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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Non-Provisional App. No. 17/641,751 filed March 9, 2022 not U.S. Pat. No. 11,921,512; to PCT AU2020/050953 filed September 9, 2020; to U.S. Provisional App. No. 63/058,001 filed July 29, 2020; and to Foreign App. No. AU2019903360 filed September 10, 2019.
Status of Claims
This Office Action is responsive to the preliminary amendment filed on May 16, 2024. As directed by the amendment: claims 1-10 have been cancelled; and claims 11-31 have been added. Thus, claims 11-31 are presently pending in this 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 (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.
Claim(s) 11-17, 25-27, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (U.S. Pub. No. 2018/0177965) in view of Cullen et al. (U.S. Pub. No. 2015/0352308; hereinafter: “Cullen”)
Regarding Claim 11, Patel discloses a patient interface for delivering a flow of air at a therapeutic pressure to a patient for treatment of sleep disordered breathing (¶¶ 0003, 0004), the patient interface comprising: a plenum chamber (2125; ¶ 0135; Examiner notes: Patel discloses the plenum chamber as the chamber defined by the first and second seal-forming structure.) comprising silicone (¶ 0135) and at least partially forming a cavity that is pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure (¶¶ 0135, 0155), said plenum chamber including a plenum chamber inlet port (2114; Fig. 4) sized and structured to, in use, receive a flow of air at the therapeutic pressure for breathing by a patient (¶¶ 0131, 0134); a first seal-forming structure (2166, 2162; Fig. 7, 8) comprising silicone (¶ 0135) and being constructed and arranged to, in use, form a seal with a region of the patient's face surrounding an entrance to the patient's mouth such that the flow of air at said therapeutic pressure is delivered to the patient's mouth (¶¶ 0136, 0137, 0139, 0142, 0144, 0146-0148), the first seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (¶¶ 0136, 0137, 0139, 0142, 0144, 0146-0148); a second seal-forming structure (2126, 2168; Fig. 3, 4, 6-8) comprising silicone (¶ 0135) and being constructed and arranged to, in use, form a seal with a region of the patient's face surrounding an entrance to the patient's nose such that the flow of air at said therapeutic pressure is delivered to the patient's nose (¶¶ 0138-0140, 0142, 0148-0155), the second seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (¶¶ 0138-0140, 0142, 0148-0155); the second seal-forming structure being configured to seal against inferior surfaces of the patient's nose such that, in use, the second seal-forming structure does not lie over a nose bridge region or nose ridge region of the patient's face (Fig. 1; ¶¶ 0127, 0138-0140, 0142, 0148-0155); the plenum chamber, the first seal-forming structure, and the second seal-forming being integrally formed as a one-piece structure that forms the cavity such that the cavity is delimited by an all-silicone structure (¶¶ 0129, 0135; Fig. 4-8, 11-21); a vent structure (2110; Fig. 1) configured to allow gases exhaled by the patient to flow from the cavity to ambient in use (¶ 0132), said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (¶ 0132); and a positioning and stabilizing structure (2178, 2180; Fig. 1-3, 22, 37, 38) configured to maintain the first seal-forming structure and the second seal-forming structure in a therapeutically effective position (¶¶ 0130, 0131, 0161, 0162, 0164), the positioning and stabilizing structure comprising: a frame (2178; Fig. 1-3, 22, 37, 38) configured to be directly coupled to the silicone of the plenum chamber (Fig. 1-3, 22, 37, 38; ¶¶ 0130, 0131, 0161, 0162, 0164), the frame including: a central portion (A, Fig. A annotated below) configured to directly engage an anterior surface (B, Fig. A annotated below) of the plenum chamber external of the cavity, and a pair of arms (C, Fig. A annotated below) that extend away from the central portion in a posterior direction (Fig. 1-3, 22, 37, 38); and a plurality of headgear straps (2180; Fig. 1, 2) configured to be coupled to the frame and exert a force on the frame which causes the frame to urge the first seal-forming structure and the second seal-forming structure into the patient's face when the patient interface is worn by the patient (¶¶ 0130, 0141, 0145, 0151, 0161).
PNG
media_image1.png
285
476
media_image1.png
Greyscale
Figure A, Adapted from Figure 37 of Patel.
Petal does not specifically disclose the patient interface wherein the pair of arms that extend away from the central portion in a posterior direction past the second seal-forming structure when the patient interface is worn by the patient, the pair of arms being more flexible than the central portion, each arm of the pair of arms being configured to extend along a respective side of the patient's face in use.
Cullen teaches a patient interface comprising a seal-forming structure (3100, 3002; Fig. 64-66); a positioning and stabilizing structure (3001, 3310, 10220, 10225, 10230; Fig. 53-55, 64-67) configured to maintain the first seal-forming structure and the second seal-forming structure in a therapeutically effective position (¶¶ 0232-0258), the positioning and stabilizing structure comprising: a frame (3310; Fig. 53-55) configured to be directly coupled to the plenum chamber (Fig. 64-66; ¶¶ 0168, 0173, 0228), the frame including: a central portion (A, Fig. B annotated below) and a pair of arms (10320; Fig. 53-55) that extend away from a central portion in a posterior direction past the seal-forming structure (Fig. 64-66) when a patient interface is worn by the patient, the pair of arms being more flexible than the central portion (¶¶ 0253, 0254), each arm of the pair of arms being configured to extend along a respective side of the patient's face in use (Fig. 64-66; ¶¶ 0228-0286) for the purpose of when displaced in certain directions the pair of arms provides the patient with greater comfort, less likelihood of seal disruption caused by tube torque and therefore leads to increased patient compliance with therapy in terms of frequency of use and therapy duration (¶ 0253).
