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 the preliminary amendment filed on 7/7/2022.
Per the amendment, claim 1 is as currently amended, claims 2-11 are as originally presented, claim 12 is as currently amended, claims 13-17 are as originally presented, and claims 18-20 are as currently amended. As such, claims 1-20 are pending in the instant application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 214 (Fig. 2). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because “A gas delivery system and method are provided that include a therapeutic gas delivery device, and a high-frequency ventilator delivering a breathing gas to a respiratory circuit” (lines 1-4) is unclear if the gas delivery and system include both the therapeutic gas delivery device and high-frequency ventilator, or if the gas system and method only include the therapeutic gas delivery device, and the high-frequency ventilator is a separate device, or system. It is recommended by the Examiner to rewrite lines 1-4 of the Abstract to read “A gas delivery system and method are provided that include a therapeutic gas delivery device and a high-frequency ventilator to deliver a breathing gas to a respiratory circuit.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
In [0004], lines 1-3: “According to an embodiment, a gas delivery system is provided that includes a therapeutic gas delivery device, and a high-frequency ventilator delivering a breathing gas to an inspiratory limb of a respiratory circuit” should read “According to an embodiment, a gas delivery system is provided that includes a therapeutic gas delivery device and a high-frequency ventilator to deliver a breathing gas to an inspiratory limb of a respiratory circuit” to clarify the gas delivery system includes both the therapeutic gas delivery device and the high-frequency ventilator.
Appropriate correction is required.
Claim Objections
Claims 1, 5, 7, 11, 12, 17, and 18 are objected to because of the following informalities:
Claim 1, line 3: “a high-frequency ventilator delivering a breathing gas” should read “a high-frequency ventilator to deliver a breathing gas”.
Claim 1, line 7: “a flow sensor connected with the therapeutic gas delivery device” should read “a flow sensor connected to the therapeutic gas delivery device”.
Claim 1, lines 9-10: “a sensor body section having an interior chamber, a sensor gas inlet and a sensor gas outlet” should read “a sensor body comprising an interior chamber, a sensor gas inlet, and a sensor gas outlet”.
Claim 5, line 2: “comprises a processor, and the flow sensor assembly provides” should read “comprises a processor, and wherein the flow sensor assembly provides”.
Claim 7, lines 2-3: “configured to provide at least one of an audio alarm and a visual alarm when backflow, high frequency flow, or another anomaly is ascertained” should read “configured to provide at least one of an audio alarm or a visual alarm when backflow, high frequency flow, or another anomaly is ascertained” for clarity.
Claim 11, line 3: “is directly connected to gas-out tubing” should read “is directly connected to a gas-out tubing”.
Claim 12, lines 7-8: “a sensor body section having an interior chamber, a sensor gas inlet and a sensor gas outlet” should read “a sensor body comprising an interior chamber, a sensor gas inlet, and a sensor gas outlet”.
Claim 17, line 3: “is directly connected to gas-out tubing” should read “is directly connected to a gas-out tubing”.
Claim 18, line 15: “a therapeutic gas delivery device” should read “the therapeutic gas delivery device”.
Claim 18, lines 16-17: “a sensor body section having an interior chamber, a sensor gas inlet and a sensor gas outlet” should read “a sensor body comprising an interior chamber, a sensor gas inlet, and a sensor gas outlet”.
Claim 19, line 2: “providing the measured flow rate from the flow sensor assembly” should read “providing the measured flow rate of the breathing gas from the flow sensor assembly” for clarity.
Claim 19, line 6: “using the measured flow rate detected” should read “using the measured flow rate of the breathing gas detected” for clarity.
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 1-20 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 1 recites the limitation “diameters of the valve gas inlet and the valve gas outlet are greater than or equal to a diameter of at least one of the sensor body section, the sensor gas inlet and the sensor gas outlet” in lines 13-16. It is unclear there is a plurality of sensor body sections in which the diameters of the valve gas inlet and the valve gas outlet must be greater than or equal to at least one of the sensor body sections, or if the diameters of the valve gas inlet and the valve gas outlet must be greater than or equal to at least one of the following: the sensor body section, the sensor gas inlet, or the sensor gas outlet. For examination purposes, the above limitation will be interpreted as – a diameter of the valve gas inlet and a diameter of the valve gas outlet are greater than or equal to a diameter of at least one of following: the sensor body section, the sensor gas inlet, or the sensor gas outlet.
