DETAILED ACTION
Primary Examiner acknowledges Claims 42-52 are pending in this application, with Claims 42-52 having been newly added, and Claims 1-41 having been cancelled by preliminary amendment on October 26, 2023.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore, the:
“pressure transducer” of Claim 43 – It is noted Figure 6 shows only a flow meter 24. Furthermore, in the disclosure, Page 13, Lines 20-30, it is noted “In the system 20 gas flow rate can be monitored in the following ways: …. Pressure transducer, which is in fluid communication with gas flow limb, incorporated into nebuliser controller system. Digital Flow meter, which is in fluid communication with gas flow limb, incorporated into nebuliser controller system.” Applicant is expressly cautioned to avoid the inclusion of new matter, as there is no disclosure of the explicit feature and/or reference character to meet the “pressure transducer” of Claim 43.
“nebulizer is placed on a gas inlet side of the humidifier” of Claim 49 – Although Page 12, Lines 25-30 considers this claimed orientation and Figure 6 shows the alternative orientation (nebulizer on the patient side of the humidifier), there is no drawing which shows the claimed orientation of the nebulizer “placed on a gas inlet side of the humidifier” of Claim 49.
“the system comprises at least two branches and a valve linked with the controller, the branches including a first branch for delivery of aerosol and a second branch for delivery of non-aerosolized gas, and the controller is configured to control delivery into the branches, in which flow is unidirectional in the first and second branches, from the gas supply towards the nasal interface; wherein the first branch includes the nebulizer; wherein the first and second branches join at their patient ends at a common conduit, and said common conduit is in turn linked with said nasal interface or coupler” of Claim 51 – It is noted the parentage of Claim 51 requires the features of “a gas flow generator” in Claim 47 and optionally in Claim 42, by the presence of the recitation of “a gas flow generator”, the original specification as filed limits this structure as a feature of “system control unit 25” (Page 12, Lines 10 thru Page 13, Line 30) which is only shown in Figure 6. Furthermore, it is noted Figure 1 which appears to show the underlined features of Claim 51 is “an alternative system” of Figure 6 (Page 7, Line 10-20). Applicant is expressly cautioned to avoid the inclusion of new matter, as there is no disclosure of the parentage of Claim 51 having “a gas flow generator” with the underlined orientation of Claim 51 to include the features of “at least two branches and a valve linked with the controller, the branches including a first branch for delivery of aerosol and a second branch for delivery of non-aerosolized gas … wherein the first branch includes the nebulizer; wherein the first and second branches join at their patient ends at a common conduit” as required in Claim 51.
“the humidifier is included in the second branch” of Claim 52 – please see the former analysis of Claim 51 which is the parent of Claim 52. It is noted the parentage of Claim 52 requires the features of “a gas flow generator” in Claim 47 and optionally in Claim 42, by the presence of the recitation of “a gas flow generator”, the original specification as filed limits this structure as a feature of “system control unit 25” (Page 12, Lines 10 thru Page 13, Line 30) which is only shown in Figure 6. Furthermore, it is noted Figure 1 which appears to show the underlined features of Claim 52 is “an alternative system” of Figure 6 (Page 7, Line 10-20). Applicant is expressly cautioned to avoid the inclusion of new matter, as there is no disclosure of the parentage of Claim 52 having “a gas flow generator” with the underlined orientation of Claim 52 to include “the humidifier is included in the second branch” as required in Claim 52.
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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 42-52 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.
Specifically Claim 42, Lines 9-10 recite the limitation “aerosol delivery to the nasal interface”; however, the breadth and scope of the term “aerosol delivery” is unclear. Primary Examiner is unsure if “aerosol delivery” is a combination of BOTH the delivery of the “nebulizer” and the “humidifier”, a feature of ONE OF the delivery of the “nebulizer” OR the “humidifier”, a feature of ONLY the “nebulizer”, a feature of ONLY the “humidifier”, or some other construction. Turning to the original disclosure, Applicant asserts “aerosol” is delivered in the first branch whereby the first branch houses the nebulizer (Page 2, Lines 20-35); however, this disclosure appears to only correlate with Figure 1, and does not meet the remaining limitations of Claim 42 which includes the features “a gas flow generator” as an optional component of the system. Dependent claims, Claims 43-52 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 42, Line 10; Claim 51, Line 6 recite “nasal interface” alone while Claim 51, Line 8 recites “nasal interface or coupler” alone. However, it appears the limitations should recite “nasal interface or coupler for connection to an external interface” in order to provide consistency in the components that are required to meet the breadth and scope of the claims. In the absence of this consistently, the breadth and scope of the claims is unclear and it is indefinite which components are required. Dependent claims, Claims 43-52 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 42, Line 15 recites “aerosol output”; however, the breadth and scope of this limitation is unclear as it appears to lack antecedent basis in the claims. Formerly within the claim listing of Claim 42, Applicant recited the term “aerosol delivery”. Primary Examiner is unsure if Applicant intends the term “aerosol output” to be coextensive with “aerosol delivery” or some other limitation. Dependent claims, Claims 43-52 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 42, Line 18 recites “means of temporarily varying aerosol output”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if Applicant is attempting to invoke 112(6/f), or alternatively if this is just a turn of phrase with a nonce term? Turning to the original disclosure, Applicant recites the phrase “means of temporarily varying aerosol output” (Page 3, Lines 20-30); yet, provides no clear and explicit corresponding structure to narrow the scope of the phrase “means of temporarily varying aerosol output”. On Page 8, Line 25-35, Applicant asserts the concept of a “heater”; yet, this term does not provide a clear and explicit corresponding structure correlate the “heater” with the phrase “means of temporarily varying aerosol output”. With reference to the use of the word “rainout” there is no a clear and explicit corresponding structure correlate the functionality of “rainout” being “removed” by a “means of temporarily varying aerosol output”. In light of the foregoing, Primary Examiner is unsure if Applicant is asserting the requirement of a ”heater”, or alternatively, the functionality of changes in flow rate as directed by the controller in the absence of a “heater” can meet the limitations of “removing any rainout…by means of temporarily varying aerosol output”. Dependent Claims 43-52 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 42, Lines 19-21 recite “receive a signal from a gas flow generator control unit and/or the flow meter and if there is no flow, or backward flow coming from the patient side towards the flow generator”; however, the breadth and scope of this limitation is unclear due to the multiple uses of alternative language. It appears one potential way to meet the claims would be to “receive a signal from the flow meter and if there is no flow”, an alterative reading to meet the claims would be “receive a signal from a gas flow generator control unit and if there is no flow, or backward flow coming from the patient side towards the flow generator”. By the alternative language it appears the claimed “gas flow generator” is optional and not expressly required until Claim 47. Dependent claims, Claims 43-46 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 42, Line 21 recites “the flow generator”; however, this limitation appears to lack anteceding basis in the claims. Primary Examiner if