DETAILED ACTION
This Office Action is in response to the filing of an amendment to the claims on 3/26/2025. As per the amendment, claims 1, 31, and 52 have been amended, claim 63 has been cancelled, and claims 70-71 have been added. Thus, claims 1-2, 4-6, 8, 13, 15-16, 26, 28, 31-32, 45-47, 52, 67-68, and 70-71 are pending in the application.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/10/2025 has been entered.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4-6, 13, 16, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Travan (US Pub. 2007/0056587) in view of Baumont (US Pat. 3,815,593) in view of Haroutunian (US Pub. 2008/0092888).
Regarding claim 1, Travan discloses a device, comprising: a fluidic amplifier (device 10 in Figs. 3 and 5; see also [0094]) with a plurality of coaxially aligned components (see Fig. 5 where device 10 has a longitudinal axis that the components aligns with, such as end portion 41, delivery outlet 17, main pipe 18, and injector 35), the fluidic amplifier comprising: a fluid inlet configured to receive a ventilation gas (see Fig. 5 passage 44 and flexible cannula 51; and further see [0002], [0042], and [0114] where the outputted gas is used for ventilatory support, and thus is a ventilation gas), a nozzle configured to control velocity of the ventilation gas moving through the device (see Fig. 5 injector 35 with a nozzle at cone portion 42 as seen in Fig. 7b, which controls velocity via a jet as seen in [0093]), a fluid outlet configured to couple with a patient, the outlet being coaxial with the nozzle (see Fig. 5 end portion 41; see also [0046] and Fig. 2 where front portion 15a connects to a patient (analogous to end portion 41 in Fig. 5)), an exhaust (see Fig. 6c where the flow through the device can be drawn out through an exhaust at filter 70 (see Fig. 5)).
Travan lacks a detailed description of the monostable fluidic amplifier, wherein the monostable fluidic amplifier is configured so that when the fluid outlet is coupled to the patient, the ventilation gas acts as a control gas to switch flow of the ventilation gas between the fluid outlet and the exhaust. Further, in the alternative that Travan does not explicitly disclose a fluidic amplifier, then it is taught by Baumont.
However, Baumont teaches a fluidic amplifier that has a monostable design (see amplifier 3 in Fig. 1; see also Col. 2 lines 30-50), the fluidic amplifier having two outlets, a first leading to a first flow path (see Fig. 1 and Col. 2 lines 30-50 where a first outlet of amplifier 3 is at 0) and a second leading to a fluid outlet (see Fig. 1 and Col. 2 lines 30-50 where a second outlet of amplifier 3 is at 1, being a fluid outlet for the incoming gas), where the gas acts as a control gas to switch flow of the gas between the fluid outlet and the exhaust (see Col. 2 lines 30-50 where the gas in the system, coming from additional gas inlet/ suction C3 and C4, act on the gas passing through the fluidic amplifier to control whether it goes to outlet 0 or outlet 1).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluidic amplifier of the modified Travan device to be a monostable fluidic amplifier that can use the incoming gas to control the outlet of the gas as taught by Baumont, as it would be a simple substitution of one type of fluidic amplifier for another, to yield the predictable result of still providing a fluidic amplifier, while also providing the benefit of control over the outlet of the gas flow for adjustment of the exhalation pause time depending on varying respiration parameters (Baumont; see Col. 1 lines 30-45). It is understood that in the modified Travan device, injector of Travan is modified to be the fluidic amplifier of Baumont that can select between the exhaust path (out the filter of Travan) or the respiratory path (through end 41 of Travan) based on the gas control of the fluidic amplifier.
The modified Travan device lacks a detailed description of a splitter between the exhaust and the patient outlet, the splitter being coaxial with the nozzle and the patient outlet.
However, Haroutunian teaches a flow modification device for respiratory use, where a flow splitting structure is located just proximal to the patient outlet end, and is coaxial with the rest of the flow path components (see Figs. 1-3 where near outlet end 36 is dividers 60 which form a plurzlity of flow passages 64a-64d in order to establish laminar flow as seen in [0025] and [0041]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outlet end of the modified Travan device to have a divider just prior to the outlet end as taught by Haroutunian, as it would create a laminar flow pattern for easier breathing and better entrainment of any suspended particles. It is understood that the modified flow divider is just prior the outlet end of Travan, such that it is coaxial, and is between the patient outlet end and the filter/ exhaust.
