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 § 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.
Claims 7, 9-11, 33-36, 38, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (US 2013/0014759) in view of Stoks et al (WO 2012/164407), hereinafter Stoks, and further in view of Feldhahn et al (US 2008/0078386), hereinafter Feldhahn, and further in view of Denyer et al (US 2008/0257337), hereinafter Denyer.
Regarding claim 7, Montgomery teaches a respiratory therapy system (Fig. 1) comprising:
a flow generator adapted to deliver gases to a patient (Fig. 1: 1, ventilator , paragraph 25);
a patient interface (paragraph 52, a mask);
a gas passageway extending between the flow generator and the patient interface (Fig. 1: tube leading from ventilator 1 to humidifier 4 and to nebulizer 5 and then to the patient);
and a nebulizer adapted to deliver a substance to at least a first portion of the gas passageway (Fig. 1: nebulizer 5)
Montgomery does not teach at least a section of the gas passageway at and/or downstream of the first portion comprising a smooth bore conduit.
However, Stoks teaches a conduit for a medical component (abstract, paragraph 12) which comprises a smooth bore conduit. (Paragraph 62, smooth lumen 207)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to substitute the tube of Montgomery with the tube of Stoks since the tube of Stoks provides a smooth lumen surface which helps keep the tube free from deposits and improves bas flow.
Montgomery in view of Stocks does not teach a housing comprising a gas humidifier and the flow generator.
However, Feldhahn teaches a respiratory device (fig. 17) with a housing (Fig. 17: see exterior housing) which comprises a gas humidifier (paragraph 207, a gas humidifier can be installed inside a ventilator) internal to the ventilator.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Montgomery so that the humidifier was inside the housing as taught by Feldhahn in order to make a single piece unit.
Montgomery does not teach wherein the flow generator is controlled based on operation of the nebulizer such that a flow rate from the flow generator is reduced prior to release of a nebulized substance from the nebulizer into the gas passageway for a predetermined period of time sufficient to account for the time expected for the nebulized substance to reach the patient.
However, Denyer teaches a ventilator with aerosol delivery (Fig. 1, Abstract) which teaches wherein the flow generator (Fig. 1: 2) is controlled based on operation of the nebulizer such that a flow rate from the flow generator is reduced prior to release of a nebulized substance from the nebulizer into the gas passageway for a predetermined period of time sufficient to account for the time expected for the nebulized substance to reach the patient. (Fig. 8, Paragraph 60, the normal flow rate of gas is decreased for a first predetermined period and the nebulizer is activated for a second predetermined period which has a duration less than the duration of the first predetermined period. See Fig. 8, the nebulizer pulse ends prior to the end of exhalation and is followed by “clean air”, paragraph 37)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Montgomery to include the flow generator is controlled based on the operation of the nebulizer as taught by Denyer to optimize delivery of the aerosolized medicament to the patient. (paragraph 14)
Regarding claim 9, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 7, and Montgomery in view of Stoks and Feldhahn further teaches wherein the first portion is downstream of the gas humidifier. (fig. 2: section 170 of the tube is downstream of the gas humidifier since the combined Montgomery and Feldhahn have the humidifier inside the ventilator housing)
Regarding claim 10, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 7, and Stoks further teaches wherein the smooth bore conduit comprises a conduit heater. (Paragraph 61, paragraph 66, Fig. 2B, heating filaments are encapsulated by member 205)
Regarding claim 11, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 10, and Stoks further teaches wherein the conduit heater is located substantially outside of a flow path of gases passing through the smooth bore conduit. (Paragraph 66, the filaments 215 may be spaced away from lumen 207 so that the filaments are not exposed to the lumen 207)
Regarding claim 33, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 11, and Stoks wherein the smooth bore conduit comprises a bead (fig. 2B: 205) and a bubble (Fig. 2B: 203, paragraph 65) to define a smooth bore with minimal surface deviations. (Paragraph 62, this configuration provides a smooth tube bore)
Regarding claim 34, Montgomery in view of Stoks. Feldhahn and Denyer the respiratory therapy system of claim 33, Stoks further teaches wherein the bead comprises at least one resistive wire. (Paragraph 66, heating filaments 215 comprised of conductive material)
