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 .
Response to Amendment
This office action is in response to the amendment filed on 01/14/2026. As directed by the amendment, claim(s) 38 and 87 has been amended and claim(s) 48 has been cancelled. As such, claims 38-47, 49, 51, 53-54, 58 and 86-87 are pending in the instant application.
Applicant has amended claim 87 to address a 112(a) rejection; the 112(a) rejection to the claim has been withdrawn.
Response to Arguments
Applicant's arguments, see pages 10-13 of Remarks, filed 01/14/2026, pertaining to the
newly amended limitations have been noted. However, a new ground(s) of rejection has been
provided below to address the newly added limitations.
Applicant argues on pages 11 that “…the amended 3-15 L/min neonatal flow regime is not taught or suggested by the cited art.” The examiner respectfully disagrees. From claim 87, the modification of Taube (US 10007238 B1) teaches modifying the airflow to maintain a flow between 3 and 14 L/min.
Applicant further argues on page 11 that “Claim 38 (pre-amendment) already required pressure determination from sensors within the inspiratory and expiratory portion only; the amendment clarifies that there is no patient-side proximal pressure sensor. Jafari's calculations utilize Pprox and Qleak estimation to derive patient parameters (cols. 8-9).” The examiner respectfully disagrees. Jafari teaches pressure sensor 60 to measure P.sub.prox in expiratory limb 60 at a location proximal to the exhaust vent as seen in Fig. 1 and Col. 5, lines 45-59, wherein the fluids being exhausted into the atmosphere can be indicated by the letter E. Therefore, Jafari does not teach a patient-side proximal pressure sensor as seen in Fig. 1 since flow sensor 38 and secondary flow sensor 70 are within the inspiratory portions and exhaust flow sensor 62 and pressure sensor 60 are within the expiratory portion.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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(s) 38-40, 45, 51, 53-54 and 86 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Jafari (US 6626175 B2) in view of Leamon (US 20140053831 A1), Taube (US 10007238 B1) and White (US 20160193438 A1).
Regarding claim 38, Jafari teaches a continuous positive airway pressure (CPAP) system (ventilator system 30, see Fig. 1; Jafari teaches a ventilator system 30 capable of doing PPAP and bi-level pressure support (see Col. 7, lines 7-23), as well as, providing a constant flow of gas (see Col. 11, lines 24-27)) comprising:
an inspiratory portion (pressure generator 34, flow sensor 38, inflation manifold 48, inspiratory limb 52, and secondary flow sensor 70, see Fig. 1) coupled to a patient interface (patient interface device 52, see Fig. 1) (see Fig. 1) to provide an airflow with positive pressure to a patient through the patient interface (pressure generator 34 is a blower which generates airflow to the patient (see Col. 4, lines 56-60) which includes positive airway pressure ventilation as seen in Fig. 1 and Col. 7, lines 13-16), the inspiratory portion including a first sensor (flow sensor 38, see Fig. 1) to measure one or more of a pressure or a flow rate of the airflow at the inspiratory portion (“…the flow of breathing gas, after being measured by flow sensor 38, is provided to an inhalation manifold 48 and delivered to patient 44 via a patient circuit 50.” See Col. 5, lines 27-30);
an expiratory portion (expiratory limb 54 and exhaust flow sensor 62, see Fig. 1) coupled to the patient interface to receive air exhaled from the patient (“…an expiratory limb 54 for carrying gas from the patient, as indicated by arrow D, to an exhaust assembly, generally indicated at 56." See Col. 5, lines 33-35), the expiratory portion including a second sensor (exhaust flow sensor 62, see Fig. 1) for measuring one or more of a pressure or a flow rate of the air exhaled at the expiratory portion (exhaust flow sensor 62 measures flow of air exhaled as seen in Fig. 1 and Col. 5, lines 56-59); and
a controller (processor 46, see Fig. 1) configured to
(i) determine a pressure at the patient interface based on data from sensors measuring conditions within the inspiratory portion and the expiratory portion only (Jafari teaches a formula for pressure at patient wherein Ppatient = Qprimary +Qsecondary -Qexhaust – Qleak as seen in Col. 8, lines 59-67, wherein Qprimary is measured by flow sensor 38 (see Col. 5, lines 16-19) and Qexhaust is measured by exhaust flow sensor 62 (see Col. 5, lines 56-59). Qsecondary is measured by the secondary flow sensor 70 as seen in Col. 6, lines 18-21 and Qleak is calculated per breath as seen in Col. 9, lines 15-25. As such, pressure at the patient is determined using only sensors from the inspiratory and expiratory portions), including
(a) the measured pressure and/or the flow rate of the air exhaled at the inspiratory portion (Qprimary is measured by flow sensor 38 (see Col. 5, lines 16-19) and Qsecondary is measured by the secondary flow sensor 70 as seen in Col. 6, lines 18-21in which both flow sensors are within the inspiratory portion as seen in Fig. 1), and
(b) the measured pressure and/or the flow rate of the air exhaled at the expiratory portion without using any patient-side proximal pressure sensor (Qexhaust is measured by exhaust flow sensor 62 as seen in Col. 5, lines 56-59 which is not a patient-side proximal pressure sensor), and
(ii) modify the airflow provided by the inspiratory portion based on the determined pressure at the patient interface (Jafari teaches monitoring patient pressure and flow to determine if there are errors in synchronization and adjusting the cycle threshold flow to account for the error as seen in Col. 19, lines 24-44. The cycle threshold flow is a percentage of the peak flow for that breath as seen in Col. 19, lines 11-13);
wherein
the inspiratory portion is configured to accept compressed oxygen from each of a wall oxygen, an oxygen canister, an oxygen tank, an oxygen concentrator, or a compressed oxygen line (pressure generator 34 can be a source of pressurized gas such as oxygen from a pressurized tank, compressor or from a wall outlet as seen in Col. 4, lines 64-67 shows that the inspiratory portion is capable of accepting numerous supplemental oxygen sources).