Regarding claim 2, the modified Travan device has wherein the fluidic amplifier comprises a Channel Depth for controlling pressure and/or volume of gas moving through the device (Travan; see Fig. 5 where the constricting section of shaped body 15 at pipe 18 and including narrowing 40, comprise a channel depth which alters the pressure of the gas by changing the volume, as per Boyle’s Law; see also [0024]).
Regarding claim 4, the modified Travan device has wherein the Channel Depth comprises a tear drop shaped channel for stabilizing incoming oxygen gas (Travan; see Fig. 5 where the shape of shaped body 15 from front portion 15a to narrowing 40, is in the shape of a tear drop (a conical end with an opposite bulbous end), which stabilizing incoming air as seen in [0133]).
Regarding claim 5, the modified Travan device has wherein the Channel Depth comprises an inspiration phase channel and/or an expiration phase channel (Travan; see [0107]-[0112] where the length of the channel from narrowing 40 to outlet 17 is an inspiration phase channel).
Regarding claim 6, the modified Travan device has wherein the fluidic amplifier comprises a nozzle width for controlling velocity of gas moving through the device (Travan; see Figs. 5 and 7b where injector 35 has a cone portion 42 with a width (being the outlet of the modified Travan injector/ fluidic amplifier), which controls the velocity of gas exiting the ejector; see also [0099]).
Regarding claim 13, the modified Travan device has wherein the fluidic amplifier is connected to a gas source (Travan; see [0044]).
Regarding claim 16, the modified Travan device has wherein the plurality of coaxially aligned components include a Nozzle (Travan; see Fig. 5 injector 35), Outlet (Travan; see Fig. 5 outlet 17), and Channel Depth (Travan; see Fig. 5 pipe 18 and narrowing 40).
Regarding claim 26, the modified Travan device has wherein the fluidic amplifier is integrated with a flow generating device (Travan; see [0044] where system 13 feeds a flow of oxygen).
Claims 31-32, 47, 52, and 67-68 rejected under 35 U.S.C. 103 as being unpatentable over Travan in view of Baumont in view of Haroutunian as applied to claim 1 above, and further in view of Homuth et al. (US Pub. 2014/0005566).
Regarding claim 31, the modified Travan device has a kit (Travan; the system of Figs. 1-9, which are provided as a single system or kit), comprising: an apparatus comprising a fluidic amplifier of claim 1 (see rejection of claim 1), the outlet and the fluidic amplifier being in line (see the in-line configuration in Fig. 5 between device 10 and its outlet 17).
The modified Travan device lacks a detailed description of an endotracheal tube, the endotracheal tube and the fluidic amplifier being in line.
However, Homuth teaches a similar pressure regulation system for respiratory use, where the system is connected to an endotracheal tube (see [0081]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outlet leading to a patient interface of the modified Travan device to be an endotracheal tube as taught by Homuth, as it would be a simple substitution of one patient interface device for another, to yield the predictable result of providing the respiratory gas to the patient.
Regarding claim 32, the modified Travan device has wherein the fluidic amplifier comprises one or more coaxially aligned components (see Fig. 5 where device 10 has a longitudinal axis that the components aligns with, such as end portion 41, delivery outlet 17, main pipe 18, and injector 35).
Regarding claim 47, the modified Traven device has wherein the apparatus is operably linked to the subject for inspiration and expiration phases of ventilation (Travan; see [0107] and [0116]).
Regarding claim 52, the modified Travan device has a method of treating a patient with an adverse condition, comprising: providing a ventilation device comprising a fluidic amplifier of claim 1 (see above rejection of claim 1) and treating the patient by ventilation (Travan; see [0002]).
The modified Travan device lacks a detailed description of wherein the fluidic amplifier is connected to and/or incorporated into a Bag Valve Mask (BVM).
However, Homuth teaches a similar pressure regulation system for respiratory use, where the system is connected to a manual resuscitating bag (see [0002] and [0012]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluidic amplifier system of the modified Travan device to be connected to a manual resuscitator bag as taught by Homuth, as it would be a simple substation of one source of positive pressure ventilation for another, to yield the predictable result of providing a positive pressure flow of air to the fluidic amplifier.
Regarding claim 67, the modified Travan device has wherein the fluidic amplifier provides a Peak Inspiratory Pressure.
