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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 07/21/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Response to Amendment
This office action is in response to the amendment filed on 02/24/2023. As directed by the amendment, claims 2-4, 9, 16-27, 29, 31-33 and 41 have been amended. As such, claims 2-4, 9, 16-27, 29, 31-33 and 41 are pending in the instant application.
Applicant has amended claims 27 and 41 to address a minor informality; the objection to claims 27 and 41 has been withdrawn.
Applicant has amended claims 24-27 and 41 from “connector element” to “connector”; the 112(f) interpretation to claims 24-27 and 41 have been withdrawn.
Response to Arguments
Applicant's arguments, see pages 6-8 of Remarks, filed 07/21/2025, pertaining to the
newly amended limitations have been fully considered but they are not persuasive. Rothermel (US 8439031 B1) teaches a control interface 34 which comprises of pneumatic signal source 102 as seen in Col. 4, lines 55-63 and Col. 10, lines 33-51. Rothermel further teaches control interface 34 to be removably attached to a headgear assembly 50 as seen in Fig. 4 and Col. 6, lines 26-48 and the control interface 34 to communicate with the gas delivery system 12 via a wired link or a wireless link as seen in Fig. 12 and Col. 11, lines 16-29. Therefore, Rothermel teaches a control interface 34 with pneumatic signals source 102 that is removably attached and can still be actuated from a position remote from the patient interface, as once the headgear assembly is removed, there is still a wired or wireless link for the control interface 34 to communicate with the gas delivery system 12. As such Rothermel teaches a removably connectable trigger configured to be actuated from a position remote from the patient interface, that allows another individual beside the patient to adjust the parameters of the system (see Col. 11, lines 11-29).
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) 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 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 16-18, 20, 23, 31-32 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothermel (US 8439031 B1) in view of Pyles (US 20100228224 A1).
Regarding claim 2, Rothermel teaches a respiratory therapy system (patient treatment system 10, see Fig. 1), the respiratory therapy system comprising:
a respiratory therapy apparatus (gas delivery system 12 and gas source 16, see Fig. 1), configured to provide a flow of breathable gas (“Gas delivery system 12 includes a pressure generator 14 that receives a supply of breathable gas from a breathable gas source 16 and elevates the pressure of that gas for delivery to the airway of a patient.” See Col. 2, lines 62-66) at, at least a first pressure and a second pressure to a patient (“By manipulating control interface 34, patient 44 may adjust, for example, a humidifier setting, a pressure relief setting, a ramp setting, an oxygen concentration level setting, and/or an on/off control. It will be appreciated that this is not a comprehensive list of the aspects of operation of gas delivery system 12 and/or patient treatment system 10, and that more or less control may be provided to patient 44 at control interface 34.” See Col. 6, line 65 to Col. 7, line 5; the gas delivery system 12 can deliver gas at a first pressure which can be adjusted by the patient through the control interface 34 to deliver gas at a second pressure), the respiratory therapy apparatus comprising;
a flow generator (gas source 16, see Fig. 1) configured to provide the flow of breathable gas (see Col. 2, lines 62-66),
a controller (controller 32, see Figs. 1 and 10), coupled to a detector (detector module 98, see Fig. 10) (detector module 98 is coupled to controller 32 as seen in Fig. 10), to control respiratory therapy apparatus operations (“The pulse of fluid along signal pathway 104 may then be detected by a suitable detector, and based on this detection, an aspect of the operation of patient treatment system 10 may be adjusted.” See Col. 10, lines 48-51; Signal pathways 104 may be implemented as signal pathways 96a and 96b as seen in Fig. 10 and Col. 10, lines 33-38. Where the signals are picked up by controller 32 to adjust the operation of patient treatment system 10 as seen in Col. 10, lines 29-32);
a breathing conduit assembly (patient circuit 26, see Fig. 1) that conveys the breathable gas to a patient via a patient interface (patient interface assembly 28 and headgear assembly 50, see Figs. 1 and 5-6) (“The flow of breathing gas is carried from gas delivery system 12 to the patient via patient circuit 26, which is typically a single flexible conduit that carries the flow of breathing gas to a patient interface assembly 28.” See Col. 4, lines 14-17 and Fig. 1);