and further teaches “Those skilled in the art would understand, for example, that a medical ventilator system could also include features such as an input/output device for setting the operating parameters of the system, alarms (audible or visual) for signaling conditions of the patient or ventilator to an operator, as well as ancillary elements connected to the patient circuit, such as a humidifier, bacteria filter, an aspiration catheter, and a tracheal gas insufflation catheter, to name a few (see Col. 6, lines 35-43)” but does not teach an air bubbler configured to provide a water-column back-pressure for neonatal CPAP;
modify the airflow provided by the inspiratory portion to maintain a flow between 3 and 15 L/min;
a user interface comprises a visual display that is configured to
display the determined pressure of the airflow at the patient, a measured oxygenation level of the airflow at the inspiratory portion, and a measured temperature at the inspiration portion, and
provide both one or more visual alerts and one or more audio alerts for a user or the patient, where the visual alerts include a captioned alert that displays a cause of an alarm.
However, Burke teaches an air bubbler configured to provide a water-column back-pressure for neonatal CPAP (Burke teaches expiratory flow 362 not being returned to a ventilator but being directed towards a bubble CPAP for a source of back pressure such as a water bath or reservoir 370 as seen in Figs. 7B-7C and 8 and [0045] and [0091]-[0092]. Furthermore, Burke teaches the patients includes both adults and infants as seen in [0003] and a neonatal application as seen in [0082]).
Burke teaches the same delivery system Fig. 7A without the bubble CPAP reservoir 370 and Fig. 7B with the bubble CPAP reservoir. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Jafari to include an air bubbler as taught by Burke for an alternative design for a delivery system which performs the same function (see Figs. 7A-7B and 8 and [0069] and [0092]).
However, Taube teaches modify the airflow provided by the inspiratory portion (system 34, oxygen source 42 and air source 46, see Fig. 2) to maintain a flow between 1 and 60 L/min (Taube teaches the system to provide a gas flow rate of between 1-60 liters/minute (LPM) as seen in Col. 6, lines 20-23 and further teaches system 34 providing the measurement for the gas flow rate to the processor 60 within the inspiratory portion as seen in Fig. 2 and Col. 8, lines 49-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Jafari in view of Burke to include the controller as taught by Taube to have a known gas flow rate in the art (see Col. 6, lines 20-23).
However, Taube does not expressly disclose the flow rate to be maintained between 3 and 15 L/min as required by the claim.
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 flow rate of modified Jafari to be from the range of between 1 and 60 L/min to be between 3 and 15 L/min as applicant appears to have placed no criticality on the claimed range (see [0077] indicating the flow rate “for example” can be within the claimed range) 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).
However, White teaches a user interface (user interface 14, see Fig. 1) comprises a visual display (White teaches the user interface can be a form of a GUI on a touch screen display as seen in [0364] and [0493]) that is configured to
display the determined pressure of the airflow at the patient, a measured oxygenation level of the airflow at the inspiratory portion, and a measured temperature at the inspiration portion (White teaches sensor readings such as flow rate, oxygen concentration, temperature, PEEP, PIP, peak pressure, mean pressure and bi-level pressure can be displayed as seen in Fig. 77 and [1014]. White further teaches the display can include information to the user regarding whether the apparatus is meeting the inspiratory demand of the patient as seen in [0487]. A temperature sensor is used for measuring the temperature of the gas flow (see [0014]) and the temperature is monitored so that the flow rate may be adjusted with the patient's inspiratory demand as seen in [0510]. White further teaches oxygen concentration sensors can be placed in various locations in the gas flow path as seen in [0945]. As such, White teaches displaying the determined pressure of the airflow at the patient, a measured oxygenation level of the airflow at the inspiratory portion, and a measured temperature at the inspiration portion), and
provide both one or more visual alerts and one or more audio alerts for a user or the patient (White teaches sounding an alarm if the patient is not wearing the interface as seen in [0566]. White further teaches a visual indicator to indicate inspiratory demand is not being met as seen in [0490]), where the visual alerts include a captioned alert that displays a cause of an alarm (White teaches a display portion 120 that can display a predetermined “Display Text” or message and further teaches it is possible to display “entrained flow”, “excess flow”, or “flow support” to inform the clinician what is occurring as seen in Fig. 77 and [1032] and [1051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to include the user interface, temperature sensor, oxygen concentration sensor and controller taught by White to inform the clinicians of the current levels/values of sensor readings and if the system notices a problem (see [0490], [0566], [1014] and [1051]). Modified Jafari teaches a neonatal continuous positive airway pressure (CPAP) system ([0072] of the original disclosure states that the neonatal CPAP generally works via the same mechanism as the ventilator system 30 taught by modified Jafari. Furthermore, modified Jafari teaches the functions of the neonatal CPAP system and therefore teaches a neonatal CPAP system).
Regarding claim 39, modified Jafari teaches the system of claim 38, and Jafari further teaches wherein the inspiratory portion comprises a blower (pressure generator 34, see Fig. 1) to generate the airflow (pressure generator 34 is a blower which generates airflow to the patient as seen in Col. 4, lines 56-60), and wherein the controller is configured to modify the airflow by regulating a speed of the blower (processor 46 can control the flow of breathing gas delivered to a patient by modulating the operating speed of the pressure generator as seen in Col. 5, lines 4-15).
