DETAILED ACTION
This office action is in response to the amendment filed 4/14/2026. As directed by the amendment, claim 80 has been amended, claims 1-79 have been cancelled, and claims 106-112 have been newly added. Thus, claims 80-112 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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 of this title, 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.
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.
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 80, 83-92, 94-98, 102-103, 106-108, and 110-112 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allan et al (2011/0146685) in view of Baigent et al (2017/0326320).
Regarding claim 1, Allan in fig 1 discloses a patient interface comprising: a chassis (112) (frame) (fig 1b, para [0312]); and in figs 1CA-1CE discloses a seal-forming structure comprising a pair of nasal pillows (104) (nasal locators) (para [0305]), each nasal pillow (104) being constructed and arranged to form a seal with a respective naris of the nose of a patient (para [0012]), each nasal pillow (104) having a hole (outlet aperture) therein such that the flow of air at a therapeutic pressure is delivered to at least the patient's nares, 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 [0305]); a membrane portion (100) (seal body (100) includes a seal surface (110) connected to the chassis portion (112) and at least partially forming the plenum chamber (102) (supple envelope) (para [0304]), wherein the nasal pillows (104) are supported on the membrane portion (100) (figs 1CA-CD, para [0308]) and the membrane portion (100) is constructed and arranged to be flexible to allow for relative movement between the nasal pillows (104) and the chassis portion (112) in use (envelope retains a seal despite substantial lateral movement of the frame relative to the head) (fig 1EA-1EC), para [0345]), and wherein the membrane portion (100) does not have a predetermined three-dimensional shape in the absence of positive pressure with respect to atmospheric pressure in the plenum chamber (as shown in fig 1CA, in the absence of positive pressure, the membrane portion (100) is limp and deflated) (para [0333]); and a vent (116) connector may include a limited flow outlet (220) for providing gas washout) comprising a plurality of holes (a collection of small apertures) sized and shaped to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient (para [0327]), said vent (116) being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (interface is configured to maintain a therapeutic pressure in the plenum chamber in order to create a seal with the nose and face of the user (para [0012]), and therefore the vent would be sized in order to allow the plenum chamber to inflate to create a seal with a nose of a user); wherein the patient interface is configured to leave the patient's mouth uncovered (as shown in fig 1a, the interface is a nasal interface configured to leave a patient’s mouth uncovered).
Allan in the fig 1 embodiment does not disclose the chassis portion is configured to at least partially form a plenum chamber and comprising one or more plenum chamber inlet ports sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
However, Allan in the fig 2 embodiment teaches a patient interface comprising: a chassis portion (950) (frame) configured to at least partially form a plenum chamber with inflatable seal body (940) including a supple envelope (para [0380) and the frame (950) comprising one or more plenum chamber inlet ports (951) (connector) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (interface is supplied with pressurized gases via tubing and the connector (951)) (para [0384]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of the fig 1 embodiment of Allan by configuring the chassis portion as a frame least partially forming a plenum chamber and comprising one or more plenum chamber inlet ports sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient as taught by the fig 2 embodiment of Allan, as the feature of providing a frame at least partially forming a plenum chamber is known in the art, an interface may incorporate different aspects of the mask while using different arrangements (Allan, para [0637]), and it appears that the device of modified Allan would perform equally well to provide an inflatable plenum chamber if the chassis is configured to at least partially form the plenum chamber and comprising one or more plenum chamber inlet ports sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient as taught by the fig 2 embodiment of Allan. See MPEP 2143(I)(A).
The now-modified Allan’s device does not disclose the plenum chamber pressurisable to a therapeutic pressure of at least 4 cm H2O above ambient air pressure.