Claim 4 recites the limitation “the flow sensor is connected with the therapeutic gas delivery device via at least one of a fluid connection, an electrical connection, and a wireless connection” in lines 1-3. It is unclear if the flow sensor is connected with the therapeutic gas deliver device via at least one of a fluid connection, wherein there are a plurality of fluid connections, at least one of an electrical connection, wherein there are a plurality of electrical connections, and at least one of a wireless connection, wherein there are a plurality of wireless connections. Further, it is unclear of the flow sensor is connected with the therapeutic gas delivery device via at least one of the following: a fluid connection, an electrical connection, or a wireless connection. For examination purposes, the above limitation will be interpreted as - the flow sensor is connected with the therapeutic gas delivery device via at least one of a fluid connection, an electrical connection, or a wireless connection.
Claim 6 recites the limitation "the measured flow rate" in line. There is insufficient antecedent basis for this limitation in the claim. It is suggested by the Examiner to rewrite the above limitation to read – a measured flow rate – to establish antecedent basis for claims 6 and 7.
Claim 9 recites the limitation " the therapeutic gas" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested by the Examiner to rewrite the above limitation to read - a therapeutic gas – to establish antecedent basis.
Claim 12 recites the limitation “diameters of the valve gas inlet and the valve gas outlet are greater than or equal to a diameter of at least one of the sensor body section, the sensor gas inlet and the sensor gas outlet” in lines 11-14. It is unclear there is a plurality of sensor body sections in which the diameters of the valve gas inlet and the valve gas outlet must be greater than or equal to at least one of the sensor body sections, or if the diameters of the valve gas inlet and the valve gas outlet must be greater than or equal to at least one of the following: the sensor body section, the sensor gas inlet, or the sensor gas outlet. For examination purposes, the above limitation will be interpreted as – a diameter of the valve gas inlet and a diameter of the valve gas outlet are greater than or equal to a diameter of at least one of following: the sensor body section, the sensor gas inlet, or the sensor gas outlet.
Claim 14 recites the limitation “the flow sensor is connected with a therapeutic gas delivery device via at least one of a fluid connection, an electrical connection, and a wireless connection” in lines 1-3. It is unclear if the flow sensor is connected with the therapeutic gas deliver device via at least one of a fluid connection, wherein there are a plurality of fluid connections, at least one of an electrical connection, wherein there are a plurality of electrical connections, and at least one of a wireless connection, wherein there are a plurality of wireless connections. Further, it is unclear of the flow sensor is connected with the therapeutic gas delivery device via at least one of the following: a fluid connection, an electrical connection, or a wireless connection. For examination purposes, the above limitation will be interpreted as - the flow sensor is connected with the therapeutic gas delivery device via at least one of a fluid connection, an electrical connection, or a wireless connection.
Claim 15 recites the limitation "the measured flow rate" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested by the Examiner to rewrite the above limitation to read – a measured flow rate – to establish antecedent basis.
Claim 18 recites the limitation “measuring a flow rate of the breathing gas from the high-frequency ventilator” in lines 6-7. The above limitation is duplicated in lines 8-9. It is unclear if the applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitations will be treated as a singular limitation.
Claim 18 recites the limitation “diameters of the valve gas inlet and the valve gas outlet are greater than or equal to a diameter of at least one of the sensor body section, the sensor gas inlet and the sensor gas outlet” in lines 20-22. It is unclear there is a plurality of sensor body sections in which the diameters of the valve gas inlet and the valve gas outlet must be greater than or equal to at least one of the sensor body sections, or if the diameters of the valve gas inlet and the valve gas outlet must be greater than or equal to at least one of the following: the sensor body section, the sensor gas inlet, or the sensor gas outlet. For examination purposes, the above limitation will be interpreted as – a diameter of the valve gas inlet and a diameter of the valve gas outlet are greater than or equal to a diameter of at least one of following: the sensor body section, the sensor gas inlet, or the sensor gas outlet.
Claims 2, 3, 5, 7, 8, 10, 11, 13, 16, 17, 19, and 20 are rejected due to dependency on a rejected claim.
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.
Claims 1-6, 9, 12-15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150314101 A1) in view of Kuehl (US 6945123 B1).