a removably connectable trigger (pneumatic signal source 102, see Fig. 11A-11B), configured to be actuated from a position remote from the patient interface (Rothermel teaches a control interface 34 which comprises of pneumatic signal source 102 as seen in Col. 4, lines 55-63 and Col. 10, lines 33-51. Rothermel further teaches control interface 34 to be removably attached to a headgear assembly 50 as seen in Fig. 4 and Col. 6, lines 26-48 and the control interface 34 to communicate with the gas delivery system 12 via a wired link or a wireless link as seen in Fig. 12 and Col. 11, lines 16-29. Therefore, Rothermel teaches a control interface 34 with pneumatic signals source 102 that is removably attached and can still be actuated from a position remote from the patient interface, as once the headgear assembly is removed, there is still a wired or wireless link for the control interface 34 to communicate with the gas delivery system 12), that produces a signal detectable by the detector (source 102 includes a depressible surface 106 and a fluid reservoir 108 as seen in Figs. 11A-11B. When the depressible source 106 is pressed, fluid flows out of fluid reservoir 108 to generate a pulse along signal pathway 104 to be detected by the detector as seen in Figs. 10 and 11A-11B and Col. 10, lines 33-51); and
wherein the controller is configured to control the flow generator to provide the flow of breathable gas at, at least the first pressure or the second pressure based on detection of the signal from the trigger (controller 32 adjusts the operation of patient system 10 as seen in Figs. 1 and 10 and Col. 10, lines 31-32. Figures 11A-11B depicts a pneumatic signal source 102 with signal pathway 104 wherein when user presses on the depressible source 106 a signal is sent through signal pathway 104 to adjust an aspect of the operation of system 10 from the first pressure to the second pressure as seen in Col. 10, lines 33-51).
but does not teach a controller, coupled to a trigger sensor, to control respiratory therapy apparatus operations;
a trigger that produces a signal detectable by the trigger sensor.
However, Pyles teaches a remote-control device (taken as controller) such as a pneumatic signal produced by a pneumatic actuator, such as a button (taken as trigger), where the pneumatic signal is conveyed to a pressure transducer (or other device capable of producing an electrical signal based at least partially upon the pneumatic signal) as seen in [0246]. The pneumatic signal is utilized to cause an adjustment in a desired pressure, flow rate, or other operating parameters as seen in [0246].
Rothermel teaches a pneumatic signal source 102 including a depressible source 106 as seen in Fig. 10. When a user presses on the depressible source 106, a signal is sent through a signal pathway to a detector to adjust an aspect of operation as seen in Figs. 10- 11A-11B and Col. 10, lines 33-51. Pyles teaches a similar mechanism with a button as a pneumatic actuator which when pressed, a pneumatic signal is sent to a pressure transducer to cause an adjustment in operating parameters as seen in [0246]. 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 Rothermel to replace the detector with a pressure transducer as taught by Pyles as an alternative device capable or producing an electrical signal based on a pneumatic signal to utilize an adjustment/change in operating parameters (see [0246] of Pyles).
Regarding claim 16, Rothermel in view of Pyles teaches the system of claim 2, and further teaches wherein the trigger is connected to the trigger sensor via a trigger sensor line (signal pathways 104/96a and 96b, as seen in Figs. 10 and 11A-11B) (Rothermel in view of Pyles teaches the pneumatic signal source 102 connected to the pressure transducer (taught by Pyles) via signal pathways 104/96a and 96b as seen in Figs. 10 and 11A-11B. Especially as the pneumatic signal source 102 can be seen as source 94A and 94B of control interface 34 seen in Fig. 10 and Col. 10, lines 33-37).
Regarding claim 17, Rothermel in view of Pyles teaches the system of claim 2, and Rothermel further teaches wherein the trigger comprises a compressible chamber (fluid reservoir 108, see Fig. 11A-11B; fluid reservoir 108 can be collapsed when a user applies a force to depressible surface 106 as seen in Figs. 11A-11B and Col. 10, 38-45).
Regarding claim 18, Rothermel in view of Pyles teaches the system of claim 17, and further teaches wherein the trigger sensor is configured to provide an output to the controller indicative of a compressible chamber pressure (Rothermel in view of Pyles teaches fluid reservoir 106 generating a pulse of fluid/pressure of fluid when, depressible surface 106 is pressed, towards a pressure actuator (taught by Pyles) to provide an output to controller 32 as seen in Figs. 10 and 11A-11B and Col. 10, lines 17-51).
