DETAILED ACTION
This office action is in response to the amendment dated 2/2/2026. As directed by the amendment, claims 1, 5, 10, and 16 have been amended, claims 2 and 14-15 has been canceled, and claim 22 has been newly added. Thus, claims 1, 3-13 and 16-22 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 5 and 10, line 10 of claims 5 and 10 recites, “wherein the first opening is smaller than the second opening”. Applicant’s specification discloses that the first opening may be larger than second opening (page 4, lines 20-21, page 6, lines 16-17, page 8, lines 10-11, page 16, lines 23-25). However, although applicant’s originally filed disclosure does not disclose that the first opening is smaller than the second opening, as embodiment 2 disclose that first opening may be larger than the second opening, embodiments 1 and 3-5 are silent on the relative sizes between the first opening and the second opening, and figures 8-12 appear to show that the first opening is larger than the second opening. Therefore, applicant’s originally filed disclosure does not disclose the limitation “wherein the first opening is smaller than the second opening” in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention.
Claims 6-9 and 11-13 are rejected for being either directly or indirectly from rejected claim base.
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.
Claims 1, 3-4, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matula, Jr (2011/0126841) et al in view of Von Moger et al (2015/0151071) and Scheiner (2015/0352306) et al.
Regarding claim 1, Matula in figs 1-4 discloses a nasal mask for use under pressure conditions, configured to deliver continuous positive pressure gas to a nasal airway of a user for treatment of sleep apnea (para [0062]), the nasal mask comprising: a flexible part (40) (sealing assembly) with a first opening (44) (opening) configured to be near a face of the user (para [0064]) and a second opening configured to be away from the face of the user (as shown in fig 4, rear of mask (40) includes an opening configured to interface with opening of support flange (46) (para [0065]), wherein the first opening, during use, is configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user (sealing surface surrounds a patient’s nares) (para [0064]), wherein the flexible part is configured to bend towards a side nearer the face of the user, to form at least one protrusion (as shown in fig 4, nasal mask (40) forms a concave sealing surface (42) and forms two peaks on lateral sides of the nasal mask (40)) (para [0064]); wherein the flexible part (40) includes a region forming a sealing section (42) (concave sealing surface) (para [0064]); and wherein the nasal mask (40) further comprises a rigid part (38) (support member formed of rigid materials) (para [0063]) with at least two connection ports, wherein one port (46) (opening of support flange) is configured to connect to the second opening of the flexible part that is configured to be away from the face of the user and to seal with the flexible part, to jointly form a chamber to accommodate gas (para [0065]), and wherein at least two ports are is configured to be an air inlet for positive pressure airflow to receive positive pressure airflow into the nasal mask, the at least two ports being respectively disposed at end portions on left and right sides of the rigid part (as shown in fig 3, left and right lateral ends of rigid part (38) each include a port configured to connect to respective elbow couplings (86) to receive a flow of gas generated by pressure support system (32)) (para [0077]).
Matula does not disclose the first opening of the flexible part, during use, is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user, wherein the flexible part includes at least one thin region forming a sealing section and a support region that is thicker than the thin region, together to form a wall of the flexible part; and wherein the sealing section includes a nasal protruding portion and is configured to seal with the face of the user and the nose of the user, wherein the nasal protruding portion encloses the nose tip without contacting a columella and the nose tip of the user
However, Von Moger teaches a patient interface system including a flexible part (150) (cushion (150) can be made of flexible materials such as an elastomer or rubber) (para [0270]) with a first opening configured to be near a face of the user (opening formed in sealing area (151) shown in fig 3-9) and a second opening configured to be away from the face of the user (opening formed in attachment region (158) shown in fig 3-8), wherein the first opening, during use, is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user (sealing area (151) includes a nose ridge region (152) adapted to engage with a nose ridge of a patient (para [0301]), sides of nose region (153) adapted to engage with sides of a patient’s nose (para [0302]), and corners of the nose region (154) that is adapted to form a seal with the corners of the patient’s nose (para [0303]), and therefore is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user), wherein the flexible part (150) is configured to bend towards a side nearer the face of the user to form at least one protrusion (160) (membrane) (as shown in fig 3-5, membrane (160) bends inwardly towards a patient’s face) (para [0301]), and wherein the flexible part (150) includes a sealing section (151) (sealing region) (para [0270]), wherein the sealing section (151) includes a nasal protruding portion (as shown in fig 3-9, sealing section (151) is shown to be generally triangular, and an apex of the triangle in nose ridge region (152) forms a nasal protruding region) and is configured to seal with the face of the user and the nose of the user (sealing region (151) is configured to form a seal with a patient’s airways) (para [0296]), wherein the nasal protruding portion (152) only encloses the nose tip without contacting a columella and the nose tip of the user (mask seals in a region of the nose that is generally above the tip of the nose (para [0299]) and the sealing region in the nose ridge region is adapted to engage along the nasal ridge between the pronasale and sellion, and along the nasal cartilage region of the nasal ridge and below or inferior to the nasal bone (para [0298]), and therefore is configured to enclose a nose tip without contacting a nose tip of a user).
