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 April 15, 2025. As directed by the amendment: no claims have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-10, 28-37, and 43-52 are presently pending in the application.
Response to Arguments
Appellant’s arguments with respect to claim(s) have been considered and persuasive as Non-final has been issued below. 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.
Appellant argues on pages 9-10 of the remarks that none of the cited references disclose or suggest that a flexible plenum chamber with a vent opening, and 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, in the claims 1, 28 and 43.
Also, Appellant argues on page 16 of the remarks that none of the cited references disclose or suggest that a cover permanently connected to the vent body in claim 28. Additionally, Appellant argues on pages 18-19 that none of the cited references disclose or suggest the limitations of claims 9, 10, 29, 37; however, the examiner addressed these limitation below with the new Non-Final rejection on the merits.
In view of the appeal brief filed on August 27, 2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
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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 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanch et al. (WO 2020037360 A1), hereafter as Blanch, in view of Huddart et al. (WO 2014129913 A1), hereafter as Huddart.
Regarding Claim 28, 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; 3160, 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 (Figs. 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 (opening in 3160) 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:
a vent body (3400) 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),
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).
Blanch does not specifically disclose 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.
However. 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 Blanch 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).
Regarding Claim 29, Modified Blanch 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 Blanch 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 Blanch discloses the patient interface of claim 28, the plurality of openings is a U-shape (Fig. 14-15; Huddart).
Regarding Claim 34, Modified Blanch 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 Blanch 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).
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over 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 Blanch discloses the patient interface of claim 30,
Modified Blanch 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 Blanch 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 Blanch discloses the patient interface of claim 30,
Modified Blanch 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 Blanch 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) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanch and Huddart, as applied to claim 35, in further view of Baluchagi et al. (WO 2019119058 A1), hereafter as Baluchagi.
Regarding Claim 36, Modified Blanch discloses the patient interface of claim 35,
Modified Blanch does not specifically wherein the diameter of the plurality of vent holes is greater than the diameter of the plurality of openings.
However, Baluchagi teaches 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)).
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 holes of Modified Blanch to include the wherein the diameter of the plurality of vent holes is greater than the diameter of the plurality of openings as taught by Baluchagi for the purpose of the holes being sized, shaped, and a large enough number provided to permit sufficient carbon dioxide washout (para. 0416).
Regarding Claim 37, Modified Blanch discloses the patient interface of claim 28,
Modified Blanch does not specifically disclose that 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.
However, Baluchagi teaches disclose that 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)).
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 holes of Modified Blanch to include 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 as taught by Baluchagi for the purpose of the holes being sized, shaped, and a large enough number provided to permit sufficient carbon dioxide washout and may provide additional and/or more diffuse venting. (para. 0416, 0417).
Claim(s) 43-47 and 49-51 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).
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.
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
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