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 .
Status of the Claims
This Office Action is in responsive to the preliminary amendment filed on 9/23/2024. As directed by the Preliminary amendment, claims 1-3, 5-11, 14-15, 17-19, 21, 23-26, and 35-36 were amended, and claims 4, 12-13, 16, 20, 22, 27-34, and 37-56 were cancelled. Thus, claims 1-3, 5-11, 14-15, 17-19, 21, 23-26, and 35-36 are currently pending in this application.
Claim Objections
Applicant is advised that should claim 17 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 1 is objected to because of the following informalities: claim 1 recites “the textile layer and resilient material” in line 6, and is suggested to read --the textile layer and the resilient material-- in order to ensure proper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 1-3, 5-7, 9, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baigent et al. (US 2017/0326320 A1).
Regarding claim 1, Baigent discloses a cushion for a respiratory therapy mask for contacting a face of a user (seal forming structure 3100 of patient interface 3000, which is worn on a patient’s 1000 face to deliver a supply of positive air pressure) (Figs. 1A-1C, 21A-21C, 36A-39C; para. [0084]; para. [0320]; para. [0332]), the cushion having an opening for communication with a breathing chamber and delivery of fluid to the user (seal forming structure 3100 has an opening 3101 to deliver a supply of positive air pressure to a user from the chamber defined by the mask) (Figs. 21A-21C, 36A-39C; para. [0084]; para. [0320]; para. [0332]; para. [0339]), the cushion comprising: a textile layer (seal forming structure 3100 has a textile membrane 3109) (Figs. 21A-21C, 36A-39C; para. [0320]; para. [0331]); and a resilient material bonded to the textile layer (silicone cushion 3108 or a foam undercushion 3114 glued or stitched to the textile membrane 3109) (Figs. 21A-21C, 36A-39C; para. [0320]; paras. [0331-0332]); wherein the textile layer and resilient material together define a profile of the cushion, the resilient material biasing the textile layer towards the profile of the cushion (silicone cushion 3108 or a foam undercushion 3114 attached to the textile membrane 3109 together form the profile of the seal forming structure 3100, wherein the silicone cushion 3108 or a foam undercushion 3114 biases the overlaid textile membrane 3109 into the profile shape) (Figs. 21A-21C, 36A-39C; para. [0320]; para. [0331]).
Regarding claim 2, Baigent discloses wherein the cushion is self-supporting (silicone cushion 3108 and foam undercushion 3114 are solid physical objects, and so are self-supporting) (Figs. 21A-21C, 36A-39C; para. [0320]; para. [0331]).
Regarding claim 3, Baigent discloses wherein the resilient material comprises an elastomer (silicone cushion 3108 is made of silicone and foam undercushion 3114 is made of a foam that conforms to a patient to form a seal, and so both are elastomeric material) (Figs. 21A-21C, 36A-39C; para. [0291]; para. [0296]; para. [0320]; para. [0323]; para. [0331]).
Regarding claim 5, Baigent discloses wherein the resilient material is substantially impermeable to air (silicone cushion 3108 is made of silicone, which is a sealing material) (Figs. 21A-21C; para. [0296]; para. [0320]).
Regarding claim 6, Baigent discloses wherein the textile layer forms an outer surface of the cushion for contacting the face of a user (textile membrane 3109 has an outer surface that contacts the patient’s face) (Figs. 21A-21C, 36A-39C; para. [0331]).
Regarding claim 7, Baigent discloses wherein the resilient material comprises an elastomeric layer bonded to a surface of the textile layer (silicone cushion 3108 is made of silicone and foam undercushion 3114 is made of a foam that conforms to a patient to form a seal, and so both are elastomeric material; silicone cushion 3108 or a foam undercushion 3114 have a layer glued or stitched to a surface of the textile membrane 3109) (Figs. 21A-21C, 36A-39C; para. [0291]; para. [0296]; para. [0320]; para. [0323]; para. [0331-0332]).
Regarding claim 9, Baigent discloses wherein the resilient material forms an inner layer of the cushion (silicone cushion 3108 or a foam undercushion 3114 has an inner surface or layer opposite the textile membrane 3109) (Figs. 21A-21C, 36A-39C; para. [0320]; para. [0331]).