Regarding claim 40, modified Jafari teaches the system of claim 38, and Jafari further teaches wherein the controller is configured to increase the airflow if the determined pressure has decreased (processor 46 can increase the airflow if the determined pressure can decrease as it can modulate the operating speed of the pressure generator as seen in Col. 5, lines 4-15. Furthermore, Jafari teaches monitoring patient pressure and flow to determine if there are errors in synchronization and adjusting the cycle threshold flow to account for the error as seen in Col. 19, lines 24-44. Therefore, if the determined pressure has decreased and it is seen as an error in synchronization, processor 46 can modify the CTF to increase the airflow as seen in Col. 20, lines 37-40).
Regarding claim 45, modified Jafari teaches the system of claim 38, and Jafari further teaches wherein the inspiratory portion further comprises one or more of a flow rate sensor, a pressure sensor, a temperature sensor, a humidity sensor, and an oxygenation sensor (flow sensor 38, see Fig. 1).
Regarding claim 51, modified Jafari teaches the system of claim 38, and White further teaches further comprising a user interface coupled to the controller (user interface 14 is coupled to controller 13 as seen in Fig. 1 and [0493]).
Regarding claim 53, modified Jafari teaches the system of claim 51, and further teaches wherein the visual display is configured to display one or more of the measured pressure of the airflow at the inspiratory portion, the measured flow rate of the airflow at the inspiratory portion, the measured pressure of the airflow at the expiratory portion, the measured flow rate of the airflow at the expiratory portion, the determined pressure at the patient interface, or a calibration status of the system (White teaches sensor readings such as flow rate, oxygen concentration, temperature, PEEP, PIP, peak pressure, mean pressure and bi-level pressure can be displayed as seen in Fig. 77 and [1014]. Jafari teaches flow sensor 38 within the inspiratory portion as seen in Fig. 1. As such, modified Jafari teaches displaying one or more of the measured flow rate at the inspiratory portion).
Regarding claim 54, modified Jafari teaches the system of claim 53, and White further teaches wherein the visual display is further configured to display one or more of a measured temperature, a measured humidity, or a measured oxygenation level of the airflow at the inspiratory portion (White teaches sensor readings such as flow rate, oxygen concentration, temperature, PEEP, PIP, peak pressure, mean pressure and bi-level pressure can be displayed as seen in Fig. 77 and [1014]. White further teaches the display can include information to the user regarding whether the apparatus is meeting the inspiratory demand of the patient as seen in [0487]. As such, White teaches displaying the determined pressure of the airflow at the patient, a measured oxygenation level of the airflow at the inspiratory portion, and a measured temperature at the inspiration portion).
Regarding claim 86, modified Jafari teaches the system of claim 38, and Jafari further teaches wherein all of the flow and pressure sensors measure conditions within the inspiratory portion and/or the expiratory portion (flow sensor 38 and secondary flow sensor 70 measures conditions within the inspiratory portion as seen in Fig. 1 and Col. 5, lines 27-30 and Col. 6, lines 18-21. Exhaust flow sensor 62 measures flow of air exhaled in the expiratory portion as seen in Fig. 1 and Col. 5, lines 56-59).
Claims 41-42 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Jafari (US 6626175 B2) in view of Leamon (US 20140053831 A1), Taube (US 10007238 B1) and White (US 20160193438 A1), as applied to claim 38 above, and further in view of Burgess (US 20190217030 A1).
Regarding claim 41, modified Jafari teaches the system of claim 38, and White teaches a temperature sensor to measure a temperature of the airflow (A temperature sensor is used for measuring the temperature of the gas flow (see [0014])) but does not teach wherein the inspiratory portion comprises a heater to provide heat to the airflow, and wherein the controller is configured to control the amount of heat provided to the airflow by the heater based on the measured temperature.
However, Burgess further teaches wherein the inspiratory portion (operation sensors 3a, 3b, 3c and 25, heater wire 16a, flow generator 11 and humidifier 12, see Fig. 1 and [0035]) comprises a heater (heater wire 16a, see Fig. 1) to provide heat to the airflow (“The patient conduit 16 can have a heater wire 16a to heat gas flow passing through to the patient.” See [0034]) and a temperature sensor to measure a temperature of the airflow (sensor 25, see Fig. 1; sensor 25 can be a temperature sensor to measure the airflow to assist the flow therapy apparatus 10 (see [0036]), and wherein the controller is configured to control the amount of heat provided to the airflow by the heater based on the measured temperature (“The apparatus 10 may have a transmitter and/or receiver 15 to enable the controller 13 to receive signals 8 from the sensors and/or to control the various components of the flow therapy apparatus 10, including but not limited to the flow generator 11, humidifier 12, and heater wire 16a, or accessories or peripherals associated with the flow therapy apparatus 10.” See [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to include a heater and a controller to control the heat based on the measure temperature as taught by Burgess to heat the gas to a desired temperature that achieves a desired level of therapy and/or level of comfort for the patient (see [0035]).
Regarding claim 42, modified Jafari teaches the system of claim 38, but does not teach wherein the inspiratory portion comprises a humidifier to provide humidity to the airflow and a humidity sensor to measure humidity of the airflow, and wherein the controller is configured to control the amount of humidity provided to the airflow by the humidifier based on the measured humidity.
