve 48 to release the second gas stream of NO in brief pulses 156A-156F to allow high concentrations of NO to be used when a total concentration of NO is desired to be kept on a lower level of total dilution with a first gas stream of breathing gas during respiratory therapy, see col. 8 lines 36-46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the CPU of the modified Tolmie system to control the valve to provide a plurality of pulses of NO, as taught by Psaros, for the purpose of allowing high concentrations of NO to be used while maintaining a low total concentration of NO, when the first gas stream is combined with the second gas stream, see col. 8 lines 36-46 of Psaros.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of Falligant (10,894,140) in view of Bathe (2013/0074838) and Yee (US 2009/0260629) and Crump (US 7,021,313).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claims recite additional features not present in the patent claims.
Regarding instant application claim 1, the following comparison between the patent claims and the instant application claims, see underlined features in the patent claims, show what elements have been excluded in the presentation of the instant application claims.
Patent claim 15
Application claim 1
13. A method of diffusing a high concentration gas into a transverse gas stream, comprising:
passing at least a portion of a first gas through a hollow internal region of a body having an inner surface surrounding the hollow internal region; and
passing a second gas stream through an injection channel to an injection port projecting into the hollow internal region of the body,
wherein the second gas stream enters and at least partially diffuses with the first gas stream within the hollow internal region,
wherein the first gas stream has a first velocity and the second gas stream has a second velocity, and the ratio of the first velocity to the second velocity is less than 2:1.
15. The method of claim 13, wherein the first gas is a breathable gas comprising molecular N2 and molecular O2, and the second gas comprises molecular NO and molecular N2.
1. A method of delivery nitric oxide (NO) to a patient, the method comprising:
combining a first gas stream comprising molecular oxygen (O2) and a second gas stream comprising NO to provide a combined gas stream,
wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port
wherein the second gas stream is provided by an NO source having an NO concentration of greater than 800 ppm to about 10,000 ppm;
mixing the combined gas stream with a mixing device downstream of the injection port; and
delivering the combined gas stream to the patient,
wherein the combined gas stream has a nitrogen dioxide (NO2) concentration of less than 1 ppm of N02 when delivered to the patient.
Thus, it is apparent, that patent claim 15 includes features that are not in application claim 1, where patent claim 15 discloses everything as claimed as recited in the table above and where patent claim 15 and instant application claim 1 differ by reciting the underlined features.
Patent claim 15 does not explicitly recite “delivering the combined gas stream to the patient”. However, page 1 lines 15-18 of the patent claim’s specification discloses that the claimed invention is directed to delivering nitric oxide, and other gases, to a patient for inhalation therapy, such that patent claim 1 is for delivering gases to a patient.
Patent claim 15 is silent with regard to the second gas stream is provided by an NO source having an NO concentration of greater than 800 ppm to about 10,000 ppm.
However, Bathe teaches that a system for delivering NO to a patient (see fig. 1 and the abstract) includes the NO source 50 (see fig. 1) having an NO concentration of 4,880 ppm, see para. [0067], and, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the concentration of patent claim 15’s NO source to be 4,880 ppm, as taught by Bathe, for the purpose of providing a higher concentration of NO for increasing the rate at which the NO relaxes vascular smooth muscle and when inhaled and the rate at which the NO dilates the pulmonary vasculature, see para. [0065] of Bathe.
Modified patent claim 15 does not explicitly recite that “the combined gas stream has a nitrogen dioxide (NO2) concentration of less than 1 ppm of N02 when delivered to the patient”. However, patent claim 15 includes a body, hollow internal region, injection channel and injection port projecting into the hollow internal region, see the table above. As the applicant’s specification discloses that “one approach for rapidly mixing the NO and FGF is the use of a mixing device placed immediately downstream or close to the point of NO injection to ensure that the combined gas stream has a homogenous NO concentration as soon as possible”, see lines 1-3 of para. [0090] of the applicant’s specification, patent claim 15’s body discloses the step of diffusing the combined gas stream to have a nitrogen dioxide (NO2) concentration of less than 1 ppm of NO2 is delivered to the patient).
Modified patent claim 15 discloses the first and gas streams are combined, but is silent regarding how the combination occurs, and thus does not disclose wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port.
However, Yee teaches (Fig. 1-3) a method of combining a first gas stream (“first gas” flowing through conduit 12,14, paragraph [0035]) and a second gas stream (“second gas” flowing through conduit 20, paragraph [0035]), wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port (second gas injected into entry end 16 of conduit and then mixed with gas stream within conduit 12,14, paragraph [0036] and [0043]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified patent claim 15 such that the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port, as taught by Yee, for the purpose of allowable for an easy way to attach/detach a second gas to the main conduit (paragraph [0043] Yee).