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 substitute the nasal cradle flexible portion of Matula with a nasal mask flexible portion wherein the first opening of the flexible part, during use, is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user; and wherein the sealing section includes a nasal protruding portion and is configured to seal with the face of the user and the nose of the user, wherein the nasal protruding portion only encloses the nose tip without contacting a columella and the nose tip of the user as taught by Von Moger in order to provide a nasal mask that is manufacturable in high volumes, provides high consumer appeal, provides comfort and seal, provides reliable quality, unobtrusive, and/or fits a large majority of the population (Von Moger, para [0256]).
The now-modified Matula’s device does not disclose the sealing section of the flexible part includes at least one thin region and a support region that is thicker than the thin region, together to form a wall of the flexible part.
However, Scheiner teaches a nasal mask including flexible portion (3100) (seal-forming structure) including a sealing section shown in fig 239, wherein the sealing section includes at least one thin region (region (3113) may be thinnest to allow for ready conformation to the tip of the nose) and a support region that is thicker than the thin region (region (3117) may be thicker to provide maximum support, resistance to deformation, and ensure an effective seal at the ala of the patient) together to form a wall of the flexible part (3100) (para [0412]).
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 sealing section of the flexible part of modified Matula to include at least one thin region and a support region that is thicker than the thin region, together to form a wall of the flexible part as taught by Scheiner in order to provide regions with thinner wall thickness to allow for ready conformation to a user’s face and regions with thicker wall thickness to provide maximum support, resistance to deformation, and ensure an effective seal to the patient (Scheiner, para [0412]).
Regarding claim 3, the modified Matula’s reference in fig 3-9 of Von Moger show the flexible part (150 of Von Moger) has a symmetrical structure, as the mask is shown to have a generally triangular shape, and the flexible part (150 of Von Moger) shown in fig 3-9 of Von Moger is shown to be symmetrical along a vertical line bisecting the flexible part (150 of Von Moger).
Regarding claim 4, Matula discloses the rigid part (38) also includes elbow couplings (86) including coupling portions (88), and in figs 5-6 disclose the elbow coupling (86) includes a tooth (114) with a wall of varying thickness (para [0083]), and the coupling portions (88) having a tapered wall for a press-fit (para [0077]).
Regarding claim 22, Matula discloses the at least two ports are configured to simultaneously serve as interfaces for receiving gas and establishing connections (as shown in fig 1, lateral ends of rigid portion receive gas from elbow couplings (86) to receive gas from pressure support system (32) and establish a connection to pressure support system (32)) (para [0077]).
Claim 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matula, Jr et al, Von Moger et al, and Scheiner et al as applied to claim 1 above, and further in view of Schlobohm (5,353,789).
Regarding claim 21, modified Matula discloses a first opening.
Modified Matula does not disclose a spring structure provided between a main body of the flexible part and the nasal protruding portion of the sealing section, wherein the spring structure is configured to adjust to different user’s noses.
However, Schlobohm in fig 1 teaches a respiratory interface including a flexible part (2) (mask body), wherein the flexible part (2) includes a main body (lower portion of the mask body) and a nasal protruding portion (6) (upper portion of nose area), and wherein a spring structure (9) (bellows like deformation zone) is positioned between the main body and the nasal protruding section (2) (as shown in fig 1, bellows deformation zone (9) is disposed between the lower portion of flexible part forming main body and upper portion of nose area (6) forming the nasal protruding portion), wherein the spring structure (9) is configured to adjust to different user’s noses (spring structure provides for better adaptation of the nose area (6) to the contours of the mask use’s face) (col 3, ln 42-53)
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 flexible part of modified Matula by providing a spring structure provided between a main body of the flexible part and the nasal protruding portion of the sealing section, wherein the spring structure is configured to adjust to different user’s noses as taught by Schlobohm in order to allow for better adaptation of the nasal protruding portion of the mask to the contours of the mask user’s face (Schlobohm, col 3, ln 47-49).
Claims 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matula, Jr et al in view of Von Moger et al, Goldspink et al (2018/0236200), and Scheiner et al.
Regarding claim 5, Matula discloses a nasal mask for use under pressure conditions, configured to deliver continuous positive pressure gas to a nasal airway of a user for treatment of sleep apnea (para [0062]), the nasal mask comprising: a flexible part (40) (sealing assembly) that is configured to bend towards a side nearer a face of the user (flexible part is made of a flexible material such as rubber or silicone and therefore can bend towards a face of a user) (para [0064]), is configured to form at least one protrusion as shown in fig 4, nasal mask (40) forms a concave sealing surface (42) and forms two peaks on lateral sides of the nasal mask (40)) (para [0064]) and to create a chamber to accommodate gas (para [0065]), and includes a first opening (44) (opening) that is configured to be near the face of the user (para [0064]) and at least one second opening configured to be away from the face of the user (as shown in fig 4, rear of mask (40) includes an opening configured to interface with opening of support flange (46) (para [0065]), wherein the second opening is configured to be an air inlet to receive continuous positive pressure airflow into the flexible part (40) (para [0077]); wherein the flexible part (40) includes a sealing section (42) (sealing surface) that is configured to be a wall formed by a protrusion extending at the first opening, which is configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and which makes contact with an area around the first nostril and the second nostril on the face of the user (as shown in fig 4, sealing surface forms a pair of peaks at lateral sides, and is configured to surround a patient’s nares) (para [0064]).