Applicant intends this term to be coextensive with the “gas flow generator control unit” of Claim 42, Line 19; an unrecited feature of the “gas supply” of Claim 42, Line 2; OR some other limitation. Dependent claims, Claims 43-52 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 42, Lines 24-25 recite “detect patient activity and control aerosol delivery according to detected periods of altered activity”; however, the breadth and scope of these limitations “patient activity” and “altered activity” is unclear. Although the term “patient activity” could be broadly interpreted to be the act of the patient breathing and/or use of the device, the term “altered activity” and the way by which the “altered activity” is being monitored is unclear. Turning to the original specification as filed it appears Applicant intends the term “altered activity” to encompass “sleep” (Page 3, Lines 15-25), Applicant provides not such structure which is required to meet the limitations of “detecting periods of altered activity“. Primary Examiner is unsure how the “controller” is able to make such a determination, when there is no disclosure to the sensor/component capable to permit the controller to determine the patient is asleep or alternatively permit the health care professional to input the patient’s state to be “asleep”. Dependent Claim 45 explicitly refers to “the controller is configured to control aerosol delivery according to detection of sleep”; yet, still it is unclear how the “controller” is able to make such a determination, when there is no disclosure to the sensor/component capable to permit the controller to determine the patient is asleep or alternatively permit the health care professional to input the patient’s state to be “asleep”. Dependent claims, Claims 43-52 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 47, Line 2 recites “a gas flow generator”; however, the breadth and scope of this limitation is unclear as it appears to lack antecedent basis in the claims. Primary Examiner is unsure if this term is mean to correspond to the “gas flow generator control unit” of Claim 42, Line 19; the “flow generator” of Claim 42, Line 21; an unrecited feature of the “gas supply” of Claim 42, Line 2; OR some other limitation. Dependent claims, Claims 48-52 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 47, Line 3 recites “aerosol therapy only”; however, the breadth and scope of this limitation is unclear as it appears to lack antecedent basis in the claims. In the parentage of Claim 47, Claim 42 recites the terms “aerosol delivery”, “aerosol output”, and “aerosol generation”. Primary Examiner is unsure if Applicant intends the term “aerosol therapy only” to be coextensive with “aerosol delivery”, “aerosol output”, “aerosol generation”, or some other limitation. Dependent claims, Claims 48-52 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
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 42-46 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (2008/0078385) in view of Sweeney et al. (2011/0253136).
As to Claim 42, Xiao disclose a high flow nasal therapy system (Figure 1), comprising: a gas supply (“Heliox gas and oxygen gas” via 10, “With reference to FIG. 1, there is shown a schematic diagram of an embodiment of a positive pressure support Heliox delivery system (10) that can blend Heliox gas and oxygen gas to attain a prescribed percent concentration of oxygen in the gas delivered to a patient.” Para 0013), a humidifier (56, “The Heliox delivery system (10) may also include one or more alarms (50), a filter (52), a heater (54), a humidifier (56), and a flow meter (58).” Para 0013), a nebulizer (62, “Such auxiliary devices may include one or more of the following devices: alarm (52), heater (54), humidifier (56), flow meter (58), auxiliary sensors (60), and nebulizer (62), or any combinations or arrangements thereof.” Para 0023), a flow line (17, “The gas blender (16) is operatively coupled to the control unit (40) which precisely controls the final oxygen level (FiO.sub.2) or the concentration of oxygen in the blended gas (17) entering the lungs of the patient from a minimum of about 10% to the upper limit of about 100%.” Para 0016; also see: “adjusting the gas concentration of helium and oxygen will result in an adjustment in the flow rate of the blended gas (17) delivered to the patient.” Para 0027), a sensor (58/60, wherein “Such auxiliary devices may include one or more of the following devices: alarm (52), heater (54), humidifier (56), flow meter (58), auxiliary sensors (60), and nebulizer (62), or any combinations or arrangements thereof.” Para 0023) for detecting flow conditions (58 – “flow meter (58)” Para 0023), the sensor (58/60) comprising a flow meter (58) in the flow line (17), a nasal interface (34/36, “The patient interface (34) can include a non-invasive nasal mask, oral mask, cannula, face mask with one way valve to allow expiration, nasal prong, or other mask type device (36) that delivers the blended gas flow to patient's airway. Preferably, a nasal mask type device (36) is used that is capable of operating at positive pressures of up to about 50 cm H.sub.2O. The patient inhales the blended gas through the nasal mask (36) and exhales through the mouth.” Para 0020), and a controller (40 including 42, “The Heliox delivery system (10) also includes a gas blender (16), one or more control valves (18), a gas analyzer (20), an outlet port (22), a breathing circuit (30) and a control unit (40). The preferred control unit (40) includes a microprocessor based controller (42), a display (44), and user interface (45).” Para 0013; also see: “The gas blender (16) is operatively coupled to the control unit (40) which precisely controls the final oxygen level (FiO.sub.2) or the concentration of oxygen in the blended gas (17) entering the lungs of the patient from a minimum of about 10% to the upper limit of about 100%.” Para 0016; “Control unit (40) operatively controls both the gas blender (16) to adjust the blending of oxygen and Heliox and the one or more control valves (18) to adjust the flow rate or pressure of the blended gas mixture (17) in response to user inputs as well as measured parameters from the gas analyzer, flow meters and associated sensors. The control unit (40) includes a microprocessor based controller (42), a display (44), and a user interface (45). The microprocessor based controller (42) includes the logic and control algorithms to effect precise control of the gas blender (16) and control valves (18) based on user inputs and other collected data and information.” Para 0021; “The flow meter (58) is operatively coupled to the control unit (40) and is controlled in response to the analyzed concentrations of helium and oxygen and a measured pressure differential in the flow path.” Para 0026; “As discussed with reference to FIG. 1, the control unit (40) includes a microprocessor based controller (42), a control unit display (44), and a user interface (45). The microprocessor based controller (42) operatively controls both the gas blender (16) to adjust the blending of oxygen and Heliox and the control valve (18) to adjust the flow rate or pressure of the blended gas mixture (17) in response to user inputs as well as the measured parameters from the gas analyzer (16), flow meters (58) and associated sensors.” Para 0034; and “The control unit (42) is further adapted to allow the user to select a final gas composition and visually confirm it without the need to use external calibration charts. The user can also select a final blended gas flow rate independent of the blended gas flow composition. Preferably, the flow rate delivered to the patient ranges from little or no flow during expiratory phase up to a maximum of about 25 liters per minute during inspiratory phase.” Para 0035) configured to control the system in real time (“The control unit can be programmed to adjust the gas composition, pressure, and flow rate automatically over time or patient's breathing pattern.” Para 0017) to vary the aerosol delivery (via 17) to the nasal interface (34/36) on a temporal basis (“The microprocessor based controller (42) includes the logic and control algorithms to effect precise control of the gas blender (16) and control valves (18) based on user inputs and other collected data and information.” Para 0021; “The microprocessor based controller (42) operatively controls both the gas