DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. This office action is responsive to the amendment filed on March 13, 2026. As directed by the amendment: claims 46 and 48-49 have been amended, no claims have been cancelled, and claims 71-82 have been added. Thus, claims 46-82 are presently pending in the application.
Claim Objections
3. Claims 58, 71, 78, and 80 objected to because of the following informalities:
Claims 58 and 78 recite “the reduced stiffness portion comprises a front wall having a height of at least about” in lines 1-2. It is suggested to change this to –the height of the front wall is at least about—to avoid issues with antecedent basis due to a front wall and height being previously defined in claims 46 and 75 respectively.
Claims 71 and 80 recites “wherein the height is less than or equal to 7.7 mm” in lines 1-2. It is suggested to change this to –wherein the height is between 6 mm and 7.7 mm—to avoid potential indefinite issues regarding the lower bound of the height of the front wall which is previously defined as “at least 6 mm” in claims 46 and 75 respectively.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 46-74 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.
Regarding claims 46 and 48-49, the limitation “a supported seal” in line 2 of claims 46 and 48-49 is suggested to be changed to –a seal supported by the seal housing—to avoid issues with antecedent basis due to reference of “the seal supported by the seal housing” in line 5.
Regarding claims 47-74, they are rejected on the basis that they are dependent on a rejected claim.
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. Claim(s) 46-47, 52-59, 61-65, 71-82 are rejected under 35 U.S.C. 103 as being unpatentable over Bearne et al. (WO 2012140514).
Regarding claim 46, Bearne discloses
a cushion module for a respiratory interface (fig. 2, mask assembly 102), comprising:
a seal housing (fig. 11, mask seal clip 112) constructed from a material more rigid than a supported seal (see paragraph [0090] which states 112 is relatively more rigid than mask seal 110), the seal housing defining an aperture (fig. 10, central passage 144) configured to allow a breathing gas to enter an interior of the cushion module (see paragraph [0127] which states a wall of the opening receives an elbow which functions as an air conduit according to [0030]); and
the seal (fig. 3, mask seal 110) supported by the seal housing ([0090] states mask seal clip 112 provides support to mask seal 110) and having an upper portion and a lower portion (fig. 3, upper portion 154 and lower portion 156), the seal further comprising a face contacting surface configured to contact a face of a user (fig. 10, face contacting flange 160) and create at least a substantial seal with the face of the user ([0100] states mask seal 110 will seal against the face of the user with air supply), the face contacting surface having an inner edge defining an opening in the face contacting surface (fig. 10, tear-drop shaped opening 162),
wherein the upper portion of the seal comprises a reduced stiffness portion (figs. 12A-12D, reduced stiffness region 172) defined between a first boundary (see annotated fig. 12A below where a first boundary is defined at the increased thickness portion under band 174) and a second boundary (see annotated fig. 12A below where a where boundary is defined at lip 124) such that the reduced stiffness portion deforms in response to forward movement of an upper portion of the face contacting surface (see figs. 12A-12D), wherein the first boundary is positioned between the face contacting surface and the reduced stiffness portion (see annotated fig. 12A below where the first boundary is between the reduced stiffness portion 152 and face contacting flange 160),
wherein the first boundary and the second boundary have an increased stiffness relative to the reduced stiffness portion (see paragraph [0109] which refers to the reduced stiffness region being between two regions of increased stiffness as shown in figs. 12A-12D), wherein the reduced stiffness portion comprises a front wall having a height defined by a distance between an apex of the seal, the apex being positioned in proximity to a nose of the user when in use, and an uppermost surface of the second boundary (see annotated fig. 12A below).
Bearne further discloses that the height allows the rolling of the region of reduced stiffness 172 (see lines 1-3 of [0109] and figs. 12A-12D), but does not expressly state that the height is at least 6 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne to be at least 6 mm, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of 6 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of 6 mm. See MPEP 2144.05(II). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the height of the front wall be at least 6 mm due to routine optimization to in determine the most effective seal dimensions for providing an effective, comfortable seal for the wearer.
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Regarding claim 47, the modified cushion module of Bearne reads on the limitations of claim 46 and further reads on the reduced stiffness portion (fig. 12A, 172) comprises a rolling portion (fig. 12A, small radius portion 152) configured to roll over an outer surface of the cushion module in response to a forward movement of the upper portion of the face contacting portion (see figs. 12A-12D regarding 152 rolling over when force is applied).
