DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. This office action is responsive to the preliminary amendment filed on November 30, 2021. As directed by the amendment: claims 1-18 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-18 are presently pending in this application.
Specification
3. The abstract of the disclosure is objected to because the abstract exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. Claim(s) 1, 4-5, 11, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell et al. (WO 2017220698) in view of Novkov (US 2019/0344038).
Regarding claim 1, Farrell discloses an active and passive humidification device (fig. 1, sedation device 1) for mounting in a patient ventilation circuit (fig. 9, device 1 is mounted between ventilator 50 and patient 51), the device comprising: a housing (fig. 1, housing 2) having a ventilator chamber (fig. 2, chamber 3) and an associated patient chamber (fig. 2, chamber 4) communicating with the ventilator chamber through a gas permeable filter (fig. 2, filter 5, see page 4 line 1) mounted between the ventilator chamber and the patient chamber, the gas permeable filter forming a passive humidifier which is operable to capture and reflect heat and moisture received from a patient back to the patient the ventilator chamber (fig. 2, filter 5 is carbon felt which can capture and reflect heat and moisture, see page 11 lines 18-23) having a ventilator connection port (fig. 2, inlet port 7) for connection to a ventilator (fig. 9, mounted to ventilator 50), and the patient chamber having a patient connector port (fig. 2, outlet port 8) for connection to a patient breathing tube (fig. 9, port 8 is connected to breathing tube 54). Farrell does not expressly disclose a humidity generating device mounted on the housing being operable to discharge moisture into the patient chamber, with a heater in the patient chamber and a temperature sensor in the patient chamber. The humidity generating device, heater, and temperature sensor are connected to a controller to control the heater and humidity generating device to maintain air at a desired temperature and humidity for delivery.
However, Novkov teaches of a humidifier comprising a humidity generating device (fig. 8, atomizer 802), a heater (fig. 8, heated tube 819 and corresponding heating elements, see [0075]), temperature sensor (fig. 8, 807), and controller ([0006]) for detecting the current humidity and creating breathing gases of a desired humidity.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Farrell with the atomizer, heating element, heating tube, sensors, and controller as taught by Novkov for the purpose of reducing instances of over or under humidification thereby maintaining a proper humidification for therapy (see Novkov [0049]).
Regarding claim 4, the modified device of Farrell reads on the limitations of claim 1 and further reads on the heater comprises a heater plate (Novkov fig. 8, heated tube 819) mounted within the patient chamber (Novkov fig. 8, heated tube is within a chamber on the patient side), the heater plate being shaped to correspond to the contour of an outer wall of the patient chamber (Novkov fig. 8, heated tube 819 curves with the air conduit which has a tube structure, Farrell fig. 2, the bottom of patient chamber 4 is cylindrical).
Regarding claim 5, the modified device of Farrell reads on the limitations of claim 4 and further reads on the heat plate being mounted against the outer wall (see annotated Novkov fig. 8 below, outer wall is defined as the wall that makes up the conduit) of the patient chamber (see annotated Novkov fig. 8 below, heated tube 819 is mounted on the tube which comprises the outer wall).
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Regarding claim 11, the modified device of Farrell reads on the limitations of claim 1 and further reads on the patient chamber (Farrell fig. 9, evaporator chamber 4) has a bottom wall (Farrell fig. 9, evaporator chamber housing 13) which slopes downwardly towards the patient connector port (Farrell fig. 9, shows the device 1 tilted downward which creates a slope towards the port 8) for delivery of any moisture collected in the patient chamber towards the patient connector port (Farrell fig. 9, the positioning of chamber 4 above outlet port 8 inherently delivers collected moisture to the port).
