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 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.
Claim(s) 1, 4-12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koehler US 2012/0103339 A1.
Regarding claim 1, Koehler discloses an apparatus 9 (fig. 1 and [0068], face mask 9), comprising:
a shell 10 of a respiratory protection device shaped to cover at least the mouth or the external nares of a human user (fig. 1 and [0068], face mask 9 has mask body 10 shaped to receive oral and nasal features of the face); and
one or more inserts 11 embedded in a first side of the shell 10 (fig. 3 and [0074], the moldable member 11 is molded over the peripheral edge 12 of the mask and inserted into fenestrations 13a on each side of the peripheral edge 12; thus, the first side is interpreted as the side facing the wearer when worn, and the moldable member 11 is embedded in the fenestration 13a on the first side),
wherein the one or more inserts 11 are formed of a thermoformable material ([0057], the moldable member is heat-activated thermoplastic), and
wherein the one or more inserts 11 are capable of being heated to a moldable temperature of the thermoformable material and form-fitted to at least a portion of the face of the human user such that the shell creates a seal around at least the mouth or the external nares of the human user ([0059], the heat-activated thermoplastic member extending around the peripheral edge of the mask can be made pliable and molded to the contours of the user’s face to produce a tight fit and reduce air flowing around the periphery).
Regarding claim 4, Koehler discloses the thermoformable material comprising a thermoplastic polymer ([0024], the heat activated material can be a thermoplastic polymer).
Regarding claim 5, Koehler discloses the thermoformable material comprising a low-temperature thermoplastic comprising polycaprolactone (PCL), ethylene-vinyl acetate (EVA), thermoplastic polyurethane (TPU), or a combination thereof ([0024], the heat activated material can be EVA).
Regarding claim 6, Koehler discloses the shell 10 comprising a first portion configured to cover the external nares of the human user and a second portion configured to cover the mouth of the human user, and wherein the first portion has a first width and the second portion has a second width (annotated fig. A below, where the first portion is the upper half of the mask above the horizontal double arrow, and the second portion is the lower half of the mask below the horizontal double arrow; the first width is the width of the upper half at the horizontal division/double arrow, and the second width is the width of the lower half at the horizontal division/double arrow).
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Regarding claim 7, Koehler discloses the first width being the same as the second width (annotated fig. A, the first and second width being the width at which the upper and lower halves meet, and are thus the same).
Regarding claim 8, Koehler discloses the one or more inserts 11 comprising one or more first inserts, and wherein each of the one or more first inserts is embedded in the first and the second portions of the shell 10 ([0069], the peripheral member 11 can extend along 100% of the peripheral edge; thus, in this interpretation, with the peripheral member 11 extending along the entire peripheral edge, annotated fig. A shows the upper portion of the member 11 being interpreted as the first insert, which extends along the first portion and part of the second portion on the left and right sides of shell 10; the path of the first insert is drawn by the solid peripheral double headed arrow).
Regarding claim 9, Koehler discloses the one or more inserts 11 comprising a second insert embedded in only the second portion of the shell 10 (annotated fig. A, the second insert being interpreted as the lower portion of member 11 following the path drawn by the dashed peripheral double headed arrow).
Regarding claim 10, Koehler discloses the one or more first inserts and the second inserts are abutting (annotated fig. A, the paths of the first and second inserts meet at the arrowheads on each of the left and right sides of the mask, such that they are abutting).
Regarding claim 11, Koehler discloses the one or more first inserts and the second inserts being connected (annotated fig. A, the paths of the first and second inserts meet at the arrowheads on each of the left and right sides of the mask, such that they are connected).
Regarding claim 12, Koehler discloses the one or more first inserts are spaced apart from the second insert (annotated fig. B below shows there being vertical space between the first insert and second insert, as the first insert traverses an upper part of the mask while the second insert traverses a lower part).
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Regarding claim 14, Koehler discloses the thermoformable material being moldable at a temperature safe to contact the skin of the human user ([0095], the thermoplastic member is placed in a hot water bath, and after briefly cooling, is applied to the face).
