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
Claim 2 is objected to because of the following informalities:
The reference characters “(3100,3130)” and “(100)” should be removed for consistency with the other mentions of the strap and yoke in the claims (Claim 2, Line 4).
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.
Claim 8 is 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 8 states “a pair of the aperture, one of the pair of apertures” (Line 2). This statement is indefinite because it is unclear how a pair can be formed from one aperture. It is also unclear if this is the same aperture as the one mentioned in Claim 2. It appears the applicant was trying to say there are two apertures and one of them is the same as the one mentioned in Claim 2. However, the wording of the claim creates confusion regarding the number of apertures involved and their relation to the aperture in Claim 2. Therefore, the number of apertures involved cannot be determined. For examination purposes, the claim limitation will be interpreted as there are two apertures and one of them is the same as the one in Claim 2.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2-8, 10, 13, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wells et al. (US 2015/0217074 A1).
It is noted that the following rejections below are in relation to the first layer of fabric of Claim 2 corresponding to the inner layer of 3315 and 3316 towards the patient of Wells and the second layer of fabric of Claim 2 corresponding to the outer layer of 3315 and 3316 away from the patient of Wells.
Regarding Claim 2, Wells discloses a headgear assembly (3300, Figs 71-72) for a patient interface (3100 and 3200, Figs 71-72) of a respiratory system (3000, Figs 71-72), wherein the headgear assembly comprises: at least one strap (3317, Figs 71-72; 3317 is made up of two straps 3317a and 3317b, Figs 71-72) to wrap around a user's head (3317 wraps around the user’s head, Figs 71-72); and a yoke (3315 and 3316, Figs 68-72) connected to ends of the at least one strap (3315 and 3316 are connected to the ends of 3317, Figs 71-72), wherein the yoke comprises: a first layer of fabric (inner layer of 3315 and 3316 towards the patient, Figs 68-72; inserting an inextensible rigidiser arm via an opening of a hollow stretchable fabric strap, paragraph 0065; elastic fabric strap 3301 may be slipped over each rigidiser arm 3302 to form the positioning and stabilising structure 3300, paragraph 0546); a second layer of fabric (outer layer of 3315 and 3316 away from the patient, Figs 68-72; inserting an inextensible rigidiser arm via an opening of a hollow stretchable fabric strap, paragraph 0065; elastic fabric strap 3301 may be slipped over each rigidiser arm 3302 to form the positioning and stabilising structure 3300, paragraph 0546); at least one opening (inside openings or cavities of 3315 and 3316, Fig 65) arranged between the first layer of fabric and second layer of fabric (inside openings or cavities of 3315 and 3316 would be arranged between the two layers of fabric, Fig 65); an aperture (3303 and 3304, Fig 65) providing access to each opening (3303 and 3304 provides access to the inside openings or cavities of 3315 and 3316, Fig 65); and one or more loops (loops of 3303 and 3304 made from the outer layer of 3315 and 3316 away from the patient, Fig 65) formed by the second layer of fabric (button- holes 3303, 3304 may be located at the outer surface of strap 3301, paragraph 0423; button holes 3303 and 3304 are on the outer surface of the strap and thus would be formed from the outer layer of 3315 and 3316), wherein at least one of the one or more loops forms the aperture (loops of 3303 and 3304 would inherently form the apertures or holes 3303 and 3304, Fig 65), the aperture configured to receive and hold a retention member (3302, Figs 67-70; 3303 and 3304 are adapted to receive rigidiser arm 3302 in order to insert the rigidiser arm 3302 into the interior of the tube- or sleeve-like strap 3301 or to remove it therefrom, paragraph 0423) or an arm (3302, Figs 67-70) of a frame (3310, Figs 35-59 and 71) of the patient interface (3303 and 3304 are adapted to receive rigidiser arm 3302 in order to insert the rigidiser arm 3302 into the interior of the tube- or sleeve-like strap 3301 or to remove it therefrom, paragraph 0423). It is noted that Applicant has not claimed the two layers of fabric are of different materials, the layers of fabric are of a specific shape or form of layering, or that the yoke is a separate component of a different material from the strap.
Regarding Claim 3, Wells discloses the first layer of fabric substantially extends along the length of the yoke (inner layer of 3315 and 3316 towards the patient extends along the length of 3315 and 3316, Figs 68-72).
Regarding Claim 4, Wells discloses the second layer of fabric substantially extends along the length of the yoke (outer layer of 3315 and 3316 away from the patient extends along the length of 3315 and 3316, Figs 68-72).
