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 Objections
Claim 13 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-5 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 3,301,255) in view of Adahan (US 2010/0139660 A1) in further view of Mullinger et al. (US 2009/0178672 A1).
Regarding claim 1, Thompson discloses:
A device for providing a flow of aerosol and/or air (figure 1), comprising
a base unit (portable case of 20 with boxlike body 21 and lid 22 and handle 23; col. 3, lines 31-33) containing
a first pump (32) for providing a nebulizer air flow,
a first channel (47) that connects the first pump to a first air outlet (48) (see figure 4),
a second air source (31) for providing a support air flow,
a second channel (38) that connects the second pump to a second air outlet (40),
a pressure sensor (43) connected to the second channel (via 42 as shown in figures 2, 3), and
a controller (34) for controlling the second pump;
a handset (26) containing
a reservoir (where 53 is stored in figure 5) for liquid (53) to be nebulized,
a mouthpiece (29), and
a mixing chamber (27) having a first air inlet (where 52 connects to 27) connected to a nebulizing nozzle for generating an aerosol flow from the nebulizer air flow and the liquid (fluidically connected as shown in figure 5), and a second air inlet (where 24 connects to 27);
a first tube (25) connecting the first air outlet to the first air inlet (see figure 1); and
a second tube (24) connecting the second air outlet to the second air inlet (see figure 1).
Thompson does not explicitly disclose the second air source is a second pump which is a multiple head diaphragm pump, such as a rolling diaphragm pump; or a rotary vane pump; or a scroll pump nor that the controller (34) controls the first pump.
However, Adahan teaches it is known to use a rolling diaphragm pump (100) as a means to provide respiration air [0025]-[0026].
Therefore it would have been obvious to one having ordinary skill in the art to have modified Thompson by substituting one known device for creating an airflow (31 of Thompson) for a rolling diaphragm pump (Adahan’s 100) since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)
Further, Mullinger teaches it is known for a controller (260) to control flow into a nebulizer [0048].
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson such that a controller controls the first pump for the benefit of allowing the delivery of medicament can be altered as needed [0048].
As modified Thompson does not explicitly disclose wherein the pressure sensor is configured to measure a drop in pressure at the mouthpiece, when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure.
However, Mullinger further teaches it is known to provide a pressure sensor (150, 230), wherein the pressure sensor is configured to measure a drop in pressure at the mouthpiece [0038] [0048], when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure (triggers vaporizing operation [0038]; [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson such that there is a pressure sensor configured to measure a drop in pressure at the mouthpiece, when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure for the benefit of only nebulizing during inhalation in order to limit waste of medicament/compressed air [0048].
Regarding claims 3 and 13, Thompson as modified further discloses wherein the second pump is a rolling diaphragm pump (Adahan’s 100).
Regarding claim 4, Thompson as modified discloses the claimed invention substantially as claimed as set forth above. The currently modified Thompson does not explicitly disclose a display screen for providing instructions and / or feedback.
However, Adahan further discloses it is known to provide a display screen (270) for providing instructions and / or feedback [0047].
Therefore it would have been obvious to one having ordinary skill in the art to include a display screen for providing instructions and / or feedback as taught by Adahan for providing important information to the user.
Regarding claim 5, Thompson as modified discloses the invention essentially as claimed as discussed above.
However, Thompson does not expressly disclose wherein the first and / or second tubes are from 1000 mm to 1300 mm in length and have an inner diameter of from 3 to 5 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Thompson to have wherein the first and / or second tubes are from 1000 mm to 1300 mm in length and have an inner diameter of from 3 to 5 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Thompson would not operate differently with the claimed dimensions and since Thompson already has tubing the device would function appropriately having the claimed dimensions Further, applicant places no criticality on the range claimed.
Claim(s) 6-12 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 3,301,255) in view of Adahan (US 2010/0139660 A1) in further view of Mullinger et al. (US 2009/0178672 A1) in further view of Luber et al. (WO 2010/097119)
Regarding claim 6, Thompson as modified discloses the invention essentially as claimed as discussed above.
Thompson does not expressly disclose wherein the device is configured to provide, during an inhalation by the patient, an aerosol period in which there is both support flow and aerosol flow so that aerosol is delivered to the patient, and one or more aerosol- free periods when there is support flow but no aerosol flow, so that only air is delivered to the patient.