Regarding claim 1, Acker discloses a gas delivery system (Fig. 3) comprising: a therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3); a high-frequency ventilator (117; Fig. 3) delivering a breathing gas ([0029], lines 1-2) to an inspiratory limb (121; Fig. 3) of a respiratory circuit ([0029], lines 3-4); and a flow sensor assembly (107, 110, 119; Fig. 3) disposed in the inspiratory limb (121; Fig. 3) and comprising: a flow sensor (119; Fig. 3) connected with the therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3) and configured to measure a flow rate of the breathing gas from the high- frequency ventilator ([0031], lines 8-10, where forward flow 133 is the breathing gas delivered from an inspiratory outlet of the high frequency ventilator 117 to the patient via an inspiratory limb 121, [0029], lines 1-4), wherein the flow sensor (119; Fig. 3) has a sensor body section (107; Fig. 3) having an interior chamber (volume enclosed by body of injector module 107), a sensor gas inlet (first opening of flow sensor 119, see Annotated Fig. 3(a)) and a sensor gas outlet (second opening of flow sensor 119, see Annotated Fig. 3(a)); and a one-way flow valve (304; Fig. 3) disposed downstream of the sensor gas outlet (second opening of flow sensor 119; check valve 304 located at therapeutic gas inlet 110 which is downstream of opening of flow sensor 119, see Annotated Fig. 3(a)) in the flow sensor assembly (107, 110, 119; Fig. 3), wherein the one-way flow valve (304; Fig. 3) comprises a valve gas inlet (inlet of 304, see Annotated Fig. 3(b)) and a valve gas outlet (outlet of 304, see Annotated Fig. 3(b)). Acker fails to explicitly disclose, wherein diameters of the valve gas inlet (inlet of 304, see Annotated Fig. 3(b)) and the valve gas outlet (outlet of 304, see Annotated Fig. 3(b)) are greater than or equal to a diameter of at least one of the sensor body section (107; Fig. 3), the sensor gas inlet (first opening of flow sensor 119, see Annotated Fig. 3(a)) and the sensor gas outlet (second opening of flow sensor 119, see Annotated Fig. 3(a)).
However, Kuehl teaches a flow sensor (18; Fig. 2) with a sensor body section (dashed-line box, see Fig. 2) with an orifice (32; Fig. 2), where the orifice (32; Fig. 2) of the flow sensor (18; Fig. 2) has a narrower diameter than the inlet and outlet of a control valve (16; Figs. 1 and 3). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Acker with Kuehl, such that diameters of the valve gas inlet (inlet of 304, see Annotated Fig. 3(b)) and the valve gas outlet (outlet of 304, see Annotated Fig. 3(b)) are greater than or equal to a diameter of at least one of the sensor body section (107; Fig. 3), the sensor gas inlet (first opening of flow sensor 119, see Annotated Fig. 3(a)) and the sensor gas outlet (second opening of flow sensor 119, see Annotated Fig. 3(a); Kuehl: body of flow sensor 18 includes orifice 32, see Fig. 2; diameter of valve 16a’s inlet and outlet are greater than the diameter of orifice 32 of flow sensor 18a, see Annotated Kuehl Fig. 3 below) to create a focused jet of gas flow to improve flow rate detection (Kuehl: Col. 3, lines 37-52).
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Regarding claim 2, Acker as modified further discloses the claimed invention as set forth in claim 1, wherein the high frequency ventilator (117; Fig. 3) comprises a high frequency jet ventilator, a high frequency oscillatory ventilator ([0004], lines 4-10), a high-frequency percussive ventilator, or a high-frequency positive pressure ventilator.
Regarding claim 3, Acker as modified further discloses the claimed invention as set forth in claim 1, wherein the flow sensor (119; Fig. 3) comprises a pneumotach, a hot wire anemometer, or an ultrasonic flow meter ([0049], lines 3-10).
Regarding claim 4, Acker as modified further discloses the claimed invention as set forth in claim 1, wherein the flow sensor (119; Fig. 3) is connected with the therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3) via at least one of a fluid connection, an electrical connection, and a wireless connection (flow sensor 119 connected to nitric oxide delivery device 100 via conduit 105, gas inlet 110, and injector module 107, [0031], lines 1-11; Fig. 3).
Regarding claim 5, Acker as modified further discloses the claimed invention as set forth in claim 1, wherein the therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3) comprises a processor (CPU 111; Fig. 3), and the flow sensor assembly (107, 110, 119; Fig. 3) provides one or more sensed parameters to the processor.
Regarding claim 6, Acker as modified further discloses the claimed invention as set forth in claim 5, wherein the one or more sensed parameters comprise at least the measured flow rate from the flow sensor (119 measures flow of patient breathing gas, [0031], lines 9-10; 119 is in communication with CPU 111, [0036], lines 1-4).
