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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority to Application No. (AU2021902143) filed on the July 14, 2021.
Response to Amendment
This office action is responsive to the amendment filed on March 26, 2026. As directed by the amendment: claims 28 and 43 have been amended, no claims have been canceled, and claim 67 has been added. Thus, claims 1-10, 28-37, 43-52, and 67 are presently pending in the application.
Response to Arguments
Applicant argues on pages 10-11 of the remarks that none of the cited references disclose or suggest “the predetermined fold lines about which the plenum chamber flexes in use” in the new amended claim 28 and 43. However, the applicant has amended the claims and the new 103 rejection stated below addresses the new limitation of the claim.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
New claim 67 have been entered and rejected below.
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 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 no obviousness.
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) 28-30 and 33-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baluchagi (WO 2019119058 A1), hereafter as Baluchagi, in view of Blanch et al. (WO 2020037360 A1), hereafter as Blanch, and Huddart et al. (WO 2014129913 A1), hereafter as Huddart.
Regarding Claim 28, Baluchagi discloses a patient interface (Fig. 39-65) comprising:
a plenum chamber (Fig. 64; 3200) including a cavity that is pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure (para. 0187), said plenum chamber including a vent opening (Fig. 54; 3401), a left plenum chamber (3202; Fig. 52) inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (para. 0406-0428), and a right plenum chamber inlet port (other side of mask at 3202; Fig. 52) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (para. 0406-0428), the plenum chamber being constructed from a flexible material (para. 0321, 0343; Examiner notes: In some forms, the plenum chamber and the seal-forming structure are formed from a single homogeneous piece of material and the seal forming structure may be constructed from a soft flexible, resilient material—silicone); the plenum chamber including a nasal portion (Fig. 54; 3101) and an oral portion (Fig. 54; 3102), wherein the vent opening (Fig. 54, 65; 3401) the left plenum chamber inlet port (Fig. 54; 3203) and the right plenum chamber inlet port are positioned on the oral portion (Fig. 54 shows it best it is on the oral “portion” of the mask), and wherein the vent opening, the left plenum chamber inlet port and the right plenum chamber inlet port are oriented to substantially face an anterior direction (Fig. 52, 64); a seal-forming structure (Fig. 39-65; 3100) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways such that the flow of air at said therapeutic pressure is delivered to the patient's airways, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (para. 0319-0331; 0340-0342), the seal-forming portion having a nasal seal portion and an oral seal portion (Fig. 54); a vent structure (Fig. 48; 3400) connected to the opening in the plenum chamber the vent structure configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to vent to ambient(par. 0368-0372, 0416-0417), said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (claim 11), and a positioning and stabilizing structure (Fig. 64-65; 3300; para. 0349-0366) configured to maintain the seal-forming structure in a therapeutically effective position (This limitation is functional).
Baluchagi does not specifically teach the vent body configured to direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening, the vent body comprising a surface having a plurality of vent holes configured to allow air to exit the plenum chamber.
However, Blanch teaches a vent body formed from a rigid material and directly positioned within the vent opening, the vent body configured to direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening (Examiner notes that this limitation is functional; it would be reasonable that the vent body would direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening as a property/result of the plenum’s flexibility and the vent body’s rigidity), the vent body comprising a surface (on 3400) having a plurality of vent holes (Fig. 12A-12C) configured to allow air to exit the plenum chamber.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the plenum and vent structure of Baluchagi to include a vent body formed from a rigid material and directly positioned within the vent opening, the vent body configured to direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening, the vent body comprising a surface having a plurality of vent holes configured to allow air to exit the plenum chamber as taught by Blanch for the purpose of the plenum being complementary to the surface contour of the face of an average person in the region where a seal will form in use and the modification would provide a simple substitution of one type of vent for exhausted gases for another vent, to yield the predictable result of expelling exhausted gases (para. para. 0098, 00370-0373).
Modified Baluchagi does not disclose a cover being permanently connected to the vent body and including a plurality of openings, each opening being in communication with one of the respective vent holes in order to provide a plurality of flow paths for air to exit the plenum chamber, and wherein an inner surface of the cover configured to face the plenum chamber and be pressurised to the therapeutic pressure in use.
