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 .
Status of Claims
This office action is in response to the filing of the application on 10/31/2023 Since the initial filing, claims 1-21 have been canceled and claims 22-37 have been added. Thus claims 22-37 are pending in the application.
Claim Objections
The claim is objected to because of the following informalities:
Claim 29 read ”includes a boarder both sides” and should read –includes a boarder along both sides—
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 29 and 31 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.
Regarding claim 29, the limitation ”periphery of the lapped region includes a border along both sides of a perimeter”, it is unclear if the Applicant is meaning to claim that the periphery of the lapped region has a border along its perimeter or if the Applicant is meaning to claim that the periphery of the unlapped region includes a boarder along both sides of the perimeter of the lapped region. For examination purposes, the claim will be interpreted as the unlapped region including a boarder along both sides of the lapped region.
Regarding claim 31, the limitation presented by the term “substantially” in is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, “substantially” will be defined as more than half; for example- more than half of material A is being covered by material B, therefore; material B is substantially covered by material A.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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.
Claims 22-31 are rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe et al. (US 20040112377 A1) as applied to the claims above, and further in view of Dua et al. (US 20180169963 A1).
Regarding claim 22, A rear portion (rear portion 20, FIG 4) for a headgear (Amarasinghe, headgear assembly 16, FIG 4) for a patient interface, the rear portion comprising:
a first textile panel (Amarasinghe, material A, FIG 7); and
a second textile panel (Amarasinghe, stiffener 46, FIG 7) the first textile panel and the second textile panel defining a lapped region (Amarasinghe, area covered by stiffener 46, FIG 5) in which the first textile panel and the second textile panel respectively overlap and underlap each other and a non-lapped region (Amarasinghe, area not covered by stiffener 46, FIG 5) in which the first textile panel is not lapped
wherein at the lapped region, adjacent surfaces of the first textile panel and the second textile panel are fused together (Amarasinghe, [0040] details how the stiffener and material A are joined through “adhesives, stitching, or other known attachment mechanisms or by semi-permanent means such as velcro, pocket sleeve, etc” ).
Amarasinghe fails to disclose the attachment of the stiffener 46 to material A through fusion via alternative means, i.e. not through stitching or adhesive.
However, Dua teaches how to fuse woven fabrics together to create fabric that has better properties together rather than it had as an individual piece ([0003]). The textiles can be combined into a singular material through the use of melting and cooling, compression, stitch binding, etc ([0096]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mask straps of Amarasinghe to have material A fused with the stiffener 46 through common textile fusion methods (such as compression, melting/cooling, stitch binding, etc) in order to have a backing for a mask that is more durable, stretch resistance and permeable. These properties allow the mask to be used multiple times without deteriorating as well as provide comfort for the user and ease of sterilization for the medical professional (Dua, [0003]).
Regarding claim 23, the modified rear portion of Amarasinghe has the adjacent surfaces of the first textile panel and the second textile panel at the lapped region are fused directly to each other without any interposed material (Amarasinghe, [0040] “As shown in FIG. 5, the stiffener 46 is secured to the straps 34, 36 by stitching around the periphery of the stiffener 46”). Utilizing the stiffener and material A depicted in Amarasinghe FIG 5, one can verify there is no interposed material in between the two materials as they are stitched together. Additionally, Dua teaches how fusing textiles together requires the two materials to be in contact with each other with no other material in-between.
Regarding claim 24, the modified rear portion of Amarasinghe has the lapped region comprises a fused portion and a non-fused portion. As stated above, fusing material provides the strap portion of the mask greater permeability, durability, and stretch-resistance. Dua also teaches that the use of fused and non-fused sections of a fabric can provide varying results of the before mentioned abilities; allowing the manufacturer to manipulate the amount of fused and unfused areas of the textile in order to have the mask provide the specific properties the manufacture prefers. (ie. More fused placed- less elasticity; less fused- more elasticity. Dua, [0084]) Depicted in FIG 6, the stiffener 46 is attached with the material A of the rear portion of the headgear assembly (Amarasinghe, [0040] “ As shown in FIG. 6, the stiffener 46 is secured to the straps by stitching an intermediate portion of the stiffener 46”). With the combination f Dua fusion ins replacement of Amarasinghe’s stitching, the stiffener 46 is then fused with the straps.