However, Baigent in figs 6-7 teaches a patient interface comprising: a chassis portion at least partially forming a plenum chamber (3200) (para [0285]), wherein the plenum chamber (3200) is pressurisable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure (patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use) (para [0072]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that the plenum chamber pressurisable to a therapeutic pressure of at least 4 cm H2O above ambient air pressure as taught by Baigent, as the feature of a plenum chamber pressurisable to a therapeutic pressure of at least 4 cm H2O above ambient air pressure is known in the art to provide a seal to a user, and it appears that the device of modified Allan would perform equally well to provide a seal to a patient if the plenum chamber is configured to be pressurisable to a therapeutic pressure of at least 4 cm H2O above ambient air pressure. See MPEP 2143(I)(A).
Regarding claim 83, Allan discloses the membrane portion (100) is configured to inflate (para [0336]), and including a sealing surface (110) configured to conform to one or more portions of the patient's nose in use (para [0306]).
Regarding claim 84, Allan discloses the membrane portion (100) is constructed and arranged to inflate to urge each of the nasal pillows (104) towards a respective one of the patient's nares in use (para [0336]).
Regarding claim 85, Allan discloses the membrane (100) includes a sealing portion (110) that may press against surfaces of the user's face to form a seal (para [0306]), and in fig 1FD discloses the membrane may have a substantially triangular seal surface (610) to increase the amount of supple seal material available to cover the user's nose, and therefore a lower portion of the seal surface would be configured to engage a patient’s lip superior in use (fig 1FD, para [0357]).
Regarding claim 86, modified Allan discloses a membrane portion.
Modified Allan does not disclose the membrane portion is formed at least partially from a textile material.
However, Baigent in figs 6-7 teaches a patient interface (3000) including a membrane portion (3100) (seal-forming structure) providing a seal-forming surface (para [0296]), and wherein the membrane portion (3100) is formed at least partially from a textile material (para [0305]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that the membrane portion is formed at least partially from a textile material as taught by Baigent in order to provide a suitable material with flexibility and ability to inflate under pressure to allow the membrane to form a seal against the patient’s face (Baigent, para [0305]).
Regarding claim 87, the modified Allan’s reference discloses the membrane portion (3100 of Baigent) comprises a textile layer and an air impermeable layer (seal-forming structure may be formed from a textile material and an air impermeable layer (sealing material) applied in a thin layer) (Baigent, para [0296]).
Regarding claim 88, Allan discloses each of the nasal pillows (104) is formed from an elastomeric material (region including the nasal locators can comprise a silicone material) (para [0077]).
Regarding claim 89, Allan discloses the membrane portion (100) is formed from an elastomer (formed from a material having sufficient elasticity and yield strength that the combination renders the envelope supple, such as latex, vinyl, silicone and polyurethane) (para [0304]).
Regarding claim 90, Allan discloses the membrane portion (100) is formed from silicone (para [0304]).
Regarding claim 91, modified Allan discloses a membrane portion connected to a chassis portion.
Modified Allan does not disclose the membrane portion is in the form of a sheet connected to the chassis portion at edges of the membrane portion.
However, Baigent teaches a patient interface including a chassis (3200) (plenum chamber) and a membrane (3100) (para [0285]), wherein the membrane portion (3100) is in the form of a sheet (membrane portion (3100) is shown to be a thin, flat sheet) connected to the chassis portion (3200) at edges of the membrane portion (3100) (edges of membrane portion (3100) are attached to clip (3103) which is structured to connect to chassis portion (3200)) (para [0308]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that the membrane portion is in the form of a sheet connected to the chassis portion at edges of the membrane portion as taught by Baigent, as the feature of the membrane portion being in the form of a sheet connected to the chassis portion at edges of the membrane portion is known in the art, and it appears that the device of modified Allan would perform equally well to provide a sealing interface of the membrane portion is in the form of a sheet connected to the chassis portion at edges of the membrane portion. See MPEP 2143(I)(A).
Regarding claim 92, Allan discloses the chassis portion (950) is formed from an elastomeric material (can be made of a more flexible material, such as silicone) (para [0383]).
