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 (IDS) submitted on 03/26/2025, 09/30/2025, 11/05/2025, and 06/15/2016 have been considered by the examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 12-13, 17-18, 24, 44-48, 50, 58, and 60 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Broberg et al. WO2014/041104
Regarding claim 1, Broberg teaches a positive pressure breathing circuit for ventilating a patient (Page 15 of the attached annotated reference states “Expiratory pressure, e.g. for a positive end expiratory pressure (PEEP) regulation is provided” because PEEP is provided, the system can be considered a positive pressure breathing circuit), the positive pressure breathing circuit comprising: an inspiratory tube (Figure 4, inspiratory tube 6) that is connectable to:
i) a patient interface for supplying a breathing gas (Patient tube 2, figure 4), ii) a source of a pressurized first gas (Driving gas 35) and iii) a source of a pressurized second gas (oxygen and air gas source 20a and 20b), wherein the pressurized second gas enters the inspiratory tube downstream to where the pressurized first gas enters the inspiratory tube (Second gas enters through 19, and first gas through 15, 19 is located downstream from 15);
and an expiratory tube (expiration tube 90) configured to receive exhaled gas and vent gases including the exhaled gas from the patient interface (Page 14 states that “An evacuation line or exhaust 36 is connected to the common expiration and inspiration line 14 and to the reflector driving gas line 35A at the junction 24.”);
wherein the inspiratory tube is connectable to the expiratory tube so that any excess of the pressurized first gas supplied to the inspiratory tube can be conveyed to the expiratory tube (Inspiratory tube 6 is connected to expiratory tube 90 via y-piece 4, excess gas from the inspiratory tube can be conveyed to the expiratory tube as they are directly connected), and the expiratory tube is configured so that an excess supply of the pressurized first gas conveyed to the expiratory tube and the exhaled gas received by the expiratory tube can be vented from the positive pressure breathing circuit (Page 14 states “An evacuation line or exhaust 36 is connected to the common expiration and inspiration line 14 and to the reflector driving gas line 35A at the junction 24).
Regarding claim 2, Broberg teaches the positive pressure breathing circuit according to claim 1, wherein a distal portion of the inspiratory tube is connectable to the source of the pressurized first gas (Distal portion of tube 6 is connected to the pressurized first gas source via junction 15, as shown in figure 4).
Regarding claim 3, Broberg teaches the positive pressure breathing circuit according to claim 1, wherein a proximal portion of the inspiratory tube is connectable to the source of the pressurized second gas (Proximal portion of inspiratory tube 6 is connected to the second gas source via junction 19 as shown in figure 4.).
Regarding claim 5, Broberg teaches the positive pressure breathing circuit claim 1, wherein the inspiratory tube includes a first non-return valve (Figure 4, one way valve 8).
Regarding claim 6, Broberg teaches the positive pressure breathing circuit according to claim 5, wherein the first non-return valve is arranged between the patient interface and the pressurized second gas entering the inspiratory tube (One way valve 8 is arranged between the gas source 20a and 20b and tubing 2).
Regarding claim 12, Broberg teaches the positive pressure breathing circuit according claim 1, wherein the expiratory tube is configured so that all of the excess supply of the pressurized first gas conveyed to the expiratory tube and all the exhaled gas in the expiratory tube are vented from the positive pressure breathing circuit (Page 5 states that “If the volume entering the reflector is greater, then it is the difference (gas entering VR minus total reflector volume) that is emptied to the exhaust.” Furthermore, page 14 states “An evacuation line or exhaust 36 is connected to the common expiration and inspiration line 14 and to the reflector driving gas line 35A at the junction 2”).
Regarding claim 13, Broberg teaches the positive pressure breathing circuit according to claim 1, wherein the expiratory tube includes a second non-return valve (Figure 4, one-way valve 12).
Regarding claim 17, Broberg teaches the positive pressure breathing circuit according to claim 13, wherein the expiratory tube and the inspiratory tube are connectable downstream of the second non-return valve (Connected at junction 15).
Regarding claim 18, Broberg teaches the positive pressure breathing circuit according to claim 13, wherein the expiratory tube is configured so that all of the excess supply of the pressurized first gas conveyed to the expiratory tube downstream of the second non- return valve and all the exhaled gas in the expiratory tube downstream of the second non-return valve are vented from the positive pressure breathing circuit (Page 15 states “During expiration, the expiratory valve 37 is controlled to release gas to the evacuation 42. Exhalation gas from the patient 60 passes through the expiratory part of the breathing circuit 40 and via junction 15 into the line 14 and volume reflector 30. The expiratory flow is measured by the gas flow meter (gas sensor unit 640) in line 14”).
Rgearding claim 24, Broberg teaches the positive pressure breathing circuit according to claim 1, wherein the inspiratory tube is configured so that a volume of the pressurized second gas can enter and be loaded in the inspiratory tube whilst the pressurized first gas can be supplied to the inspiratory tube (Page 13 states “the common expiration and inspiration line 14 is coupled to the breathing circuit 40 at a junction 15”), and the pressurized first gas supplied in excess can be conveyed to the expiratory tube and vented from the expiratory tube (Page 14 states “An evacuation line or exhaust 36 is connected to the common expiration and inspiration line 14 and to the reflector driving gas line 35A at the junction 2”).