Regarding claim 25, the modified rear portion of Amarasinghe has the lapped region comprises a transition zone between a fused portion and a non-fused portion, the transition zone defining a degree of fusion between that of the non-fused portion and the fused portion, and the transition zone comprises a gradient of degrees of fusion between that of the fused portion and the non-fused portion. Dua teaches the fusion methods of above as well as fusion material through a differing degree of fusion between one material and the other. This allows the degree attachment of the rear portion to be manipulated for comfort (i.e. thicker for more comfort when laying down, or thinner for more elasticity) or for greater stretch resistance noted in paragraph [0086]. (Dua, FIG 6, [0076] “Accordingly, one material (i.e., non-woven textile 100) may be used throughout the shirt, but by fusing different areas to different degrees, the properties may be advantageously-varied in different areas of the shirt).
Regarding claim 26, the modified rear portion of Amarasinghe has the rear portion comprises different stretch properties at each of:
(a) a fused portion of the lapped region,
(b) a non-fused portion of the lapped region, and
(c) the non-lapped region of the first textile panel. (Amarasinghe,[0047] “The reduced width of strap 28 allows it to stretch over the fatter lower neck, that is, there is a different stretch between strap 36 and strap 28”) Dua in turn states, [0083] “the fused and non-fused portions of the textile will have a varying degree of properties”. This allows the breathability and elasticity to be manipulated to the degree needed by the used. It would therefore be that each region whether fused or non-fused, lapped or non-lapped, would have different properties due to the material interactions.
Regarding claim 27, the modified rear portion of Amarasinghe has adjacent surfaces of the first textile panel and the second textile panel about a periphery of the lapped region are fused together (Amarasinghe [0040] “As shown in FIG. 5, the stiffener 46 is secured to the straps 34, 36 by stitching around the periphery of the stiffener 46”). Depicted in Amarasinghe FIG 5, the stiffener 46 is attached with the material A of the rear portion of the headgear assembly. Amarasinghe FIG 5, teaches the stitching to go around the perimeter of the stiffener 46 in order to attach it to the material A. Using the method of fusion that Dua teaches and following along the path of the stitching, Amarasinghe’s material A and the stiffener 46 can be fused along the periphery of the lapped region.
Regarding claim 28, the modified rear portion of Amarasinghe has the second textile panel is fully lapped by the first textile panel, and the adjacent surfaces of the first textile panel and the second textile panel are fused together about a whole periphery of the second textile panel (Amarasinghe [0040] “As shown in FIG. 5, the stiffener 46 is secured to the straps 34, 36 by stitching around the periphery of the stiffener 46”). Depicted in Amarasinghe FIG 5, the stiffener 46 is attached with the material A of the rear portion of the headgear assembly. Using the method of fusion that Dua teaches and following along the path of the stitching, Amarasinghe’s material A and the stiffener 46 can be fused along the about a whole periphery of the of the stiffener 46.
Regarding claim 29, the modified rear portion of Amarasinghe has a periphery of the lapped region includes a border both sides of a perimeter of the unlapped region. As depicted in FIG 5, there is a slight border where the stitching of the stiffener misses. This boarder is there to allow for machine error and/or to encompasses a smaller or larger desired fused portion of material A and the stiffener. (Amarasinghe, [0040] “As shown in FIG. 5, the stiffener 46 is secured to the straps 34, 36 by stitching around the periphery of the stiffener 46”).
Regarding claim 30, the modified rear portion of Amarasinghe has the first textile panel and the second textile panel at the lapped region are continuously fused together across the lapped region between two or more points about the perimeter of the lapped region. (Amarasinghe [0040] “As shown in FIG. 5, the stiffener 46 is secured to the straps 34, 36 by stitching around the periphery of the stiffener 46”). Depicted in Amarasinghe FIG 5, the stiffener 46 is attached with the material A of the rear portion of the headgear assembly. Using the method of fusion that Dua teaches and following along the path of the stitching, Amarasinghe’s material A and the stiffener 46 can be fused along the about a whole periphery of the of the stiffener 46 through the process by Dua. Thus, the material A and the stiffener 46 would be fused a more than one point along the perimeter.