Regarding claim 35, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 33, and Stoks teaches wherein the smooth bore of the smooth bore conduit has an internal diameter of 13-14mm. (See table 1A of Stoks, the adult tube diameter is 18mm with a range of +/- 5mm so 13 to 14mm would be within the range)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of Montgomery in view of Stoks from 18 +/- 5mm to 13 to 14mm as applicant appears to have placed no criticality on the claimed range (see paragraph 91, in one configuration the internal bore diameter is 13-14mm) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 36, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 33, but does not teach wherein the smooth bore of the smooth bore conduit has a surface roughness of 0.15 -0.25 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 smooth bore conduit of Montgomery in view of Stoks to have a surface roughness of 0.15 – 0.25 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 Montgomery in view of Stoks would not operate differently with the claimed surface roughness since the internal diameter is intended to be smooth (paragraph 62 of Stoks) and the conduit would function appropriately having the claimed surface roughness. Further, applicant places no criticality on the range claimed, indicating simply that the surface roughness “in general” be within the claimed ranges (paragraph 91 of the instant specification).
Regarding claim 38, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 7, and Montgomery further teaches wherein the patient interface comprises a mask but is silent as to the type of mask.
However, Stoks teaches that any suitable patient interface may be incorporate such as a mask, nasal mask, cannulas, tracheal mask. (paragraph 53)
It would have been obvious to a person of ordinary skill in the art to have substituted the mask of Montgomery with a nasal cannula as taught by Stoks as it would provide the predictable result of delivery air to the user.
Regarding claim 43, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 7, and Montgomery further teaches comprising a mount that connects the nebulizer and a portion of the gas passageway. (fig. 1: T- piece section that the nebulizer is mounted on, paragraph 25, in-line nebulizer 5 and fixture 6 for connecting the system to a patient. )
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Stoks, further in view of Feldhahn, further in view of Denyer and further in view of Smith et al (US 2001/0054422), hereinafter Smith.
Regarding claim 37, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 7, but does not teach wherein at least a portion of the gas passageway downstream of the first portion of the gas passageway comprises a breathable wall to transmit vapor through the breathable wall.
However, Smith teaches a breathing circuit component (abstract) wherein at least a portion of the gas passageway downstream of the first portion of the gas passageway comprises a breathable wall to transmit vapor through the breathable wall. (Abstract, expiratory tube made of breathable material, paragraph 7, catheter mounts paragraph 91, 92, the examiner notes that since the breathable wall of Smith is in the expiratory portion of the breathing circuit it would be down stream of the first portion of the gas passageway of Montgomery in view of Stoks)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Montgomery in view of Stoks with the breathable wall as taught by Smith in order to allow expired water vapor to be released from the expired gases to reduce the relative saturation of the expiratory flow and therefore reduce rainout. (Paragraph 92)
Claims 41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Stoks, further in view of Feldhahn, further in view of Denyer and further in view of Tuck (US 2003/0000531), hereinafter Tuck.
Regarding claim 41, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 7, and Stoks teaches further comprising at least one sensor (paragraph 61) but does not teach wherein the sensor detects at least one characteristic of gases delivered to the patient and/or at least one health characteristic of the patient.
However, Tuck teaches a respiratory system (Fig. 1) with sensors (Flow and temperature sensors 11 and 12, Fig. 1, paragraph 47) that detect at least one characteristic of gases delivered to the patient. (paragraph 47, temperature and flow of the gas)
It would have been obvious to one of ordinary skill in the art prior to the filing date of the invention to have provided Montgomery in view of Stoks and Feldhahn with the sensors as taught by Tuck in order to control the temperature and humidity of gases provided to the patient. (paragraph 47)
Regarding claim 42, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 41, and Tuck further teaches wherein the at least one sensor is downstream of the gas humidifier. (Fig. 1: sensors 11, 12 are downstream of humidifier 1)
Claims 44-47 rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Stoks, Feldhahn, further in view of Denyer and further in view of Fink et al (US 2005/0217666), hereinafter Fink.
