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 .
Response to Amendments
This office action is responsive to the amendment filed on 07/24/2026. As directed by the amendment: claims 1, 6, 8, and 16-17 have been amended, claims 2-3 and 11 have been canceled, and new claims 146-150 have been added. Thus, claims 1, 4-10, 12-19, and 146-150 are presently pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 147-148 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 147 and 148 recite the limitation "the distal end of the tie" in line 1. It is unclear whether the “the distal end of the tie" is the same distal end from claim 1, wherein a tie that extends to “a distal end connected to the support structure”.
For examination purposes, the “distal end” from claims 1, 147, and 148 is where the tie is connected to the support structure.
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.
Claims 1, 4-10, 12-19, and 146-149 are rejected under 35 U.S.C. 103 as being unpatentable over Eves (US 20180272095 A1) in view of Guney (WO 2010148453 A1).
Regarding claim 1, Eves discloses a patient interface (FIG. 3A Patient interface 3000 as set forth in [0237]) comprising:
a plenum chamber (FIG. 3A Plenum chamber 3200 as set forth in [0237]) pressurisable to a therapeutic pressure of at least 6cmH2O above ambient air pressure (As set forth in [0239]), said plenum chamber including a plenum chamber inlet port (FIG. 3A Connection port 3600 as set forth in [0237]), said plenum chamber inlet port being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (FIG. 1A-C and 3A Connection port 3600 configured for connection to air circuit 4170 receiving air from the RPT device 4000 as set forth in [0114] and [0237], for treating a respiratory disorder comprising the step of applying positive pressure to the entrance of the airways of a patient 1000 as set forth in [0233]); a sealing structure (FIG. 3A, 5, and 7-7A Seal forming structure 3100 as set forth in [0237] and [0242]) comprising a support structure (FIG. 7 Relatively thick portion 3130 as set forth in [0256]) and a portion joined to the support structure (FIG. 7 Relatively thin portion 3135 as set forth in [0256]), the portion at least partly forming a sealing surface (FIG. 7 Sealing surface 3105 which is formed of a majority of the thick portion, and a portion of the relatively thin portion 3135 as set forth in [0256]) to seal with a region of the patient's face surrounding an entrance to the patient's airways to deliver the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's, and the sealing structure being structured and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use nares (FIG. 3A Seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to facilitate the supply of air at positive pressure to the airways as set forth in [0237], maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle as set forth in [0074]); and a positioning and stabilizing structure comprising a strap configured to hold the sealing structure in a therapeutically effective position on the patient's head (FIG. 3A Positioning and stabilizing structure 3300 as set forth in [0237], comprising at least one strap as seen in the figure and set forth in [0250]), wherein the portion comprises a free, inner edge that at least partly forms a hole through which the flow of air is delivered to at least the entrance to the patient's nares (The free inner edge of the relatively thin portion 3135, an edge being the outside limit of an object, area, or surface; a place or part farthest away from the center of something, in this case, being “inner” given the edge is located towards an internal portion of the sealing stucture, free given the edge exposed and uninhibited by any other portion of the invention, the hole formed being the hole formed by the sealing structure that surrounds the patient’s nares and mouth through which the air is delivered the inner edge of the sealing structure formed by the portion as shown in the annotated figure below), and wherein the portion of the sealing structure comprises a tie (FIG. 7 The seal forming structure 3100 includes a tie, connecting portion, or loop 3110 as set forth in [0249]) that extends to a distal end or an inner surface of the textile portion opposite the sealing surface connected to the support structure (As shown in the annotated figure below), and the tie is configured to be tensioned to resist deformation of the sealing structure (FIG. 4-5 and 7-7A The sealing structure comprises a tie that extends between a first interior surface region of the sealing structure that is opposite the sealing surface and a second interior surface region of the patient interface such that the tie resists deformation of the sealing structure as set forth in [0074]) to prevent blowout (FIG. 4-5 and 7-7A The seal forming structure 3100 has an edge and the tie 3110 holds the edge to prevent blowout at the edge as set forth in [0252]).
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Eves fails to explicitly disclose, wherein the portion is a “textile” portion.
