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 .
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.
Claim(s) 161, 168-176, 181, and 188-196 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho (US 2011/0056495 A1).
Regarding claim 161, Ho teaches a conduit connector (conduit exhaust assembly 1, Paragraph 0028, Abstract and Figures 1-3) and vent assembly (see vent assembly comprising base portion 10, exhaust portion 30, moveable member 20, Figure 4 and Paragraphs 0032-0035) for connecting an air circuit to a patient interface to direct pressurized air into the patient interface from the air circuit (exhaust assembly 1 connected to patient interface device 105 to delivery pressurized air from an air circuit conduit 104, Paragraph 0028 and Figure 1), the conduit connector and vent assembly comprising: a conduit connector comprising: an inlet portion having an inlet end configured to be connected to the air circuit (exhaust assembly 1 comprises an inlet portion 12 adapted to couple with air circuit, Paragraph 0031 and Figure 2) and having a vent assembly receiving hole that extends through the inlet portion in a radial direction (see recess 15 extending through inlet portion 12 in a radial direction, to therefore receive moveable member 20, Paragraph 0035 and Figure 4) and an outlet portion having an outlet end configured to be connected to the patient interface (outlet end 11 adapted to rotatably couple with patient interface device 105, Paragraph 0031 and Figure 2) and a vent assembly positioned in the vent assembly receiving hole (exhaust member 30 and moveable member 20 positioned in recess 15, Paragraph 0035 and Figure 4), constructed and arranged to allow for washout of exhaled gases to ambient (exhaust portion 30 comprises a number of vent holes 32 allowing exhaled gases to escape to ambient, Paragraph 0036 and Figure 2), and comprising: a base positioned proximal to an interior of the conduit connector (base portion 10 positioned proximal to an interior of conduit connector, Figure 4); a cover positioned distal to the interior of the conduit connector (wall 33 disposed distal the interior of conduit connector, Paragraph 0036 and Figure 4); and a flap positioned between the base and the cover (moveable member 20 comprising a flexible surface 21 is positioned between wall 33 and base portion 10, Paragraph 0035 and Figure 4) and not connected to the base or the cover so as to be freely movable between the base and the cover during use (the flexible surface 21 of moveable member 20 is able to freely move between the base portion 10 and the cover 33, Paragraph 0039 and Figure 4).
Regarding claim 168, Ho further discloses wherein the flap is configured to rest on the base until sufficient pressure within the conduit connector causes the flap to lift off from the base (the greater the pressure exerted by the flow of supply gas 53 on side 21a of flexible membrane 21 relative to the pressure exerted by the flow of exhaust gas 54 on side 21b of flexible membrane 21, the more moveable member 20 moves into exhaust gas flow passage 52. As less pressure is exerted by the flow of supply gas 53 on side 21a relative to the pressure exerted by the flow of exhaust gas 54 on side 21b, the more moveable member 20 returns to its at-rest state and the less exhaust gas flow passage 52 is blocked, Paragraph 0039).
Regarding claim 169, Ho further discloses wherein the cover (wall 33, Figure 4) includes a plurality of cover holes to allow exhaled gases to pass through the cover to ambient (wall 33 comprises a plurality of orifices 32 to allow exhaled gases to pass through wall 33, Paragraph 0040 and Figure 4).
Regarding claim 170, Ho further discloses wherein the cover includes an annular portion (see annular rim 30 of wall 33, Figure 4) and a central portion (see central area of wall 33, Figure 4), the cover holes being positioned between the annular portion and the central portion (orifices 32 positioned between rim 30 and central area of wall 33, Figure 4).
Regarding claim 171, Ho further discloses wherein the flap is configured to completely block the cover holes when the flap contacts the annular portion and the central portion (moveable member 20 comprises flexible surface 21 completely blocks cover holes when flap is in contact with the annular and central portion of wall 33, Figure 4).