Regarding claim 44, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 43, and but does not teach wherein the mount comprises a first duct with at least one portion extending vertically and at least on portion extending horizontally.
However, Fink teaches methods and systems for operating an aerosol generator (Abstract) with a similar nebulizer and mount (fig. 1A) wherein the mount (Fig. 1A: 106) comprises a first duct (Fig. 3: portion extending towards y connector) with at least one portion extending vertically (portion extending upwardly to connect to nebulizer) and at least on portion extending horizontally. (portion connecting to the y connector)
It would have been obvious to a person of ordinary skill to include a mount with a portion extending vertically and a portion extending horizontally as claimed to allow proper mounting to the ventilator circuit and to the nebulizer.
Regarding claim 45, Montgomery in view of Stoks. Feldhahn and Denyer and Fink teaches the respiratory therapy system of claim 44, Fink teaches an inlet port configured to receive the nebulizer. (fig. 1A: connects to 102)
Regarding claim 46, Montgomery in view of Stoks. Feldhahn and Denyer and Fink teaches the respiratory therapy system of claim 45, wherein the mount connects to the gas humidifier. (Fig 1, the mount connects to the humidifier via gas passageway)
Regarding claim 47, Montgomery in view of Stoks, Feldhahn, Denyer and Fink teaches the respiratory therapy system of claim 44, and further teaches wherein the mount comprises a second duct (Fig. 1A, second vertical duct) and, at a first portion, the first duct and the second duct are separated by a first distance (See fig. 1A, the first portion is taken to be the distance from the end of the horizontal section to the beginning of the vertical section) and, at a second portion, the first duct and the second duct are separated by a second distance. (the second distance is the distance from the connection of the vertical section to the horizontal section to the end of the vertical section)
Claims 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Stoks. Feldhahn and Denyer, and further in view of Weinstein et al (US 2007/0137646), hereinafter Weinstein.
Regarding claim 48, Montgomery in view of Stoks. Feldhahn and Denyer teaches the respiratory therapy system of claim 10, but does not teach wherein a temperature or duty cycle of the conduit heater is reduced before delivery of the substance of the nebulizer.
However, Weinstein teaches an inline vaporizer (Abstract, Figs. 2-3) wherein a temperature or duty cycle of a heater is reduced before delivery of the substance of the nebulizer. (Paragraph 93, when the gas is too warm, the temperature of the heater may be reduced to lower the temperature of the gas, paragraph 94, the vapor is released into the carrier gas line after the heat is reduced.)
It would have been obvious to a person or ordinary skill in the art prior to the filing date of the invention to have modified Montgomery to include a temperature or duty cycle of the conduit heater is reduced before delivery of the substance of the inhaler to ensure that the temperature is the desired temperature.
Regarding claim 49, Montgomery in view of Stoks. Feldhahn and Denyer the respiratory therapy system of claim 7, but does not teach wherein a temperature or duty cycle of a heater of the gas humidifier is reduced before delivery of the substance of the nebulizer.
However, Weinstein teaches an inline vaporizer (Abstract, Figs. 2-3) wherein a temperature or duty cycle of a heater is reduced before delivery of the substance of the nebulizer. (Paragraph 93, when the gas is too warm, the temperature of the heater may be reduced to lower the temperature of the gas, paragraph 94, the vapor is released into the carrier gas line after the heat is reduced.)
Therefore, a temperature or duty cycle of a heater of the gas humidifier is reduced before delivery of the substance of the nebulizer frows from the combination.
It would have been obvious to a person or ordinary skill in the art prior to the filing date of the invention to have modified Montgomery to include a temperature or duty cycle of a heater of the gas humidifier is reduced before delivery of the substance of the nebulizer before delivery of the substance of the inhaler to ensure that the temperature is the desired temperature.
Response to Arguments
Applicant’s arguments with respect to claim 7 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785