Regarding claim 23, Baigent discloses wherein edges of the cushion comprise cut edges (textile membrane 3109 of the seal forming structure 3100 is cut to shape, and so has cut edges which are subsequently joined) (Figs. 36A-39C; para. [0332]).
Claims 1, 10-11, 14-15, 17-19, 21, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunley et al. (US 2018/0043120 A1).
Regarding claim 1, Hunley discloses a cushion for a respiratory therapy mask for contacting a face of a user (a mask cushion of a respiratory mask configured to interface with a patient’s face) (Figs. 1-4; abstract; claim 9), the cushion having an opening for communication with a breathing chamber and delivery of fluid to the user (rounded triangular opening in the mask cushion would allow fluid communication between the chamber defined by the mask and the patient when positive airway pressure is administered) (Figs. 1-4; para. [0002]; claim 9), the cushion comprising: a textile layer (liner 10 made of knitted fabric) (Figs. 1-4; para. [0024]); and a resilient material bonded to the textile layer (liner 10 stretched over the CPAP mask cushion 22, which is made of elastomeric materials; liner 10 is attached to cushion 22 via rubber tape or fasteners) (Figs. 1-4; para. [0005]; para. [0021]; para. [0027]; para. [0034]); wherein the textile layer and resilient material together define a profile of the cushion, the resilient material biasing the textile layer towards the profile of the cushion (as the liner 10 is stretched over the CPAP mask cushion 22, the liner 10 and cushion 22 together form a profile of the whole mask cushion with the cushion 22 biasing the stretchable liner 10 into the profile shape) (Figs. 1-4; para. [0005]; para. [0021]; para. [0027]).
Regarding claim 10, Hunley discloses wherein the textile layer is formed from a textile tube (liner 10 is a knitted cylindrical tube) (Figs. 1, 4; para. [0025]).
Regarding claim 11, Hunley discloses comprising a first textile layer and a second textile layer bonded to the resilient material, the second textile layer forming an inner surface of the cushion (liner 10 over cushion 22 has a first layer tucked inside the cushion 22 and a second layer over the top of mask 20; liner 10, and thus its layers, is attached to cushion 22 via rubber tape or fasteners) (Figs. 1-4; para. [0031]).
Regarding claim 14, Hunley discloses wherein the second textile layer and the first textile layer are formed from a continuous textile tube (liner 10, which forms both layers, is a continuous knitted tube) (Figs. 1-4; para. [0025]).
Regarding claim 15, Hunley discloses wherein the textile tube comprises a cylindrical tube (liner 10 is a knitted cylindrical tube) (Figs. 1, 4; para. [0025]).
Regarding claim 17, Hunley discloses wherein the textile tube comprises a cross sectional shape that varies along a length of the textile tube (during and after being stretched to fit the cushion 22, the liner 10 tube would have varying cross sectional shapes along its length) (Figs. 1-4; para. [0025]).
Regarding claim 19, Hunley discloses wherein a cross sectional area of the textile tube varies along a length of the textile tube (during and after being stretched to fit the cushion 22, the liner 10 tube would have varying cross sectional shapes along its length) (Figs. 1-4; para. [0025]).
Regarding claim 26, Hunley discloses wherein the textile layer comprises a knitted textile (liner 10 is a knitted cylindrical tube) (Figs. 1, 4; para. [0025]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Baigent as applied to claim 1 above, and further in view of Henry et al. (WO 2009/026627 A1).
Regarding claim 8, Baigent discloses the invention as previously claimed, including wherein resilient material comprises an elastomer (silicone cushion 3108 is made of silicone and foam undercushion 3114 is made of a foam that conforms to a patient to form a seal, and so both are elastomeric material) (Baigent; Figs. 21A-21C, 36A-39C; para. [0291]; para. [0296]; para. [0320]; para. [0323]; para. [0331]), but does not disclose the textile layer is impregnated with the elastomer.
However, Henry teaches a patient interface (Henry; abstract) wherein the textile layer is impregnated with the elastomer (textile or fabric impregnated with silicone) (Henry; Fig. 1-5; para. [0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Baigent textile layer such that he textile layer is impregnated with the elastomer, as taught by Henry, for the purpose of providing the soft appearance of a textile with sealing properties without the weight (Henry; para. [0063]).
Claims 18 and 21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hunley.