Matula does not disclose the flexible part includes a flexible part which is configured to surround an only area including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user, wherein the flexible part includes at least one thin region forming a sealing section and a support region that is thicker than the thin region, together to form a wall of the flexible part; and wherein the sealing section includes a nasal protruding portion and is configured to seal with the face of the user and the nose of the user, wherein the nasal protruding portion encloses the nose tip without contacting a columella and the nose tip of the user, wherein the distance between the first opening and the second opening is less than a length of the flexible part extending to both sides of the face.
However, Von Moger teaches a patient interface system including a flexible part (cushion (150) can be made of flexible materials such as an elastomer or rubber) (para [0270]), wherein the flexible part (150) configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user (sealing area (151) includes a nose ridge region (152) adapted to engage with a nose ridge of a patient (para [0301]), sides of nose region (153) adapted to engage with sides of a patient’s nose (para [0302]), and corners of the nose region (154) that is adapted to form a seal with the corners of the patient’s nose (para [0303]), and therefore is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user as shown in fig 3-35), and in figs 3-14-3-30, flexible part (250) includes a sealing section (251) (sealing region) (para [0331]), wherein the sealing section (251) includes a nasal protruding portion (as shown in fig 3-2, sealing section (251) is shown to be generally triangular, and an apex of the triangle in nose ridge region (252) forms a nasal protruding region) and is configured to seal with the face of the user and the nose of the user (sealing region (251) is configured to form a seal with a patient’s airways) (para [0331]), wherein the nasal protruding portion (252) only encloses the nose tip without contacting a columella and the nose tip of the user (mask seals in a region of the nose that is generally above the tip of the nose (para [0299]) and the sealing region in the nose ridge region is adapted to engage along the nasal ridge between the pronasale and sellion, and along the nasal cartilage region of the nasal ridge and below or inferior to the nasal bone (para [0298]), and therefore, as shown in fig 3-35, is configured to enclose a nose tip without contacting a nose tip of a user, and because the nasal protrusion (252) is on a upper portion of the seal, would not contact the columella because the nasal protrusion (252) seals above the nose tip); and as shown in figs 3-20 and 3-21, the distance (D2) (35-55 mm, e.g. 48 mm) between the first opening and the second opening is less than a length (D7) (40-60 mm, e.g. 50 mm) of the flexible part extending to both sides of the face (250) (distance D2 can be less than distance D7 when D2 is 48 mm and D7 is 50 mm)
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 substitute the nasal cradle flexible portion of Matula with a nasal mask flexible portion configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user, wherein the sealing section includes a nasal protruding portion and is configured to seal with the face of the user and the nose of the user, wherein the nasal protruding portion encloses the nose tip without contacting a columella and the nose tip of the user a distance between the first opening and the second opening is less than a length of the flexible part extending to both sides of the face as taught by Von Moger in order to provide a nasal mask that is manufacturable in high volumes, provides high consumer appeal, provides comfort and seal, provides reliable quality, unobtrusive, and/or fits a large majority of the population (Von Moger, para [0256]).
The now-modified Matula’s device, as shown in fig 3-20 of Van Moger, discloses the first opening being generally triangularly shaped with a base D6 of 20-30 mm and a height D8 of 20-30 mm (Van Moger, para [0272]), and therefore would have an opening with size of approximately 200 mm2 (0.5*20 mm*20 mm) to 450 mm2 (0.5*30 mm*30 mm) and a second circular opening proximate to attachment region (258 of Van Moger) (Van Moger, para [0331]).
Modified Matula does not disclose that the first opening is smaller than the second opening.
However, Goldspink in figs 37-47 teaches a respiratory interface including a patient interface including an opening (7120) (circular channel) configured to attach to an elbow assembly (7600) including a swivel component (7610) configured to be inserted into the opening (7120) (para [0220]), wherein the swivel component (7610) has a diameter of 25-35 mm to connect to a standard 22 mm airway tube) (para [0221]).
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 Matula so that the second opening has a diameter of 25-35 mm as taught by Goldspink in order for the second opening to correspond to a standard 22 mm airway tube (Goldspink, para [0221]). The now-modified Matula’s device is considered that the first opening is smaller than the second opening, as Von Moger discloses that the first opening can be between 200 mm2 (0.5*20 mm*20 mm) to 450 mm2 (0.5*30 mm*30 mm) (Von Moger, para [0272]) and Goldspink discloses that the second opening can be 490 mm2 ((25 mm/2)2*p) and 962 mm2 (mm/2)2* p), and in the cases where ranges overlap, a prima facie case of obviousness exists. See MPEP 2144.05.
