DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 29-48 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.
Claims 29, 39, and 44 are each rejected as being indefinite because each of these claims recites the limitations “an output rate of the nebulizer” and “a nebulization rate of the nebulizer”, and it is unclear how these two limitations differ in scope. Both limitations appear to require the same element, just by different names. Further, the as-filed Specification does not appear to describe the “output rate” and the “nebulization rate” as different elements. As a result, it is unclear how the recitation of each of these limitations in these claims further limits the metes and bounds of the claims.
Claims 30-38, 40-43, and 45-48 are rejected for depending from indefinite claims 29, 39, and 44, respectively.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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 29-33, 39-41, and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Weinstein et al. (US 2007/0137646) in view of Minocchieri et al. (US 2008/0000470) and Hunsicker et al. (US 2011/0180063).
Regarding claim 29, Weinstein discloses an aerosol delivery system (fig. 4), comprising:
a gas flow circuit including a nebulizer (par. 61 –the separate nebulizer for the drug), a humidifier (420), and a tube connecting the nebulizer and the humidifier (par. 61 – “feed line”);
a plurality of sensors (450) configured to generate operational data of the gas flow circuit (par. 52 – “individual sensors at one or more locations that detect temperature, flow rate, and/or vapor content data”); and
a controller (440) configured to:
receive the operational data of the gas flow circuit from the plurality of sensors (fig. 4; par. 52);
determine, using the operational data of the gas flow circuit generated by the plurality of sensors, a temperature of a gas flow downstream of the nebulizer (par. 52 – “temperature”; par. 90), a humidity level of the gas flow downstream of the nebulizer (par. 52 – “vapor content”; par. 90), a gas flow rate of the gas flow downstream of the nebulizer (par. 52 – “flow rate”; par. 90); and
vary a humidity level of a gas flow based at least in part on two or more of the temperature of the gas flow downstream of the nebulizer, the humidity level of the gas flow downstream of the nebulizer, or the gas flow rate of the gas flow downstream of the nebulizer (par. 96).
Weinstein does not disclose that the controller is configured to determine an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors; or to vary the humidity level of gas flow upstream of the nebulizer. Weinstein does not explicitly disclose if the “separate nebulizer” in the “feed line” is upstream or downstream of the humidifier in the gas circuit.
Minocchieri teaches an aerosol delivery system (fig. 5), comprising: a gas flow circuit including a nebulizer (1), a humidifier (36), and a tube connecting the nebulizer and the humidifier (fig. 4); a plurality of sensors (35/37) configured to generate operational data of the gas flow circuit (par. 41, 51); and a controller (34) configured to: receive the operational data of the gas flow circuit from the plurality of sensors (fig. 5; par. 41, 46); and vary a humidity level of a gas flow upstream of the nebulizer based at least in part on the temperature of the gas flow downstream of the nebulizer and the humidity level of the gas flow downstream of the nebulizer (par. 51).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol delivery system of Weinstein to arrange the nebulizer downstream of the humidifier and configure the controller to vary the humidity level of gas flow upstream of the nebulizer, as taught by Minocchieri, since this was a known arrangement for providing a separate nebulizer and humidifier in the feed line of such a system.
Hunsicker teaches an aerosol delivery system (fig. 1) comprising a gas flow circuit (fig. 1) including a nebulizer (24), a plurality of sensors (32/36/44/46) configured to generate operational data of the gas flow circuit (par. 17-19), and a controller (40) configured to determine an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors (par. 28).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol delivery system of Weinstein such that the controller is configured to determine an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors, as taught by Hunsicker, since this was known to account for the effect of the nebulizer flow on the total gas flow of the circuit (Hunsicker, par. 26).
Regarding claim 30, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 29, and further wherein the controller is configured to vary the humidity level of the gas flow upstream of the nebulizer based at least in part on three or more of the temperature of the gas flow downstream of the nebulizer, the humidity level of the gas flow downstream of the nebulizer, the gas flow rate of the gas flow downstream of the nebulizer, the output rate of the nebulizer, and the nebulization rate of the nebulizer (par. 96 – “temperature, flow rate, and vapor content”).
Regarding claim 31, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 29, and further wherein the plurality of sensors includes two or more of a temperature sensor, a humidity sensor, and a flow sensor (par. 52 – “signal sent by the sensor system 250 to the controller 240 may include data regarding temperature, flow rate, and/or vapor content”).
Regarding claim 32, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 29, and further wherein the plurality of sensors includes a temperature sensor, a humidity sensor, and a flow sensor (par. 52 – “signal sent by the sensor system 250 to the controller 240 may include data regarding temperature, flow rate, and/or vapor content”).