Regarding claim 18, while Hunley does not explicitly recite wherein the cross sectional shape transitions from circular to triangular along the length of the textile tube, Hunley does teach its liner 10 is stretchy and so would be capable of such shapes. Specifically, the circular cross section of liner 10 at rest can be stretched into a triangular shape to match the mask cushion 22, as seen in Figs. 1-4. Due to the liner 10 being made of such stretchable material, the liner 10 is capable of having both circular and triangular cross sectional areas along its length when being stretched at one end and at rest or stretched less on the other end when fitting a mask (Figs. 1-4; paras. [0030-0031]; claim 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hunley textile tube such that the cross sectional shape transitions from circular to triangular along the length of the textile tube, as suggested by Hunley, in order to fit a mask that similarly transitions from circular to triangular cross sectional areas.
Regarding claim 21, while Hunley does not explicitly recite wherein the textile tube transitions from a circle of a first radius to a circle of a second radius along a length of the textile tube, Hunley does teach its liner 10 is stretchy and so would be capable of such shapes. Specifically, the circular cross section of liner 10 at rest has a diameter d2 that can be stretched into a larger circular shape of diameter d1 when being fit over the mask cushion 22. Due to the liner 10 being made of stretchable material, the liner 10 is capable of having both a smaller and a larger circular cross sectional area along its length when being stretched at one end and at rest or stretched less on the other end (Figs. 1-4; paras. [0030-0031]; claim 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hunley textile tube such that the textile tube transitions from a circle of a first radius to a circle of a second radius along a length of the textile tube, as suggested by Hunley, in order to fit a mask that similarly transitions from a circle of a first radius to a circle of a second radius of cross sectional areas.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Baigent as applied to claim 1 above, and further in view of Veliss et al. (US 2008/0060649 A1).
Regarding claim 24, Baigent discloses the invention as previously claimed, but does not disclose wherein the textile layer comprises an air permeable textile.
However, Veliss teaches an air delivery system (Veliss; abstract) wherein the textile layer comprises an air permeable textile (skin contacting layer can have a textile which is breathable or air permeable) (Veliss; para. [0292]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Baigent textile layer such that the textile layer comprises an air permeable textile, as taught by Baigent, for the purpose of helping to enhance patient comfort and compliance by decreasing the accumulation of sweat, keeping skin drier, and moderating the temperature of the contacted skin (Veliss; para. [0273]).
Regarding claim 25, the modified Baigent teaches wherein the textile layer comprises an absorbent textile (skin contacting layer can have a textile with wicking properties, which thereby absorbs and moves moisture such as sweat) (Veliss; para. [0275]; para. [0292]).
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Baigent as applied to claim 1 above, and further in view of Skipper et al. (US 2011/0088699 A1).
Regarding claim 35, Baigent discloses the invention as previously claimed, but does not disclose wherein the textile layer is patterned or comprises a plurality of decorative cut-outs.
However, Skipper teaches a cushion assembly for use with a respiratory mask (Skipper; abstract) wherein the textile layer is patterned (cushion with skin 6445 made from fabric or textile with designs for aesthetics) (Skipper; Fig. 131; para. [0252]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Baigent textile layer such that the textile layer is patterned, as taught by Skipper, for the purpose of providing the cushion with aesthetics (Skipper; para. [0252]).
Regarding claim 36, the modified Baigent teaches the invention as previously claimed, but does not teach comprising one or more air permeable cushion portions free of the resilient material.
However, Skipper further teaches comprising one or more air permeable cushion portions free of the resilient material (gel cushion 6140 with open windows 6147) (Skipper; Fig. 128; para. [0250]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Baigent cushion such that one or more air permeable cushion portions free of the resilient material, as taught by Skipper, for the purpose of providing variable structural qualities such as differing elasticities (Skipper; para. [0250]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2012/0080035 A1 by Guney et al. is considered to be relevant as it discloses a mask system with a cushion with a fabric membrane cover.
US 2018/0264218 A1 by Chodkowski is considered to be relevant as it discloses a patient interface with both a resilient layer and fabric layer for the cushion body.
US 2007/0267017 A1 by Edwin McAuley et al. is considered to be relevant as it discloses a breathing assistance apparatus wherein the mask cushion has cut outs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 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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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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