Regarding claim 9, Acker as modified further discloses the claimed invention as set forth in claim 1, wherein the therapeutic gas is nitric oxide (Abstract).
Regarding claim 12, Acker as modified discloses a flow sensor assembly (107, 110, 119; Fig. 3) comprising: a gas inlet (gas inlet of flow sensor assembly, see red line of Annotated Fig. 3(a)); a gas outlet (gas outlet of flow sensor assembly, see blue line of Annotated Fig. 3(a)); a flow sensor (119; Fig. 3) disposed between the gas inlet (gas inlet of flow sensor assembly, see red line of Annotated Fig. 3(a)) and the gas outlet (gas outlet of flow sensor assembly, see blue line of Annotated Fig. 3(a)) and configured to measure a gas flow rate ([0031], lines 8-10, where forward flow 133 is the breathing gas delivered from an inspiratory outlet of the high frequency ventilator 117 to the patient via an inspiratory limb 121, [0029], lines 1-4), the flow sensor (119; Fig. 3) having a sensor body section (107; Fig. 3) having an interior chamber (volume enclosed by body of injector module 107), a sensor gas inlet (first opening of flow sensor 119, see Annotated Fig. 3(b)) and a sensor gas outlet (second opening of flow sensor 119, see Annotated Fig. 3(b)); and a one-way flow valve (304; Fig. 3) disposed between the sensor gas outlet (second opening of flow sensor 119; check valve 304 located at therapeutic gas inlet 110 which is downstream of opening of flow sensor 119, see Annotated Fig. 3(b)) and the gas outlet (gas outlet of flow sensor assembly, see blue line of Annotated Fig. 3(b)), wherein the one-way flow valve (304; Fig. 3) comprises a valve gas inlet (inlet of 304, see Annotated Fig. 3(c)) and a valve gas outlet (outlet of 304, see Annotated Fig. 3(c)), and wherein a diameter of the valve gas inlet and a diameter of the valve gas outlet are greater than or equal to a diameter of at least one of the sensor body section, the sensor gas inlet, and the sensor gas outlet (Kuehl: body of flow sensor 18 includes orifice 32, see Fig. 2; diameter of valve 16a’s inlet and outlet are greater than the diameter of orifice 32 of flow sensor 18a, see Annotated Kuehl Fig. 3 below).
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Regarding claim 13, Acker as modified further discloses the claimed invention as set forth in claim 12, wherein the flow sensor (119; Fig. 3) comprises a pneumotach, a hot wire anemometer, or an ultrasonic flow meter ([0049], lines 3-10).
Regarding claim 14, Acker as modified further discloses the claimed invention as set forth in claim 12, wherein the flow sensor (119; Fig. 3) is connected with a therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3) via at least one of a fluid connection, an electrical connection, and a wireless connection (flow sensor 119 connected to nitric oxide delivery device 100 via conduit 105, gas inlet 110, and injector module 107, [0031], lines 1-11; Fig. 3).
Regarding claim 15, Acker as modified further discloses the claimed invention as set forth in claim 14, wherein the flow sensor (119; Fig. 3) provides the measured flow rate to the therapeutic gas delivery device (119 measures flow of patient breathing gas, [0031], lines 9-10; 119 provides CPU 111 with measured flow rate of patient breathing gas, [0036], lines 1-4; CPU 111 is within therapeutic gas delivery device 100, see Fig. 3).