Regarding Claim 5, Wells discloses an inner edge of the at least one of the one or more loops forms the aperture (the inner edge of the loops of 3303 and 3304 does form the openings or holes 3303 and 3304 as the inner edge of these loops would form the boundaries of these openings or holes, Fig 65).
Regarding Claim 6, Wells discloses the first layer of fabric and the second layer of fabric are arranged in only some regions of the yoke (the inner and outer layers of 3315 and 3316 only make up a majority of the regions of 3315 and 3316, only the areas within the holes 3303 and 3304 have solely the inner layer of 3315 and 3316, Fig 65).
Regarding Claim 7, Wells discloses the second layer of fabric is arranged at two or more locations along the length of the yoke (outer layer of 3315 and 3316 away from the patient is at multiple locations along the length of 3315 and 3316, Figs 68-72). It is noted that Applicant has not specified if these locations are separate and that there are different layers of fabric in between these locations.
Regarding Claim 8, Wells discloses the yoke comprises a pair of the aperture (3303 and 3304, Fig 65), one of the pair of apertures is provided at each side region of the yoke (3303 is provided at 3315 and 3304 is provided at 3316, Fig 65).
Regarding Claim 10, Wells discloses the first layer of fabric and the second layer of fabric are made of the same material (the strap 3301 may be made of an elastic material, may be made of or comprise any elastomeric material such as elastane, TPE, silicone etc., paragraph 0410; 3301 shown to be made of same material, Fig 66).
Regarding Claim 13, Wells discloses the first layer of fabric and the second layer of fabric are joined together by bonding, welding, stitching, or fusing (the strap 3301 including the side strap portions 3315, 3316 and back strap portion 3317 are made by warp knitting a textile material, paragraph 0412; the strap 3301 may comprise multiple individual straps which are or may be directly connected to one another, for example, stitching or ultrasonic welding, paragraph 0413; Product by Process claim: the product does not depend on its method of production, See MPEP 2113).
Regarding Claim 17, Wells discloses the yoke is at least partially formed from an elastomeric material that allows the yoke to stretch and flex (strap 3301 may be made of an elastic material and may have elastic properties, strap 3301 may be made of or comprise any elastomeric material such as elastane, TPE, silicone etc., paragraph 0410).
Regarding Claim 18, Wells discloses the yoke is dimensioned so that a middle region of the yoke (middle regions of 3315 and 3316, Fig 65) is held under tension when the yoke is attached to the frame (middle regions of 3315 and 3316 would be held under tension since 3315 and 3316 go around the patient’s head when attached to frame 3310, Fig 72; the strap 3301 may be elastically stretched, e.g., by a stretching force applied by the patient and, upon release of the stretching force, returns or contracts to its original length in a neutral state, paragraph 0410).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wells et al. (US 2015/0217074 A1) alone.
In the alternative, regarding Claim 6, Wells discloses the claimed invention of Claim 2. The current embodiment of Wells does not explicitly disclose the first layer of fabric and the second layer of fabric are arranged in only some regions of the yoke.
However, an alternate embodiment of Wells teaches the first layer of fabric and the second layer of fabric are arranged in only some regions of the yoke (two or more button-holes may be provided, 3301 may not be tube-like or sleeve-like but may have a flat single or laminate layer configuration, 3302 may be positioned relative to 3301 by provision of retaining means including one or more loops, sleeve-like portions or pockets provided at outer surface (e.g., the surface facing away from the patient in use) of strap 3301, paragraph 0428; areas within the button-holes would not have the outer layer of 3315 and 3316 and would solely have the inner layer of 3315 and 3316; only areas with the loops, sleeve-like portions, or pockets would have both layers of fabric in a flat laminate layer configuration) since these are known alternative ways to secure an arm to the strap (paragraph 0428).
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 yoke to have multiple button-holes or to be of a flat laminate layer configuration with loops, sleeve-like portions, or pockets only on parts of the outer surface of the yoke, as taught by Wells, since these are known alternative ways to secure an arm to the strap (Wells: paragraph 0428).
Regarding Claim 9, Wells discloses the claimed invention of Claim 2. The current embodiment of Wells does not disclose the one or more loops comprises multiple loops extending across the length of the yoke and providing multiple attachment or anchor points for the respective retention member or arm.