blender (16) to adjust the blending of oxygen and Heliox and the control valve (18) to adjust the flow rate or pressure of the blended gas mixture (17) in response to user inputs as well as the measured parameters from the gas analyzer (16), flow meters (58) and associated sensors. … Through the user interface (45), the user inputs such parameters that are used to control or adjust the helium and oxygen concentrations, blended gas pressure and flow rate over time or according to patient's breathing pattern.” Para 0034; also see: “The control unit can be programmed to adjust the gas composition, pressure, and flow rate automatically over time or patient's breathing pattern.” Para 0017; and “The Heliox delivery system can deliver the blended gas mixture at adjustable flow rates depending on the patient condition and needs.” Para 0038), wherein the controller (40 including 42) is configured to: provide an increased aerosol delivery during patient inhalation and reduced aerosol delivery during patient exhalation (“the flow rate delivered to the patient ranges from little or no flow during expiratory phase up to a maximum of about 25 liters per minute during inspiratory phase.” Para 0035), characterized in that, the controller (40 including 42) is also configured to: vary the aerosol output (via 17) at least partially in response to sensed flow conditions (“The microprocessor based controller (42) includes the logic and control algorithms to effect precise control of the gas blender (16) and control valves (18) based on user inputs and other collected data and information.” Para 0021; “The microprocessor based controller (42) operatively controls both the gas blender (16) to adjust the blending of oxygen and Heliox and the control valve (18) to adjust the flow rate or pressure of the blended gas mixture (17) in response to user inputs as well as the measured parameters from the gas analyzer (16), flow meters (58) and associated sensors.” Para 0034); receive a signal (“alarm” OR “display”, whereby “Alternatively, the user can set up the alarm to be activated based on adverse gas concentration levels, oxygen saturation levels in the patient, system flow rates, pressures, temperatures, and humidity levels.” Para 0015; OR “The display (44) is preferably an LCD type screen that displays gas delivery parameters such as flow rate of mixed gas, helium concentration of the blended gas, oxygen concentration of the blended gas, breathing curve of the patient, oxygen saturation of the patient, inspiratory positive pressure support, alarm settings, audible and visual alarms indicators, and auxiliary sensor measurements such as temperature, humidity, pressure, etc.” Para 0021) and if there is no flow (“Alternatively, the user can set up the alarm to be activated based on adverse gas concentration levels, oxygen saturation levels in the patient, system flow rates, pressures, temperatures, and humidity levels.” Para 0015).
Yet, Xiao does not expressly disclose the configuration of the controller to “control aerosol delivery to remove any rainout building up in a breathing circuit by means of temporally varying aerosol output”, “preventing the nebuliser and/or the humidifier from generating aerosol and/or humidity”, nor “to detect patient activity and control aerosol delivery according to detected periods of altered activity”.
Regarding “control aerosol delivery to remove any rainout building up in a breathing circuit by means of temporally varying aerosol output”, although Xiao expresses concern with the generation of humidity from the humidifier with or without a heater (“The humidifier (56) is also preferably included within the illustrated embodiment to deliver a saturated gas mixture of Heliox and oxygen to the patient. The humidification of the blended gas (17) can occur with a jet nebulizer, a bubble humidifier, or a pass-over humidifier, with or without the addition of heat from the heater (54).” Para 0025), Xiao does not expressly disclose the functionality of the controller to “control aerosol delivery to remove any rainout building up in a breathing circuit by means of temporally varying aerosol output”.
Sweeney teaches a high flow nasal therapy system (Figure 1), comprising: a gas supply (via 104, “For example, the airway treatment delivery device will typically include a flow generator such as a servo-controlled blower 104. The blower 104 will typically include an air inlet and impeller driven by a motor (not shown). Optionally, the air inlet may be coupled with a gas supply, such as for oxygen as shown in FIG. 1, to mix with or supplement the breathable gas supplied by the impeller to the airway of a user.” Para 0038; also see: “Breathable gas is supplied to the patient by a blower (104 of FIG. 1), which may be integrated with other elements of the apparatus, or from a reticulated source, or from bottled gas, or otherwise. The air may be filtered at the input to the blower (104) or at some other point in the gas flow path.” Para 0052), a humidifier (112, “Optionally, the apparatus may also include a humidifier and/or heater (112, 111) and a delivery tube heater (135) (or apparatus to regulate heat loss from the delivery tube 106).” Para 0052), a flow line (106, “The airway treatment device 102 will also typically include a patient interface such as an air delivery conduit 106 and nasal prongs or nasal cannula 108 to carry the flow of air or breathable gas to the upper airway of a user of the device or patient. The blower 104 can be coupled with the air delivery conduit 106 and the nasal cannula 108 so as to provide the breathable gas from the blower 104.” Para 0042, and “Optionally, the apparatus may also include a humidifier and/or heater (112, 111) and a delivery tube heater (135) (or apparatus to regulate heat loss from the delivery tube 106).” Para 0052), a sensor (116, “In some embodiments, the airway treatment delivery device may optionally include one or more flow sensors 116. For example, flow through the nasal cannula 108 may be measured using a pneumotachograph and differential pressure transducer or similar device such as one employing a bundle of tubes or ducts to derive a flow signal. Although the flow sensor is illustrated in FIG. 1 in a location proximate to the blower, the flow sensor may optionally be located closer to the patient, such as in the patient interface or nasal cannula 108.” Para 0059) comprising a flow meter (“one or more flow sensors 116”), a nasal interface (108, “The airway treatment device 102 will also typically include a patient interface such as an air delivery conduit 106 and nasal prongs or nasal cannula 108 to carry the flow of air or breathable gas to the upper airway of a user of the device or patient. The blower 104 can be coupled with the air delivery conduit 106 and the nasal cannula 108 so as to provide the breathable gas from the blower 104.” Para 0042; and “In some embodiments, the airway treatment delivery device may optionally include one or more flow sensors 116. For example, flow through the nasal cannula 108 may be measured using a pneumotachograph and differential pressure transducer or similar device such as one employing a bundle of tubes or ducts to derive a flow signal. Although the flow sensor is illustrated in FIG. 1 in a location proximate to the blower, the flow sensor may optionally be located closer to the patient, such as in the patient interface or nasal cannula 108.” Para 0059), and a controller (120, “The sensor(s) generate temperature and/or humidity signals and/or a flow rate signal, and/or pressure signals (illustrated in FIG. 1) for controlling the humidifier and/or heater and/or tube heater using control logic (120) to maintain the temperature and/or humidity of the breathable gas delivered to the patient. In some applications, this device can be controlled to alter the temperature and humidity of the breathable gas such that the delivery conditions are within the acceptable or preferred ranges as stated above.” Para 0052; “The signals from the various sensors (when present) may be sent to a controller or processor 120.” Para 0062; “Thus, the processor 120 or controller may make controlled changes to the flow delivered to the patient interface by the blower 104. … The controller or processor 120 is typically configured and adapted to implement particular control methodology such as the methods described in more detail herein.” Paras 0062-0063).