The now-modified Matula’s device does not disclose the sealing section includes at least one thin region and a support region that is thicker than the thin region, together to form a wall of the sealing section.
However, Scheiner in fig 238a teaches a nasal mask including a flexible part (3100) with a seal section including at least one thin region (3112.1) (first region proximal to the opening of the gas chamber (3104) (para [0409]) and a support region (3112.2, 3112.3) (second, third regions proximal to the connection to the plenum chamber (3200)) (para [0410]) that is thicker than the thin region (3112.1), together to form a wall of the sealing section (para [0409]).
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 sealing section of modified Matula by including at least one thin region and a support region that is thicker than the thin region, together to form a wall of the sealing section as taught by Scheiner in order to provide a thinner and, thus, more compliant region of cushion material at the area where a large amount of contact is made with the patient's nose (Scheiner, para [0409]).
Regarding claim 6, Matula discloses the nasal mask includes a rigid part (38) (support member) that connects to the at least one second opening of the flexible part (40) that is configured to be away from the face of the user (via support flange (46)) (para [0065]), with the rigid part (38) being configured to form a connection with other components for treatment of sleep disorders (can connect to conduits (86) of pressure support system (32) (fig 1, para [0077]).
Regarding claim 7, the modified Matula’s reference in fig 238a-c of Scheiner discloses the support region (3112.2, 3112.3 of Scheiner) of the sealing section (3100 of Scheiner) has more than one wall thickness (support region (3112.2, 3112.3 of Scheiner) has a smoothly variable thickness) (Scheiner, para [0411]).
Regarding claim 8, the modified Matula’s reference in fig 238a of Scheiner discloses a wall thickness between the thin region (3112.1 of Scheiner) and the support region (3112.2, 3112.3 of Scheiner) of the sealing section (3100 of Scheiner) changes uniformly (smoothly variable thickness for the seal-forming structure from region (3112.1 of Scheiner) to region (3112.3 of Scheiner) is provided) (Scheiner, para [0411]).
Regarding claim 9, the modified Matula’s reference in figs 238a-c of Scheiner disclose an area of the support region (3112.2, 3112.3 of Scheiner) of the sealing section is larger than an area of the thin region (3112.1 of Scheiner) of the sealing section (as shown in fig s238a-c of Scheiner, area of thin section with thickness x is smaller than area of support regions with areas of y and z) (Scheiner, figs 238a-c).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Matula, Jr. et al, in view of Von Moger et al and Golgspink et al.
Regarding claim 10, Matula discloses a nasal mask for use under pressure conditions, configured to deliver continuous positive pressure gas to a nasal airway of a user for treatment of sleep apnea, the nasal mask comprising: a flexible part (40) (sealing assembly) that is configured to bend towards a side nearer a face of the user (flexible part is made of a flexible material such as rubber or silicone and therefore can bend towards a face of a user) (para [0064]), configured to form at least one protrusion as shown in fig 4, nasal mask (40) forms a concave sealing surface (42) and forms two peaks on lateral sides of the nasal mask (40)) (para [0064]) and to create a chamber to accommodate gas (para [0065]), and includes a first opening (44) (opening) configured to be near the face of the user (para [0064]) and at least one second opening configured to be away from the face of the user (as shown in fig 4, rear of mask (40) includes an opening configured to interface with opening of support flange (46) (para [0065]), wherein the second opening is configured to be an air inlet to receive continuous positive pressure airflow into the flexible part (40) (para [0077]); wherein the flexible part (40) includes a sealing section that is configured to be a wall formed by the protrusion extending at the first opening, which is configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and which makes contact with an area around the first nostril and the second nostril on the face of the user (as shown in fig 4, sealing surface forms a pair of peaks at lateral sides, and is configured to surround a patient’s nares) (para [0064]), and an exhaust port (41) (exhaust assembly), with at least one hole (43) (plurality of vent holes) (para [0067]) to discharge positive pressure gas from the chamber through the hole to an external environment (allow patient’s exhaled gases to vent to atmosphere) (para [0066]). As shown in fig 3, flexible part shown in fig 3 is a cushion type of seal and therefore the sealing section is configured to seal with the face of the user without positioning or contacting a columella of the user, as the sealing section does not appear to include a structure in the center of the opening to contact a columella of a user) (para [0064]).