However, Burgess further teaches wherein the inspiratory portion (operation sensors 3a, 3b, 3c and 25, heater wire 16a, flow generator 11 and humidifier 12, see Fig. 1 and [0035]) comprises a humidifier (humidifier 12, see Fig. 1) to provide humidity to the airflow (“The controller 13 can control the flow generator 11 to generate a gas flow of the desired flow rate, control one or more valves to control a gas mix (for example, O.sub.2 control), and/or control the humidifier 12 if present to humidify the gas flow and/or heat the gas flow to an appropriate level.” See [0035]) and a humidity sensor to measure humidity of the airflow (operation sensor 3b, see Fig. 1; operation sensor 3b is a humidity sensor to measure humidity in the airflow (see [0036]), and wherein the controller is configured to control the amount of humidity provided to the airflow by the humidifier based on the measured humidity (“The apparatus 10 may have a transmitter and/or receiver 15 to enable the controller 13 to receive signals 8 from the sensors and/or to control the various components of the flow therapy apparatus 10, including but not limited to the flow generator 11, humidifier 12, and heater wire 16a, or accessories or peripherals associated with the flow therapy apparatus 10.” See [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to include a humidifier, humidity sensor and the controller to control the amount of humidity based on the measured humidity as taught by Burgess to heat the gas to a desired temperature that achieves a desired level of therapy and/or level of comfort for the patient (see [0035]).
Claim 43 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Jafari (US 6626175 B2) in view of Leamon (US 20140053831 A1), Taube (US 10007238 B1) and White (US 20160193438 A1), as applied to claim 38 above, and further in view of Andrieux (US 20100078024 A1) and Smith (US 20070125374 A1).
Regarding claim 43, modified Jafari teaches the system of claim 38, and further teaches wherein the inspiratory portion comprises a mixing chamber to blend a primary gas flow with a secondary gas flow (Jafari teaches an inflation manifold 48 mixes a second gas flow with a primary gas flow as seen in Fig. 1 and Col. 6, lines 15-18) and one or more sensors to determine oxygenation of the airflow (White teaches oxygen concentration sensors can be placed in various locations in the gas flow path as seen in [0945]) but does not teach wherein the inspiratory portion comprises a blender to blend ambient air with compressed oxygen, and wherein the controller is configured to control a ratio of compressed oxygen to ambient air based on the determined oxygenation.
However, Andrieux teaches wherein the inspiratory portion comprises a mixing chamber to blend ambient air with compressed oxygen (air flows through the air inlet filter 140 (taken as ambient air) is mixed with compressed oxygen from the O2 inlet within a mixing chamber as seen in Figs. 5 and [0189] and [0197]), and wherein the controller (control system 22, see Fig. 5) is configured to control a ratio of compressed oxygen to ambient air based on the determined oxygenation (Andrieux teaches a FiO2 sensor to measure the oxygen concentration in which the ventilator system 12 can use the measurements to monitor the oxygen concentration and trigger low/high FiO2 thresholds set by GUI 40 as seen in [0213]. An O2 safety system 38 includes O2 safety valve 156 to stop or slow the oxygen into the ventilation system 12 as seen in Figs. 4a-4b [0140]. As such, Andrieux teaches an O2 safety system 38 to control the amount of oxygen using the oxygen measurements from the FiO2 sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to use ambient air as a secondary gas flow and include a controller and O2 safety valve as taught by Andrieux as it is known to mix air and oxygen together (see [0040]) and to stop or slow the oxygen into the ventilation system to prevent an overheat condition (see [0141]) and/or oxygen toxicity.
However, Smith teaches the inspiratory portion further comprises a blender to blend two gases (Smith teaches a gas blender with auxiliary mixed gas outlet 100, see Fig. 1 and [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to replace the mixing chamber with the blender as taught by Smith as an alternative mixing/blending mechanism. Furthermore, the blender taught by Smith allows for an improved control over the mixture by having a predetermined mixing setpoint as seen in [0037].
Claim 44 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Jafari (US 6626175 B2) in view of Leamon (US 20140053831 A1), Taube (US 10007238 B1) and White (US 20160193438 A1), as applied to claim 38 above, and further in view of Andrieux (US 20100078024 A1), Burgess (US 20190217030 A1) and Smith (US 20070125374 A1).
Regarding claim 44, modified Jafari teaches the system of claim 38, and Jafari further teaches wherein the inspiratory portion further comprises a blower to generate the airflow (pressure generator 34 is a blower which generates airflow to the patient as seen in Fig. 1 and Col. 4, lines 56-60) and a mixing chamber to blend a primary gas flow with a secondary gas flow (Jafari teaches an inflation manifold 48 mixes a second gas flow with a primary gas flow as seen in Fig. 1 and Col. 6, lines 15-18) but does not teach the inspiratory portion further comprises a heater for the airflow, a humidifier for the airflow, and a blender to blend ambient air with compressed oxygen.
However, Andrieux teaches a mixing chamber to blend ambient air with compressed oxygen (air flows through the air inlet filter 140 (taken as ambient air) is mixed with compressed oxygen from the O2 inlet within a mixing chamber as seen in [0189] and [0197] and Figs. 5-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to use ambient air as a secondary gas flow as taught by Andrieux as it is known to mix air and oxygen together (see [0040]).
However, Burgess teaches the inspiratory portion (operation sensors 3a, 3b, 3c and 25, heater wire 16a, flow generator 11 and humidifier 12, see Fig. 1 and [0035]) further comprises a heater for the airflow (heater wire 16a, see Fig. 1 and [0035]), a humidifier for the airflow (humidifier 12, see Fig. 1 and [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to include a heater and humidifier as taught by Burgess to heat the gas to a desired temperature that achieves a desired level of therapy and/or level of comfort for the patient (see [0035]).
However, Smith teaches the inspiratory portion further comprises a blender to blend two gases (Smith teaches a gas blender with auxiliary mixed gas outlet 100, see Fig. 1 and [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to replace the mixing chamber with the blender as taught by Smith as an alternative mixing/blending mechanism. Furthermore, the blender taught by Smith allows for an improved control over the mixture by having a predetermined mixing setpoint as seen in [0037].
