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 .
Claim Objections
Claims 21, 23, 26-28, 30, and 39 are objected to because of the following informalities:
The phrase “pressurized gas” should be changed to –the pressurized gas—for consistency (Claim 21, Line 10).
The phrase “in use” should be removed because it is redundant (Claim 23, Line 2).
The phrase “plenum connection” should be changed to –plenum connection region—for consistency (Claim 26, Line 1).
The phrase “pressurized gas” should be changed to –the pressurized gas—for consistency (Claim 27, Line 2).
The phrase “pressurized gas” should be changed to –the pressurized gas—for consistency (Claim 28, Line 2).
The phrase “the upper back strap portion and the lower back strap portion” should be changed to –the back strap portions—for consistency with Claim 21 (Claim 30, Lines 1-2).
The phrase “end distal” should be changed to –an end distal—since this is the first time this is mentioned (Claim 39, Line 2).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 states “a pair of back strap portions, each of the back strap portions being connected to both of the side of the side strap portions” (Lines 27-28). There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what is considered the “side” of the “side” strap portion and how the back strap portions are connected. It appears the applicant was trying to say the pair of back strap portions include an upper back strap portion and a lower back strap portion, each back strap portion is connected to both ends of the side strap portions. However, the use of “the side of the side strap portions” creates confusion regarding the number of sides involved since the side strap portions are already referred to as “side strap portions”. Additionally, previously, the pair of side strap portions are inferred as left and right side strap portions that are separate. It is possible that the pair of back strap portions can be interpreted as being left and right back strap portions that are separate. Yet, later in the claim, the back strap portions are referred to as “an upper one” or “a lower one”, creating confusion regarding the number of back strap portions and how they’re connected. Therefore, the connection of the back strap portions with the side strap portions cannot be determined. For examination purposes, the claim limitation will be interpreted as the pair of back strap portions include an upper back strap portion and a lower back strap portion, each back strap portion is connected to both ends of the side strap portions as depicted as the back strap portions 3317a and 3317b in Figs 291-305.
Claim 21 states “a soft and elastic textile material” and “a textile material” (Lines 17 and 31-32). This statement is indefinite because it is unclear if the textile materials are the same. It appears the applicant was trying to say they’re the same. However, it is possible that the textile materials are different from each other. Therefore, the number of textile materials involved cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same.
Claims 22-42 are rejected for being dependent on rejected Claim 21.
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 21-26, 28, 33-38, and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (US 2009/0241961 A1) in view of Allan et al. (US 2011/0146685 A1) and Doherty et al. (US 2010/0258136 A1).
Regarding Claim 21, discloses McAuley discloses a patient interface (apparatus of Figs 201-22; apparatus of Figs 20-22 share similar components to the apparatus of Figs 2-3) to deliver pressurized gas to a patient to treat sleep disordered breathing (apparatus for treating sleep apnoea, a nasal interface for the supply of respiratory gases, but most particularly positive pressure gases, paragraph 0003), the patient interface comprising: a seal-forming structure (305, Fig 22) configured to contact and seal against the patient's face to provide pressurized gas to the patient's nares (body 23 is substantially tubular with two nasal pillows 24, 25 extending from it, nasal pillows 24, 25 are preferably frustoconical in shape and in use rest against a patient's nares, to substantially seal the patient's nares, paragraph 0064; the mask body 305 has integral nasal pillows 306, 307 similar to that described above in relation to FIG. 2, paragraph 0085); a plenum chamber (chamber of 305, Fig 22) connected to the seal-forming structure (chamber of 305 is connected or encased by the body 305, Fig 22), the plenum chamber including a plenum connection region (region of 305 that connects to 301, Figs 21-22); a frame (301, Figs 21-22) releasably attachable to the plenum connection