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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 21-25, 37-46, 49-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,040,165 B2 in view of Veliss (U.S 2008/0047560 A1).
Regarding claim 21, Patent 11,040,165 discloses a patient interface for sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH2O with respect to ambient air pressure throughout the patient's respiratory cycle in use (Claim 1), the patient interface comprising:
a cushion assembly (Claim 1) comprising:
a plenum chamber pressurisable to the therapeutic pressure, said plenum chamber including a pair of plenum chamber inlet ports, each of the plenum chamber inlet ports being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Claim 1);
a nasal seal-forming structure that is configured to contact and seal against the patient's face and around the patient's nose in use, the nasal seal-forming structure having a nasal hole configured to deliver the flow of air at said therapeutic pressure to the patient's nares in use, and the nasal seal-forming structure being joined to the plenum chamber (Claim 1);
a positioning and stabilising structure configured to hold the cushion assembly in a therapeutically effective position on a head of a patient (Claim 1), the positioning and stabilising structure comprising:
two gas delivery tubes, each of the two gas delivery tubes being connected at a first end to a corresponding one of plenum chamber inlet ports to deliver the flow of air to the entrance to the patient's airways via the cushion assembly, each of the two gas delivery tubes being configured to be positioned on a corresponding lateral side of the patient's head in use, each of the two gas delivery tubes being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head (Claim 1), and each of the two gas delivery tubes comprising a tab projecting in a generally posterior direction relative to the patient's head in use, the tab having a hole (Claim 1);
a connection port configured to fluidly connect, in use, the gas delivery tubes with an air circuit to deliver the flow of air to the patient's airways, the connection port configured to be located, in use, superior to the patient's head (Claim 1);
a length-adjustable rear strap, an end of the length-adjustable rear strap being configured to pass through the hole of the tab to removably connect the length-adjustable rear strap to the gas delivery tube and the length-adjustable rear strap being configured, in use, to pass around a posterior portion of the patient's head (Claim 1); and
a sleeve constructed from an elastic material that at least partially covers each of the two gas delivery tubes (Claim 17).
Patent 11,040,165 is silent regarding the sleeve comprising a pair of side holes, the tab of each of the gas delivery tubes extending through a corresponding one of the side holes.
However, Veliss teaches a sleeve constructed from an elastic material that at least partially covers each of the two gas delivery tubes (Figs. 1-1 to 1-5, Fig. 3-1 to 3-3, Fig. 5-1 and Paragraphs 0031, 0069, the cover 40 envelops/covers the tubing and headgear along its length on the head; Additionally see Paragraph 0074, 0249 regarding the cover being formed of stretchy fabric, with stretch lycra as a particular fabric) the sleeve comprising a pair of side holes, the tab of each of the gas delivery tubes extending through a corresponding one of the side holes (see Figs. 1-4, 5-1, 13-1; The cover may have an opening to allow the backstrap/tab of the backstrap extending therethrough to extend along the back of the head and to allow manual adjustment).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,040,165 to have included an elastic sleeve that covers the delivery tubes and wherein the sleeves include side holes for the tabs to extend therethrough, such as that taught by Veliss, in order to allow manual adjustment of the uncovered straps (Paragraph 0072).
Regarding claim 22, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 further discloses wherein the sleeve is an elastic material (Claim 17).
Patent 11,040,165 is silent regarding specifically the elastic material being an elastic fabric.
Veliss further teaches wherein the elastic material is an elastic fabric (see Paragraph 0074, 0249, wherein the cover may be formed of elastic fabric such as lycra or Polar Fleece power stretch fabric).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,040,165 to have formed the sleeve out of elastic fabric, such as that taught by Veliss, in order to provide a known textile suitable for enveloping and stretching/adjusting to headgear on the patient (Paragraph 0074, 0249).
Regarding claim 23, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 further discloses an elbow including a first end rotatably connected to the positioning and stabilising structure at the connection port and a second end having a swivel configured to be connected to the air circuit, the elbow being rotatable 360° about the connection port, the swivel being rotatable 360° about the second end of the elbow, and the elbow being configured to direct the flow of air from the air circuit to the gas delivery tubes via the connection port (Claim 17).
Regarding claim 24, the modified device of Patent 11,040,165 discloses the device of claim 23.
Veliss further teaches wherein the sleeve comprises a center hole, the connection port being exposed through the center hole to allow the first end of the elbow to be rotatably connected to the positioning and stabilising structure at the connection port (Fig. 1-1, 1-3, 1-6; At the top, the sleeve includes a center hole/opening for the connector 32 to extend therethrough, which allows the swivel to rotatably connect relative to the base).
Regarding claim 25, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 further discloses wherein the length-adjustable rear strap is configured to overlay or lie inferior to the occipital bone of the patient's head in use (Claim 1; The strap passes around a posterior portion of the patient’s head and thus may overlay or lie inferior to the occipital bone in use; Minor adjustment of the strap across a portion of the back of the head can easily be recognized to lie over/across the occipital bone).
Alternatively, Veliss also teaches the strap extending across the back of the head and across the occipital bone (Fig. 1-4) as a known configuration suitable for securing headgear to the user.
Regarding claim 37, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 further discloses wherein each of the gas delivery tubes is configured to extend, in use, across the patient's corresponding cheek region (Claim 17, the tubes extend between the eye and ear and thus across the patient’s cheek region).
Regarding claim 38, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 further discloses wherein each of the two gas delivery tubes is configured to extend, in use, between the patient's corresponding eye and the patient's corresponding ear (Claim 17).
Regarding claim 39, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 further discloses wherein the length-adjustable rear strap comprises a loop material and a hook material portion, the loop material and the hook material portion being configured to removably connect the length-adjustable rear strap to the tab (Claim 17).
Regarding claim 40, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 further discloses wherein each of the gas delivery tubes comprises a concertina portion that is more flexible than adjacent portions of the gas delivery tube (Claim 1, the concertina structure is specifically said to adjust length-wise and thus must be longitudinally more compliant/flexible than adjacent portions of the tube; Additionally see claim 17 regarding the concertina structure being smaller in width/diameter than adjacent tube portions).
Regarding claim 41, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 further discloses wherein each of the two gas delivery tubes varies in width and diameter along the length of each concertina portion (Claim 17, the tubes taper in width, diameter and length along the concertina structure).
Regarding claim 42, the modified device of Patent 11,040,165 discloses the device of claim 40.
Patent 11,040,165 further discloses wherein each of the two gas delivery tubes tapers along the length of each concertina portion so that the width and diameter of each of the two gas delivery tubes at one end of the concertina portion is smaller than the width and diameter of each of the two gas delivery tubes at the other end of concertina portion (Claim 17).
Regarding claim 43, the modified device of Patent 11,040,165 discloses the device of claim 40.
Patent 11,040,165 further discloses wherein each concertina portion is positioned between the tab of a corresponding one of the gas delivery tubes and the connection port (Claim 1 and 17, the concertina is formed between the first end and the connection port, the tab positioned between the portion of the gas delivery tube having the concertina and the first end, which is attached to the cushion assembly; Thus the concertina section is between the tab and connection port).
Regarding claim 44, the modified device of Patent 11,040,165 discloses the device of claim 40.
Patent 11,040,165 further discloses wherein the sleeve covers each concertina portion (Claim 17, the sleeve covers the two deliver tubes, and thus is inclusive of the concertina of the tubes).
Regarding claim 45, the modified device of Patent 11,040,165 discloses the device of claim 40.
Patent 11,040,165 further discloses wherein each concertina portion is positioned on a corresponding one of the gas delivery tubes so as to be spaced away from the patient's face during use (Claim 17, the positioning and stabilizing structure is configured such that the bias and adjustment mechanism, the concertina structure, does not contact the patient’s face; Thus, the concertina is spaced from the face in use).
Regarding claim 46, the modified device of Patent 11,040,165 discloses the device of claim 40.
Patent 11,040,165 further discloses wherein each concertina portion is positioned on a corresponding one of the gas delivery tubes so as to be spaced away from the patient's corresponding cheek during use (Claim 17, the positioning and stabilizing structure is configured such that the bias and adjustment mechanism, the concertina structure, does not contact the patient’s face; Thus, the concertina is spaced from the cheeks in use).
Regarding claim 49, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 is silent regarding wherein the sleeve is constructed from a single sheet of elastic material.
However, Veliss further teaches wherein the sleeve is constructed from a single sheet of elastic material (see Paragraph 0008, the cover may include a textile material; also see Paragraph 0074-0082 regarding textile forming the sleeve, wherein at least a single layer is disclosed). Veliss also teaches use of single layer textile in forming the sealing portion (Paragraph 0044-0045, the single layer provides breathability and retains warmth).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,040,165 to have included forming the sleeve out of multiple elastic sheets, such as that taught by Veliss, in order to adjust the support and texture across different regions of the mask (Paragraph 0078-0080) and to adjust aesthetics.