Regarding claim 31, the modified rear portion of Amarasinghe has the first textile panel and the second textile panel are fused together at a substantial entirety of the lapped region. (Amarasinghe [0040] “As shown in FIG. 5, the stiffener 46 is secured to the straps 34, 36 by stitching around the periphery of the stiffener 46”). Depicted in Amarasinghe FIG 5, the stiffener 46 is attached with the material A of the rear portion of the headgear assembly. Using the method of fusion that Dua teaches and Amarasinghe’s material A and stiffener 46 can be fused along a portion of the lapped region or part of the area covered by the stiffener 46 rather than or in addition to the attachment method depicted via stitching.
Claims 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe et al. (US 20040112377 A1) and Dua et al. (US 20180169963 A1) as applied to the claims above, and further in view of McLauren et al (DE 112014004759 T5).
Regarding claim 32, Amarasinghe discloses the modified rear portion of the device of claim 22.
However, Amarasinghe is silent on the non-lapped region being provided at a lower periphery of the rear portion along one or more curved portions of the lapped region.
McLauren teaches a headgear assembly that comprises of multiple straps connected to a backing that goes around the user’s head for the attachment of an oxygen mask. The design of this headgear includes a backing portion (FIG 23, P5) that has a curved portion (FIG 23, bottom edge 46) that connects to the two lower straps of the assembly. This curved portion (FIG 23, bottom edge 46) allows for the rear portion of the headgear to fit snuggly along the curve of the user’s neck; providing a more comfortable wearing experience for the user.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to design the modified rear portion of Amarasinghe device to have a curved lower portion as to allow the user a better comfortable strapping system. The stiffener 46 within Amarasinghe’s device is easily added to the curved portion (fig 23, bottom edge 46) of McLauren’s fig 23. As P5 has extra space and will easily fit the addition of a stiffener or alternatively the device of Amarasinghe can easily change the bottom strap 28 in FIG 4 to be a single curved portion instead of its current small curved sections R12 and then a straight section under the stiffener 46. As comfort is the main object of the device of both McLauren and Amarasinghe, the combination of the curved portion and the stiffener would be highly beneficial for the usability of the device.
Regarding claim 33, the modified rear portion of Amarasinghe has the non-lapped region at the lower periphery of the rear portion comprises a varying width. As depicted in Amarasinghe [0048] and FIG 8, the straps of the headgear interface rear portion are all set with varying widths. The lower end portion 24 being a range of 16-23mm, preferably 19 mm. and the lower side strap being a ranged width of 17-23 mm, preferably 20 mm. Thus, the lower periphery of the rear portion of the interface have varying width in comparison to the non-lapped region.
Regarding claim 34, Amarasinghe discloses the modified rear portion of the device of claim 32 wherein the non-lapped region at the lower periphery of the rear portion comprises an edge with a radius of curvature less than that of an adjacent curved portion of the lapped region.
McLauren teaches a headgear assembly that comprises of multiple straps connected to a backing that goes around the user’s head for the attachment of an oxygen mask. The design of this headgear includes a backing portion (FIG 23, P5) that has a curved portion (FIG 23, bottom edge 46) that connects to the two lower straps of the assembly. The curvature of the bottom strap having a lower radial curvature then the adjacent curves of the rear portion. The curved sides of P5 being greater as to extend along the shape of the cranium to the top straps of the headgear. This curved portion’s lower radial curvature allows for the rear portion of the headgear to fit snuggly along the curve of the user’s neck; providing a more comfortable wearing experience for the user.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to design the modified rear portion of Amarasinghe device to have a curved lower portion as to allow the user a better comfortable strapping system. The stiffener 46 within Amarasinghe’s device is easily added to the curved portion (fig 23, bottom edge 46) of McLauren’s fig 23. As P5 has extra space and will easily fit the addition of a stiffener or alternatively the device of Amarasinghe can easily change the bottom strap 28 in FIG 4 to be a single curved portion instead of its current small curved sections R12 and then a straight section under the stiffener 46. The Curvature along its bottom strap being of lower radius comparted to the angle showed by the lower straps 34 connection points to the upper strap 32, depicted in FIG 8. As comfort is the main object of the device of both McLauren and Amarasinghe, the combination of the curved portion and the stiffener would be highly beneficial for the usability of the device.
