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 Amendment
This office action is responsive to the amendment filed on February 4, 2026. As directed by the amendment: claims 11 and 19 have been amended, claims 1-10, 20, and 22 have been canceled, and no new claims have been added. Thus, claims 11-19, 21, and 23-30 are presently pending in the application.
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.
Claims 11-14, 16, 18, 19, 21, and 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Veliss et al. (US2008/0060649), in view of Bornholdt et al. (US 2020/0016358), and further in view of Grashow et al. (US 2015/0182719).
As to claim 11, Veliss discloses a patient interface 10 (Fig. 1-5, 1-6) for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's airways, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH20 to about 30 cmH20 above ambient air pressure in use, throughout a patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing (Veliss’ patient interface 10 delivers pressurized air to treat obstructive sleep apnea (see paragraph [0002]); thus it is capable of delivering the pressure levels necessary to treat an apnea during CPAP therapy, which are known in the art to be within the claimed range); said patient interface comprising:
a plenum chamber (cylindrical support or base 82, Fig. 13-1 to 13-2) at least partially forming a cavity pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, said plenum chamber 82 including a plenum chamber inlet port (either end of the cylindrical support 82 which connects to tube 42, see Fig. 13-2, Fig. 1-6) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (paragraph [0203]); and
a seal-forming structure (interface 80, Fig. 13-1 to 13-2, paragraphs [0203]-[0204]) including:
a textile membrane (paragraph [0214] discloses that the interface 80 may be constructed of a textile covered foam; thus, the textile material covering the foam material of interface 80 is considered the textile membrane) constructed and arranged to, in use, form a seal with an underside of the patient’s nose at or below the patient’s pronasale (paragraphs [0204],[0214]), said textile membrane having two holes formed therein and a bridge portion disposed between the two holes to deliver the flow of air at said therapeutic pressure to an entrance to the patient's nares (paragraph [0206]: may have a central portion that divides the orifice into two orifices), the seal-forming structure 80 constructed and arranged to maintain said therapeutic pressure in the cavity throughout the patient's respiratory cycle in use (paragraph [0203]-[0204]); and
a silicone support structure 80 (Fig. 13-1, 13-2 and paragraph [0204] disclose foam interface 80; paragraphs [0347],[0349] discloses that the foam may be a foamed silicone in lieu of the visco-elastic polyurethane foam described in paragraph [0208]; see also paragraph [0278]) configured to support the textile membrane, wherein the textile membrane is attached to the support structure 80 (textile covered foam, paragraph [0214]),
wherein the textile membrane is attached to the support structure 80 at an overlapping region along an outer perimeter region of the textile membrane where the textile membrane overlaps with the support structure 80 (paragraph [0214], since the textile covers the surface of the foam interface 80, the overlapping region is considered the entirety of the textile membrane, including the outer perimeter region, see also Figs. 13-6 and 13-8 showing two configurations of the skinned surface/textile SS over the foam interface 80, paragraph [0278]).
wherein the textile membrane includes a three-dimensional shape having multiple curvatures, and the textile membrane has a saddle shape in at least one region of the textile membrane (see Figs. 15-1 to 15-2, paragraphs [0258]-[0259], the top surface of the foam interface 80 has a saddle shape; thus, the outer textile layer that forms the top surface of the interface 80 will have the same saddle shape).
wherein, in use, the textile membrane is configured to press against the patient's face such that the patient's nose is not received in the cavity (the bridge portion between the two orifices will prevent any part of the nose from being pressed into the chamber, see paragraph [0206]),
wherein the plenum chamber 82 and the seal-forming structure 80 together form the cavity, the plenum chamber 82 forming a non-patient contacting structure on an anterior side of the cavity (see Fig. 13-1 to 13-2 and Fig.1-8), the seal-forming structure 80 forming a patient-contacting structure on a posterior side of the cavity (see Fig. 13-1 to 13-2 and Fig.1-8, paragraph [0201]), the plenum chamber 82 comprising silicone (paragraph [0203]), and
wherein the patient interface 10 is configured to, in use, deliver the flow of air only to the entrance to the patient's nares and to leave the patient's mouth uncovered (see Fig. 1-8).
Veliss does not expressly disclose that the textile membrane extends from the overlapping region radially inwardly beyond the support structure.