Matula does not disclose the flexible part includes a sealing section which is configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user, and wherein the sealing section includes a nasal protruding portion and is configured to seal with the face of the user and the nose of the user, wherein the nasal protruding portion encloses the nose tip without contacting a columella and the nose tip of the user
However, Von Moger teaches a patient interface system including a flexible part (cushion (150) can be made of flexible materials such as an elastomer or rubber) (para [0270]), wherein the flexible part (150) configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user (sealing area (151) includes a nose ridge region (152) adapted to engage with a nose ridge of a patient (para [0301]), sides of nose region (153) adapted to engage with sides of a patient’s nose (para [0302]), and corners of the nose region (154) that is adapted to form a seal with the corners of the patient’s nose (para [0303]), and therefore is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user as shown in fig 3-35), and in figs 3-14-3-30, flexible part (250) includes a sealing section (251) (sealing region) (para [0331]), wherein the sealing section (251) includes a nasal protruding portion (as shown in fig 3-2, sealing section (251) is shown to be generally triangular, and an apex of the triangle in nose ridge region (252) forms a nasal protruding region) and is configured to seal with the face of the user and the nose of the user (sealing region (251) is configured to form a seal with a patient’s airways) (para [0331]), wherein the nasal protruding portion (252) only encloses the nose tip without contacting a columella and the nose tip of the user (mask seals in a region of the nose that is generally above the tip of the nose (para [0299]) and the sealing region in the nose ridge region is adapted to engage along the nasal ridge between the pronasale and sellion, and along the nasal cartilage region of the nasal ridge and below or inferior to the nasal bone (para [0298]), and therefore, as shown in fig 3-35, is configured to enclose a nose tip without contacting a nose tip of a user, and because the nasal protrusion (252) is on a upper portion of the seal, would not contact the columella because the nasal protrusion (252) seals above the nose tip); and as shown in figs 3-20 and 3-21, the distance (D2) (35-55 mm, e.g. 48 mm) between the first opening and the second opening is less than a length (D7) (40-60 mm, e.g. 50 mm) of the flexible part extending to both sides of the face (250) (distance D2 can be less than distance D7 when D2 is 48 mm and D7 is 50 mm).
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 substitute the nasal cradle flexible portion of Matula with a nasal mask flexible portion including a sealing section configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user, wherein the flexible part includes at least one thin region forming a sealing section and a support region that is thicker than the thin region, together to form a wall of the flexible part; and wherein the sealing section includes a nasal protruding portion and is configured to seal with the face of the user and the nose of the user, wherein the nasal protruding portion encloses the nose tip without contacting a columella and the nose tip of the user, wherein the nose tip of the user a distance between the first opening and the second opening is less than a length of the flexible part extending to both sides of the face as taught by Von Moger in order to provide a nasal mask that is manufacturable in high volumes, provides high consumer appeal, provides comfort and seal, provides reliable quality, unobtrusive, and/or fits a large majority of the population (Von Moger, para [0256]).
The now-modified Matula’s device, as shown in fig 3-20 of Van Moger, discloses the first opening being generally triangularly shaped with a base D6 of 20-30 mm and a height D8 of 20-30 mm (Van Moger, para [0272]), and therefore would have an opening with size of approximately 200 mm2 (0.5*20 mm*20 mm) to 450 mm2 (0.5*30 mm*30 mm) and a second circular opening proximate to attachment region (258 of Van Moger) (Van Moger, para [0331]).
Modified Matula does not disclose that the first opening is smaller than the second opening.
However, Goldspink in figs 37-47 teaches a respiratory interface including a patient interface including an opening (7120) (circular channel) configured to attach to an elbow assembly (7600) including a swivel component (7610) configured to be inserted into the opening (7120) (para [0220]), wherein the swivel component (7610) has a diameter of 25-35 mm to connect to a standard 22 mm airway tube) (para [0221]).
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 Matula so that the second opening has a diameter of 25-35 mm as taught by Goldspink in order for the second opening to correspond to a standard 22 mm airway tube (Goldspink, para [0221]). The now-modified Matula’s device is considered that the first opening is smaller than the second opening, as Von Moger discloses that the first opening can be between 200 mm2 (0.5*20 mm*20 mm) to 450 mm2 (0.5*30 mm*30 mm) (Von Moger, para [0272]) and Goldspink discloses that the second opening can be 490 mm2 ((25 mm/2)2*p) and 962 mm2 (mm/2)2* p), and in the cases where ranges overlap, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 11, Matula discloses the nasal mask includes a rigid part (38) (support member) that connects to the at least one second opening of the flexible part (40) that is configured to be away from the face of the user (via support flange (46)) (para [0065]), with the rigid part (38) being configured to form a connection with other components for treatment of sleep disorders (can connect to conduits (86) of pressure support system (32) (fig 1, para [0077]).
Regarding claim 12, Matula discloses the exhaust port (41) is configured to be detachably joined with the flexible part (40) (exhaust port disposed on support member (38), which is detachable from the flexible part (40)) (para [0065]).
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matula, Jr et al, Von Moger et al, and Goldspink et al as applied to claim 10 above, and further in view of Scheiner et al.
Regarding claim 13, modified Matula discloses a sealing section.
Modified Matula does not disclose the sealing section has more than one wall thickness.