Regarding claims 52, the modified cushion module of Bearne reads on the limitations of claim 46 and further reads on an inner edge (fig. 12A, the thinnest portion of face contacting flange 160) which extends along at least an entirety of the upper portion of the seal (fig. 10, 160 extends around the entire opening). Bearne further depicts the face contacting flange getting thinner (see fig. 12A, 160), it does not expressly disclose that the inner edge is a thickness of equal to or less than 0.6 mm, wherein the continuous portion of the inner edge extends inwardly from the inner edge at least 1 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the inner edge of the device of Bearne to be a thickness of equal to or less than 0.6 mm, wherein the continuous portion of the inner edge extends inwardly from the inner edge at least 1 mm, for the purpose of providing a cushion that can seal against a patient’s face (Bearne [0110]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the inner edge being a thickness of equal to or less than 0.6 mm, wherein the continuous portion of the inner edge extends inwardly from the inner edge at least 1 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the inner edge has a thickness that is equal to or less than about 0.6 mm or equal to or less than about 0.4 mm in some configurations to improve sealing characteristics of the seal for at least some conditions or facial geometries, see paragraphs [0192] and [0209] in the specification. Further it appears the inner edge of the face contacting flange of Bearne would perform equally well with the recited thickness of equal to or less than 0.6 mm extending inwardly from the inner edge at least 1 mm. See MPEP 2144.05(II).
Regarding claim 53, the modified cushion module of Bearne reads on the limitations of claim 52, and further depicts the face contacting flange (fig. 12A, 160) as getting progressively thinner, but does not expressly state that a section of the continuous portion of the inner edge located within 0.5 mm of the inner edge is equal to or less than 0.4 mm in thickness.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the inner edge of the device of Bearne to be a thickness of equal to or less than 0.4 mm within 0.5 mm of the inner edge, for the purpose of providing a cushion that can seal against a patient’s face (Bearne [0110]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the inner edge being a thickness of equal to or less than 0.4 mm within 0.5 mm of the inner edge provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the inner edge has a thickness that is equal to or less than about 0.6 mm or equal to or less than about 0.4 mm in some configurations, the continuous thin internal edge section 1030 can vary in thickness, and the internal edge improves sealing characteristics of the seal for at least some conditions or facial geometries, see paragraphs [0192] and [0209] in the specification. Further it appears the inner edge of the face contacting flange of Bearne would perform equally well with the recited thickness of equal to or less than 0.4 mm within 0.5 mm of the inner edge. See MPEP 2144.05(II).
Regarding claim 54, the modified cushion module of Bearne reads on the limitations of claim 46 and further reads on the upper portion of the seal defining a nose bridge portion (see annotated fig. 10 below, upper portion 154) for contacting the nose bridge of the user ([0099] states that upper portion 154 extends over a nose bridge of the user) wherein the nose bridge portion defines a continuously curved portion of the inner edge (see annotated fig. 10 below).
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Regarding claims 55, the modified cushion module of Bearne reads on the limitations of claim 54, but does not expressly disclose that a width of the nose bridge portion is equal to or less than about 11 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the nose bridge portion of the device of Bearne to have a width of equal to or less than about 11 mm, for the purpose of providing a cushion that can extend over a nose bridge of a user (Bearne [0099]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the nose bridge portion having a width of equal to or less than about 11 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the nose bridge portion has a width of equal to or less than 12, 11.5, or 11 mm for a desirable level of sealing for a variety of nasal sizes, see paragraphs [0187] in the specification. Further it appears the nose bridge portion of Bearne would perform equally well with the recited width of 11 mm. See MPEP 2144.05(II).
Regarding claim 56, the modified cushion module of Bearne reads on the limitations of claim 54, but does not expressly state that a vertical dimension of a vertical center of the nose bridge portion is equal to or greater than about 15 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the nose bridge portion of the device of Bearne to have a vertical center of equal to or greater than about 15 mm, for the purpose of providing a cushion that can extend over a nose bridge of a user (Bearne [0099]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the nose bridge portion having a vertical center of equal to or greater than about 15 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the nose bridge portion has a vertical center is equal to or greater than about 15 mm, see paragraphs [0025] in the specification. Further it appears the nose bridge portion of Bearne would perform equally well with the recited vertical center of 15 mm. See MPEP 2144.05(II).