The modified Travan device lacks a detailed description of wherein the fluidic amplifier provides a Peak Inspiratory Pressure (PIP) of 9 cmH20, a Positive End Expiratory Pressure (PEEP) of 7 cmH20, and/or a CPAP of 8 cmH20.
However, Homuth further teaches the system having a PIP of 10 cmH2O (see [0176]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PIP of the modified Travan device to be 9 cmH2O as taught by Homuth, as it would provide a positive pressure above atmosphere to ensure the gas can flow into an enter the patient airway. A person of ordinary skill in the art would consider it a simple matter of design choice for choose a PIP that fits the needs of their device, and as such it would be obvious to choose a value for the PIP such as 9 cmH2O, which is between the values of 4 and 10 recited by Homuth ([0176]-[0177]), as the particular value chosen lacks criticality.
Regarding claim 68, the modified Travan device has wherein the fluidic amplifier provides pressure cycled mechanical ventilation (Travan; see [0090], [0121], and [0131]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Travan in view of Baumont in view of Haroutunian as applied to claim 1 above, and further in view of Kroupa (US Pat. 8,656,913).
Regarding claim 8, the modified Travan device has wherein the fluidic amplifier provides gas.
The modified Travan device lacks a detailed description of wherein the fluidic amplifier provides a Respiratory Rate of 2 to 200 bpm.
However, Kroupa teaches a similar patient ventilation system, where the delivered bpm is controlled by the user and can be 10 or 30 bpm (see Col. 16 line 53 to Col. 17 line 18).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supplied bpm of the modified Travan device to be 10 or 30 bpm as taught by Kroupa, as it would provide a flow of ventilatory gas that is known to maintain a healthy breathing rate.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Travan in view of Baumont in view of Haroutunian as applied to claim 1 above, and further in view of Minskoff et al. (WO 2017/177068).
Regarding claim 15, the modified Travan device has wherein the fluidic amplifier connects to the oxygen tubing.
The modified Travan device lacks a detailed description of wherein the fluidic amplifier comprises a barb and/or threaded connector that connects to the oxygen tubing.
However, Minskoff teaches a similar fluidic amplifier device (see [00233]) that has a barbed connector that attached to tubing (see [00235] and Fig. 12 where the connection to the positive pressure inlet 1211 is via barbed connector).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector between the fluidic amplifier and oxygen tubing of the modified Travan device to be a barbed connection as taught by Minskoff, as it would be a simple substation of one type of connection to a hose for another, to yield the predictable result of attaching the fluidic amplifier to the oxygen tubing.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Travan in view of Baumont in view of Haroutunian as applied to claim 1 above, and further in view of Homuth.
Regarding claim 28, the modified Travan device has wherein the fluidic amplifier provides a PIP.
The modified Travan device lacks a detailed description of wherein the fluidic amplifier provides a PIP of between 5 and 50 cmH20.
However, Homuth further teaches a similar pressure regulating system, where the system has a PIP of 10 cmH2O (see [0176]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PIP of the modified Travan device to be 10 cmH2O as taught by Homuth, as it would provide a positive pressure above atmosphere to ensure the gas can flow into an enter the patient airway.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Travan in view of Baumont in view of Haroutunian in view of Homuth as applied to claim 31 above, and further in view of Kroupa.
Regarding claim 45, the modified Travan device has a fluidic amplifier.
The modified Travan device lacks a detailed description of a fluidic amplifier with a RR between 10- 19 bpm, a fluidic amplifier with a RR between 20-27 bpm, and/or a fluidic amplifier with a RR between 28-50 bpm.
However, Kroupa teaches a similar patient ventilation system, where the delivered bpm is controlled by the user and can be 10 or 30 bpm (see Col. 16 line 53 to Col. 17 line 18).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supplied bpm of the modified Travan device to be 10 or 30 bpm as taught by Kroupa, as it would provide a flow of ventilatory gas that is known to maintain a healthy breathing rate. It is noted that the claim only requires one fluidic amplifier that has an acceptable bpm range.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Travan in view of Baumont in view of Haroutunian in view of Homuth as applied to claim 31 above, and further in view of Dugan et al. (US Pub. 2012/0285448).
Regarding claim 46, the modified Travan device has one or more fluidic amplifiers as part of an overall protocol for treating a severe lung condition in a patient.
The modified Travan device lacks a detailed description of one or more color coded fluidic amplifiers as part of an overall protocol for treating a severe lung condition in a patient.