However, Huddart teaches a cover (Fig. 14-15; 570) being permanently connected to the vent body (para. 0079-0083) and including a plurality of openings (572), each opening being in communication with one of the respective vent holes (514) ) in order to provide a plurality of flow paths for air to exit the plenum chamber (para. 0079-0083), and wherein an inner surface of the cover (Figs. 14-15) configured to face the plenum chamber and be pressurised to the therapeutic pressure in use.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the vent structure of Modified Baluchagi to include a cover including a plurality of openings each opening being in communication with one of the respective vent holes in order to provide a plurality of flow paths for air to exit the plenum chamber, and wherein an inner surface of the cover configured to face the plenum chamber and be pressurised to the therapeutic pressure in use and a cover being permanently connected to the vent body as taught by Huddart as it is known in the art that these parts could be attached permanently or removable (para. 0079) and also so in these configurations, the vent module can be removed easily for service, cleaning or replacement and allows improved manufacturing and product quality (para. 0082).
Modified Baluchagi does not specifically teach wherein the oral portion of the plenum chamber includes first and second predetermined fold lines about which the plenum chamber flexes in use, the vent body configured to direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening and along the first and second predetermined fold lines positioned on the oral portion of the plenum chamber, and that the first predetermined fold line being positioned between the vent opening and the left plenum chamber inlet port and the second predetermined fold line being positioned between the vent opening and the right plenum chamber inlet port.
However, Baluchagi teaches a patient interface in which the plenum chamber and seal member are formed from silicone, a material well known for its flexibility and ability to bend and fold and conform to a patient’s face (para. 0321, 0343; Examiner notes: In some forms, the plenum chamber and the seal-forming structure are formed from a single homogeneous piece of material and the seal forming structure may be constructed from a soft flexible, resilient material—silicone).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the patient interface of Baluchagi to incorporate first and second predetermined fold lines about which the plenum chamber flexes in use and be at selected location on the mask because person of the skill of the art would be motivated to include such predefined flex regions to control where and how the mask deforms during use, it well known to provide localized areas of reduced stiffness or grooves to achieve predictable behavior. Such modification represents no more than a routine design optimization of the known flexible silicone structure for predictable result. Due to an absence of the limitations of the first and second predetermined fold lines of the patient interface, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that flexible silicone patient interface would inherently deform along the predictable regions corresponding to applied forces during use. For example, when the mask is secured with headgear, the mask is subjected to recurring pressure at consistent location because of the locations of certain pieces on the mask and how it deforms on the patient face. These folds or bends would reasonably encompass the absent limitation of predetermined fold lines.
Regarding Claim 29, Modified Baluchagi discloses the patient interface of claim 28, wherein the plurality of openings on the cover are oriented radially outward (Fig. 14-15; Huddart).
Regarding Claim 30, Modified Baluchagi discloses the patient interface of claim 29, wherein first axes through a center of each opening of the plurality of openings is inclined relative to second axes through a center of each vent hole of a plurality of vent holes (Figs. 14-15; The opening of the cover are through a different axes; Huddart).
Regarding Claim 33, Modified Baluchagi discloses the patient interface of claim 28, wherein the plurality of openings is a U-shape (Fig. 14-15; Huddart).
Regarding Claim 34, Modified Baluchagi discloses the patient interface of claim 28, wherein the cover (570; Fig. 14-15; Huddart) projects away from the remainder of the vent body in a direction away from the plenum chamber (Fig. 14-15; Huddart).
Regarding Claim 35, Modified Baluchagi discloses the patient interface of claim 28, wherein the plurality of openings on the cover (Fig. 14-15; Huddart) are oriented in the substantially same direction as the plurality of vent holes (Examiner notes: the vent are “substantially’ in the same direction out of the plenum to vent the exhale air; para. 0098, 00370-0373; Blanch).
Regrading Claim 36, Modified Baluchagi discloses the patient interface of claim 35, wherein that diameter of the plurality of vent holes is greater than the diameter of the plurality of openings (Fig. 42-43). Examiner notes: in Fig. 42-46 the vent holes are bigger in size than the openings on the cover; prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Regarding Claim 37, Modified Baluchagi discloses the patient interface of claim 28, wherein the plurality of vent holes are arranged in clusters, wherein each cluster is arranged in a given pattern and is spaced apart from adjacent clusters (Fig. 42-43). The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baluchagi, Blanch and Huddart, as applied to claim 30, in further view of Gusky et al. (US 20160095996 A1), hereafter as Gusky.
Regarding Claim 31, Modified Baluchagi discloses the patient interface of claim 30,
Modified Baluchagi does not specifically disclose wherein the first axes and the second axes are oriented approximately 45 with respect to one another.
However, Gusky shows that the first axes and the second axes are oriented approximately 45 with respect to one another (Fig. 8d; 106, 110, 112).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the openings of Modified Baluchagi to include the first axes and the second axes are oriented approximately 45 with respect to one another as taught by Gusky for the purpose of creating a laminar flow, and then the exhaust passage expands to slow down and quiet the airflow (para. 0109).