Regarding claim 57, the modified cushion module of Bearne reads on the limitations of claim 56, but does not expressly state that a depth between a rearmost point of the nose bridge portion and a lower edge of the nose bridge portion on the vertical center of the seal is at least about 4 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the nose bridge portion of the device of Bearne to have a depth of at least about 4 mm, for the purpose of providing a cushion that can extend over a nose bridge of a user (Bearne [0099]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the nose bridge portion having a depth of at least about 4 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the nose bridge portion has a depth of equal to or greater than about 3.5, 3.75, 4, or 4.25 mm to contact the bridge of the user’s nose to improve the seal for at least some nasal geometries, see paragraphs [0190] in the specification. Further it appears the nose bridge portion of Bearne would perform equally well with the recited depth of 4 mm. See MPEP 2144.05(II).
Regarding claims 58, the modified cushion module of Bearne reads on the limitations of claim 46, but does not expressly state that the reduced stiffness portion comprises a front wall having a height of at least about 7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne to be at least about 7 mm, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of at least about 7 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the front wall having a height of at least about 7 mm, see the paragraph [0027] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of 6 mm. See MPEP 2144.05(II).
Regarding claims 59, the modified cushion module of Bearne reads on the limitations of claim 46, but does not expressly state that the height of the front wall is between about 7.3 mm and about 7.7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne to be between about 7.3-7.7 mm, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of between about 7.3-7.7 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating the height of the front wall if about 7.3, 7.6, or 7.7, see the paragraph [0228] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of 6 mm. See MPEP 2144.05(II).
Regarding claims 61, the modified cushion module of Bearne reads on the limitations of claim 46 and further reads on that the distance between the top and bottom of the seal can vary in height as pressure is applied to seal (see figs, 12A-12D), but does not expressly state that a distance between a point on a centerline of the upper portion and a point on the centerline of the lower portion of the face contacting surface of the seal varies by more than 2 mm between a neutral position and a depressed position of the reduced stiffness portion.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the distance of the seal between a neutral and depressed position, for the purpose of maintaining or reducing hoop stress during seating of the mask (see Bearne [0115]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the distance between an upper point of the seal varies by more than 2 mm in a neutral position versus a depressed position, is used for a particular purpose, or solves a stated problem beyond stating that the variation in the dimension 1204 can allow a particular size or embodiment of the seal to fit a wider range of users, see the paragraphs [0233]-[0234] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited distance variance of more than 2 mm. See MPEP 2144.05(II).
Regarding claim 62, the modified cushion module of Bearne reads on the limitations of claim 61 and further reads on the distance between the point on a centerline of the upper portion and the point on the centerline of the lower portion of the face contacting surface of the seal varies by at least about 5 mm, at least about 6 mm, at least about 8 mm or at least about 10 mm or at least about 12 mm between the neutral position and the depressed position of the reduced stiffness portion (see the rationale presented in the rejection to claim 61 above).
Regarding claim 63, the modified cushion module of Bearne reads on the limitations of claim 61 and further reads on wherein the distance varies between about 90 mm to about 84 mm between the neutral position and the depressed position of the reduced stiffness portion (see the rationale presented in the rejection to claim 61 above, where the variance in this case is about 6 mm between a neutral and depressed position).
Regarding claim 64, the modified cushion module of Bearne reads on the limitations of claim 61 and further reads on wherein the distance varies by at least about 5 percent between the neutral position and the depressed position of the reduced stiffness portion (see the rationale presented in the rejection to claim 61 above).
Regarding claim 65, the modified cushion module of Bearne reads on the limitations of claim 61 and further reads on wherein the distance varies by at least about 6 and 2/3 percent between the neutral position and the depressed position of the reduced stiffness portion (see the rationale presented in the rejection to claim 61 above).
Regarding claim 71, the modified cushion module of Bearne reads on the limitations of claim 46, but does not expressly state the height is less than or equal to 7.7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of less than or equal to 7.7 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of less than or equal to 7.7 mm. See MPEP 2144.05(II).
Regarding claim 72, the modified cushion module of Bearne reads on the limitations of claim 46, but does not expressly state the height is at least about 7.0 mm and up to about 7.7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of between about 7.0 to 7.7 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of between about 7.0 to 7.7 mm. See MPEP 2144.05(II).
Regarding claim 73, the modified cushion module of Bearne reads on the limitations of claim 46, and further reads on an angle between the first boundary and the second boundary (see annotated fig. 11 below), but does not expressly state that this angle is at least 20 degrees.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the angle between the first and second boundaries of the device of Bearne, for the purpose of contributing to the ability of the seal to roll over a portion of the seal to roll over (see Bearne fig. 11 and [0110]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that an angle between the first and second boundaries of 20 degrees provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that in some configurations an angle between the boundaries is 20, 30, or 27 degrees among other configurations, see the paragraph [0226] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited angle between boundaries of 20 degrees. See MPEP 2144.05(II).