Regarding claim 94, Allan in fig 1GA that each of the nasal pillows (720) is stalkless (includes a wide flange (722) adjacent the envelope and tapering to a narrow tip) (fig 1GA, para [0359]).
Regarding claim 95, Allan discloses in fig 1GA that each of the nasal pillows (720) comprises a frustoconical portion having a tip and a base wider than the tip, the base being attached directly to the membrane portion (includes a wide flange (722) adjacent the envelope and tapering to a narrow tip) (fig 1GA, para [0359]).
Regarding claim 96, modified Allan discloses a nasal pillow and a membrane portion.
Modified Allan does not disclose each nasal pillow is formed from a different material to the membrane portion.
However, Baigent in figs 6-7 teaches a patient interface (3000) including a membrane portion (3100) (seal-forming structure) providing a seal-forming surface (para [0296]), and wherein the membrane portion (3100) is formed from a textile material (para [0305]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that the membrane portion is formed at least partially from a textile material as taught by Baigent in order to provide a suitable material with flexibility and ability to inflate under pressure to allow the membrane to form a seal against the patient’s face (Baigent, para [0305]). The now-modified Allan’s device is considered that each nasal pillow is formed from a different material to the membrane portion, as the nasal pillow can be formed from and elastomeric material such as silicone (Allan, para [0077]), which is a different material from a textile material forming the membrane portion (Baigent, para [0305])
Regarding claim 97, Allan discloses each of the nasal pillows (104) is formed from an elastomeric material (region including the nasal locators can comprise a silicone material) (para [0077]).
Regarding claim 98, Allan discloses each of the nasal pillows (104) is formed from silicone (region including the nasal locators can comprise a silicone material) (para [0077]).
Regarding claim 102, modified Allan discloses a seal-forming structure.
Modified Allan does not disclose the seal-forming structure further comprises an oral portion configured to form a seal around the patient's mouth such that the flow of air at said therapeutic pressure is delivered to the patient's mouth.
However, Baigent in fig 11 teaches a patient interface including a chassis portion (3200) and a seal-forming portion (3100), wherein the seal-forming portion further comprises an oral portion configured to form a seal around the patient's mouth such that the flow of air at said therapeutic pressure is delivered to the patient's mouth (as shown in fig 11C, seal forming structure (3100) may be provided with openings (3101) to seal with the nares and the mouth of the patient) (para [0314]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that the seal-forming structure further comprises an oral portion configured to form a seal around the patient's mouth such that the flow of air at said therapeutic pressure is delivered to the patient's mouth as taught by the fig 11 embodiment of Baigent in order to allow air to be delivered to a mouth of a patient (Baigent, para [0314]).
Regarding claim 103, Baigent in fig 11A-C discloses the membrane portion forms the oral portion of the seal-forming structure (as shown in fig 11A and C, sealing-forming portion is formed by the membrane portion (3100) by combining thermoformed textiles and forms the oral portion at opening (3101) configured to seal with a mouth of a patient) (para [0314]).
Regarding claim 106, Allan discloses the vent (116) is uncovered so as to be exposed to ambient during use (as shown in fig 1, holes in connector (116) are shown to be exposed to ambient).
Regarding claim 107, Allan in fig 1B discloses a vent module (116) (connector) connected to the chassis portion and comprising the vent (connector (116) includes a collection of small apertures comprising the vent) (para [0327]).
Regarding claim 108, Allan discloses the membrane portion includes a seal surface (110) configured to conform to inferior-facing surfaces of the patient's nasal ala (seal surface (110) is configured to form a seal that conforms around the nose, and therefore would be configured to conform to inferior-facing surfaces of the patient's nasal ala) (para [0306]).
Regarding claim 110, Allan discloses the membrane portion includes a seal surface (100) which is configured to seal against the columella of the patient's nose (seal surface (110) is configured to form a seal that conforms around the nose and to surround nasal locators, and therefore would be configured to seal against the columella of the patient's nose in the region between the nasal locators (para [0306]).