Regarding claim 172, Ho further discloses wherein the flap is configured to allow exhaled gases to pass through the cover to ambient when the flap contacts only one of the annular portion or the central portion (the greater the pressure exerted by the flow of supply gas 53 on side 21a of flexible membrane 21 relative to the pressure exerted by the flow of exhaust gas 54 on side 21b of flexible membrane 21, the more moveable member 20 moves into exhaust gas flow passage 52. As less pressure is exerted by the flow of supply gas 53 on side 21a relative to the pressure exerted by the flow of exhaust gas 54 on side 21b, the more moveable member 20 returns to its at-rest state and the less exhaust gas flow passage 52 is blocked, Paragraph 0039).
Regarding claim 173, Ho further discloses wherein the annular portion and the central portion are offset relative to one another in an axial direction of the cover (annular rim 30 of wall 33 and central area of wall 33 are offset one another in an axial direction, Figure 4).
Regarding claim 174, Ho further discloses wherein the flap is constructed from a flexible material (flexible membrane 21, Paragraph 0039).
Regarding claim 175, Ho further discloses wherein the flexible material is silicone (moveable member 20 is a resiliently deformable material such as silicone rubber, Paragraph 0043).
Regarding claim 176, Ho further discloses wherein each of the base (base portion 10 is rigid, Paragraph 0034) and the cover is constructed from a rigid material (rigid exhaust assembly to include wall 33, Paragraph 0014).
Regarding claim 181, Ho discloses a conduit connector (conduit exhaust assembly 1, Paragraph 0028, Abstract and Figures 1-3) and vent assembly (see vent assembly comprising base portion 10, exhaust portion 30, moveable member 20, Figure 4 and Paragraphs 0032-0035) for connecting an air circuit to a patient interface to direct pressurized air into the patient interface from the air circuit (exhaust assembly 1 connected to patient interface device 105 to delivery pressurized air from an air circuit conduit 104, Paragraph 0028 and Figure 1), the conduit connector and vent assembly comprising: a conduit connector comprising: an inlet portion having an inlet end configured to be connected to the air circuit (exhaust assembly 1 comprises an inlet portion 12 adapted to couple with air circuit, Paragraph 0031 and Figure 2) and having a vent assembly receiving hole that extends through the inlet portion in a radial direction (see recess 15 extending through inlet portion 12 in a radial direction, to therefore receive moveable member 20, Paragraph 0035 and Figure 4); and an outlet portion having an outlet end configured to be connected to the patient interface (outlet end 11 adapted to rotatably couple with patient interface device 105, Paragraph 0031 and Figure 2); and a vent assembly positioned in the vent assembly receiving hole (exhaust member 30 and moveable member 20 positioned in recess 15, Paragraph 0035 and Figure 4), constructed and arranged to allow for washout of exhaled gases to ambient (exhaust portion 30 comprises a number of vent holes 32 allowing exhaled gases to escape to ambient, Paragraph 0036 and Figure 2), and comprising: a base positioned proximal to an interior of the conduit connector (base portion 10 positioned proximal to an interior of conduit connector, Figure 4); a cover positioned distal to the interior of the conduit connector (wall 33 disposed distal the interior of conduit connector, Paragraph 0036 and Figure 4); and a flap positioned between the base and the cover (moveable member 20 comprising a flexible surface 21 is positioned between wall 33 and base portion 10, Paragraph 0035 and Figure 4), the flap being configured to move between the base and the cover during use (the flexible surface 21 of moveable member 20 is able to freely move between the base portion 10 and the cover 33, Paragraph 0039 and Figure 4)., and the flap having an annulus shape (see moveable member 20 comprising flexible surface 21 having an annulus shape, Figure 4).
Regarding claim 188, Ho further discloses wherein the flap is configured to rest on the base until sufficient pressure within the conduit connector causes the flap to lift off from the base (the greater the pressure exerted by the flow of supply gas 53 on side 21a of flexible membrane 21 relative to the pressure exerted by the flow of exhaust gas 54 on side 21b of flexible membrane 21, the more moveable member 20 moves into exhaust gas flow passage 52. As less pressure is exerted by the flow of supply gas 53 on side 21a relative to the pressure exerted by the flow of exhaust gas 54 on side 21b, the more moveable member 20 returns to its at-rest state and the less exhaust gas flow passage 52 is blocked, Paragraph 0039).