With respect to “control aerosol delivery to remove any rainout building up in a breathing circuit by means of temporally varying aerosol output”, Sweeney teaches the controller (120) is configured to control the aerosol delivery to remove any rainout building up in the breathing circuit by means of temporally varying the aerosol output, by the usage of “5.6.1 Re-Ramp Methodology” (Paras 0080-0083). In the operation of “5.6.1 Re-Ramp Methodology”, Sweeney teaches the controller (120) will act using “control of the re-ramp procedure may be implemented as a function of the presence of humidification and/or heating so as to assist with avoiding rainout or condensation” (Para 0080), wherein the controller (120) will permit “in some embodiments the reduced flow rate may be a function of humidity and/or temperature such that the reduced flow rate selection is at least partially set in a manner that prevents condensation from forming in the patient interface and/or delivery tube. For example, the algorithm may monitor the temperature and humidity internal and/or external to the apparatus, for example by means of temperature and humidity sensors, and then automatically select a reduced flow rate, such as from a look-up table based on the temperature and/or humidity information.” (Para 0082). In this configuration, the system (Figure 1) of Sweeney is selecting the flow rate of aerosol to be delivered based upon the proper flow rate to “avoiding rainout or condensation” in which “prevents condensation from forming in the patient interface and/or delivery tube”.
Hence, the decision to modify the controller of Xiao to include the functionality of “control aerosol delivery to remove any rainout building up in a breathing circuit by means of temporally varying aerosol output” as taught by Sweeney is a known consideration in order to prevent rainout or condensation that would effectuate the operability of the system.
Regarding “preventing the nebuliser and/or the humidifier from generating aerosol and/or humidity”, although Xiao expresses concern with the generation of humidity from the humidifier with or without a heater (“The humidifier (56) is also preferably included within the illustrated embodiment to deliver a saturated gas mixture of Heliox and oxygen to the patient. The humidification of the blended gas (17) can occur with a jet nebulizer, a bubble humidifier, or a pass-over humidifier, with or without the addition of heat from the heater (54).” Para 0025), Xiao does not expressly disclose the functionality of the controller to “preventing the nebuliser and/or the humidifier from generating aerosol and/or humidity”.
Sweeney teaches a high flow nasal therapy system (Figure 1), comprising: a gas supply (via 104, “For example, the airway treatment delivery device will typically include a flow generator such as a servo-controlled blower 104. The blower 104 will typically include an air inlet and impeller driven by a motor (not shown). Optionally, the air inlet may be coupled with a gas supply, such as for oxygen as shown in FIG. 1, to mix with or supplement the breathable gas supplied by the impeller to the airway of a user.” Para 0038; also see: “Breathable gas is supplied to the patient by a blower (104 of FIG. 1), which may be integrated with other elements of the apparatus, or from a reticulated source, or from bottled gas, or otherwise. The air may be filtered at the input to the blower (104) or at some other point in the gas flow path.” Para 0052), a humidifier (112, “Optionally, the apparatus may also include a humidifier and/or heater (112, 111) and a delivery tube heater (135) (or apparatus to regulate heat loss from the delivery tube 106).” Para 0052), a flow line (106, “The airway treatment device 102 will also typically include a patient interface such as an air delivery conduit 106 and nasal prongs or nasal cannula 108 to carry the flow of air or breathable gas to the upper airway of a user of the device or patient. The blower 104 can be coupled with the air delivery conduit 106 and the nasal cannula 108 so as to provide the breathable gas from the blower 104.” Para 0042, and “Optionally, the apparatus may also include a humidifier and/or heater (112, 111) and a delivery tube heater (135) (or apparatus to regulate heat loss from the delivery tube 106).” Para 0052), a sensor (116, “In some embodiments, the airway treatment delivery device may optionally include one or more flow sensors 116. For example, flow through the nasal cannula 108 may be measured using a pneumotachograph and differential pressure transducer or similar device such as one employing a bundle of tubes or ducts to derive a flow signal. Although the flow sensor is illustrated in FIG. 1 in a location proximate to the blower, the flow sensor may optionally be located closer to the patient, such as in the patient interface or nasal cannula 108.” Para 0059) comprising a flow meter (“one or more flow sensors 116”), a nasal interface (108, “The airway treatment device 102 will also typically include a patient interface such as an air delivery conduit 106 and nasal prongs or nasal cannula 108 to carry the flow of air or breathable gas to the upper airway of a user of the device or patient. The blower 104 can be coupled with the air delivery conduit 106 and the nasal cannula 108 so as to provide the breathable gas from the blower 104.” Para 0042; and “In some embodiments, the airway treatment delivery device may optionally include one or more flow sensors 116. For example, flow through the nasal cannula 108 may be measured using a pneumotachograph and differential pressure transducer or similar device such as one employing a bundle of tubes or ducts to derive a flow signal. Although the flow sensor is illustrated in FIG. 1 in a location proximate to the blower, the flow sensor may optionally be located closer to the patient, such as in the patient interface or nasal cannula 108.” Para 0059), and a controller (120, “The sensor(s) generate temperature and/or humidity signals and/or a flow rate signal, and/or pressure signals (illustrated in FIG. 1) for controlling the humidifier and/or heater and/or tube heater using control logic (120) to maintain the temperature and/or humidity of the breathable gas delivered to the patient. In some applications, this device can be controlled to alter the temperature and humidity of the breathable gas such that the delivery conditions are within the acceptable or preferred ranges as stated above.” Para 0052; “The signals from the various sensors (when present) may be sent to a controller or processor 120.” Para 0062; “Thus, the processor 120 or controller may make controlled changes to the flow delivered to the patient interface by the blower 104. … The controller or processor 120 is typically configured and adapted to implement particular control methodology such as the methods described in more detail herein.” Paras 0062-0063).
