DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Non-Provisional Application No. 16/387,893 filed April 18, 2019 now Patent No. 11,452,832; to U.S. Non-Provisional Application No. 14/131,737 filed January 9, 2014 now Patent No. 10,300,235; and to PCT AU2012/000836 filed July 12, 2012; to Provisional Application No. 61/457,935 filed July 12, 2011.
Status of Claims
This Office Action is responsive to the amendment filed on November 17, 2025. As directed by the amendment: claims 11-12, 14-15, 17, and 36 have been amended; claims 37-42 have been added; and claims 23, 25, 30, and 32-34 have been cancelled. Thus, claims 11-22, 24, 26-29, 31, and 35-42 are presently pending in this application.
Claim 11, 13, 15-18, 20, 21, 24, and 26-35 were previously rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Handke et al. (U.S. Pat. No. 5,724,965) in view of Veliss et al. (U.S. Pub. No. 2008/0047560) in view of Veliss et al. (U.S. Pub. No. 2008/0060649). Claims 12, 23 and 36 were previously rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable further in view of Groll (U.S. Pub. No. 2008/0142015). Claim 19 was previously rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable further in view of Gunaratnam et al. (U.S. Pub. No. 2004/0226566). Claim 22 was previously rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable further in view of Brackenreg (WO 2008011682 A1).
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 37-42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Veliss et al. (U.S. Pub. No. 2008/0047560; hereinafter: “Veliss’560”) in view of Veliss et al. (U.S. Pub. No. 2008/0060649; hereinafter: Veliss’649) in view of Groll (U.S. Pub. No. 2008/0142015).
Regarding Claim 37, Veliss’560 discloses a mask system for delivering pressurized breathable gas to a patient for treatment of sleep disordered breathing (Abstract), comprising: a mask (50, 52, 250, 252, 350, 352; Fig. 2-1to 2-10) including: a non-patient-contacting side (at 50, 250, 350; Fig. 2-1 to 2-10); a patient-contacting side (at 52, 252 or 352; Fig. 2-1 to 2-10) forming a posterior portion of the mask in use (Fig. 3-7), the non-patient contacting side and the patient-contacting side together at least partially forming a cavity (A, Fig. A annotated below) configured to receive the patient's nose therein in use (Fig. 1-1 to 1-3; ¶ 0031); and a textile seal member (52, 252 or 352; Fig. 2-1 to 2-10) adapted to sealingly engage the patient's face in use (¶¶ 0044-0051), wherein the textile seal member includes an opening (B, Fig. B annotated below) formed therein and configured to receive the patient's nose into the cavity in use (¶¶ 0044-0051) wherein the textile seal member being formed as part of the patient-contacting side (Fig. 2-7; ¶¶ 0048-0051) and wherein the textile seal member being formed as part of the patient-contacting side and including a plurality of layers (Fig. 2-4 to 2-8; ¶¶ 0043-0051).
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Figure A, Adapted from Figure 2-8 of Veliss’560.
Veliss’560 does not specifically disclose the mask system wherein the non-patient contacting side comprises silicone and wherein the textile seal member includes a first layer of textile and a second layer of silicone.
Veliss’649 teaches a mask system comprising a non-patient-contacting side (22; Fig. 1-6, 1-8, 1-10, 13-1 to 13-2, 21-1 to 21-3) comprising silicone forming an anterior-most portion of the mask (Fig. 1-6, 1-8, and 1-10; ¶¶ 0180, 0202, 0203, 0290, 0334-0336, 0342, 0343) and a patient-contacting side (80; Fig. 1-6, 1-8, 1-10, 13-1 to 14-1) covered in a textile (¶¶ 0200-0204, 0278) configured to compress in use when the textile seal member sealingly engages the patient's face (¶¶ 0200, 0229, 0263) for the purpose of the making the patient-contacting side self-supporting and offering stiffness, while deforming to establish the seal (¶¶ 0229, 0263), thereby allowing a small deliberate flow of air to escape through the body of the foam structure (¶ 0229) and providing a vent (627; Fig. 21-2 and 21-3) inserted within the silicone for CO2 washout (¶¶ 0342, 0343).