Regarding claim 44, Broberg teaches the positive pressure breathing circuit according to claim 13, wherein the pressurized first gas received by the expiratory tube is vented from the positive pressure breathing circuit without being accumulated or stored, and the expiratory tube is configured so that the exhaled gas passes through the second non-return valve and is vented from the positive pressure breathing circuit without being accumulated or stored (No accumulation means are depicted within the expiratory tube).
Regarding claim 45, Broberg teaches the positive pressure breathing circuit according to claim 13, wherein the expiratory tube is configured so that the pressurized first gas and the exhaled gas downstream of the second non-return valve are vented from the positive pressure breathing circuit without re-entering the inspiratory tube (Page 14 states “The evacuation line 36 leads, via a flow meter 37A and a pressure sensor to an expiratory valve 37 that is devised to control output of evacuated gas flow from the breathing circuit 40 via the VR 30 to a scavenging system 42 or to the atmosphere”).
Regarding claim 46, Broberg teaches the positive pressure breathing circuit according claim 1, wherein the positive pressure breathing circuit is configured so that a flow resistance for the pressurized first gas from the inspiratory tube to the expiratory tube via the patient interface is greater than a flow resistance for the pressurized first gas that is supplied in excess from the inspiratory tube to the expiratory tube (Flow resistance from the first pressurized gas that is passed via the patient interface of tubing 2 would by default have a higher resistance as it is passing back through an additional piece of tubing, as opposed to excess gas that directly passes from the inspiration to the expiration tubes without actually passing the y-piece.).
Regarding claim 47, Broberg teaches the positive pressure breathing circuit according to claim 1, further including a pressure regulation device configured to regulate pressure in the expiratory tube (Expiratory valve 37).
Regarding claim 48, Broberg teaches the positive pressure breathing circuit according to claim 47, wherein the pressure regulation device includes a pressure relief valve configured to vent the pressurized first gas and the exhaled gas from the expiratory tube (Page 14 states “The evacuation line 36 leads, via a flow meter 37A and a pressure sensor to an expiratory valve 37 that is devised to control output of evacuated gas flow from o the breathing circuit”).
Regarding claim 50, Broberg teaches the positive pressure breathing circuit according to claim 48, wherein the pressure relief valve is a positive end expiratory pressure valve having a fixed operating pressure or an operating pressure that can be manually adjusted (Page 15 states “Expiratory pressure, e.g. for a positive end expiratory pressure (PEEP) regulation is provided by a pressure sensor, that may be integrated with flow meter 37A”. Since the PEEP pressure does have the ability to be regulated, manual adjustment by the user can occur.).
Regarding claim 58, Broberg teaches the positive pressure breathing circuit according to claim 1, wherein the pressurized first gas comprises pressurized air (Page 14 states “Gas sources 20A,B,D,E provide the ventilation system 70 with air and 02.”).
Regarding claim 60, Broberg teaches the positive pressure breathing circuit according to claim 1, wherein the pressurized second gas comprises pressurized oxygen gas (Page 14 states “Gas sources 20A,B,D,E provide the ventilation system 70 with air and 02.”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Broberg in view of Eriksson et al. 2020/0038605
Regarding claim 26, Broberg teaches the positive pressure breathing circuit according to claim 1, but fails to teach wherein the positive pressure breathing circuit includes a bypass tube connecting the inspiratory tube and the expiratory tube, and the bypass tube conveys the pressurized first gas from the inspiratory tube to the expiratory tube. Eriksson teaches an analogous breathing apparatus that does teach wherein the positive pressure breathing circuit includes a bypass tube connecting the inspiratory tube and the expiratory tube, and the bypass tube conveys the pressurized first gas from the inspiratory tube to the expiratory tube (0059 states “the continuous flow of oxygen bypasses the patient 8 by traveling from the patient inspiration tube 19 directly to the patient expiration tube 18”, there would be some sort of tubing or conduit in between 19 and 18 that allows for this bypass to occur, the gas supply coming in from gas supply 16 makes its way directly to the inspiratory limb). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Broberg with the teachings of Eriksson and include wherein the positive pressure breathing circuit includes a bypass tube connecting the inspiratory tube and the expiratory tube, and the bypass tube conveys the pressurized first gas from the inspiratory tube to the expiratory tube for the purpose of allowing the expiratory phase of the breath to be provided (0059).
Regarding claim 27, Broberg in view of Eriksson teaches the positive pressure breathing circuit according to claim 26, wherein the inspiratory tube includes a first gas inlet for the pressurized first gas (inlet letting in fresh gas supply 16 of Eriksson), the first gas inlet is configured so that the pressurized first gas enters laterally to the inspiratory tube (Enters laterally to tube 19 as the inlet tubing laterally enters into tubing 19) and parallel or coaxial to the bypass tube (the relative direction of this gas inlet is located coaxial to the bypass tubing between 19 and 18).
Conclusion
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/ROHAN PATEL/ Examiner, Art Unit 3785
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
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