With respect to “preventing the nebuliser and/or the humidifier from generating aerosol and/or humidity”, Sweeney teaches the controller (120) is configured to control the aerosol delivery to remove any rainout building up in the breathing circuit by means of temporally varying the aerosol output, by the usage of “5.6.1 Re-Ramp Methodology” (Paras 0080-0083). In the operation of “5.6.1 Re-Ramp Methodology”, Sweeney teaches the controller (120) will act using “control of the re-ramp procedure may be implemented as a function of the presence of humidification and/or heating so as to assist with avoiding rainout or condensation” (Para 0080), wherein the controller (120) will permit “in some embodiments the reduced flow rate may be a function of humidity and/or temperature such that the reduced flow rate selection is at least partially set in a manner that prevents condensation from forming in the patient interface and/or delivery tube. For example, the algorithm may monitor the temperature and humidity internal and/or external to the apparatus, for example by means of temperature and humidity sensors, and then automatically select a reduced flow rate, such as from a look-up table based on the temperature and/or humidity information.” (Para 0082). Further, Sweeney teaches the controller (120) is configured to “regulate heat loss from the delivery tube 106).” (Para 0052). In this configuration, the system (Figure 1) of Sweeney is permits for the energizing of a heaters (111/135, “Optionally, the apparatus may also include a humidifier and/or heater (112, 111) and a delivery tube heater (135) (or apparatus to regulate heat loss from the delivery tube 106). … One or more heating elements (not shown separately from heater 111) may be provided to warm the fluid to create the vapor and/or to warm the breathable gas by convection.” Para 0052) to modulate the generation of humidity within the system, with the express desire to prevent rainout or condensation.
Hence, the decision to modify the controller of Xiao to include the functionality of “preventing the nebuliser and/or the humidifier from generating aerosol and/or humidity” as taught by Sweeney is a known consideration in order to modulate the generation of humidity within the system, with the express desire to prevent rainout or condensation.
Regarding “to detect patient activity and control aerosol delivery according to detected periods of altered activity”, although Xiao expresses concern with the general use of the system to modulate flow rate as a function of whether the patient is inhaling or exhaling (“the flow rate delivered to the patient ranges from little or no flow during expiratory phase up to a maximum of about 25 liters per minute during inspiratory phase.” Para 0035), Xiao does not expressly disclose the functionality of the controller to “… control aerosol delivery according to detected periods of altered activity”.
Sweeney teaches a high flow nasal therapy system (Figure 1), comprising: a gas supply (via 104, “For example, the airway treatment delivery device will typically include a flow generator such as a servo-controlled blower 104. The blower 104 will typically include an air inlet and impeller driven by a motor (not shown). Optionally, the air inlet may be coupled with a gas supply, such as for oxygen as shown in FIG. 1, to mix with or supplement the breathable gas supplied by the impeller to the airway of a user.” Para 0038; also see: “Breathable gas is supplied to the patient by a blower (104 of FIG. 1), which may be integrated with other elements of the apparatus, or from a reticulated source, or from bottled gas, or otherwise. The air may be filtered at the input to the blower (104) or at some other point in the gas flow path.” Para 0052), a humidifier (112, “Optionally, the apparatus may also include a humidifier and/or heater (112, 111) and a delivery tube heater (135) (or apparatus to regulate heat loss from the delivery tube 106).” Para 0052), a flow line (106, “The airway treatment device 102 will also typically include a patient interface such as an air delivery conduit 106 and nasal prongs or nasal cannula 108 to carry the flow of air or breathable gas to the upper airway of a user of the device or patient. The blower 104 can be coupled with the air delivery conduit 106 and the nasal cannula 108 so as to provide the breathable gas from the blower 104.” Para 0042, and “Optionally, the apparatus may also include a humidifier and/or heater (112, 111) and a delivery tube heater (135) (or apparatus to regulate heat loss from the delivery tube 106).” Para 0052), a sensor (116, “In some embodiments, the airway treatment delivery device may optionally include one or more flow sensors 116. For example, flow through the nasal cannula 108 may be measured using a pneumotachograph and differential pressure transducer or similar device such as one employing a bundle of tubes or ducts to derive a flow signal. Although the flow sensor is illustrated in FIG. 1 in a location proximate to the blower, the flow sensor may optionally be located closer to the patient, such as in the patient interface or nasal cannula 108.” Para 0059) comprising a flow meter (“one or more flow sensors 116”), a nasal interface (108, “The airway treatment device 102 will also typically include a patient interface such as an air delivery conduit 106 and nasal prongs or nasal cannula 108 to carry the flow of air or breathable gas to the upper airway of a user of the device or patient. The blower 104 can be coupled with the air delivery conduit 106 and the nasal cannula 108 so as to provide the breathable gas from the blower 104.” Para 0042; and “In some embodiments, the airway treatment delivery device may optionally include one or more flow sensors 116. For example, flow through the nasal cannula 108 may be measured using a pneumotachograph and differential pressure transducer or similar device such as one employing a bundle of tubes or ducts to derive a flow signal. Although the flow sensor is illustrated in FIG. 1 in a location proximate to the blower, the flow sensor may optionally be located closer to the patient, such as in the patient interface or nasal cannula 108.” Para 0059), and a controller (120, “The sensor(s) generate temperature and/or humidity signals and/or a flow rate signal, and/or pressure signals (illustrated in FIG. 1) for controlling the humidifier and/or heater and/or tube heater using control logic (120) to maintain the temperature and/or humidity of the breathable gas delivered to the patient. In some applications, this device can be controlled to alter the temperature and humidity of the breathable gas such that the delivery conditions are within the acceptable or preferred ranges as stated above.” Para 0052; “The signals from the various sensors (when present) may be sent to a controller or processor 120.” Para 0062; “Thus, the processor 120 or controller may make controlled changes to the flow delivered to the patient interface by the blower 104. … The controller or processor 120 is typically configured and adapted to implement particular control methodology such as the methods described in more detail herein.” Paras 0062-0063).