However, an alternate embodiment of Wells teaches the one or more loops comprises multiple loops extending across the length of the yoke and providing multiple attachment or anchor points for the respective retention member or arm (two or more button-holes may be provided, 3301 may not be tube-like or sleeve-like but may have a flat single or laminate layer configuration, 3302 may be positioned relative to 3301 by provision of retaining means including one or more loops, sleeve-like portions or pockets provided at outer surface (e.g., the surface facing away from the patient in use) of strap 3301, paragraph 0428; the rigidiser arm 3302 may be disposed unattached into one or more pockets (e.g., a single open-ended pocket of sheath of appreciable, length supporting the rigidiser arm somewhere in the middle, or a pair of pockets, each supporting a respective end of the rigidiser arm), or a plurality of loops distributed along the length of the strap 3301, paragraph 0429) to control the positioning of the rigidiser arm relative to the strap (paragraph 0428).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add multiple holes or multiple loops on the yoke, as taught by Wells, to control the positioning of the rigidiser arm relative to the strap (Wells: paragraph 0428). This improvement would allow for better adjustment of the arms relative to the straps for various patient heads.
Claims 11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wells et al. (US 2015/0217074 A1) in view of Dunn et al. (US 2014/0209098 A1).
Regarding Claim 11, Wells discloses the claimed invention of Claim 2. Wells also discloses material of the strap 3301 may also represent a combination of any of the above materials with other materials, strap 3301 may comprise or may be made of a textile material such as a woven material, and strap 3301 may be a single layer or multilayer strap (paragraph 0410). Wells further discloses the strap 3301 may not be tube-like or sleeve-like but may have a flat single or laminate layer configuration (paragraph 0428). Wells fails to disclose the first layer of fabric and the second layer of fabric are made of different materials.
However, Dunn, of the same field of endeavor, teaches a headgear (Abstract) including the first layer of fabric and the second layer of fabric are made of different materials (pockets or tunnels may be reinforced with materials having a higher stiffness or rigidity than the knitted textile, thereby rigidizing the headgear, materials used for rigidizing the headgear may include higher stiffness textiles such as braided ropes, paragraph 0128; double knit fabric may also permit a first characteristic or pattern/structure on one side of the fabric with a second characteristic or pattern/structure on the opposite side of the fabric, a soft yarn may be provided on the patient contacting side, and a more durable yarn or construction on the non-patient contacting side, paragraph 0157) to better stabilize the pockets or tunnels of the straps and to provide more comfortability to the patient (paragraph 0128).
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 outer fabric layer to be of a stiffer textile material and/or to modify the inner fabric layer to be of a softer material, as taught by Dunn, to better stabilize the pockets or tunnels of the straps and to provide more comfortability to the patient (Dunn: paragraph 0128). This modification would allow the straps to better conform with the patient by making the straps more comfortable and also provide structural rigidity to the straps.
Regarding Claim 14, Wells discloses the claimed invention of Claim 2. Wells also discloses material of the strap 3301 may also represent a combination of any of the above materials with other materials, strap 3301 may comprise or may be made of a textile material such as a woven material, and strap 3301 may be a single layer or multilayer strap (paragraph 0410). Wells further discloses the strap 3301 may not be tube-like or sleeve-like but may have a flat single or laminate layer configuration (paragraph 0428). Wells fails to disclose the yoke comprises three or more layers of fabric, the three or more layers of fabric comprising the first layer of fabric and the second layer of fabric.
However, Dunn, of the same field of endeavor, teaches a headgear (Abstract) including the yoke comprises three or more layers of fabric (Figs 14-5, 14-6, and 14-6A show at least three layers of fabric), the three or more layers of fabric comprising the first layer of fabric (469-2, Figs 14-5, 14-6, and 14-6A; knitting a pocket layer 469-2 that forms a gap 470-2 (or pocket), paragraph 0166; pockets or tunnels may be reinforced with materials having a higher stiffness or rigidity than the knitted textile, thereby rigidizing the headgear, materials used for rigidizing the headgear may include higher stiffness textiles such as braided ropes, paragraph 0128; double knit fabric may also permit a first characteristic or pattern/structure on one side of the fabric with a second characteristic or pattern/structure on the opposite side of the fabric, a soft yarn may be provided on the patient contacting side, and a more durable yarn or construction on the non-patient contacting side, paragraph 0157) and the second layer of fabric (461-2, 465-2, and/or 463-2, Figs 14-5, 14-6, and 14-6A; spacer fabric provides a soft cushioning between a hard part (e.g., the rigidizer 472-2) and the patient's face, paragraph 0167; the second layer would be part of a stack of multiple layers) to provide further cushioning between the rigidizer and the patient’s face (paragraph 0167).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional layers of fabric on the inner side of the strap, as taught by Dunn, to provide further cushioning between the rigidizer and the patient’s face (Dunn: paragraph 0167).