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.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koehler US 2012/0103339 A1 in view of Wiener et al. US 2004/0011363 A1.
Regarding claim 2, Koehler discloses the claimed invention as discussed above.
Koehler is silent on the shell being made of a rigid material, and wherein the rigid material comprises acrylonitrile butadiene styrene, nylon, polycarbonate, polyethylene, polypropylene, or a combination thereof.
However, Wiener teaches a mask shell 12 (fig. 1 and [0040], facepiece 12) being made of a rigid material, and wherein the rigid material comprises acrylonitrile butadiene styrene, nylon, polycarbonate, polyethylene, polypropylene, or a combination thereof ([0040], the facepiece 12 may be polycarbonate and may be rigid).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the semirigid shell of Koehler to be made of a rigid material, and wherein the rigid material comprises acrylonitrile butadiene styrene, nylon, polycarbonate, polyethylene, polypropylene, or a combination thereof, as taught by Wiener, to provide greater structure and durability to the shell.
Regarding claim 3, Koehler discloses the claimed invention as discussed above.
Koehler further discloses the shell 10 being made of a semi-rigid material ([0051], the shell may be semi-rigid).
Koehler is silent on the semi-rigid material comprising silicone, polyurethane, or a combination thereof.
However, Wiener teaches a mask shell 12 (fig. 1 and [0040], facepiece 12) being made of a semi-rigid material comprising silicone, polyurethane, or a combination thereof ([0040], the facepiece 12 may be polyurethane and may be semi-rigid).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the semirigid material of Koehler to be silicone, polyurethane, or a combination thereof, as taught by Wiener, as these materials are known in the art to be durable while still flexible.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koehler US 2012/0103339 A1 in view of Russell US 2,818,861.
Regarding claim 13, Koehler discloses the claimed invention as discussed above.
Koehler is silent on the shell further comprising a metal wire embedded in the first portion.
However, Russell teaches a mask shell 10 (fig. 1 and col. 2, lines 44-45, face piece 10) comprising a metal wire embedded in the first portion (fig. 1 and col. 2, lines 59-65, face piece 10 comprises a malleable metal wire embedded across the nasal section, which is in the upper portion of the mask (i.e., analogous first portion)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the shell of Koehler with a metal wire embedded in the first portion, as taught by Russell, for additional structure across the nose to help support the mask on the face.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koehler US 2012/0103339 A1 in view of Takeuchi et al. US 2020/0071488 A1.
Regarding claim 15, Koehler discloses the claimed invention as discussed above.
Koehler is silent on the thermoformable material having a Young’s modulus from a range of 0.03 GPa to 1 GPa at temperatures of less than 30 deg C.
However, Takeuchi teaches an analogous thermoformable material ([0021], thermoplastic resin which may be polyurethane) having a Young’s modulus from a range of 0.03 GPa to 1 GPa at temperatures of less than 30 deg C ([0021], the thermoplastic resin has an elastic modulus of 0.01-1 GPa at 25 deg C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the thermoformable material of Koehler to have a Young’s modulus from a range of 0.03 GPa to 1 GPa at temperatures of less than 30 deg C, as taught by Takeuchi, to be sufficiently flexible, soft, and comfortable while sealing against the face when the mask is worn.
Claim(s) 1 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niemeyer US 4,951,664 in view of Koehler US 2012/0103339 A1.
Regarding claim 1, Niemeyer disclose an apparatus 10” (fig. 6 and col. 1, lines 11-12), comprising:
a shell 40 of a respiratory protection device 10” shaped to cover at least the mouth or the external nares of a human user (fig. 6 and col. 6, lines 62-65); and
one or more inserts 30”/32” on a first side of the shell 40 (fig. 6 and col. 7, lines 1-11, foam strips 30”/32” form a seal between the mask and face and are thus on the first/inner side of the shell 40).
Niemeyer is silent on the one or more inserts being embedded in the first side of the shell, the one or more inserts being formed of a thermoformable material, and wherein the one or more inserts are capable of being heated to a moldable temperature of the thermoformable material and form-fitted to at least a portion of the face of the human user such that the shell creates a seal around at least the mouth or the external nares of the human user.