However, Luber discloses a device utilizing a jet nebulizer (similar to Thompson; see page 7, lines 3-5 of Luber) comprising a support flow (flow 2 of figure 6) and an aerosol flow (flow 1 of figure 6), wherein the device is configured to provide, during an inhalation by the patient, an aerosol period in which there is both support flow and aerosol flow so that aerosol is delivered to the patient (see figure 6 where flow 1 and 2 overlap; page 31, paragraph 3), and one or more aerosol- free periods when there is support flow but no aerosol flow, so that only air is delivered to the patient (see figure 6, after aerosol flow finishes only air is delivered via flow 2; page 31, paragraph 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson such that the device is configured to provide, during an inhalation by the patient, an aerosol period in which there is both support flow and aerosol flow so that aerosol is delivered to the patient, and one or more aerosol- free periods when there is support flow but no aerosol flow, so that only air is delivered to the patient to minimize waste and also ensure the medicament is delivered to the desired location (page 33, paragraph 1).
Regarding claims 7 and 16, Thompson as modified discloses the invention essentially as claimed as discussed above. Thompson does not explicitly disclose wherein the device is configured to provide, in each inhalation: an aerosol-free period or an aerosol-free period followed by an aerosol period or a first aerosol-free period, followed by an aerosol period, followed by a second aerosol-free period.
Luber discloses wherein in each inhalation an aerosol period followed by an aerosol-free period is provided (figure 6 of Luber).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson such that wherein in each inhalation an aerosol period followed by an aerosol-free period is provided to minimize waste and also ensure the medicament is delivered to the desired location (page 33, paragraph 1).
Regarding claim 8, Thompson as modified discloses the invention essentially as claimed as discussed above. Thompson as modified is not explicit in that the device is configured to increase the support flow rate during the aerosol-free period(s) so that the total flow rate is approximately constant throughout the inhalation.
However, Luber discloses the support flow rate (second flow rate) as well as the aerosol flow rate (first flow rate) as results effective in that they can be optimized in order to achieve optimal aerosol generation and transport (page 6, paragraph 3). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Thompson so that the device is configured to increase the support flow rate during the aerosol-free period(s) so that the total flow rate is approximately constant throughout the inhalation as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 9, Thompson as modified discloses the invention essentially as claimed as discussed above. Thompson as modified does not explicitly disclose the device is configured to vary the support flow rate so that the total flow rate mimics the patient’s natural breathing pattern.
Luber discloses the device which is configured to vary the support flow rate so that the total flow rate mimics the patient's natural breathing pattern (Luber: see figure 6 shows that support flow 2 is turned on and off; claim 33 indicates vibration only occurs during exhalation).
It would have been obvious to one having ordinary skill in the art to have modified Thompson such that the device is configured to vary the support flow rate so that the total flow rate mimics the patient’s natural breathing pattern to minimize waste and also ensure the medicament is delivered to the desired location (page 33, paragraph 1).
Regarding claim 10, Thompson as modified discloses the invention essentially as claimed as discussed above. Thompson as modified does not explicitly disclose the device is configured to vary the support flow rate in response to the patient’s inhalation rate.
Luber discloses that the initiation of support flow (flow 2) is dependent on aerosol generation flow (see figure 6), but does not explicitly describe that aerosol generation flow is dependent on a breathing pattern of the patient.
It would have been obvious to vary the support flow based on aerosol generation flow to minimize waste and also ensure the medicament is delivered to the desired location (page 33, paragraph 1).
Therefore, currently Thompson as modified does not explicitly disclose that the device is does not explicitly describe the device is configured to vary the support flow rate in response to the patient's inhalation rate.
However, Mullinger further teaches that it is known to time aerosol administration with the patient’s inhalation/exhalation [0005] [0010] [0038].
Therefore, it would have been obvious to have modified Thompson such that aerosol administration is initiated upon inspiration so that aerosol is not wasted. With this modification, the support flow would also be varied in response to the patient’s inhalation rate.
Regarding claim 11, Thompson as modified discloses the invention essentially as claimed as discussed above. Thompson does not explicitly disclose the device is configured to pulse the support flow.
Luber further discloses the device which is configured to pulse the support flow (Luber: figure 6).
Therefore, it would have been obvious to have modified Thompson such that the device is configured to pulse the support flow to minimize waste and also ensure the medicament is delivered to the desired location (page 33, paragraph 1).
Regarding claim 12, Thompson as modified discloses the invention essentially as claimed as discussed above. Thompson as modified does not explicitly disclose the device configured to provide feedback to the patient through the support flow.
However, Luber discloses the support flow rate (second flow rate) can be higher than the first flow rate (page 6, paragraph 3).
It would have been obvious one having ordinary skill in the art to have modified Thompson such that the second flow rate is higher than the first flow rate in order to optimize transportation (page 6, paragraph 3). This increased flow is configured to provide feedback to the patient through the support flow. For example, this increased flow would indicate to the user that aerosol transportation is occurring.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 3,301,255) in view of Adahan (US 2010/0139660 A1) in further view of Mullinger et al. (US 2009/0178672 A1) in further view Zambon et al. (US 2008/0078381 A1).