Regarding Claim 32, Modified Baluchagi discloses the patient interface of claim 30,
Modified Baluchagi does not specifically disclose wherein the first axes and the second axes are oriented approximately 90 with respect to one another.
However, Gusky shows that the first axes and the second axes are oriented approximately 90 with respect to one another (Fig. 8d; 106, 110, 112).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the openings of Modified Baluchagi to include the first axes and the second axes are oriented approximately 90 with respect to one another as taught by Gusky for the purpose of creating a laminar flow, and then the exhaust passage expands to slow down and quiet the airflow (para. 0109).
Claim(s) 43-47, 49-51, and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baluchagi in view of Blanch.
Regarding Claim 43 Baluchagi discloses a patient interface (Fig. 39-65) comprising:
a plenum chamber (Fig. 64; 3200) including a cavity that is pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure (para. 0187), said plenum chamber including a vent opening (Fig. 54; 3401), a left plenum chamber (one side 3800 at 3204; Fig. 52) inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (para. 0406-0428), and a right plenum chamber inlet port (other side of mask at 3204; Fig. 52) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (para. 0406-0428), the plenum chamber further including a left groove (Fig. 54; 3202) at least partially surrounding the left plenum chamber inlet port and a right groove at least partially surrounding the right plenum chamber inlet port (Fig. 54; 3202) (para. 0411);
a seal-forming structure (Fig. 39-65; 3100) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways such that the flow of air at said therapeutic pressure is delivered to the patient's airways, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (para. 0319-0331; 0340-0342);
a vent structure (Fig. 48; 3400) connected to the opening in the plenum chamber the vent structure configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to vent to ambient(par. 0368-0372, 0416-0417), said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (claim 11),
and a positioning and stabilizing structure (Fig. 64-65; 3300; para. 0349-0366) configured to maintain the seal-forming structure in a therapeutically effective position (This limitation is functional), the positioning and stabilizing structure comprising:
a first left clip (Fig. 63; 3891; para. 0423) received in the left plenum chamber inlet port,
a second left clip (Fig. 63; 3890; para. 0423) received in the left groove,
a first right clip (Fig. 63; 3891 on the other side; para. 0423) received in the right plenum chamber inlet port,
and a second right clip (Fig. 63; 3890 on the other side; para. 0423) received in the right groove.
Baluchagi does not disclose that the plenum chamber being constructed from a flexible material; the vent structure comprising: a vent body formed from a rigid material and directly positioned within the vent opening, the vent body configured to direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening, the vent body comprising a surface having a plurality of vent holes configured to allow air to exit the plenum chamber;
However, Blanch teaches the plenum chamber being constructed from a flexible material (para. 0205, 0226); the vent structure comprising: the vent body configured to direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening (Examiner notes that this limitation is functional; it would be reasonable that the vent body would direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening as a property/result of the plenum’s flexibility and the vent body’s rigidity), the vent body comprising a surface (on 3400) having a plurality of vent holes (Fig. 12A-12C) configured to allow air to exit the plenum chamber.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the plenum and vent structure of Baluchagi to include the a flexible material; the vent structure comprising: a vent body formed from a rigid material and directly positioned within the vent opening, the vent body configured to direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening, the vent body comprising a surface having a plurality of vent holes configured to allow air to exit the plenum chamber; as taught by Blanch for the purpose of the plenum being complementary to the surface contour of the face of an average person in the region where a seal will form in use and the modification would provide a simple substitution of one type of vent for exhausted gases for another vent, to yield the predictable result of expelling exhausted gases (para. para. 0098, 00370-0373).
Modified Baluchagi does not disclose the plenum chamber including predetermined fold lines about which the plenum chamber flexes in use and the vent body configured to direct flexing movement of the plenum chamber along the predetermined fold lines of the plenum chamber.
However, Baluchagi teaches a patient interface in which the plenum chamber and seal member are formed from silicone, a material well known for its flexibility and ability to bend and fold and conform to a patient’s face (para. 0321, 0343; Examiner notes: In some forms, the plenum chamber and the seal-forming structure are formed from a single homogeneous piece of material and the seal forming structure may be constructed from a soft flexible, resilient material—silicone).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the patient interface of Baluchagi to incorporate first and second predetermined fold lines about which the plenum chamber flexes in use and be at selected location on the mask because person of the skill of the art would be motivated to include such predefined flex regions to control where and how the mask deforms during use, it well known to provide localized areas of reduced stiffness or grooves to achieve predictable behavior. Such modification represents no more than a routine design optimization of the known flexible silicone structure for predictable result. Due to an absence of the limitations of the first and second predetermined fold lines of the patient interface, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that flexible silicone patient interface would inherently deform along the predictable regions corresponding to applied forces during use. For example, when the mask is secured with headgear, the mask is subjected to recurring pressure at consistent location because of the locations of certain pieces on the mask and how it deforms on the patient face. These folds or bends would reasonably encompass the absent limitation of predetermined fold lines.