Regarding claim 50, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 is silent regarding specifically wherein the sleeve is constructed from multiple sheets of the elastic material that are connected together.
However, Veliss teaches use of multi-layer textile arrangement for the seal (Paragraph 0046-0047) and wherein the sleeve may include differing regions of textiles with differing properties connected together (Paragraph 0078-0080, differing textile textiles may be used and connected adjacent one another to adjust bulkiness across regions of the mask or to impart color or different textures to the skin).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,040,165 to have included forming the sleeve out of multiple elastic sheets, such as that taught by Veliss, in order to adjust the support and texture across different regions of the mask (Paragraph 0078-0080) and to adjust aesthetics.
Claims 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,040,165 B2 in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Grashow (U.S 2015/0182719 A1).
Regarding claim 26, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 is silent regarding wherein the plenum chamber comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient.
However, Grashow teaches wherein the plenum chamber comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient (Paragraph 0028, Fig. 2-3; Exhaust holes 32 allow exhaustion of gas from patient and washout of exhaled gases).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,040,165 to include vent holes on the plenum chamber, such as that taught by Grashow, in order to provide exhaustion of exhaled gases from the patient (Paragraph 0028) and prevent buildup of carbon dioxide within the circuit/mask.
Regarding claim 27, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 is silent regarding wherein the cushion assembly comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient.
However, Grashow teaches wherein the plenum chamber of a cushion assembly comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient (Paragraph 0028, Fig. 2-3; Exhaust holes 32 allow exhaustion of gas from patient and washout of exhaled gases).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,040,165 to include vent holes on the plenum chamber of the cushion assembly, such as that taught by Grashow, in order to provide exhaustion of exhaled gases from the patient (Paragraph 0028) and prevent buildup of carbon dioxide within the circuit/mask.
Regarding claim 28, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 is silent regarding wherein the nasal seal-forming structure is constructed from silicone.
Grashow further teaches wherein the nasal seal-forming structure is constructed from silicone (Paragraph 0026, 0037, the sealing cushion 10 can be formed of unitary cushioning material such as silicone rubber).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,040,165 to form the nasal seal-forming structure of silicone, such as that taught by Grashow, in order to provide a known material for a nasal seal and cushion (Paragraph 0026, 0037).
Regarding claim 29, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 is silent regarding specifically wherein the plenum chamber comprises a shell.
Veliss teaches wherein the plenum chamber comprises a shell (Fig. 2-11 and Paragraph 0051-0053, the sealing arrangement may have a plenum chamber comprised of a semi-rigid shell).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,040,165 to have included a plenum chamber with a semi-rigid shell, such as that taught by Veliss, in order to provide a known alternative sealing arrangement and plenum chamber (Paragraph 0051-0053) and to adjust the sealing and seating of the mask against the user.
Claims 30-36 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,040,165 B2 in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Formica (U.S 2013/0199537 A1).
Regarding claim 30, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 is silent regarding wherein the cushion assembly further comprises an oral seal-forming structure that is configured to seal around the patient's mouth in use, the oral seal-forming structure having an oral hole configured to deliver the flow of air at said therapeutic pressure to the patient's mouth in use, and the oral seal-forming structure being joined to the plenum chamber.
However, Formica teaches a mask assembly wherein a nasal seal is connected to an oral seal-forming structure that is configured to seal around the patient's mouth in use, the oral seal-forming structure having an oral hole configured to deliver the flow of air at said therapeutic pressure to the patient's mouth in use, and the oral seal-forming structure being joined to the plenum chamber (see Fig. 1-3, 1-5, 2-4 and Paragraphs 0223, 0024; The nares portion 20 may be connectable to the mouth portion 40 via engagement of connector 30 to opening 46; Air can pneumatically flow between nares portion to mouth portion to allow air delivered to the mouth).
It would have been obvious to one having ordinary skill in the prior art to have modified the device of Patent 11,040,165 to include an oral seal connectable to the nasal seal which can deliver the pressurized gas to the mouth, such as that taught by Formica, in order to provide a modular mask which can be adjusted to fit patient needs (Paragraph 0010-0015, 0206).
Regarding claim 31, the modified device of Patent 11,040,165 discloses the device of claim 30.
Formica further teaches wherein the oral seal-forming structure is constructed from silicone (Paragraph 0251, 0278; The mouth sealing portion can be constructed from silicone).
Regarding claim 32, the modified device of Patent 11,040,165 discloses the device of claim 30.
Formica further teaches wherein the nasal seal-forming structure and the oral seal-forming structure are integrally formed (Claim 44, the nares and mouth sealing portions can be formed integrally as a one-piece structure).
Regarding claim 33, the modified device of Patent 11,040,165 discloses the device of claim 30.
Formica further teaches wherein the nasal seal-forming structure and the oral seal-forming structure are removably attached (Claim 43, the nares and mouth sealing portions can be selectively connectable and disconnectable).
Regarding claim 34, the modified device of Patent 11,040,165 discloses the device of claim 30.
Formica further teaches further comprising an anti-asphyxia valve configured to allow the patient to breathe from ambient in the absence of the flow of air at the therapeutic pressure (Paragraph 0198; The mask may be provided with an anti-asphyxia valve; also see Paragraph 0368, 0393, the valve may be inline to an inlet tube or through adaptor, or through gusset elbow).
Regarding claim 35, the modified device of Patent 11,040,165 discloses the device of claim 30.
Formica further teaches wherein the positioning and stabilising structure further comprises a length-adjustable lower strap configured to pass behind the patient's head and below the patient's ears to indirectly connect to the oral seal-forming structure (see Fig. 5-1 and Paragraph 0295, the mouth portion may have headgear connector 41 to receive lower headgear strap 63; The strap is shown to pass behind the head and below the ears to connect to the mouth seal and fix the headgear in place).
Regarding claim 36, the modified device of Patent 11,040,165 discloses the device of claim 35.
Formica further teaches wherein the lower strap is not connected to the two gas delivery tubes (see Fig. 5-1 and Paragraph 0295; The lower strap is only connected to the mouth seal at connectors 41 on either side).
Claims 47-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,040,165 B2 in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Smith (U.S 2012/0325219 A1).
Regarding claim 47, the modified device of Patent 11,040,165 discloses the device of claim 21.
Patent 11,040,165 is silent regarding wherein each of the two gas delivery tubes is constructed from a relatively flexible material.
However, Smith further teaches wherein the gas delivery tubes/conduits can be constructed from a relatively flexible material (see Paragraph 0020, the segments 20 of the tubing can include a soft, flexible material such as silicone or thermoplastic elastomer; also see Paragraph 0023 regarding forming the bellows similarly of silicone).
It would have been obvious to one having ordinary skill in the prior art before the effective filling date of the claimed invention to have modified the device of Patent 11,040,165 to have formed the air delivery tubing from flexible silicone, such as that taught by Smith, in order to provide a known alternative construction material suitable for headgear tubing (Paragraph 0020) and to allow for adjustment of the tubing relative to the user (Paragraph 0023).
Regarding claim 48, the modified device of Patent 11,040,165 discloses the device of claim 47.
Smith further teaches wherein the relatively flexible material is silicone (Paragraph 0020, 0023; The material is silicone).
Claims 21-25, 37-46, 49-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 9, 11, 13-14 of U.S. Patent No. 11,793,965 B2 in view of Veliss (U.S 2008/0047560 A1).
Regarding claim 21, Patent 11,793,965 discloses a patient interface for sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH2O with respect to ambient air pressure throughout the patient's respiratory cycle in use (Claim 1), the patient interface comprising:
a cushion assembly (Claim 1) comprising:
a plenum chamber pressurisable to the therapeutic pressure, said plenum chamber including a pair of plenum chamber inlet ports, each of the plenum chamber inlet ports being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Claim 1);
a nasal seal-forming structure that is configured to contact and seal against the patient's face and around the patient's nose in use, the nasal seal-forming structure having a nasal hole configured to deliver the flow of air at said therapeutic pressure to the patient's nares in use, and the nasal seal-forming structure being joined to the plenum chamber (Claim 1);
a positioning and stabilising structure configured to hold the cushion assembly in a therapeutically effective position on a head of a patient (Claim 1), the positioning and stabilising structure comprising:
two gas delivery tubes, each of the two gas delivery tubes being connected at a first end to a corresponding one of plenum chamber inlet ports to deliver the flow of air to the entrance to the patient's airways via the cushion assembly, each of the two gas delivery tubes being configured to be positioned on a corresponding lateral side of the patient's head in use, each of the two gas delivery tubes being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head (Claim 1), and each of the two gas delivery tubes comprising a tab projecting in a generally posterior direction relative to the patient's head in use, the tab having a hole (Claim 1);
a connection port configured to fluidly connect, in use, the gas delivery tubes with an air circuit to deliver the flow of air to the patient's airways, the connection port configured to be located, in use, superior to the patient's head (Claim 1);
a length-adjustable rear strap, an end of the length-adjustable rear strap being configured to pass through the hole of the tab to removably connect the length-adjustable rear strap to the gas delivery tube and the length-adjustable rear strap being configured, in use, to pass around a posterior portion of the patient's head (Claim 1).