Regarding claim 18, Acker as modified discloses a method for a delivering therapeutic gas ([0002], lines 1-2), the method comprising steps of: providing a therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3); delivering, by a high-frequency ventilator (117; Fig. 3), a breathing gas to an inspiratory limb (121; Fig. 3) of a respiratory circuit ([0029], lines 3-4); measuring a flow rate of the breathing gas from the high-frequency ventilator ([0031], lines 8-10, where forward flow 133 is the breathing gas delivered from an inspiratory outlet of the high frequency ventilator 117 to the patient via an inspiratory limb 121, [0029], lines 1-4) measuring a flow rate of the breathing gas from the high-frequency ventilator ([0031], lines 8-10, where forward flow 133 is the breathing gas delivered from an inspiratory outlet of the high frequency ventilator 117 to the patient via an inspiratory limb 121, [0029], lines 1-4) using a flow sensor assembly (107, 110, and 119; flow rate is measured by flow sensor 119 of the flow assembly, [0031], lines 9-10); and dosing a therapeutic gas (nitric oxide, [0018], lines 5-6) from the therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3) to the inspiratory limb (121; Fig. 3; [0029], lines 6-12) of the respiratory circuit ([0029], line 12) based on the measured flow rate of the breathing gas ([0033]); wherein the flow sensor assembly (107, 110, and 119; Fig. 3) comprises: a flow sensor (119; Fig. 3) connected with a therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3) and having a sensor body section (107; Fig. 3) having an interior chamber (volume enclosed by body of injector module 107), a sensor gas inlet (first opening of flow sensor 119, see Annotated Fig. 3(a)) and a sensor gas outlet (second opening of flow sensor 119, see Annotated Fig. 3(a)); and a one-way flow valve (304; Fig. 3) disposed downstream of the sensor gas outlet (second opening of flow sensor 119; check valve 304 located at therapeutic gas inlet 110 which is downstream of opening of flow sensor 119, see Annotated Fig. 3(a)) and comprising a valve gas inlet (inlet of 304, see Annotated Fig. 3(b)) and a valve gas outlet (outlet of 304, see Annotated Fig. 3(b)), wherein a diameter of the valve gas inlet and a diameter of the valve gas outlet are greater than or equal to a diameter of at least one of the sensor body section, the sensor gas inlet, and the sensor gas outlet (Kuehl: body of flow sensor 18 includes orifice 32, see Fig. 2; diameter of valve 16a’s inlet and outlet are greater than the diameter of orifice 32 of flow sensor 18a, see Annotated Kuehl Fig. 3 below).
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Regarding claim 20, Acker as modified further discloses the claimed invention as set forth in claim 18, further comprising the steps of combining the dosed therapeutic gas (nitric oxide) from the therapeutic gas delivery device (nitric oxide delivery device 100; Fig. 3) with the breathing gas in the inspiratory limb (121; Fig. 3) of the respiratory circuit ([0029], lines 1-12); and delivering the combined dosed therapeutic gas and the breathing gas ([0029], lines 2-4, where breathing gas is delivered to inspiratory limb 121; [0029], lines 6-12, where therapeutic gas is delivered to inspiratory limb 121; combined therapeutic gas and breathing gas in inspiratory limb 121 are delivered to patient 108, [0029], lines 11-14, see Fig. 3) to a patient (108; Fig. 3).
Claims 7, 8, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150314101 A1) in view of Kuehl (US 6945123 B1) as applied to claims 5, 6, and 18 above, and further in view of Tolmie (US 20130192595 A1).
Regarding claim 7, Acker as modified discloses the claimed invention as set forth in claim 6, but fails to disclose wherein the processor (CPU 111; Fig. 3) is configured to provide at least one of an audio alarm and a visual alarm when backflow, high frequency flow, or another anomaly is ascertained by the processor using the measured flow rate detected by the flow sensor.
However, Tolmie teaches an alert that includes one or more of an audible alert, a visual alert and a text alert ([0045], lines 7-8) when a flow rate, measured by a flow sensor (115) is above or below a predetermined level ([0042], lines 1-5; [0036], lines 21-23). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Acker with Tolmie, such that the processor (CPU 111; Fig. 3) is configured to provide at least one of an audio alarm and a visual alarm (Tolmie: [0045], lines 7-8) when backflow, high frequency flow, or another anomaly is ascertained by the processor using the measured flow rate detected by the flow sensor ([0042], lines 1-5; [0036], lines 21-23) to guarantee consistent drug delivery to the user (Tolmie: [0043], lines 7-10).
Regarding claim 8, Acker as modified discloses the claimed invention as set forth in claim 5, but fails to disclose wherein the processor (CPU 111; Fig. 3) is configured to provide instruction to a user to confirm a presence or condition of the one-way flow valve when the backflow, the high frequency flow, or the other anomaly is ascertained by the processor.
However, Tolmie further teaches clinical decision support software of the CPU (108) providing instructions to a user ([0043], lines 3-6) where the user must confirm the condition of the one-way flow valve and reset the upper and lower limits of maximum and minimum concentrations of nitric oxide, dose errors, or flows at which the alert was triggered ([0043], lines 1-6). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Acker with Tolmie, such that wherein the processor (CPU 111; Fig. 3) is configured to provide instruction to a user (Tolmie: [0043], lines 3-6) to confirm a presence or condition of the one-way flow valve when the backflow, the high frequency flow, or the other anomaly is ascertained by the processor (Tolmie: [0043], lines 1-6) to prevent device shutdown and ensure consistent drug delivery to the user (Tolmie: [0043], lines 7-10).