Regarding claim 189, Ho further discloses wherein the cover includes a plurality of cover holes to allow exhaled gases to pass through the cover to ambient (wall 33 comprises a plurality of orifices 32 to allow exhaled gases to pass through wall 33, Paragraph 0040 and Figure 4).
Regarding claim 190, Ho further discloses wherein the cover includes an annular (see annular rim 30 of wall 33, Figure 4) and a central portion (see central area of wall 33, Figure 4), the cover holes being positioned between the annular portion and the central portion (orifices 32 positioned between rim 30 and central area of wall 33, Figure 4).
Regarding claim 191, Ho further discloses wherein the flap is configured to completely block the cover holes when the flap contacts the annular portion and the central portion (moveable member 20 comprises flexible surface 21 completely blocks cover holes when flap is in contact with the annular and central portion of wall 33, Figure 4).
Regarding claim 192, Ho further discloses wherein the flap is configured to allow exhaled gases to pass through the cover to ambient when the flap contacts only one of the annular portion or the central portion (the greater the pressure exerted by the flow of supply gas 53 on side 21a of flexible membrane 21 relative to the pressure exerted by the flow of exhaust gas 54 on side 21b of flexible membrane 21, the more moveable member 20 moves into exhaust gas flow passage 52. As less pressure is exerted by the flow of supply gas 53 on side 21a relative to the pressure exerted by the flow of exhaust gas 54 on side 21b, the more moveable member 20 returns to its at-rest state and the less exhaust gas flow passage 52 is blocked, Paragraph 0039).
Regarding claim 193, Ho further discloses wherein the annular portion and the central portion are offset relative to one another in an axial direction of the cover (annular rim 30 of wall 33 and central area of wall 33 are offset one another in an axial direction, Figure 4).
Regarding claim 194, Ho further discloses wherein the flap is constructed from a flexible material (flexible membrane 21, Paragraph 0039).
Regarding claim 195, Ho further discloses wherein the flexible material is silicone (moveable member 20 is a resiliently deformable material such as silicone rubber, Paragraph 0043).
Regarding claim 196, Ho further discloses wherein each of the base and the cover is constructed from a rigid material (rigid exhaust assembly to include wall 33, Paragraph 0014).
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.
Claim(s) 162, 167, 182 and 187 are rejected under 35 U.S.C. 103 as being unpatentable over Ho (US 2011/0056495 A1) in view of Battersby et al. (US 2016/0256661 A1).
Regarding claim 162, Ho teaches the conduit connector and vent assembly of claim 161, however are silent wherein a radial protrusion extends from the inlet portion within the vent assembly receiving hole.
However, Battersby teaches a respiratory device (Abstract and Figure 1) comprising a conduit connector (connector 12, Figure 13 and 0093) and a vent assembly receiving hole (expiratory valve 38 assembly is received within a respective hole of valve housing 50, Paragraph 0075 and Figure 13), the vent assembly comprising a base, cover, and a moveable flap (base 116, cover 104, and a moveable diagram 102 positioned between base and cover, Figure 13 and Paragraph 0100), wherein a radial protrusion extends from the inlet portion within the vent assembly receiving hole (radial valve seat 118 comprising radially extending arms 120 extend from inlet portion, Paragraph 0102 and Figures 13-14).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Ho’s patient interface device by including a radial protrusion extending from the inlet portion within the vent assembly receiving hole, as taught by Battersby, as providing such a protrusion may further aide in securing the vent assembly components to one another within the conduit connector.
Regarding claim 167, Ho teaches the conduit connector and vent assembly of claim 161, however is silent wherein the base includes a plurality of spokes forming a plurality of base holes to allow exhaled gases to pass through the base.