Patent 11,793,965 is silent regarding a sleeve constructed from an elastic material that at least partially covers each of the two gas delivery tubes, the sleeve comprising a pair of side holes, the tab of each of the gas delivery tubes extending through a corresponding one of the side holes.
However, Veliss teaches a sleeve constructed from an elastic material that at least partially covers each of the two gas delivery tubes (Figs. 1-1 to 1-5, Fig. 3-1 to 3-3, Fig. 5-1 and Paragraphs 0031, 0069, the cover 40 envelops/covers the tubing and headgear along its length on the head; Additionally see Paragraph 0074, 0249 regarding the cover being formed of stretchy fabric, with stretch lycra as a particular fabric) the sleeve comprising a pair of side holes, the tab of each of the gas delivery tubes extending through a corresponding one of the side holes (see Figs. 1-4, 5-1, 13-1; The cover may have an opening to allow the backstrap/tab of the backstrap extending therethrough to extend along the back of the head and to allow manual adjustment).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to have included an elastic sleeve that covers the delivery tubes and wherein the sleeves include side holes for the tabs to extend therethrough, such as that taught by Veliss, in order to allow manual adjustment of the uncovered straps (Paragraph 0072).
Regarding claim 22, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding specifically the elastic material being an elastic fabric.
Veliss further teaches wherein the elastic material is an elastic fabric (see Paragraph 0074, 0249, wherein the cover may be formed of elastic fabric such as lycra or Polar Fleece power stretch fabric).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to have formed the sleeve out of elastic fabric, such as that taught by Veliss, in order to provide a known textile suitable for enveloping and stretching/adjusting to headgear on the patient (Paragraph 0074, 0249).
Regarding claim 23, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 further discloses an elbow including a first end rotatably connected to the positioning and stabilising structure at the connection port and a second end having a swivel configured to be connected to the air circuit, the elbow being rotatable 360° about the connection port, the swivel being rotatable 360° about the second end of the elbow, and the elbow being configured to direct the flow of air from the air circuit to the gas delivery tubes via the connection port (Claim 14).
Regarding claim 24, the modified device of Patent 11,793,965 discloses the device of claim 23.
Veliss further teaches wherein the sleeve comprises a center hole, the connection port being exposed through the center hole to allow the first end of the elbow to be rotatably connected to the positioning and stabilising structure at the connection port (Fig. 1-1, 1-3, 1-6; At the top, the sleeve includes a center hole/opening for the connector 32 to extend therethrough, which allows the swivel to rotatably connect relative to the base).
Regarding claim 25, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 further discloses wherein the length-adjustable rear strap is configured to overlay or lie inferior to the occipital bone of the patient's head in use (Claim 1; The strap passes around a posterior portion of the patient’s head and thus may overlay or lie inferior to the occipital bone in use; Minor adjustment of the strap across a portion of the back of the head can easily be recognized to lie over/across the occipital bone).
Alternatively, Veliss also teaches the strap extending across the back of the head and across the occipital bone (Fig. 1-4) as a known configuration suitable for securing headgear to the user.
Regarding claim 37, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 further discloses wherein each of the gas delivery tubes is configured to extend, in use, across the patient's corresponding cheek region (Claim 9, the tubes extend between the eye and ear and thus across the patient’s cheek region).
Regarding claim 38, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,040,165 further discloses wherein each of the two gas delivery tubes is configured to extend, in use, between the patient's corresponding eye and the patient's corresponding ear (Claim 9).
Regarding claim 39, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 further discloses wherein the length-adjustable rear strap comprises a loop material and a hook material portion, the loop material and the hook material portion being configured to removably connect the length-adjustable rear strap to the tab (Claim 11).
Regarding claim 40, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 further discloses wherein each of the gas delivery tubes comprises a concertina portion that is more flexible than adjacent portions of the gas delivery tube (Claim 1, the concertina structure is specifically said to adjust length-wise and thus must be longitudinally more compliant/flexible than adjacent portions of the tube; Additionally see claim 13 regarding the concertina structure being smaller in width/diameter than adjacent tube portions).
Regarding claim 41, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 further discloses wherein each of the two gas delivery tubes varies in width and diameter along the length of each concertina portion (Claim 12 or 13, the tubes taper in width, diameter and length along the concertina structure).
Regarding claim 42, the modified device of Patent 11,793,965 discloses the device of claim 40.
Patent 11,793,965 further discloses wherein each of the two gas delivery tubes tapers along the length of each concertina portion so that the width and diameter of each of the two gas delivery tubes at one end of the concertina portion is smaller than the width and diameter of each of the two gas delivery tubes at the other end of concertina portion (Claim 13).
Regarding claim 43, the modified device of Patent 11,793,965 discloses the device of claim 40.
Patent 11,793,965 further discloses wherein each concertina portion is positioned between the tab of a corresponding one of the gas delivery tubes and the connection port (Claim 1 and 13, the concertina is formed between the first end and the connection port, the tab positioned between the portion of the gas delivery tube having the concertina and the first end, which is attached to the cushion assembly; Thus the concertina section is between the tab and connection port).
Regarding claim 44, the modified device of Patent 11,793,965 discloses the device of claim 40.
Patent 11,793,965 further discloses wherein the sleeve covers each concertina portion (Claim 2, the sleeve covers the two deliver tubes, and thus is inclusive of the concertina of the tubes).
Regarding claim 45, the modified device of Patent 11,793,965 discloses the device of claim 40.
Patent 11,793,965 further discloses wherein each concertina portion is positioned on a corresponding one of the gas delivery tubes so as to be spaced away from the patient's face during use (Claim 4, the positioning and stabilizing structure is configured such that the bias and adjustment mechanism, the concertina structure, does not contact the patient’s face; Thus, the concertina is spaced from the face in use).
Regarding claim 46, the modified device of Patent 11,040,165 discloses the device of claim 40.
Patent 11,040,165 further discloses wherein each concertina portion is positioned on a corresponding one of the gas delivery tubes so as to be spaced away from the patient's corresponding cheek during use (Claim 5, the positioning and stabilizing structure is configured such that the bias and adjustment mechanism, the concertina structure, does not contact the patient’s face; Thus, the concertina is spaced from the cheeks in use).
Regarding claim 49, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding wherein the sleeve is constructed from a single sheet of elastic material.
However, Veliss further teaches wherein the sleeve is constructed from a single sheet of elastic material (see Paragraph 0008, the cover may include a textile material; also see Paragraph 0074-0082 regarding textile forming the sleeve, wherein at least a single layer is disclosed). Veliss also teaches use of single layer textile in forming the sealing portion (Paragraph 0044-0045, the single layer provides breathability and retains warmth).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to have included forming the sleeve out of multiple elastic sheets, such as that taught by Veliss, in order to adjust the support and texture across different regions of the mask (Paragraph 0078-0080) and to adjust aesthetics.
Regarding claim 50, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding specifically wherein the sleeve is constructed from multiple sheets of the elastic material that are connected together.
However, Veliss teaches use of multi-layer textile arrangement for the seal (Paragraph 0046-0047) and wherein the sleeve may include differing regions of textiles with differing properties connected together (Paragraph 0078-0080, differing textile textiles may be used and connected adjacent one another to adjust bulkiness across regions of the mask or to impart color or different textures to the skin).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to have included forming the sleeve out of multiple elastic sheets, such as that taught by Veliss, in order to adjust the support and texture across different regions of the mask (Paragraph 0078-0080) and to adjust aesthetics.
Claims 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,793,965 B2 in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Grashow (U.S 2015/0182719 A1).
Regarding claim 26, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding wherein the plenum chamber comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient.
However, Grashow teaches wherein the plenum chamber comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient (Paragraph 0028, Fig. 2-3; Exhaust holes 32 allow exhaustion of gas from patient and washout of exhaled gases).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to include vent holes on the plenum chamber, such as that taught by Grashow, in order to provide exhaustion of exhaled gases from the patient (Paragraph 0028) and prevent buildup of carbon dioxide within the circuit/mask.
Regarding claim 27, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding wherein the cushion assembly comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient.
However, Grashow teaches wherein the plenum chamber of a cushion assembly comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient (Paragraph 0028, Fig. 2-3; Exhaust holes 32 allow exhaustion of gas from patient and washout of exhaled gases).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to include vent holes on the plenum chamber of the cushion assembly, such as that taught by Grashow, in order to provide exhaustion of exhaled gases from the patient (Paragraph 0028) and prevent buildup of carbon dioxide within the circuit/mask.