region (305 and 301 shown to separate, Fig 22; when assembling the mask body 23 to the mask base 22 the channel 45 receives the lip 28, paragraph 0072) and comprising a connection port (port that connects tubing to 301, Figs 21-22; semi-tubular projection 29 is curved in this embodiment such that a ball jointed connector end 46 such that a connector 30 can be fitted into it, paragraph 0073); a tube (tubing connected to 301, Figs 20-22; equivalent structure 31, Fig 3) having a first end fixed to the frame at the connection port (first end of tubing shown to connect to 301, Figs 20-22; equivalent structure 46, Fig 3) and a second end (second end of tubing at top of head of user, Figs 20-22) configured to be connected to an air circuit to receive pressurized gas from a respiratory pressure therapy device (tubing 31 may be attached to inspiratory conduit 3 or the tubing 31 may simply be the inspiratory conduit 3, paragraph 0073; 3 receives gas from 15, Fig 1); a pair of rigidiser arms (302, Figs 21-22; 302 has 303 and 304, Figs 21-22), each of the rigidiser arms having a proximal portion (portion of 302 closest to 301, Figs 21-22) connected to a corresponding lateral side of the frame (the mask base 301 and the curved elongate member 302 are integrally formed, paragraph 0085; 303 and 304 shown on both sides of 301, Figs 21-22), each of the rigidiser arms having a distal portion (distal portions of 303 and 304, Figs 21-22) distal from the corresponding lateral side of the frame (distal portions of 303 and 304 are distal from 301, Figs 21 and 22), the distal portion of each of the rigidiser arms having a hole (313 and 310, Fig 21), and the distal portion of each of the rigidiser arms being wider than the proximal portion of the corresponding rigidiser arm (distal portions of 303 and 304 at the recesses 313 and 310 are shown to be wider than the proximal portions closest to 301, Figs 20-22); and a positioning and stabilising structure (308 and 309, Figs 20-22) configured to engage the patient's head (308 and 309 shown to engage the patient’s head, Fig 20) and maintain the seal-forming structure in sealing contact with the patient's face (308 and 309 would maintain sealing contact of 305 with patient’s face, Fig 20), the positioning and stabilising structure comprising: a pair of side strap portions (side strap portions of 308 and 309 closest to 310 and 313, Figs 21-22), each of the side strap portions being connected to a corresponding one of the rigidiser arms at the hole (side strap portions of 308 and 309 shown to connect to 303 and 304 via 310 and 313, Figs 21-22; the headgear straps 308, 309 attach through recesses 310, 313 at the end of the arms 303, 304, paragraph 0086), and each of the side strap portions being configured to extend between the patient's eye and ear along a corresponding lateral side of the patient's face (side strap portions of 308 and 309 shown to extend between patient’s eye and ear, Fig 20); and a pair of back strap portions (back strap portions of 308 and 309 that go on top of and on the back of the patient’s head, Figs 20-22), each of the back strap portions being connected to both of the side of the side strap portions (each of the back strap portions of 308 and 309 are connected to the distal ends of the side strap portions of 308 and 309, Figs 20-22), an upper one of the back strap portions being configured to engage the patient's head superior to the occiput in use (upper back strap portion of 308 and 309 shown to engage the top of the patient’s head, Figs 20-22), and a lower one of the back strap portions being configured to engage the patient's head inferior to the occiput in use (lower back strap portion of 308 and 309 shown to engage the back of the patient’s head, Figs 20-22).
McAuley also discloses the straps are made from a composite foam layered material, such as Breathoprene.TM. (paragraph 0077), the elbow having a number of holes 419 to provide an exhaust vent for gases exhaled (paragraph 0115), and pads 312 and 311 that rest against the patient’s cheekbones in use and provide comfort to the patient's face and are made of a foam type material such as the laminated material that the headgear straps are made from (paragraph 0086).
McAuley fails to disclose a frame comprising a plurality of vent holes; a pair of sleeves constructed from a soft and elastic textile material, each of the sleeves having a tubular shape, and each of the rigidiser arms extending through a corresponding one of the sleeves to cushion the patient's face against the rigidiser arms; the side strap portions and the back strap portions are constructed from a textile material.