Regarding Claim 15, the current Wells-Dunn combination fails to explicitly teach the aperture is formed through two or more layers of the three or more layers of fabric.
However, Wells-Dunn combination further teaches the button- holes 3303, 3304 may be located at the inner surface of the strap 3301 (Wells: paragraph 0423), that there is a spacer fabric that provides a soft cushioning between a hard part and the patient's face (Dunn: paragraph 0167), and the pocket layer 469-2 is a single layer on the outer surface of the strap (Dunn: Figs 14-5, 14-6, and 14-6A). One of ordinary skill in the art would be capable of relocating the holes to be on the inner surface of the strap which would require the holes to go through at least two layers of fabric since it is a known alternative configuration (Wells: paragraph 0423) and doing so would not affect the operation of the device.
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 holes to be on the inner layers of the strap, as taught by Wells, since it is a known alternative configuration (Wells: paragraph 0423) and doing so would not affect the operation of the device. It is noted that Applicant admits that having apertures going through two or more layers of fabric is merely to provide access to a pocket opening between deeper layers of the yoke and does not provide any additional, significant benefits (Specification: Page 26, Lines 19-23).
Regarding Claim 16, Wells-Dunn combination teaches the aperture is formed in only the second layer of fabric (Wells: apertures 3303 and 3304 made from the outer layer of 3315 and 3316 away from the patient, Fig 65; Dunn: pocket layer 469-2 is a single layer on the outer surface of the strap, Figs 14-5, 14-6, and 14-6A; the hole would only be required to be formed by a single layer to access the pocket below).
In the alternative, Claims 2-10, 13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wells et al. (US 2015/0217074 A1) alone.
It is noted that the following rejections below are in relation to the first layer of fabric of Claim 2 corresponding to the outer layer of 3315 and 3316 away from the patient of Wells and the second layer of fabric of Claim 2 corresponding to the inner layer of 3315 and 3316 towards the patient of Wells.
In the alternative, regarding Claim 2, Wells discloses a headgear assembly (3300, Figs 71-72) for a patient interface (3100 and 3200, Figs 71-72) of a respiratory system (3000, Figs 71-72), wherein the headgear assembly comprises: at least one strap (3317, Figs 71-72; 3317 is made up of two straps 3317a and 3317b, Figs 71-72) to wrap around a user's head (3317 wraps around the user’s head, Figs 71-72); and a yoke (3315 and 3316, Figs 68-72) connected to ends of the at least one strap (3315 and 3316 are connected to the ends of 3317, Figs 71-72), wherein the yoke comprises: a first layer of fabric (outer layer of 3315 and 3316 away from the patient, Figs 68-72; inserting an inextensible rigidiser arm via an opening of a hollow stretchable fabric strap, paragraph 0065; elastic fabric strap 3301 may be slipped over each rigidiser arm 3302 to form the positioning and stabilising structure 3300, paragraph 0546); a second layer of fabric (inner layer of 3315 and 3316 towards the patient, Figs 68-72; inserting an inextensible rigidiser arm via an opening of a hollow stretchable fabric strap, paragraph 0065; elastic fabric strap 3301 may be slipped over each rigidiser arm 3302 to form the positioning and stabilising structure 3300, paragraph 0546); at least one opening (inside openings or cavities of 3315 and 3316, Fig 65) arranged between the first layer of fabric and second layer of fabric (inside openings or cavities of 3315 and 3316 would be arranged between the two layers of fabric, Fig 65); an aperture (3303 and 3304, Fig 65) providing access to each opening (3303 and 3304 provides access to the inside openings or cavities of 3315 and 3316, Fig 65); and one or more loops (loops of 3303 and 3304 made from the outer layer of 3315 and 3316 away from the patient, Fig 65) formed by the first layer of fabric (button- holes 3303, 3304 may be located at the outer surface of strap 3301, paragraph 0423; button holes 3303 and 3304 are on the outer surface of the strap and thus would be formed from the outer layer of 3315 and 3316), wherein at least one of the one or more loops forms the aperture (loops of 3303 and 3304 would inherently form the apertures or holes 3303 and 3304, Fig 65), the aperture configured to receive and hold a retention member (3302, Figs 67-70; 3303 and 3304 are adapted to receive rigidiser arm 3302 in order to insert the rigidiser arm 3302 into the interior of the tube- or sleeve-like strap 3301 or to remove it therefrom, paragraph 0423) or an arm (3302, Figs 67-70) of a frame (3310, Figs 35-59 and 71) of the patient interface (3303 and 3304 are adapted to receive rigidiser arm 3302 in order to insert the rigidiser arm 3302 into the interior of the tube- or sleeve-like strap 3301 or to remove it therefrom, paragraph 0423). It is noted that Applicant has not claimed the two layers of fabric are of different materials, the layers of fabric are of a specific shape or form of layering, or that the yoke is a separate component of a different material from the strap.