Regarding claim 33, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 29, and further wherein the controller is configured to vary the humidity level of the gas flow upstream of the nebulizer to maintain a target humidity level of the gas flow downstream of the nebulizer (par. 96 – “controller determines whether adjustment to the flow rate of the fluid or the rate of vaporization at the vaporizer is required”).
Regarding claim 39, Weinstein discloses controller (440) for an aerosol delivery system (fig. 4), configured to:
receive, from a plurality of sensors (450), operational data (par. 52 – “individual sensors at one or more locations that detect temperature, flow rate, and/or vapor content data”) of a gas flow circuit (fig. 4) including a nebulizer (par. 61 –the separate nebulizer for the drug), a humidifier (420), and a tube connecting the nebulizer and the humidifier (par. 61 – “feed line”);
determine, using the operational data of the gas flow circuit generated by the plurality of sensors, a temperature of a gas flow downstream of the nebulizer (par. 52 – “temperature”; par. 90), a humidity level of the gas flow downstream of the nebulizer (par. 52 – “vapor content”; par. 90), a gas flow rate of the gas flow downstream of the nebulizer (par. 52 – “flow rate”; par. 90); and
vary a humidity level of a gas flow based at least in part on two or more of the temperature of the gas flow downstream of the nebulizer, the humidity level of the gas flow downstream of the nebulizer, or the gas flow rate of the gas flow downstream of the nebulizer (par. 96).
Weinstein does not disclose that the controller is configured to determine an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors; or to vary the humidity level of gas flow upstream of the nebulizer. Weinstein does not explicitly disclose if the “separate nebulizer” in the “feed line” is upstream or downstream of the humidifier in the gas circuit.
Minocchieri teaches an aerosol delivery system (fig. 5), comprising: a gas flow circuit including a nebulizer (1), a humidifier (36), and a tube connecting the nebulizer and the humidifier (fig. 4); a plurality of sensors (35/37) configured to generate operational data of the gas flow circuit (par. 41, 51); and a controller (34) configured to: receive the operational data of the gas flow circuit from the plurality of sensors (fig. 5; par. 41, 46); and vary a humidity level of a gas flow upstream of the nebulizer based at least in part on the temperature of the gas flow downstream of the nebulizer and the humidity level of the gas flow downstream of the nebulizer (par. 51).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol delivery system of Weinstein to arrange the nebulizer downstream of the humidifier and configure the controller to vary the humidity level of gas flow upstream of the nebulizer, as taught by Minocchieri, since this was a known arrangement for providing a separate nebulizer and humidifier in the feed line of such a system.
Hunsicker teaches an aerosol delivery system (fig. 1) comprising a gas flow circuit (fig. 1) including a nebulizer (24), a plurality of sensors (32/36/44/46) configured to generate operational data of the gas flow circuit (par. 17-19), and a controller (40) configured to determine an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors (par. 28).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Weinstein to be configured to determine an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors, as taught by Hunsicker, since this was known to account for the effect of the nebulizer flow on the total gas flow of the circuit (Hunsicker, par. 26).
Regarding claim 40, Weinstein in view of Minocchieri and Hunsicker discloses the controller described regarding claim 39, and further configured to vary the humidity level of the gas flow upstream of the nebulizer based at least in part on three or more of the temperature of the gas flow downstream of the nebulizer, the humidity level of the gas flow downstream of the nebulizer, the gas flow rate of the gas flow downstream of the nebulizer, the output rate of the nebulizer, and the nebulization rate of the nebulizer (par. 96 – “temperature, flow rate, and vapor content”).
Regarding claim 41, Weinstein in view of Minocchieri and Hunsicker discloses the controller described regarding claim 39, and further configured to vary the humidity level of the gas flow upstream of the nebulizer to maintain a target humidity level of the gas flow downstream of the nebulizer (par. 96 – “controller determines whether adjustment to the flow rate of the fluid or the rate of vaporization at the vaporizer is required”).
Regarding claim 44, Weinstein discloses a method for controlling an aerosol delivery system (fig. 4), the method comprising,
receiving, from a plurality of sensors (450), operational data (par. 52 – “individual sensors at one or more locations that detect temperature, flow rate, and/or vapor content data”) of a gas flow circuit (fig. 4) including a nebulizer (par. 61 –the separate nebulizer for the drug), a humidifier (420), and a tube connecting the nebulizer and the humidifier (par. 61 – “feed line”);
determining, using the operational data of the gas flow circuit generated by the plurality of sensors, a temperature of a gas flow downstream of the nebulizer (par. 52 – “temperature”; par. 90), a humidity level of the gas flow downstream of the nebulizer (par. 52 – “vapor content”; par. 90), a gas flow rate of the gas flow downstream of the nebulizer (par. 52 – “flow rate”; par. 90); and
varying a humidity level of a gas flow based at least in part on two or more of the temperature of the gas flow downstream of the nebulizer, the humidity level of the gas flow downstream of the nebulizer, or the gas flow rate of the gas flow downstream of the nebulizer (par. 96).