Regarding claim 111, Allan discloses the chassis portion (950) is stiffer than the membrane portion (100) (frame (950) can be made of a more rigid type material such as polycarbonate) (para [0383]).
Regarding claim 112, Allan in fig 1 discloses a patient interface comprising: a chassis (112) (frame) (fig 1b, para [0312]); a vent (116) (connector may include a limited flow outlet (220) for providing gas washout) comprising a plurality of holes (a collection of small apertures) sized and shaped to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient (para [0327]) and, said vent (116) being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (interface is configured to maintain a therapeutic pressure in the plenum chamber in order to create a seal with the nose and face of the user (para [0012]), and therefore the vent would be sized in order to allow the plenum chamber to inflate to create a seal with a nose of a user); a membrane portion (100) (seal body (100) includes a seal surface (110) connected to the chassis portion (112) and at least partially forming a plenum chamber (102) (supple envelope) (para [0304]), and in figs 1CA-1CE discloses a seal-forming structure comprising a pair of nasal pillows (104) (nasal locators) (para [0305]), each nasal pillow (104) being constructed and arranged to form a seal with a respective naris of the nose of a patient (para [0012]), each nasal pillow (104) having a hole (outlet aperture) therein such that the flow of air at a therapeutic pressure is delivered to at least the patient's nares, 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 [0305]); wherein the nasal pillows (104) are supported on the membrane portion (100) (figs 1CA-CD, para [0308]) and the membrane portion (100) is constructed and arranged to be flexible to allow for relative movement between the nasal pillows (104) and the chassis portion (112) in use (envelope retains a seal despite substantial lateral movement of the frame relative to the head) (fig 1EA-1EC), para [0345]), each of the nasal pillows (104) is formed from silicone (region including the nasal locators can comprise a silicone material) (para [0077]), each of the nasal pillows (720) is stalkless (includes a wide flange (722) adjacent the envelope and tapering to a narrow tip) (fig 1GA, para [0359]), and each of the nasal pillows (720) comprises a frustoconical portion having a tip and a base wider than the tip, the base being attached directly to the membrane portion (includes a wide flange (722) adjacent the envelope and tapering to a narrow tip) (fig 1GA, para [0359]).
Allan in the fig 1 embodiment does not disclose the chassis portion is configured to at least partially form a plenum chamber and comprising one or more plenum chamber inlet ports sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.
However, Allan in the fig 2 embodiment teaches a patient interface comprising: a chassis portion (950) (frame) configured to at least partially form a plenum chamber with inflatable seal body (940) including a supple envelope (para [0380) and the frame (950) comprising one or more plenum chamber inlet ports (951) (connector) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (interface is supplied with pressurized gases via tubing and the connector (951)) (para [0384]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of the fig 1 embodiment of Allan by configuring the chassis portion as a frame least partially forming a plenum chamber and comprising one or more plenum chamber inlet ports sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient as taught by the fig 2 embodiment of Allan, as the feature of providing a frame at least partially forming a plenum chamber is known in the art, an interface may incorporate different aspects of the mask while using different arrangements (Allan, para [0637]), and it appears that the device of modified Allan would perform equally well to provide an inflatable plenum chamber if the chassis is configured to at least partially form the plenum chamber and comprising one or more plenum chamber inlet ports sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient as taught by the fig 2 embodiment of Allan. See MPEP 2143(I)(A).
The now-modified Allan’s device does not disclose the plenum chamber pressurisable to a therapeutic pressure of at least 4 cm H2O above ambient air pressure.
However, Baigent in figs 6-7 teaches a patient interface comprising: a chassis portion at least partially forming a plenum chamber (3200) (para [0285]), wherein the plenum chamber (3200) is pressurisable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure (patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use) (para [0072]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that the plenum chamber pressurisable to a therapeutic pressure of at least 4 cm H2O above ambient air pressure as taught by Baigent, as the feature of a plenum chamber pressurisable to a therapeutic pressure of at least 4 cm H2O above ambient air pressure is known in the art to provide a seal to a user, and it appears that the device of modified Allan would perform equally well to provide a seal to a patient if the plenum chamber is configured to be pressurisable to a therapeutic pressure of at least 4 cm H2O above ambient air pressure. See MPEP 2143(I)(A).