Claim(s) 46 and 49 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Jafari (US 6626175 B2) in view of Leamon (US 20140053831 A1), Taube (US 10007238 B1) and White (US 20160193438 A1), as applied to claim 38 above, and further in view of Mahadevan (US 20150320955 A1).
Regarding claim 46, modified Jafari teaches the system of claim 38, but does not teach wherein the inspiratory portion is removably coupled to the patient interface.
However, Mahadevan teaches the patient interface 42 to be removably coupled to conduit 40 for cleaning and/or other purposes as seen in [0023] and Fig. 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to have the conduit attached to the patient interface be removably coupled as taught by Mahadevan to allow cleaning for the mask (see [0023]). Modified Jafari teaches wherein the inspiratory portion is removably coupled to the patient interface (Jafari teaches inspiratory limb 52 to be attached to patient interface 58 as seen in Fig. 1. Mahadevan teaches the patient interface to be removably coupled to conduits. Therefore, modified Mahadevan teaches patient interface 58 to be removably coupled to inspiratory limb 52).
Regarding claim 49, modified Jafari teaches the system of claim 38, but does not teach wherein the expiratory portion is removably coupled to the patient interface.
However, Mahadevan teaches the patient interface 42 to be removably coupled to conduit 40 for cleaning and/or other purposes as seen in [0023] and Fig. 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to have the conduit attached to the patient interface be removably coupled as taught by Mahadevan to allow cleaning for the mask (see [0023]). Modified Jafari teaches wherein the expiratory portion is removably coupled to the patient interface (Jafari teaches expiratory limb 54 to be attached to patient interface 58 as seen in Fig. 1. Mahadevan teaches the patient interface to be removably coupled to conduits. Therefore, modified Mahadevan teaches patient interface 58 to be removably coupled to expiratory limb 54).
Claim 47 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Jafari (US 6626175 B2) in view of Leamon (US 20140053831 A1), Taube (US 10007238 B1) and White (US 20160193438 A1), as applied to claim 38 above, and further in view of Andrieux (US 20100078024 A1) and Gluck (US 4838259 A).
Regarding claim 47, modified Jafari teaches the system of claim 38 but does not teach wherein the inspiratory portion is a standalone module.
However, Andrieux teaches wherein the inspiratory portion is a standalone device (The specification cites “Additionally, standalone CPAP employs a combination of air and oxygen to ensure proper oxygen saturation while using the lowest amount of oxygen possible (see [0061] of supplied specification)” and “The indigenous CPAP approach is often 100% oxygen, which is either dry or passively humidified using a bottle of water. Similar to the delivery of low flow oxygen, it carries risks of oxygen toxicity such as blindness (see [0068]).” The examiner’s interpretation of the standalone module from the cited specification is the CPAP machine should employ a combination of air and oxygen for proper oxygen saturation with a lower risk for oxygen toxicity. Andrieux teaches mixing air with oxygen before supplying it to the patient (see [0189] and Fig. 5) and therefore meets the requirement to be a standalone device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to use ambient air as a secondary gas flow as taught by Andrieux as it is known to mix air and oxygen together (see [0040]).
However, Gluck teaches wherein the inspiratory portion is a standalone module (“Ventilator 10 is an integrated modular system which generally comprises a control unit 12, a high-pressure gas supply unit 14, a low pressure gas supply unit 15 and an entrainment module 16… The above-mentioned modular units and their sub-units may be easily connected and disconnected. The modular construction thus facilitates maintenance of the ventilator and also provides a ventilator which, to the extent required, may be easily disinfected and sterilized as will be more fully apparent from the discussion below.” See Col. 3, lines 23-49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to be modularly constructed as taught by Gluck to allow for easy connection and disconnection of units and sub-units, as well as, ease of disinfection and sterilization (see Col. 3, lines 43-49).
Claim 58 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Jafari (US 6626175 B2) in view of Leamon (US 20140053831 A1), Taube (US 10007238 B1) and White (US 20160193438 A1), as applied to claim 38 above, and further in view of Andrieux (US 20100078024 A1), Burgess (US 20190217030 A1), Mahadevan (US 20150320955 A1), Smith (US 20070125374 A1) and Milne (US 20120216809 A1).
Regarding claim 58, modified Jafari teaches the system of claim 38, and further teaches further comprising a user interface coupled to the controller (user interface 14 is coupled to controller 13 as seen in Fig. 1 and [0493] of White), wherein
the controller is configured to increase the airflow if the determined pressure has decreased (processor 46 can increase the airflow if the determined pressure can decrease as it can modulate the operating speed of the pressure generator as seen in Col. 5, lines 4-15 of Jafari. Furthermore, Jafari teaches monitoring patient pressure and flow to determine if there are errors in synchronization and adjusting the cycle threshold flow to account for the error as seen in Col. 19, lines 24-44. Therefore, if the determined pressure has decreased and it is seen as an error in synchronization, processor 46 can modify the CTF to increase the airflow as seen in Col. 20, lines 37-40);
the inspiratory portion comprises
a blower (pressure generator 34, see Fig. 1 of Jafari) to generate the airflow (pressure generator 34 is a blower which generates airflow to the patient as seen in Col. 4, lines 56-60 of Jafari), and wherein the controller is configured to modify the airflow by regulating a speed of the blower (processor 46 can control the flow of breathing gas delivered to a patient by modulating the operating speed of the pressure generator as seen in Col. 5, lines 4-15 of Jafari),
a temperature sensor to measure a temperature of the airflow (White teaches a temperature sensor is used for measuring the temperature of the gas flow (see [0014]) and the temperature is monitored so that the flow rate may be adjusted with the patient's inspiratory demand as seen in [0510])
one or more sensors to determine oxygenation of the airflow (White further teaches oxygen concentration sensors can be placed in various locations in the gas flow path as seen in [0945])
a mixing chamber to blend a primary gas flow with a secondary gas flow (Jafari teaches an inflation manifold 48 mixes a second gas flow with a primary gas flow as seen in Fig. 1 and Col. 6, lines 15-18) but does not teach a heater to provide heat to the airflow, and wherein the controller is configured to control the amount of heat provided to the airflow by the heater based on the measured temperature,
a blender to blend ambient air with compressed oxygen,
wherein the controller is configured to control a ratio of compressed oxygen to ambient air based on the determined oxygenation,
the expiratory portion is removably coupled to the patient interface;
the one or more of the visual alert or the audio alert indicates one or more of a low inspiratory air pressure, a high inspiratory air pressure, a low inspiratory oxygenation level, a high inspiratory oxygenation level, a low inspiratory air temperature, a high inspiratory air temperature, a battery level, and a system error.
