DETAILED ACTION
This Office Action is in response to the filing of a preliminary amendment to the claims on 11/06/2024. As per the preliminary amendment, claims 1-181 have been cancelled, claims 182-201 have been added, and no claims have been amended. Thus, claims 182-201 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 .
Drawings
The drawings are objected to because Figs. 18, and 54-55 fail to comply with 37 CFR 1.84(h)(1) whereby exploded figures should have the elements embraced by a bracket in order to show the structural relationship between the components.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 182-201 are rejected under 35 U.S.C. 103 as being unpatentable over Schwaiger et al. (US Pub. 2021/0338960) in view of Tatkov (US Pub. 2016/0158476).
Regarding claim 182, Schwaiger discloses a nasal interface (nasal cannulas 110/ 210 in Figs. 3-4) comprising: an interface body (see Figs. 3-4 supply conduits 126/128 and 226/228) configured to substantially form a fluid connection with a nasal airway of a patient (where the end prong-tips of the supply conduits 126/128 and 226/228 in Figs. 3-4 are designed to deliver air to the nasal airway of the patient), the interface body configured to deliver gases to a first naris of the patient and to a second naris of the patient (the supply conduits 126/128 and 226/228 in Figs. 3-4 to delivery air to both nares of the patient), and a gases inlet for delivery of respiratory gases into the nasal interface, wherein the gases inlet is in fluid communication with the interface body to deliver the respiratory gases from the gases inlet through the interface body to the first naris and second naris of the patient in use (see Figs. 3-4 delivery opening 124/ 224 that delivers therapeutic gases to the interface), and wherein the nasal interface is configured to receive incoming gases from the gases inlet and to provide, from the incoming gases, a first flow stream of gases configured to be substantially provided to the first naris of the patient in use and a second flow stream of gases configured to be substantially provided to the second naris of the patient in use (see Figs. 3-4 where gases enter the interface, and are directed to first flow-directing surface 144/ 244 and second flow-directing surface 166/ 266, to send air to each nare), and is configured to direct more of the incoming gases to the first flow stream of gases than to the second flow stream of gases, to create an asymmetric flow of gases at a patient's nasal airways throughout at least a part of a respiratory cycle of a patient (see [0085]-[0090] where the different shaped and sized flow-directing surfaces deflect different amounts of incoming air in order to create an asymmetric flow of gas into each nare).
Schwaiger lacks a detailed description of a seal being formed with the nasal airways of the patient.
However, Tatkov teaches a similar nasal cannula device for asymmetric flow control, where the outlet ends can seal to the patient’s nares (see [0115] where nasal delivery elements are known to be able to seal or semi-seal at the nose if desired).
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 nasal prongs of Schwaiger to seal at the nares as taught by Tatkov, as it would be a simple substitution of one type of nasal prong for another, with the benefit of providing a sealing connection which is useful depending on the therapy desired (Tatkov; see [0115]).
Regarding claim 183, the modified Schwaiger device has wherein the interface body comprises a first outlet configured to substantially deliver gases to the first naris of the patient, and comprises a second outlet configured to substantially deliver gases to the second naris of the patient (Schwaiger; see branches 126/128 and 226/228 in Figs. 3-4 which form first and second outlet ends to deliver gas to each nare).
Regarding claim 184, the modified Schwaiger device has wherein the gases inlet is at least partly aligned with the first outlet and is less aligned or is not aligned with the second outlet (Schwaiger; see Figs. 3-4 where the shape of flow-directing surface 144/ 244 aligns the delivery opening 124/ 224 more with the first branch 126/ 226 than the more 246 orthogonally placed second branch 128/ 228).
Regarding claim 185, the modified Schwaiger device has wherein the gases inlet is substantially axially aligned with the first outlet (Schwaiger; see Figs. 3-4 where the delivery openings 124/224 at least substantially aligns with the flow-directing surface 144/ 244, such that an openings to the branches 126/ 226 is at least substantially aligned with the delivery openings 124/ 224).
Regarding claim 186, the modified Schwaiger device has at least half of a transverse cross-sectional area of the gases inlet is axially aligned with at least half of a transverse cross- sectional area of the first outlet (Schwaiger; see Fig. 3 where along a midpoint of the curve of flow-directing surface 144 is halfway aligned with the axis of the delivery opening 124 and the axis of the branch 126).
Regarding claim 187, the modified Schwaiger device has wherein the gases inlet comprises an outer portion for connecting to a respiratory conduit to provide a flow of gases for a gases source to the interface body (Schwaiger; see Figs. 3-4 where an outer portion of the delivery openings 124/ 224 connects to the delivery hose 118/ 218 to provide gas), and further comprises an inner portion in fluid communication with the interface body (Schwaiger; see Figs. 3-4 where an inner surface of delivery openings 124/ 224 connects with and interfaces with the interface at connector fitting 16/ 116).
Regarding claim 188, the modified Schwaiger device has wherein the inner portion of the gases inlet is at least partly aligned with the first outlet (Schwaiger; see Figs. 3-4 where the shape of flow-directing surface 144/ 244 aligns the delivery opening 124/ 224 at connector 116/ 216).
Regarding claim 189, the modified Schwaiger device has wherein the gases inlet is angled toward the first outlet (Schwaiger; see Figs. 3-4 where the delivery openings 124/ 224 is angled so as to be in-line with the start of the flow-directing surface 144/ 224 of the branch 126/ 226).