However, Battersby teaches a respiratory device (Abstract and Figure 1) comprising a conduit connector (connector 12, Figure 13 and 0093) and a vent assembly receiving hole (expiratory valve 38 assembly is received within a respective hole of valve housing 50, Paragraph 0075 and Figure 13), the vent assembly comprising a base, cover, and a moveable flap (base 116, cover 104, and a moveable diagram 102 positioned between base and cover, Figure 13 and Paragraph 0100), wherein the base includes a plurality of spokes forming base holes to allow exhaled gases to pass therethrough (base 116 comprises spokes 116 forming holes in the base to therefore allow exhaled gases to pass through membrane 102, Figure 14 and Paragraph 0106).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Ho’s patient interface device by including a plurality of spokes on the base to therefore form a plurality of base holes to allow gases to pass therethrough, as providing spokes to the vent assembly structure may further aide in the structural integrity of the vent assembly.
Regarding claim 182, Ho teaches the conduit connector and vent assembly of claim 181, however are silent wherein a radial protrusion extends from the inlet portion within the vent assembly receiving hole.
However, Battersby teaches a respiratory device (Abstract and Figure 1) comprising a conduit connector (connector 12, Figure 13 and 0093) and a vent assembly receiving hole (expiratory valve 38 assembly is received within a respective hole of valve housing 50, Paragraph 0075 and Figure 13), the vent assembly comprising a base, cover, and a moveable flap (base 116, cover 104, and a moveable diagram 102 positioned between base and cover, Figure 13 and Paragraph 0100), wherein a radial protrusion extends from the inlet portion within the vent assembly receiving hole (radial valve seat 118 comprising radially extending arms 120 extend from inlet portion, Paragraph 0102 and Figures 13-14).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Ho’s patient interface device by including a radial protrusion extending from the inlet portion within the vent assembly receiving hole, as taught by Battersby, as providing such a protrusion may further aide in securing the vent assembly components to one another within the conduit connector.
Regarding claim 187, Ho teaches the conduit connector and vent assembly of claim 181, however is silent wherein the base includes a plurality of spokes forming a plurality of base holes to allow exhaled gases to pass through the base.
However, Battersby teaches a respiratory device (Abstract and Figure 1) comprising a conduit connector (connector 12, Figure 13 and 0093) and a vent assembly receiving hole (expiratory valve 38 assembly is received within a respective hole of valve housing 50, Paragraph 0075 and Figure 13), the vent assembly comprising a base, cover, and a moveable flap (base 116, cover 104, and a moveable diagram 102 positioned between base and cover, Figure 13 and Paragraph 0100), wherein the base includes a plurality of spokes forming base holes to allow exhaled gases to pass therethrough (base 116 comprises spokes 116 forming holes in the base to therefore allow exhaled gases to pass through membrane 102, Figure 14 and Paragraph 0106).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Ho’s patient interface device by including a plurality of spokes on the base to therefore form a plurality of base holes to allow gases to pass therethrough, as providing spokes to the vent assembly structure may further aide in the structural integrity of the vent assembly.
Claim(s) 177 and 197 are rejected under 35 U.S.C. 103 as being unpatentable over Ho (US 2011/0056495 A1) in view of Dantanrayana et al. (US 2018/0264222 A1).
Regarding claim 177, Ho teaches the conduit connector and vent assembly of claim 161, however is silent wherein the inlet end include a bayonet connector such that when the air circuit is connected to the conduit connector, the air circuit and the conduit connector are not rotatable relative to one another.
However, Dantanarayana teaches a conduit connector for a patient interface device (Abstract and Figure 1) comprising a conduit connector (conduit connector 9110, Figures 36A-36C and Paragraph 0440) wherein the inlet end of the conduit connector includes a bayonet connector such that when the air circuit is connected, the air circuit and connector are not rotatable relative to one another (the air circuit connector 9116 may include a bayonet connector 9117 to correspondingly connect to air circuit 4170, Paragraph 0440 and Figures 36A-36C).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Ho’s patient interface device such that the inlet end of the conduit connector is connected to the air circuit with a bayonet connector, as taught by Dantanarayana, as a bayonet connection provides a quick, releasable, yet secure connection between the two components.