Regarding claim 28, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding wherein the nasal seal-forming structure is constructed from silicone.
Grashow further teaches wherein the nasal seal-forming structure is constructed from silicone (Paragraph 0026, 0037, the sealing cushion 10 can be formed of unitary cushioning material such as silicone rubber).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to form the nasal seal-forming structure of silicone, such as that taught by Grashow, in order to provide a known material for a nasal seal and cushion (Paragraph 0026, 0037).
Regarding claim 29, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding specifically wherein the plenum chamber comprises a shell.
Veliss teaches wherein the plenum chamber comprises a shell (Fig. 2-11 and Paragraph 0051-0053, the sealing arrangement may have a plenum chamber comprised of a semi-rigid shell).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to have included a plenum chamber with a semi-rigid shell, such as that taught by Veliss, in order to provide a known alternative sealing arrangement and plenum chamber (Paragraph 0051-0053) and to adjust the sealing and seating of the mask against the user.
Claims 30-36 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,793,965 B2 in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Formica (U.S 2013/0199537 A1).
Regarding claim 30, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding wherein the cushion assembly further comprises an oral seal-forming structure that is configured to seal around the patient's mouth in use, the oral seal-forming structure having an oral hole configured to deliver the flow of air at said therapeutic pressure to the patient's mouth in use, and the oral seal-forming structure being joined to the plenum chamber.
However, Formica teaches a mask assembly wherein a nasal seal is connected to an oral seal-forming structure that is configured to seal around the patient's mouth in use, the oral seal-forming structure having an oral hole configured to deliver the flow of air at said therapeutic pressure to the patient's mouth in use, and the oral seal-forming structure being joined to the plenum chamber (see Fig. 1-3, 1-5, 2-4 and Paragraphs 0223, 0024; The nares portion 20 may be connectable to the mouth portion 40 via engagement of connector 30 to opening 46; Air can pneumatically flow between nares portion to mouth portion to allow air delivered to the mouth).
It would have been obvious to one having ordinary skill in the prior art to have modified the device of Patent 11,793,965 to include an oral seal connectable to the nasal seal which can deliver the pressurized gas to the mouth, such as that taught by Formica, in order to provide a modular mask which can be adjusted to fit patient needs (Paragraph 0010-0015, 0206).
Regarding claim 31, the modified device of Patent 11,793,965 discloses the device of claim 30.
Formica further teaches wherein the oral seal-forming structure is constructed from silicone (Paragraph 0251, 0278; The mouth sealing portion can be constructed from silicone).
Regarding claim 32, the modified device of Patent 11,040,165 discloses the device of claim 30.
Formica further teaches wherein the nasal seal-forming structure and the oral seal-forming structure are integrally formed (Claim 44, the nares and mouth sealing portions can be formed integrally as a one-piece structure).
Regarding claim 33, the modified device of Patent 11,793,965 discloses the device of claim 30.
Formica further teaches wherein the nasal seal-forming structure and the oral seal-forming structure are removably attached (Claim 43, the nares and mouth sealing portions can be selectively connectable and disconnectable).
Regarding claim 34, the modified device of Patent 11,793,965 discloses the device of claim 30.
Formica further teaches further comprising an anti-asphyxia valve configured to allow the patient to breathe from ambient in the absence of the flow of air at the therapeutic pressure (Paragraph 0198; The mask may be provided with an anti-asphyxia valve; also see Paragraph 0368, 0393, the valve may be inline to an inlet tube or through adaptor, or through gusset elbow).
Regarding claim 35, the modified device of Patent 11,793,965 discloses the device of claim 30.
Formica further teaches wherein the positioning and stabilising structure further comprises a length-adjustable lower strap configured to pass behind the patient's head and below the patient's ears to indirectly connect to the oral seal-forming structure (see Fig. 5-1 and Paragraph 0295, the mouth portion may have headgear connector 41 to receive lower headgear strap 63; The strap is shown to pass behind the head and below the ears to connect to the mouth seal and fix the headgear in place).
Regarding claim 36, the modified device of Patent 11,793,965 discloses the device of claim 35.
Formica further teaches wherein the lower strap is not connected to the two gas delivery tubes (see Fig. 5-1 and Paragraph 0295; The lower strap is only connected to the mouth seal at connectors 41 on either side).
Claims 47-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,793,965 B2 in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Smith (U.S 2012/0325219 A1).
Regarding claim 47, the modified device of Patent 11,793,965 discloses the device of claim 21.
Patent 11,793,965 is silent regarding wherein each of the two gas delivery tubes is constructed from a relatively flexible material.
However, Smith further teaches wherein the gas delivery tubes/conduits can be constructed from a relatively flexible material (see Paragraph 0020, the segments 20 of the tubing can include a soft, flexible material such as silicone or thermoplastic elastomer; also see Paragraph 0023 regarding forming the bellows similarly of silicone).
It would have been obvious to one having ordinary skill in the prior art before the effective filling date of the claimed invention to have modified the device of Patent 11,793,965 to have formed the air delivery tubing from flexible silicone, such as that taught by Smith, in order to provide a known alternative construction material suitable for headgear tubing (Paragraph 0020) and to allow for adjustment of the tubing relative to the user (Paragraph 0023).
Regarding claim 48, the modified device of Patent 11,793,965 discloses the device of claim 47.
Smith further teaches wherein the relatively flexible material is silicone (Paragraph 0020, 0023; The material is silicone).
Claim 21-29, 37-46, 49-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-10, 12-15 of copending Application No. 18/908,396 in view of Grashow (U.S 2015/0182719 A1) and Veliss (U.S 2008/0047560 A1).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 21, App. 18/908,396 discloses a patient interface for sealed delivery of a flow of air throughout the patient's respiratory cycle in use (Claim 1), the patient interface comprising:
a cushion assembly (Claim 1) comprising:
a plenum chamber pressurisable to the therapeutic pressure, said plenum chamber including a pair of plenum chamber inlet ports, each of the plenum chamber inlet ports being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (Claim 1, the plenum chamber inlet ports must correspond to a plenum chamber of the cushion assembly);
a nasal seal-forming structure that is configured to contact and seal against the patient's face and around the patient's nose in use, the nasal seal-forming structure having a nasal hole configured to deliver the flow of air at said therapeutic pressure to the patient's nares in use, and the nasal seal-forming structure being joined to the plenum chamber (Claim 1, the flow of air is delivered to the airways and thus must cover the patient’s airways including the mouth and nose);
a positioning and stabilising structure configured to hold the cushion assembly in a therapeutically effective position on a head of a patient (Claim 1), the positioning and stabilising structure comprising:
two gas delivery tubes, each of the two gas delivery tubes being connected at a first end to a corresponding one of plenum chamber inlet ports to deliver the flow of air to the entrance to the patient's airways via the cushion assembly, each of the two gas delivery tubes being configured to be positioned on a corresponding lateral side of the patient's head in use, each of the two gas delivery tubes being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head (Claim 1), and each of the two gas delivery tubes comprising a tab projecting in a generally posterior direction relative to the patient's head in use, the tab having a hole (Claim 1);
a connection port configured to fluidly connect, in use, the gas delivery tubes with an air circuit to deliver the flow of air to the patient's airways, the connection port configured to be located, in use, superior to the patient's head (Claim 1).
App. 18/908,396 is silent regarding wherein sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH2O with respect to ambient air pressure throughout the patient's respiratory cycle in use.
However, Grashow teaches a patient interface wherein sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH2O with respect to ambient air pressure throughout the patient's respiratory cycle in use (Fig. 1-2, system 2; also see Paragraph 0037 and claims 4-5 regarding pressure of 4-30 cmH2O).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to have included delivering air at a therapeutic pressure of 4 cmH2O, such as that taught by Grashow, since 4 cmH2O is a known standard pressure for PAP delivery and for PAP headwear (Paragraph 0037).
App. 18/908,396 is silent regarding a length-adjustable rear strap, an end of the length-adjustable rear strap being configured to pass through the hole of the tab to removably connect the length-adjustable rear strap to the gas delivery tube and the length-adjustable rear strap being configured, in use, to pass around a posterior portion of the patient's head.
However, Grashow further teaches a rear strap, an end of the rear strap being configured to pass through the hole of the tab to removably connect the rear strap to the gas delivery tube and the rear strap being configured, in use, to pass around a posterior portion of the patient's head (Paragraph 0006 and 0025, Figs. 1, 9, 15; Rear strap 18 passes through hole in tab 20 on either side of the head; Thus, if the strap is configured to be inserted through the opening, it is removably connected; Additionally, the strap extends around the posterior of the head).