However, Bornholdt teaches a seal forming structure (cushion 540, Fig. 18D) of a patient interface having a textile membrane (textile cover 541) whose free end 542 extends radially inwardly beyond the underlying support structure (at opening 134, see Fig. 18D, paragraphs [0253], ln. 19-27).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the patient interface of Bornholdt so that the textile membrane extends radially inwardly beyond the support structure such that it overhangs the openings, as taught by Bornholdt, in order to provide a soft sealing surface covering the rough edge of the orifices (paragraph [0253], ln. 19-27]).
Veliss further does not expressly disclose that the support structure 80 is integrally formed with the plenum chamber as a one-piece structure.
However, Grashow teaches a patient interface 8 (Fig. 1) having a seal forming structure (sealing surface 38, Fig. 2, Fig. 5) that is integrally formed with a plenum chamber (central body 22) as a one-piece structure (unitary sealing cushion 10, see Fig. 2, Fig. 5, paragraph [0026]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Veliss so that the support structure of the seal forming structure is integrally formed with the plenum chamber as a one-piece structure, as taught by Grashow, in order to reduce the number of separate parts for easier assembly.
As to claim 12, Veliss discloses the patient interface according to claim 11, but does not expressly disclose wherein the textile membrane is air impermeable. However, Bornholdt teaches that the textile membrane (dual layer textile material 314, Figs. 7A-7F) for contacting the patient’s face is air impermeable (see Bornholdt, paragraphs [0197]: textile material 314 may comprise a laminate material having at least one layer that is air tight). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of modified Veliss to be air impermeable, as taught by Bornholdt, in order to improve the seal and minimize leaks (see Bornholdt, paragraph [0197]).
As to claim 13, modified Veliss discloses the patient interface according to claim 11, but lacks detailed description as to the limitation that the textile membrane includes a textile layer and an air impermeable layer. However, Bornholdt teaches that the textile membrane 314 (Fig. 7A-7F) includes a textile layer and an air impermeable layer (see Bornholdt, paragraph [0197]: dual-layer textile material 314 may comprise a laminate material having at least one layer that is air tight and at least one comfort layer). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of modified Veliss so that the textile membrane includes a textile layer and an air tight layer, as taught by Bornholdt, in order to improve the seal while also increasing the softness, cushioning, texture, and/or breathability of the interface (see Bornholdt, paragraph [0197]).
As to claim 14, modified Veliss discloses the patient interface according to claim 13, and further discloses that multiple portions of the patient interface may be co-molded in the same mold (paragraph [0180]), but lacks detailed description as to the limitation that the support structure is molded onto the air impermeable layer of the textile membrane along an inner edge portion of the support structure.
However, Bornholdt teaches a support structure (cushion 540 having non face contacting portion 204 and face contacting portion 202, Fig. 18A) attached to a textile membrane (textile cover 541) at the inner edge of the support structure 202, 204 (see Figs. 18A-18B where the fixed end 543 of the textile cover 541 is fixed to the inner surface of the non-face contacting portion 204 and the inner edge (opposite opening 134) before being pulled over the outer surface of the non-face contacting portion 204, sealing region 244 and face contacting portion 202, see Figs. 18C-18D, paragraphs [0252]-[0253]) by overmolding the support structure 540 onto the textile membrane 541 (paragraph [0251]: the fixed end 543 of the textile cover 541 may be overmolded to the interior (e.g. breathing chamber-facing) side of the cushion 540 using an overmolding process.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Veliss so that the support structure is molded onto the inner edge portion of the air impermeable layer of the textile membrane, as taught by Bornholdt, in order to provide a secure means of attachment while ensuring all exposed surfaces of the cushion are covered by the textile material.
As to claim 16, modified Veliss discloses the patient interface according to claim 11, wherein an outer surface of the support structure 80 matches an outer surface of the textile membrane so as to form a smooth, continuous outer surface of the seal-forming structure extending across the support structure and the textile membrane (the textile material will match the smooth continuous outer surface shape of the foam interface 80 to which its covers, see Veliss Fig. 13-1, paragraphs [0214], [0278]).
As to claim 18, modified Veliss discloses the patient interface according to claim 11, wherein the textile membrane is configured to, in use, form the seal only on portions of the patient's face inferior to a nasal bridge region of the patient (see Veliss, Fig. 1-8, paragraph [0201]), and wherein the seal is a pressure-assisted seal (see Grashow, paragraph [0263]: the interface may deform outwardly by the positive air pressure inside the mask chamber).