However, Allan, of the same field of endeavor, teaches a patient interface (Abstract) including a frame comprising a plurality of vent holes (frame has bias flow holes 904 formed about a connector for the conduit, bias flow holes 904 provide gas washout from the interface, paragraph 0377) since it is a known location to place the vent holes on the frame around the conduit (Fig 1I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to relocate the vent holes to be on the sides of the frame 301, as taught by Allan, since it is a known location to place the vent holes on the frame around the conduit (Allan: Fig 1I). Relocating the vent holes to be on the frame itself would not change or affect the operation of the device as it would achieve the same effect as venting exhaled gases from the nasal interface. Since McAuley already teaches vent holes on the elbow of the device, it would be obvious for one of ordinary skill in the art to merely relocate the vent holes to the frame as a simple design choice.
The current McAuley-Allan combination fails to teach a pair of sleeves constructed from a soft and elastic textile material, each of the sleeves having a tubular shape, and each of the rigidiser arms extending through a corresponding one of the sleeves to cushion the patient's face against the rigidiser arms; the side strap portions and the back strap portions are constructed from a textile material.
However, Allan further teaches the side strap portions and the back strap portions are constructed from a textile material (suitable strap materials may include a woven elastic strip or a narrow strip of foam and fabric, such as Breathoprene.TM., for example but without limitation, paragraph 0317; head straps detailed above may be formed of any appropriate material, such as, flexible plastics, silicone, laminated fabrics, or other appropriate materials, paragraph 0539) since it is known for straps to be made of fabric or woven like Breathoprene.TM. (paragraph 0317).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straps to be of a fabric or woven material, as taught by Allan, since it is known for straps to be made of fabric or woven like Breathoprene.TM. (Allan: paragraph 0317).
McAuley-Allan combination fails to teach a pair of sleeves constructed from a soft and elastic textile material, each of the sleeves having a tubular shape, and each of the rigidiser arms extending through a corresponding one of the sleeves to cushion the patient's face against the rigidiser arms.
However, Doherty, of the same field of endeavor, teaches a headgear (Abstract) including a pair of sleeves constructed from a soft and elastic textile material (the sleeve 17 covering the front strap 15 (e.g., constructed of Breath-O-Prene.TM.), paragraph 0220; Breath-O-Prene.TM. is known to be a fabric and elastic material as shown above), each of the sleeves having a tubular shape (17 shown to be tubular in shape, Figs 20-223), and each of the rigidiser arms extending through a corresponding one of the sleeves to cushion the patient's face against the rigidiser arms (17 shown to encompass the rigidiser 80, Figs 22-23) to provide comfort to the patient (paragraph 0220).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the pads for sleeves made of fabric or woven like material like Breathoprene.TM. and have the sleeves wrap around the rigidisers, as taught by Doherty, to provide comfort to the patient (Doherty: paragraph 0220). Since McAuley already teaches the use of pads and the pads being made of similar materials to the straps, it would be obvious to replace those pads with sleeves since it would be an obvious alternative configuration that provides the same comfort to the patient.
Regarding Claim 22, McAuley-Allan-Doherty combination teaches the side strap portions and the back strap portions are constructed from a composite material that includes the textile material and foam (McAuley: the straps are made from a composite foam layered material, such as Breathoprene.TM. paragraph 0077; Allan: suitable strap materials may include a woven elastic strip or a narrow strip of foam and fabric, such as Breathoprene.TM., for example but without limitation, paragraph 0317).
Regarding Claim 23, McAuley-Allan-Doherty combination teaches the first end of the tube is fixed to the frame at the connection port such that in use the tube extends from the frame in an inferior direction relative to the patient in use (McAuley: first end of tubing shown to connect to 301, Figs 20-22; equivalent structure 46, Fig 3; projection 29 forms a socket for the connector end 46 and the connector end can swivel within the socket, paragraph 0073; connector 30 in the preferred form is a ball and socket jointed connector to allow for the tubing 31 to swivel in the mask base 22, the tubing 31 may be attached to either the side straps 37, 38 or merely allowed to fall freely from the nasal mask 2, paragraph 0090; connection between the base and tubing must be able to be flexed or rotated to allow for the tubing to be moved without causing the dislodgement of the nasal mask 2 from the user's nares, paragraph 0091; the tubing is fully capable of extending in an inferior direction relative to the patient due to its ability to swivel and fall freely from the mask). It is noted that Applicant has not claimed how the first end of the tube is fixed to the frame.