Regarding claim 190, the modified Schwaiger device has wherein the first flow stream of gases has at least one dimension that is larger than a corresponding dimension of the second flow stream of gases (Schwaiger; see [0098]).
Regarding claim 191, the modified Schwaiger device has wherein the at least one dimension comprises a lateral dimension of the first flow stream of gases, and wherein the corresponding dimension comprises a lateral dimension of the second flow stream of gases (Schwaiger; see [0098] where the compared dimension are flow cross sections, which are lateral dimensions across the stream of gases flowing through each outlet).
Regarding claim 192, the modified Schwaiger device has wherein the first flow stream of gases has a larger diameter, cross-sectional area, and/or volume than a corresponding diameter, cross- sectional area, and/or volume of the second flow stream of gases (Schwaiger; see [0098]).
Regarding claim 193, the modified Schwaiger device has wherein a cross-sectional area of the first outlet and a cross-sectional area of the second outlet are substantially similar (Schwaiger; see Figs. 3-4 where the outlet tips of branches 126/ 128 and 226/ 228 are shown to be at least substantially similar in cross-sectional area; see also [0069] directed to a similar embodiment).
Regarding claim 194, the modified Schwaiger device has wherein the nasal interface is configured to deliver a lower velocity of gases flow through the first outlet than a velocity of gases flow through the second outlet during an inhalation phase of a respiratory cycle (Schwaiger; see [0090] where the nasal cannula can use different plug sizes to alter the geometry and thus flow volumes of the branch openings. The asymmetric flow conditions allow for changes to the flow mechanisms, including velocity, such that certain plug shapes/ positions would result in a lower velocity of gas through the first branch when compared to the second branch).
Regarding claim 195, the modified Schwaiger device has wherein the nasal interface is configured to deliver a higher pressure of gases flow through the first outlet than a pressure of gases flow through the second outlet during an inhalation phase of a respiratory cycle (Schwaiger; see [0096] where the branch openings 226b has a smaller flow cross section than branch openings 228b, leading to a higher pressure through the first outlet of branch 226).
Regarding claim 196, the modified Schwaiger device has a single outlet for delivering gases to the first naris and the second naris of the patient, wherein the single outlet comprises the first outlet and the second outlet (Schwaiger; see Figs. 3-4 where the combination of branches 126/ 128 in Fig. 3, and branches 226/ 228 in Fig. 4 form a combined outlet, making up the two sub-outlets for delivering gas to each nare), and wherein the nasal interface is configured such that the first flow stream of gases is configured to be substantially delivered to the first outlet and the second flow stream of gases is configured to be substantially delivered to the second outlet (Schwaiger; see Figs. 3-4 where a first flow of gas enters the branch 126/ 226, and a second flow of gas enters the branch 128/ 228).
Regarding claim 197, the modified Schwaiger device has wherein the interface body comprises a first nasal delivery element comprising the first outlet and a second nasal delivery element comprising the second outlet (Schwaiger; see Figs. 3-4 the distal end of branches 126/ 128 and 226/ 228 which have ports that deliver the gas to the respective nare), wherein the nasal interface is configured such that the first flow stream of gases is configured to be substantially delivered to the first nasal delivery element and the second flow stream of gases is configured to be substantially delivered to the second nasal delivery element (Schwaiger; see Figs. 3-4 the distal end of branches 126/ 128 and 226/ 228 which have ports that deliver the gas to the respective nare), and wherein the first nasal delivery element and the second nasal delivery element are each configured to seal with a respective naris of a patient (Tatkov; see [0115] where nasal delivery elements are known to be able to seal or semi-seal at the nose if desired.
Regarding claim 198, the modified Schwaiger device has a flow director that is configured to direct more of the incoming gases from the gases inlet to the first flow stream of gases than to the second flow stream of gases (Schwaiger; see Figs. 3-4 flow-directing surfaces 144/244 and 166/ 266; and see [0090] where the nasal cannula can use different plug sizes to alter the geometry and thus flow volumes of the branch openings. The asymmetric flow conditions allow for changes to the flow mechanisms, including the amount of flow directed to each branch, such that certain plug shapes/ positions would result in a greater deflection of gas into the first flow stream compared to the second flow stream).
Regarding claim 199, the modified Schwaiger device has a connector or elbow for connecting a respiratory conduit to the nasal interface (Schwaiger; see Figs. 3-4 where a connector 1126/ 226 combined with plug 114/214 forms a connector assembly, which connects the interface to a delivery hose 118/218).
Regarding claim 200, the modified Schwaiger device has wherein the connector or elbow comprises or is the flow director (Schwaiger; see Figs. 3-4 where flow-directing surface 144/214 is part of plug 114/ 214 of the connector assembly).
Regarding claim 201, the modified Schwaiger device has wherein the flow director comprises a nozzle that is configured to accelerate flow towards the first outlet (Schwaiger; see Figs. 3-4 where flow-directing surface 144/ 244 has a distal end forming a nozzle that leads into branch 126/ 226, increasing the flow by constricting the cross-sectional area at branch openings 126b/ 226b).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Evans et al. (US Pat. 11,420,002) and Lubke et al. (US Pat. 8,136,525) are cited to show nasal cannula members that have asymmetric shapes and/or asymmetric flow characteristics.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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