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 06/22/2023, 09/25/2023, 12/13/2024, and 10/14/2025 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 55-57, 64-71, and 74 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Holyaoke et al. 2018/0085544
Regarding claim 55, Holyoake teaches a multi-lumen assembly (Figure 44a, tubes 2306 and 2202) for use with a respiratory support system (Flowmeter 2124), the multi- lumen assembly comprising: a plurality of conduits including: a first inspiratory conduit (Inspiratory conduit of 2306) comprising a first conduit inflow end couplable with a first gas outlet of the respiratory support system (First end is connected to anesthetic machine 2404); a second inspiratory conduit (high flow gas conduit 2202) comprising a second conduit inflow end couplable with a second gas outlet of the respiratory support system (0862 states “to supply high flow gas to the cannula”, second gas outlet located on the flowmeter 2124); and an expiratory conduit comprising an expiratory conduit outflow end couplable with an expired gas inlet of the respiratory support system (0932 states “patient expiratory flow will be back into the tube to the bag/anaesthetic machine.”).
Regarding claim 56, Holyaoke teaches the multi-lumen assembly of Claim 55, wherein the first inspiratory conduit comprises a first conduit outflow end couplable with a first patient interface (outlet of inspiratory tube of 2306 is connected to mask 2300) configured to sealingly engage with and direct flow into an airway of a patient (Figure 3 depicts the mask sealed with the face of the patient).
Regarding claim 57, Holyaoke teaches the multi-lumen assembly of Claim 56, wherein the second inspiratory conduit comprises a second conduit outflow end couplable with a second patient interface configured to direct flow into an airway of the patient (Cannula 2200 is coupled with conduit 2202) and is a non-sealing interface (This is a non-sealing interface as it is a cannula that is placed within the patient’s nostrils).
Regarding claim 64, Holyaoke teaches the multi-lumen assembly of Claim 55, wherein the first inspiratory conduit is configured to deliver breathing gases including an anesthetic agent to a patient (Inspiratory conduit of 2306 is connected to anesthetic machine 2404.).
Regarding claim 65, Holyaoke teaches the multi-lumen assembly of Claim 55, wherein the expiratory conduit is configured to return expired gases from a patient to the respiratory support system (0932 states “patient expiratory flow will be back into the tube to the bag/anaesthetic machine.”).
Regarding claim 66, Holyaoke teaches the multi-lumen assembly of Claim 55, wherein the second inspiratory conduit is configured to deliver breathing gases to a patient at a flow rate between 20 L/min and 90 L/min (0653 states “a flowrate of gases supplied or provided to an interface or via a system, such as through a flowpath, may comprise, but is not limited to, flows of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 L/min, or more, and useful ranges may be selected between any of these values (for example, about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 100 L/min, about 70 to 80 L/min)”).
Regarding claim 67, Holyaoke teaches the multi-lumen assembly of Claim 55, wherein a flow switching mechanism operable to direct flow of breathing gas into the first inspiratory conduit or into the second inspiratory conduit (0354 states “The mechanically activated switch may be activated by a user, or alternatively may be activated by placement of a component of a respiratory delivery system being brought into contact with the switch, such as a subsequent patient interface being brought into contact with the conduit comprising the switch.”).
Regarding claim 68, Holyaoke teaches the multi-lumen assembly of Claim 67, but fails to teach wherein the flow switching mechanism is operatively linked with a respiratory support system controller (0072 states “a controller configured to determine, based on a generated signal or output from the first and second sensors, when the system switches or is to switch between the first and second respiratory modes.”).
Regarding claim 69, Holyaoke teaches the multi-lumen assembly of Claim 68 wherein the respiratory support system controller controls the respiratory support system to deliver breathing gases to the multi- lumen assembly according to operation of the flow switching mechanism by a user (0467 states “The sensor may be a mechanical switch activated by the second patient interface being placed into contact with said sensor, and generating the signal or output. The mechanical switch may comprise an actuatable projection or prong extending from the item, the projection or prong extending from the item at a point which is to come into contact with the second patient interface when the second patient interface is provided in an operational configuration with the patient.”).
Regarding claim 70, Holyaoke teaches the multi-lumen assembly of Claim 68, wherein the respiratory support system controller controls operation of the flow switching mechanism (0476 states “The pressure sensitive switch or sensing system may comprise a pressure sensor within the seal of the second patient interface, and the placement of the second patient interface upon the patient induces a change in pressure within the seal which is sensed by the sensor and a signal or output generated indicative of the presence of the second patient interface on the patient.”).