Regarding Claim 24, McAuley-Allan-Doherty combination teaches the seal-forming structure is constructed from silicone (McAuley: body and pillows are preferably integrally moulded in a substantially flexible plastics material, in the preferred form this material is silicone, paragraph 0065).
Regarding Claim 25, McAuley-Allan-Doherty combination teaches the seal-forming structure and the plenum chamber are constructed from a single, unitary piece of silicone (McAuley: 305 and the chamber of 305 is shown to be a singular unitary piece, Fig 22; 23 is depicted to have the chamber being part of the interior of 23, Figs 6-7; body and pillows are preferably integrally moulded in a substantially flexible plastics material, in the preferred form this material is silicone, paragraph 0065).
Regarding Claim 26, McAuley-Allan-Doherty combination teaches the plenum connection is structured to be thicker than the seal-forming structure and a remainder of the plenum chamber (McAuley: 24 and 25 are shown to have thinner walls compared to 28, Figs 6-7).
The current McAuley-Allan-Doherty combination fails to explicitly teach the plenum connection is structured to be more rigid than the seal-forming structure and a remainder of the plenum chamber.
However, Allan further teaches the plenum connection is structured to be more rigid than the seal-forming structure and a remainder of the plenum chamber (opening 403 is more thick and rigid compared to the rest of 301 and the chamber of 301, Fig 4C; the opening 403 will be substantially thicker and more rigid than the supple sealing portions of the seal 301, paragraph 0419) to facilitate engagement with the frame (paragraph 0419).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plenum connection to be thicker and more rigid, as taught by Allan, to facilitate engagement with the frame (Allan: paragraph 0419). This improvement ensures the seal or mask body is attached to the frame in the correct spot by keeping its shape while also allowing the nasal pillows to better conform with the patient’s nares. Thus, parts of the seal or mask body have different rigidity depending on what the seal or mask body contacts.
Regarding Claim 28, McAuley-Allan-Doherty combination teaches the seal-forming structure comprises nasal pillows, each of the nasal pillows having a nasal hole configured to provide pressurized gas to a corresponding one of the patient's nares (McAuley: pillows 307 and 306, Fig 22; body 23 is substantially tubular with two nasal pillows 24, 25 extending from it, nasal pillows 24, 25 are preferably frustoconical in shape and in use rest against a patient's nares, to substantially seal the patient's nares, paragraph 0064; nasal pillows 24 and 25 shown to have holes, Figs 6-7).
Regarding Claim 33, McAuley-Allan-Doherty combination teaches the rigidiser arms are connected to the frame separately from the plenum chamber (McAuley: 303 and 304 are connected to 301 and are not directly connected or are separate from the chamber of 305, Fig 22; 303 and 304 are not directly connected to 305, Fig 22). It is noted that Applicant has not further claimed what this separation is.
Regarding Claim 34, McAuley-Allan-Doherty combination teaches the plurality of vent holes includes a group of vent holes positioned on each lateral side of the connection port (Allan: frame has bias flow holes 904 formed about a connector for the conduit, bias flow holes 904 provide gas washout from the interface, paragraph 0377; 904 shown on both sides of 902, Fig 1I).
Regarding Claim 35, McAuley-Allan-Doherty combination teaches the seal-forming structure is configured to leave the patient's mouth uncovered (McAuley: 305 is shown to leave patient’s mouth uncovered, Fig 20; patient interface is a nasal mask 2, paragraph 0064).
Regarding Claim 36, McAuley-Allan-Doherty combination teaches the rigidiser arms are shaped and dimensioned to extend along corresponding ones of the patient's cheeks in use (McAuley: 303 and 304 shown to extend along patient’s cheeks, Fig 20).
Regarding Claim 37, McAuley-Allan-Doherty combination teaches the plenum connection region and the frame are configured such that the plenum connection region is connectable to the frame in only one orientation (McAuley: presence of 47 and its connection to 48 only allows 28 to be connected to the frame 22 in one orientation, Figs 4-7; a projection 47 may be provided on the lip 28 that fits with a corresponding recess or channel on the mask base 22 to ensure correct assembly of the nasal mask, paragraph 0071).