Regarding claim 20, Rothermel in view of Pyles teaches the system of claim 18, and Rothermel further teaches wherein the controller is configured to control the respiratory therapy system to deliver the first pressure when the compressible chamber pressure is below a compressible chamber pressure threshold (Rothermel teaches controller 32 controlling the patient treatment system 10 as seen Fig. 1 and Col. 10, lines 29-32, wherein a first pressure is delivered when the depressible surface 196 has not been pressed by the user and the fluid reservoir 108 has not been collapsed. Therefore, the pressure in fluid reservoir 108 is below a compressible chamber pressure threshold as the fluid reservoir has not been pressed/collapsed as shown in Fig. 11A), and the second pressure when the compressible chamber pressure is above the compressible chamber pressure threshold (when the depressible surface 106 has been pressed by a user, fluid reservoir 108 collapses and fluid is forced out of the reservoir 108 as seen in Fig. 11B and Col. 10, lines 33-51.When the fluid is forced out of the reservoir 108, a pneumatic signal/pulse of fluid is generated (due to the pressure being above the compressible chamber press threshold) which is detected by controller 32 to deliver gas at a second pressure as seen in Col. 10, lines 33-51).
Regarding claim 23, Rothermel in view of Pyles teaches the system of claim 16, and Rothermel further teaches wherein the trigger sensor line is located internally of the breathing conduit assembly (Rothermel teaches the control interface 34 to be removably attached to a headgear assembly 50 as seen in Fig. 4 and Col. 6, lines 26-48 and the control interface 34 to communicate with the gas delivery system 12 via a wired link as seen in Fig. 12 and Col. 11, lines 16-29. As such, the signal pathways 104/96a and 96b is to be at least partially located internally of patient circuit 26 to reach gas delivery system 12 as seen in Fig. 1). Regarding claim 31, Rothermel in view of Pyles teaches the system of claim 2, and further teaches wherein the trigger sensor is located on the breathing conduit assembly or the patient interface (Rothermel teaches the control interface 34 to be removably attached to a headgear assembly 50 as seen in Fig. 4 and Col. 6, lines 26-48, therefore the pneumatic source 102 is on the surface of the control interface 34 and the pressure transducer (taught by Pyles) is located internally of the headgear assembly 50).
Regarding claim 32, Rothermel in view of Pyles teaches the system of claim 17, and Rothermel further teaches wherein the trigger is a pneumatic trigger (pneumatic signal source 102, see Fig. 11A-11B) comprising a housing (housing, see Annotated Rothermel’s Fig. 11A) and a moveable member (depressible surface 106, see Figs. 11A-11B) (see Annotated Rothermel’s Fig. 11A), wherein the housing and the moveable member at least partially define the compressible chamber (the housing and the movable member at least partially define fluid reservoir 108 as seen in Annotated Rothermel’s Fig. 11A).
Annotated Rothermel’s Fig. 11A
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Regarding claim 41, Rothermel in view of Pyles teaches the system of claim 2, and Rothermel further teaches wherein the trigger is configured to interact with a respiratory therapy apparatus or system, or a connector (pneumatic signal source 102 interacts with patient treatment system 10 as seen in Figs. 1, 10 and 11A-11B and Col. 10, lines 33-51).
Claim(s) 3-4 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothermel (US 8439031 B1) in view of Pyles (US 20100228224 A1), as applied to claim 2 above, and further in view of Schindhelm (WO 2013067580 A1).
Regarding claim 3, Rothermel in view of Pyles teaches the system of claim 2, but does not teach wherein the second pressure is greater than the first pressure.
However, Schindhelm teaches wherein the second pressure is greater than the first pressure (Schindhelm teaches a patient manually changing pressure support by activation of a button from a first pressure relating to a EPAP level (taken as PEEP) to a second pressure relating to a IPAP level (taken as PIP) as seen in Fig. 6 and [85], [91]-[92] and [108]. Schindhelm further teaches IPAP to be from 11-15 cm H2O and EPAP to be about 10 cm H2O as seen in Fig. 7A and [37], where the IPAP is a greater pressure than the EPAP (also shown in Fig. 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 Rothermel in view of Pyles to have the respiratory therapy apparatus generate a first pressure related to PEEP and a second pressure related to PIP as taught by Schindhelm to allow the apparatus to more closely match a patient’s needs, particularly in the face of a changing need and for more comfort (see [216]-[217]).
Regarding claim 4, Rothermel in view of Pyles teaches the system of claim 2, but does not teach wherein the first pressure relates to a positive end expiratory pressure (PEEP) and the second pressure relates to a peak inspiratory pressure (PIP).