Veliss also teaches wherein a rear strap attached to lateral delivery conduits can be length-adjustable (Paragraph 0072; Back strap 46/48 can have selectively adjustable length through baseball cap adjuster, hook and loop material, elastic, etc.).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to include a length-adjustable rear strap, such as that taught by Grashow and Veliss, in order to provide adjustment for use of the headgear with different head sizes (Paragraph 0072, 0094 of Veliss) and to secure the headgear to the patient in a known manner.
App. 18/908,396 is silent regarding a sleeve constructed from an elastic material that at least partially covers each of the two gas delivery tubes, the sleeve comprising a pair of side holes, the tab of each of the gas delivery tubes extending through a corresponding one of the side holes.
However, Veliss teaches a sleeve constructed from an elastic material that at least partially covers each of the two gas delivery tubes (Figs. 1-1 to 1-5, Fig. 3-1 to 3-3, Fig. 5-1 and Paragraphs 0031, 0069, the cover 40 envelops/covers the tubing and headgear along its length on the head; Additionally see Paragraph 0074, 0249 regarding the cover being formed of stretchy fabric, with stretch lycra as a particular fabric) the sleeve comprising a pair of side holes, the tab of each of the gas delivery tubes extending through a corresponding one of the side holes (see Figs. 1-4, 5-1, 13-1; The cover may have an opening to allow the backstrap/tab of the backstrap extending therethrough to extend along the back of the head and to allow manual adjustment).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to have included an elastic sleeve that covers the delivery tubes and wherein the sleeves include side holes for the tabs to extend therethrough, such as that taught by Veliss, in order to allow manual adjustment of the uncovered straps (Paragraph 0072).
Regarding claim 22, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding specifically the elastic material being an elastic fabric.
Veliss further teaches wherein the elastic material is an elastic fabric (see Paragraph 0074, 0249, wherein the cover may be formed of elastic fabric such as lycra or Polar Fleece power stretch fabric).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,793,965 to have formed the sleeve out of elastic fabric, such as that taught by Veliss, in order to provide a known textile suitable for enveloping and stretching/adjusting to headgear on the patient (Paragraph 0074, 0249).
Regarding claim 23, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 further discloses an elbow including a first end rotatably connected to the positioning and stabilising structure at the connection port and a second end having a swivel configured to be connected to the air circuit, the elbow being rotatable 360° about the connection port, the swivel being rotatable 360° about the second end of the elbow, and the elbow being configured to direct the flow of air from the air circuit to the gas delivery tubes via the connection port (Claim 15).
Regarding claim 24, the modified device of App. 18/908,396 discloses the device of claim 23.
Veliss further teaches wherein the sleeve comprises a center hole, the connection port being exposed through the center hole to allow the first end of the elbow to be rotatably connected to the positioning and stabilising structure at the connection port (Fig. 1-1, 1-3, 1-6; At the top, the sleeve includes a center hole/opening for the connector 32 to extend therethrough, which allows the swivel to rotatably connect relative to the base).
Regarding claim 25, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 further discloses wherein the length-adjustable rear strap is configured to overlay or lie inferior to the occipital bone of the patient's head in use (Claim 10; The strap passes around a posterior portion of the patient’s head and thus may overlay or lie inferior to the occipital bone in use; Minor adjustment of the strap across a portion of the back of the head can easily be recognized to lie over/across the occipital bone).
Regarding claim 26, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding wherein the plenum chamber comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient.
However, Grashow teaches wherein the plenum chamber comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient (Paragraph 0028, Fig. 2-3; Exhaust holes 32 allow exhaustion of gas from patient and washout of exhaled gases).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to include vent holes on the plenum chamber, such as that taught by Grashow, in order to provide exhaustion of exhaled gases from the patient (Paragraph 0028) and prevent buildup of carbon dioxide within the circuit/mask.
Regarding claim 27, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding wherein the cushion assembly comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient.
However, Grashow teaches wherein the plenum chamber of a cushion assembly comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient (Paragraph 0028, Fig. 2-3; Exhaust holes 32 allow exhaustion of gas from patient and washout of exhaled gases).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to include vent holes on the plenum chamber of the cushion assembly, such as that taught by Grashow, in order to provide exhaustion of exhaled gases from the patient (Paragraph 0028) and prevent buildup of carbon dioxide within the circuit/mask.
Regarding claim 28, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding wherein the nasal seal-forming structure is constructed from silicone.
Grashow further teaches wherein the nasal seal-forming structure is constructed from silicone (Paragraph 0026, 0037, the sealing cushion 10 can be formed of unitary cushioning material such as silicone rubber).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to form the nasal seal-forming structure of silicone, such as that taught by Grashow, in order to provide a known material for a nasal seal and cushion (Paragraph 0026, 0037).
Regarding claim 29, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding specifically wherein the plenum chamber comprises a shell.
Veliss teaches wherein the plenum chamber comprises a shell (Fig. 2-11 and Paragraph 0051-0053, the sealing arrangement may have a plenum chamber comprised of a semi-rigid shell).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to have included a plenum chamber with a semi-rigid shell, such as that taught by Veliss, in order to provide a known alternative sealing arrangement and plenum chamber (Paragraph 0051-0053) and to adjust the sealing and seating of the mask against the user.
Alternatively, Veliss also teaches the strap extending across the back of the head and across the occipital bone (Fig. 1-4) as a known configuration suitable for securing headgear to the user.
Regarding claim 37, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 further discloses wherein each of the gas delivery tubes is configured to extend, in use, across the patient's corresponding cheek region (Claim 6).
Regarding claim 38, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 further discloses wherein each of the two gas delivery tubes is configured to extend, in use, between the patient's corresponding eye and the patient's corresponding ear (Claim 9).
Regarding claim 39, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 further discloses wherein the length-adjustable rear strap comprises a loop material and a hook material portion, the loop material and the hook material portion being configured to removably connect the length-adjustable rear strap to the tab (Claim 12).
Regarding claim 40, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 further discloses wherein each of the gas delivery tubes comprises a concertina portion that is more flexible than adjacent portions of the gas delivery tube (Claim 1, the concertina structure is specifically said to adjust length-wise and thus must be longitudinally more compliant/flexible than adjacent portions of the tube; Additionally see claim 13-14 regarding the concertina structure being smaller in width/diameter than adjacent tube portions).
Regarding claim 41, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 further discloses wherein each of the two gas delivery tubes varies in width and diameter along the length of each concertina portion (Claim 13 or 14, the tubes taper in width, diameter and length along the concertina structure).
Regarding claim 42, the modified device of App. 18/908,396 discloses the device of claim 40.
App. 18/908,396 further discloses wherein each of the two gas delivery tubes tapers along the length of each concertina portion so that the width and diameter of each of the two gas delivery tubes at one end of the concertina portion is smaller than the width and diameter of each of the two gas delivery tubes at the other end of concertina portion (Claim 14).
Regarding claim 43, the modified device of App. 18/908,396 discloses the device of claim 40.
App. 18/908,396 further discloses wherein each concertina portion is positioned between the tab of a corresponding one of the gas delivery tubes and the connection port (Claim 1 and 15, the concertina is formed between the first end and the connection port, the tab positioned between the portion of the gas delivery tube having the concertina and the first end, which is attached to the cushion assembly; Thus the concertina section is between the tab and connection port).
Regarding claim 44, the modified device of App. 18/908,396 discloses the device of claim 40.
App. 18/908,396 further discloses wherein the sleeve covers each concertina portion (Claim 2, the sleeve covers the two deliver tubes, and thus is inclusive of the concertina of the tubes).
Regarding claim 45, the modified device of App. 18/908,396 discloses the device of claim 40.
App. 18/908,396 further discloses wherein each concertina portion is positioned on a corresponding one of the gas delivery tubes so as to be spaced away from the patient's face during use (Claim 4, the positioning and stabilizing structure is configured such that the bias and adjustment mechanism, the concertina structure, does not contact the patient’s face; Thus, the concertina is spaced from the face in use).
Regarding claim 46, the modified device of App. 18/908,396 discloses the device of claim 40.
App. 18/908,396 further discloses wherein each concertina portion is positioned on a corresponding one of the gas delivery tubes so as to be spaced away from the patient's corresponding cheek during use (Claim 5, the positioning and stabilizing structure is configured such that the bias and adjustment mechanism, the concertina structure, does not contact the patient’s face; Thus, the concertina is spaced from the cheeks in use).
Regarding claim 49, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding wherein the sleeve is constructed from a single sheet of elastic material.
However, Veliss further teaches wherein the sleeve is constructed from a single sheet of elastic material (see Paragraph 0008, the cover may include a textile material; also see Paragraph 0074-0082 regarding textile forming the sleeve, wherein at least a single layer is disclosed). Veliss also teaches use of single layer textile in forming the sealing portion (Paragraph 0044-0045, the single layer provides breathability and retains warmth).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to have included forming the sleeve out of multiple elastic sheets, such as that taught by Veliss, in order to adjust the support and texture across different regions of the mask (Paragraph 0078-0080) and to adjust aesthetics.