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Regarding claim 74, the modified cushion module of Bearne reads on the limitations of claim 71, and further reads on an angle between the first boundary and the second boundary (see annotated fig. 11 above), but does not expressly state that this angle is at least 20 degrees.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the angle between the first and second boundaries of the device of Bearne, for the purpose of contributing to the ability of the seal to roll over a portion of the seal to roll over (see Bearne fig. 11 and [0110]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that an angle between the first and second boundaries of 20 degrees provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that in some configurations an angle between the boundaries is 20, 30, or 27 degrees among other configurations, see the paragraph [0226] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited angle between boundaries of 20 degrees. See MPEP 2144.05(II).
Regarding claim 75, A cushion module for a respiratory interface, comprising:
a seal member (fig. 3, mask seal 110) having an upper portion and a lower portion (fig. 3, upper portion 154 and lower portion 156), the seal member further comprising a face contacting surface configured to contact a face of a user (fig. 10, face contacting flange 160) and create at least a substantial seal with the face of the user ([0100] states mask seal 110 will seal against the face of the user with air supply), the face contacting surface having an inner edge defining an opening in the face contacting surface (fig. 10, tear-drop shaped opening 162),
wherein the upper portion of the seal comprises a reduced stiffness portion (figs. 12A-12D, reduced stiffness region 172) defined between a first boundary (see annotated fig. 12A below where a first boundary is defined at the increased thickness portion under band 174) and a second boundary (see annotated fig. 12A below where a where boundary is defined at lip 124) such that the reduced stiffness portion deforms in response to forward movement of an upper portion of the face contacting surface (see figs. 12A-12D), wherein the first boundary is positioned between the face contacting surface and the reduced stiffness portion (see annotated fig. 12A below where the first boundary is between the reduced stiffness portion 152 and face contacting flange 160), and
wherein the first boundary and the second boundary have an increased stiffness relative to the reduced stiffness portion (see paragraph “[θθθδ]” which refers to the reduced stiffness region being between two regions of increased stiffness as shown in figs. 12A-12D), wherein the reduced stiffness portion comprises a front wall having a height defined by a distance between an apex of the seal, the apex being positioned in proximity to a nose of the user when in use, and an uppermost surface of the second boundary (see annotated fig. 12A below).
Bearne further discloses that the height allows the rolling of the region of reduced stiffness 172 (see lines 1-3 of [0109] and figs. 12A-12D), but does not expressly state that the height is at least 6 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne to be at least 6 mm, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of 6 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of 6 mm. See MPEP 2144.05(II).
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Regarding claim 76, the modified cushion module of Bearne reads on the limitations of claim 75 and further reads on the reduced stiffness portion (fig. 12A, 172) comprises a rolling portion (fig. 12A, small radius portion 152) configured to roll over an outer surface of the cushion module in response to a forward movement of the upper portion of the face contacting portion (see figs. 12A-12D regarding 152 rolling over when force is applied).
Regarding claim 77, the modified cushion module of Bearne reads on the limitations of claim 75 and further reads on a seal housing attached to the seal member (fig. 11, mask seal clip 112).
Regarding claim 78, the modified cushion module of Bearne reads on the limitations of claim 75, but does not expressly state the height is at least about 7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of at least about 7 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of at least about 7 mm. See MPEP 2144.05(II).
Regarding claim 79, the modified cushion module of Bearne reads on the limitations of claim 78, but does not expressly state the height of the front wall is between about 7.3 mm and about 7.7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of between about 7.3 to 7.7 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of between about 7.3 to 7.7 mm. See MPEP 2144.05(II).
Regarding claim 80, the modified cushion module of Bearne reads on the limitations of claim 75, but does not expressly state the height is less than or equal to 7.7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of less than or equal to 7.7 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of less than or equal to 7.7 mm. See MPEP 2144.05(II).
Regarding claim 81, the modified cushion module of Bearne reads on the limitations of claim 75, but does not expressly state the height is at least about 7.0 mm and up to about 7.7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of between about 7.0 to 7.7 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of between about 7.0 to 7.7 mm. See MPEP 2144.05(II).
Regarding claim 82, the modified cushion module of Bearne reads on the limitations of claim 75 and further reads on an angle between the first boundary and the second boundary (see annotated fig. 11 above), but does not expressly state that this angle is at least 20 degrees.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the angle between the first and second boundaries of the device of Bearne, for the purpose of contributing to the ability of the seal to roll over a portion of the seal to roll over (see Bearne fig. 11 and [0110]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that an angle between the first and second boundaries of 20 degrees provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that in some configurations an angle between the boundaries is 20, 30, or 27 degrees among other configurations, see the paragraph [0226] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited angle between boundaries of 20 degrees. See MPEP 2144.05(II).