Regarding claim 197, Ho teaches the conduit connector and vent assembly of claim 181, however is silent wherein the inlet end include a bayonet connector such that when the air circuit is connected to the conduit connector, the air circuit and the conduit connector are not rotatable relative to one another.
However, Dantanarayana teaches a conduit connector for a patient interface device (Abstract and Figure 1) comprising a conduit connector (conduit connector 9110, Figures 36A-36C and Paragraph 0440) wherein the inlet end of the conduit connector includes a bayonet connector such that when the air circuit is connected, the air circuit and connector are not rotatable relative to one another (the air circuit connector 9116 may include a bayonet connector 9117 to correspondingly connect to air circuit 4170, Paragraph 0440 and Figures 36A-36C).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Ho’s patient interface device such that the inlet end of the conduit connector is connected to the air circuit with a bayonet connector, as taught by Dantanarayana, as a bayonet connection provides a quick, releasable, yet secure connection between the two components.
Claim(s) 178-180, and 198-200 are rejected under 35 U.S.C. 103 as being unpatentable over Ho (US 2011/0056495 A1) in view of JP Patent #6316721 B2.
Regarding claim 178, Ho teaches a patient interface (patient interface 105, Figure 1) comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure by a flow of air at the therapeutic pressure for breathing by a patient (see rigid shell 106 of patient interface device 105 connected to pressure generating device 103, pressure generating device 103 fully capable of delivering a therapeutic pressure of at least 4cmH20 above ambient, Paragraph 0027 and Figure 1), a seal-forming structure connected to the plenum chamber (cushion 107 connected to rigid shell 105, Figure 1 and Paragraph 0029), the seal-forming structure being constructed and arranged to seal with a region of the patient's face that at least partly surrounds an entrance to the patient's airways (patient interface 104 is either a nasal or nasal/oral mask to be placed over a patients face, with the cushion 107 creating an air-tight seal between the interfaced 105 and the face, Paragraph 0029 and Figure 1), the seal-forming structure having a hole therein to deliver the flow of air at the therapeutic pressure to at least the patient's nares during use (see hole formed in cushion 107 to thereby delivery flow of air to at least the patient’s nares during use, Figure 1), the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use (cushion 107 forms an airtight seal, with the pressure generating device 103 fully capable of maintaining therapeutic pressure throughout the user’s respiratory cycle, Figure 1); and the conduit connector (conduit exhaust assembly 1, Paragraph 0028, Abstract and Figures 1-3) and vent assembly of claim 161 (see vent assembly comprising base portion 10, exhaust portion 30, moveable member 20, Figure 4 and Paragraphs 0032-0035; see claim 161 analysis above), wherein the patient interface is configured to leave the patient's mouth uncovered (patient interface 104 is either a nasal or nasal/oral mask to be placed over a patients face, with the cushion 107 creating an air-tight seal between the interfaced 105 and the face, Paragraph 0029 and Figure 1), or the seal-forming structure is configured to seal around the patient's nose and mouth and the patient interface is configured to allow the patient to breath from ambient in the absence of the flow of air at the therapeutic pressure (the Examiner notes due to the presence of the term “or”, the remaining limitations are considered optional).
However, Ho is silent on the plenum chamber further comprising two plenum chamber connectors, each of the plenum chamber connectors being positioned on a corresponding lateral side of the plenum chamber and configured to receive the flow of air at the therapeutic pressure; a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure further comprising two conduits and a central section between the conduits, the central section having a conduit connector receiving hole, each of the conduits being configured to be positioned on a corresponding lateral side of the patient's head in use and being configured to connect to a corresponding one of the plenum chamber connectors; and the conduit connector and vent assembly being connected to the central section at the conduit connector receiving hole.