Regarding claim 50, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding specifically wherein the sleeve is constructed from multiple sheets of the elastic material that are connected together.
However, Veliss teaches use of multi-layer textile arrangement for the seal (Paragraph 0046-0047) and wherein the sleeve may include differing regions of textiles with differing properties connected together (Paragraph 0078-0080, differing textile textiles may be used and connected adjacent one another to adjust bulkiness across regions of the mask or to impart color or different textures to the skin).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of App. 18/908,396 to have included forming the sleeve out of multiple elastic sheets, such as that taught by Veliss, in order to adjust the support and texture across different regions of the mask (Paragraph 0078-0080) and to adjust aesthetics.
Claims 30-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 18/908,396 in view of Grashow (U.S 2015/0182719 A1) and Veliss (U.S 2008/0047560 A1), in further view of Formica (U.S 2013/0199537 A1).
Regarding claim 30, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding wherein the cushion assembly further comprises an oral seal-forming structure that is configured to seal around the patient's mouth in use, the oral seal-forming structure having an oral hole configured to deliver the flow of air at said therapeutic pressure to the patient's mouth in use, and the oral seal-forming structure being joined to the plenum chamber.
However, Formica teaches a mask assembly wherein a nasal seal is connected to an oral seal-forming structure that is configured to seal around the patient's mouth in use, the oral seal-forming structure having an oral hole configured to deliver the flow of air at said therapeutic pressure to the patient's mouth in use, and the oral seal-forming structure being joined to the plenum chamber (see Fig. 1-3, 1-5, 2-4 and Paragraphs 0223, 0024; The nares portion 20 may be connectable to the mouth portion 40 via engagement of connector 30 to opening 46; Air can pneumatically flow between nares portion to mouth portion to allow air delivered to the mouth).
It would have been obvious to one having ordinary skill in the prior art to have modified the device of App. 18/908,396 to include an oral seal connectable to the nasal seal which can deliver the pressurized gas to the mouth, such as that taught by Formica, in order to provide a modular mask which can be adjusted to fit patient needs (Paragraph 0010-0015, 0206).
Regarding claim 31, the modified device of App. 18/908,396 discloses the device of claim 30.
Formica further teaches wherein the oral seal-forming structure is constructed from silicone (Paragraph 0251, 0278; The mouth sealing portion can be constructed from silicone).
Regarding claim 32, the modified device of App. 18/908,396 discloses the device of claim 30.
Formica further teaches wherein the nasal seal-forming structure and the oral seal-forming structure are integrally formed (Claim 44, the nares and mouth sealing portions can be formed integrally as a one-piece structure).
Regarding claim 33, the modified device of App. 18/908,396 discloses the device of claim 30.
Formica further teaches wherein the nasal seal-forming structure and the oral seal-forming structure are removably attached (Claim 43, the nares and mouth sealing portions can be selectively connectable and disconnectable).
Regarding claim 34, the modified device of App. 18/908,396 discloses the device of claim 30.
Formica further teaches further comprising an anti-asphyxia valve configured to allow the patient to breathe from ambient in the absence of the flow of air at the therapeutic pressure (Paragraph 0198; The mask may be provided with an anti-asphyxia valve; also see Paragraph 0368, 0393, the valve may be inline to an inlet tube or through adaptor, or through gusset elbow).
Regarding claim 35, the modified device of App. 18/908,396 discloses the device of claim 30.
Formica further teaches wherein the positioning and stabilising structure further comprises a length-adjustable lower strap configured to pass behind the patient's head and below the patient's ears to indirectly connect to the oral seal-forming structure (see Fig. 5-1 and Paragraph 0295, the mouth portion may have headgear connector 41 to receive lower headgear strap 63; The strap is shown to pass behind the head and below the ears to connect to the mouth seal and fix the headgear in place).
Regarding claim 36, the modified device of App. 18/908,396 discloses the device of claim 35.
Formica further teaches wherein the lower strap is not connected to the two gas delivery tubes (see Fig. 5-1 and Paragraph 0295; The lower strap is only connected to the mouth seal at connectors 41 on either side).
Claims 47-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 18/908,396 in view of Grashow (U.S 2015/0182719 A1) and Veliss (U.S 2008/0047560 A1), in further view of Smith (U.S 2012/0325219 A1).
Regarding claim 47, the modified device of App. 18/908,396 discloses the device of claim 21.
App. 18/908,396 is silent regarding wherein each of the two gas delivery tubes is constructed from a relatively flexible material.
However, Smith further teaches wherein the gas delivery tubes/conduits can be constructed from a relatively flexible material (see Paragraph 0020, the segments 20 of the tubing can include a soft, flexible material such as silicone or thermoplastic elastomer; also see Paragraph 0023 regarding forming the bellows similarly of silicone).
It would have been obvious to one having ordinary skill in the prior art before the effective filling date of the claimed invention to have modified the device of App. 18/908,396 to have formed the air delivery tubing from flexible silicone, such as that taught by Smith, in order to provide a known alternative construction material suitable for headgear tubing (Paragraph 0020) and to allow for adjustment of the tubing relative to the user (Paragraph 0023).
Regarding claim 48, the modified device of App. 18/908,396 discloses the device of claim 47.
Smith further teaches wherein the relatively flexible material is silicone (Paragraph 0020, 0023; The material is silicone).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-29, 37-39, 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Grashow (U.S 2015/0182719 A1) in view of Veliss (U.S 2008/0047560 A1).
Regarding claim 21, Grashow discloses a patient interface for sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH2O with respect to ambient air pressure throughout the patient's respiratory cycle in use (Fig. 1-2, system 2; also see Paragraph 0037 and claims 4-5 regarding pressure of 4-30 cmH2O), the patient interface comprising:
a cushion assembly (patient interface device 8, see Paragraph 0025 and Fig. 1-2) comprising:
a plenum chamber pressurisable to the therapeutic pressure, said plenum chamber including a pair of plenum chamber inlet ports, each of the plenum chamber inlet ports being sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (sealing cushion 10, Fig. 1-5 and Paragraphs 0027-0030, 0037, the body includes inlet ports 26A/B, which receive pressurized air from the arms/conduits to deliver to the nares);
a nasal seal-forming structure that is configured to contact and seal against the patient's face and around the patient's nose in use, the nasal seal-forming structure having a nasal hole configured to deliver the flow of air at said therapeutic pressure to the patient's nares in use, and the nasal seal-forming structure being joined to the plenum chamber (central sealing surface 38, Fig. 1-5 and Paragraph 0029, 0039; The sealing surface seals about the nostrils of the patient and may include on or more holes 39/72A/72B to deliver the gas flow into the nares; The sealing surface is joined to the plenum chamber);
a positioning and stabilising structure configured to hold the cushion assembly in a therapeutically effective position on a head of a patient (headgear including arms 14A/B and strap 18, Figs. 1-5, 9 and Paragraph 0006, 0025), the positioning and stabilising structure comprising:
two gas delivery tubes (arms 14A/B, see Figs. 1-5, 9; also see Paragraph 0025), each of the two gas delivery tubes being connected at a first end to a corresponding one of plenum chamber inlet ports to deliver the flow of air to the entrance to the patient's airways via the cushion assembly (Paragraph 0025 and Fig. 1-5, the arms have an end coupled to the sealing cushion inlet ports), each of the two gas delivery tubes being configured to be positioned on a corresponding lateral side of the patient's head in use (Fig. 1, 9; The arms are on either lateral side of the head), each of the two gas delivery tubes being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head (Fig. 1, 9, the tubes extend across the head above the otabasion superior of the ears), and each of the two gas delivery tubes comprising a tab projecting in a generally posterior direction relative to the patient's head in use, the tab having a hole (Paragraph 0025, Fig. 9; The arms include attachment members 20 which are tabs through which a strap runs therethrough; The tabs extend in a posterior direction of the head);
a connection port configured to fluidly connect, in use, the gas delivery tubes with an air circuit to deliver the flow of air to the patient's airways, the connection port configured to be located, in use, superior to the patient's head (coupling connector 16, see Fig. 1, 8-9; The tubes meat at the connection port at the top of the head to connect to a coupling connector 16 which receives flow from a pressure generating device 4; The coupling connector rests on top of the head);
a rear strap, an end of the rear strap being configured to pass through the hole of the tab to removably connect the rear strap to the gas delivery tube and the rear strap being configured, in use, to pass around a posterior portion of the patient's head (Paragraph 0006 and 0025, Figs. 1, 9, 15; Rear strap 18 passes through hole in tab 20 on either side of the head; Thus, if the strap is configured to be inserted through the opening, it is removably connected; Additionally, the strap extends around the posterior of the head).