Weinstein does not disclose the step of determining an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors; or varying the humidity level of gas flow upstream of the nebulizer. Weinstein does not explicitly disclose if the “separate nebulizer” in the “feed line” is upstream or downstream of the humidifier in the gas circuit.
Minocchieri teaches an aerosol delivery system (fig. 5), comprising: a gas flow circuit including a nebulizer (1), a humidifier (36), and a tube connecting the nebulizer and the humidifier (fig. 4); a plurality of sensors (35/37) configured to generate operational data of the gas flow circuit (par. 41, 51); and a controller (34) configured to: receive the operational data of the gas flow circuit from the plurality of sensors (fig. 5; par. 41, 46); and vary a humidity level of a gas flow upstream of the nebulizer based at least in part on the temperature of the gas flow downstream of the nebulizer and the humidity level of the gas flow downstream of the nebulizer (par. 51).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol delivery system of Weinstein to arrange the nebulizer downstream of the humidifier and, consequently, to vary the humidity level of gas flow upstream of the nebulizer, as taught by Minocchieri, since this was a known arrangement for providing a separate nebulizer and humidifier in the feed line of such a system.
Hunsicker teaches an aerosol delivery system (fig. 1) comprising a gas flow circuit (fig. 1) including a nebulizer (24), a plurality of sensors (32/36/44/46) configured to generate operational data of the gas flow circuit (par. 17-19), and a controller (40) configured to determine an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors (par. 28).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Weinstein to determine an output rate of the nebulizer and a nebulization rate of the nebulizer using the operational data of the gas flow circuit generated by the plurality of sensors, as taught by Hunsicker, since this was known to account for the effect of the nebulizer flow on the total gas flow of the circuit (Hunsicker, par. 26).
Regarding claim 45, Weinstein in view of Minocchieri and Hunsicker discloses the method described regarding claim 44, and further comprising varying the humidity level of the gas flow upstream of the nebulizer to maintain a target humidity level of the gas flow downstream of the nebulizer (par. 96 – “controller determines whether adjustment to the flow rate of the fluid or the rate of vaporization at the vaporizer is required”).
Claims 34-38, 42-43, and 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Weinstein in view of Minocchieri and Hunsicker, and further in view of Seakins et al. (US 7,146,979).
Regarding claim 34, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 29, but not further comprising an electronically-operated flow restrictor and wherein the controller is configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by dynamically controlling the electronically-operated flow restrictor.
Seakins teaches an aerosol delivery system (fig. 1) comprising a humidifier (fig. 5) with an electronically-operated flow restrictor (26, see col. 7, ln. 61-64) and wherein a controller (1400) is configured to vary the humidity level of the gas flow from the humidifier at least in part by dynamically controlling the electronically-operated flow restrictor (col. 7, ln. 64-67).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol delivery system of Weinstein in view of Minocchieri and Hunsicker to further comprise an electronically-operated flow restrictor and wherein the controller is configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by dynamically controlling the electronically-operated flow restrictor, as taught by Seakins, since this was known to supply the gas at a constant level of humidity when used with intermittent flow rates when used with a ventilator (Seakins - col. 7, ln. 64-67). Further, since the humidifier of Weinstein in view of Minocchieri and Hunsicker is upstream of the nebulizer such a modification would vary the humidity level of the gas flow upstream of the nebulizer.
Regarding claim 35, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 29, but not further wherein the gas flow circuit further includes a heater and a two-branch inlet and wherein the two-branch inlet includes a first branch including the heater and a second branch including the humidifier.
Seakins teaches the aerosol delivery system described regarding claim 34, and further comprising a gas circuit including a heater and a two-branch inlet (fig. 5) and wherein the two-branch inlet includes a first branch including the heater (col. 7, ln. 51-52) and a second branch including the humidifier (col. 7, ln. 48-55).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol delivery system of Weinstein in view of Minocchieri and Hunsicker to further include a heater and a two-branch inlet and wherein the two-branch inlet includes a first branch including the heater and a second branch including the humidifier, as taught by Seakins, since this was known to supply the gas at a constant level of humidity when used with intermittent flow rates when used with a ventilator (Seakins - col. 7, ln. 64-67).
Regarding claim 36, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 35, and Weinstein further discloses wherein the controller is configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by adjusting a temperature of the heater (par. 53).
Regarding claim 37, Weinstein in view of Minocchieri, Hunsicker, and Seakins discloses the aerosol delivery system described regarding claim 35, and Seakins further teaches wherein the controller is configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by controlling a percentage of flow through each branch of the two-branch inlet (col. 7, ln. 48--55).