However, JP Patent ‘721 teaches a respiratory therapy device configured to delivery pressurized gas to a user (Abstract, Figures 1-1, 1-2) comprising a plenum chamber (interface structure 20, Figure 1-3) comprising two plenum chamber connectors, such that each plenum chamber connector are positioned on lateral sides of the plenum chamber and configured to receive the flow of air (see each frame end 22 disposed on lateral sides of the interface structure 20, Figure 1-8), a seal forming structure (cushion 80, Figure 1-6) a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head (air delivery and stabilization system 30, Figure 1-8), the positioning and stabilizing structure further comprising two conduits (stabilization system 30 comprising two conduits 42, Figure 1-6) and a central section between the conduits (see central section of stabilization system 30 comprising manifold 70 disposed in center, Figure 1-6), the central section having a conduit connector receiving hole (see central section of stabilization system 30 comprising manifold 70 having a conduit receiving hole, Figure 1-4), each of the conduits being configured to be positioned on a corresponding lateral side of the patient's head in use and being configured to connect to a corresponding one of the plenum chamber connectors (see each conduit 42 positioned on lateral sides of the patient heads and connected to each frame end 22, Figure 1-6); and the conduit connector and vent assembly being connected to the central section at the conduit connector receiving hole (see manifold 70 connected to central section of the stabilization 30; therefore once modified with the connector and vent assembly of Ho, the connector and vent assembly components would be positioned at the crown portion of the stabilization structure 30).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Ho’s patient interface device with the plenum chamber and stabilization structure of the JP Patent, such that the stabilization structure comprises two conduits delivery air to two lateral connections of the plenum chamber, as providing such a configuration may better aide in securing the sealing structure/cushion to the user’s face and head while the device is in use.
Regarding claim 179, Ho in view of the JP Patent ‘721 teach the patient interface of claim 178, with Ho further teaching wherein the conduit connector and vent assembly is rotatably and releasably connected to the central section (exhaust assembly 1 rotatably connected, Paragraph 0031 and Figure 2).
Regarding claim 180, Ho further teaches wherein the plenum chamber comprises a passive vent configured to allow exhaled gases to pass to ambient independent of therapeutic pressure and throughout the patient's respiratory cycle (see washout vents disposed on plenum chamber 1602, Figure 27-5).
Regarding claim 198, Ho teaches a patient interface (patient interface 105, Figure 1) comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure by a flow of air at the therapeutic pressure for breathing by a patient (see rigid shell 106 of patient interface device 105 connected to pressure generating device 103, pressure generating device 103 fully capable of delivering a therapeutic pressure of at least 4cmH20 above ambient, Paragraph 0027 and Figure 1), a seal-forming structure connected to the plenum chamber (cushion 107 connected to rigid shell 105, Figure 1 and Paragraph 0029), the seal-forming structure being constructed and arranged to seal with a region of the patient's face that at least partly surrounds an entrance to the patient's airways (patient interface 104 is either a nasal or nasal/oral mask to be placed over a patients face, with the cushion 107 creating an air-tight seal between the interfaced 105 and the face, Paragraph 0029 and Figure 1), the seal-forming structure having a hole therein to deliver the flow of air at the therapeutic pressure to at least the patient's nares during use (see hole formed in cushion 107 to thereby delivery flow of air to at least the patient’s nares during use, Figure 1), the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use (cushion 107 forms an airtight seal, with the pressure generating device 103 fully capable of maintaining therapeutic pressure throughout the user’s respiratory cycle, Figure 1); and the conduit connector (conduit exhaust assembly 1, Paragraph 0028, Abstract and Figures 1-3) and vent assembly of claim 181 connected to the central section at the conduit connector receiving hole (see vent assembly comprising base portion 10, exhaust portion 30, moveable member 20, Figure 4 and Paragraphs 0032-0035; see claim 181 analysis above), wherein the patient interface is configured to leave the patient's mouth uncovered (patient interface 104 is either a nasal or nasal/oral mask to be placed over a patients face, with the cushion 107 creating an air-tight seal between the interfaced 105 and the face, Paragraph 0029 and Figure 1), or the seal-forming structure is configured to seal around the patient's nose and mouth and the patient interface is configured to allow the patient to breath from ambient in the absence of the flow of air at the therapeutic pressure (the Examiner notes due to the presence of the term “or”, the remaining limitations are considered optional).