However, Koehler teaches an apparatus 9 (fig. 1 and [0068], face mask 9) comprising analogous one or more inserts 11 embedded in the first side of the shell 10 (fig. 3 and [0074], the moldable member 11 is molded over the peripheral edge 12 of the mask and inserted into fenestrations 13a on each side of the peripheral edge 12; thus, the first side is interpreted as the side facing the wearer when worn, and the moldable member 11 is embedded in the fenestration 13a on the first side), wherein the one or more inserts 11 are formed of a thermoformable material ([0057], the moldable member is heat-activated thermoplastic), and wherein the one or more inserts 11 are capable of being heated to a moldable temperature of the thermoformable material and form-fitted to at least a portion of the face of the human user such that the shell creates a seal around at least the mouth or the external nares of the human user ([0059], the heat-activated thermoplastic member extending around the peripheral edge of the mask can be made pliable and molded to the contours of the user’s face to produce a tight fit and reduce air flowing around the periphery).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the one or more inserts of Niemeyer to be embedded in the first side of the shell, the one or more inserts being formed of a thermoformable material, and wherein the one or more inserts are capable of being heated to a moldable temperature of the thermoformable material and form-fitted to at least a portion of the face of the human user such that the shell creates a seal around at least the mouth or the external nares of the human user, as taught by Koehler, so that the inserts are more securely attached to the shell and can be easily molded to the shape of the wearer’s face for enhanced sealing.
Regarding claim 16, Niemeyer in view of Koehler discloses the claimed invention as discussed above.
Niemeyer further discloses the shell 40 having a groove 57 formed on a second side of the shell 40 opposite of the first side of the shell 40 (fig. 7 and col. 7, lines 23-28, the outer edge 57 of opening 56 being a groove on the second/outer side of shell 40), and wherein the apparatus 10” further comprises a filter medium 44 (fig. 6 and col. 7, line 22), the filter medium 44 comprising: a filter material 44; and an edge defining a perimeter around the filter material 44 (fig. 6, the filter layer 44 having a perimeter defined by the edges of the layer), wherein the edge is configured to be inserted into the groove 57 on the second side of the shell 40 (figs. 6 and 7 and col. 7, lines 22-28).
Regarding claims 17 and 18, Niemeyer disclose an apparatus 10” (fig. 6 and col. 1, lines 11-12), comprising:
a shell 40 of a respiratory protection device 10” shaped to cover at least the mouth or the external nares of a human user (fig. 6 and col. 6, lines 62-65); and
one or more inserts 30”/32” on a first side of the shell 40 (fig. 6 and col. 7, lines 1-11, foam strips 30”/32” form a seal between the mask and face and are thus on the first/inner side of the shell 40).
Niemeyer is silent on the one or more inserts being embedded in the first side of the shell, the one or more inserts being formed of a thermoformable material; and a filter medium, the filter medium comprising: a filter material; and an edge defining a perimeter around the filter material, wherein the filter medium is configured to attach to a second side of the shell opposite of the first side of the shell, wherein the edge of the filter medium is configured to be inserted into a groove on the second side of the shell.