However, Scheiner teaches a nasal mask including flexible portion (3100) (seal-forming structure) including a sealing section shown in fig 239, wherein the sealing section has more than one wall thickness (region (3113) may be thinnest to allow for ready conformation to the tip of the nose, and region (3117) may be thicker to provide maximum support, resistance to deformation, and ensure an effective seal at the ala of the patient (para [0412]).
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 sealing section of modified Matula so that the sealing section has more than one wall thickness as taught by Scheiner in order to provide regions with thinner wall thickness to allow for ready conformation to the tip of the nose and regions with thicker wall thickness to provide maximum support, resistance to deformation, and ensure an effective seal to the patient (Scheiner, para [0412]).
Claims 16-17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matula, Jr et al in view of Von Moger et al, Scheiner et al and Baigent et al (2017/0326320).
Regarding claim 16, Matula discloses a nasal mask for use under pressure conditions, configured to deliver continuous positive pressure gas to a nasal airway of a user for treatment of sleep apnea, the nasal mask comprising: a flexible part (40) (sealing assembly) with a first opening (44) (opening) configured to be near a face of the user (para [0064]) and a second opening configured to be away from the face of the user (as shown in fig 4, rear of mask (40) includes an opening configured to interface with opening of support flange (46) (para [0065]), wherein the first opening, during use, is configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user (sealing surface surrounds a patient’s nares) (para [0064]), wherein the flexible part is configured to bend towards a side nearer the face of the user, to form at least one protrusion (as shown in fig 4, nasal mask (40) forms a concave sealing surface (42) and forms two peaks on lateral sides of the nasal mask (40)) (para [0064]) and to create a chamber to accommodate gas (para [0065]), and wherein the flexible part (40) has at least one region forming a sealing section (42) (sealing surface) (para [0064]).
Matula does not disclose the first opening of the flexible part, during use, is configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user, wherein the flexible part is triangularly-shaped and includes at least three protrusions that are configured to be bendable towards both sides of the face of the user to create a chamber to accommodate gas, wherein the flexible part includes at least one thin region forming a sealing section and a support region that is thicker than the thin region, together to form a wall of the flexible part; and wherein the sealing section includes a nasal protruding portion and is configured to seal with the face of the user and the nose of the user, wherein the nasal protruding portion only encloses the nose tip without contacting a columella and the nose tip of the user.
However, Von Moger teaches a patient interface system including a flexible part (150) (cushion (150) can be made of flexible materials such as an elastomer or rubber) (para [0270]) includes a sealing section (151) (sealing region) (para [0270]) including a first opening configured to be near a face of the user (opening formed in sealing area (151) shown in fig 3-9) and a second opening configured to be away from the face of the user (opening proximate to attachment portion (158)), wherein the first opening, during use, is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user (sealing area (151) includes a nose ridge region (152) adapted to engage with a nose ridge of a patient (para [0301]), sides of nose region (153) adapted to engage with sides of a patient’s nose (para [0302]), and corners of the nose region (154) that is adapted to form a seal with the corners of the patient’s nose (para [0303]), and therefore is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the user during use and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user),
wherein the flexible part is triangularly shaped (as shown in fig 3-9, sealing section (151) is shown to be generally triangular) with at least three protrusions (as shown in fig 3-9, sealing section (151) is shown to be generally triangular with a first protrusions corresponding to a first apex of the triangle corresponding to a nose ridge region (152) and second and third protrusions corresponding to respective second and third apexes of the triangle corresponding to the corners of the nose region (154)) (para [0184]) that are configured to be bendable towards both sides of the face of the user, to create a chamber to accommodate gas (cushion (150) can be made of flexible materials such as an elastomer or rubber (para [0270]), and therefore protrusions at nose ridge region (152) and corners of nose regions (154) are capable of bending towards left and right sides of a user’s face, respectively (para [0184]), and forming a chamber to accommodate gas as shown in fig 3-10);
and wherein the flexible part (150) includes a sealing section (151) (sealing region) (para [0270]), wherein the sealing section (151) includes a nasal protruding portion (as shown in fig 3-9, sealing section (151) is shown to be generally triangular, and an apex of the triangle in nose ridge region (152) forms a nasal protruding region) and is configured to seal with the face of the user and the nose of the user (sealing region (151) is configured to form a seal with a patient’s airways) (para [0296]), and
wherein the nasal protruding portion (152) only encloses the nose tip without contacting a columella and the nose tip of the user (mask seals in a region of the nose that is generally above the tip of the nose (para [0299]) and the sealing region in the nose ridge region is adapted to engage along the nasal ridge between the pronasale and sellion, and along the nasal cartilage region of the nasal ridge and below or inferior to the nasal bone (para [0298]), and therefore is configured to enclose a nose tip without contacting a nose tip of a user, and because the nasal protrusion (152) is on a upper portion of the seal, would not contact the columella because the nasal protrusion (152) seals above the nose tip).