Regarding claim 2, Thompson as modified discloses the claimed invention as claimed as set forth for claim 1 above. Thompson does not explicitly disclose wherein the first pump (32) is a piston-type compressor.
However, Zambon teaches it is known for nebulizers of a pneumatic type to be run by piston compressors [0005].
Therefore it would have been obvious to one having ordinary skill in the art to have modified Thompson by substituting one known device for creating an airflow (32 of Thompson) for a piston type compressor (as taught by Zambon [0005]) since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim(s) 1 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 3,301,255) in view of Schneider et al. (US 2011/0247622 A1) in further view of Mullinger et al. (US 2009/0178672 A1).
Regarding claims 1 and 14, Thompson discloses:
A device for providing a flow of aerosol and/or air (figure 1), comprising
a base unit (portable case of 20 with boxlike body 21 and lid 22 and handle 23; col. 3, lines 31-33) containing
a first pump (32) for providing a nebulizer air flow,
a first channel (47) that connects the first pump to a first air outlet (48) (see figure 4),
a second air source (31) for providing a support air flow,
a second channel (38) that connects the second pump to a second air outlet (40),
a pressure sensor (43) connected to the second channel (via 42 as shown in figures 2, 3), and
a controller (34) for controlling the second pump;
a handset (26) containing
a reservoir (where 53 is stored in figure 5) for liquid (53) to be nebulized,
a mouthpiece (29), and
a mixing chamber (27) having a first air inlet (where 52 connects to 27) connected to a nebulizing nozzle for generating an aerosol flow from the nebulizer air flow and the liquid (fluidically connected as shown in figure 5), and a second air inlet (where 24 connects to 27);
a first tube (25) connecting the first air outlet to the first air inlet (see figure 1); and
a second tube (24) connecting the second air outlet to the second air inlet (see figure 1).
Thompson does not explicitly disclose the second air source is a second pump which is a multiple head diaphragm pump, such as a rolling diaphragm pump; or a rotary vane pump; or a scroll pump nor that the controller (34) controls the first pump.
However, Schneider teaches it is known to use a rotary vane pump as a means to provide respiration air [0277].
Therefore it would have been obvious to one having ordinary skill in the art to have modified Thompson by substituting one known device for creating an airflow (31 of Thompson) for a rotary vane pump (Schneider) since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)
Further, Mullinger teaches it is known for a controller (260) to control flow into a nebulizer [0048].
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson such that a controller controls the first pump for the benefit of allowing the delivery of medicament can be altered as needed [0048].
As modified Thompson does not explicitly disclose wherein the pressure sensor is configured to measure a drop in pressure at the mouthpiece, when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure.
However, Mullinger further teaches it is known to provide a pressure sensor (150, 230), wherein the pressure sensor is configured to measure a drop in pressure at the mouthpiece [0038] [0048], when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure (triggers vaporizing operation [0038]; [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson such that there is a pressure sensor configured to measure a drop in pressure at the mouthpiece, when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure for the benefit of only nebulizing during inhalation in order to limit waste of medicament/compressed air [0048].
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 3,301,255) in view of Friberg et al. (US 2005/0000519 A1) in further view of Mullinger et al. (US 2009/0178672 A1).
Regarding claims 1 and 15, Thompson discloses:
A device for providing a flow of aerosol and/or air (figure 1), comprising
a base unit (portable case of 20 with boxlike body 21 and lid 22 and handle 23; col. 3, lines 31-33) containing
a first pump (32) for providing a nebulizer air flow,
a first channel (47) that connects the first pump to a first air outlet (48) (see figure 4),
a second air source (31) for providing a support air flow,
a second channel (38) that connects the second pump to a second air outlet (40),
a pressure sensor (43) connected to the second channel (via 42 as shown in figures 2, 3), and
a controller (34) for controlling the second pump;
a handset (26) containing
a reservoir (where 53 is stored in figure 5) for liquid (53) to be nebulized,
a mouthpiece (29), and
a mixing chamber (27) having a first air inlet (where 52 connects to 27) connected to a nebulizing nozzle for generating an aerosol flow from the nebulizer air flow and the liquid (fluidically connected as shown in figure 5), and a second air inlet (where 24 connects to 27);
a first tube (25) connecting the first air outlet to the first air inlet (see figure 1); and
a second tube (24) connecting the second air outlet to the second air inlet (see figure 1).