Regarding Claim 38, the current McAuley-Allan-Doherty combination fails to teach the seal-forming structure comprises a pair of thickened sections having a greater thickness than adjacent portions of the seal-forming structure, each of the thickened sections being positioned on a corresponding lateral side of the seal-forming structure, and each of the thickened sections being positioned so as to be proximal to the patient's corresponding nasolabial sulcus when the seal-forming structure engages the patient's face.
However, Allan further teaches the seal-forming structure comprises a pair of thickened sections having a greater thickness than adjacent portions of the seal-forming structure, each of the thickened sections being positioned on a corresponding lateral side of the seal-forming structure, and each of the thickened sections being positioned so as to be proximal to the patient's corresponding nasolabial sulcus when the seal-forming structure engages the patient's face (outer wall portions 413 of the side portions of the seal are substantially thicker than the portions adjacent the nostril locators, paragraph 0442; 413 shown to be thicker than the 401, Figs 4A-4C; seal 301 is shown on a patient and is configured to be proximal to the patient’s nasolabial sulcus, Fig 3A) to provide substantial form to the seal and provides stability with the seal in place (paragraph 0444).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the seal or mask body to have additional thickened sections on both sides of the seal or mask body, as taught by Allan, to provide substantial form to the seal and provides stability with the seal in place (Allan: paragraph 0444). This addition would ensure the seal on the nose is maintained even when under positive pressure.
Regarding Claim 40, McAuley-Allan-Doherty combination teaches the rigidiser arms are permanently connected to the frame (McAuley: the mask base 301 and the curved elongate member 302 are integrally formed, paragraph 0085; mask base 22 may be formed integrally with the curved member 34, paragraph 0084).
Regarding Claim 41, the current McAuley-Allan-Doherty combination fails to teach the rigidiser arms are connected to the frame with a mechanical interlock and without an integral bond.
However, McAuley further teaches the rigidiser arms are connected to the frame with a mechanical interlock and without an integral bond (43 which has 41 is shown to connect to 33, Figs 2-3; a patient merely needs to slide the mask base 22 into the central section 42 such that the raised area 43 fits into the slot 33 on the mask base 22, paragraph 0082) since it is a known form to make the mask base separate from the side arms.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the frame to be separable from the rigidiser arms, as taught by McAuley, since it is a known form to make the mask base separate from the side arms. This modification would make it easier to disassemble the device when not in use and would allow for easier replacement of parts. Additionally, such a modification would be a design choice since McAuley teaches embodiments with both separable and integral components.
Regarding Claim 42, McAuley-Allan-Doherty combination teaches the tube is non-rotatably connected to the frame (McAuley: tubing is shown to be non-rotatably connected to the top back strap, Figs 20-22; 37 is unable to rotate around 22 due to 37 being locked by 44, Fig 2; tubing 31 may be attached to any of the headgear straps, however, a tube attachment 44 is shown where the tubing is attached by fasteners, such as hook and loop fastener, to the first strap 35, paragraph 0090). It is noted that Applicant has not further claimed how the tube is non-rotatably connected to the frame.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (US 2009/0241961 A1), Allan et al. (US 2011/0146685 A1), and Doherty et al. (US 2010/0258136 A1) as applied to Claim 21, and in further view of Smith et al. (US 2012/0204880 A1).
Regarding Claim 27, McAuley-Allan-Doherty combination teaches the claimed invention of Claim 21. McAuley-Allan-Doherty combination also teaches other masks such as oral, full face or nasal cannula may be used (McAuley: paragraph 0060). McAuley-Allan-Doherty combination fails to teach the seal-forming structure consists of a single nasal hole configured to provide pressurized gas to both of the patient's nares.
However, Smith, of the same field of endeavor, teaches a patient interface device (Abstract) including the seal-forming structure consists of a single nasal hole configured to provide pressurized gas to both of the patient's nares (patient interface device 2' according to an alternative embodiment of the present invention that includes cradle style cushion 30, paragraph 0027) since it is known to utilize various forms of mask/cushion styles to accommodate for various facial anatomies (paragraph 0027).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the nasal cushion with a cradle style nasal cushion, as taught by Smith, since it is known to utilize various forms of mask/cushion styles to accommodate for various facial anatomies (Smith: paragraph 0027). Switching from nasal pillows to a cradle style nasal cushion would be an obvious modification since it would merely be dependent on the patient’s needs. Replacing one for the other would not change the operation of the device as both types of cushions would be capable of delivering pressurized gas to the patient.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (US 2009/0241961 A1), Allan et al. (US 2011/0146685 A1), and Doherty et al. (US 2010/0258136 A1) as applied to Claim 21, and in further view of Ng et al. (US 2009/0126739 A1) and Bordewick et al. (US 2007/0277825 A1).