Modified patent claim 15 does not disclose mixing the combined gas stream with a mixing device downstream of the injection port.
However, Crump teaches (Fig. 5a-5c) a method of mixing fluids wherein the mixing occurs via a mixing device (helical grooves 450, which causes the flow to be turbulent and thus improve mixing, Col. 10 lines 9-14 and 24-34) located downstream of the injection port (port 480, Col. 10 lines 9-14 and 24-34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified patent claim 15 such that mixing the combined gas stream with a mixing device downstream of the injection port, as taught by Crump, for the purpose of improving turbulence and thus mixing of the two fluids (Col. 10 lines 9-14 and 24-34 Yee) and thus improve therapeutic outcome of the patient.
Since instant application claim 1 is anticipated by patent claim 15, and since anticipation is the epitome of obviousness, then instant application claim 1 is obvious over patent claim 15.
Claims 16 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-23 of Falligant (10,894,140) and Bathe (2013/0074838).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claims recite additional features not present in the patent claims.
Regarding instant application claim 16, the following comparison between the patent claims and the instant application claims, see underlined features in the patent claims, show what elements have been excluded in the presentation of the instant application claims.
Patent claim 22
Application claim 16
22. A method of diffusing a high concentration NO-containing gas into a transverse oxygen-containing gas stream, the method comprising:
receiving a dose of NO from a user;
receiving a first gas stream comprising oxygen through a hollow internal region of a body having an inner surface surrounding the hollow internal region; and
passing a second gas stream comprising NO through an injection channel to an injection port projecting into the hollow internal region of the body,
wherein the second gas stream enters and at least partially diffuses with the first gas stream within the hollow internal region,
wherein the injection port has an outlet recessed from a center of the hollow internal region and wherein an orifice is located within the flow path of the injection channel and injection port, and
the orifice size provides a ratio of the velocity of the first gas and the velocity of the second gas, wherein the ratio is less than 2:1.
16. A method of delivery nitric oxide (NO) to a patient, the method comprising:
combining a first gas stream comprising molecular oxygen (02) and a second gas stream comprising NO to provide a combined gas stream having a set dose of NO,
wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port
wherein the second gas stream is provided by an NO source having an NO concentration of greater than 800 ppm to about 10,000 ppm;
mixing the combined gas stream with a mixing device downstream of the injection port; and
delivering the combined gas stream to the patient,
wherein the combined gas stream has a nitrogen dioxide (NO2) concentration of less than 1 ppm of NO2 when delivered to the patient.
Thus, it is apparent, that patent claim 22 includes features that are not in application claim 16, where patent claim 22 discloses everything as claimed as recited in the table above and where patent claim 22 and instant application claim 16 differ by reciting the underlined features.
Patent claim 22 does not explicitly recite “delivering the combined gas stream to the patient”. However, page 1 lines 15-18 of the patent claim’s specification discloses that the claimed invention is directed to delivering nitric oxide, and other gases, to a patient for inhalation therapy, such that patent claim 22 is for delivering gases to a patient.
Patent claim 22 is silent with regard to the second gas stream is provided by an NO source having an NO concentration of greater than 800 ppm to about 10,000 ppm.
However, Bathe teaches that a system for delivering NO to a patient (see fig. 1 and the abstract) includes the NO source 50 (see fig. 1) having an NO concentration of 4,880 ppm, see para. [0067], and, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the concentration of patent claim 22’s NO source to be 4,880 ppm, as taught by Bathe, for the purpose of providing a higher concentration of NO for increasing the rate at which the NO relaxes vascular smooth muscle and when inhaled and the rate at which the NO dilates the pulmonary vasculature, see para. [0065] of Bathe.
Patent claim 22 does not explicitly recite that “the combined gas stream has a nitrogen dioxide (NO2) concentration of less than 1 ppm of N02 when delivered to the patient”. However, patent claim 22 includes a body, hollow internal region, injection channel, orifice and injection port projecting into the hollow internal region, see the table above. As the applicant’s specification discloses that “one approach for rapidly mixing the NO and FGF is the use of a mixing device placed immediately downstream or close to the point of NO injection to ensure that the combined gas stream has a homogenous NO concentration as soon as possible”, see lines 1-3 of para. [0090] of the applicant’s specification, patent claim 22’s body discloses the step of diffusing the combined gas stream to have a nitrogen dioxide (NO2) concentration of less than 1 ppm of NO2 is delivered to the patient).
Modified patent claim 22 discloses the first and gas streams are combined, but is silent regarding how the combination occurs, and thus does not disclose wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port.