However, Andrieux further teaches wherein the inspiratory portion (turbine 20, inspiration air outlet 130, air inlet 140 and O2 inlet 154, see Fig. 5) comprises a mixing chamber to blend ambient air with compressed oxygen (air flows through the air inlet filter 140 (taken as ambient air) is mixed with compressed oxygen from the O2 inlet within a mixing chamber as seen in Figs. 5 and [0189] and [0197]), and wherein the controller (control system 22, see Fig. 5) is configured to control a ratio of compressed oxygen to ambient air based on the determined oxygenation (Andrieux teaches a FiO2 sensor to measure the oxygen concentration in which the ventilator system 12 can use the measurements to monitor the oxygen concentration and trigger low/high FiO2 thresholds set by GUI 40 as seen in [0213]. An O2 safety system 38 includes O2 safety valve 156 to stop or slow the oxygen into the ventilation system 12 as seen in Figs. 4a-4b [0140]. As such, Andrieux teaches an O2 safety system 38 to control the amount of oxygen using the oxygen measurements from the FiO2 sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to use ambient air as a secondary gas flow and include a controller taught by Andrieux as it is known to mix air and oxygen together (see [0040]).
However, Burgess teaches the inspiratory portion (operation sensors 3a, 3b, 3c and 25, heater wire 16a, flow generator 11 and humidifier 12, see Fig. 1 and [0035]) further comprises a heater for the airflow (heater wire 16a, see Fig. 1 and [0035]), and wherein the controller is configured to control the amount of heat provided to the airflow by the heater based on the measured temperature (“The apparatus 10 may have a transmitter and/or receiver 15 to enable the controller 13 to receive signals 8 from the sensors and/or to control the various components of the flow therapy apparatus 10, including but not limited to the flow generator 11, humidifier 12, and heater wire 16a, or accessories or peripherals associated with the flow therapy apparatus 10.” See [0036])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to include a heater and a controller to control the heat based on the measure temperature as taught by Burgess to heat the gas to a desired temperature that achieves a desired level of therapy and/or level of comfort for the patient (see [0035]).
However, Mahadevan teaches the patient interface 42 to be removably coupled to conduit 40 for cleaning and/or other purposes as seen in [0023] and Fig. 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to have the conduit attached to the patient interface be removably coupled as taught by Mahadevan to allow cleaning for the mask (see [0023]). Modified Jafari teaches wherein the inspiratory portion is removably coupled to the patient interface (Jafari teaches inspiratory limb 52 to be attached to patient interface 58 as seen in Fig. 1. Mahadevan teaches the patient interface to be removably coupled to conduits. Therefore, modified Mahadevan teaches patient interface 58 to be removably coupled to inspiratory limb 52).
However, Smith teaches the inspiratory portion further comprises a blender to blend two gases (Smith teaches a gas blender with auxiliary mixed gas outlet 100, see Fig. 1 and [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to replace the mixing chamber with the blender as taught by Smith as an alternative mixing/blending mechanism. Furthermore, the blender taught by Smith allows for an improved control over the mixture by having a predetermined mixing setpoint as seen in [0037].
However, Milne teaches the one or more of the visual alert or the audio alert indicates one or more of a low inspiratory air pressure, a high inspiratory air pressure, a low inspiratory oxygenation level, a high inspiratory oxygenation level, a low inspiratory air temperature, a high inspiratory air temperature, a battery level, and a system error (“Specifically, smart prompt 510 may alert the clinician that an inadequate flow has been detected, for example by notification message 512. As described herein, notification message 512 may alert the clinician that the inadequate flow is implicated via any suitable means, e.g., "Inadequate Flow Alert" (shown), "Inadequate Flow Detected" (not shown), or "Inadequate Flow Implicated" (not shown).” See [0178]; Milne teaches smart prompt 510 to alert the clinician with notification messages 512 regarding inadequate flow which occurs when a mean airway pressure s delivered less than a set PEEP or predetermined pressure (see [0167])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to include the GUI, smart prompt module, inadequate flow detection module, data processing module and display module as taught by Milne to display ventilatory information that will have notification messages when there is inadequate flow and smart prompts to notify and provide recommendations to the clinician to aid in mitigating the flow (see [0105)]).
Claim 87 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Jafari (US 6626175 B2) in view of White (US 20160193438 A1), Spence (US 20160175548 A1), Taube (US 10007238 B1) and Sweeney (US 20110253136 A1).