However, Schindhelm teaches wherein the first pressure relates to a positive end expiratory pressure (PEEP) and the second pressure relates to a peak inspiratory pressure (PIP) (Schindhelm teaches a patient manually changing pressure support by activation of a button from a first pressure relating to a EPAP level (taken as PEEP) to a second pressure relating to a IPAP level (taken as PIP) as seen in Fig. 6 and [85], [91]-[92] and [108]).
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 Rothermel in view of Pyles to have the respiratory therapy apparatus generate a first pressure related to PEEP and a second pressure related to PIP as taught by Schindhelm to allow the apparatus to more closely match a patient’s needs, particularly in the face of a changing need and for more comfort (see [216]-[217]).
Regarding claim 9, Rothermel in view of Pyles teaches the system of claim 2, but does not teach wherein the controller is configured to deliver (i) positive end expiratory pressure (PEEP) based on the detection of a signal produced by the trigger, (ii) peak inspiratory pressure (PIP) based on the detection of a signal produced by the trigger, or (iii) both (i) and (ii).
However, Schindhelm teaches wherein the controller is configured to deliver (i) positive end expiratory pressure (PEEP) based on the detection of a signal produced by the trigger, (ii) peak inspiratory pressure (PIP) based on the detection of a signal produced by the trigger (Schindhelm teaches a patient manually changing pressure support by activation of a button from a first pressure relating to a EPAP level (taken as PEEP) to a second pressure relating to a IPAP level (taken as PIP) as seen in Fig. 6 and [85], [91]-[92] and [108]. Therefore, when the trigger button is pressed, the controller is configured to deliver a IPAP based on the detection of the signal produced by the trigger button as seen in Fig. 6 and [108]), or (iii) both (i) and (ii).
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 Rothermel in view of Pyles to have the respiratory therapy apparatus generate a first pressure related to PEEP and a second pressure related to PIP as taught by Schindhelm to allow the apparatus to more closely match a patient’s needs, particularly in the face of a changing need and for more comfort (see [216]-[217]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothermel (US 8439031 B1) in view of Pyles (US 20100228224 A1), as applied to claim 2 above, and further in view of Boulanger (US 20190160241 A1).
Regarding claim 19, Rothermel in view of Pyles teaches the system of claim 2, and Pyles further teaches a pressure transducer (see [0246]) but does not teach wherein the trigger sensor is a gauge, absolute or differential pressure sensor.
However, Boulanger teaches wherein the pressure sensor is a gauge, absolute or differential pressure sensor (Boulanger teaches an absolute pressure sensor for measuring an absolute pressure and transmitting an absolute pressure signal to the processing unit as seen in Fig. 5A and [0106]).
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 Rothermel in view of Pyles to replace the pressure transducer with the pressures sensor taught by Boulanger as an alternative pressure sensor that performs a similar function that is also inexpensive and has a low power consumption (see [0081]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothermel (US 8439031 B1) in view of Pyles (US 20100228224 A1), as applied to claim 18 above, and further in view of Schindhelm (WO 2013067580 A1).
Regarding claim 21, Rothermel in view of Pyles teaches the system of claim 18, but does not teach wherein the controller is configured to control the respiratory therapy system to deliver the second pressure when the compressible chamber pressure is below a compressible chamber pressure threshold, and the first pressure when the compressible chamber pressure is above the compressible chamber pressure threshold.
However, Schindhelm teaches a controller configured to allow a patient to manually adjust IPAP or EPAP as seen in [31]. Schindhelm further teaches the controller 104 generating a desired pressure set point as seen in Fig. 10 and [188]-[189].