Grashow is silent regarding specifically wherein the strap is length-adjustable.
Veliss teaches wherein a rear strap attached to lateral delivery conduits can be length-adjustable (Paragraph 0072; Back strap 46/48 can have selectively adjustable length through baseball cap adjuster, hook and loop material, elastic, etc.).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Grashow to include a length-adjustable rear strap, such as that taught by Veliss, in order to provide adjustment for use of the headgear with different head sizes (Paragraph 0072, 0094).
Grashow is silent regarding a sleeve constructed from an elastic material that at least partially covers each of the two gas delivery tubes, the sleeve comprising a pair of side holes, the tab of each of the gas delivery tubes extending through a corresponding one of the side holes.
However, Veliss teaches a sleeve constructed from an elastic material that at least partially covers each of the two gas delivery tubes (Figs. 1-1 to 1-5, Fig. 3-1 to 3-3, Fig. 5-1 and Paragraphs 0031, 0069, the cover 40 envelops/covers the tubing and headgear along its length on the head; Additionally see Paragraph 0074, 0249 regarding the cover being formed of stretchy fabric, with stretch lycra as a particular fabric) the sleeve comprising a pair of side holes, the tab of each of the gas delivery tubes extending through a corresponding one of the side holes (see Figs. 1-4, 5-1, 13-1; The cover may have an opening to allow the backstrap/tab of the backstrap extending therethrough to extend along the back of the head and to allow manual adjustment).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Grashow to have included an elastic sleeve that covers the delivery tubes and wherein the sleeves include side holes for the tabs to extend therethrough, such as that taught by Veliss, in order to maintain the form/shape of the headgear in use and non-use (Paragraph 0031) and to provide a comfortable interface with the skin/face of the user (Paragraph 0073), and to allow for adjustment of the uncovered strap sections (Paragraph 0072, Fig. 1-4).
Regarding claim 22, the modified device of Grashow discloses the device of claim 21.
Veliss further teaches wherein the elastic material is an elastic fabric (see Paragraph 0074, 0249, wherein the cover may be formed of elastic fabric such as lycra or Polar Fleece power stretch fabric).
Regarding claim 23, the modified device of Grashow discloses the device of claim 21.
Grashow is silent regarding an elbow including a first end rotatably connected to the positioning and stabilising structure at the connection port and a second end having a swivel configured to be connected to the air circuit, the elbow being rotatable 360° about the connection port, the swivel being rotatable 360° about the second end of the elbow, and the elbow being configured to direct the flow of air from the air circuit to the gas delivery tubes via the connection port.
However, Veliss teaches an elbow including a first end rotatably connected to the positioning and stabilising structure at the connection port and a second end having a swivel configured to be connected to the air circuit, the elbow being rotatable 360° about the connection port, the swivel being rotatable 360° about the second end of the elbow, and the elbow being configured to direct the flow of air from the air circuit to the gas delivery tubes via the connection port (Paragraph 0063 and Fig. 1-7; The connection port at the top of the headgear includes a swiveling inlet tube portion 36/37 which rotates relative to a base 34 for angled connection and adjustment to an air delivery tube from a flow generator).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Grashow to have included an elbow rotatably connected to the headgear at the connection port using a swivel connected to the air circuit, such as that taught by Veliss, in order to allow for adjustment and movement of the conduit from the flow generator relative to the headgear (Paragraph 0063).
Regarding claim 24, the modified device of Grashow discloses the device of claim 23.
Veliss further teaches wherein the sleeve comprises a center hole, the connection port being exposed through the center hole to allow the first end of the elbow to be rotatably connected to the positioning and stabilising structure at the connection port (Fig. 1-1, 1-3, 1-6; At the top, the sleeve includes a center hole/opening for the connector 32 to extend therethrough, which allows the swivel to rotatably connect relative to the base).
Regarding claim 25, the modified device of Grashow discloses the device of claim 21.
Grashow further discloses wherein the length-adjustable rear strap is configured to overlay or lie inferior to the occipital bone of the patient's head in use (see Fig. 1, 9, 15; The strap extends and overlays the back of the head/occipital bone in use; It is also noted that the strap may simple be adjusted across the back of the head to fit the user and thus its position can and overlap the occipital bone).
Veliss also teaches the back strap overlaying the occipital bone (Fig. 1-3, 1-4).
Regarding claim 26, the modified device of Grashow discloses the device of claim 21.
Grashow further discloses wherein the plenum chamber comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient (Paragraph 0028, Fig. 2-3; Exhaust holes 32 allow exhaustion of gas from patient and washout of exhaled gases).
Regarding claim 27, the modified device of Grashow discloses the device of claim 21.
Grashow further discloses wherein the cushion assembly comprises a plurality of vent holes sized and shaped to maintain the therapeutic pressure in the plenum chamber and configured to allow washout of exhaled gases from within the plenum chamber to ambient (Paragraph 0028, Fig. 2-3; Exhaust holes 32 allow exhaustion of gas from patient and washout of exhaled gases).
Regarding claim 28, the modified device of Grashow discloses the device of claim 21.
Grashow further discloses wherein the nasal seal-forming structure is constructed from silicone (Paragraph 0026, 0037, the sealing cushion 10 can be formed of unitary cushioning material such as silicone rubber).
Regarding claim 29, the modified device of Grashow discloses the device of claim 21.
Grashow is silent regarding specifically wherein the plenum chamber comprises a shell.
Veliss teaches wherein the plenum chamber comprises a shell (Fig. 2-11 and Paragraph 0051-0053, the sealing arrangement may have a plenum chamber comprised of a semi-rigid shell).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Grashow to have included a plenum chamber with a semi-rigid shell, such as that taught by Veliss, in order to provide a known alternative sealing arrangement and plenum chamber (Paragraph 0051-0053) and to adjust the sealing and seating of the mask against the user.
Regarding claim 37, the modified device of Grashow discloses the device of claim 21.
Grashow further discloses wherein each of the gas delivery tubes is configured to extend, in use, across the patient's corresponding cheek region (Fig. 1, 9; The tubes extend across the cheeks).
Regarding claim 38, the modified device of Grashow discloses the device of claim 21.
Grashow further discloses wherein each of the two gas delivery tubes is configured to extend, in use, between the patient's corresponding eye and the patient's corresponding ear (Fig. 1, 9; The tubes extend between the eye and ear on either side).
Regarding claim 39, the modified device of Grashow discloses the device of claim 21.
Veliss further teaches wherein the length-adjustable rear strap comprises a loop material and a hook material portion, the loop material and the hook material portion being configured to removably connect the length-adjustable rear strap to the tab (Paragraph 0072, the strap may be adjustable via hook and loop material; Hook and loop is reversibly couplable to itself and thus is configured for removable connection to the tab, as the strap/material can be removed from the opening of the tab when not engaged with itself).
Regarding claim 49, the modified device of Grashow discloses the device of claim 21.
Veliss further teaches wherein the sleeve is constructed from a single sheet of elastic material (see Paragraph 0008, the cover may include a textile material; also see Paragraph 0074-0082 regarding textile forming the sleeve, wherein at least a single layer is disclosed). Veliss also teaches use of single layer textile in forming the sealing portion (Paragraph 0044-0045, the single layer provides breathability and retains warmth).
Regarding claim 50, the modified device of Grashow discloses the device of claim 21.
Veliss is silent regarding specifically wherein the sleeve is constructed from multiple sheets of the elastic material that are connected together.
However, Veliss teaches use of multi-layer textile arrangement for the seal (Paragraph 0046-0047) and wherein the sleeve may include differing regions of textiles with differing properties connected together (Paragraph 0078-0080, differing textile textiles may be used and connected adjacent one another to adjust bulkiness across regions of the mask or to impart color or different textures to the skin).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Grashow to have included forming the sleeve out of multiple elastic sheets, such as that taught by Veliss, in order to adjust the support and texture across different regions of the mask (Paragraph 0078-0080) and to adjust aesthetics.
Claims 30-36 are rejected under 35 U.S.C. 103 as being unpatentable over Grashow (U.S 2015/0182719 A1) in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Formica (U.S 2013/0199537 A1).
Regarding claim 30, the modified device of Grashow discloses the device of claim 21.
Grashow is silent regarding wherein the cushion assembly further comprises an oral seal-forming structure that is configured to seal around the patient's mouth in use, the oral seal-forming structure having an oral hole configured to deliver the flow of air at said therapeutic pressure to the patient's mouth in use, and the oral seal-forming structure being joined to the plenum chamber.