PNG
media_image2.png
340
674
media_image2.png
Greyscale
Figure B, Adapted from Figure 55 of Cullen.
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 patient interface of Patel to include the pair of arms that extend away from the central portion in the posterior direction past the second seal-forming structure when the patient interface is worn by the patient, the pair of arms being more flexible than the central portion, each arm of the pair of arms being configured to extend along a respective side of the patient's face in use as taught by Cullen for the purpose of when displaced in certain directions the pair of arms provides the patient with greater comfort, less likelihood of seal disruption caused by tube torque and therefore leads to increased patient compliance with therapy in terms of frequency of use and therapy duration (See Cullen: ¶ 0253).
Regarding Claim 12, the modified device of Patel discloses the patient interface wherein each arm of the pair of arms is more flexible than the frame (See Cullen: ¶¶ 0253, 0254).
Regarding Claim 13, the modified device of Patel discloses the patient interface wherein herein the central portion (at B, Fig. B annotated above) is thicker than each arm of the pair of arms (at C, Fig. B annotated above).
Regarding Claim 14, the modified device of Patel discloses the patient interface wherein the central portion and each arm of the pair of arms are constructed from a same material (See Patel: ¶ 0130, See Cullen: ¶¶ 0228, 0231).
Regarding Claim 15, the modified device of Patel discloses the patient interface wherein each arm of the pair of arms includes a first connection point (A, Fig. C annotated below, See Cullen: 10325; Fig. 53-55), the plurality of headgear straps including a pair of superior headgear straps (See Patel: B, Fig. C annotated below, See Cullen: 10230; Fig. 64-66) configured to be coupled, respectively, to the first connection point of each arm (See Patel: ¶¶ 0130, 0161, See Cullen: ¶¶ 0235, 0238-0240, 0250, 0253, 0294-0296).
PNG
media_image3.png
518
598
media_image3.png
Greyscale
Figure C, Adapted from Figure 1 of Patel.
Regarding Claim 16, the modified device of Patel discloses the patient interface wherein a pair of inferior strap connectors (C, Fig. C annotated above, See Cullen: 10331; Fig. 53-55) is attached to the central portion of the frame, the plurality of headgear straps including a pair of inferior headgear straps (See Patel: D, Fig. C annotated above, See Cullen: 10220; Fig. 64-66), each inferior headgear strap including a frame connector (E, Fig. C annotated above) configured to be removably coupled to a respective one of the inferior strap connectors to secure the inferior headgear strap to the frame (See Patel: ¶¶ 0130, 0161, See Cullen: Fig. 53-55; ¶¶ 0232, 0235-0252) and wherein the first connector point of each arm is spaced a farther distance from the central portion of the frame than each inferior strap connector is spaced from the central portion of the frame due to a length of each arm (See Patel: Fig. 1, 2, See Cullen: Fig. 53-55; ¶¶ 0232, 0235-0252).
Regarding Claim 17, the modified device of Patel discloses the patient interface wherein each first connection point forms a loop (A, Fig. C annotated above) configured to receive a respective one of the superior headgear straps (See Patel: Fig. 1).
Regarding Claim 25, the modified device of Patel discloses the patient interface wherein the central portion includes an annular shape (C, Fig. A annotated above), the plenum chamber inlet port disposed radially within the central portion when the frame is coupled to the plenum chamber (See Patel: Fig. 1-3; ¶¶ 0134, 0135, 0137, 0161).
Regarding Claim 26, the modified device of Patel discloses the patient interface further comprising an elbow (See Patel: 2016; Fig. 1-3) configured to be received in the plenum chamber inlet port (See Patel: ¶¶ 0130-0132, 0134, 0137, 0139, 0161), the elbow being configured to be spaced apart from the central portion while received within the plenum chamber inlet port (See Patel: Fig. 1-3, ¶¶ 0130-0132, 0134, 0137, 0139, 0161).
Regarding Claim 27, the modified device of Patel discloses the patient interface wherein each arm of the pair of arms is pivotable relative to the central portion about a pivot point (D, Fig. B, annotated above).
Regarding Claim 29, the modified device of Patel discloses the patient interface wherein the plenum chamber inlet port is an opening formed in the silicone of the anterior surface of the plenum chamber (See Patel: Fig. 4; ¶¶ 0134, 0135, 0137, 0161).
Regarding Claim 30, the modified device of Patel discloses the patient interface wherein the second seal-forming structure comprises at least one nasal aperture (See Patel:2124; Fig. 5, 8) configured to deliver the flow of air at said therapeutic pressure to the patient's nasal airways (See Patel: ¶¶ 0136, 0137).