Regarding claim 87, Jafari teaches a neonatal continuous positive airway pressure (CPAP) system (ventilator system 30, see Fig. 1; Jafari teaches a ventilator system 30 capable of doing PPAP and bi-level pressure support (see Col. 7, lines 7-23), as well as, providing a constant flow of gas (see Col. 11, lines 24-27)) comprising:
an inspiratory (pressure generator 34, flow sensor 38, inflation manifold 48, inspiratory limb 52, and secondary flow sensor 70, see Fig. 1) coupled to a patient interface (patient interface device 52, see Fig. 1) (see Fig. 1) to provide an airflow with positive pressure to a patient through the patient interface (pressure generator 34 is a blower which generates airflow to the patient (see Col. 4, lines 56-60) which includes positive airway pressure ventilation as seen in Fig. 1 and Col. 7, lines 13-16), the inspiratory portion including:
a first sensor (flow sensor 38, see Fig. 1) configured to measure one or more of a pressure or a flow rate of the airflow at the inspiratory portion (“…the flow of breathing gas, after being measured by flow sensor 38, is provided to an inhalation manifold 48 and delivered to patient 44 via a patient circuit 50.” See Col. 5, lines 27-30);
an expiratory portion (expiratory limb 54 and exhaust flow sensor 62, see Fig. 1) coupled to the patient interface to receive air exhaled from the patient (“…an expiratory limb 54 for carrying gas from the patient, as indicated by arrow D, to an exhaust assembly, generally indicated at 56." See Col. 5, lines 33-35), the expiratory portion including:
a second sensor (exhaust flow sensor 62, see Fig. 1) configured to measure one or more of a pressure or a flow rate of the air exhaled at the expiratory portion (exhaust flow sensor 62 measures flow of air exhaled as seen in Fig. 1 and Col. 5, lines 56-59);
a controller (processor 46, see Fig. 1) configured to:
determine a pressure at the patient interface based only on:
(a) the measured pressure and/or flow rate at the inspiratory portion, and
(b) the measured pressure and/or flow rate at the expiratory portion (Jafari teaches a formula for pressure at patient wherein Ppatient = Qprimary +Qsecondary -Qexhaust – Qleak as seen in Col. 8, lines 59-67, wherein Qprimary is measured by flow sensor 38 (see Col. 5, lines 16-19) and Qexhaust is measured by exhaust flow sensor 62 (see Col. 5, lines 56-59). Qsecondary is measured by the secondary flow sensor 70 as seen in Col. 6, lines 18-21 and Qleak is calculated per breath as seen in Col. 9, lines 15-25. As such, pressure at the patient is determined using only sensors from the inspiratory and expiratory portions)
wherein, the inspiratory portion is configured to accept compressed oxygen from each of a wall oxygen, an oxygen canister, an oxygen tank, an oxygen concentrator, or a compressed oxygen line (pressure generator 34 can be a source of pressurized gas such as oxygen from a pressurized tank, compressor or from a wall outlet as seen in Col. 4, lines 64-67 shows that the inspiratory portion is capable of accepting numerous supplemental oxygen sources) and further teaches “Those skilled in the art would understand, for example, that a medical ventilator system could also include features such as an input/output device for setting the operating parameters of the system, alarms (audible or visual) for signaling conditions of the patient or ventilator to an operator, as well as ancillary elements connected to the patient circuit, such as a humidifier, bacteria filter, an aspiration catheter, and a tracheal gas insufflation catheter, to name a few (see Col. 6, lines 35-43).”
but does not teach the inspiratory portion including:
a blender configured to blend ambient air with compressed oxygen from any of a wall oxygen, an oxygen canister, an oxygen tank, an oxygen concentrator, or a compressed oxygen line;
a heater and a humidifier configured to heat the blended air to between 34°C and 41°C and humidify the blended air to between 50% and 100% humidity;
the expiratory portion including:
an air bubbler configured to receive the exhaled air;
the controller configured to:
control a ratio of compressed oxygen to ambient air based on a target oxygenation level;
control the heater to maintain the blended air temperature between 34°C and 41C;
control the humidifier to maintain humidity between 50% and 100%;
modify the airflow to maintain a flow rate between 3 and 15 L/min; and
a user interface comprising a visual display configured to:
display the determined pressure at the patient interface, a measured oxygenation level, and a measured temperature;
provide visual and audio alerts; and
display captioned alerts indicating causes of alarms.
However, White teaches wherein
a user interface (user interface 14, see Fig. 1) comprises a visual display (White teaches the user interface can be a form of a GUI on a touch screen display as seen in [0364] and [0493]) that is configured to
display the determined pressure of the airflow at the patient, a measured oxygenation level of the airflow at the inspiratory portion, and a measured temperature at the inspiration portion (White teaches sensor readings such as flow rate, oxygen concentration, temperature, PEEP, PIP, peak pressure, mean pressure and bi-level pressure can be displayed as seen in Fig. 77 and [1014]. White further teaches the display can include information to the user regarding whether the apparatus is meeting the inspiratory demand of the patient as seen in [0487]. A temperature sensor is used for measuring the temperature of the gas flow (see [0014]) and the temperature is monitored so that the flow rate may be adjusted with the patient's inspiratory demand as seen in [0510]. White further teaches oxygen concentration sensors can be placed in various locations in the gas flow path as seen in [0945]. As such, White teaches displaying the determined pressure of the airflow at the patient, a measured oxygenation level of the airflow at the inspiratory portion, and a measured temperature at the inspiration portion), and
provide visual and audio alerts (White teaches sounding an alarm if the patient is not wearing the interface as seen in [0566]. White further teaches a visual indicator to indicate inspiratory demand is not being met as seen in [0490]), and
display captioned alerts indicating causes of alarms (White teaches a display portion 120 that can display a predetermined “Display Text” or message and further teaches it is possible to display “entrained flow”, “excess flow”, or “flow support” to inform the clinician what is occurring as seen in Fig. 77 and [1032] and [1051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Jafari to include the user interface, temperature sensor, oxygen concentration sensor and controller taught by White to inform the clinicians of the current levels/values of sensor readings and if the system notices a problem (see [0490], [0566], [1014] and [1051]).