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 substitute the nasal cradle flexible portion of Matula with a nasal mask flexible portion wherein the first opening of the flexible part, during use, is configured to surround an area at least including a nose tip, a first nostril, and a second nostril of the user during use, and to make contact with an area around the first nostril and the second nostril on the face of the user and a nose of the user; and wherein the sealing section includes a nasal protruding portion and is configured to seal with the face of the user and the nose of the user, wherein the nasal protruding portion only encloses the nose tip without contacting a columella and the nose tip of the user as taught by Von Moger in order to provide a nasal mask that is manufacturable in high volumes, provides high consumer appeal, provides comfort and seal, provides reliable quality, unobtrusive, and/or fits a large majority of the population (Von Moger, para [0256]).
The now-modified Matula’s device does not disclose the flexible part includes at least one thin region and a support region that is thicker than the thin region, together to form a wall of the flexible part.
However, Scheiner in fig 238a teaches a nasal mask including a flexible part (3100) including at least one thin region (3112.1) (first region proximal to the opening of the gas chamber (3104) (para [0409]) and a support region (3112.2, 3112.3) (second, third regions proximal to the connection to the plenum chamber (3200)) (para [0410]) that is thicker than the thin region (3112.1), together to form a wall of the flexible part (para [0409]).
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 flexible part of modified Matula by including at least one thin region and a support region that is thicker than the thin region, together to form a wall of the flexible part as taught by Scheiner in order to provide a thinner and, thus, more compliant region of cushion material at the area where a large amount of contact is made with the patient's nose (Scheiner, para [0409]).
The now-modified Matula’s device does not disclose a comfort layer, configured to attach to at least a portion of the flexible part and to join with the face of the user.
However, Baigent in figs 21-22 teaches a nasal interface including a flexible part (3108) (silicone cushion) including a comfort layer (3109) (cushion membrane layer) configured to attach to at least a portion of the flexible part (3108) and to join with the face of the user (para [0320]).
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 flexible part of modified Matula be providing a comfort layer, configured to attach to at least a portion of the flexible part and to join with the face of the user as taught by Baigent in order to provide a cushion layer that is soft and comfortable to be worn against a patient’s skin (Baigent, para [0317]).
Regarding claim 17, the modified Matula’s reference discloses a material of the comfort layer (3109 of Baigent) includes a sponge or a fabric (foam or textile) (Baigent, para [0320]).
Regarding claim 19, the modified Matula’s reference in fig 21 of Baigent discloses an inner edge of the comfort layer (3109 of Baigent) is greater than or equal to an edge of the first opening of the flexible part (3108 of Baigent), and wherein during use, the comfort layer (3109 of Baigent) and the flexible part (3108 of Baigent) jointly define a pathway for an airflow to enter the nasal airway in a sealed manner (as shown in fig 21b, edge of comfort layer (3109 of Baigent) is flush with edge of flexible part (3108 of Baigent), and therefore would jointly define a pathway for an airflow to enter the nasal airway in a sealed manner) (Baigent, fig 21b)
Regarding claim 20, the modified Matula’s reference in fig 22 of Baigent discloses the inner edge of the comfort layer (3109 of Baigent) is smaller than the edge of the first opening of the flexible part (3108 of Baigent), and wherein during use, the comfort layer (3109 of Baigent) alone defines the pathway for the airflow to enter the nasal airway in a sealed manner (as shown in fig 22a, comfort layer (3109 of Baigent) can include a pair of openings (3101 of Baigent) with an edge that is smaller than the edge of the first opening of the flexible part (3108 of Baigent), and therefore, the edge of the openings (3101 of Baigent) would alone define the pathway for the airflow to enter the nasal airway in a sealed manner (Baigent, para 22a).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Matula, Jr et al, Von Moger et al, Scheiner et al and Baigent et al as applied to claim 16 above, and further in view of Haibach.
Regarding claim 18, modified Matula discloses a first opening and a second opening.
Modified Matula does not disclose that the first opening is larger than the second opening.
However, Haibach in figs 1-5 teaches a nasal mask including a flexible part (16) (cushion) including a first opening (66) near the face of the user and a second opening (68) (aperture) configured to engage a frame (18) (para [0030]), the flexible part including a magnet (50) (para [0032]), and as shown in figs 2-3, the first opening (66) is larger than the second opening (68).
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 flexible portion of modified Matula so that the first opening near the face of the user is larger than the second opening as taught by Haibach in order allow the flexible part and frame to be provided with a magnetic coupling mechanism to allow the flexible part and frame to not unexpectedly come undone, while also allowing the flexible part and frame to be disassembled and reassembled in a fast and generally simple fashion) (Haibach, para [0005]).
Response to Arguments
Applicant's arguments filed 2/2/2026 have been fully considered but they are not persuasive.
Applicant argues of page 9, eighth full paragraph-page 10, first paragraph of applicant’s remarks, that Matula discloses two support members (38) on the frame (36) for receiving an airflow, However, figs 3-4 of Maula shows that the support member (38) (corresponding to the claimed rigid part) is shown to be made of a single element, and opposite ends of the support member (38) are configured to connect to corresponding elbow couplings (86) (para [0077]). Therefore, because Matula in figs 1-4 disclose a rigid part (38) having two ports being respective end portions on a left and right side of the rigid part (38), the rejection is maintained.