With respect to “… control aerosol delivery according to detected periods of altered activity”, Sweeney teaches the controller (120) is configured to modulate the flow rate when sleep is desired by the usage of “5.6.1 Re-Ramp Methodology” (Paras 0080-0083). In the operation of “5.6.1 Re-Ramp Methodology”, Sweeney teaches “during the course of therapy with the apparatus a patient may desire a temporary decrease in the flow rate to permit the patient to more comfortably fall asleep with a lower flow rate before the flow rate would then return to a higher prescription or therapeutic level during sleep. Thus, in some embodiments of the apparatus, a re-ramp methodology may be implemented by the controller.” (Para 0080). Additionally, Sweeney teaches “When the user is asleep and SDB events are detected, such as by the controller of the device, the flow rate would be incrementally increased in response to the SDB events (for example, apneas, hypopneas, flow limitation and snoring) to prevent them from repeating and hence maximizing the efficacy of the therapy. Another method would be to set the flow rate to the highest rate that is comfortable for the user when awake. When the user is asleep, the necessary changes in flow rate may be made in response to the SDB events, again to maximize the efficacy of the therapy.” (Para 0091) and “Changes to flow rates and temperature may be done manually, by an observer of the user when they are asleep. For example, by a sleep technologist observing the user using polysomnography (PSG).” (Para 0092). In this configuration, the system (Figure 1) of Sweeney is monitoring the altered activity of the patient sleeping to determine the next steps in treatment in order to “maximize the efficacy of the therapy”.
Hence, the decision to modify the controller of Xiao to include the functionality of “… control aerosol delivery according to detected periods of altered activity” as taught by Sweeney is a known consideration in order “maximize the efficacy of the therapy”.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the high flow nasal therapy system of Xiao to include the functionality of the controller to “control aerosol delivery to remove any rainout building up in a breathing circuit by means of temporally varying aerosol output” as taught by Sweeney is a known consideration in order to prevent rainout or condensation that would effectuate the operability of the system, to include the functionality of the controller to “preventing the nebuliser and/or the humidifier from generating aerosol and/or humidity” as taught by Sweeney is a known consideration in order to modulate the generation of humidity within the system, with the express desire to prevent rainout or condensation, and finally to include the functionality of “… control aerosol delivery according to detected periods of altered activity” as taught by Sweeney is a known consideration in order “maximize the efficacy of the therapy”.
As to Claim 43, the modified Xiao, specifically Xiao discloses an additional sensor (60) could be a pressure transducer (“auxiliary sensor measurements such as temperature, humidity, pressure, etc.”) Para 0021; while Sweeney teaches expressly teaches pressure sensors (114/131, “The airway treatment device may also optionally include one or more pressure sensors 114, 131, such as a pressure transducer. The pressure sensor(s) 114, 131 can be configured to measure the pressure generated by the blower 104 and/or supplied at the nasal cannula or patient airway. In the illustrated embodiment, the pressure sensors 114, 131 are proximate to the blower and located downstream of the blower proximate to the patient interface. For example, one or more pressure sensors may be located in the prongs or body of the nasal cannula. The pressure sensor(s) 114, 131 generates a pressure signal(s) indicative of the measurement(s) of pressure at its particular location. Such a signal(s) can be utilized in settings or calculations of the device. The pressure sensor 114 has only been shown symbolically in FIG. 1 since it is understood that other configurations and other components may be implemented to measure the pressure associated with the blower 104. For example, the pressure may be deduced from knowledge of the blower performance characteristics and the operating blower current and/or voltage and/or rotational speed and/or flow rate. Optionally, different groups of sensors may be provided for a delivery tube associated with each nare of the nasal cannula. For example, a delivery tube for each nare may include a pressure sensor and/or flow sensor so that independent measurements of flow and/or pressure may be measured for each nare.” Para 0060) were known to determine the pressure within the system.
As to Claim 44, the modified Xiao, specifically Sweeney expressly teaches the location of the flow meter (116) can be modified as claimed whereby “the flow meter is downstream of the nebulizer”. Explicitly, Sweeney states “Although the flow sensor is illustrated in FIG. 1 in a location proximate to the blower, the flow sensor may optionally be located closer to the patient, such as in the patient interface or nasal cannula 108.” Para 0059).
As to Claim 45, the modified Xiao, specifically Sweeney teaches the controller (120) is configured to control aerosol delivery according to detection of sleep. Explicitly, Sweeney states “When the user is asleep and SDB events are detected, such as by the controller of the device, the flow rate would be incrementally increased in response to the SDB events (for example, apneas, hypopneas, flow limitation and snoring) to prevent them from repeating and hence maximizing the efficacy of the therapy. Another method would be to set the flow rate to the highest rate that is comfortable for the user when awake. When the user is asleep, the necessary changes in flow rate may be made in response to the SDB events, again to maximize the efficacy of the therapy.” (Para 0091).
As to Claim 46, the modified Xiao, specifically Xiao discloses the controller (40) is configured to control aerosol delivery on the basis that controlling pressure or flow may help avoid wastage of medication. Explicitly, Xiao expresses concern with the general use of the system to modulate flow rate as a function of whether the patient is inhaling or exhaling (“the flow rate delivered to the patient ranges from little or no flow during expiratory phase up to a maximum of about 25 liters per minute during inspiratory phase.” Para 0035). In this configuration, the medication is only delivered when it can be inhaled by the user; thus preventing wastage of medication.
Claims 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (2008/0078385) in view of Sweeney et al. (2011/0253136), as applied to Claim 46, and further in view of Lepel (7,448,376).
As to Claim 47, the modified Xiao, specifically Sweeney teaches the controller (120) is configured to control aerosol delivery according to detection of sleep; yet, does not expressly disclose the configuration “wherein the controller is configured to control a gas flow generator to reduce the gas flow rate to optimal levels for the duration of aerosol therapy only, and to restore gas flow rates again at end of dose.”