However, Guney teaches, wherein the portion of a sealing structure is a “textile” portion (Guney: FIG. 114 The sealing structure and tie are comprised of a laminated foam/fabric (air tight) fascia 7012, a semi-rigid skeleton frame 7010, a silicone/TPE undercushion 7004, a foam portion 7006, and a fabric layer 7008 along the outer side of the foam portion, undercushion, skeleton frame, and fascia, and the inner side of the undercushion, skeleton frame, and fascia as set forth in [00324]; wherein the material of the tie is a unitary homogenous material interpreted under its broadest interpretation as meaning the material, in this case used for the sealing structure and tie, are formed together to form one piece).
Eves and Guney are both considered to be analogous to the claimed invention because they are in the same field of respiratory facemasks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sealing structure including the “portion” as well as the support structure of Eves to incorporate the material composition of the sealing structure of Guney and include, wherein the portion is a “textile” portion (Guney: FIG. 114 The sealing structure and tie are comprised of a laminated foam/fabric (air tight) fascia 7012, a semi-rigid skeleton frame 7010, a silicone/TPE undercushion 7004, a foam portion 7006, and a fabric layer 7008 along the outer side of the foam portion, undercushion, skeleton frame, and fascia, and the inner side of the undercushion, skeleton frame, and fascia as set forth in [00324]; wherein the material of the tie is a unitary homogenous material interpreted under its broadest interpretation as meaning the material, in this case used for the sealing structure and tie, are formed together to form one piece). Doing so would improve the durability of the portion and may improve comfort (smooth surface finish, soft to touch, etc.) and aesthetics (Guney: As set forth in [00318]).
Regarding claim 4, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves as modified by Guney further teaches the patient interface, wherein the tie and the sealing structure comprise a unitary structure formed from a homogeneous material (The tie and the sealing structure may comprise a unitary structure formed from a homogeneous material as set forth in [0075]; and further, Guney: FIG. 114 The sealing structure and tie are comprised of a laminated foam/fabric (air tight) fascia 7012, a semi-rigid skeleton frame 7010, a silicone/TPE undercushion 7004, a foam portion 7006, and a fabric layer 7008 along the outer side of the foam portion, undercushion, skeleton frame, and fascia, and the inner side of the undercushion, skeleton frame, and fascia as set forth in [00324]; wherein the material of the tie is a unitary homogenous material interpreted under its broadest interpretation as meaning the material, in this case used for the sealing structure and tie, are formed together to form one piece).
Regarding claim 5, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Eves as modified by Guney further teaches the patient interface, wherein the homogeneous material comprises a textile material (Guney: FIG. 114 Fabric layer 7008 as set forth in [00324]).
Regarding claim 6, Eves discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Eves as modified by Guney further teaches the patient interface, wherein the homogeneous material comprises multiple layers, with at least one layer being a textile material (Guney: FIG. 114 The sealing structure and tie comprised of a laminated foam/fabric (air tight) fascia 7012, a semi-rigid skeleton frame 7010, a silicone/TPE undercushion 7004, a foam portion 7006, and a fabric layer 7008 along the outer side of the foam portion, undercushion, skeleton frame, and fascia, and the inner side of the undercushion, skeleton frame, and fascia as set forth in [00324]; A unitary homogenous material interpreted under its broadest interpretation as meaning the material, in this case used for the sealing structure and tie, are formed together to form one piece).
Regarding claim 7, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 6 above.
Eves as modified by Guney further teaches the patient interface, wherein at least one layer is air impermeable (Guney: FIG. 114 The sealing structure and tie comprised of a laminated foam/fabric (air tight) fascia 7012 and silicone/TPE undercushion 7004 as set forth in [00324]; set forth in as being air impermeable in Applicant specification [0329]).
Regarding claim 8, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Eves as modified by Guney further teaches the patient interface, wherein the at least one layer that is air-impermeable comprises at least one of silicone (Guney: FIG. 114 The sealing structure and tie comprised of a laminated foam/fabric (air tight) fascia 7012 and silicone/TPE undercushion 7004 as set forth in [00324]; set forth in as being air impermeable in Applicant specification [0329]).