Regarding Claim 44, Modified Baluchagi discloses the patient interface of claim 43, wherein the first left clip (Fig. 63; 3891; para. 0423) and the second left clip (Fig. 63; 3890; para. 0423) are connected to the positioning and stabilizing structure independently of one another( Fig. 63, 54; para. 0423), and wherein the first right clip(Fig. 63; 3891; para. 0423) and the second right clip (Fig. 63; 3890; para. 0423) are connected to the plenum chamber independently of one another.
Regarding Claim 45, Modified Baluchagi discloses the patient interface of claim 44, wherein the second left clip (Fig. 63; 3890; para. 0423) and the second right clip (Fig. 63; 3890; para. 0423) are permanently connected to the plenum chamber (para. 0411).
Regarding Claim 46, Modified Baluchagi discloses the patient interface of claim 43, wherein the first left clip (Fig. 63; 3891; para. 0423) and the second left clip (Fig. 63; 3890; para. 0423) are connected to and wherein the first right clip(Fig. 63; 3891; para. 0423) and the second right clip (Fig. 63; 3890; para. 0423) are connected to one another (Fig. 63).
Regarding Claim 47, Modified Baluchagi discloses the patient interface of claim 43, wherein the second left clip (Fig. 63; 3890; para. 0423) and the second right clip (Fig. 63; 3890; para. 0423) each include a connection member (3861).
Regarding Claim 49, Modified Baluchagi discloses the patient interface of claim 43, wherein the positioning and stabilizing structure (Fig. 65-66; 3300) includes a conduit headgear (3900) configured to convey the flow of air to the plenum chamber (Fig. 65-66; This limitation is functional).
Regarding Claim 50, Modified Baluchagi discloses the patient interface of claim 49, wherein the first left clip (Fig. 63; 3891; para. 0423) and the first right clip (Fig. 63; 3891; para. 0423) are connected to the conduit headgear (Fig. 65-66; they are connected to 3800 which is connected to 3900).
Regarding Claim 51, Modified Baluchagi discloses the patient interface of claim 49, wherein the positioning and stabilizing structure (Fig. 65-66; 3300) further comprises at least one strap(3302), and wherein the conduit headgear includes a tab configured to removably receive the at least one strap.
Regarding Claim 67, Modified Baluchagi discloses the patient interface of claim 43,
Modified Baluchagi does not specifically disclose wherein the first predetermined fold lines are positioned between 1) the vent opening and the left plenum chamber inlet port and 2) the vent opening and right plenum chamber inlet port.
However, Baluchagi teaches a patient interface in which the plenum chamber and seal member are formed from silicone, a material well known for its flexibility and ability to bend and fold and conform to a patient’s face (para. 0321, 0343; Examiner notes: In some forms, the plenum chamber and the seal-forming structure are formed from a single homogeneous piece of material and the seal forming structure may be constructed from a soft flexible, resilient material—silicone).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the patient interface of Baluchagi to incorporate the first predetermined fold lines are positioned between 1) the vent opening and the left plenum chamber inlet port and 2) the vent opening and right plenum chamber inlet port because person of the skill of the art would be motivated to include such predefined flex regions to control where and how the mask deforms during use, it well known to provide localized areas of reduced stiffness or grooves to achieve predictable behavior. Such modification represents no more than a routine design optimization of the known flexible silicone structure for predictable result. Due to an absence of the limitations of the first predetermined fold lines are positioned between 1) the vent opening and the left plenum chamber inlet port and 2) the vent opening and right plenum chamber inlet port, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that flexible silicone patient interface would inherently deform along the predictable regions corresponding to applied forces during use. For example, when the mask is secured with headgear, the mask is subjected to recurring pressure at consistent location because of the locations of certain pieces on the mask and how it deforms on the patient face. These folds or bends would reasonably encompass the absent limitation of predetermined fold lines.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baluchagi and Blanch, as applied to claim 47, in view of in view of Busch et al. (US 20100307497 A1), hereafter as Busch.
Regarding Claim 48, Modified Baluchagi discloses the patient interface claim 47,
Modified Baluchagi does not teach that the connection member is a magnet.