Thompson does not explicitly disclose the second air source is a second pump which is a multiple head diaphragm pump, such as a rolling diaphragm pump; or a rotary vane pump; or a scroll pump nor that the controller (34) controls the first pump.
However, Friberg teaches it is known to use a scroll pump as a means to provide respiration air (claim 15).
Therefore it would have been obvious to one having ordinary skill in the art to have modified Thompson by substituting one known device for creating an airflow (31 of Thompson) for a scroll pump (Friberg) since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)
Further, Mullinger teaches it is known for a controller (260) to control flow into a nebulizer [0048].
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson such that a controller controls the first pump for the benefit of allowing the delivery of medicament can be altered as needed [0048].
As modified Thompson does not explicitly disclose wherein the pressure sensor is configured to measure a drop in pressure at the mouthpiece, when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure.
However, Mullinger further teaches it is known to provide a pressure sensor (150, 230), wherein the pressure sensor is configured to measure a drop in pressure at the mouthpiece [0038] [0048], when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure (triggers vaporizing operation [0038]; [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson such that there is a pressure sensor configured to measure a drop in pressure at the mouthpiece, when the patient begins to inhale, and wherein the controller is configured to switch on the first pump and/or the second pump in response to the drop in pressure for the benefit of only nebulizing during inhalation in order to limit waste of medicament/compressed air [0048].
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 3,301,255) in view of Adahan (US 2010/0139660 A1) in further view of Mullinger et al. (US 2009/0178672 A1) in further view of Tatarek (US 2010/0043790 A1).
Regarding claim 16, Thompson as modified does not explicitly disclose, the device which is configured to provide, in each inhalation: an aerosol period followed by an aerosol-free period.
However, Tatarek discloses a nebulizer (abstract) wherein during in each inhalation: an aerosol period followed by an aerosol-free period [0094] (pulses) [0097].
It would have been obvious to have modified Thompson such that the device is configured to provide, in each inhalation: an aerosol period followed by an aerosol-free period as taught by Tatarek for the benefit of preventing waste and preventing a potential health hazard [0004] [0006] [0010] [0103].
Regarding claim 17, Thompson as modified does not explicitly disclose, the device which is configured to provide, in each inhalation: an aerosol-free period followed by an aerosol period.
However, Tatarek discloses a nebulizer (abstract) wherein in each inhalation there is an aerosol-free period followed by an aerosol period [0094] (pulses) [0097].
It would have been obvious to have modified Thompson such that the device is configured to provide, in each inhalation: an aerosol-free period followed by an aerosol period as taught by Tatarek for the benefit of preventing waste and preventing a potential health hazard [0004] [0006] [0010] [0103].
Regarding claim 18, Thompson as modified does not explicitly disclose, the device which is configured to provide, in each inhalation: a first aerosol-free period, followed by an aerosol period, followed by a second aerosol-free period.
However, Tatarek discloses a nebulizer (abstract) wherein in each inhalation there is a first aerosol-free period, followed by an aerosol period, followed by a second aerosol-free period [0094] (pulses) [0097].
It would have been obvious to have modified Thompson such that the device is configured to provide, in each inhalation: a first aerosol-free period, followed by an aerosol period, followed by a second aerosol-free period as taught by Tatarek for the benefit of preventing waste and preventing a potential health hazard [0004] [0006] [0010] [0103].
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 3,301,255) in view of Adahan (US 2010/0139660 A1) in further view of Mullinger et al. (US 2009/0178672 A1) in further view of Kruner et al. (US 2013/0112197 A1).
Regarding claims 19-20, Thompson as modified does not explicitly disclose, the device wherein the controller switches off the nebulizer pump and / or the support flow pump after a pre-set period of time, wherein the pre-set period of time is adjustable by the patient.
However, Kruner discloses an aerosol delivery device (abstract) with a controller which switches off the nebulizer pump and / or the support flow pump after a pre-set period of time, [0031] wherein the pre-set period of time is adjustable by the patient [0114] [0118]-[0119]. As described in [0118]-[0119] the device operates in different modes with different pre-set periods of time and thus is adjustable as claimed.
It would be obvious to one of ordinary skill in the art to have modified Thompson such that the controller switches off the nebulizer pump and / or the support flow pump after a pre-set period of time, wherein the pre-set period of time is adjustable by the patient in order to reach a specific target area [0007]-[0008].
Response to Arguments
Applicant’s arguments filed 4/15/2026 with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The prior art of Mullinger is now relied upon to disclose a drop in pressure when the patient begins to inhale.
The examiner notes that WO 2010/097119 A1 was listed on the Notice of References Cited. The * was not included in the column next to the reference as a copy of the prior art document was provided along with the office action. See MPEP 707.05(a).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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