Lepel teaches a high flow nasal therapy system (Figure 4), comprising: a gas supply (102, “Oxygen and/or air is directed to nebulizer 30 from a gas source 102 through fitting 38 and gas supply tube 36, to nebulize the medication 160 to an aerosol 162. The gas source 102 may be the same source which supplies the CPAP unit 100, or may comprise a different source, e.g. a different oxygen cylinder. The oxygen/air supplied to the nebulizer 30 must be of a higher pressure than the oxygen/air supplied to the CPAP device, to compensate for the pressure drop across the nebulizing nozzle, not shown, within the nebulizer 30.” Column 10, Lines 10-35; also see: “FIG. 1 shows the major elements of a conventional PRIOR ART Constant Positive Airway Pressure (CPAP) apparatus 100 in simplified form. These elements include an oxygen source 102, a first conduit means connected to the oxygen source 102 by fitting 125, and first conduit means 128 connected to inlet port 124 of dilution device 106.” Column 8, Lines 20-50), a nebulizer (30, “The medication delivery device 10 comprises a nebulizer 30 shown with a medication container 26 e.g. jar which is removable from nebulizer cap 28 along jar/cap interface 29 for placement of a liquid medication 160 therein. Typically, the container 26 is sealably attached to the cap 28 by screw threads or a compression (snap) fitting, not shown. The nebulizer 30 may be of any design or manufacture useful in medication nebulization, provided that it will assume an upright attitude for full nebulization when freely suspended from a medicinal aerosol delivery tube 20 attached to the first port 16 of Tee fitting 12. Oxygen and/or air is directed to nebulizer 30 from a gas source 102 through fitting 38 and gas supply tube 36, to nebulize the medication 160 to an aerosol 162. The gas source 102 may be the same source which supplies the CPAP unit 100, or may comprise a different source, e.g. a different oxygen cylinder. The oxygen/air supplied to the nebulizer 30 must be of a higher pressure than the oxygen/air supplied to the CPAP device, to compensate for the pressure drop across the nebulizing nozzle, not shown, within the nebulizer 30.” Column 10, Lines 10-35), a flow line (18, “The third Tee fitting port 18 is shown connected to the mask inhalation port 112, for mixing and simultaneous continuous injection of a pressurized oxygenation gas 158 and an aerosol 162 of medication 160 into a CPAP mask 110.” Column 10, Lines 55-70; “Third port 18 of Tee fitting 12 is configured to mate with the inhalation port 112 of the CPAP mask 110.” Column 10, Lines 40-50), a nasal interface (110, “CPAP mask 110” Column 10, Lines 40-70), and a controller (The gas supply stream to the nebulizer is controlled at a flow rate which provides a desired nebulization rate independently of the flowrate of the CPAP oxygen stream.” Summary, Column 5, Lines 30-70; also see: “The pressure and flow rate of oxygen/air are controlled by means known in the art to provide the desired aerosolization rate. Such pressure and flow controlling means may be further incorporated into a BiPAP/CPAP machine, so that the CPAP gas 158 and nebulizer gas 162 have independently controlled pressures and flow rates.” Column 11, Line 45 thru Column 12, Line 5).
Regarding the operation of the controller to “control a gas flow generator to reduce the gas flow rate to optimal levels for the duration of aerosol therapy only, and to restore gas flow rates again at end of dose”, Lepel teaches the configuration of the nebulizer (30) remote from the primary gas line (125, “FIG. 1 shows the major elements of a conventional PRIOR ART Constant Positive Airway Pressure (CPAP) apparatus 100 in simplified form. These elements include an oxygen source 102, a first conduit means connected to the oxygen source 102 by fitting 125, and first conduit means 128 connected to inlet port 124 of dilution device 106.” Column 8, Lines 20-50) wherein the nebulizer (30) has its own gas line in the form of a gas flow generator control unit (38, “Oxygen and/or air is directed to nebulizer 30 from a gas source 102 through fitting 38 and gas supply tube 36, to nebulize the medication 160 to an aerosol 162. The gas source 102 may be the same source which supplies the CPAP unit 100, or may comprise a different source, e.g. a different oxygen cylinder. The oxygen/air supplied to the nebulizer 30 must be of a higher pressure than the oxygen/air supplied to the CPAP device, to compensate for the pressure drop across the nebulizing nozzle, not shown, within the nebulizer 30.” Column 10, Lines 10-35) which operates independently from that of primary gas line (125) in order to achieve “desired aerosolization rate” Column 11, Line 45 thru Column 12, Line 5; also see: “desired nebulization rate” Summary, Column 5, Lines 30-70). In this configuration of separate gas sources for the primary gas line (125) and the gas flow generator control unit (38) the controller acts to “reduce the gas flow rate to optimal levels for the duration of the aerosol therapy only and to restore gas flow rates again at the end of the dose” so that the delivery of nebulized gas is optimized.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the operational controls of the controller of the modified Xiao to include a gas flow generator control unit as taught by Lepel to independently achieve “desired aerosolization rate.”
As to Claim 48, the modified Xiao, specifically Sweeney teaches the controller (120) is configured to control the aerosol delivery (via 106) for protection of equipment (“prevents condensation from forming in the patient interface and/or delivery tube.” Para 0082). The presence of condensation not only may provide harm/discomfort to the patient, but also results in microbial growth that would effectuate the cleanliness and sanitization of the delivery tube and/or patient interface.
Claims 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (2008/0078385) in view of Sweeney et al. (2011/0253136) and Lepel (7,448,376), as applied to Claim 48, and further in view of Pizzini (2013/0239970).
As to Claim 49, the modified Xiao, specifically Xiao discloses the features of a nebulizer (62) and humidifier (56) oriented with a common pathway ending at a nasal interface (34/36); yet, does not expressly disclose the orientation of “the nebuliser is placed on a gas inlet side of the humidifier to allow for pre-conditioning of the gas prior to humidification.”
Pizzini teaches a high flow nasal therapy system (Figure 4), comprising: a gas supply (80, “The external end of the airway device 60 may comprise a standard fixture 64, connector 64, or adapter 64 that enables the airway device 60 to be operably connected to a gas source 80.” Para 0044; “In some aspects, the system 90 comprises a gas supply 80. The gas supply 80 is preferably an oxygen supply, but may include other gases, for example, anesthetic gases such as nitrous oxide sevoflurane, enflurane, desflurane, isoflurane, and halothane; air; heliox (mixture of helium and oxygen), nitrogen; or combinations of the listed gases. The gas supply 80 may be a wall supply, or a tank, or an anesthesia gas machine.” Para 0050), a humidifier (88, “The system may comprise a humidifier 88 for adding moisture to the gas being administered to the patient.” Para 0050), a nebulizer (86, “The system 90 may comprise a nebulizer 86 for aerosolizing medications to be administered to the patient, for example, through the nasal cannula 50.” Para 0050), a flow line (defined by the path of gas from 80 to 12), a nasal interface (50, “The system 90 may comprise a nebulizer 86 for aerosolizing medications to be administered to the patient, for example, through the nasal cannula 50.” Para 0050).