Regarding claim 16, the modified device of Farrell reads on the limitations of claim 1 and further reads on a humidifier mounting chamber (see annotated Novkov fig. 8 below, the chamber allows the atomizer to be mounted) being formed in the housing adjacent the patient connector port (Novkov fig. 8 it would be obvious for the atomizer to be placed near the patient connector port so that the water can be delivered to the patient) and the humidity generating device (Novkov fig. 8, atomizer 802) being housed within the humidifier mounting chamber, a passageway connects between the humidifier chamber and the patient connector port within which the humidity generating device being mounted (see annotated Novkov fig. 8 below, the passage which delivers water to the breathing chamber is connected between the mounting chamber and the patient port).
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Regarding claim 18, the modified device of Farrell reads on the limitations of claim 1 and further reads on an evaporator (Farrell fig. 2, evaporator 10) being mounted within the patient chamber (Farrell fig. 2, chamber 4) for delivery of a volatile anesthetic into the patient chamber (Farrell fig. 2, sedative delivery line 40 connects to evaporator 10 which is volatile, see abstract).
7. Claim(s) 2-3 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Novkov and Kadrichu et al. (US 2010/0282247).
Regarding claim 2, the modified device of Farrell presented in claim 1 reads on the limitations of claim 1 and further reads on the controller being able to receive flow information from a flow sensor (Novkov [0005] states that the inspiratory flow is considered when determining an amount of water to add). The modified device of Farrell does not expressly disclose that the humidity generating device is switched on by the controller during a patient inhalation and switched off by the controller during a patient exhalation.
However, Kadrichu teaches of a controller configured to begin and end aerosolization at a first point and a second point during inhalation, respectively ([0112]) using readings from a flow sensor ([0110]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Farrell with the program for controlling the start and end of aerosolization and a sensor for detecting a breathing cycle as taught by Kadrichu for the purpose of providing greater delivery efficiency (Kadrichu [0202]).
Regarding claim 3, the modified device of Farrell reads on the limitations of claim 2 and further reads on the controller being operable to switch off the humidity generating device at a preset time interval before the end of a patient inhalation (Kadrichu [0112] states that stops aerosolization at a second point which occurs after a second predetermined percentage of inhalation has passed thereby occurring before the end of inhalation by a remaining percentage).
Regarding claim 13, the modified device of Farrell reads on the limitations of claim 2 and further reads on the air flow sensor being operable to detect the direction of air flow through the housing (Kadrichu [0110] states that the start of an inhalation cycle is sensed via a sensor which inherently means the direction of flow can be detected if the inhalation/exhalation state is detected).
Regarding claim 14, the modified device of Farrell reads on the limitations of claim 2 and further reads on wherein the air flow sensor being operable to detect the volume of air flow through the housing (Kadrichu [0110] states that the detected flow rate and time values can be used to find a tidal volume).
Regarding claim 15, the modified device of Farrell reads on the limitations of claim 2 and reads on a flow sensor, but does not expressly disclose the flow sensor as mounted within the ventilator connection port or the ventilator chamber.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to place the flow sensor in the ventilator connection port or chamber as an obvious design choice which would not impact the function of the humidification device as there is no criticality to the flow sensor placement (specification page 5 lines 6-10 states that the sensor is mounted within the housing in one embodiment) and the device would function the same in being able to detect the breathing state.
8. Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Novkov and Jassell et al. (US 2008/0251073).
Regarding claim 6, the modified device of Farrell reads on the limitations of claim 4, but does not expressly state that the heater plate is mounted spaced-apart from the outer wall.
However, Jassell teaches of an insulation chamber (fig. 3, insulation chamber 23) between the heating element (fig. 3, heating element 28) and the outer wall (fig. 3, outer wall 24).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Farrell with an insulation chamber to separate the heater plate (Novkov fig. 8, heated tube 819) from an outer wall as taught by Jassell to reduce heat loss thereby increasing heating efficiency and reduce the temperature of the exterior surfaces (Jassell [0011]).
9. Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Novkov and Drew (US 2016/0310692).
Regarding claim 7, the modified device of Farrell reads on the limitations of claim 4, but is silent on the heater plate having fin on an inner face of the heater plate.