As to claim 19, modified Veliss discloses the patient interface according to claim 18, wherein the at least one region of the textile membrane having the saddle shape is configured to seal against the patient’s subnasale in use (see Veliss, Fig. 1-8, Fig. 15-2, paragraph [0259]).
As to claim 21, modified Veliss discloses the patient interface according to claim 11, wherein the support structure 80 is stiffer than the textile membrane (see Veliss, [0292]: the thin textile material that covers the foam must be flexible enough to adapt to the curved shape of the foam and soft against the skin; the foamed silicone material of interface 80 in contrast, is much thicker and meant to not fully compress its thickness when pressed against the patients face, paragraph [0265],[0214],[0292]).
As to claim 23, modified Veliss discloses the patient interface according to claim 22, wherein the bridge portion limits the patient's nose from entering into the cavity during use (see Veliss, paragraph [0206]).
As to claim 24, modified Veliss discloses the patient interface according to claim 11, wherein the plenum chamber inlet port is a first plenum chamber inlet port and is disposed at a first lateral side portion of the plenum chamber 82, and wherein said plenum chamber 82 further comprises a second plenum chamber inlet port sized and structured to receive the flow of air at the therapeutic pressure for breathing by the patient, the second plenum chamber inlet port being disposed at a second lateral side portion of the plenum chamber 82 opposite the first lateral side portion (see Veliss, Figs. 1-8, 13-1, paragraph [0103]).
As to claim 25, modified Veliss discloses the patient interface according to claim 11, wherein the plenum chamber 82 and the seal-forming structure form a cushion assembly 20 (see Figs. 13-1, 13-2 of Veliss, paragraph [0203],[0099]).
As to claim 26, modified Veliss discloses the patient interface according to claim 11, further comprising a positioning and stabilising structure (air delivery and stabilizong system 30) to provide a force to hold the seal-forming structure 80 in a therapeutically effective position on the patient's head (see Veliss, Figs. 1-6, 1-8, paragraph [0099]).
As to claim 27, modified Veliss discloses the patient interface according to claim 26, said positioning and stabilising structure 30 comprising a pair of conduits 42 (see Figs. 1-6 of Veliss) for delivering the flow of air to the cavity in use, the pair of conduits 42 being configured to extend along respective sides of the patient's head when the patient interface 20 is worn (see Veliss, Figs. 1-6, 1-8, paragraph [0102]).
As to claim 28, modified Veliss discloses the patient interface according to claim 27, said positioning and stabilising structure 30 further comprising a posterior strap 60 having respective end portions configured to connect to a respective one of the pair of conduits 42 (see Veliss, Figs. 1-2, 1-6, paragraphs [0101],[0129]).
As to claim 29, modified Veliss discloses the patient interface according to claim 11, further comprising a vent structure 627 (see Veliss, Fig. 21-1) to allow a continuous flow of gases exhaled by the patient from an interior of the cavity to ambient, said vent structure 627 being sized and shaped to maintain the therapeutic pressure in the cavity in use (see Veliss, paragraph [0336], [0342]-[0344]).
As to claim 30, modified Veliss discloses a treatment system used for treatment of sleep disordered breathing (paragraph [0002]), comprising: the patient interface 10 according to claim 11; a respiratory pressure therapy (RPT) device to supply a flow of air at positive pressure (blower, paragraph [0190]); and an air delivery tube T1, T2, 42 (Fig. 1-2) to deliver the flow of air from the RPT device to the patient interface 10 (see Veliss, Fig. 1-1 to 1-6, paragraph [0190]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Veliss et al. (US2008/0060649), in view of Bornholdt et al. (US 2020/0016358), and Grashow et al. (US 2015/0182719), as applied to claims 11 and 13 above, and further in view of Hunley et al. (US 2018/0043120).
As to claim 15, modified Veliss discloses the patient interface according to claim 13, but does not disclose that the textile material is weft knit. However, Hunley teaches a fabric liner 10 for a mask seal 22 which is weft knit (paragraph [0029]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Veliss so that the textile material of the interface is weft knit, as taught by Hunley, in order to provide a known means to create a textile material that is soft and flexible against the patient’s skin.
Allowable Subject Matter
Claim 17 is 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.
Response to Arguments
Applicant’s arguments with respect to claims 11-19, 21, and 23-30 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached Monday - Friday 8:30 am - 4:30 pm.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785