The current embodiment of Wells does not explicitly disclose one or more loops formed by the second layer of fabric.
However, an alternate embodiment of Wells teaches one or more loops formed by the second layer of fabric (the button- holes 3303, 3304 may be located at the inner surface of the strap 3301, paragraph 0423; the loops of the holes 3303 and 3304 would be made of the inner layer of 3315 and 3316) since this is a known, alternative configuration for the holes (paragraph 0423).
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 loops of 3303 and 3304 to be on the inner layer of 3315 and 3316, as taught by Wells, since this is a known, alternative configuration for the holes (Wells: paragraph 0423). Relocating the holes to be on the inner layer would not change the operation of the device and would be an obvious design choice.
Regarding Claim 3, Wells teaches the first layer of fabric substantially extends along the length of the yoke (outer layer of 3315 and 3316 away from the patient extends along the length of 3315 and 3316, Figs 68-72).
Regarding Claim 4, Wells teaches the second layer of fabric substantially extends along the length of the yoke (inner layer of 3315 and 3316 towards the patient extends along the length of 3315 and 3316, Figs 68-72).
Regarding Claim 5, Wells teaches an inner edge of the at least one of the one or more loops forms the aperture (the button- holes 3303, 3304 may be located at the inner surface of the strap 3301, paragraph 0423; the inner edge of the loops of 3303 and 3304 does form the openings or holes 3303 and 3304 as the inner edge of these loops would form the boundaries of these openings or holes).
Regarding Claim 6, Wells teaches the first layer of fabric and the second layer of fabric are arranged in only some regions of the yoke (the inner and outer layers of 3315 and 3316 only make up a majority of the regions of 3315 and 3316, only the areas within the holes 3303 and 3304 have solely the outer layer of 3315 and 3316).
In the alternative, regarding Claim 6, Wells teaches the claimed invention of Claim 2. The current embodiment of Wells does not teach the first layer of fabric and the second layer of fabric are arranged in only some regions of the yoke.
However, an alternate embodiment of Wells teaches the first layer of fabric and the second layer of fabric are arranged in only some regions of the yoke (two or more button-holes may be provided, 3301 may not be tube-like or sleeve-like but may have a flat single or laminate layer configuration, 3302 may be positioned relative to 3301 by provision of retaining means including one or more loops, sleeve-like portions or pockets provided at outer surface (e.g., the surface facing away from the patient in use) of strap 3301, paragraph 0428; areas within the button-holes would not have the outer layer of 3315 and 3316 and would solely have the inner layer of 3315 and 3316; only areas with the loops, sleeve-like portions, or pockets would have both layers of fabric in a flat laminate layer configuration) since these are known alternative ways to secure an arm to the strap (paragraph 0428).
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 yoke to have multiple button-holes or to be of a flat laminate layer configuration with loops, sleeve-like portions, or pockets only on parts of the inner surface of the yoke, as taught by Wells, since these are known alternative ways to secure an arm to the strap (Wells: paragraph 0428).
Regarding Claim 7, Wells teaches the second layer of fabric is arranged at two or more locations along the length of the yoke (inner layer of 3315 and 3316 towards the patient is at multiple locations along the length of 3315 and 3316, Figs 68-72). It is noted that Applicant has not specified if these locations are separate and that there are different layers of fabric in between these locations.
Regarding Claim 8, Wells teaches the yoke comprises a pair of the aperture (3303 and 3304, Fig 65), one of the pair of apertures is provided at each side region of the yoke (3303 is provided at 3315 and 3304 is provided at 3316, Fig 65; the button- holes 3303, 3304 may be located at the inner surface of the strap 3301, paragraph 0423).