Regarding claim 9, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the sealing structure comprises a sealing flap at an edge region (FIG. 4-5 Sealing flap 3125 that protrudes inwards towards an inner perimeter of the sealing structure 3100 having an unconnected edge as set forth in [0253] and [0075]), the sealing flap being shaped and positioned to seal at least against a side of the patient's nose in use (FIG. 4-5 The sealing flap 3125 may include a portion 3125a that is configured to form a seal against the sides of the nose above the nasal bones of the patient as set forth in [0253] and [0075]).
Regarding claim 10, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 9 above.
Eves further discloses the patient interface, wherein the sealing flap comprises a thin edge region that is thinner than adjacent regions of the sealing structure (As set forth in [0075]).
Regarding claim 12, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves fails to explicitly disclose wherein the tie extends contiguously from the sealing structure at an edge region such that the tie forms an extension of the sealing surface in reference to the embodiment of FIG. 4-5 and 7-7A.
However, Eves teaches, wherein the tie extends contiguously from the sealing structure at an edge region such that the tie forms an extension of the sealing surface in reference to the embodiment of FIG. 31K (FIG. 31K the tie 3110 extends contiguously from the sealing flap 3125 as set forth in [0322]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of FIG. 4-5 and 7-7A to incorporate the teaching of the embodiment of FIG. 31K and include wherein the tie extends contiguously from the sealing structure at an edge region such that the tie forms an extension of the sealing surface in reference to the embodiment of FIG. 31K (FIG. 31K the tie 3110 extends contiguously from the sealing flap 3125 as set forth in [0322]). Doing so provides another possible configuration forming the tie structure of the sealing structure for the resistance of deformation and the prevention of blowout that may be more suitable to the user than other embodiments of the patient interface (As set forth in [0076] and 0275]).
Regarding claim 13, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the tie comprises an inner surface and the sealing structure comprises an interior surface, the inner surface of the tie being adjacent to and separated from the interior surface of the sealing structure (As set forth in [0075], as well as shown in annotated FIG. 5 below).
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Regarding claim 14, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the plenum chamber is constructed from a rigid, transparent material (FIG. 3A Plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate as set forth in [0075] and [0344])
Regarding claim 15, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the plenum chamber is constructed from a resiliently flexible transparent material (FIG. 3A Plenum chamber 3200 is constructed from transparent polycarbonate as set forth in [0344]; know by one ordinary skill in the art as a resiliently flexible material).
Regarding claim 16, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the tie is configured to be positioned proximal to the patient's frontal process of the maxilla in use (FIG. 7 The tie 3110 may be positioned to contact a side wall of the nose including the alar and provide a continuous surface to maintain contact with the sides of the nose above the nasal bones of the patient as set forth in [0259], which would be proximal to the patient's frontal process of the maxilla in use, as shown by an embodiment of the interface affixed to the patient as shown in FIG. 34B).
Regarding claim 17, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the tie extends from the textile portion (As shown in the annotated FIG. 7 below) inferior to an uppermost portion of the sealing structure and superior to a lowermost portion of the sealing structure (As shown in annotated figure 5 below).
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Regarding claim 18, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the sealing structure is configured so as to not extend below a mental protuberance region in use and the plenum chamber is configured so as not to cover the eyes in use (As set forth in [0075]).
Regarding claim 19, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the sealing structure is a single wall sealing structure (As set forth in [0273]).
Regarding claim 146, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the textile portion comprises an outer edge connected to the support structure and positioned radially outward of the free, inner edge around the hole (The outer edge of the relatively thin portion 3135, an edge being the outside limit of an object, area, or surface; a place or part farthest away from the center of something, in this case the outside limit of the thin portion 3135, being “outer” given the edge is located further from the most internal portion of the sealing structure, as shown in the annotated figure below).
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Regarding claim 147, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the distal end of the tie is connected to the support structure such that the support structure and an inner surface of the tie opposite the patient in use are spaced apart (As shown in the annotated figure below).