The now-modified Allan’s device does not disclose the membrane portion is formed at least partially from a textile material.
However, Baigent in figs 6-7 teaches a patient interface (3000) including a membrane portion (3100) (seal-forming structure) providing a seal-forming surface (para [0296]), and wherein the membrane portion (3100) is formed at least partially from a textile material (para [0305]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that the membrane portion is formed at least partially from a textile material as taught by Baigent in order to provide a suitable material with flexibility and ability to inflate under pressure to allow the membrane to form a seal against the patient’s face (Baigent, para [0305]).
Claim 81-82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allan et al and Baigent et al as applied to claim 80 above, and further in view of McAuley et al (2010/0006101).
Regarding claim 81, modified Allan discloses a membrane portion.
Modified Allan does not disclose the membrane portion is stretchable.
However, McAuley in fig 46 teaches a patient interface including a membrane portion including a thin section (26), wherein the thin section of the membrane portion is stretchable (ultra thin section (26) inflates under CPAP pressure to an elastically stretched state) (para [0200]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan by configuring the membrane portion to be stretchable in order to allow the membrane to be inflated to an elastically stretched state to helps the sealing performance of the patient interface, as the seal elastically inflates to the facial contours of the user's face and allows for more movement of the mask on the user's face (McAuley, para [0200]).
Regarding claim 82, the modified Allan’s reference discloses the membrane portion is constructed and arranged to stretch during inflation upon pressurisation of the plenum chamber to the therapeutic pressure in use (McAuley, para [0200]).
Claim 93 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allan et al and Baigent et al as applied to claim 80 above, and further in view of Trimble et al (4,782,832).
Regarding claim 93, modified Allan discloses nasal pillows.
Modified Allan does not disclose the nasal pillows are formed separately from the membrane portion and are attached to the membrane portion.
However, Trimble in figs 15-16 teaches a patient interface including a plenum chamber (106) having a forward face (110), and a pair of nasal pillows (180) (hollow nares elements) formed with a soft, deformable synthetic resin material that is shown to be formed separately from the plenum chamber (106) and are attached to the forward face (110) of the plenum chamber (106) (col 5, ln 66-col 6, ln 9).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that the nasal pillows are formed separately from the membrane portion and are attached to the membrane portion as taught by Trimble in order to allow the nasal pillows to be movable to fit a variety of patients (Trimble, col 4, ln 32-35).
Claim 99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allan et al and Baigent et al as applied to claim 80 above, and further in view of Ellis (2017/0049983).
Regarding claim 99, modified Allan discloses nasal pillows.
Modified Allan does not disclose each of the nasal pillows is formed at least partially from a textile material.
However, Ellis in fig 10 teaches a patient interface including nasal pillows (410) (nasal pillow cushion) (para [0129]), wherein the nasal pillows (410) are formed from a laminar composite body (414) least partially formed from a textile material (composite body (414) includes a first layer (428) which may be a fleeced knit fabric such as a sweatshirt fabric and a second layer (430) that can be a puffy brushed surface (430a) and a fleeced knit fabric (430b)) (para [0115]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan by forming the nasal pillows at least partially from a textile material to form a laminar composite body as taught by Ellis in order to provide a seal made of a soft resilient material that can comfortably conform to the contours of a person's face, having sufficient resilience to return to its original, or at least substantially its original, shape upon removal from the wearer's face (Ellis, para [0025]) and to counteract the oils emanating from human skin that allow filmy surfaces of existing interface devices to slide around during use (Ellis, para [0026]).