Regarding Claim 29, McAuley-Allan-Doherty combination teaches the claimed invention of Claim 21. McAuley-Allan-Doherty combination also teaches although a ball and socket joint between the mask base 22 and tubing 31 is preferred other connections may be utilised, such as a flexible piece of silicone, or other appropriate connection (McAuley: paragraph 0091). McAuley-Allan-Doherty combination fails to teach the first end of the tube comprises a frame cuff that does not allow the tube to swivel relative to the frame and the second end of the tube comprises a swivel cuff that allows the tube to rotate relative to the air circuit when connected.
However, Ng, of the same field of endeavor, teaches a system of breathing arrangements (Abstract) including the first end of the tube comprises a frame cuff that does not allow the tube to swivel relative to the frame (elbow should be stiff enough to prevent rotation under pressure, a locking or ratcheting mechanism may be implemented to lock the rotation on the elbow when the desired angle is found, locking may be achieved using an interference fit, and/or locking components, such as detents or a pin/groove arrangement, paragraph 0050; the elbow 30 is the frame cuff that locks onto 10, Fig 1) to prevent rotation under pressure and allow better control of the desired angle (paragraph 0050).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elbow at the first end of the tube to have a locking or ratcheting mechanism, as taught by Ng, to prevent rotation under pressure and allow better control of the desired angle (Ng: paragraph 0050). This improvement would still provide the desired swiveling on the device while also allowing better control over the angle of the elbow by locking it into place.
McAuley-Allan-Doherty-Ng combination fails to teach the second end of the tube comprises a swivel cuff that allows the tube to rotate relative to the air circuit when connected.
However, Bordewick, of the same field of endeavor, teaches a respiratory therapy apparatus (Abstract) including the second end of the tube comprises a swivel cuff that allows the tube to rotate relative to the air circuit when connected (130 shown to be at the backend of the conduit 50 and is connected to 30 which is connected to flow generator 20, Fig 1A; the connector 130 may swivel in order to prevent twisting of the delivery tube 30 by the user during sleep, paragraph 0045; connector, in this embodiment, may allow the delivery tube to swivel in order to avoid kinks and twists in the delivery tube while allowing the user interface 40 including the mask 60 to maintain a generally fixed orientation with respect to the user, paragraph 0068) to prevent kinking or twisting of the delivery tube (paragraphs 0045 and 0068).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second end of the tube to have a swivel cuff or connector, as taught by Bordewick, to prevent kinking or twisting of the delivery tube (Bordewick: paragraphs 0045 and 0068). This improvement would be important when the patient is moving from one location to the other or the patient is turning their body as it would prevent the tube from getting twisted or blocked.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (US 2009/0241961 A1), Allan et al. (US 2011/0146685 A1), and Doherty et al. (US 2010/0258136 A1) as applied to Claim 21, and in further view of Formica et al. (US 2011/0197341 A1).
Regarding Claim 30, McAuley-Allan-Doherty combination teaches the claimed invention of Claim 21. McAuley-Allan-Doherty combination fails to teach the upper back strap portion and the lower back strap portion have a different spring constant from the side strap portions.
However, Formica, of the same field of endeavor, teaches a headgear (Abstract) including the upper back strap portion and the lower back strap portion have a different spring constant from the side strap portions (7466 and 7464 are more elastic than 7462 and 7460, Fig 38; bottom and top straps 7464, 7466 may be more elastic or extensible than the crown strap 7462, the rigidizer 7460 may support or position the lower straps of the headgear underneath or out of contact with the patient's ears, paragraph 0146) to prevent the headgear from riding up or translating vertically upwards on the patient’s head and secure the headgear in position (paragraph 0146).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the back strap portions to be more rigid than the side strap portions, as taught by Formica, to prevent the headgear from riding up or translating vertically upwards on the patient’s head and secure the headgear in position (Formica: paragraph 0146). This ensures the headgear is secure to the patient’s head and does not move.