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 Rothermel in view of Pyles to include the controller taught by Schindhelm to have the controller generate a desired pressure set point so that it can be used for different pressure treatment therapies (see [189]). Modified Rothermel teaches wherein the controller (controller 104, see Fig. 10 of Schindhelm) is configured to control the respiratory therapy system to deliver the second pressure when the compressible chamber pressure is below a compressible chamber pressure threshold (Schindhelm teaches controller 104 generating a desired pressure set and allowing a patient to manually adjust to a target IPAP or EPAP as seen in [31]. Therefore, the second pressure, chosen by the controller 104 of Schindhelm to be the starting pressure, is delivered when the depressible surface 106 of Rothermel has not been pressed by the user and the fluid reservoir 108 of Rothermel has not been collapsed. As such, the pressure in fluid reservoir 108 is below a compressible chamber pressure threshold as the fluid reservoir has not been pressed/collapsed as shown in Fig. 11A of Rothermel), and the first pressure when the compressible chamber pressure is above the compressible chamber pressure threshold (when the depressible surface 106 has been pressed by a user, fluid reservoir 108 collapses and fluid is forced out of the reservoir 108 as seen in Fig. 11B and Col. 10, lines 33-51 of Rothermel. When the fluid is forced out of the reservoir 108, a pneumatic signal/pulse of fluid is generated (due to the pressure being above the compressible chamber press threshold) which is detected by controller 32 to deliver gas at a first pressure (chosen by the controller 104 of Schindhelm to be the pressure manually adjusted to by the patient as seen in [31] of Schindhelm) as seen in Col. 10, lines 33-51 of Rothermel).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothermel (US 8439031 B1) in view of Pyles (US 20100228224 A1), as applied to claim 16 above, and further in view of Jafari (US 20100051029 A1).
Regarding claim 22, Rothermel in view of Pyles teaches the system of claim 16, but does not teach wherein the trigger sensor line is located externally of the breathing conduit assembly.
However, Jafari teaches wherein the sensor line (sensor tubes 62 and 64, see Fig. 1) is located externally of the breathing conduit assembly (sensor tubes 62 and 64 are located externally of the ventilator circuit 30 as seen in 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 Rothermel in view of Pyles to have the trigger sensor line be external of the breathing conduit assembly as taught by Jafari as a design choice that will not affect the functionality of the system. Furthermore, one of ordinary skill in the art would recognize that the sensor line can either be external or internal of the breathing conduit assembly.
Claim(s) 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothermel (US 8439031 B1) in view of Pyles (US 20100228224 A1), as applied to claim 2 above, and further in view of Moody (US 20040040559 A1).
Regarding claim 24, Rothermel in view of Pyles teaches the system of claim 2, and Rothermel further teaches control interface 34 to be on any structure mounted or connected to a patient interface and is immediately accessible of the patient (see Col. 5, lines 48-61) but does not teach wherein the respiratory therapy system comprises a connector disposed between the breathing conduit assembly and the patient interface.
However, Moody teaches wherein the respiratory therapy system (Fig. 1 shows a PEEP system to provide pressured gas to an infant as seen in [0069]) comprises a connector (pressure regulator 134, see Figs. 1 and 6; Applicant teaches a connector element 310 shown in Figure 5 which is similar in structure to the pressure regulator 134 shown in Fig. 6 taught by Moody) disposed between the breathing conduit assembly and the patient interface (pressure regulator 134 is disposed between the inhalatory conduit 121 and nasal mask 128 as seen in Fig. 1 and [0069]).
Rothermel teaches the control interface 34 to be on any structure mounted or connected to a patient interface and is immediately accessible of the patient as seen in Col. 5, lines 48-61. Furthermore, Rothermel gives an example of a pneumatic signal source 102 as a source of control interface 34 as shown in Figs. 11A-11B and Col. 10, lines 33-38., which includes a depressible surface 106 for a user to apply force to. Moody teaches a pressure regulator 134 connected to a patient interface as seen in Figs. 1 and 6 with an orifice 306 that can be occluded by an operator to vary pressure as seen in [0081]. As both prior arts teach a trigger (pneumatic signal source 102 of Rothermel and umbrella valve 308 with orifice 306 of Moody) near the patient interface for an operator to interact with to adjust pressure for the respiratory therapy system, 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 Rothermel in view of Pyles to include a connector between the breathing conduit and patient interface and have the trigger disposed on the connector as taught by Moody as an alternative structure to place the trigger on that is connected to the patient interface.
Regarding claim 25, modified Rothermel teaches the system of claim 24, and further teaches wherein the trigger is disposed on the connector (Modified Rothermel teaches pneumatic signal source 102 (taught by Rothermel) disposed on the pressure regulator 134 (taught by Moody)).