However, Ho is silent on the plenum chamber further comprising two plenum chamber connectors, each of the plenum chamber connectors being positioned on a corresponding lateral side of the plenum chamber and configured to receive the flow of air at the therapeutic pressure; a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure further comprising two conduits and a central section between the conduits, the central section having a conduit connector receiving hole, each of the conduits being configured to be positioned on a corresponding lateral side of the patient's head in use and being configured to connect to a corresponding one of the plenum chamber connectors; and the conduit connector and vent assembly being connected to the central section at the conduit connector receiving hole.
However, JP Patent ‘721 teaches a respiratory therapy device configured to delivery pressurized gas to a user (Abstract, Figures 1-1, 1-2) comprising a plenum chamber (interface structure 20, Figure 1-3) comprising two plenum chamber connectors, such that each plenum chamber connector are positioned on lateral sides of the plenum chamber and configured to receive the flow of air (see each frame end 22 disposed on lateral sides of the interface structure 20, Figure 1-8), a seal forming structure (cushion 80, Figure 1-6) a positioning and stabilizing structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head (air delivery and stabilization system 30, Figure 1-8), the positioning and stabilizing structure further comprising two conduits (stabilization system 30 comprising two conduits 42, Figure 1-6) and a central section between the conduits (see central section of stabilization system 30 comprising manifold 70 disposed in center, Figure 1-6), the central section having a conduit connector receiving hole (see central section of stabilization system 30 comprising manifold 70 having a conduit receiving hole, Figure 1-4), each of the conduits being configured to be positioned on a corresponding lateral side of the patient's head in use and being configured to connect to a corresponding one of the plenum chamber connectors (see each conduit 42 positioned on lateral sides of the patient heads and connected to each frame end 22, Figure 1-6); and the conduit connector and vent assembly being connected to the central section at the conduit connector receiving hole (see manifold 70 connected to central section of the stabilization 30; therefore once modified with the connector and vent assembly of Ho, the connector and vent assembly components would be positioned at the crown portion of the stabilization structure 30).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Ho’s patient interface device with the plenum chamber and stabilization structure of the JP Patent, such that the stabilization structure comprises two conduits delivery air to two lateral connections of the plenum chamber, as providing such a configuration may better aide in securing the sealing structure/cushion to the user’s face and head while the device is in use.
Regarding claim 199, Ho in view of the JP Patent ‘721 teach the patient interface of claim 198, with Ho further teaching wherein the conduit connector and vent assembly is rotatably and releasably connected to the central section (exhaust assembly 1 rotatably connected, Paragraph 0031 and Figure 2).
Regarding claim 200, Ho further teaches wherein the plenum chamber comprises a passive vent configured to allow exhaled gases to pass to ambient independent of therapeutic pressure and throughout the patient's respiratory cycle (see washout vents disposed on plenum chamber 1602, Figure 27-5).
Allowable Subject Matter
Claims 163-166 and 183-186 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 183-186 and 163-166, these claims are directed towards structural details of the vent assembly, including the base includes a radial base notch configured to receive the radial protrusion when the base is positioned within the vent assembly receiving hole, the cover includes a radial cover notch configured to receive the radial protrusion when the cover is positioned within the vent assembly receiving hole, wherein the base includes a post configured to contact the cover and maintain a gap between the base and the cover, the flap being positioned within the gap, when the vent assembly is positioned within the vent assembly receiving hole. Although Ho teaches a vent assembly comprising a base and cover, Ho is silent on the structural details recited above. A radical structural modification of Ho’s vent assembly would be required in order to achieve the structural relationship of the vent assembly as described in claims 183-186 and 163-166.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Nelson et al. (US 2020/0129724 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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