Claims 31 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (US 2009/0241961 A1), Allan et al. (US 2011/0146685 A1), and Doherty et al. (US 2010/0258136 A1) as applied to Claim 21, and in further view of Gunaratnam et al. (US 2002/0096176 A1).
Regarding Claim 31, McAuley-Allan-Doherty combination teaches the claimed invention of Claim 21. McAuley-Allan-Doherty combination also teaches the side straps may attach to the curved member at distal ends of the straps via hook and loop material (McAuley: paragraph 0081) and the side straps folded over around the recesses 313 and 310 (McAuley: Fig 21).
McAuley-Allan-Doherty combination fails to explicitly teach the side strap portions are length- adjustable.
However, Gunaratnam, of the same field of endeavor, teaches a connector arrangement joining a respiratory mask and headgear (Abstract) including the side strap portions are length- adjustable (the four straps are passed through the four corresponding loops and held in place at an appropriate length by the hook and loop material, paragraph 0005) since it is a known way to adjust the length of the strap to ensure a good fit of the mask (paragraph 0005).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize hook and loop material to adjust the length of the side straps, as taught by Gunaratnam, since it is a known way to adjust the length of the strap to ensure a good fit of the mask (Gunaratnam: paragraph 0005). Gunaratnam teaches a typical, well-known mask that has hook and loop material to adjust the length of the straps.
Regarding Claim 39, McAuley-Allan-Doherty combination teaches the claimed invention of Claim 21. McAuley-Allan-Doherty combination also teaches the side straps may attach to the curved member at distal ends of the straps via hook and loop material (McAuley: paragraph 0081) and the side straps folded over around the recesses 313 and 310 (McAuley: Fig 21).
McAuley-Allan-Doherty combination fails to explicitly teach each of the side strap portions comprises an outer layer of loop material and a tab of hook material at end distal from the back strap portions, and the tab of hook material of each side strap portion being configured to releasably attach to the outer layer of loop material of the corresponding side strap portion to connect the side strap portion to the corresponding rigidiser arm.
However, Gunaratnam, of the same field of endeavor, teaches a connector arrangement joining a respiratory mask and headgear (Abstract) including the straps having hook and loop material (the four straps are passed through the four corresponding loops and held in place at an appropriate length by the hook and loop material, paragraph 0005) since it is a known way to adjust the length of the strap to ensure a good fit of the mask (paragraph 0005).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize hook and loop material to adjust the length of the side straps, as taught by Gunaratnam, since it is a known way to adjust the length of the strap to ensure a good fit of the mask (Gunaratnam: paragraph 0005). Gunaratnam teaches a typical, well-known mask that has hook and loop material to adjust the length of the straps.
The current McAuley-Allan-Doherty-Gunaratnam combination fails to teach each of the side strap portions comprises an outer layer of loop material and a tab of hook material at end distal from the back strap portions, and the tab of hook material of each side strap portion being configured to releasably attach to the outer layer of loop material of the corresponding side strap portion to connect the side strap portion to the corresponding rigidiser arm.
However, Allan further teaches a collar strap (collar strap with alternative connection features, Figs 45-49) comprises an outer layer of loop material (4808, Fig 48) and a tab of hook material at end (4804, Fig 48), and the tab of hook material at the end being configured to releasably attach to the outer layer of loop material to connect portions of the collar strap together (outer end portion 4802 may include a short section 4804 of a material with projecting hooks; inner strap end 4806 may include an outwardly-facing section 4808 covered with loops to which the hooks may engage and disengage, paragraph 0560) since this is a known way to adjust the length of the straps using hook and loop fasteners (paragraph 0561).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the side strap portions to have an outer layer of loop material with a tab of hook material at the end, as taught by Allan, since this is a known way to adjust the length of the straps using hook and loop fasteners (Allan: paragraph 0561). McAuley and Gunaratnam already teach on the use of hook and loop fasteners to adjust the length of the straps. Allan merely further details the placement of the hook and loop fasteners on the strap.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (US 2009/0241961 A1), Allan et al. (US 2011/0146685 A1), and Doherty et al. (US 2010/0258136 A1) as applied to Claim 21, and in further view of Busch et al. (US 2013/0008449 A1).