Regarding Claim 9, Wells teaches the claimed invention of Claim 2. The current embodiment of Wells does not teach the one or more loops comprises multiple loops extending across the length of the yoke and providing multiple attachment or anchor points for the respective retention member or arm.
However, an alternate embodiment of Wells teaches the one or more loops comprises multiple loops extending across the length of the yoke and providing multiple attachment or anchor points for the respective retention member or arm (two or more button-holes may be provided, 3301 may not be tube-like or sleeve-like but may have a flat single or laminate layer configuration, 3302 may be positioned relative to 3301 by provision of retaining means including one or more loops, sleeve-like portions or pockets provided at outer surface (e.g., the surface facing away from the patient in use) of strap 3301, paragraph 0428; the rigidiser arm 3302 may be disposed unattached into one or more pockets (e.g., a single open-ended pocket of sheath of appreciable, length supporting the rigidiser arm somewhere in the middle, or a pair of pockets, each supporting a respective end of the rigidiser arm), or a plurality of loops distributed along the length of the strap 3301, paragraph 0429) to control the positioning of the rigidiser arm relative to the strap (paragraph 0428).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add multiple holes or multiple loops on the yoke, as taught by Wells, to control the positioning of the rigidiser arm relative to the strap (Wells: paragraph 0428). This improvement would allow for better adjustment of the arms relative to the straps for various patient heads.
Regarding Claim 10, Wells teaches the first layer of fabric and the second layer of fabric are made of the same material (the strap 3301 may be made of an elastic material, may be made of or comprise any elastomeric material such as elastane, TPE, silicone etc., paragraph 0410; 3301 shown to be made of same material, Fig 66).
Regarding Claim 13, Wells teaches the first layer of fabric and the second layer of fabric are joined together by bonding, welding, stitching, or fusing (the strap 3301 including the side strap portions 3315, 3316 and back strap portion 3317 are made by warp knitting a textile material, paragraph 0412; the strap 3301 may comprise multiple individual straps which are or may be directly connected to one another, for example, stitching or ultrasonic welding, paragraph 0413; Product by Process claim: the product does not depend on its method of production, See MPEP 2113).
Regarding Claim 17, Wells teaches the yoke is at least partially formed from an elastomeric material that allows the yoke to stretch and flex (strap 3301 may be made of an elastic material and may have elastic properties, strap 3301 may be made of or comprise any elastomeric material such as elastane, TPE, silicone etc., paragraph 0410).
Regarding Claim 18, Wells teaches the yoke is dimensioned so that a middle region of the yoke (middle regions of 3315 and 3316, Fig 65) is held under tension when the yoke is attached to the frame (middle regions of 3315 and 3316 would be held under tension since 3315 and 3316 go around the patient’s head when attached to frame 3310, Fig 72; the strap 3301 may be elastically stretched, e.g., by a stretching force applied by the patient and, upon release of the stretching force, returns or contracts to its original length in a neutral state, paragraph 0410).
In the alternative, Claims 11, 12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wells et al. (US 2015/0217074 A1) in view of Dunn et al. (US 2014/0209098 A1).
Regarding Claim 11, Wells teaches the claimed invention of Claim 2. Wells also teaches material of the strap 3301 may also represent a combination of any of the above materials with other materials, strap 3301 may comprise or may be made of a textile material such as a woven material, and strap 3301 may be a single layer or multilayer strap (paragraph 0410). Wells further teaches the strap 3301 may not be tube-like or sleeve-like but may have a flat single or laminate layer configuration (paragraph 0428). Wells fails to teach the first layer of fabric and the second layer of fabric are made of different materials.
However, Dunn, of the same field of endeavor, teaches a headgear (Abstract) including the first layer of fabric and the second layer of fabric are made of different materials (pockets or tunnels may be reinforced with materials having a higher stiffness or rigidity than the knitted textile, thereby rigidizing the headgear, materials used for rigidizing the headgear may include higher stiffness textiles such as braided ropes, paragraph 0128; double knit fabric may also permit a first characteristic or pattern/structure on one side of the fabric with a second characteristic or pattern/structure on the opposite side of the fabric, a soft yarn may be provided on the patient contacting side, and a more durable yarn or construction on the non-patient contacting side, paragraph 0157) to better stabilize the pockets or tunnels of the straps and to provide more comfortability to the patient (paragraph 0128).