Regarding claim 19, Acker as modified further discloses the claimed invention as set forth in claim 18, further comprising steps of: providing the measured flow rate from the flow sensor assembly to the therapeutic gas delivery device (flow assembly includes 119, see claim 18; 119 measures flow of patient breathing gas, [0031], lines 9-10; 119 provides CPU 111 with measured flow rate of patient breathing gas, [0036], lines 1-4; CPU 111 is within therapeutic gas delivery device 100, see Fig. 3); and issuing an alarm, by the therapeutic gas delivery device (CPU 111 of therapeutic gas delivery device 100; Tolmie: [0045], lines 7-8), when backflow, high frequency flow, or another anomaly is ascertained by the therapeutic gas delivery device using the measured flow rate detected by the flow sensor assembly (Tolmie: [0042], lines 1-5; [0036], lines 21-23).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150314101 A1) in view of Kuehl (US 6945123 B1) as applied to claims 1 and 12 above, and further in view of Zapol (US 20200139072 A1).
Regarding claim 10, Acker as modified discloses the claimed invention as set forth in claim 1, but fails to explicitly disclose wherein the one-way flow valve (304; Fig. 3) is a diaphragm one-way flow valve, a duckbill one-way flow valve, a disc one-way flow valve, or a ball one-way flow valve.
However, Zapol teaches a one-way flow valve that can be a duck-bill valve, flapper valve, ball in cage valve, tricuspid valve, or a similar type of valve to those mentioned ([0112], lines 5-6; [0150], lines 6-7). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Acker with Zapol, such that the one-way flow valve (304; Fig. 3) is a duckbill one-way flow valve (Zapol: [0112], lines 5-6; [0150], lines 6-7) to prevent backflow of gas through the valve (Zapol: [0109], lines 2-5).
Regarding claim 16, Acker as modified further discloses the claimed invention as set forth in claim 12, wherein the one-way flow valve (304; Fig. 3) is a diaphragm one-way flow valve, a duckbill one-way flow valve, a disc one-way flow valve, or a ball one-way flow valve (Zapol: [0112], lines 5-6; [0150], lines 6-7).
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Acker (US 20150314101 A1) in view of Kuehl (US 6945123 B1) as applied to claims 1 and 12 above, and further in view of Callaghan (US 20170246419 A1).
Regarding claim 11, Acker as modified further discloses the claimed invention as set forth in claim 1, wherein the flow sensor (119; Fig. 3) is directly connected to the one-way flow valve (304; Fig. 3), and the one- way flow valve (304; Fig. 3) is directly connected to gas-out tubing (105; Fig. 3) via a second connector (therapeutic gas inlet 110; [0028], lines 16-18). Acker as modified does not explicitly disclose the direct connection of the flow sensor (119; Fig. 3) to the one-way flow valve (304; Fig. 3) via a first connector.
However, Callaghan teaches supply lines (111, 112) couple multiple components of the fluid blending system (100) including coupling a flow sensor (113) to a one-way valve (116) via a supply line (111, see Fig. 1; [0020], lines 7-13). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Acker with Callaghan, such that the flow sensor (119; Fig. 3) is directly connected to the one-way flow valve (304; Fig. 3) via a first connector (Callaghan: supply line 111; Fig. 1; [0020], lines 7-13) to regulate and sense the flow of the breathing gas and/or therapeutic gas (Callaghan: [0020], lines 7-13).
Regarding claim 17, Acker as modified further discloses the claimed invention as set forth in claim 12, wherein the flow sensor (119; Fig. 3) is directly connected to the one-way flow valve (304; Fig. 3) via a first connector (Callaghan: supply line 111; Fig. 1; [0020], lines 7-13), and the one- way flow valve (304; Fig. 3) is directly connected to gas-out tubing (105; Fig. 3) via a second connector (therapeutic gas inlet 110; [0028], lines 16-18).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tamiya & Matsui (US 20210386954 A1): Regarding a nitric oxide administration device that can control and change the concentration of nitric oxide delivered to the patient, where the administration device includes a one-way check valve downstream of a flow sensor.
Harvie (US 20030189492 A1): Regarding the monitoring of the flow and pressure of oxygen and/or compressed air being delivered to a user; and an alarm to warn users of oxygen and/or compressed air of low pressure or no supply of oxygen and/or compressed air.
Flanagan et al. (US 20190216377 A1): Regarding a device and methods for measuring and monitoring various oxygenation parameters during the delivery of nitric oxide to a user, and the general concept of the applicant’s invention.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785