Regarding Claim 31, the modified device of Patel discloses the patient interface wherein the patient interface does not include a structure intended to contact the patient's forehead in use (See Patel: Fig. 1, 2).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Cullen as applied to claim 11 above, and further in view of Scheiner et al. (U.S. Pub. No. 2018/0318539; hereinafter: “Scheiner”).
Regarding Claim 18, the modified device of Patel discloses the patient interface wherein the plurality of headgear straps including a pair of inferior headgear straps (See Patel: D, Fig. C annotated above, See Cullen: 10220; Fig. 64-66).
The modified device of Patel does not specifically disclose the patient interface wherein a pair of first magnets is overmolded onto the central portion of the frame, wherein each inferior headgear strap including a second magnet configured to be removably coupled to a respective one of the first magnets.
Scheiner teaches headgear connectors comprising a pair of first magnets (6150; Fig. 5-7, 9) overmolded onto a central portion of a frame (6100; Fig. 4-9; ¶¶ 0178, 0179, 0183), a plurality of headgear straps (6802, 6804; Fig. 4-6, 8) including a pair of inferior headgear straps (6804; Fig. 4-6, 8), each inferior headgear strap including a second magnet (6162; Fig. 4, 5) configured to be removably coupled to a respective one of the first magnets (¶ 0183) for the purpose of providing a simple method of connecting the headgear to the frame.
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 modified device of Patel to include the pair of first magnets is overmolded onto the central portion of the frame, wherein each inferior headgear strap including the second magnet configured to be removably coupled to a respective one of the first magnets as taught by Scheiner for the purpose of providing a simple method of connecting the headgear to the frame.
Claim(s) 19-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Cullen as applied to claim 11 above, and further in view of Mazzone et al. (U.S. Pub. No. 2012/0234326; hereinafter: “Mazzone”).
Regarding Claim 19, the modified device of Patel discloses the patient interface, shown above.
The modified device of Patel does not specifically disclose the patient interface wherein the plenum chamber includes a groove, the central portion being configured to be positioned within the groove to couple the frame to the plenum chamber.
Mazzone teaches a mask system comprising a plenum chamber (1112; Fig. 23-1to 23-5) includes a groove (1154; Fig. 23-1to 23-5), a central portion being configured to be positioned within the groove to couple a frame to the plenum chamber (¶ 0146) for the purpose of connecting the plenum chamber to the frame in order to position and stabilize the plenum chamber on the patient's face (¶ 0146).
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 modified device of Patel to include the plenum chamber including the groove, the central portion being configured to be positioned within the groove to couple the frame to the plenum chamber as taught by Mazzone for the purpose of connecting the plenum chamber to the frame in order to position and stabilize the plenum chamber on the patient's face (See Mazzone: ¶ 0146).
Regarding Claim 20, the modified device of Patel discloses the patient interface wherein the central portion is removably positionable within the groove via a press fit, friction fit and/or snap-fit (See Mazzone: ¶ 0146).
Regarding Claim 21, the modified device of Patel discloses the patient interface wherein the groove includes a projection (See Mazzone: 1151; Fig. 23-1, 23-4) formed therein, the central portion including a complimentary slot configured to receive the projection (See Mazzone: ¶ 0146)..
Regarding Claim 23, the modified device of Patel discloses the patient interface wherein the plenum chamber includes a protrusion (See Mazzone: 1151; Fig. 23-1, 23-4) disposed adjacent to the groove, the protrusion configured to retain the central portion within the groove (See Mazzone: ¶ 0146).
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Cullen as applied to claim 27 above, and further in view of Amarasinghe et al. (U.S. Pub. No. 2018/0250486; hereinafter: “Amarasinghe”).
Regarding Claim 28, the modified device of Patel discloses the patient interface, shown above.
The modified device of Patel does not specifically disclose the patient interface wherein each pivot point is a living hinge.
Amarasinghe teaches an arm comprising a living hinge as the pivot point (¶ 0268) for the purpose of increasing flexibility of the arm (¶ 0268).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify XX of Smith to include the each pivot point as the living hinge as taught by Amarasinghe for the purpose of increasing flexibility of the arm (See Amarasinghe: ¶ 0268).
Allowable Subject Matter
Claims 22 and 24 are 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 a statement of reasons for the indication of allowable subject matter: Prior art of record disclose the patient interface, shown above.
Patel, Cullen, Scheiner, Mazzone, and Amarasinghe alone or in combination fail to disclose or render obvious the patient interface wherein the slot is tapered and includes a wider opening at a first end and a narrower opening at a second end, the projection configured to be received through the wider opening before being received through the narrower opening, as recited in dependent claim 22.
Patel, Cullen, Scheiner, Mazzone, and Amarasinghe alone or in combination fail to disclose or render obvious the patient interface wherein an outer surface of the central portion is flush with an outer surface of the plenum chamber when the frame is coupled to the plenum chamber, and wherein, in use, the outer surface of the central portion and the outer surface of the plenum chamber are configured to be faced away from the patient., as recited in dependent claim 24.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
Prosecution Insights