Claims 100-101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allan et al and Baigent et al as applied to claim 80 above, and further in view of Guney et al (2009/0044808).
Regarding claim 100, modified Allan discloses nasal pillows.
Modified Allan does not disclose each of the nasal pillows is formed from a single wall.
However, Guney in fig 5-14-1 teaches a patient interface comprising a nasal pillow (1624), wherein the nasal pillow is formed from a single wall with a relatively thin wall thickness (para [0282]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan by providing the nasal pillows with a single wall with a relatively thin wall thickness as taught by Guney in order to allow the single wall to bulge outwardly or slightly inflate (in use to accommodate and/or conform to the patient's nose in use (Guney, para [0282]).
Regarding claim 101, modified Allan discloses nasal pillows.
Modified Allan does not disclose each of the nasal pillows comprises a double wall structure.
However, Guney in fig 3-1 teaches a patient interface comprising a nasal pillow (24) (nasal prongs), wherein the nasal pillows comprise a double wall structure (includes inner wall (26) and outer wall (28)) (para [0236]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan so that each of the nasal pillows comprises a double wall structure as taught by Guney in order to improve jetting performance by making it possible to reorient the inner exit hole at any angle while retaining a "square" sealing orientation for the outer wall (Guney, para [0237]).
Claims 104-105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allan et al and Baigent et al as applied to claim 80 above, and further in view of Veliss et al (2008/0060649).
Regarding claim 104, modified Allan discloses a patient interface comprising a positioning and stabilising structure comprising straps (128, 130, 132 of Allan) (Allan, para [0317]).
Modified Allan does not disclose the positioning and stabilising structure comprising a tie, the tie being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in use.
However, Veliss teaches a patient interface including a an interfacing structure (20) including a chassis (22) (frame) (para [0103]) and a positioning and stabilizing structure (30) (air delivery and stabilizing system) (para [0102]), wherein the positioning and stabilizing comprises a pair of inlet conduits (42) configured to deliver breathable gas to a respective end of the chassis (22) and including a tie (70) (manifold), and shown in fig 1-4, the tie (70) being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in use (manifold (70) is configured to located on or in front of the crown of the patient's head in use, which is superior to an otobasion superior of the patient's head) (para [0101]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Allan by substituting the side strap positioning and stabilizing structure with a positioning and stabilizing positioning and stabilizing positioning and stabilizing structure comprising a pair of inlet conduits configured to deliver breathable gas to a respective end of the chassis and including a tie being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in us as taught by Veliss in order to provide a positioning and stabilizing structure with two inlet tubes that are comfortable to lie on (Veliss, para [0015]) and having sufficient redundancy that if some or one of the conduits is occluded, the system retains sufficient flow of air at therapeutic pressure (Veliss, para [0016]).
Regarding claim 105, the modified Allan’s reference discloses the positioning and stabilising structure (30 of Veliss) comprises a pair of gas delivery tubes (42 of Veliss) (inlet conduits) (para [0102]) and the chassis portion (22 of Veliss) comprises a pair of laterally projecting connection portions (25 of Veliss) (tube portions) configured to connect to the gas delivery tubes (42 of Veliss) and which are sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Veliss, fig 2-1, para [0103]).
Allowable Subject Matter
Claim 109 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.
The following is an examiner’s statement of reasons for allowance: The closest prior of record, Allan et al (2011/0146685) and Baigent et al (2017/0326320) disclose the limitations of claim 80, and wherein the membrane portion includes a seal surface (110) configured to form a seal that conforms around the nose (Baigent, para [0306]). However, neither Allan et al, Baigent et al, nor the other prior art of record, either alone or in combination, disclose the membrane is configured to seal against the patient lip superior, as the seal surface shown in fig 1 of Baigent is shown to engage an underside of a patient’s nose, but does not show the seal surface configured to seal against the patient’s lip superior.
Response to Arguments
Applicant’s arguments with respect to claim(s) 80-105 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 DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached on 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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