Regarding claim 26, Rothermel in view of Pyles teaches the system of claim 24, and further teaches wherein the connector (pressure regulator 134, see Figs. 1 and 6 of Moody) has a first outlet (first outlet 304, see Fig. 6 of Moody) in fluid communication with the patient interface (outlet 304 is connected to the mask and neonate as seen in [0081] of Moody), an inlet (inlet 302, see Fig. 6 of Moody) in fluid communication with the breathing conduit assembly (inlet 302 of pressure regulator 134 is in fluid communication with inhalatory conduit as seen in Fig. 1 and [0068] of Moody) and an opening that defines a chamber (fluid reservoir 109 comprises of an opening (defined as “a hole or space that something or someone can pass through” by the Cambridge dictionary) which defines it as seen by the space in Annotated Rothermel’s Fig. 11A), and wherein the trigger is located on the chamber (Modified Rothermel teaches pneumatic signal source 102 of Rothermel located on the fluid reservoir 108 of Rothermel as seen on Figs. 11A-11B).
Regarding claim 27, Rothermel in view of Pyles teaches the system of claim 16, but does not teach wherein a portion of the trigger sensor line terminates inside the connector at the trigger.
However, Moody teaches wherein the respiratory therapy system (Fig. 1 shows a PEEP system to provide pressured gas to an infant as seen in [0069]) comprises a connector (pressure regulator 134, see Figs. 1 and 6; Applicant teaches a connector element 310 shown in Figure 5 which is similar in structure to the pressure regulator 134 shown in Fig. 6 taught by Moody).
Rothermel teaches the control interface 34 to be on any structure mounted or connected to a patient interface and is immediately accessible of the patient as seen in Col. 5, lines 48-61. Furthermore, Rothermel gives an example of a pneumatic signal source 102 as a source of control interface 34 as shown in Figs. 11A-11B and Col. 10, lines 33-38., which includes a depressible surface 106 for a user to apply force to. Moody teaches a pressure regulator 134 connected to a patient interface as seen in Figs. 1 and 6 with an orifice 306 that can be occluded by an operator to vary pressure as seen in [0081]. As both prior arts teach a trigger (pneumatic signal source 102 of Rothermel and umbrella valve 308 with orifice 306 of Moody) near the patient interface for an operator to interact with to adjust pressure for the respiratory therapy system, 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 Rothermel in view of Pyles to include a connector and have the trigger disposed on the connector as taught by Moody as an alternative structure to place the trigger on that is connected to the patient interface. Modified Rothermel teaches wherein a portion of the trigger sensor line terminates inside the connector element at the trigger (a portion of the signal pathway 104 of Rothermel terminates/starts inside the pressure regulator 134 of Moody at the pneumatic signal source 102 of Rothermel).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothermel (US 8439031 B1) in view of Pyles (US 20100228224 A1), as applied to claim 2 above, and further in view of McGroary (US 20110308518 A1).
Regarding claim 29, Rothermel in view of Pyles teaches the system of claim 2, but does not teach wherein the respiratory therapy apparatus comprises a vent arrangement.
However, McGroary teaches wherein the respiratory therapy apparatus comprises a vent arrangement (“…exhaust vent 57 is provided in delivery conduit 56 for venting exhaled gasses from the system, as generally indicated by arrow E. It will be appreciated that exhaust vent 57 can be provided at other locations (not shown) in addition to, or instead of, in delivery conduit 56 such as, for example and without limitation, in patient interface device 58.” See [0028] and Fig. 2).
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 Rothermel in view of Pyles to include a vent arrangement as taught by McGroary to help maintain a desired level of pressure in the system (see [0029]).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothermel (US 8439031 B1) in view of Pyles (US 20100228224 A1), as applied to claim 32 above, and further in view of Kriesel (US 5743879 A).
Regarding claim 33, Rothermel in view of Pyles teaches the system of claim 32, but does not teach wherein the trigger comprises a plurality of projections within the compressible chamber to define a boundary for the inward deflection of the moveable member.
However, Kriesel teaches wherein the trigger (push button assembly 180, see Figs. 21, 23 and 33) comprises a plurality of projections (circumferentially spaced, arcuate shaped retaining segments 200, see Figs. 21, 23 and 33) within the compressible chamber (chamber 194, see Figs. 23 and 33) to define a boundary for the inward deflection of the moveable member (push button 192, see Figs. 21, 23 and 33) (circumferentially spaced, arcuate shaped retaining segments 200 define a boundary for the inward deflection of push button 192 as seen in Fig. 33 and Col. 13, lines 23-26).
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 Rothermel in view of Pyles to include the plurality of projections taught by Kriesel to have the plurality of projections engage the trigger (see Col. 13, lines 23-26) to prevent the trigger from further inward deflection than necessary.
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