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Regarding claim 148, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves further discloses the patient interface, wherein the distal end of the tie is connected to the inner surface of the textile portion (The entire support structure, tie, and textile portion are formed, or connected, to make the sealing structure) such that the inner surface of the textile portion an inner surface of the tie opposite the patient in use are spaced apart (As shown in the annotated figure below).
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Regarding claim 149, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Eves as modified by Guney further teaches the patient interface, wherein the support structure is constructed from silicone (Guney: FIG. 114 The sealing structure and tie are comprised of a laminated foam/fabric (air tight) fascia 7012, a semi-rigid skeleton frame 7010, a silicone/TPE undercushion 7004, a foam portion 7006, and a fabric layer 7008 along the outer side of the foam portion, undercushion, skeleton frame, and fascia, and the inner side of the undercushion, skeleton frame, and fascia as set forth in [00324], as set forth above for claim 1, the sealing structure including the “portion” as well as the support structure of Eves is modified to incorporate the material composition of the sealing structure of Guney, which includes silicone, meaning that the support structure is constrcted partially of silicone).
Claim 150 is rejected under 35 U.S.C. 103 as being unpatentable over Eves (US 20180272095 A1) in view of Guney (WO 2010148453 A1) as applied to claim 149, in view of Romagnoli (US 20150335846 A1).
Regarding claim 150, Eves as modified discloses the claimed invention substantially as claimed as set forth for claim 149 above.
Eves as modified further discloses, wherein the plenum chamber is constructed from a plastic material (FIG. 3A Plenum chamber 3200 is constructed from transparent polycarbonate as set forth in [0344]; know by one ordinary skill in the art as a plastic material),
Eves as modified fails to explicitly disclose the support structure is overmolded onto the plastic material.
However, Romagnoli teaches, wherein a portion of the sealing structure can be attached to a portion of the plenum by the sealing structure being overmolded onto a portion of the plenum (Romagnoli: FIG. 11b The main body 3180 may be permanently (e.g., co-molded, overmolded) connected to the seal-forming structure 3200. In an example, the seal-forming structure 3200 is constructed of a relatively flexible or pliable material (e.g., silicone) and the main body 3180 is constructed of a relatively rigid material (e.g., polycarbonate as set forth in [0130]).
Eves and Romagnoli are both considered to be analogous to the claimed invention because they are in the same field of respiratory facemasks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified connection between the support structure and plenum chamber of Eves to incorporate the method of connection utilized by Romagnoli and include, wherein a portion of the sealing structure can be attached to a portion of the plenum by the sealing structure being overmolded onto a portion of the plenum (Romagnoli: FIG. 11b The main body 3180 may be permanently (e.g., co-molded, overmolded) connected to the seal-forming structure 3200. In an example, the seal-forming structure 3200 is constructed of a relatively flexible or pliable material (e.g., silicone) and the main body 3180 is constructed of a relatively rigid material (e.g., polycarbonate) as set forth in [0130]). In the case of Eves as modified, the portion of the sealing structure being the support structure connected to the plenum. Doing so provides a method in which the sealing structure portion of a mask can be attached to the plenum or frame portion of the mask known in the art (Romagnoli: As set forth in [0120])
Response to Arguments
Applicant's arguments filed 07/24/2026 have been fully considered but they are not persuasive.
New grounds of rejection are made above to address the amendments to the claims.
Applicant argues that the term textile does not appear anywhere in the rejection to claim 1, however, the fabric layer taught by Guney is the feature relied upon when considering the “portion” to be “textile”, which is clear given that a textile is a fabric and is further explained in the rejection for claim 1 above. How Eves as modified by Guney discloses a “textile portion comprises a free, inner edge that at least partly forms a hole through which the flow of air is delivered to at least the entrance to the patient's nares” and “a distal end connected to the support structure or an inner surface of the textile portion opposite the sealing surface” are also set forth above in the rejection for claim 1. Additionally, it is noted that the definition of an edge used is "the outside limit of an object, area, or surface; a
place or part farthest away from the center of something" which the Examiner believes is consistent with what would be interpreted as the "edge" of the textile portion of Eves as modified by Guney set forth above.
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 KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