Applicant argues on page 10, first full paragraph-11, first paragraph of applicant’s remarks, that Matula in the fifth embodiment shown in figs 27-30A, the eighth embodiment shown in figs 33A-33B, and the eleventh embodiment shown in fig 36A-C does not disclose the features of the rigid part as recited in claim 1. However, as discussed above, because Matula in figs 1-4 discloses a rigid part having two connection ports configured to be in inlet for positive pressure airflow and having respective end portions on a left and right side of the rigid part, the rejection is maintained.
Applicant argues on page 11, first full paragraph-page 12, third full paragraph of applicant’s remarks, the Von Moger and Schiener does not disclose a rigid part having two connection ports configured to be in inlet for positive pressure airflow and having respective end portions on a left and right side of the rigid part as recuted in claims 5 and 10. However, as discussed above, because Matula discloses the claimed limitations of the rigid part, the rejection is maintained.
Applicant argues on page 12, fourth full paragraph-page 14, second full paragraph of applicant’s remarks, that the prior art does not disclose that a distance between the first opening and the second opening is less than a length of the flexible part extending to both sides of the face. However, as shown in figs 3-20 and 3-21 of Von Moger, the distance (D2) (35-55 mm, e.g. 48 mm) between the first opening and the second opening is less than a length (D7) (40-60 mm, e.g. 50 mm) of the flexible part extending to both sides of the face (250) (distance D2 can be less than distance D7 when D2 is 48 mm and D7 is 50 mm). A distance D2 of 48 mm between a first opening and the second opening is less than a length D7 of 50 mm of the flexible part extending to both sides of the face. Von Moger discloses that the first opening being generally triangularly shaped with a base D6 of 20-30 mm and a height D8 of 20-30 mm (Van Moger, para [0272]), and therefore would have an opening with size of approximately 200 mm2 (0.5*20 mm*20 mm) to 450 mm2 (0.5*30 mm*30 mm) and a second circular opening proximate to attachment region (258 of Van Moger) (Van Moger, para [0331]); and Goldspink teaches respiratory interface having an opening with a diameter of 25-35 mm to connect to a standard 22 mm airway tube (para [0221]), which would correspond to the second opening having an area between 490 mm2 ((25 mm/2)2*p) and 962 mm2 (mm/2)2* p), and therefore, discloses a range that wherein the second opening is larger than the first opening. Therefore, the rejection is maintained. It is noted that the limitation “wherein the first opening is smaller than the second opening, the distance between the first opening and the second opening is less than a length of the flexible part extending to both sides of the face” constitutes new matter, as support for the limitation was not present in applicant’s originally filed disclosure.
Applicant argues on page 14, third paragraph-page 16, first full paragraph of applicant’s remarks, that there is no indication in Von Moger of a combination of the first opening, during use, is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the used and to make contact with an area around the first nostril and the second nostril of the user, wherein the flexible part is triangularly shaped and includes at least three protrusions that are configured to be bendable towards both sides of the of the face to create a chamber to accommodate gas and wherein the flexible part has at least one thin region forming a sealing section and a support region that is thicker than the thin region, together to form a wall of the flexible part. However, Von Moger in fig 3-35 shows that the first opening, during use, is configured to surround only an area including a nose tip, a first nostril, and a second nostril of the used and to make contact with an area around the first nostril and the second nostril of the user, and as shown in fig 3-20, sealing section (251) is shown to be generally triangular with a first protrusions corresponding to a first apex of the triangle corresponding to a nose ridge region (252) and second and third protrusions corresponding to respective second and third apexes of the triangle corresponding to the corners of the nose region (254) (para [0184]) that are configured to be bendable towards both sides of the face of the user, to create a chamber to accommodate gas (cushion can be made of flexible materials such as an elastomer or rubber (para [0270]), and therefore membrane forming sealing section at protrusions at left and right corners of nose regions are configured to be bendable towards left and right sides of a user’s face, respectively) (para [0184]); and furthermore, Scheiner in fig 238a teaches a nasal mask including a flexible part (3100) including at least one thin region (3112.1) (first region proximal to the opening of the gas chamber (3104) (para [0409]) and a support region (3112.2, 3112.3) (second, third regions proximal to the connection to the plenum chamber (3200)) (para [0410]) that is thicker than the thin region (3112.1), together to form a wall of the flexible part (para [0409]), Therefore because Van Moger teaches a flexible part that triangularly shaped and includes at least three protrusions that are configured to be bendable towards both sides of the of the face to create a chamber to accommodate gas, and Scheiner teaches that the flexible part has at least one thin region forming a sealing section and a support region that is thicker than the thin region, together to form a wall of the flexible part, the modified Matula’s device discloses the limitations of claim 16. Therefore, the rejection is maintained.
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.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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