Regarding claim 35, Amarasinghe discloses the modified device of claim 34
However, Amarasinghe is silent on the non-lapped region at the lower periphery of the rear portion defining one or more crescent shapes.
McLauren teaches a headgear assembly that comprises of multiple straps connected to a backing that goes around the user’s head for the attachment of an oxygen mask. The design of this headgear includes a backing portion (FIG 23, P5) that has a curved portion (FIG 23, bottom edge 46) that connects to the two lower straps of the assembly; this curved portion can be additionally defined instead as a crescent shape. This curved portion (FIG 23, bottom edge 46) allows for the rear portion of the headgear to fit snuggly along the curve of the user’s neck; providing a more comfortable wearing experience for the user.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to design the modified rear portion of Amarasinghe device to have a curved lower portion as to allow the user a better comfortable strapping system. The stiffener 46 within Amarasinghe’s device is easily added to the curved portion (fig 23, bottom edge 46) or otherwise seen as the crescent shape of the lower strap of McLauren’s fig 23. As P5 has extra space and will easily fit the addition of a stiffener or alternatively the device of Amarasinghe can easily change the bottom strap 28 in FIG 4 to be a crescent shape instead of its current small curved sections R12 and then a straight section under the stiffener 46. As comfort is the main object of the device of both McLauren and Amarasinghe, the combination of the crescent shaped bottom strap and the stiffener would be highly beneficial for the usability of the device.
Claims 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe et al. (US 20040112377 A1) and Dua et al. (US 20180169963 A1) as applied to the claims above, and further in view of Formica et al. (WO 2010066004 A1).
Regarding claim 36, Amarasinghe discloses the modified device of claim 34, wherein the rear portion (Amarasinghe, rear portion 20) comprises a central section (Amarasinghe, central section, Annotated FIG 1) comprising laterally spaced strap connection portions (Amarasinghe, hook material 44/material B, FIG 4, FIG 7), and wherein the non-lapped region is a first non-lapped region and is located between the laterally spaced strap connection portions of the central section. As detailed in Amarasinghe [0035-0036] and illustrated in FIG 4, the rear portion of the headgear assembly contained 2 upper and lower straps on either side of the central portion of the rear portion.
Amarasinghe is silent on having two connection portions on either side of the lateral strap wherein one of the lateral connection portions attaches to the central portion of the headgear assembly.
Formica teaches of a headband for an oxygen mark system. Within his iterations FIG 10-13, he describes a mask system where the lower strap contains dual connectors on either end allowing the lower strap to be adjustable around both the headband headgear system as well as around the oxygen mark attachment.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to design the modified device of Amarasinghe to allow for an additional level of adjustability through an additional attachment along the lower straps of the headgear interface. This adjustability allows the user to tighten the headgear interface around the base of the neck and head instead of just around the mask portion of the device, giving the user a much-needed avenue for comfort.
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Annotated Figure 1
Regarding claim 37, Amarasinghe discloses the modified device of claim 36 wherein the rear portion comprises lateral sections either side of the central section, each lateral section comprising a strap connection portion at a lateral extent thereof, and wherein the rear portion comprises a second non-lapped region located at a lateral peripheral edge of the rear portion between each strap connection portion of the lateral sections and a respective strap connection portion of the central section. As detailed in Amarasinghe [0035-0036] and illustrated in FIG 4, the rear portion of the headgear assembly contained 2 upper and lower straps on either side of the central portion of the rear portion. Both straps are said to have hook and loop connectors at the tip allowing the straps to go around a mouth piece for oxygen consumption. ([0036] “As shown in FIG. 4, the free end of each upper and lower strap 22, 24 includes a strip of hook material 44 attached thereto by stitching, for example. The upper and lower straps 22, 24 are constructed of a loop material that engages the strip of hook material 44 when the upper and lower straps 22, 24 are connected to the frame 12”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B RESTAINO whose telephone number is (571)272-8697. The examiner can normally be reached Mon-Fri 8:00AM - 5:00PM.
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/DANIELLE B RESTAINO/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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