However, Formica teaches a mask assembly wherein a nasal seal is connected to an oral seal-forming structure that is configured to seal around the patient's mouth in use, the oral seal-forming structure having an oral hole configured to deliver the flow of air at said therapeutic pressure to the patient's mouth in use, and the oral seal-forming structure being joined to the plenum chamber (see Fig. 1-3, 1-5, 2-4 and Paragraphs 0223, 0024; The nares portion 20 may be connectable to the mouth portion 40 via engagement of connector 30 to opening 46; Air can pneumatically flow between nares portion to mouth portion to allow air delivered to the mouth).
It would have been obvious to one having ordinary skill in the prior art to have modified the device of Grashow to include an oral seal connectable to the nasal seal which can deliver the pressurized gas to the mouth, such as that taught by Formica, in order to provide a modular mask which can be adjusted to fit patient needs (Paragraph 0010-0015, 0206).
Regarding claim 31, the modified device of Grashow discloses the device of claim 30.
Formica further teaches wherein the oral seal-forming structure is constructed from silicone (Paragraph 0251, 0278; The mouth sealing portion can be constructed from silicone).
Regarding claim 32, the modified device of Grashow discloses the device of claim 30.
Formica further teaches wherein the nasal seal-forming structure and the oral seal-forming structure are integrally formed (Claim 44, the nares and mouth sealing portions can be formed integrally as a one-piece structure).
Regarding claim 33, the modified device of Grashow discloses the device of claim 30.
Formica further teaches wherein the nasal seal-forming structure and the oral seal-forming structure are removably attached (Claim 43, the nares and mouth sealing portions can be selectively connectable and disconnectable).
Regarding claim 34, the modified device of Grashow discloses the device of claim 30.
Formica further teaches further comprising an anti-asphyxia valve configured to allow the patient to breathe from ambient in the absence of the flow of air at the therapeutic pressure (Paragraph 0198; The mask may be provided with an anti-asphyxia valve; also see Paragraph 0368, 0393, the valve may be inline to an inlet tube or through adaptor, or through gusset elbow).
Regarding claim 35, the modified device of Grashow discloses the device of claim 30.
Formica further teaches wherein the positioning and stabilising structure further comprises a length-adjustable lower strap configured to pass behind the patient's head and below the patient's ears to indirectly connect to the oral seal-forming structure (see Fig. 5-1 and Paragraph 0295, the mouth portion may have headgear connector 41 to receive lower headgear strap 63; The strap is shown to pass behind the head and below the ears to connect to the mouth seal and fix the headgear in place).
Regarding claim 36, the modified device of Grashow discloses the device of claim 35.
Formica further teaches wherein the lower strap is not connected to the two gas delivery tubes (see Fig. 5-1 and Paragraph 0295; The lower strap is only connected to the mouth seal at connectors 41 on either side).
Claims 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Grashow (U.S 2015/0182719 A1) in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Kwok (U.S 2007/0246043 A1).
Regarding claim 40, the modified device of Grashow discloses the device of claim 21.
Grashow is silent regarding wherein each of the gas delivery tubes comprises a concertina portion that is more flexible than adjacent portions of the gas delivery tube.
However, Kwok teaches wherein each of the gas delivery tubes comprises a concertina portion that is more flexible than adjacent portions of the gas delivery tube (see Paragraph 0133 and Fig. 12, the conduits may include a collapsible cuff 1112 at the ends which allow extension and contraction to adjust the length of the conduits; The bellows portions are configured to collapse and thus are more flexible, at least longitudinally, than adjacent sections of the tubes).
It would have been obvious to one having ordinary skill in the prior art before the effective filling date of the claimed invention to have modified the device of Grashow to have included a concertina portion that is more flexible than adjacent portions of the gas delivery tube, such as that taught by Kwok, in order to provide adjustment to the overall length of the conduits for fitting to the user (Paragraph 0133).
Regarding claim 41, the modified device of Grashow discloses the device of claim 40.
Kwok further teaches wherein each of the two gas delivery tubes varies in width and diameter along the length of each concertina portion (see Fig. 1-3, 12; The tubes taper in thickness from the bodies at 12 down to the second ends 40 where they connect to the nasal interface; The concertina section 1112 similarly tapers along the length towards the thinner second end at 40; Additionally, it is noted that the concertina portion already tapers in width/diameter along the length, as across the length it transitions between crests and troughs of the pleats and thus the width/diameter varies across the length).
Regarding claim 42, the modified device of Grashow discloses the device of claim 40.
Kwok further teaches wherein each of the two gas delivery tubes tapers along the length of each concertina portion so that the width and diameter of each of the two gas delivery tubes at one end of the concertina portion is smaller than the width and diameter of each of the two gas delivery tubes at the other end of concertina portion (see Fig. 1-3, 12; The tubes taper in thickness from the bodies at 12 down to the second ends 40 where they connect to the nasal interface; The concertina section 1112 similarly tapers along the length towards the thinner second end at 40).
Claims 40, 43-48 are rejected under 35 U.S.C. 103 as being unpatentable over Grashow (U.S 2015/0182719 A1) in view of Veliss (U.S 2008/0047560 A1), as applied to claim 21, in further view of Smith (U.S 2012/0325219 A1).
Regarding claim 40, the modified device of Grashow discloses the device of claim 21.
Grashow is silent regarding wherein each of the gas delivery tubes comprises a concertina portion that is more flexible than adjacent portions of the gas delivery tube.
However, Smith teaches wherein each of the gas delivery tubes comprises a concertina portion that is more flexible than adjacent portions of the gas delivery tube (Paragraph 0020-0024; The headgear includes bellows segments in the gas delivery tubes which can vary in length to fit different heads and provide adjustment to the user; The bellows portions can bend and elongate relative to the straight sections).
It would have been obvious to one having ordinary skill in the prior art before the effective filling date of the claimed invention to have modified the device of Grashow to have included an upper concertina portion that is more flexible than adjacent portions of the gas delivery tube, such as that taught by Smith, in order to provide adjustment to the overall length of the conduits for fitting to the user (Paragraph 0020-0024) and fit larger/longer heads
Regarding claim 43, the modified device of Grashow discloses the device of claim 40.
Smith further teaches wherein each concertina portion is positioned between the tab of a corresponding one of the gas delivery tubes and the connection port (see Fig. 1-2, the concertina section extends to/past where the strap connects to the tubing, and thus where the according tab may be in Grashow; Thus, the concertina section is at least partially disposed between the tab and the upper connection port on top of the head).
Regarding claim 44, the modified device of Grashow discloses the device of claim 40.
Grashow is silent regarding specifically wherein the sleeve covers each concertina portion.
However, Smith teaches wherein the sleeve covers each concertina portion (see Figs. 1-2 and Paragraph 0028; The sleeves 46A/B encase the conduits/arms, inclusive of the concertina portions).
It would have been obvious to one having ordinary skill in the prior art before the effective filling date of the claimed invention to have modified the device of Grashow to have included the concertina portion within the sleeve, such as that taught by Smith, in order provide dampening of noise across multiple sections of the conduit (Paragraph 0029) and to fix portions of the conduit to the user (Paragraph 0028).
Veliss additionally teaches wherein the cover extends across substantially all of the conduit/tubing (Figs. 1-5; Thus, the cover would also cover the concertina portions as taught in claim 40 above).
Regarding claim 45, the modified device of Grashow discloses the device of claim 40.
Smith further teaches wherein each concertina portion is positioned on a corresponding one of the gas delivery tubes so as to be spaced away from the patient's face during use (see Fig. 1-2 and rejection of claim 40 above, the upper concertina portion is spaced away from the patient’s face, as it lies on the side of the head).
Regarding claim 46, the modified device of Grashow discloses the device of claim 40.
Smith further teaches wherein each concertina portion is positioned on a corresponding one of the gas delivery tubes so as to be spaced away from the patient's corresponding cheek during use (see Fig. 1-2 and rejection of claim 40 above, the upper concertina portion is spaced away from the patient’s face and cheek, as it lies on the side of the head).
Regarding claim 47, the modified device of Grashow discloses the device of claim 21.
Grashow is silent regarding wherein each of the two gas delivery tubes is constructed from a relatively flexible material.
However, Smith further teaches wherein the gas delivery tubes/conduits can be constructed from a relatively flexible material (see Paragraph 0020, the segments 20 of the tubing can include a soft, flexible material such as silicone or thermoplastic elastomer; also see Paragraph 0023 regarding forming the bellows similarly of silicone).
It would have been obvious to one having ordinary skill in the prior art before the effective filling date of the claimed invention to have modified the device of Grashow to have formed the air delivery tubing from flexible silicone, such as that taught by Smith, in order to provide a known alternative construction material suitable for headgear tubing (Paragraph 0020) and to allow for adjustment of the tubing relative to the user (Paragraph 0023).
Regarding claim 48, the modified device of Grashow discloses the device of claim 47.
Smith further teaches wherein the relatively flexible material is silicone (Paragraph 0020, 0023; The material is silicone).
Conclusion
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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