Regarding claim 38, Weinstein in view of Minocchieri, Hunsicker, and Seakins discloses the aerosol delivery system described regarding claim 37, and Seakins further teaches comprising at least one electronically-operated flow restrictor (26) and wherein the controller (1400) is configured to control the percentage of flow through each branch of the two-inlet branch by dynamically controlling the electronically-operated flow restrictor (col. 7, ln. 63; fig. 5).
Regarding claim 42, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 39, but not further wherein the gas flow circuit further includes an electronically-operated flow restrictor and wherein the controller is further configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by dynamically controlling the electronically-operated flow restrictor.
Seakins teaches an aerosol delivery system (fig. 1) comprising a humidifier (fig. 5) with an electronically-operated flow restrictor (26, see col. 7, ln. 61-64) and wherein a controller (1400) is configured to vary the humidity level of the gas flow from the humidifier at least in part by dynamically controlling the electronically-operated flow restrictor (col. 7, ln. 64-67).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol delivery system of Weinstein in view of Minocchieri and Hunsicker to further comprise an electronically-operated flow restrictor and wherein the controller is configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by dynamically controlling the electronically-operated flow restrictor, as taught by Seakins, since this was known to supply the gas at a constant level of humidity when used with intermittent flow rates when used with a ventilator (Seakins - col. 7, ln. 64-67). Further, since the humidifier of Weinstein in view of Minocchieri and Hunsicker is upstream of the nebulizer such a modification would vary the humidity level of the gas flow upstream of the nebulizer.
Regarding claim 43, Weinstein in view of Minocchieri and Hunsicker discloses the aerosol delivery system described regarding claim 39, but not further wherein the gas flow circuit further includes a two-branch inlet and wherein the controller is further configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by controlling a percentage of flow through each branch of the two-branch inlet.
Seakins teaches the aerosol delivery system described regarding claim 42, and further comprising a gas circuit a two-branch inlet (fig. 5) and wherein the controller is configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by controlling a percentage of flow through each branch of the two-branch inlet (col. 7, ln. 48--55).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aerosol delivery system of Weinstein in view of Minocchieri and Hunsicker to further include a two-branch inlet and wherein the controller is further configured to vary the humidity level of the gas flow upstream of the nebulizer at least in part by controlling a percentage of flow through each branch of the two-branch inlet, as taught by Seakins, since this was known to supply the gas at a constant level of humidity when used with intermittent flow rates when used with a ventilator (Seakins - col. 7, ln. 64-67).
Regarding claim 46, Weinstein in view of Minocchieri and Hunsicker discloses the method described regarding claim 44, but not further wherein the gas flow circuit further includes a heater and a two-branch inlet, wherein the two-branch inlet includes a first branch including the heater and a second branch including the humidifier, and further comprising varying the humidity level of the gas flow upstream of the nebulizer at least in part by controlling a percentage of flow through each branch of the two-branch inlet.
Seakins teaches the aerosol delivery system described regarding claim 34, and further comprising a gas circuit including a heater and a two-branch inlet (fig. 5), wherein the two-branch inlet includes a first branch including the heater (col. 7, ln. 51-52) and a second branch including the humidifier (col. 7, ln. 48-55), and further comprising varying the humidity level of the gas flow upstream of the nebulizer at least in part by controlling a percentage of flow through each branch of the two-branch inlet (col. 7, ln. 48--55).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Weinstein in view of Minocchieri and Hunsicker such that the gas flow circuit further includes a heater and a two-branch inlet, wherein the two-branch inlet includes a first branch including the heater and a second branch including the humidifier, and further comprising varying the humidity level of the gas flow upstream of the nebulizer at least in part by controlling a percentage of flow through each branch of the two-branch inlet, as taught by Seakins, since this was known to supply the gas at a constant level of humidity when used with intermittent flow rates when used with a ventilator (Seakins - col. 7, ln. 64-67).
Regarding claim 47, Weinstein in view of Minocchieri and Hunsicker discloses the method described regarding claim 46, and Weinstein further discloses varying the humidity level of the gas flow upstream of the nebulizer at least in part by adjusting a temperature of the heater (par. 53).
Regarding claim 48, Weinstein in view of Minocchieri, Hunsicker, and Seakins discloses the method described regarding claim 46, and Seakins further teaches wherein the gas flow circuit further includes an electronically-operated flow restrictor (26) and further comprising varying the humidity level of gas flow upstream of the nebulizer at least in part by dynamically controlling the electronically-operated flow restrictor (col. 7, ln. 63; fig. 5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Korneff et al. (US 2012/0125334) and Roberts et al. (US 4,805,609) both disclose aerosol delivery systems having elements of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CODY J LIEUWEN whose telephone number is (571)272-4477. The examiner can normally be reached Monday - Thursday 8-5, Friday varies.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arthur Hall can be reached at (571) 270-1814. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CODY J LIEUWEN/Primary Examiner, Art Unit 3752
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