Regarding the orientation of “the nebuliser is placed on a gas inlet side of the humidifier to allow for pre-conditioning of the gas prior to humidification”, Pizzini teaches the orientation of the nebulizer (86) placed on the gas inlet side of the humidifier (88) was known in order to aerosolize medications prior to adding moisture to the gas.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Xiao, as the orientation of the nebulizer on the gas inlet side of the humidifier would yield the predictable results of aerosolizing medication and providing moisture to the gas to be delivered to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the orientation of the nebulizer and humidified of the modified Xiao, to be in the configuration whereby the nebuliser is placed on a gas inlet side of the humidifier to allow for pre-conditioning of the gas prior to humidification” as claimed and taught by Pizzini to be known result effective variable in order to yield aerosolizing medication and providing moisture to the gas to be delivered to the patient.
As to Claim 50, the modified Xiao, specifically Sweeney teaches the controller (120) is configured to temporarily reduce gas flow rate in the flow line (106) for the duration of active aerosol generation, in which the system (Figure 1) of Sweeney is selecting the flow rate of aerosol to be delivered based upon the proper flow rate to “avoiding rainout or condensation” in which “prevents condensation from forming in the patient interface and/or delivery tube”. (Paras 0080 and 0082).
As to Claim 51, modified Xiao, specifically Xiao discloses a valve (18, “The Heliox delivery system (10) also includes a gas blender (16), one or more control valves (18), a gas analyzer (20), an outlet port (22), a breathing circuit (30) and a control unit (40).” Para 0013; “The blended gas (17) exits the gas blender (16) and then passes through one or more control valves (18) which operatively control the final pressure and flow of the blended gas (17).” Para 0017; “Control unit (40) operatively controls both the gas blender (16) to adjust the blending of oxygen and Heliox and the one or more control valves (18) to adjust the flow rate or pressure of the blended gas mixture (17) in response to user inputs as well as measured parameters from the gas analyzer, flow meters and associated sensors. The control unit (40) includes a microprocessor based controller (42), a display (44), and a user interface (45). The microprocessor based controller (42) includes the logic and control algorithms to effect precise control of the gas blender (16) and control valves (18) based on user inputs and other collected data and information.” Para 0021; “The microprocessor based controller (42) operatively controls both the gas blender (16) to adjust the blending of oxygen and Heliox and the control valve (18) to adjust the flow rate or pressure of the blended gas mixture (17) in response to user inputs as well as the measured parameters from the gas analyzer (16), flow meters (58) and associated sensors.” Para 0034) linked with the controller (40 including 42) in which unidirectional flow is provided from the gas supply (“Heliox gas and oxygen gas” via 10) towards the nasal interface (34/36).
Regarding the features of the “at least two branches”, “the branches including a first branch for delivery of aerosol and a second branch for delivery of non-aerosolized gas, and the controller is configured to control delivery into the branches”, and “wherein the first branch includes the nebulizer; wherein the first and second branches join at their patient ends at a common conduit, and said common conduit is in turn linked with said nasal interface or coupler”, Lepel teaches the system (Figure 4) comprises at least two branches (via 125 or via 38), wherein the first branch (via 38) includes the nebulizer (30) for aerosol delivery, and the second branch (via 125) is for non-aerosolized gas, the controller (The gas supply stream to the nebulizer is controlled at a flow rate which provides a desired nebulization rate independently of the flowrate of the CPAP oxygen stream.” Summary, Column 5, Lines 30-70; also see: “The pressure and flow rate of oxygen/air are controlled by means known in the art to provide the desired aerosolization rate. Such pressure and flow controlling means may be further incorporated into a BiPAP/CPAP machine, so that the CPAP gas 158 and nebulizer gas 162 have independently controlled pressures and flow rates.” Column 11, Line 45 thru Column 12, Line 5) independently controls the delivery into the branches (via 125 or via 38), the first branch (via 38) joins with the second branch (via 125) at their patient ends (via 12, “The three port Tee fitting 12 has a second port 14 which is connectable to the second end 131B of second conduit means 130, for flow of CPAP oxygen 158 therethrough. Third port 18 of Tee fitting 12 is configured to mate with the inhalation port 112 of the CPAP mask 110. As already indicated, first port 16 of Tee fitting 12 is connectable to the medicinal delivery tube 20.” Column 10, Lines 40-50) in which the first branch (38) has a patient end (16 of 12, “first port 16 of Tee fitting 12 is connectable to the medicinal delivery tube 20” Column 10, Lines 40-50), and the second branch has a patient end (14 of 12, “a second port 14 which is connectable to the second end 131B of second conduit means 130, for flow of CPAP oxygen 158 therethrough” Column 10, Lines 40-50) at a common conduit (18, “Third port 18 of Tee fitting 12 is configured to mate with the inhalation port 112 of the CPAP mask 110.” Column 10, Lines 40-50) that is linked with the nasal interface (110, “CPAP mask 110.” Column 10, Lines 40-50).
The resultant effect being the optimization of a “desired aerosolization rate” (Column 11, Line 45 thru Column 12, Line 5; also see: “desired nebulization rate” Summary, Column 5, Lines 30-70).
As to Claim 52, the modified Xiao, specifically Lepel teaches the configuration of the first branch (via 38) including the nebulizer (30) for aerosol delivery; yet, does not expressly disclose the location of the humidifier on the second branch as claimed.
The configuration of the humidifier on the second branch is obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the humidifier to operate at a rate different from that of the aerosolized medication delivery rate as provided by the nebulizer.
Applicant has not asserted the specific location of the humidifier on the second branch, provide a particular advantage, solves a stated problem or serves a particular purpose different from that of ensuring moisturized gas is supplied to the patient; thus, the use of the specific orientation of the humidifier located on the second branch lacks criticality.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Xiao as the construction of the humidifier on the second branch would enable the humidifier to operate at a rate different from that of the aerosolized medication delivery rate as provided by the nebulizer.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the humidifier to be located on the second branch, a known result effective variable in order to enable the humidifier to operate at a rate different from that of the aerosolized medication delivery rate as provided by the nebulizer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Xiao et al. (2008/0078389) discloses an additional high flow nasal therapy system having a gas supply, nebulizer, humidifier, nasal interface, sensor in the form of a flow meter, and controller.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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