Regarding claim 71, Holyoake teaches the multi-lumen assembly of Claim 55, wherein the outflow end of the first inspiratory conduit and an inflow end of the expiratory conduit form a common gas flow pathway comprising a single gas exchange conduit which is couplable with a first patient interface (Figure 44A depicts tubes 2306 going into a singular gas flow pathway which is connected to the patient interface).
Regarding claim 74, Holyaoke teaches the multi-lumen assembly of Claim 55, further comprising a gas sampling conduit for monitoring one or more characteristics of gas (Figure 35 depicts sampling line 629 for monitoring pressure).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 58-59 and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Holyaoke, in view of Fitch et al. 2022/0126052
Regarding claim 58, Holyaoke teaches the multi-lumen assembly of Claim 55, but, wherein the conduits are arranged co-axially for at least a portion of a length of the plurality of conduits (Figure 44A depicts one of the inspiratory conduits and expiratory conduit with tubes 2306 arranged in a coaxial manner). However, Holyaoke fails to teach the second inspiratory conduit being located coaxially to the other two. Fitch discloses an analogous ventilator interface that does teach two different inspiratory conduits located coaxially (Figure 1, tubing 1110 and 1160 are both located coaxially) 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 the conduits of Holyaoke with the teachings of Fitch and include the second inspiratory conduit being arranged co-axially for at least a portion of a length of the plurality of conduits as this would allow for the inclusion of a switching mechanism to switch between both interfaces when desired (0056).
Regarding claim 59, Holyaoke teaches the multi-lumen assembly of Claim 58, wherein, for the portion of the length of the plurality of conduits that is arranged co-axially, an outer wall of an inner lumen of the plurality of conduits defines an inner wall of a co-axially adjacent lumen of the plurality of conduits (Figure 44a of Holyaoke depicts this configuration with the setup of tubing 2306, the outer wall of the expiratory tube defines an inner wall of the inspiratory tube.).
Regarding claim 72, Holyaoke teaches the multi-lumen assembly of Claim 55, but fails to explicitly wherein the multi-lumen assembly includes a patient-end connector for coupling: (a) an outflow end of the first inspiratory conduit with a first patient interface; and (b) an outflow end of the second inspiratory conduit with a second patient interface. Fitch does disclose an analogous ventilator interface that does teach wherein the multi-lumen assembly (Multi-lumen tubing 1140) includes a patient-end connector for coupling (Connector containing switch 1162): (a) an outflow end of the first inspiratory conduit with a first patient interface (1112 is connected to a first inspiratory conduit); and (b) an outflow end of the second inspiratory conduit with a second patient interface (tubing 1160 is connected to a second patient interface with a second inspiratory conduit). 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 Holyaoke with the teachings of Fitch and include a patient end connector as it provides a method of switching the type of therapy that is applied (0056).
Regarding claim 73, Holyaoke in view of Fitch teaches the multi-lumen assembly of Claim 72, wherein the patient end connector comprises a switching element operable to switch the connector between a first mode of operation in which the connector directs breathing gas to the first patient interface, and a second mode of operation in which the connector directs breathing gas to the second patient interface (Figure 1 of Fitch, switch 1162, 0056).
Claims 60-62 are rejected under 35 U.S.C. 103 as being unpatentable over Holyaoke, in view of Milne et al. 2016/0045702
Regarding claim 60, Holyaoke in view of Milne teaches the multi-lumen assembly of Claim 55, further comprising a mechanism to retain at least a length of the plurality of conduits in a group (Figure 11A depicts a retaining mechanism in the middle, holding the plurality of conduits together.). Regarding claim 61, Holyaoke in view of Milne teaches the multi-lumen assembly of Claim 60, wherein the mechanism comprises a webbing arranged between at least pairs of the plurality of conduits at intervals or continuously along at least a length of the plurality of conduits (Figure 11a of Milne depicts a configuration where there is webbing arranged between a plurality of conduits.).
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Regarding claim 62, Holyaoke in view of Milne teaches the multi-lumen assembly of Claim 61, but fails to explicitly teach wherein the webbing is frangible to facilitate separation of at least a length of one or more of the plurality of conduits from the group. However, making components separable may be considered obvious to a person of ordinary skill in the art and one of ordinary skill in the art would modify Holyaoke in view of Milne to make it wherein the webbing is frangible to facilitate separation of at least a length of one or more of the plurality of conduits from the group as this allows for . MPEP § 2144.04-V-C.
Conclusion
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785