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 outer fabric layer to be of a stiffer textile material and/or to modify the inner fabric layer to be of a softer material, as taught by Dunn, to better stabilize the pockets or tunnels of the straps and to provide more comfortability to the patient (Dunn: paragraph 0128). This modification would allow the straps to better conform with the patient by making the straps more comfortable and also provide structural rigidity to the straps.
Regarding Claim 12, Wells-Dunn combination teaches the second layer of fabric is softer than the first layer of fabric (Dunn: pockets or tunnels may be reinforced with materials having a higher stiffness or rigidity than the knitted textile, thereby rigidizing the headgear, materials used for rigidizing the headgear may include higher stiffness textiles such as braided ropes, paragraph 0128; double knit fabric may also permit a first characteristic or pattern/structure on one side of the fabric with a second characteristic or pattern/structure on the opposite side of the fabric, a soft yarn may be provided on the patient contacting side, and a more durable yarn or construction on the non-patient contacting side, paragraph 0157; the outer layer would be made of a stiffer material since it would be reinforcing the pocket, opening, or sleeve of the strap and would not be contacting the patient and the inner layer would be made of a softer material since it would be provided on the contacting side of the patient).
Regarding Claim 14, Wells teaches the claimed invention of Claim 2. Wells also teaches material of the strap 3301 may also represent a combination of any of the above materials with other materials, strap 3301 may comprise or may be made of a textile material such as a woven material, and strap 3301 may be a single layer or multilayer strap (paragraph 0410). Wells further teaches the strap 3301 may not be tube-like or sleeve-like but may have a flat single or laminate layer configuration (paragraph 0428). Wells fails to teach the yoke comprises three or more layers of fabric, the three or more layers of fabric comprising the first layer of fabric and the second layer of fabric.
However, Dunn, of the same field of endeavor, teaches a headgear (Abstract) including the yoke comprises three or more layers of fabric (Figs 14-5, 14-6, and 14-6A show at least three layers of fabric), the three or more layers of fabric comprising the first layer of fabric (469-2, Figs 14-5, 14-6, and 14-6A; knitting a pocket layer 469-2 that forms a gap 470-2 (or pocket), paragraph 0166; pockets or tunnels may be reinforced with materials having a higher stiffness or rigidity than the knitted textile, thereby rigidizing the headgear, materials used for rigidizing the headgear may include higher stiffness textiles such as braided ropes, paragraph 0128; double knit fabric may also permit a first characteristic or pattern/structure on one side of the fabric with a second characteristic or pattern/structure on the opposite side of the fabric, a soft yarn may be provided on the patient contacting side, and a more durable yarn or construction on the non-patient contacting side, paragraph 0157) and the second layer of fabric (461-2, 465-2, and/or 463-2, Figs 14-5, 14-6, and 14-6A; spacer fabric provides a soft cushioning between a hard part (e.g., the rigidizer 472-2) and the patient's face, paragraph 0167; the second layer would be part of a stack of multiple layers) to provide further cushioning between the rigidizer and the patient’s face (paragraph 0167).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add additional layers of fabric on the inner side of the strap, as taught by Dunn, to provide further cushioning between the rigidizer and the patient’s face (Dunn: paragraph 0167).
Regarding Claim 15, Wells-Dunn combination teaches the aperture is formed through two or more layers of the three or more layers of fabric (Wells: the button- holes 3303, 3304 may be located at the inner surface of the strap 3301, paragraph 0423; Dunn: a spacer fabric that provides a soft cushioning between a hard part and the patient's face, paragraph 0167; the pocket layer 469-2 is a single layer on the outer surface of the strap, Figs 14-5, 14-6, and 14-6A; since the holes are on the inner surface, the holes would go through two layers to reach the pocket or opening or sleeve of the strap). It is noted that Applicant admits that having apertures going through two or more layers of fabric is merely to provide access to a pocket opening between deeper layers of the yoke and does not provide any additional, significant benefits (Specification: Page 26, Lines 19-23).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including:
US 20110197341 A1 discusses straps with different types of layering.
US 20100000544 A1 discusses straps with multiple layers of fabric.
US 20100258136 A1 discusses straps with different ways to cover a rigid arm.
US 20140026890 A1 discusses straps with holes and openings for insertion of a rigid arm.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN THAI-BINH KHONG whose telephone number is (571)272-1857. The examiner can normally be reached Monday to Thursday 9:00 am-6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN T KHONG/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785