9. Claim(s) 48 is rejected under 35 U.S.C. 103 as being unpatentable over Bearne in view of Sleeper et al. (US 2008/0053446) and Prentice et al. (US 2014/0174446).
Regarding claim 48, Bearne discloses a cushion module for a respiratory interface (fig. 2, mask assembly 102), comprising:
a seal housing (fig. 11, mask seal clip 112) constructed from a material more rigid than a supported seal (see paragraph [0090] which states 112 is relatively more rigid than mask seal 110), the seal housing defining an aperture (fig. 10, central passage 144) configured to allow a breathing gas to enter an interior of the cushion module (see paragraph [0127] which states a wall of the opening receives an elbow which functions as an air conduit according to [0030]); and
the seal (fig. 3, mask seal 110) supported by the seal housing ([0090] states mask seal clip 112 provides support to mask seal 110) and having an upper portion and a lower portion (fig. 3, upper portion 154 and lower portion 156), the seal further comprising a face contacting surface configured to contact a face of a user (fig. 10, face contacting flange 160) and create at least a substantial seal with the face of the user ([0100] states mask seal 110 will seal against the face of the user with air supply), the face contacting surface having an inner edge defining an opening in the face contacting surface (fig. 10, tear-drop shaped opening 162),
wherein the upper portion of the seal comprises a reduced stiffness portion (figs. 12A-12D, small radius portion 152 which is inherently less stiff due to it being thinner) defined between a first boundary (see annotated fig. 12A below where a first boundary is defined at the increased thickness portion under band 174) and a second boundary (see annotated fig. 12A below where a where boundary is defined at lip 124) such that the reduced stiffness portion deforms in response to forward movement of an upper portion of the face contacting surface (see figs. 12A-12D), wherein the first boundary is positioned between the face contacting surface and the reduced stiffness portion (see annotated fig. 12A below where the first boundary is between the reduced stiffness portion 152 and face contacting flange 160),
wherein the first boundary and the second boundary have an increased stiffness relative to the reduced stiffness portion (see paragraph [0109] which refers to the reduced stiffness region being between two regions of increased stiffness as shown in figs. 12A-12D), wherein the reduced stiffness portion comprises a front wall having a height defined by a distance between an apex of the seal, the apex being positioned in proximity to a nose of the user when in use, and an uppermost surface of the second boundary (see annotated fig. 12A below).
Bearne further discloses that the height allows the rolling of the region of reduced stiffness 172 (see lines 1-3 of [0109] and figs. 12A-12D), but does not expressly state that the height is at least 6 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne to be 6 mm, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of 6 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of 6 mm. See MPEP 2144.05(II). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the height of the front wall be at least 6 mm due to routine optimization to in determine the most effective seal dimensions for providing an effective, comfortable seal for the wearer.
The modified cushion module of Bearne does not expressly read on a portion of the seal defining the face contacting surface comprises a pair of nose pads positioned on each side of the opening in the upper portion of the seal, wherein an entirety of each of the nose pads is spaced laterally outward from the inner edge of the opening.
However, Prentice teaches of an interface assembly that includes thickening panels (fig. 4, 130) that rest against the nose of the user thereby functioning as nose pads ([0071]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified cushion module of Bearne with the thickening panels of Prentice to allow the seal to better contour to the shape of the nose of the user (Prentice [0071]).
Regarding an entirety of the nose pads is spaced laterally outward from the inner edge of the opening, Sleeper teaches of a flexible cushion (fig. 3, 302) which has a generally triangularly-shaped outer-periphery (fig. 3, 306).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified cushion module of Bearne with the cushion shape as taught by Sleeper in order to fit contours of a patient’s face (Sleeper [0039]) thereby enhancing the seal between the cushion and the patient’s face (see annotated Sleeper fig. 3 below for relative positions of the added nose pads and inner opening edge).
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10. Claim(s) 49 is rejected under 35 U.S.C. 103 as being unpatentable over Bearne in view of Prentice.