However, Spence teaches the expiratory portion including:
an air bubbler configured to receive the exhaled air (“…the system 20 is configured to provide pressure oscillations during at least a portion of a breathing cycle, such as during one or both of the inhalation phase and the exhalation phase of the breathing cycle. It is believed that such pressure oscillations are beneficial to the infant patient and may result in improved gas exchange and reduce the infant patient's work of breathing. A common oscillating pressure expiratory pressure device is a fluid resistance valve, in particular a liquid or water resistance valve, which is often referred to as a bubbler.” See [0028]; the bubbler is an expiratory pressure device and therefore is found within the expiratory portion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Jafari in view of White to include a bubbler as taught by Spence to provide pressure oscillations during the exhalation phase of the breathing cycle to improve gas exchange and reduce an infant patient’s work of breathing (see [0028]).
However, Taube teaches the inspiratory portion (oxygen source 42, air source 46, oxygen mixer 64, inspired gas heater 68 and inspired gas humidifier 72, see Fig. 2) including:
a blender (oxygen mixer 64, see Fig. 2) configured to blend ambient air with compressed oxygen (oxygen mixer 64 is controlled by blender controller 60 to form a blended gas using compressed oxygen from oxygen source 42 (see Col. 5, lines 47-49) and air source 46 which may be ambient air (see Col. 7, lines 21-25) as seen in Col. 6, lines 61-65 and Fig. 2);
a heater (inspired gas heater 68, see Fig. 2) and humidifier (inspired gas humidifier 72, see Fig. 2) configured to heat the blended air to between 34°C and 41°C (“…processor 60 that uses the measured temperature to adjust the heater 68 so as to achieve a target temperature. Such target temperature is most often, but not necessarily, about 37° C. ± approximately 2°-3° C.” see Col. 8, lines 31-34; the blended air leaves the oxygen mixer 64 and flows to the inspired gas heater 68 as seen in Fig. 2) and humidify the blended air (the blended air leaves the oxygen mixer 64 and flows to the inspired gas heater 68 before flowing to the inspired gas humidifier 72 as seen in Fig. 2);
the controller (adaptive controller system 18 and blender controller/processor 60, see Fig. 2) configured to:
control a ratio of compressed oxygen to ambient air based on a target oxygenation level (“The PID controller of 26 calculates the desired FiO.sub.2 to be generated by the oxygen mixer 64 and controls the oxygen mixer 64 in order to achieve the calculated gas mixture to obtain or maintain a target SpO.sub.2.” see Col. 7, lines 5-8; adaptive controller system 18 includes adaptive controller 26 as seen in Fig. 2 and Col. 6, lines 35-44);
control the heater to maintain the blended air temperature between 34°C and 41C (“…processor 60 that uses the measured temperature to adjust the heater 68 so as to achieve a target temperature. Such target temperature is most often, but not necessarily, about 37° C. ± approximately 2°-3° C.” see Col. 8, lines 31-34);
modify the airflow to maintain a flow rate between 1 and 60 L/min (“…the system described by way of example herein can provide control of the gases to provide a gas flow rate (between about 1 and 60 liters/minute (LPM)) …” see Col. 6, lines 20-23);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to include a blender, heater, humidifier and controller as taught by Taube to have a known gas flow rate in the art (Col. 6, lines 20-23), blend the gas mixture to achieved a target SpO2 (Col. 7, lines 5-8), and to heat and humidify the gas for patient comfort (see Col. 7, lines 52-61). Furthermore, modified Jafari teaches a blender configured to blend ambient air with compressed oxygen from any of a wall oxygen, an oxygen canister, an oxygen tank, an oxygen concentrator, or a compressed oxygen line (Modified Jafari teaches a blender configured to blend ambient air with compressed oxygen (as taught by Taube) from a pressured gas such as oxygen from a pressurized tank, compressor, or from a wall outlet as seen in Col. 4, lines 64-67 by Jafari).
However, Taube does not expressly disclose the flow rate to be maintained between 3 and 15 L/min as required by the claim.
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 flow rate of modified Jafari to be from the range of between 1 and 60 L/min to be between 3 and 14 L/min as applicant appears to have placed no criticality on the claimed range (see [0077] indicating the flow rate “for example” can be within the claimed range) 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).
However, Sweeney teaches a humidifier (humidifier 112, see Fig. 1) configured to humidify the air to between 50% and 100% humidity (Sweeney teaches delivering breathing gas humidity to be in the range of 50% to 100% to provide for comfort and efficacy as seen in [0041]);
a controller (control logic 120, see Fig. 1) configured to:
control the humidifier to maintain humidity between 50% and 100% (Sweeney teaches using sensors to general signals for controlling the humidifier and/or heater using control logic 120 to maintain the temperature and/or humidity of the breathable gas delivered to the patient in ranges stated above as seen in [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Jafari to include the control logic and humidity sensor as taught by Sweeney to maintain humidity between 50% and 100% as a known humidity used within the art. Furthermore, applicant appears to have placed no criticality on the claimed range as seen in [0077] where the blended air may be humidified to be at 100% or less or 50% humidity or less. Modified Jafari teaches a neonatal continuous positive airway pressure (CPAP) system ([0072] of the original disclosure states that the neonatal CPAP generally works via the same mechanism as the ventilator system 30 taught by modified Jafari. Furthermore, modified Jafari teaches the functions of the neonatal CPAP system and therefore teaches a neonatal CPAP system).
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 Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785