However, Busch teaches a connection member (magnetic elements 62 and 82; Fig. 2-4; Col. 5 line 43-Col. 6 line 9) is a magnet.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of modified Baluchgi to include a connection member (magnetic elements 62 and 82; Fig. 2-4; Col. 5 line 43-Col. 6 line 9) is a magnet as taught by Busch for the purpose of making easier assemble and disassemble for users with impaired physical and/or mental ability (para. 0009).
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baluchagi and Blanch, as applied to claim 43, in view of in view Huddart.
Regarding Claim 52, Modified Baluchagi discloses the patient interface of claim 43,
Modified Baluchagi does not disclose wherein includes a cover that includes a plurality of openings, and wherein each opening is in communication with one of the respective vent holes in order to provide a plurality of flow paths for air to exit the plenum chamber and that the cover is permanently connected to the vent body.
However, Huddart teaches Huddart teaches a cover (Fig. 14-15; 570) including a plurality of openings (572) each opening being in communication with one of the respective vent holes (514) in order to provide a plurality of flow paths for air to exit the plenum chamber (para. 0079-0083), and wherein an inner surface of the cover (Figs. 14-15) configured to face the plenum chamber and be pressurised to the therapeutic pressure in use a cover being permanently connected to the vent body (para. 0079-0083).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the vent structure of Baluchagi to include plurality of openings, and wherein each opening is in communication with one of the respective vent holes in order to provide a plurality of flow paths for air to exit the plenum chamber and a cover being permanently connected to the vent body as taught by Huddart as it is known in the art that these parts could be attached permanently or removable (para. 0079) and also so in these configurations, the vent module can be removed easily for service, cleaning or replacement and allows improved manufacturing and product quality (para. 0082). For the purpose of the modification would provide a simple substitution of one type of vent for exhausted gases for another vent, to yield the predictable result of expelling exhausted gases (para. 0079-0083).
Allowable Subject Matter
Claim 1-10 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art to the claimed subject matter is over the prior art of Blanch (as mentioned above) and Huddart.
Regarding Claim 1, Blanch discloses a patient interface comprising:
a plenum chamber (Fig. 12A-12F; 3200) including a cavity (in 3200) that is pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure (para. 0199-0210), said plenum chamber including a vent opening (Fig. 12A-12C; 3400), a left plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Fig. 12A-12F; 3300, into 3200; para. 0271-0273), and a right plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient(Fig. 1A-12F; 3300, into 3200; para. 0271-0273), the plenum chamber being constructed from a flexible material (para. 0205, 0226);a seal-forming structure (Fid. 12A-12F; 3100) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways such that the flow of air at said therapeutic pressure is delivered to the patient's airways (Fig. 12A-12F; Examiner notes: a region is the patient nose), the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (para. 0098);
a vent structure (Fig. 12A-12F; 3400) connected to the vent opening in the plenum chamber, the vent structure configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to vent to ambient said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (claim 1, 9, 28, 48, 73; para. 0098, 00370-0373), the vent structure comprising: the vent body configured to direct flexing movement of the plenum chamber away from a central axis that intersects the vent opening (Examiner notes: since the plenum is flexible and the vent is rigid it should be configured to direct flexing movement of the plenum; this limitation is functional)and a positioning and stabilizing structure (Fig. 12A-12F; 3300) configured to maintain the seal-forming structure in a therapeutically effective position (para. 0335, 0338, 0339-0342).
Huddart teach a vent body (Figs. 14-15) formed from a rigid material and directly positioned within the vent opening (Fig. 14-15; 514), the vent body comprising a surface having a plurality of vent holes (Fig. 14-15; 572) configured to allow air to exit the plenum chamber and at least one connecting feature, the at least one connecting feature being spaced apart from an outermost edge of the surface, a dampening member (Fig. 14-15; 566) positioned in the vent body and at least partially projecting over the plurality of vent holes (Fig. 15), the dampening member configured to decrease a noise output of air through the vent holes (para. 00113-00119), and a cover (Fig.14-15; 570).
However, Blanch nor Huddart mentioned above alone or in combination fail to disclose or render obvious of the cover having an outer diameter less than an inner diameter of the vent body, the at least one complementary connection feature being radially inside of and spaced apart from the outer diameter of the cover, wherein a circumferential gap is formed between the outer diameter of the cover and the inner diameter of the vent body, the circumferential gap extends around an entire perimeter of the cover, the circumferential gap forming a first pathway that is configured to allow air to exit the vent structure after passing through the plurality of vent holes, in independent claim 1. Therefore, independent claim 1 and claims 2-10 by dependency are rendered allowable.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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/MAAP AHMED ELLABIB/ Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785