Regarding claim 49, Bearne discloses a cushion module for a respiratory interface (fig. 2, mask assembly 102), comprising:
a seal housing (fig. 11, mask seal clip 112) constructed from a material more rigid than a supported seal (see paragraph [0090] which states 112 is relatively more rigid than mask seal 110), the seal housing defining an aperture (fig. 10, central passage 144) configured to allow a breathing gas to enter an interior of the cushion module (see paragraph [0127] which states a wall of the opening receives an elbow which functions as an air conduit according to [0030]); and
the seal (fig. 3, mask seal 110) supported by the seal housing ([0090] states mask seal clip 112 provides support to mask seal 110) and having an upper portion and a lower portion (fig. 3, upper portion 154 and lower portion 156), the seal further comprising a face contacting surface configured to contact a face of a user (fig. 10, face contacting flange 160) and create at least a substantial seal with the face of the user ([0100] states mask seal 110 will seal against the face of the user with air supply), the face contacting surface having an inner edge defining an opening in the face contacting surface (fig. 10, tear-drop shaped opening 162),
wherein the upper portion of the seal comprises a reduced stiffness portion (figs. 12A-12D, small radius portion 152 which is inherently less stiff due to it being thinner) defined between a first boundary (see annotated fig. 12A below where a first boundary is defined at the increased thickness portion under band 174) and a second boundary (see annotated fig. 12A below where a where boundary is defined at lip 124) such that the reduced stiffness portion deforms in response to forward movement of an upper portion of the face contacting surface (see figs. 12A-12D), wherein the first boundary is positioned between the face contacting surface and the reduced stiffness portion (see annotated fig. 12A below where the first boundary is between the reduced stiffness portion 152 and face contacting flange 160),
wherein the first boundary and the second boundary have an increased stiffness relative to the reduced stiffness portion (see paragraph “[θθθδ]” which refers to the reduced stiffness region being between two regions of increased stiffness as shown in figs. 12A-12D), wherein the reduced stiffness portion comprises a front wall having a height defined by a distance between an apex of the seal, the apex being positioned in proximity to a nose of the user when in use, and an uppermost surface of the second boundary (see annotated fig. 12A below).
Bearne further discloses that the height allows the rolling of the region of reduced stiffness 172 (see lines 1-3 of [0109] and figs. 12A-12D), but does not expressly state that the height is at least 6 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height defined by a distance between an apex of the seal and an uppermost surface of the second boundary of the device of Bearne to be 6 mm, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height of 6 mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “the reduced stiffness region 172 and/or upper portion 1002 of the seal 180 can comprise features that facilitate desirable rolling of the upper portion 1002 of the seal 180”, see the paragraph [0229] in the specification. Further it appears the cushion module of Bearne would perform equally well with the recited height of 6 mm. See MPEP 2144.05(II).
The modified cushion module of Bearne does not expressly read on a portion of the seal defining the face contacting surface comprises a pair of nose pads positioned on each side of the opening in the upper portion of the seal, wherein an entirety of each of the nose pads is spaced outward from the opening, wherein the nose pards are the thickest portions of the portion of the seal defining the face contacting surface.
However, Prentice teaches of an interface assembly that includes thickening panels (fig. 4, 130) that rest against the nose of the user thereby functioning as nose pads ([0071]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified cushion module of Bearne with the thickening panels of Prentice to allow the seal to better contour to the shape of the nose of the user (Prentice [0071]).
The modified cushion module of Bearne reads on a portion of the seal defining the face contacting surface comprises a pair of nose pads (Prentice fig. 4, thickening panels 130) positioned on each side of the opening in the upper portion of the seal (Prentice fig. 4, shows panels 130 on each side of an upper portion of the seal), wherein an entirety of each of the nose pads is spaced outward from the opening (see annotated Bearne fig. 11 below), wherein the nose pards are the thickest portions of the portion of the seal defining the face contacting surface (Prentice [0071] states that thickening panels 130 are locally thick to enhance sealing capability of the seal).
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11. Claim(s) 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Bearne in view of Prentice as applied to claim 49 above, and further in view of Davidson (US 2008/0110464).
Regarding claim 50, the modified cushion module of Bearne reads on the limitations of claim 49 and contemplates the use of reinforcing structures (paragraph “[Θ1Θ4]“ states that a region of significantly increased thickness can be used to enhance the structure of the upper portion), but is silent on a pair of thickened outer peripheral portions of the seal positioned below the nose pads.
However, Davidson teaches of a cushion which varies in thickness in different regions of the cushion (fig. 15, shows the cushion divided into sections that can be modified and [0075] states the thickness of the cushion varies in different sections) which allows for improved comfort and seal effectiveness regardless of face shape ([0007]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the thickness of the cushion device of Bearne to vary with different regions as taught by Davidson to increase the thickness above and below the nose pads to allow for a comfortable fit and help support the upper portion of the cushion module during flexion.