Groll teaches mask system comprising a textile seal member (57, 58; Fig. 1, 2) comprises a first layer of textile (58; Fig. 2) and a second layer of silicone (57; Fig. 2; ¶¶ 0031, 0053-0055, 0057, 0060) for the purpose of providing air impermeability while ensuring flexibility and softness (¶ 0053).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the mask system of Veliss’560 to include the non-patient contacting side comprises silicone as taught by Veliss’649 and the textile seal member including the first layer of textile and the second layer of silicone as taught by Groll for the purpose of the making the patient-contacting side self-supporting and offering stiffness, while deforming to establish the seal (See Veliss’649: ¶¶ 0229, 0263), thereby allowing a small deliberate flow of air to escape through the body of the foam structure (See Veliss’649: ¶ 0229) and providing a vent (See Veliss’649: 627; Fig. 21-2 and 21-3) inserted within the silicone for CO2 washout (See Veliss’649: ¶¶ 0342, 0343) and of providing air impermeability while ensuring flexibility and softness (See Groll: ¶ 0053).
Regarding Claim 38, the modified device of Veliss’560 discloses the mask system wherein the layer of silicone is an air impermeable layer (See Groll: ¶¶ 0031, 0053-0055, 0057, 0060).
Regarding Claim 39, the modified device of Veliss’560 discloses the mask system wherein the non-patient contacting side of the mask includes a front panel (See Veliss’560: 50, 250, 350; Fig. 2-1 to 2-10), and the patient contacting side of the mask includes a back panel (See Veliss’560: 52, 252 or 352; Fig. 2-1 to 2-10).
Regarding Claim 40, the modified device of Veliss’560 discloses the mask system wherein the front panel comprises the silicone (See Veliss’649: 627; Fig. 21-2 and 21-3).
Regarding Claim 41, the modified device of Veliss’560 discloses the mask system wherein the front panel and the back panel sealingly engage one another along respective outer perimeters (along A, Fig. B annotated below) of the front panel and the back panel to together at least partially form the cavity (See Veliss’560: ¶¶ 0043-0053).
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Figure B, Adapted from Figure 2-10 of Veliss’560.
Regarding Claim 42, the modified device of Veliss’560 discloses the mask system wherein the mask has a headgear connection point (See Veliss’560: 351; Fig. 2-7 to 2-10) on each side of the mask (See Veliss’560: ¶ 0050).
Allowable Subject Matter
Claims 11-22, 24, 26-29, 31, and 35-36 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Prior art of record Veliss’560, Veliss’649, and Groll disclose the mask system, shown above.
Prior art of record Handke et al. (U.S. Pat. No. 5,724,965) discloses a mask system for delivering pressurized breathable gas to a patient for treatment of sleep disordered breathing (Abstract), comprising: a mask (10; Fig. 1-8) including: a non-patient-contacting side (at 48; Fig. 2, 4, 6) forming an anterior portion of the mask in use (Fig. 2, 4, 6); a patient-contacting side (at 58, Fig. 3-7) forming a posterior portion of the mask in use (Fig. 3-7), the non-patient contacting side and the patient-contacting side together at least partially forming a cavity (56; Fig. 3, 4, 6) adapted to be in fluid communication with the patient's airway such that both the non-patient contacting side and the patient-contacting side are exposed to therapeutic pressurized breathable gas in use (col 3, ln 66 to col 4, ln 5); a padding (100; Fig. 4, 6) on the patient-contacting side (col 4, ln 61-67; col 5, ln 34-53), a first thickness (A, Fig. C annotated below) of the padding in a first region (at A, Fig. C annotated below) of the mask being different than a second thickness (B, Fig. C annotated below) of the padding in a second region (at B, Fig. C annotated below) of the mask; and a textured seal member (58; Fig. 3-5, 7) adapted to sealingly engage the patient's face in use (col 2, ln 19-33; col 5, ln 19-33), the textured seal member being attached to and provided over the padding (Fig. 4, 6), wherein the textile seal member includes an opening (60; Fig. 3, 7) formed therein and configured to deliver breathable gas to the patient's airways in use (col 3, ln 66 to col 4, ln 5).
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Figure C, Adapted from Figure 6 of Handke.
Prior art of record Veliss’560, Veliss’649, Groll,, Handke et al., Brackenreg (WO 2008011682 A1), and Gunaratnam et al. (U.S. Pub. No. 2004/0226566) alone or in combination fail to disclose or render obvious the mask system wherein the non-patient contacting side comprises a first flexible material, the non-patient-contacting side forming an anterior portion of the mask in use, the first flexible material including a pair of lateral ends forming cuff connecting surfaces having curved shapes adapted to, respectively, engage and form at least part of an annular seal around a pair of cuffs adapted to connect to a pair of air delivery conduits, as recited in independent claim 11.
Therefore, independent claim 11, and claims 12-22, 24, 26-29, 31, and 35-36 by dependency, are allowable.
Response to Arguments
Applicant’s arguments, see Pg. 7-11, filed November 17, 2025, with respect to amended independent claim 11 have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of amended independent claim 11 has been withdrawn.
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 ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785