However, Yee teaches (Fig. 1-3) a method of combining a first gas stream (“first gas” flowing through conduit 12,14, paragraph [0035]) and a second gas stream (“second gas” flowing through conduit 20, paragraph [0035]), wherein combining the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port (second gas injected into entry end 16 of conduit and then mixed with gas stream within conduit 12,14, paragraph [0036] and [0043]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified patent claim 22 such that the first gas stream and the second gas stream comprises injecting the second gas stream into the first gas stream at an injection port, as taught by Yee, for the purpose of allowable for an easy way to attach/detach a second gas to the main conduit (paragraph [0043] Yee).
Modified patent claim 22 does not disclose mixing the combined gas stream with a mixing device downstream of the injection port.
However, Crump teaches (Fig. 5a-5c) a method of mixing fluids wherein the mixing occurs via a mixing device (helical grooves 450, which causes the flow to be turbulent and thus improve mixing, Col. 10 lines 9-14 and 24-34) located downstream of the injection port (port 480, Col. 10 lines 9-14 and 24-34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified patent claim 22 such that mixing the combined gas stream with a mixing device downstream of the injection port, as taught by Crump, for the purpose of improving turbulence and thus mixing of the two fluids (Col. 10 lines 9-14 and 24-34 Yee) and thus improve therapeutic outcome of the patient.
Since instant application claim 16 is anticipated by patent claim 22, and since anticipation is the epitome of obviousness, then instant application claim 16 is obvious over patent claim 22.
Regarding application claim 19, patent claim 23 reads on the application claim.
Response to Arguments
Applicant’s arguments filed 12/5/2025 have been fully considered.
Regarding the Crump reference, applicant argued (page 7 paragraph 3 Remarks) that the Crump references is for creating a turbulent mixture of air and cleaning solution for removing mucus/other secretions from a catheter, not for the general purpose of “improving turbulence and thus mixing of the two fluids”.
Examiner respectfully disagrees.
In response to applicant's argument that Crump is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Crump is reasonably pertinent to applicant’s particular problem of mixing two fluids.
It is well understood in the scientific community that turbulent flow mixes two fluids better than laminar flow, see Dimotakis (Dimotakis, Paul E. “TURBULENT MIXING.” Annual Review of Fluid Mechanics, vol. 37, no. 1, Jan. 2005, pp. 329–356, https://doi.org/10.1146/annurev.fluid.36.050802.122015. Accessed 27 June 2020.). While the intended use of Crump is for removing mucus and secretions, and thus not the same field of endeavor as applicant, Crump accomplishes this function through the use of a turbulent flowing cleaning solution, which contains a mixture of the turbulent air and a cleaning solution that are mixed (and mixed more effectively via the turbulent flow. While this is not stated outright, it is inherent and the scientific reason Crump’s design is more effective than a laminar flowing design as discussed in Dimotakis, and the fluids are inherently mixed because in order for the liquid to be turbulentized and moved more effectively it must be mixed with the turbulent air flow). Thus Crump teaches that providing for turbulent flowing air provides for better mixing of two fluids, which is reasonably pertinent to applicant’s particular problem of providing mixing of two fluid sources.
Applicant further argues (page 8 paragraph 1 and 2 Remarks) that there would have been no reason to incorporate the cleaning methodology of Crump into a gas mixing application because Crump only discusses gas/liquid mixing and not gas/gas mixing, and because gas and liquid have significantly different densities, one of ordinary skill would not have extended the turbulent conditions of liquid/gas mixture of Crump to the gas/gas mixture of applicant.
Examiner respectfully disagrees.
First, applicant is reminded that the Tolmie reference already discloses for mixing of the two gases. The purpose of the Crump reference teaching is to improve the mixing of the Tolmie reference by increasing turbulent flow via mixing device.
As stated above, it is well known in the art that turbulent flow improves mixing of fluids, and the fact that Crump discloses (implicitly) an invention using turbulent flow to improve mixing of a liquid and a gas, one of ordinary skill would recognize this teaching would extend to a gas-gas mixture, since both gases and liquids are fluids (and in a way would be more obvious, since gas-gas mixing is easier than gas-liquid mixing due to the space between the particles in a gas compared to a liquid).
Applicant further argued (page 8 paragraph 3 Remarks) that Crump does not teach the helical grooves generally improve mixing of two fluids, and instead are for generating turbulence to remove mucus, and thus the problem solved by Crump does not apply.
Examiner respectfully disagrees, as in order for the ultimate goal of Crump to be achieved, improved fluid mixing must occur (in order for the liquid solution to become more turbulent itself so that cleaning can be improved), and thus while Crump does not explicitly state that improve mixing occur, improved mixing has to and must occur for the goal of Crump to be accomplished in the first place.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785