Regarding claim 51, the modified cushion device of Bearne reads on the limitations of claim 50 and further reads on wherein at least a portion of the thickened outer peripheral portions are positioned above the nose pads (Davidson fig. 15, shows the cushion divided into sections that can be modified and [0075] states the thickness of the cushion varies in different sections).
12. Claim(s) 60 is rejected under 35 U.S.C. 103 as being unpatentable over Bearne in view of Takashita et al. (US 2009/0014008).
Regarding claim 60, the modified cushion module of Bearne reads on the limitations of claim 58. Bearne further discloses an increase in thickness at the end of the top wall (see annotated fig. 12A above).
Bearne is silent on the thickness of the front and top wall progressively increasing from the bottom of the front wall to the back of the top wall.
However, Takashita teaches of a nasal respiratory mask with an elastic portion (fig. 4, 2a) of which the portion closer to the face can be made thicker for improved deformation resistance (see [0085] which states the facial side half is made thicker regarding deformation resistance).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the thickness of the deforming portion of the cushion module of Bearne with the progressively increasing thickness as taught by Takashita for the purpose of increasing deformation resistance which may be beneficial to improve comfort of the device by providing slightly more resistance to deformation.
13. Claim(s) 66-70 are rejected under 35 U.S.C. 103 as being unpatentable over Bearne in as applied to claim 46 above, and further in view of Davidson.
Regarding claim 66, the modified cushion module of Bearne reads on the limitations of claim 46, but does not expressly disclose a set of cushion modules in at least two different sizes wherein the height of the front wall is different between the sizes.
However, Davidson teaches of a cushion which comes in an extra small, small, medium, and large size (see figs. 16-21) for the purpose of accommodating different facial sizes ([0069]) while being comfortable and maintaining a seal ([0007]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the cushion module of Bearne with varying sizes as taught be Davidson to allow use by people with varying face shapes.
The modified set of cushions of Bearne reads on a set of cushion modules in at least two different sizes (Davidson figs. 16-21), but does not expressly disclose the height of the front wall is different between the sizes.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height of the front wall of the device of Bearne to be vary between sizes, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height variance between sizes provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “in some configurations, the height 1100A is smaller than 1100B and the height 1100C is greater than 1100B”, see paragraphs [0176] and [0228] in the specification. Further it appears the cushion modules of Bearne would perform equally well with the recited relative height differences. See MPEP 2144.05(II).
Regarding claim 67, the modified set of cushions of Bearne reads on the limitations of claim 66 and further reads on a small, medium, and large size (Davidson figs. 16-21) wherein the height of the front wall of the small size is less than the height of the front wall of one or both of the medium and large sizes (see rationale presented in the rejection to claim 66 above).
Regarding claim 68, the modified set of cushions of Bearne reads on the limitations of claim 67 and further reads on wherein the height of the front wall of the large size is greater than the height of the front wall of one or both of the small and medium sizes (see the rationale presented in the rejection to claim 66 above).
Regarding claim 69, the modified set of cushions of Bearne reads on the limitations of claim 67 and further reads on wherein the height of the front wall of the large size is greater than the height of the front wall of the medium size and the height of the front wall of the medium size is greater than the height of the front wall of the small size (see the rationale presented in the rejection to claim 66 above).
Regarding claim 70, the modified set of cushions of Bearne reads on the limitations of claim 67, but does not expressly disclose that the height of the front wall of the small size is about 7.3 mm, the height of the front wall of the medium size is about 7.6 mm and the height of the front wall of the large size is about 7.7 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the height of the front wall of the device of Bearne to be vary between sizes, for the purpose of providing a portion of the seal to roll over (see Bearne lines 1-3 of [0109], Bearne figs. 12A-12D, and the application specification paragraphs [0228]-[00229]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the height variance between sizes provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that “In some configurations, the height 1100A is about 7.3 mm. In some configurations, the height 1100B is about 7.6 mm. In some configurations, the height 1100C is about 7.7 mm”, see paragraph [0228] in the specification. Further it appears the cushion modules of Bearne would perform equally well with the recited front wall heights. See MPEP 2144.05(II).
Response to Arguments
14. Applicant’s arguments, see the affidavit, filed 03/13/2026, with respect to the rejection(s) of claim(s) 46-70 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bearne as a routine optimization of the apex height.