Regarding Claim 32, McAuley-Allan-Doherty combination teaches the claimed invention of Claim 21. McAuley-Allan-Doherty combination also teaches the sides are made to be thinner so that they can be bent and adjusted to provide a better or more comfortable fit (McAuley: paragraph 0079). McAuley-Allan-Doherty combination fails to teach the frame is constructed from a first material and the rigidiser arms are constructed from a second material and that is more flexible than the first material.
However, Busch, of the same field of endeavor, teaches a patient interface device (Abstract) including the frame is constructed from a first material (shell 16 is made of a rigid or semi-rigid material such as, without limitation, polycarbonate or reinforced silicone, paragraph 0015) and the rigidiser arms are constructed from a second material and that is more flexible than the first material (mask attachment portion 24 is made of a rigid or semi-rigid material, such as, without limitation, polycarbonate, reinforced silicone, high consistency silicone rubber (70 shore A and above), EVA copolymer, thermoplastic polyester elastomers (TPC-ET) (suitable examples of which are Hytrel.RTM. sold by DuPont, Riteflex.RTM. sold by Ticona), low-density polyethylene (LDPE), high-density polyethylene (HDPE), and polypropylene (PP), paragraph 0017; strap attachment portion 26 is also made of a rigid or semi-rigid material, such as, without limitation, the rigid or semi-rigid materials described above, and includes slotted or looped portion 34 at a first end thereof that is structured to receive the end of a strap 20, paragraph 0019; flexible linkage portion 28 may be made a material such as, without limitation, a thermoplastic elastomer (TPE), silicone, rubber, silicone rubber, polyurethane (TPU), structural foam, or vinyl (PVC), and may be mechanically bonded to (e.g., by a strong friction fit or an adhesive) or overmolded onto the second ends of mask attachment portion 24 and strap attachment portion 26, paragraph 0020; shell 16 can be made of a rigid material while mask attachment portion 24, strap attachment portion 26, and/or flexible linkage portion 28 are made of semi-rigid or flexible materials) to enable the mask attachment element to flex, bend, and/or twist to conform to particular facial contours of the patient (paragraph 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the arms to be of a more flexible material, as taught by Busch, to enable the mask attachment element to flex, bend, and/or twist to conform to particular facial contours of the patient (Busch: paragraph 0006). Since McAuley already teaches that the sides were meant to be bent or adjusted, Busch would merely further support this motivation through the modification of materials.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (US 2009/0241961 A1), Allan et al. (US 2011/0146685 A1), and Doherty et al. (US 2010/0258136 A1) as applied to Claim 21, and in further view of Ng et al. (US 2009/0126739 A1).
Regarding Claim 42, in the alternative, McAuley-Allan-Doherty combination teaches the claimed invention of Claim 21. McAuley-Allan-Doherty combination fails to teach the tube is non-rotatably connected to the frame.
However, Ng, of the same field of endeavor, teaches a system of breathing arrangements (Abstract) including the tube is non-rotatably connected to the frame (elbow should be stiff enough to prevent rotation under pressure, a locking or ratcheting mechanism may be implemented to lock the rotation on the elbow when the desired angle is found, locking may be achieved using an interference fit, and/or locking components, such as detents or a pin/groove arrangement, paragraph 0050; the elbow 30 is the frame cuff that locks onto 10 and would prevent the tubing of 30 from rotating, Fig 1) to prevent rotation under pressure and allow better control of the desired angle (paragraph 0050).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elbow at the first end of the tube to have a locking or ratcheting mechanism, as taught by Ng, to prevent rotation under pressure and allow better control of the desired angle (Ng: paragraph 0050). This improvement would still provide the desired swiveling on the device while also allowing better control over the angle of the elbow by locking it into place.
Conclusion
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/BRIAN T KHONG/ Examiner, Art Unit 3785
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