However, Koehler teaches an apparatus 9 (fig. 1 and [0068], face mask 9) comprising analogous one or more inserts 11 embedded in the first side of the shell 10 (fig. 3 and [0074], the moldable member 11 is molded over the peripheral edge 12 of the mask and inserted into fenestrations 13a on each side of the peripheral edge 12; thus, the first side is interpreted as the side facing the wearer when worn, and the moldable member 11 is embedded in the fenestration 13a on the first side), wherein the one or more inserts 11 are formed of a thermoformable material ([0057], the moldable member is heat-activated thermoplastic); and a filter medium 44 (fig. 6 and col. 7, line 22), the filter medium 44 comprising: a filter material 44; and an edge defining a perimeter around the filter material 44 (fig. 6, the filter layer 44 having a perimeter defined by the edges of the layer), wherein the filter medium 44 is configured to attach to a second side of the shell 40 opposite of the first side of the shell 40 (fig. 6, the filter 44 is attached on the front/outer side of the shell 40, which is opposite the inner/first side), wherein the edge of the filter medium 44 is configured to be inserted into a groove 57 on the second side of the shell 40 (fig. 7 and col. 7, lines 22-28, the outer edge 57 of opening 56 being a groove on the second/outer side of shell 40, and the filter 44 being inserted on the front/second side as shown in fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the one or more inserts of Niemeyer to be embedded in the first side of the shell, the one or more inserts being formed of a thermoformable material; and a filter medium, the filter medium comprising: a filter material; and an edge defining a perimeter around the filter material, wherein the filter medium is configured to attach to a second side of the shell opposite of the first side of the shell, wherein the edge of the filter medium is configured to be inserted into a groove on the second side of the shell, as taught by Koehler, so that the inserts are more securely attached to the shell and can be easily molded to the shape of the wearer’s face for enhanced sealing.
Regarding claims 19 and 20, Niemeyer disclose an apparatus 10” (fig. 6 and col. 1, lines 11-12), comprising:
a shell 40 of a respiratory protection device 10” shaped to cover at least the mouth or the external nares of a human user (fig. 6 and col. 6, lines 62-65); and
one or more inserts 30”/32” on a first side of the shell 40 (fig. 6 and col. 7, lines 1-11, foam strips 30”/32” form a seal between the mask and face and are thus on the first/inner side of the shell 40).
Niemeyer is silent on the one or more inserts being embedded in the first side of the shell, and a filter medium, the filter medium comprising: a filter material; and an edge defining a perimeter around the filter material, the one or more inserts being formed of a thermoformable material, wherein the one or more inserts are capable of being heated to a moldable temperature of the thermoformable material and form-fitted to at least a portion of the face of the human user such that the shell creates a seal around at least the mouth or the external nares of the human user, wherein the filter medium is configured to attach to a second side of the shell opposite of the first side of the shell.
However, Koehler teaches an apparatus 9 (fig. 1 and [0068], face mask 9) comprising analogous one or more inserts 11 embedded in the first side of the shell 10 (fig. 3 and [0074], the moldable member 11 is molded over the peripheral edge 12 of the mask and inserted into fenestrations 13a on each side of the peripheral edge 12; thus, the first side is interpreted as the side facing the wearer when worn, and the moldable member 11 is embedded in the fenestration 13a on the first side), and a filter medium 44 (fig. 6 and col. 7, line 22), the filter medium 44 comprising: a filter material 44; and an edge defining a perimeter around the filter material 44 (fig. 6, the filter layer 44 having a perimeter defined by the edges of the layer), wherein the one or more inserts 11 are formed of a thermoformable material ([0057], the moldable member is heat-activated thermoplastic), wherein the one or more inserts 11 are capable of being heated to a moldable temperature of the thermoformable material and form-fitted to at least a portion of the face of the human user such that the shell creates a seal around at least the mouth or the external nares of the human user ([0059], the heat-activated thermoplastic member extending around the peripheral edge of the mask can be made pliable and molded to the contours of the user’s face to produce a tight fit and reduce air flowing around the periphery), wherein the filter medium 44 is configured to attach to a second side of the shell 40 opposite of the first side of the shell 40 (fig. 6, the filter 44 is attached on the front/outer side of the shell 40, which is opposite the inner/first side).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the one or more inserts of Niemeyer to be embedded in the first side of the shell, and a filter medium, the filter medium comprising: a filter material; and an edge defining a perimeter around the filter material, the one or more inserts being formed of a thermoformable material, wherein the one or more inserts are capable of being heated to a moldable temperature of the thermoformable material and form-fitted to at least a portion of the face of the human user such that the shell creates a seal around at least the mouth or the external nares of the human user, wherein the filter medium is configured to attach to a second side of the shell opposite of the first side of the shell, as taught by Koehler, so that the inserts are more securely attached to the shell and can be easily molded to the shape of the wearer’s face for enhanced sealing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786