However, Drew teaches of an induction heater assembly which uses cooling fins (fig. 2, 110) that can extend into the gas flow line ([0027]) to improve the heat transfer between the induction element into the gas flow ([0027)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the heater plate of the modified device of Farrell with fins as taught by Drew to improve the efficiency when heating the gas within the device (Drew [0027]).
10. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Novkov and Liu et al. (US 2020/0368468).
Regarding claim 8, the modified device of Farrell reads on the limitations of claim 1, but is silent on the heater being a ceramic heater plate.
However, Liu teaches of a heating device which uses a ceramic heater plate (fig. 44B, heater plate 4420, can be ceramic according to [0405]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the material of the heater (Novkov fig. 8, heated tube 819) of the modified device of Farrell with ceramic as taught by Liu as an obvious design choice which would not impact the function of the humidification device as there is no criticality for the material of the heater and the device would function the same in being able to vaporize water.
11. Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Novkov and Church (US 2014/0232024).
Regarding claim 9, the modified device of Farrell reads on the limitations of claim 4, but is silent on an insulation element being mounted on the patient chamber outside the heater plate.
However, Church discloses a humidifier with an outer wall which can be insulated ([0106])
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Farrell with insulation on the outer wall outside the heater plate to minimize heat loss from the heater element and improve safety when handling the device (Church [0106]).
Regarding claim 10, the modified device of Farrell reads on the limitations of claim 9, and further reads on having wiring provided to the heated tube (Novkov [0075] states that internal or external wiring can be used to deliver thermal energy to the heating tube 819) and other components inherently have wires to provide power to the components, but does not expressly disclose the wiring passing through the insulation element.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to move the wiring between the heating element and heating tube of the modified device of Farrell to be positioned in the insulation element as an obvious design choice which would not impact the function of the humidification device as there is no criticality to the placement of the wiring conduit and the device would function the same in being able to deliver thermal energy to the heating tube.
12. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Novkov, Kadrichu, and Bath et al. (US 2016/0310691).
Regarding claim 12, the modified device of Farrell reads on the limitations of claim 2, but is silent on a cowl being provided to the air flow sensor.
However, Bath teaches of a cowl (a cowl is interpreted as a hood or covering according to Merriam Webster, fig. 11o, water shield 4020sp) and water trap (fig. 11o, 4020wt) positioned near the flow sensor ports (fig. 11o, 4020sp) to prevent water from entering the flow sensor ports ([0304]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Farrell with the water shield and water trap as taught by Bath to prevent excess humidity or water from entering the flow sensor port to prevent the sensor from being compromised due to an ingress of water (Bath [0304]).
13. Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Novkov and Suzuki (US 5,163,423).
Regarding claim 17, the modified device of Farrell reads on the limitations of claim 1 and further reads on a temperature sensor (Novkov fig. 8, sensor 807), but does not expressly state that the temperature sensor is positioned at an exit from the patient chamber, downstream of the humidity generating device and upstream of an outlet of the patient connector port.
However, Suzuki teaches of a humidifier with a temperature sensor for feedback control of the humidification device (col. 2, lines 1-7).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Farrell with a temperature sensor placed at the outlet of the humidification device and the feedback control program as taught by Suzuki ensure the temperature of the delivered air is within a set range (Suzuki col. 2, lines 2-7) to prevent condensation within the tube and ensure gas of an appropriate humidity is supplied (Suzuki abstract).
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Goff et al. (US 2017/0216552) discloses a portable positive pressure device which includes a humidifier that only humidifies as necessary, and can be specified to only be active during inhalation (see [0036]). Korneff (US 2009/0301475) discloses a heat and moisture exchange unit which has outer walls that slope toward the outlets (fig. 9) and includes a heat and moisture media (fig. 9, 54) which can retain heat and moisture, [0030]).
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Thursday (Every other Friday) 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached at (571)272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785