Regarding avoiding impairment of vision, see paragraphs 24-29 of the affidavit, it is argued that one of ordinary skill would avoid modifying mask shapes in a way that would increase intrusion into the visual field. However, before the effective filing date of the claimed invention, the mask of Bearne already intrudes on the visual field of the patient and contemplates using visual indicators/cues on the rollover portion (see Bearne [0116]-[0117]), therefore one of ordinary skill at the time may still contemplate optimizing the height of the front wall.
Regarding Bearne not disclosing a front wall height of at least 6 mm, see paragraphs 46-48, the examiner has issued a new grounds of rejection to clarify that it is recognized that Bearne does not expressly state the front wall is 6 mm.
Regarding modifying Bearne as an obvious design choice in response to a problem discovered by the inventors, see paragraphs 49-60 of the affidavit, a new grounds of rejection is issued as the mask structures and purpose of Bearne and the claimed invention are very similar, discovering the optimum or workable ranges would be obvious to one of ordinary skill in the art.
15. Applicant's arguments filed 03/13/2026, regarding Bearne expressly suggesting minimizing the Apex height, have been fully considered but they are not persuasive.
Applicant argues, see paragraphs 3-4 of page 14, that Bearne suggests that the Apex Height should be minimized in reference to the affidavit and Bearne paragraph [0114]. Applicant defines Apex Height as the height of a front wall of the reduced stiffness portion (see page 10 paragraph 2). Regarding the affidavit, Applicant argues one would avoid increasing the overall height of a mask, however, increasing the Apex height may not increase the overall height as the uppermost portion of the mask is not the front wall (see Bearne fig. 4, bend 152 represents the front wall, see also the response to the affidavit above), further, it is not clear if increasing the Apex Height from 4.4 mm to 6 mm would impact the overall height of the mask. Regarding Bearne paragraph [0114], Bearne suggests that it is possible for radii R1 and R3 to be substantially the same (Bearne fig. 4), however, Bearne additionally states that R1 is preferably smaller than R3 to facilitate side profile radius 136 to slightly increase (see Bearne [0114] and fig. 7, 136). Therefore, it is unclear how Bearne [0114] teaches away from adjusting the Apex Height of the mask, it appears to be that Bearne is suggesting to keep an offset to facilitate rolling of the mask while maintaining side profile radius 136 (Bearne [0114] and fig. 7, 136).
16. Applicant’s arguments, see Remarks, filed 03/13/2026, with respect to the rejection(s) of claim(s) 46-70 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bearne as a routine optimization of the Apex Height.
Applicant argues, see paragraph 5 of page 16, that the drawings of Bearne are not to scale and do not suggest a front wall height of 6 mm. A new grounds of rejection has been issued to state that Bearne does not expressly state the apex height is 6 mm, see new rejections to claims 46-70 above.
Applicant argues, see paragraph 3 of page 17, that Bearne does not inherently disclose an apex height of 6 mm or greater. A new grounds of rejection has been that states Bearne does not expressly state that the apex height is 6 mm see new rejections to claims 46-70 above.
Applicant argues, see paragraph 3 of page 18, that it is not well known to scale every part of a mask seal for different sizes. A new grounds of rejection has been issued that states the adjustment of the Apex Height is instead a routine optimization, see rejections to claims 46-70 above.
Applicant argues, see paragraph 3 of page 19, that the existing Simplus ® masks all have Apex Heights of 4.4 which contradicts that all mask parts are scaled. A new grounds of rejection has been issued that states the adjustment of the Apex Height is instead a routine optimization, see rejections to claims 46-70 above.
Applicant argues, see paragraphs 5—6, that a 6 mm Apex Height is not an obvious design choice. A new grounds of rejection has been issued that states the adjustment of the Apex Height is instead a routine optimization, see rejections to claims 46-70 above.
Applicant argues, see paragraph 2 of page 20, that increasing the vertical spacing of the apex of the seal and the uppermost surface of the seal housing provides different results. A new grounds of rejection has been issued that states the adjustment of the Apex Height is instead a routine optimization due to the functions of the prior art and the claimed invention being the same, see rejections to claims 46-70 above.
Applicant argues, see paragraphs 4-5 of page 20 and paragraph 1 of page 21, that the Applicant has identified a bottoming-out problem, defined by Spear Decl. paragraph 59 as when rolling action is complete and can no longer adjust due to nose bridge variations, and the claimed Apex Height of 6 mm solves this problem. A new grounds of rejection has been issued that states the adjustment of the Apex Height is instead a routine optimization of the Apex Height which would similarly solve the problem, see rejections to claims 46-70 above.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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