However, Dugan teaches a similar respiratory device, where the system can come color coded to make it easier to distinguish between different part sets (see [0178]-[0179]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluidic amplifier of the modified Travan device to be color coded with its compatible parts as taught by Dugan, as it would ensure that the proper parts are used together, making sure that the device is properly assembled for the patient.
Claims 70-71 are rejected under 35 U.S.C. 103 as being unpatentable over Travan in view of Baumont in view of Haroutunian as applied to claim 1 above, and further in view of Richards (US Pub. 2017/0319800).
Regarding claim 70, the modified Travan device has wherein the monostable fluidic amplifier further comprises: a biased port attachment surface (Travan; see Fig. 5 where a front portion 15a of body 15 is a surface that narrows and biases towards the central axis).
In the alternative that the modified Travan device does not have wherein the monostable fluidic amplifier further comprises: a biased port attachment surface, then it is taught by Richards.
Richards teaches a respiratory device, where a flowpath can have a biased port attachment surface (see Fig. 4 where conduit 204 is a port, with a free end 206 having a surface at inwardly-stepped Coanda profile 208 that biases inward).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flow path of the modified Travan device to include a conduit with a Coanda profile surface as taught by Richards, as it would amplify the positive air pressure provided to the patient during inhalation (Richards; see [0021]).
Regarding claim 71, the modified Travan device has wherein the biased port attachment surface is configured to provide a Coanda effect inspiration flow (Richards; see Fig. 4 where Coanda profile 208 is a surface that provides a Coanda effect during inspiration; see also [0021]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record. Specifically, the newly applied teaching references of Haroutunian and Richards.
Applicant argues on pages 6-7 that the claimed invention has advantages over the prior art. The argument is not well-taken. Any advantages should be clearly conveyed though the claim language, and the breadth of the claim language does not fully capture the argued advantages.
Applicant argues on pages 7-8 that Travan in view of Baumont does not have the ventilation gas acting as a control gas, as Baumont relies on control lines, valves, and pneumatic circuits that would change the principle of operation of Travan. The argument is not well-taken. Firstly, Travan is directed to a system that can amplify the fluid (see [0094] and [0098]-[0099]). Baumont is then directed to a fluid amplifier system that is well known (see Col. 2 lines 35-40, and the fact the patent is from 1974). Hence, a person of ordinary skill in the art would be capable of taking a fluidic amplifier such as Travan, and modifying it in light of a well-known fluidic amplification configuration as taught by Baumont. While the modified Travan device does have different structures than Travan by itself, it is understood that both perform a fluidic amplification, and thus the principle of operation does not change.
Applicant argues on pages 9-10 that the modification of Travan renders it unsuitable for its intended purpose, as Travan is directed to a CPAP system, and a monostable fluidic amplifier would be switching between different outlets. The argument is not well-taken. The flow of fluid in the modified Travan device would remain constant and positive until acted upon to change outlets. Hence, a practitioner or user can keep the system in a CPAP-like state for an extended period of time before switching the outlet via the amplifier. Thus, the modification does not destroy the ability for Travan to deliver a CPAP flow, but rather adds an additional control that allows for the flow to be selectively interrupted (e.g. when the patient resumes strong spontaneous breathing, or is in discomfort).
Applicant argues on page 10 that the claimed invention yields unexpected and non-obvious advantages. The argument is not well-taken. It is understood that the modified Travan device includes the necessary components to function as taught by Baumont in order to selectively change the output via a control gas. The amplifier is part of an inspiratory circuit, and the control is between a patient outlet and an environmental outlet, rather than an expiratory functionality. Other advantages are not part of the present claim language, such as the disposability and reduced gas consumption. The advantages of the claimed invention should be captured by claim language in order to be fully considered and weighted.
Applicant argues on pages 10-13 of the remarks that Travan does not disclose a fluidic amplifier, as it is instead a venturi entrainment system and includes no active control or signal amplification. The argument is not well-taken. The Travan device is understood to amplify the gas flow through the system, and thus acts as a fluidic amplifier (as seen in [0094] and [0098]-[0099]). That fluidic amplification is done through the physical shape and characteristics of the flow path (and as modified by Baumont) such that the modified Travan device is a fluidic amplifier. Thus, the Travan device does at least disclose an air amplifier (where air is a fluid). Further, in the alternative that Traven does not explicitly have a fluidic amplifier, it is then taught by the applied Baumont reference.
Thus, for the reasons above, the rejections hold.
Conclusion
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785